History, Present and Prospect of World Traditional Medicine (in 2 Volumes) 9811287104, 9789811287107

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For photocopying of material in this volume, please pay a copying fee through the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA. In this case permission to photocopy is not required from the publisher. ISBN 978-981-12-8710-7 (set_hardcover) ISBN 978-981-12-8217-1 (set_ebook for institutions) ISBN 978-981-12-8218-8 (set_ebook for individuals) ISBN 978-981-12-8695-7 (vol. 1_hardcover) ISBN 978-981-12-8696-4 (vol. 2_hardcover) For any available supplementary material, please visit https://www.worldscientific.com/worldscibooks/10.1142/13565#t=suppl Desk Editor: Vanessa Quek ZhiQin Typeset by Stallion Press Email: [email protected] Printed in Singapore

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Informative Abstract

Traditional medicine plays a significant role in health maintenance as well as disease diagnosis and treatment. Available in almost every country in the world and in a growing demand for its services, traditional medicine contributes to the goal of ensuring universal access to health care through its accessibility, safety, and effectiveness. This book reviews and summarizes the history, present, and prospect of mainstream traditional medicine around the world. It aims to promote the integration of traditional medicine and conventional medicine, to contribute to Universal Health Coverage as a reference for policy makers, academies, and stakeholders. This book consists of nine chapters, involving Ayurveda, chiropractic, European Traditional Herbal Medicine, Greco-Arab and Islamic Herbal Medicine, Homeopathy, Japanese Kampo, Korean Medicine, Traditional Chinese Medicine, and Thai Medicine.

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List of Editors

Chief Editor Shen Yuandong Associate Editors Sang Zhen Xu Xiaoting Editorial Board Anupama Kizhakkeveettil Robb Russell Hans Rausch Bashar Saad To Ka Lun (Aaron) Toshihiro Togo Byungmook Lim Yan Shiyun Anchalee Chuthaputti Editorial Assistant Huang Yiran

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Preface

Traditional medicine has become an important part of the world healthcare system. It has made outstanding contributions to human health and disease prevention and treatment. According to WHO Global Report on Traditional and Complementary Medicine 2019, more countries are recognizing the role of Traditional and Complementary Medicine (T&CM) in their national health systems. For instance, by 2018, 98 Member States had developed national policies on T&CM, 109 had launched national laws or regulations on T&CM, and 124 had implemented regulations on herbal medicines. Available in almost every country in the world and in a growing demand for its services, traditional medicine contributes to the goal of ensuring universal access to healthcare through its accessibility, safety, and effectiveness. The inclusion of traditional medicine into the International Classification of Diseases (WHO ICD11-ICTM) symbolizes the WHO recognition of its value and widespread use. It is also a milestone for traditional medicine to be incorporated into the WHO International Health Care System. As the President of Shanghai University of Traditional Chinese Medicine, I am delighted to know that more than 39 countries around the world offer higher education programs in T&CM (including bachelor, master, and doctoral degrees at university level). In recent years,

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an increasing number of countries have facilitated training programs in traditional medicine, and some have included traditional medicine into academic curriculum for health profession students. As a WHO Collaborating Center for Traditional Medicine since 1983, our University has been cooperating with WHO headquarters and the West Pacific Region for a long period of time. We have provided technical support and advisory services on Traditional Chinese Medicine (TCM) terminology standards, guidelines, medical service standards, safety of Chinese Medicine, and training programs in traditional medicine for WHO member states. Every year, more than 3,000 international students come to our University to study Traditional Chinese Medicine. We have established an international exchange network system covering more than 50 partners in over 20 countries and territories. In 2009, International Organization for Standardization established a technical committee for Traditional Chinese Medicine (ISO/ TC 249), whose Secretariat was based in our University. Since then, this platform has been playing an important role in improving the quality and safety of TCM and other traditional medicine. To better strengthen international exchange and cooperation in the field of traditional medicine and maximize its role in global health governance and benefit public health and well-being, we hosted the Shanghai Forum for World Traditional Medicine in 2017 and 2019. The forum has facilitated international academic exchanges in the field of traditional medicine. For the purpose of promoting academic ideas among traditional medicine experts, the Organizing Committee of the Forum invited guest speakers of the forum to compile a book named “History, Present and Prospect of World Traditional Medicine.” The book consists of nine chapters, involving Ayurveda, chiropractic, European Traditional Herbal Medicine, GrecoArab and Islamic Herbal Medicine, Homeopathy, Japanese Kampo, Korean Medicine, Traditional Chinese Medicine, and Thai Medicine. It is with great pleasure to witness the publication of History, Present and Prospect of World Traditional Medicine. I sincerely hope that the

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Shanghai Forum for World Traditional Medicine will become an important academic platform for international cooperation and contribute more to the further development of traditional medicine.

Prof. Xu Jianguang, M.D., Ph.D. President, Shanghai University of Traditional Chinese Medicine May, 2022

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Preface

I am not a traditional medicine practitioner. My interest in Traditional Medicine arose from working as a regulator for ensuring the quality, safety, and efficacy of marketed therapeutic products (medicines and medical devices), being involved in the development of international standards for traditional therapeutic products derived from ancient Chinese medicine and ensuring the educational standards and professional services of Chinese Medicine practitioners. All forms of medical services have been derived from medical products and techniques which evolved through observation and experience, in some cases, over thousands of years. These original products and techniques provided accessible and affordable healthcare to their communities, were aligned with, as well as influencing, the culture and values of those communities and provided a holistic approach to the well-being of individuals. Many of those practices have carried on to the present day and are classified as Traditional Medicine. More recently, scientific approaches to investigation, extraction, and the gathering of evidence are now able to increasingly explain the biological effects and demonstrate the efficacy of treatments. Traditional Medicine is also evolving and has incorporated some of these advances such as the use of electrical medical devices. The availability of newer scientific methods for assessing efficacy has often caused tension between Traditional Medicine and what is generally

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referred to as Western Medicine. From the point of view of public safety there is a legitimate expectation that these scientific methods should be used, as far as possible, to validate the efficacy of traditional treatments. This is occurring and is now a very active area of research. At the same time, it is very important not to lose other benefits provided by Traditional Medicine: remaining true to the underlying paradigm, the holistic approach to wellbeing, the level of involvement of patients in their own treatment, affordability, and ease of access to health care. In many countries, the educational and practice standards of Traditional Medicine practitioners have also become much more sophisticated. Many national governments and regulators have been in a quandary about how to recognize and then regulate the services and practitioners of Traditional Medicine, for example some classifying traditional medicines as foods. However, with consumers universally being active users of traditional products and techniques, health regulators are increasingly recognizing these important components of health care and the practitioners who deliver them. This book is a very important collection of descriptions of several Traditional Medicine systems that have evolved to meet the needs of their own communities and, in many cases, now provide health services much more widely. It includes the philosophy of these systems, the increasing standards of education and practice of practitioners and the advances in ensuring the quality, safety, and efficacy of treatments. Traditional Medicine continues to be a very important component of healthcare, both in developing and developed countries.

Dr. David Graham Past National Manager of the Therapeutic Goods Administration, Australia Past chair, ISO TC 249 Traditional Chinese Medicine Past vice chair, Chinese Medicine Board of Australia May, 2022

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Foreword

Traditional Medicine (TM) is the collection of skills and practices based on people’s life experiences or observations. With strong historical and cultural roots, it has long been used in health maintenance and in disease prevention and treatment. Thanks to the progress in modern science and civilization, TM has undergone and is still undergoing an evolutionary process to “keep what’s good and remove what’s bad.” TM has a long history. It is defined by the World Health Organization (WHO) as “the sum total of the knowledge, skill, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.” In some countries or territories, TM or non-conventional medicine may be termed alternative or complementary medicine. The social development and changes in the spectrum of human diseases have resulted in the medicine’s paradigm shift from the biomedical to the biopsychosocial model. At the same time, population aging, advances in rehabilitation medicine, and emerging contagious diseases brought new challenges and opportunities for TM. TM is found in almost every country in the world and the demand for its service is increasing. It has been used for thousands of years and has made great contributions to human health. According to the newly released WHO Global Report on Traditional and Complementary Medicine 2019, as of 2018, 170 WHO Member xv

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States (88%) acknowledged their use of Traditional and Complementary Medicine (T&CM), 107 had a national office for T&CM, 98 had developed national policies on T&CM, 75 reported the presence of a national research institute for T&CM, and 109 reported the presence of a legal or regulatory framework for T&CM. In addition, 124 Member States had implemented regulations on herbal medicines, 45 reported the coverage of T&CM by health insurance [public and (or) private], and 34 included traditional or herbal medicines in their national essential medicines lists (NEMLs). TM, with its availability and accessibility, is playing a key role in implementing the idea of people-centered health service and ensuring that all people have access to care. Thanks to the national policy of placing equal emphasis on Traditional Chinese Medicine (TCM) and Western Medicine in China, TCM is a key component in national healthcare system. It makes up 16.4% of the National Health Service and 23% of medical visits in grass-root medical institutions. The total output value of TCM pharmaceutical industry was approximately RMB 800 billion and the total value of international trade value reached $80 billion. Over 100 million Europeans are current users of T&CM, most (86%) Koreans have used traditional Korean Medicine at some point in their lives, and 76% of Singaporeans are regular users of TM. In the United States, more than 65% of the population use alternative and complementary medicine. In India, there are over 500,000 registered T&CM practitioners. In Western countries, there has been an increasing demand for health service of TM, along with the rapid increase in chronic disease, intractable conditions, and rehabilitation medicine. In some developing countries, TM plays a major role in primary healthcare service and TM practitioners remain the sole or main health providers for people living in rural areas. Globally, TM is playing a significant role in health maintenance as well as disease diagnosis and treatment. However, the current status of TM varies greatly from country to country due to the imbalance of economic-social development and differences in health system and policies. TM, as pointed out in the WHO Traditional Medicine Strategy 2014– 2023, “is an important and often underestimated part of health services.” Despite the fact that more and more countries have launched laws or regulations on TM, not so many countries reported the integration of TM

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within national health care system. There is still a gap between TM practitioners, skills and products and medical doctors, technologies, and pharmaceutical drugs. In addition, there are many challenges for TM in healthcare delivery, education, research, and pharmaceutical industry to meet the demand for health maintenance as well as disease prevention and treatment. In 2009, a new technical committee entitled “Traditional Chinese Medicine” (TCM) and coded “249” was established in the ISO family. It focuses on the TCM safety and quality. I was honored to serve as the secretary general and worked with the chairman Dr. David Graham (the former chairman of TGA, Australia) for nine years. I’ve served as the chairman of ISO/TC 249 since 2019. The ISO/TC 249 offers a work platform for top experts in the field of TM. We are making every effort to develop TM and improve the TCM safety and quality. We have organized two forums on world TM in Shanghai, once in 2017 and once in 2019. Inspired by the information exchanged among experts during the forum on the past, present, and future challenges of TM, I came up with the idea of compiling a book entitled History, Present and Prospect of World Traditional Medicine which received very positive feedback from TM scholars. After over two years of hard work from senior experts in different countries, we are now ready to publish this book, which involves Ayurveda, chiropractic, European Traditional Herbal Medicine, Ancient Greco-Arab and Islamic Herbal Medicine, Homeopathy, Japanese Kampo Medicine, Traditional Korean Medicine, Traditional Chinese Medicine, and Traditional Thai Medicine. We hope this book can serve as a useful reference for TM regulators and practitioners and thus contribute to human health and global development of TM. We will continue to gather more information on other types of T&CM across the world. Shen Yuandong Prof. Shen Yuandong Institute of TCM International Standardization, Shanghai University of Traditional Chinese Medicine April, 2022

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Contents v vii ix xiii xv

Informative Abstract List of Editors Preface Preface Foreword Chapter 1  History, Present and Prospect of Ayurveda

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Anupama Kizhakkeveettil, Jayagopal Parla, Kishor Patwardhan, Aanchal Sharma, Swati Sharma Introduction3 1.1  History of Ayurveda 4 1.1.1  Vedic period 5 1.1.2  Upanishadic literature 12 1.1.3  Purana literature 13 1.1.4  Buddhist literature 14 1.1.5  Samhita period 15 1.1.6  Medieval period and colonial rule 21 1.2  Basic concepts in Ayurveda 23 1.2.1  Panchamahabhutas (five elements) 23 1.2.2  Doshas (biologicial energies) 25 1.2.3  Prakriti (constitution) 29 1.2.4  Dhatus (tissues) 31 1.2.5  Ojas (essence of dhatu) 34 1.2.6  Malas (waste products) 35 1.2.7  Agni (transinformatory energy) 36 1.2.8  Ama (undigested metabolities) 37 1.2.9  Srotas (circulatory channels) 38 xix

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1.2.10  Manas (mind) 39 1.2.11  Ayurvedic treatment approaches 40 1.2.12  Traya upastamaba (three supportive pillars) 42 1.2.13  Swasthavrtta (healthy lifestyle practice) 45 1.3  Present status of Ayurveda in India 47 1.3.1  Present status of Ayurveda in India 47 1.3.2  Present status of Ayurveda outside India 65 1.4  Ayurveda in future 69 References70 Chapter 2  History, Present and Prospect of Chiropractic

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Robb Russell, William F. Updyke, Bart N. Green Introduction74 2.1 The history of chiropractic (1880s through 1990s) 74 2.1.1  Antecedents to chiropractic 74 2.1.2  Origins of chiropractic 77 2.1.3  Clinical elements of practice 79 2.1.4 Training 79 2.1.5 Licensure 80 2.1.6  Scope and practice 81 2.1.7  Research, journals, and scientific conferences 81 2.2  The chiropractic profession today (2000 to the present) 84 2.2.1  Training 86 2.2.2  Licensure 89 2.2.3   Scope and practice 90 2.2.4   Spinal adjustments as the common thread 91 2.2.5  Specialties 92 2.2.6  Diagnostic imaging 92 2.2.7   Athletic and sports-related care 93 2.2.8  Economic considerations 94 2.2.9  Reimbursement 95 2.2.10  Emerging models of practice 97 2.2.11  Public perception 101 2.2.12  Research, journals, and scientific conferences 102 2.2.13  The world view 103

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2.3  Potential futures for the chiropractic profession 103 2.3.1 Introduction 103 2.3.2  Healthcare landscape and trends 105 2.3.3  The Internet of Things (IOT) 109 2.3.4 Training, licensing, scope of practice and regulations 112 2.3.5 Market for chiropractic services and the practice of chiropractic 117 2.3.6 Integration 119 2.3.7  Competition from other provider types 120 2.3.8  Chiropractic research 121 2.3.9 Public perception of the chiropractic profession 123 References124 Chapter 3 History and Present of European Traditional Herbal Medicine (Phytotherapy)

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Hans Rausch (lchenhausen/Neu-Ulm), Sven Schröder (Hamburg), Thomas Friedemann (Hamburg), Silke Cameron (Göttingen), Kenny Kuchta (Göttingen), Marius Konrad (Neu-Ulm) Introduction132 3.1  Main concepts 133 3.1.1  Phytotherapy and mainstream medicine 133 3.1.2  Effect and efficacy 134 3.1.3  Finding and feeling 134 3.2 The history of European traditional herbal medicine (European Phytotherapy) 137 3.3 Traditional European Herbal Medicine in the health system 150 3.3.1 Phytotherapeutic products in Germany and Europe in the last 100 years 150 3.3.2 Policies and regulations specific to this traditional medicine156 3.3.3  Clinical management 166 3.3.4 Standardization 168 3.3.5  Education and training 172 3.3.6 Organizations in the field of European Phytopharmaceuticals180

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3.3.7  Seven scientific research and evaluation for efficacy, quality and safety 188 3.3.8   Products and trading 195 3.3.9   Dosage forms of herbal medicinal products 200 3.3.10  Overseas communication 203 3.3.11  Current challenges: Synergism the new concept? 204 3.3.12  Cultivation and origin of medicinal drugs 206 References212 Appendix — Short Overview of Typical Phytochemical Applications 214 Chapter 4 History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine

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Bashar Saad Introduction236 4.1  A brief history of Arab medicine 238 4.1.1   Early Arab and Islamic medicine 238 4.1.2   Greco-Arab and Islamic medicine 240 4.1.3   Prominent Arab and Muslim physicians 242 4.1.4   Rhazes (Al-Razi, 864–930 AD) 243 4.1.5   Avicenna (Ibn Sina, 980–1037 AD) 245 4.1.6   Alhacen (Ibn al-Haitham, 965–1040 AD) 248 4.1.7   Ibn al-Nafis (1213–1288 AD) 248 4.1.8   Abulcasis (Al-Zahrawi, 936–1013 AD) 250 4.1.9   Alkindus (Al-Kindi, 800–873 AD) 250 4.1.10  Avenzoar (Ibn Zuhr 1091–1162 AD) 251 4.1.11 The role of Arabs and Muslims in the development of pharmacology 251 4.1.12 Poisons and their antidotes in Greco-Arab and Islamic herbal medicine 254 4.1.13 Hospitals in the Greco-Arab and Islamic herbal medicine 254 4.1.14 Current status of Greco-Arab and Islamic herbal medicine 256 4.2 Commonly used medicinal plants in the mediterranean 263

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4.3 Medicinal plants used in the treatment of diabetes, obesity, cardiovascular diseases 269 4.3.1  Olea europaea (olive tree) 270 4.3.2  Punica granatum (the pomegranate) 276 4.3.3  Black seeds (Nigella sativa) 280 4.3.4  Curcuma longa rhizomes (Turmeric) 283 4.3.5  Cumin (cuminum cyminum L.) 285 4.4 Prospect of Greco-Arab and Islamic herbal medicine 286 References292 Chapter 5  History, Present and Prospect of Homeopathy

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To Ka Lun Introduction301 5.1  History and philosophy of homeopathy 302 5.1.1  Definition of homeopathy 302 5.1.2  Origin of homeopathy 303 5.1.3  Basic principles 306 5.1.4  Specific concept of health and disease 312 5.2  Current status of homeopathy 320 5.2.1  Overview of national health service system and integration of homeopathy into national health system 320 5.2.2  Policies and regulations specific to homeopathic practice 323 5.2.3  Regulation of Homeopathic Medicinal Products (HMP)331 5.2.4  Clinical management 350 5.2.5    Standardization 358 5.2.6   Education and training 361 5.2.7  Scientific research and evaluation for efficacy, quality, and safety (if available) 366 5.2.8  Homeopathic medicines 379 5.2.9  Trading 380 5.2.10  Overseas communication 381 5.3  Prospect of homeopathy 381

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5.3.1  The need for water research 381 5.3.2  The need for good research strategy 382 5.3.3 The need for targeted research into specific medical conditions 383 5.3.4 The need for international awareness of national policies which are not T&CM friendly 384 5.3.5  The possibility of supranational collaboration 387 References387

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Chapter 1

History, Present and Prospect of Ayurveda Anupama Kizhakkeveettil, Jayagopal Parla, Kishor Patwardhan, Aanchal Sharma, Swati Sharma

Abstract Ayurveda, India’s traditional healthcare system, originated more than 5,000 years ago. Originally transmitted orally, Ayurveda’s earliest concepts were first recorded during Vedic period. Documented history available today from the Indian subcontinent dates 3,500 years and those references suggests that the oral tradition of Ayurveda is much older. Ayurveda is considered as a time-tested system of healthcare that reflects applied aspects of human life. This healthcare system incorporates the physical, psychological, spiritual, social, and subtle dimensions of life as well as bring balance in life by health promotion and wellness care, prevention, and management of diseases. This comprehensive system of traditional medicine mainly focuses on bringing optimum quality of life. Ayurveda Medicine states that building a healthy community starts with individual responsibility — to actively participate in the process of health maintenance and health-promoting actions through various lifestyle practices. Ayurvedic Medicine utilizes various interventions such as medications including herbs, detoxification therapies, body work therapies, rejuvenation therapies, diet, yoga/exercise, daily routine, seasonal routine, self, inter-personal, and social perspective conduct. 1

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Ayurveda has an age-old history since the Vedic period and Ayurveda textbooks were composed somewhere between 4th century BCE and 2nd century AD. Since, Ayurveda Medicine has evolved as a system of medicine with rational and logical foundation. During the 6th century BC to 7th century AD, there was systematic development of this science, and that period is known as Samhita period. Major literary work developed during this period. The current status of Ayurveda in countries outside India is reflected in its increasing visibility globally. While these traditional Indian life science applications have been enthusiastically embraced in many Western countries, most Westerners have yet to realize the value of Ayurveda as a medical system whose scope encompasses the prevention, treatment, and management of a plethora of diseases. The World Health Organization has played a key role in spreading Ayurvedic knowledge worldwide. The traditional health systems that are officially recognized in India include Ayurveda, Yoga, Unani, Siddha, Homeopathy, and so on, which are represented by the acronym AYUSH. AYUSH systems have been absorbed into the national healthcare delivery system in India and play a major role in development of Ayurveda nationally and internationally. In the recent few decades, there has been increased awareness in Ayurveda globally. However, there is an urgent need for strategic planning to address certain challenges. The advancement of Ayurvedic Medicine both within and beyond India will require a multi-pronged effort to align it with contemporary evidence-based medicine. Pharmaco-epidemiologic studies documenting its safety and effectiveness and new clinical processes, research protocols, and whole system treatment regimens are needed. As one of the oldest traditional healthcare system that pioneered a holistic, personalized approach to medicine that has thrived for thousands of years, Ayurveda promises to play an innovative, dynamic, and highly valued role in the continued evolution of integrative healthcare. This chapter provides comprehensive overview of basic foundational concepts in Ayurvedic Medicine including historical background and present status of Ayurveda in India and other foreign countries. Keywords: Ayurveda Medicine, Indian Traditional Medicine, Holistic Healing, herbal medicine, lifestyle medicine, evidence based complementary and alternative medicine

History, Present and Prospect of Ayurveda  3

Introduction Ayurveda, India’s indigenous medical system, has flourished on the Indian subcontinent for more than 5,000 years. Originally transmitted orally, Ayurveda’s earliest concepts were first recorded during the Vedic period in ancient Sanskrit scriptures known as the Vedas. Ayurveda is most closely associated with the fourth book of the Vedic canon, the Atharva Veda. The classical Ayurvedic textbooks that emerged in subsequent eras refined and built on these ideas, developing the fundamentals of eight branches of clinical science (i.e., internal medicine, pediatrics, toxicology, psychiatry, ophthalmology and otorhinolaryngology, rejuvenation, and sexual vitality). Ayurveda is considered one of the world’s oldest medical systems delivering personalized healthcare. This holistic approach to healing that evolved from these origins relies on natural remedies including medicinal plants and minerals, exercise, lifestyle modifications, and bodywork and detoxification therapies, to optimize health and manage disease. Ayurveda strongly advocates the pursuit of physical, mental, and spiritual well-being through self-discipline and strict adherence to a code of good conduct and to proper diet, exercise, and daily living routines. As a traditional medical model that still prevails in India and many other regions of Asia, Ayurveda offers patients preventative and therapeutic strategies that are individualized according to their unique constitution and their current and long-term health needs. Ayurveda’s purpose extends beyond providing this customized approach to healthcare, as it also serves as a source of guidance on how to live a long, healthy, happy, and peaceful life. This intention is captured in the word Ayurveda, which means “science/knowledge of life.” That science lays out the principles of harmonious living and being in tune with nature, our individual consciousness, universal consciousness, our environment, and our individual constitution. Ayurveda aims at the prevention of diseases, promotion of health, and cure of diseases. Ayurveda is not just a system of medicine but also deals with all the aspects of life. Ayurveda, as a system of healthcare and medicine, reflects time-tested knowledge of health and illness during a human life span for leading a healthy, happy, and peaceful life. It is still widely used in India as a system of primary healthcare and interest in it is growing globally.

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1.1  History of Ayurveda The roots of Ayurvedic science are so ancient that it is difficult to conjure up the chronological history of Ayurveda. Long before Ayurveda was documented in writing, it existed as an oral tradition. The preceptor and the pupil recited hymns that conveyed Ayurvedic knowledge; this tradition exists even today in certain traditional families, where the knowledge is passed from one generation to the next by reciting the hymns and memorizing them. One can clearly observe that Ayurveda has been a living tradition for quite a long time and that its concepts remain intertwined with present-day life on the Indian subcontinent. The number of Ayurvedic literary works available shows that Ayurveda had a glorious past. Albrecht Weber in his History of Indian Literature remarks: “The number of medical works (compiled in Sanskrit language) and authors is extraordinarily large. The sum of knowledge embodied in their content appears to be the most respectable. Many of the statements on dietetics and on origin and diagnosis of disease speak of very keen observations. Also, in surgery, the Indians seem to have attained a special prophecy and proficiency. European surgeons might have learned something from them as they have adopted the operation of rhinoplasty from them.” In one of the most ancient medical works of Ayurveda, the Charaka Samhita, its author, Charaka, states “Ayurveda (knowledge of life) is eternal.” The explanation for the eternal nature of Ayurveda is linked to the mystery of the origins of human life. Since the origins of human life cannot be determined, so is the knowledge of life. Charaka holds Ayurveda higher than any other knowledge as it imparts health without which human life cannot progress. The information in the history sections were compiled from the History of Indian Medicine by Mukhopadhyaya, History of Ayurveda by N.K. Krishna Kutty Warrier, and Handbook of History of Ayurveda by Dr. K. Nishteswar.[1–3] In order to understand the origins and historic development of Ayurveda we have to comb through the literature in chronological order, starting from the following five sources: The Vedas, Upanishadic literature, Purana literature, Buddhist literature, and Medival period.

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1.1.1  Vedic period In his classical compilation of surgical procedures, the Sushruta Samhita, Sushruta, the Father of Surgery, described Ayurveda as an upaveda (subbranch) of the Atharva Veda. The Atharva Veda is the last among the four canons of Vedic literature. To know the origins of Ayurveda it is important to explore the four Vedas, namely Rig Veda, Yajur Veda, Sama Veda, and Atharva Veda. Unquestionably the Vedas are one of the most ancient literatures available to humans. The literal word veda in Sanskrit language originates from the root vid, which means “to know or to reason upon.” The purpose of Vedas is to elevate human values and raise human consciousness. The Vedic civilization documented in the Vedas can be approximately placed in the late Mesolithic age, which archaeologically and historically refers to the period between 5000 BCE to 3500 BCE, when early humans started settling down in farming villages. The dates when these villages emerged vary widely across different geographical regions. Geographically, excavations at Indus Valley sites link the early Vedic period to Indus Valley civilization, and archeologically, the sites and numerous artifacts discovered there directly correlate with references found in the Rig Veda. In contrast, references in the last of the four Vedas, namely, the Atharva Veda, link Vedic civilization to the Gangetic Valley. This evidence suggests that Vedic civilization spanned for over 2,000 years, starting with early human settlements in the Indus Valley and continuing to evolve into an advanced society in the Gangetic Valley. The excavations of Neolithic archaeological sites in south central Asia, including the pre-Harappa phase in the Baluchistan region, also point to a connection between the Indus Valley sites and Vedas. Additionally, excavations in and historical references to the Gangetic Valley of the Indian subcontinent show a continuum of traditions across this period. A detailed study of food articles and herbs used in the Vedic ceremonies, as well as healing practices recorded in the Vedas, suggests that Ayurveda co-evolved and co-existed with the earlier volumes of the Vedas and is entitled to equal respect. Its association with the Atharva Veda seems to stem mainly from the fact that both deal with methods of disease management and detail practices that promote long life. Information about

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medicine and healing practices appears frequently throughout the Vedas and is included in the literature as far back its first volume, the Rig Veda. A comparison of the four Vedas indicates that the amount of information pertaining to healing gradually increased over the period extending from the appearance of Rig Veda to the later arrival of the Atharva Veda. Traditionally attributed to a class of holy sages known as Atharvans, the Atharva Veda describes various treatment modalities, elaborating in detail on the origins and pathogenesis of a variety of diseases and enumerating remedies. Ayurveda seems to have branched out from Atharva Veda due to its extensive information about health and disease management. The celebrated commentator on the Charaka Samhita, Chakrapani Datta (12th century CE) noted that the Atharva Veda itself evolved into Ayurveda as the information contained in it primarily focused on therapeutics. Scholar Darila-Bhatta, an early commentator on the Atharva Veda’s Kaushika Sutra section explained the difference between Ayurveda and Atharva Veda in terms of their contrasting goals. He noted that there are two kinds of diseases: those that stem from an unwholesome diet and those result from sins and transgressions. Ayurveda aims to increase knowledge of diseases of the first type, whereas Atharva Veda focuses on the second kind. The origins of many Ayurvedic theories trace back to the earliest Vedas. One such doctrine is the connection between the “macro-universe” and “micro-human body.” This analogy between nature and the human body appears in the Rig Veda’s observations on the similarities between the body and rest of the material universe in terms of their makeup, operation, and constituent elements. Ayurveda’s focus on the role of balance in health and disease likewise appears rooted in the Rig Veda. The Rig Veda’s conception of the wind, sun, and water as forces that can manifest as either supportive or destructive is echoed in the Atharva Veda’s view of health or disease as an outcome determined by the balance or the imbalance of these forces. Sayana, the famous commentator on the Vedas, interprets these three elemental forces as precursors of the three doshas (vata, pitta, and kapha). The tridosha (three humoral) doctrine of Ayurveda also reflects this Vedic concept. The Rig Veda identified a number of anatomical structures that roughly correspond to those defined in modern anatomy. The following

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list shows the correlation between the structures described in the Vedas and their modern equivalents: Hridaya (heart), Yakrit (liver), Pleeha (spleen), Antra (intestines), Kaphodau (lungs), Kukshi (stomach), Kloma (pancreas), Mastishka (brain), Vasti (bladder), Gaveni (ureters), Vrishana (testes), Guda (anus), Manya (neck), Dhamani (arteries), and Nadi (nerves). The Atharva Veda also details many features of the human anatomy. In its discussion on the creation of human body and various structures that constitute it, this text names several different skeletal structures, including the following: Gulpha (comparable to heel), Anguli (identified as digits), Shroni (comparable to pelvic cavity), Uru (identified as femur), Uras (comparable to thoracic cavity), Greeva (comparable to cervical region), Skandha (identified as trunk), Prishta (comparable to spine), Amsa (identified as contour of the shoulder), Lalata (identified as forehead), Kapala (comparable to cranial vault), and Hanu (identified as jaw). Physiological processes such as circulation, metabolism, and immune function are also explained in Vedic literature. The location, structure, and physiology of the heart, as well as the circulation of blood are precisely described. The Sama Veda presents its explanation of the digestion, absorption, and assimilation of food in the form of a dialogue between Swetaketu and his father Uddalaka. The father’s description of this process prefigures the Ayurvedic concept of agni (digestive fire) as a primal transformative force: “While the universal consciousness itself is without a cause and uncreated, it is the cause and creator of all. Standing alone, it wanted to be many and became many by taking the form of fire. The highest being of all exists as Agni (fire), whose essence is heat and light. As a conveyor of all things, it exists in us as the digestive fire and consumes the food we eat through the heat it generates.”

1.1.1.1  Materia-medica in the Vedas Discussions on herbal, mineral, and animal products used in the various rituals and healing practices appear in all four Vedas. Medicinal plants are classified based on morphology and their properties and special actions (Table 1-1). Some of the herbs are said to have powerful healing effects,

8  History, Present and Prospect of World Traditional Medicine Table 1–1    Medicinal herbs described in the Vedas. Herb’s Sanskrit Name

Herb’s English Name

Rajini

Tumeric

Kushta

Costus root

Haritala

Realgar

Application Jaundice Leprosy, tuberculosis, malarial fever Skin diseases

Prisniparni

Dabra root

Abortions, ailments of blood

Harina shringa

Deer horn

Leprosy, tuberculosis, epilepsy

Satavari Rohini

Wild asparagus Rohini plant

Rejuvenation Healing fractures

Sahadevi

Ironweed

Relieving thirst

Apamarga

Chaff flower

Toothbrush

Guggulu

Guggul resin

Fumigation in wasting disease

Aswatha

Bodi tree

Communicable diseases

such as the removal of deep-seated pathological imbalances. These herbs were used externally as well as internally to ward off the negative consequences of diseases attributed to unrighteous actions and sins. In addition to numerous medicinal herbs, the Vedas describe a wide range of minerals, such as iron, gold, and silver, that were used for health purposes.

1.1.1.2  Soma: The plant of eternity In Vedic tradition, the word soma is associated to plants whose juice was said to confer immortality. Ritual offerings of this juice in Vedic fire ceremonies were believed to enhance the well-being of all the members of the family and the community. Considered the king of plants, soma is frequently cited in ancient Ayurvedic texts as an elixir of long life and rejuvenation.

1.1.1.3  Vedic herbal therapy Internal administration of a single herb was a prevalent healing practice during this period. The herbs administered in these healing rituals, which often involved the use of gems and chanting, were said to have potent physical and spiritual properties. Divine therapeutic measures were indispensable to any type of healing ritual or disease treatment.

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Properties of medicinal herbs recorded in the Vedas: A shrub known as ajashringi that emits intensive odor like that of an antelope was said to repel rakshasas (evil spirits). Apamarga was used as an anti-parasitic and antidote for poisons. The same plant is said to help with dysuria. The ashwatha tree was highly revered for its spiritual power. Its twigs served as offerings in fire ceremonies to help bring wellness to the community and to ward off infectious diseases. The substitution of arjuna (also known as phalguna) for the soma plant when it was not available demonstrates the acceptance of substitution of substances during the Vedic period. Chitraparni (a plant with variegated leaves) was said to protect and nourish the fetus. The variegated leaves were also thought to be helpful in removing skin discolorations. This idea reflects the “doctrine of signatures,” the belief that characteristics of a plant, such as its appearance or smell, reveal the condition of the body that it can heal. Guggulu was burned as incense during healing rituals. Inhaling the fumes was believed to be therapeutic. Numerous references to the use of medicinal plants for veterinary purposes are also found in the Vedas.

1.1.1.4  References to pathological conditions and causative factors for pathogenesis in the Vedas The following list shows the Sanskrit names of diseases mentioned in Vedas. The English definition for each one describes the condition it is believed to be comparable to: Jwara [takma (fever)], Kasa (cough), Balasa (emaciating disease), Apachi (soft tissue swelling), Jayanya (wasting disease), Harima (jaundice), Mutrarodha (urinary obstruction), Kilasa (leukoderma), Visuchi (cholera), and Unmada (psychosis).

1.1.1.5  Emergence of therapeutic branches of Ayurveda in Vedas Three types of factors for the manifestation of diseases have been mentioned in the Vedas: accumulated toxins in the body (Ama), krimi (parasites), and Tridoshas (three biological energies).

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Eight branches (Ashtanga Ayurveda) of therapeutics in Ayurveda are seen to have precursors in Vedas. For example, the branch of danshtra (toxicology), which deals with exposure to poisons, mentions two groups of poisonous substances: Sthavara visha (toxic substance of plant origin) and Jangama visha (toxic substance of animal origin). Vedic literature shows that people of that era had a clear understanding of properties, signs, and symptoms of poisoning, and had formulated and used antidotes effectively. Management of snakebite, for example, involved herbal remedies, precious stones, and incantations. This approach is still in practice among folk healers. According to Vedic philosophy, the two fundamental purposes of life on earth are longevity and reproduction. These concerns are reflected in the attention given to rasayana (anti-aging and geriatrics) and to vajeekarana (aphrodisiacs) throughout the Vedas. The literature also features narrative accounts of rejuvenation, such as the story of the sage Chyavana regaining his youth following treatment by the Ashwini (twin celestial physicians). The Vedas describe many surgeries performed by the Ashwinis and documents surgical techniques that seem remarkably prophetic. Some examples of shalya (surgery) include: the use of a prosthesis to replace the amputated lower limb of Vishphala which was lost in a battle, a prosthesis made of iron and installed surgically, and surgically replacing the severed head of Dakshaprajapathi with a goat head to restore his life. The Vedas also praise the obstetrical and gynecological skills of Vedic physicians such as Susha, Vishkala, Saraswati, and Savitri and describe their pregnancy care, childbirth, and infant care practices in detail: Setting up a labor room along with equipment required, the steps involved in labor, and the management of complications are elaborated in the Atharva Veda. Among the labor positions, dorsal position is recommended during labor to facilitate childbirth. Rituals and specific herbal remedies during and after the childbirth are also described. To relieve complications of childbirth such as puerperal fever, spiritual practices are performed along with certain oblations. In case of a breech delivery of the infant, a set of austerities are performed by the caregiver so as to counteract the ill effects.

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There is mention of artificial respiration for asphyxia neonatorum, using oral tubing to resuscitate the infant. Specific information regarding infertility due to female reproductive system infection is also explained.

1.1.1.6  Preventive care Daily routine and sadvritta prakarana (section on good conduct): Vedic literature and rituals promoted a positive way of life through good conduct in thought, action, and communication. The details of this code of conduct are enumerated and its benefits reiterated throughout the Vedic literature. Conduct for mental hygiene is also explained. Societal values and social behavior were strongly influenced by Sanskrit precepts such as the following: Matru devo bhava, pitru devo bhava, Acharya devo bhava, Atithi devo bhava (“Mother is divine, so is the father, and the teacher, divine are the guests that come my home”).

1.1.1.7  Spiritual therapy Spiritual healing or using divine austerities to relieve various maladies is seen as the most common practice. A number of rituals involving chanting, oblations, fasting, gemstones, and fire ceremonies can be seen in the Vedas as remedies for both physical and mental disorders. A priest or the holy man facilitated the healing by invoking the gods, kindling a ceremonial fire, and offering necessary austerities.

1.1.1.8  Nature therapy Using the natural elements is the specialty of Rig Vedic healing. This text attributes divine healing powers to the natural resources detailed in the following list: Sun exposure was believed to alleviate disorders such as parasites/ worms, cardiac problems, anemia, and jaundice. Water was said to have the most powerful healing properties. Its lifesustaining and growth-promoting qualities were believed to hold miraculous therapeutic properties.

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The fierce quality of fire is mentioned as destroyer of visible and invisible parasites and was applied in various morbid conditions involving cold and stagnation. Flowing air was thought to increase the life force, and its expansive quality was said to have tremendous healing power. In conclusion, all these previously outlined features of the Rig Veda and subsequent volumes of the Vedas provide strong evidence of a deep connection between Ayurveda and the entire body of Vedic literature. Indeed, the earliest foundations of Ayurveda’s natural approach to medicine and health promotion were laid down in their preliminary form in the Rig Veda. This first volume of the canon even includes a hymn (Oshadhi sukta) entirely dedicated to herbs and dietary substances. Extensive evidence likewise supports the belief that the Atharva Veda is the direct precursor of Ayurvedic Medicine. This relationship is borne out in the Atharva Veda’s many references to the nature, causes, and pathophysiology of disease, to disease management practices, and to the structure and functions of the human body, as well as in this Veda’s focus on both the spiritual and rational aspects of health, all of which prefigure the fundamental concerns of Ayurveda.

1.1.2  Upanishadic literature The large collection of texts known as the Upanishads can be considered elaborations on the earlier Vedas. Among the most important of these approximately 108 works are the Katha, Mundaka, Isa, Aitareeya, Brihadaranyaka, Taittiriya and Chandogya Upanishads. The two earliest, the Brihadaranyaka and the Taittiriya Chandogya, were composed before Buddhist period, between 800 BCE and 100 CE. Like the Vedas, the Upanishads consider living human beings as synthesis of body, mind, and soul. They also contain extensive references to spiritual healing practices and other healing modalities. The idea of prana as the life force that supports and sustains nature as well as the human body feature prominently. The Upanishads detail methods of enhancing the abundance of prana in order to protect health and promote longevity. They specify five types of vata, governed by prana (i.e., prana vata, udana vata, samana vata, vyana vata, and apana vata) that regulate all bodily

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functions. When properly controlled through spiritual breathing exercises, prana was said to awaken the kundalini energy that enables individuals to experience the higher self. Digestive fire, or agni, is represented in the Upanishads as a conveyor of offerings to the higher self and sustainer of life that, when offered wholesome food, brings about clarity of thought and enhances lifespan. Fasting as a spiritual practice to promote health was in wide practice during this era as much as the use of a wholesome diet and herbs to enrich body, sense organs, and mind and to achieve longevity. The Upanishads also continued the Vedic tradition of describing various plants that were used for healing and spiritual purposes, including the ashwatha and Nyagroda, which were worshiped as eternal trees that enhanced health and spiritual well-being.

1.1.3  Purana literature At the turn of the 4th century CE, Purana literature emerged and began disseminating Vedic knowledge in the form of mythological narrations that glorify Vedic lifestyle and spiritual practices. The main purpose of these texts, which were 18 in total, was to motivate people toward meditation, righteous living, health, and longevity. In terms of health information, the Puranas describe the mythological origins of certain health conditions such as fever, skin ailments, and wasting diseases. Fundamental doctrines of Ayurveda like five elements and tridosha theories are explained in the Padma Purana. Other Puranic literature details the healing properties of certain dietary preparations, herbs, precious metal, and gemstones. This information both draws on and adds to knowledge preserved in the Vedas and Upanishads. The Vishnu Purana also provides daily and seasonal routines for health promotion and a code of conduct for a positive lifestyle. The Skanda Purana describes the qualities of an ideal Ayurvedic physician as well as a code of ethics and the setup required for a successful Ayurvedic practice. Thus, the Puranas present a spiritually driven healthcare model aimed at delivering physical and mental well-being.

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1.1.4  Buddhist literature Buddhist literature suggests that this philosophy had a major impact on the development of Ayurveda: Buddha himself was referred to in the literature as the Maha Bhishak (“greatest physician”), as he showed the path of liberation from disease and death. The Taittiriya (c. 200 BCE), the oldest treatise of Buddhism, talks about native medicine in Buddhist tradition. The Navanitaka (a.k.a. the Bowers Manuscript) provides a glimpse of a Buddhist version of Ayurvedic healing. The Saddharma Pundarika Sutra (c. 1st century CE) mentions that special nursing homes attached to flower gardens, with good infrastructure for healing, were used for diagnosis and treatment of illness. Ayurveda had an equally profound impact on Buddhism. Buddhist literature shows that the Buddhist theory of disease was drawn directly from Ayurvedic principles. Diseases were classified as follows: originating from imbalance of vata dosha, originating from imbalance of pitta dosha, originating from imbalance of kapha dosha, and originating from imbalance of all three doshas (sannipatika). Formulations of herbs such as the following were also in wide use: freshly expressed juices, pastes, decoctions, cold infusions, and hot infusions. The pancha mahabhuta (five elements) theory is explained in Buddhist literature, and the word dhatu (primitive matter), serving as the equivalent to mahabhuta (elements), is used to represent the basic unit of matter that forms all structures in nature, including the human body. In the Suvarna Prabha Sutra, the influence of the seasons on health and the need for seasonal adjustments in lifestyle and diet changes are explained. The literature also elaborates on the anatomical and physiological features of many organs and organelles. The Buddhist scripture, the Vinaya Pitika, adapts the eight limbs of Ayurveda that were already developed and in practice to the Buddhist way of life and values. Buddhists and Hindus alike, revered the ancient university Takshashila and its life science curriculum included Ayurveda. The Ayurvedic concept of the six tastes and its utility in disease management was also popular among Buddhist healers. It is documented that

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the renowned physician, Jeevaka, administered some of the purification procedures used in Ayurvedic panchakarma (five cleansing procedures) therapy to the Buddha himself and prescribed a special post-detoxification diet afterward. In the Vinaya Pitaka, there are references to a remedy called pancha bheshaja, a combination of five substances that promote health and manage diseases by pacifying the three doshas: ghee and butter (alleviates pitta), oil (reduces vata), and honey jaggery (pacifies kapha). A later text, the Milinda Prashna, describes the same combination as an antidote for poisoning. In the same text, tridosha theory serves as the basis for understanding the pathophysiology of disease. This theory is explained in the form of a dialogue between a Greek king, Milinda, and his teacher, the Buddhist sage Nagasen, who sorted the causes of diseases into eight categories: Vata imbalance, Pitta imbalance, Kapha imbalance, imbalance of sannipata (all three dosha), seasonal influences, irregular diet, improper treatment, and past deeds. As Buddhist teachings spread, a refined form of Ayurveda reached distant nations. Along with other ancient Indian knowledge systems such as astrology and architecture, Ayurveda became part of the repertoire of scholars that traveled abroad.

1.1.5  Samhita period This era is considered the golden age of Ayurveda. In the early days of Ayurveda, its principles were transmitted orally by sages who shared the knowledge they had intuited while deep in meditation with their disciples. During the Samhita period, this knowledge was codified in the classic works of Ayurvedic literature, and the main therapeutic branches emerged as full- fledged schools of medicine, such as Athreya (internal medicine), Dhanvanatari (surgery), and Kashyapa (pediatrics). Although each of the samhita focused on one specialty, these works concisely conveyed the basics of all eight therapeutic branches of Ashtanga Ayurveda. Compilations that covered all the branches were entitled samhitas. Students who initially concentrated on any one of the branches ultimately gained the gist of all of them. Each of these specialties advocated the same basic approach of treating prevention and cure as

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its two equally important aims. Rulers of this period encouraged the growth and development of Ayurveda. The three major compilations: Charaka Samhita, Sushruta Samhita, and Ashtanga Sangraha and Ashtanga Hridaya. Charaka Samhita This is the earliest major medical text of Ayurveda, attributed to the physician Charaka. Although traditionally he is thought to have lived around during the period between 1000 and 800 BCE, most Western scholars now place him around the 1st century CE, when the Charaka Samhita probably reached its present form. The work contains the basic philosophy of disease, based on an imbalance of the three humors (vata, pitta, and kapha). The Charaka Samhita catalogs the following fundamental aspects of medical philosophy, medical care, and treatment: Sutra (aphorism) — origin of Ayurveda, general principles, and philosophy. Nidana (diagnosis) — causes, and symptoms of disease. Vimana (measure) — many subjects, including physiology, methodology, and ethics. Sharira (body) — anatomy, embryology, metaphysics, and ethics. Indriya (sense organ) — prognosis. Chikitsa (treatment) — therapeutics. Kalpa (preparation) — pharmacy. Siddhi (success in treatment) — purification therapy. The Charaka Samhita contains 120 adhyayas (chapters), divided into 8 parts: Sutra Sthana (30 chapters), Nidana Sthana (8 chapters), Vimana Sthana (8 chapters), Sharir Sthana (8 chapters), Indriya Sthana (12 chapters), Chikitsa Sthana (30 chapters), Kalpa Sthana (12 chapters), and Siddhi Sthana (12 chapters). Commentaries on the Charaka Samhita: Dridabala — 4th century CE, Chakrapani — 11th century CE, and Gangadhara — 16th century CE. Sushruta Samhita In his compendium of surgical procedures, Sushruta mentions that his teacher and surgical mentor was Divodasa, the king of Kashi, who was considered the incarnation of Lord Dhanvanthari, the physician of the gods. Ancient texts recognized Sushruta as son of the sage Vishwamitra. He was reputed to have written his treatise in Varanasi (Banaras)

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sometime between 600 and 200 BCE. It was through Sushruta’s accomplishments that surgery achieved a leading position in general medical training. The Sushruta Samhita contains discussions of surgical equipment, a classification of abscesses, and treatments for burns, fractures, and wounds, as well as instructions for amputation. It gives a complete description of human anatomy, including bones, nerves, blood vessels, and the circulatory system, and it mentions the brain as the center of the senses. Sushruta’s treatise describes anatomical dissection and details surgical techniques that were the most advanced in the world at the time of their recording. The text is divided into two parts, each comprising several sections: the Purva-tantra (Sutra-sthana, Nidana-sthana, Sarira-sthana, Kalpasthana, and Chikitsa-sthana) and the Uttara- tantra (Salakya Kaumarabhrtya, Kayacikitsa, and Bhutavidya). In addition to surgery (shalya and salakya), those two parts together encompass specialties such as general medicine; pediatrics; geriatrics; diseases of the ear, nose, throat, and eye; toxicology; aphrodisiacs; and psychiatry. Thus, the complete samhita, despite its devotion to the science of surgery, manages to incorporate the salient portions of numerous other disciplines as well. Sushruta describes nine types of surgical procedures: Chedana (excision) — the surgical removal of a part or whole of the limb. Bhedana (incision) — a cut made in the flesh to achieve effective drainage or to expose underlying structures. Lekhya (scraping) — the removal by scraping of scooping out material such as a growth, flesh of an ulcer, or tooth tartar. Vedhya (puncturing) — piercing tissue with a special instrument (vyadhana) to drain veins, hydroceles, or ascitic fluid in the abdomen. Esya (exploration) — probing sinuses and cavities to locate foreign bodies and determine their size, number, shape, position, and condition. Visravaniya (evacuation of fluids). Ahrya (extraction). Sravana (blood-letting) — draining blood from the body to treat skin diseases, abscesses (vidradhis), localized swelling, etc. Svana (suturing) — sewing together the flaps of a wound or surgical incision.

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Sushruta also classifies the different bones and characterizes their reaction to injuries. Various dislocations of joints (sandhimukta) and fractures of the shaft (kanda-bhagna) are systematically described. He also describes over 120 surgical instruments, 300 surgical procedures, and identifies 8 categories of surgery in categories, including plastic surgery operations. The earliest of these types of procedure probably involve nasal reconstruction. He enumerates 107 marma points that are essential for healing injuries, identifying their structure, anatomical location, and complications due to their injury. Ashtanga Sangraha and Ashtanaga Hridaya: Two separate authors with the same name, Vagbhata I (c. 2nd century CE) and Vagbhata II (c. 7th century CE) are considered the respective authors of the Ashtanga Sangraha and the Ashtanga Hridaya. Where does the word Ashtanga start for eight branches of Ayurveda? In the Ashtanga Sangraha, Vagbhata I or Vridda Vagbhata, a Mahayana Buddhist, edited content from earlier texts and arranged it in a well-organized format. Similar to Sushruta’s text, there are two major divisions of the text, namely, the Poorva (introductory section) and the Uttara (treatment section). The author combined relevant sections from Charaka and Sushruta’s writings with his own work to create a comprehensive text. The Ashtanga Sangraha has six sections with 150 chapters. The number of chapters in each section is as follows: Sutra (introductory section) — principles of Ayurveda, preventative care, dietetic principles, and therapeutic methods. Sharira (body section) — embryology, anatomy, and physiology. Nidana (diagnosis section) — causes and symptoms of disease, and pathogenesis. Chikitsa (treatment section) — line of treatment of disease, herbal prescriptions, dietetics and patient care. Kalpa (formulations section) — formulations for cleansing procedures. Uttara (second half) ENT and ophthalmology, toxicology, geriatrics, and general surgery.

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The text deals exclusively with the etiology, symptomatology, and therapeutics of disease. The conciseness of Vagbhata I’s work makes it clear that the author has no patience for irrelevant content, does not elaborate on any unnecessary information, and shuns unnecessary repetition. Vagbhata II edited and reorganized Ayurvedic knowledge from other texts in a simple and student-friendly fashion. In the Ashtanga Hridayam, he remarks that earlier text (i.e., the Ashtanga Sangraha) was composed by collecting only the relevant and important information from the other works. The Ashtanga Hridayam provides an even more refined knowledge of Ayurveda that is highly beneficial for students. The title Ashtanga Hridaya means “the heart of eight branches of Ayurveda.” Due to its popularity, the text was translated into the Arabic, Persian, Tibetan, and German languages. The Ashtanga Hridayam is divided into 6 sections and has a total of 120 chapters. The number of chapters in each section is as follows: Sutra (introductory section) — 30 chapters dealing with principles of Ayurveda, preventative care, dietary principles, and therapeutic methods. Sharira (body section) — 6 chapters dealing with embryology, anatomy, and physiology. Nidana (diagnosis section) — 16 chapters that deal with causes and symptoms of disease and pathogenesis. Chikitsa (treatment section) — 22 chapters dealing with a line of treatments for disease, herbal prescriptions, dietetics, and patient care. Kalpa (formulations section) — 6 chapters explaining formulations for cleansing and detoxification procedures. Uttara (second half) — 40 chapters dealing with pediatrics, psychiatry, ENT and ophthalmology, toxicology, geriatrics, and general surgery. The three minor compilations: Madhava Nidhana, Sharnagadhara Samhita, and Bhava Prakasha. Madhava Nidana Written in the 7th century BCE by Madhavakara, the son of Indukara, this compendium of information pertains exclusively to pathology. In addition to quoting earlier works by Charaka, Sushruta, and Vagbhata, the author offers his views on specific pathologies.

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The layout of the content is based on the five categories of pathogenesis: Nidana — the factors responsible for producing disease (i.e., etiological factors). Purvaroopa — the warning signs of disease that arise as doshas (bioenergies) become aggravated. Roopa — the manifestation of disease with prominent clinical features. Upashaya — aggravating and relieving factors. Samprapti — the entire process of manifestation of disease. There are 69 chapters in the text: Chapters 2–19, 22–37, and 49–54 deal with pathologies of diseases explained under kaya chikitsa (internal medicine); Chapters 20 and 21 explain pathologies of diseases explained under bhutavidya (psychiatry); Chapters 38 and 55 discuss pathologies of diseases explained under shalya (surgical conditions); Chapters 56–60 deal with pathologies of diseases explained under shalakhya (ENT and ophthalmology); Chapters 61–68 enumerate the pathologies of diseases explained under kaumara brithya (pediatrics); Chapter 69 explains pathologies of diseases explained under agada tantra (toxicology). Sharangadhara Samhita Compiled around 12th century CE, by Sharangadhara, this work has 32 chapters and 2,600 verses. The author has systematically arranged information on Ayurvedic pharmacy. It is one of the most important contributions to the field of Ayurveda, as earlier texts had not yet organized formulation methods that systematically progressed from simple preparations to compound formulations. Sharangadhara’s text has three sections: Section 1 — anatomy, pathophysiology, basic principles, pulse diagnosis, pharmacological actions, weights, and measures. Section 2 — extensive information on pharmacy with specific examples of formulations for various pathologies, including detailed instructions on alchemical preparations. Section 3 — formulations used in detoxification procedures and method of administration, diseases of the head and neck region.

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Concepts of Pharmacy in second section of Sharangadhara’s text: Chapter 1 — Swarasa Kalpana (freshly extracted juice) and examples. Chapter 2 — Kwatha Kalpana (herbal concoction) and examples. Chapter 3 — Phanta Kalpana (hot infusion) and examples. Chapter 4 — Hima Kalpana (cold infusion) and examples. Chapter 5 — Kalka Kalpana (herbal paste) and examples. Chapter 6 — Choorna Kalpana (herbal powders) and examples. Chapter 7 — Gutika Kalpana (pills) and examples. Chapter 8 — Avalehya Kalpana (herbal jams) and examples. Chapter 9 — Sneha Kalpana (herbal oils and ghee) and examples. Chapter 10 — Sandhana Kalpana (fermentative preparations) and examples. Chapter 11 — Dhatu Shodhana Marana (mineral and metal purifications). Chapter 12 — Rasa Shodhana Marana (purification of mercury). Bhavaprakasha: Bhava Mishra is the 16th century CE author of the Bhavaprakash. This significant work focuses primarily on materia- medica. The text stands as a historical landmark since it reflects the state of Ayurvedic Medicine at the transition from medieval to modern times. The content of the Bhavaprakasha was compiled from earlier texts, however, the author has contributed a significant amount of information regarding medicinal substances. This comprehensive guide to a successful Ayurvedic practice has three voluminous sections: Part 1 (seven chapters) — discusses the origins of Ayurveda, the evolution of life and cosmology, embryology, anatomy, preventive science, and the properties and actions of herbs. Part 2 (70 chapters) — details the etio-pathogenesis of several diseases and their management. Part 3 (two chapters) — discusses geriatrics and aphrodisiacs.

1.1.6  Medieval period and colonial rule Medieval times in India extended from the start of the 6th century CE until the beginning of the 16th century CE. Influenced by religious conflicts, the development of Ayurveda was limited at this period. Prior to this time,

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Ayurveda had received strong support from Indian kings and emperors. Ayurvedic practitioners served as court physicians, and royal treasuries subsidized the practice and development of the science. Resources were provided to advance strategies not only for the health of the royal family but also for the entire kingdom. With the coming of foreign rulers, however, the progress of Ayurveda languished. Muslim rulers attempted to squelch Ayurveda in order to patronize the Unani system of medicine and other forms of Greco-Arab Medicine; Ayurveda was treated like an unwanted stepchild. This situation persisted until the assumption of the throne by Firoz Tughlaq at the beginning of 14th century, when Muslim rulers began to appreciate the importance of Ayurveda and take steps to patronize it. The survival of Ayurveda during this period, and later under British rule, stemmed from its close entwinement with Indian culture. In fact, the Unani system of medicine, introduced by the Mughals, had to borrow and incorporate concepts of Ayurveda for its own good. Since Ayurveda was a rich and widely valued science, the Unani system needed to draw from it to expand its knowledge base and broaden its appeal. Eventually, the two systems came to coexist. Ayurvedic vaidyas and Unani practitioners (hakims) were accorded equal status and encouragement, even though the hakims easily outnumbered the vaidyas. Ayurvedic texts were translated into the Persian language and Ayurvedic medical knowledge spread to the Middle East and Europe. Kings like Akbar and Jahangir built hospitals and encouraged the practice of Ayurveda. An important, rather a peculiar, medical development in medieval India is the increasing number of compilations of materia-medica knowledge. Known as nigantu (lexicons), these compilations systematically group diet, herbal, and mineral substances for easy reference. Identification, location, morphology, and qualities along with their actions of various medicinal substances are collected and arranged according to different rationales. To date, there are 57 nigantus from various medieval periods. This effort remained a trend even during British rule. Nigantus seems to be the genuine and persistent attempt by the Ayurvedic scholars of the time to resolve the confusion regarding correct identification and application of medicinal substances. Colonial rule in India extended from 1757 to 1947. During this time, except few small kingdoms, the entire Indian subcontinent was governed by the British Empire. This period saw a resurgence of doctors in India. Various

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levels of Western medical education were provided in local languages in the beginning and subsequently in English. There was a significant advancement in Western Medicine, and Ayurveda was regarded as a folk medicine.

1.2  Basic concepts in Ayurveda Ayurvedic theory conceptualizes the human body in terms of pancha mahabhutas (five elements), three doshas (biological forces that maintain and regulate the body), its seven dhatus (tissues), malas (waste products), and its agni (the fiery energy that fuels digestion and metabolism) and describes the impact of these substances and energies on the body’s srotas (metabolic pathways) and on the functioning of its organs. Ayurveda also posits that all various forms of matter that exist in the universe are made up of the same five elements that constitute the body. In substances that the body ingests, such as foods and herbs, these elements are said to manifest in the substance’s rasa (taste), gunas (qualities), virya (potency), and vipaka (the taste that arises after digestion and metabolism). Information explained under the Basic concepts of Ayurveda were compiled from Charaka Samhita and Ashtanaga Hrudaya.[4,5] Ayurveda explains that life comprises sarira (the physical body), indriya (the senses), sattva (the mind), and atma (the soul or conscious elements). This understanding of life is rooted in the laws of nature. According to Ayurveda, one of the most important principles that govern natural phenomena is the connection between the macrocosm and the microcosm. This principle holds that human life is a microcosm that exists in a state of constant interplay with the cosmos (the macrocosm).

1.2.1  Panchamahabhutas (five elements) Ayurveda proposes that the interdependence of the individual human being and all matter in the external universe stems from the precept that everything in nature consists of the same five elements, or pancha mahabhutas (five basic elements): air, fire, earth, ether, and water. In Ayurvedic terms, health is defined as a state in which both the quantities

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and the qualities of these five basic elements are in perfect balance. Panchamahabootas are considered as basic building blocks of the universe. The concept of panchamahabootas helps to understand physiology, pathology, and pharmacokinetics. These are the minutest elements which constitute living and nonliving matters. Any living body is an outcome of the interplay of the panchamahaboota in a specific manner. According to panchamahaboota theory, manifestation of the entire physical universe including human body is made possible by the combined attributes of Panachamahabootas which are listed below. Aakasha (Space): Akashamahaboota is the first expression of consciousness and is the space without which matter cannot exist. The main sense attribute to Akasha mahaboot is Sound. Nonresistance is its chief property. It is present in hollow cavities within the body and empty areas of cosmos, transmit sound, nonresistant to anything, frictionless or smooth, subtle, soft, and abundant. Any diet, food or herbs with similar properties will increase Akashamahaboota in the body. Vayu (Air): Vayumahabootas evolved from Aakashamahabootas. The main sense attributed to Vayu mahabootas is Touch. As it evolves from Aakasha mahaboota, it also inherits the attribute of sound. Mobility is its chief property. Properties of Vayumahaboota include light, dry, subtle, mobile, transparent, and rough. It is responsible for movement and dryness in the body. Any diet, exercise, and food which has similar properties will increase Vayumahaboota in the body. Agni (Heat): Agnimahabootas evolved from Vayumahaboota. The main sense attributed to Agni mahabootas is Vision. It also inherits sense attributes of Sound and Touch from Akasha and Vayu mahabootas. Hot is its chief property. Properties of Agniumahaboota include hot, sharp, intense, dry, and light. Any food, exercise, or herbs with similar properties, will increase Agnimahaboota. Aapa (Water): Aapa mahaboota evolved from Agni mahaboota. The main sense attributed to Aapa mahaboot is Taste. It also inherits sense attributes of Sound, Touch, and Vision from Akasha Vayu and Agni mahabootas. Liquidity is the chief property. Properties of Aapmahaboota include moist, cohesive, sticky, cool, soft, and oily. Any food or herbs with similar properties will in increase Aap mahaboota.

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Prithvi (Earth): Pritvi mahaboota evolved from Aapa mahaboota. The main sense attributed to Pritvi mahaboot is Smell. It also inherits sense attributes of Sound, Touch, Vision, and Taste from Akasha Vayu Agni and Aapa mahabootas. Roughness is the chief property. Properties of Prithvi mahaboota include solid, dense, stable, heavy, hard, dull, and slow. Any food, exercise or herbs which have similar properties will increase Pritvi mahaboota.

1.2.2  Doshas (biologicial energies) There are two kinds of doshas: somatic (vata, pitta, and kapha) and psychological (rajas and tamas). The somatic and psychological doshas constitute an axis that facilitates the seamless integration of crosstalk between the mind and the body’s neurological, endocrine, and immunological systems. Whenever one of these doshas undergoes changes, the others become deranged. Each one has certain gunas (qualities) and karmas (functions) and needs to be present in the body in a specific pramana (quantity) to bring health. The central concept of Ayurvedic Medicine is the tridoshic theory. This theory proposes that there are three doshas, or biological energies, that govern all the body’s biomotor, metabolic, and physiological activities. Doshas determine longevity at the cellular level and maintain homeostasis in the body. Every living species contains a unique combination of all three doshas (vata, pitta, and kapha). While all the five elements (air, fire, earth, ether, and water) are present in each of these dynamic physiological forces, the two elements that dominate its makeup define its nature. For example, the vata dosha is dominated by akasha (ether) and vayu (air); pitta dosha, by tejas (fire); aap (water) and kapha doshas, by aap and prithvi (earth). These three innate physiologic forces govern the entire life process from conception and growth through decay and death. While the doshas pervade the entire body, there are particular organs/body parts where they primarily reside. For example, vata is located mainly in the large intestine, pelvic region, thighs, ears, bones, and the organ of touch (skin); pitta in the small intestine, stomach, blood, eyes, skin, sweat glands, lymph, and

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body nourishing fluid; kapha in the chest, larynx, head, pharynx or esophagus or pancreas, all joints, the stomach, body nourishing fluid, body fat, nose, and tongue. Vata governs all types of movement in the body and thereby governs all life functions. Its specific functions include controlling respiration and speech, maintaining coordination between body and mind, excreting waste products from the body, transporting body elements, and regulating intestinal movements. Pitta controls all types of digestion, metabolism, and transformational actions in the body. Its particular functions include maintenance of body temperature, softness of the body and luster of the skin, visual acuity, taste, appetite, thirst, intellect, and courage. Kapha is responsible for anabolism and the stability and strength of the body. This general role encompasses maintaining stability of joints, unctuousness of body, and the ability of mind and body to tolerate stress. Each dosha has its own characteristics, anatomical, physiological, and psychological properties. Vata is dry, light, cold, rough, subtle, and mobile. Pitta is oily, sharp, hot, light, spreading, liquid, pungent, and fleshy smelling. Kapha is wet, cold, heavy, dull, sticky, soft, dense, and static. Each of the doshas is divided into five types. The five types of vata are: Prana vata: Situated in the head. It moves around in the chest and larynx. It is represented by the functional units of the respiratory center and governs the sensory and motor organs, mind, intellect, and consciousness. Prana vata also regulates inhalation, swallowing, sneezing, and expectoration. Udana vata: Situated in the chest. It moves around in the nose, umbilicus, throat, and trachea. It maintains the act of speech and governs energy, enthusiasm, color of the skin/ complexion, and memory. Vyana vata: Situated in the heart. It moves all over the body. It controls walking, flexion, extension of limbs, blinking, and yawning. Samana vata: Situated near digestive fire (stomach and small intestine). It moves around the abdominal cavity. It controls digestion and absorption and assimilation of nutrients. Apana vata: Situated in the anal canal. It moves around in the area of urinary bladder, genitals, thighs, and pelvis. It controls excretion of urine

History, Present and Prospect of Ayurveda  27

and feces, ejaculation of semen, the flow of menstrual fluids, and delivery of infants. The five types of pitta are: Pachaka pitta: Situated in stomach and large intestine. It governs digestion and assimilation of food and nourishes the other types of pitta. Ranjaka pitta: Situated in liver, spleen, stomach, and small intestine. It governs the synthesis of hemoglobin and imparts red color to the blood. Sadhaka pitta: Situated in the heart. It helps individuals to achieve their desires by maintaining mental activity and intellect. Alochaka pitta: Situated in the eyes. It is responsible for vision. Bharajaka pitta: Situated in the skin. It maintains a healthy, lustrous complexion. The five types of kapha are: Avalambaka kapha: Situated in the chest. It nourishes other types of kapha. Kledaka kapha: Situated in the stomach. It is represented mainly by mucus secretion in the gastrointestinal tract and helps to moisten food. Bodhaka kapha: Situated in the tongue. It enhances the sense of taste. Tarpaka kapha: Situated in the head. It nourishes all the sensory organs. Shleshaka kapha: Situated in the joints. It helps in maintaining joint stability. During different seasons of the year, the doshas undergo certain changes. For example, at the end of summer, vata tends to become aggravated, increasing beyond the level required to maintain the proper balance of the doshas. This typically happens to pitta during autumn and to kapha during spring. Failure to harmonize dietary and lifestyle practices with the seasons, as well as improper eating habits and an unhealthy lifestyle, may also lead to aggravation of the doshas and eventually manifest as symptoms of disease. Please see below for the factors that cause each of the doshas to increase.

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1.2.2.1  Increase of the doshas: Causative factors Vata Excessive consumption of bitter, astringent, and pungent tastes, overconsumption of cold, dry, and light food, intake of food at improper time, intake of less nutritive food, and fasting, suppression of natural urges, late bedtimes, loud conversations, excessive physical exercise, overexposure to erratic motion due to traveling in a vehicle for long time, rainy weather. Pitta Excessive consumption of salty, pungent, and sour tastes, overconsumption of alcoholic beverages and hot, spicy, oily fried foods, excessive sorrow, fear, and anger, leading to reduced intake of food and lack of sleep; overexposure to the sun and fire. Kapha Excessive intake of sweet, sour, and salty tastes, overconsumption of oily, cold, heavy, sweet, and sticky food, sedentary lifestyles and sleep during daytime, excessive intake of meat, heavy or unctuous food, and milk, overeating. If a dosha that has increased due to these factors continues to accumulate, the aggravation progresses to a more severe state, known as provocation. Doshas can also decrease to a point below their optimal level. The following section outlines the signs and symptoms of increased (aggravated), provoked (agitated), and decreased (depleted) doshas.

1.2.2.2  Signs and symptoms of dosha imbalances Increased vata Emaciation, black discoloration of skin, craving for heat, tremors, flatulence, constipation, loss of power of body and organs, sleeplessness, talkativeness, dizziness, sorrow, hoarseness of voice, and dry skin. Provoked vata Prolapse of organ, ptosis, dilatation of organs, throbbing pain, numbness, tiredness, pain, cutting pain, retention due to obstruction, body ache, muscle contractions, rounding of an organ, shivering, dehydration, abnormal movements in limbs, dryness, sponginess, atrophy, pulsation, feeling of covering, rigidity, astringent taste in the mouth, and appearance of blue or crimson discoloration of skin. Decreased vata Slow movements, slow, diminished speech, laziness, diminished functioning of sense organs, unconsciousness, and disease due to increased kapha.

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Increased pitta Yellowish coloration of skin, feces, urine, and eyes, increased appetite, thirst, anger, affection for cold, reduced sleep, unconsciousness, loss of power, and weakness of organs. Provoked pitta Burning sensation, redness, rise in body temperature, suppuration, sweating, discharge, secretion, gangrene, coma, sour and pungent taste in the mouth, discoloration of skin except in white or black skin. Decreased pitta Reduced body temperature, diminished digestive power, and loss of luster of skin. Increased kapha Anorexia, excessive salivation, laziness, heaviness, pallor, reduced body temperature, tiredness, cough, breathlessness, excessive sleep, dullness, drowsiness, weakness in joints. Provoked kapha Unctuousness of body and stools, hardness, thickening, obstruction, wetness, heaviness, edema, itching, indigestion, coldness, excessive sleep, salty or sweet taste in mouth, pallor, chronicity of diseases. Decreased kapha Dizziness, feeling of emptiness in stomach, palpitations, weakness in joints, dryness of skin, burning sensation, excessive thirst, weakness, and reduced sleep. A thorough understanding of each dosha’s primary locations, functions, and the symptoms associated with its increase and decrease is crucial for understanding the causes and effects of diseases. Health and disease are a direct reflection of the balance/imbalance of the doshas in the body and mind. Proper diet, exercise, and a harmonious lifestyle promote balance among the doshas. Restoring and maintaining the proper balance of the three doshas with respect to their quantity (pramana), quality (guna), and functions (karmas) leads to health.

1.2.3  Prakriti (constitution) In Ayurvedic Medicine, constitutional phenotypes or psychobiological tendencies are referred to as prakriti. This term equates to the innate balance of the combination of mental and physical qualities that is unique to each individual. This distinctive constellation of qualities is determined at conception and correlates with the patterns of gene expression that shape the individual’s physical, psychological, emotional, and structural characteristics, physiological functioning, metabolic tendencies, personality, and disease susceptibility (immunity). An individual’s prakriti reflects his or

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her baseline characteristics. It determines an individual’s capacity for transformation at the physical, mental, and emotional levels and influences how that individual interacts with external and internal stimuli, all of which affect the aging process.[6] The idea that there is a delicate balance between biophysiological forces (doshas) and constitution (prakriti) is central to Ayurveda’s understanding of health and disease. Ayurvedic theory ascribes prakriti to the preponderance doshas at the time of an individual’s conception, while also factoring in external influences such as the environment inside the mother’s womb and the dietary and lifestyle habits of both parents. As described in classical Ayurvedic texts, these features of prakriti point to its genetic origin and to its dependence on the interplay between innate characteristics and external factors. There are seven types of prakriti: vata, pitta, kapha, vata-pitta, pittakapha, vata- kapha, and sama. Three Basic Types of Prakriti: Characteristic Features Vata prakriti Dry, rough skin and nails, cracks in soles of the feet and palms, production of cracking noise in joints during movement, thin or emaciated body, prominence of tendons and veins; irregular teeth; loss of hair and beard, dry, rough hair with split ends, and dry eyes. Pitta prakriti Medium build, feeling of excessive heat, early appearance of grey hair and wrinkles, baldness, numerous black moles, foul body odor, coppery color of nails, whites of eyes, tongue, palate, limbs, palms, and soles of feet, enthusiasm, bloodshot eyes. Kapha prakriti Large, compact physique, soft, smooth, and unctuous skin, big eyes with plenty of eyelashes, whitish tinge in the eye, curly dark hair, prominent forehead, chest, and arms. Mixed Prakritis The mixed prakritis combine the characteristic features of the different doshas that govern them. While the vata-pitta, pitta-kapha, and vata-kapha prakritis combine the characteristics of two doshas, the sama prakriti possesses the features of all three doshas in equal proportions. The Importance of Understanding Prakriti Effective Ayurvedic treatment requires a firm grasp of the patient’s prakriti, including its susceptibility to certain diseases. For example, a person with kapha prakriti is

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particularly vulnerable to kapha-type diseases, such as ailments of the respiratory tract. Hence, the clinician should advise this person to consistently avoid any factors that can aggravate kapha. Factors Responsible for Determining Prakriti These include the following: The quality of sperm and ovum, the season when conception occurred, diet and lifestyle of mother and father at the time of conception, lifestyle and diet of the mother during the pregnancy, and nature of the elements that constitute the fetus. Researchers continue to evaluate whether the various prakritis can be grouped according to anthropometric measurements and biochemical variables like serum cholesterol, blood sugar, and blood types.[7] Studies have also looked into variations in whole genome expression among the different prakriti types. The Psychic Components of Prakriti An individual’s prakriti encompasses not only the body’s physical aspects but also the characteristics of his or her mind. Ayurveda proposes that three fundamental attributes (gunas) exist in everything in the universe, including our body and mind: sattva (purity), rajas (motion/action), and tamas (inertia). Rajas and tamas represent opposing influences on the mind that, like the doshas, can cause disturbances when they are present in excess. Sattva is the state of perfect balance. The gunas that predominate at the time of an individual’s conception determine the nature of his or her manas (mind).

1.2.4  Dhatus (tissues) Dhatus are seven basic tissues in the body: rasa (plasma/lymph), rakta (blood), mamsa (muscle), meda (adipose tissue), asthi (bone, or osseous tissue), majja (bone marrow/nerve tissue), and shukra (reproductive tissue). The term dhatu means “that which assists the body or which serves as building block of the body.” These seven dhatus and several updhatus (secondary tissues) make up the physical bulk of the body and occur in particular proportions in various organs of the body. Any changes in these proportions and in their proper equilibrium can lead to disease. As long as the production and nourishment of the seven dhatus proceeds normally, health is maintained. The following list describes the main functions of each dhatu: Rasa (plasma/lymph) — nourishes all the other tissues.

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Rakta (blood) — gives vital energy to all bodily functions. Mamsa (muscle tissue) — covers all the other tissues. Meda (adipose tissue) — lubricates all the tissues. Asthi (bone tissue) — supports the body. Majja (bone marrow/nerve tissue) — f ills bones. Shukra (reproductive tissue) — reproduction.

1.2.4.1  Dhatu imbalances: Signs and symptoms The following section lists the signs and symptoms that arise in each of the seven dhatus when there is an increase or a decrease in that dhatu. Rasa Dhatu Increase: Discomfort in chest area and excessive salivation. Decrease: Chest pain, tremors, numbness, excessive thirst, dryness of body, tiredness, drowsiness, and intolerance to sound. Rakta Dhatu Increase: Skin rash, splenomegaly, abscesses, dermatitis, gout, excessive bleeding, tumors, thickening of gums, jaundice, discoloration of skin, loss of digestive power, unconsciousness, redness of eyes, skin, and urine, craving for blood, and enlarged veins. Decrease: Liking for sour and cold foods, varicose veins, dry skin, and loss of luster of skin. Mamsa Dhatu Increase: Cervical tumors, enlarged cervical and other lymph glands, enlarged thyroid and abdomen, hypertrophy of cervical muscles, thighs, neck, lips, phallus and arms, and buttocks appearing big and muscular. Decrease: Emaciation of buttocks, neck, abdomen, lips, chest and calves, dryness and pain in the organs, drowsiness, joint pains, weakness of organs, and varicosity of blood vessels. Meda Dhatu Increase: Mental confusion, breathlessness on little exercise, flabby buttocks, breasts, abdomen and back, oily skin, cough, breathlessness, and foul body odor.

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Decrease: Joint pain, drowsiness, weakness, emaciation, reduced abdomen, numbness in lower back, splenomegaly, numbness of joints, dryness of body, and affection for oil and flesh. Asti Dhatu Increase: Excessive bone growth and extra teeth. Decrease: Loss of body hair, scalp hair and beard nails, loss of teeth, tiredness, weakness of joints, pain in bones, breaking of teeth and nails, and dryness of body. Majja Dhatu Increase: Heaviness of eyes and body, and non-healing ulcers over joints. Decrease: Weak and light bones, disease of bone due to aggravated vata, reduced semen, joint pains, and numbness. Shukra Dhatu Increase: Formation of stones of semen, excess semen, and increased sexual desire. Decrease: Weakness, dryness of mouth, paleness, tiredness, lethargy, impotency, absence of ejaculation of semen, pain in testes and penis, reduced sexual power, premature scanty, and blood-stained ejaculation of semen.

1.2.4.2  Formation of the dhatus Rasa dhatu is formed directly from ahara rasa (the nutrient portion of food obtained from the digestive process). The rasa dhatwagni (the metabolic fire within that tissue) further processes the rasa tissue, producing the plasma and lymph that circulate throughout body as well as components of its successor tissue, rakta dhatu. The metabolic fire within those components (rakta dhatwagni) then complete the transformation of rasa into blood. The formation of the other tissues proceeds step-by step from the initial creation of rasa (the first tissue) to the production of rakta (the second one) and continues until the last one (shukra) is generated.

34  History, Present and Prospect of World Traditional Medicine Table 1–2    Upadhatus and malas produced during dhatu formation. Dhatu

Upadhatus

Malas

Rasa Dhatu

Breast milk, menstrual fluid

Kapha

Rakta Dhatu

Tendons, blood carrying vessels

Pitta

Mamsa Dhatu

Muscle fat, skin layers

Excretions from ears, nose, eyes, genitals

Meda Dhatu

Ligaments and joints

Sweat

Asthi Dhatu

Teeth

Hair, nails

Majja Dhatu

N/A

Shukra Dhatu

N/A

Oiliness of skin, eyes, N/A

During the formation of dhatus, upadhatus (secondary tissues) and malas (waste products) are produced. Table 1–2 shows the secondary tissues and waste products associated with the various dhatus.

1.2.4.3  The impact of dosha imbalances on the dhatus Doshas imbalances are usually reflected in the dhatus that they govern, where they can lead to dosha-specific diseases. For example, pitta diseases typically involve the blood; vata diseases, the bone; kapha diseases, the plasma. That said, a doshas can enter any tissue and cause various diseases.

1.2.5  Ojas (essence of dhatu) The ultimate essence of all the dhatus is known as ojas. As the body’s source of biological strength, vitality, and immunity, ojas determines a person’s vigor and resistance against disease. The word ojas means “shining, bright, or full of luster.” While it is present throughout the body, its main seat is the heart. In terms of its qualities, ojas is described as white with yellowish and reddish tinge, cold, oily, soft, smooth, steady, sweet, heavy, viscid, and clear. Ayurvedic texts refer to two kinds of ojas: Para ojas — Located in the heart, it consists of eight drops. Its loss leads immediately to death.

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Apara ojas — Circulates all over the body. Its volume is approximately that of a fist (10 –15 mL). All the activities of all cells, tissues, and organs depend on ojas. If ojas is diminished or absent, the tissue won’t function properly. Increased ojas makes a person happier, stronger, and more energetic. Disorders of Ojas Injury, overexertion, and psychological disturbances such as anger, sorrow, fear, and worry can all lead to disorders of ojas. These include the following: Ojo visramsa — Displacement of Ojas from its own site. Symptoms include pain, dull complexion, dislocation of joints, inactivity, and disturbance of doshas. Ojo-vyapat — Ojas is disturbed by one or more doshas. Symptoms include emaciation, wasting, weak digestive power, exhaustion, edema of vata type, splitting pain, excessive sleep, drowsiness, dizziness, and fainting. Ojo-kshaya — Decrease of Ojus. Weakness, exhaustion, dull complexion, dryness of skin, weak digestive fire, fear, disorders of sensory and motor system, impaired thinking, blindness, wasting of muscles, fainting, delusions, delirium, and loss of consciousness, sometimes leading to death.

1.2.6  Malas (waste products) The word mala means “dirty” or “unclean” and refers to excretable products of the body. The body produces two kinds of malas: ahara malas (food wastes) and dhatu malas (tissue wastes). Ahara malas comprise purisha (feces), muthra (urine), and sweda (sweat). According to Ayurveda, these waste products help maintain health as long as they are properly eliminated and normal in their quantity, qualities, and functions. Malas play a vital physiological role — their extreme depletion may lead to death. The signs and symptoms of imbalances in the malas are listed below: Signs and symptoms of increased feces Flatulence, heaviness, and pain sides of chest and abdomen.

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Signs and symptoms of decreased feces Pain in cardiac region and back, intestinal pain, shifting pain due to vata in the sides of chest, backache. Signs and symptoms of increased urine Pricking pain in urinary bladder, feeling of incomplete excretion of urine, increased urine output, frequency of micturition, and flatulence. Signs and symptoms of decreased urine Painful micturition, discoloration of urine, excessive thirst, dryness of mouth, pricking pain in urinary bladder, decreased urine output, and blood in the urine. Signs and symptoms of increased sweat Excessive sweating, bad smell to skin, and itching. Signs and symptoms of decreased sweat Loss of body hair, numbness, dry cracked skin, abnormal sensation, and decreased or absent sweating.

1.2.7  Agni (transinformatory energy) Agni (digestive fire) is the force responsible for digesting, absorbing, and assimilating everything that the body takes in. It resides chiefly in the kostha (gastrointestinal tract) and dhatus (tissues). Any imbalance in the function of agni can lead to disease. Agni has a profound influence on the individual’s lifespan and health span. In addition to digestion and metabolism, it controls sensory perceptions, intellectual functions, and the transformation and assimilation of mental and emotional impressions. Agni fuels the production of various types of enzymes in the gastrointestinal tract and in the liver and in the tissues. The 13 different types of agni that govern digestion of food and metabolism at different levels fall into the following three categories: Jatharagni — This is the primary digestive fire located in the stomach (amashaya) and duodenum (grahani) of the small intestine. Bhutagni — These five types of agni correlate with the pancha mahabhutas (five elements). Their role is to metabolize and transform external heterogenous mahabhutas into internal homogeneous ones. Dhatvagni — The seven dhatvagni reside in the body’s tissues. They help in assimilation and transformation of nutrient materials after processing in the liver (bhutagnipaka).

History, Present and Prospect of Ayurveda  37

Weak agni undermines digestive functions, resulting in malabsorption and the accumulation of ama (digestive and metabolic toxins). Due to its central role in the body’s digestive and metabolic functions, disturbances of agni are considered the most critical factor in the development of disease. One of the core treatment principles in Ayurveda is to restore and to strengthen the patient’s agni. When the doshas are in a state of equilibrium, agni functions normally. When there is imbalance in the functioning of doshas, the functioning of agni is impaired. These states are described below: Vishamagni — This state stems from excess vata. It is characterized by erratic digestion that ranges from slow to normal and may also include symptoms such as abdominal distension, colicky pain, constipation, heaviness, and gurgling sounds in the intestinal tract. This type is seen in individuals with Vata-predominant body constitution. Tikshnagni — The predominance of the pitta dosha fuels extremely sharp and strong agni that can quickly digest large frequent meals. This type of digestion may be followed by a burning sensation in the abdomen and the palate, parched lips, and a feeling of heat. This type is seen in individuals with Pitta-predominant body constitution. Mandagni — This state of agni is mainly due to the influence of kapha. Agni in this state is very sluggish and sometimes unable to digest and metabolize even a small quantity of food. It also leads to heaviness in the abdomen and head, coughing, dyspnea, salivation, vomiting, and weakness of the body. This type is seen in individuals with Kapha-predominant body constitution. Samagni — This term describes balanced agni that can properly digest a normal diet. Before starting the treatment of any disease, all the effort should be made to balance the agni. The concept of agni and its role in digestion, metabolism, and assimilation is fundamental to the theory and practice of Ayurveda.

1.2.8  Ama (undigested metabolities) Ama is the undigested, toxic, foul-smelling, viscid, sticky substance formed as result of weak digestive fire such as weak jatharagni or

38  History, Present and Prospect of World Traditional Medicine

dhatvagni. Ama is considered as the root cause of the diseases. The undigested food is not easily absorbed and remains in the gastrointestinal tract where it stagnates and acts like a poison. There are many factors that can cause weak digestive fire: quantity of food — excessive food intake, quality of food — intake of excessive fluids and dry, heavy, cold, contaminated food, improper administration of panchakarma (detoxification therapies), suppression of natural urges, and abnormal season (aberration in the seasons).

1.2.9  Srotas (circulatory channels) Srotas are channels of circulation, where nutrients and other essential materials and energies are assimilated, transformed, and transported to and from the body’s organs and tissues. Within these structures, body elements are produced, nourished, transformed into other body elements, and catabolized, and metabolic wastes are carried out of the cells for elimination by the body’s excretory organs. The structure and functions of the srotas are deemed normal as long as the doshas, agni, and the dhatus are functioning normally. When damaged or impaired, however, srotas serve as a base for the production of a lesion or manifestation of disease. This typically occurs when a vitiated dosha spreads throughout the network of channels and comes into contact with a defective srotas. The disturbed dosha may then settle there, creating the conditions for the development of a disease. The various causes of defective srotas include the following: Kulaja (heredity) — the cause of an impairment that’s linked to the genetic makeup of a person’s mother or father. Jataja (teratogenicity) — improper diet and lifestyle of a pregnant women that produces a defect in the system. Aharaja (dietary causes) — irregularities in diet and daily regimen that cause imbalances in the doshas, dhatus, or other aspects of a person’s constitution, setting the stage for disease. Agantuja (external causes) — factors such as excessive heat or cold or toxins that produce imbalances in the doshas or dhatus or other aspects of the person’s constitution, leading to diseases.

History, Present and Prospect of Ayurveda  39

Shesha doshaja (remnant causes) — improper management of an existing disease that causes relapse of that diseases or new diseases. The classical Ayurvedic text, the Charaka Samhita, describes the body’s major systems in terms of 13 srotas: Pranavaha srotas (respiratory system), Annavaha srotas (digestive system up to small intestine), Udakavaha srotas (water metabolism system), Rasavaha srotas (body nourishing fluid system), Rakthavaha srotas (cardiovascular system), Mamsavaha srotas (muscular system), Medovaha srotas (fatty tissue system), Asthivaha srotas (bony tissue and skeletal system), Majjavaha srotas (bone marrow/nervous system), Sukravaha srotas (reproductive system), Mutravaha srotas (urinary system), Purishavaha srotas (defecation system), and Swedavaha srotas (perspiratory system). In another foundational Ayurvedic text written later, the revered physician Sushruta delineated 11 srotas, excluding the asthi vaha srotas and majja vaha srotas, and introducing a system called the artava vaha srotas (channels for transporting nutrients to the female reproductive tissues). Ayurveda also recognizes two other srotas: Manovaha srotas (system of mind) and Stanyavaha srotas (lactation system).

1.2.10  Manas (mind) According to Ayurveda, the mind is considered as the controller of the sense faculties. Ayurveda explains that mind plays a major role in the knowledge of happiness and unhappiness, etc., and it is Atindriya-Transsensual. It has been considered as the controller of sense faculties. The mind is part of a person, consisting of thoughts, feelings, and the function of willing. There are three qualities of Mind explained in Ayurveda: Satva-state of balance, harmony and stability; Raja-Incharge of activity; Tamas-leads to inertia. Satva Guna makes the mind more conscious. Our eternal Self could be discovered by pure Satva. Raja and Tamas cause disharmony, agitation, and delusion in mind. Raja makes the difference in perception of the mind as it perceives false ideas of the external world and makes the impression like real. This may

40  History, Present and Prospect of World Traditional Medicine

temporarily cause happiness for some time but lose the inner peace in longer run. Desires and emotional upsets are caused by Raja. Rajas is in charge of activity of the mind. Ignorance comes from Tamas. Adequate balance of these three Guna is very much essential as Satva makes balance in the energy of Raja, while stability with Tamas. According to Ayurveda, brain and heart are the seat or location of mind. Peace of mind, sensory satisfaction, and positive mind play a major role in healthy life. Disturbances in the balance of quality of mind cause various disorders in the functioning of mind, which can lead to various psychological and physiological disorders. According to Ayurveda, the body and the mind are connected.

1.2.11  Ayurvedic treatment approaches Ayurveda defines health as a state in which an individual sustains the balance between the 3 doshas, the 7 dhatus, the 3 malas, and the 13 agnis that is ideal for his or her constitution. In this state, the person experiences total biological equilibrium along with sensorial, mental, emotional, and spiritual well-being. Ayurvedic teachings help individuals achieve this healthy balance by providing comprehensive guidance on lifestyle, diet, exercise, and personal and social behavior, as well as detailing daily, nightly, and seasonal routines that are specifically designed for their unique constitution. Ayurveda also promotes health through the use of various types of rejuvenating (rasayana) herbs and therapies and detoxification therapies (panchakarma). These treatment approaches are based on a holistic understanding of the various factors that cause imbalances of the doshas, dhatus, and malas. According to Ayurveda, the primary cause of all disease is a lack of harmony between the individual and his or her environment. Thus, malfunctions of kala (time), such as unseasonable weather and improper use of budhi (the intellect) or indriyartha (objects of five sense organs) can be considered causes of disease. The Ayurvedic approach to diagnosis is a two-fold process: examination of the patient and examination of the disease. Examination of the patient helps the clinician determine and understand the prognosis of the disease and to decide how to manage it. This part of the diagnostic process

History, Present and Prospect of Ayurveda  41

entails an assessment of 10 aspects of the patient: constitution, imbalance, quality of tissues, compactness of the body, anthropometric data (e.g., weight, height, etc.), adaptability, mental stamina, digestive power, physical strength, age, and rate of aging. This assessment provides the clinician with a general picture of the patient’s constitution and the status of his or her health and vitality. The second part of the diagnostic process is carried out in order to identify the patient’s present disease. This threefold process includes the following: patient interview (to determine the chief complaint and obtain a health history), general examination (observation of the patient’s pulse, tongue, voice, skin, eyes, urine, stool, general appearance, etc.), systematic examination of the whole body, including the channels. Ayurveda’s approach to restoring the balance of doshas, dhatus, malas, and agnis draws on the principle of samanya and vishesha (similarity and dissimilarity). According to this principle, materials that are similar to various constituents of the body strengthen those constituents and dissimilar materials deplete them. Based on this principle, Ayurveda recommends dietary, lifestyle, behavioral, and psychological interventions with qualities that are either similar or different from the qualities of the patient’s dosha, dhatus, or other constituents, depending on whether they are depleted or present in excess. The entire approach is individualized to restore balance to the body and mind of each patient. Ayurvedic Medicine encompasses three main categories of interventions: daivavyapashraya (divine therapy), yukthivyapashraya (rational therapy), and sattvavajaya (psychotherapy). Divine therapy includes chanting, offering oblations and prayers, and wearing stones with special properties. Psychotherapy aims to support the mind, and rational therapy strives to restore balance by recommending strategies based on tridoshic theory and on the state of the patient’s agni and other indications of his or her health status. The rational therapy comprises of two parts: samshodhana (purificatory therapy) and samshamana (curative treatment). The purificatory therapy aims to clean the channels of the body to facilitate absorption of nutrients and herbs. It is practiced in two forms: external purification such as oleation, fomentation, and massage to liquefy the impurities and push them to gross channels from where they get easily excreted using internal purificatory therapies and internal purifications (panchakarma), which consists of vamana (emesis), virechana

42  History, Present and Prospect of World Traditional Medicine

(purgation), anuvasana vasti (oil enema), asthapana vasti (decoction enema), and nasya (nasal cleansing). When a disease is present, purificatory therapy is followed by specific curative treatment. This typically consists of herbs, diet and lifestyle practices that are appropriate for the patient’s constitution and the state of his or her dosha, dhatus, malas, and agni. The classical texts of Ayurveda contain detailed explanations on how to achieve its twin goals of protecting the health of healthy persons and managing disease in persons suffering from disease. In addition to recommending daily and seasonal routines, practices that promote physical and emotional balance and a code of proper conduct and three pillars of health (traya upastamba) are also explained.

1.2.12  Traya upastamaba (three supportive pillars) Ayurveda identifies three supportive pillars/values for the maintenance of life and health: Ahara (food), Nidra (sleep), and Brahmacharya (positive lifestyle).

1.2.12.1  Ahara (food) The adequate growth and maintenance of body depend on a healthy and balanced diet. Ayurveda provides detailed advice about wholesome food and describes a wide variety of foods and drinks and methods of preparation, as well as a code of discipline that should be followed while eating, and factors that need to be considered when cooking food. In Ayurveda, ingredients used for food and drinks have been classified into the following 12 groups: Sukadhanya (corn with bristles), Samidhanya (pulses), Mamsa (meat), Saka (vegetables), Phala (fruits), Harita (vegetables eaten raw), Madya (wines), Ambu (water), Gorasa (milk and milk products), Iksuvikara (products of sugarcane), Kritanna (cooked food preparations), and Aharayogin (other supplies used for cooking food such as oil, spices, salts). According to Ayurvedic wisdom, one’s diet should be easily digestible, simple, small in quantity, and sattvik (balanced). One must always give thought to agni (digestive power) before consuming food. When taking food, one should fill half of the stomach with solid food, one fourth

History, Present and Prospect of Ayurveda  43

with liquids, and leave the rest of the stomach empty. This will promote easy digestion of food. One must consume food containing different rasas (tastes) so that all the doshas will be balanced. One must pay attention to the quality and quantity of the food. The proper choices may vary from person to person. When planning and eating meals, individuals must also consider the potential effects on their constitution of the combination of foods, the method of preparing and eating the food, and their emotional state during the meal. The following factors play a significant role in determining the makeup of a balanced diet: Matra (quantity), Kala (time of the day or season), Kriya (mode of preparation or cooking), Bhumi (habitat or place or climate), Deha (constitution of person who will consume the diet), and Desa (body and environment). Ayurvedic Medicine also considers the issues surrounding dietary incompatibility. It advises against eating foods that present any of the following issues: combinations of foods with biological qualities that conflict with one another, foods that are incompatible with your constitution, and foods that are incompatible with the place or time of consumption. All the factors outlined above can be used to determine the wholesomeness or unwholesomeness of various foods. In addition, Ayurveda identifies eight other factors that should be considered: Prakriti (nature of food articles), Karana (method of processing), Samyoga (combinations), Rasi (quantity), Desa (habitat or climate), Kala (time), Upyoga samstha (rules for governing intake of food), and Upyokta (wholesomeness of the individual who is taking food). Other important considerations include the impact of processing/cooking food. The qualities of food may be transformed in ways that can either enhance or degrade the food’s wholesomeness by activities such as diluting, applying heat, cleaning, churning, storing, maturing, and flavoring. Ayurveda also lays out 10 rules for governing the intake of food: one should eat warm food; one should consume unctuous food; one should take food in the proper quantity; one should wait to consume a meal until the previous meal is digested; one should avoid food with contradictory properties; one should eat in the proper place and use the appropriate utensils; one should not eat too hurriedly; one should not eat too slowly; one should

44  History, Present and Prospect of World Traditional Medicine Table 1–3    The effects of the 6 tastes on the 3 doshas. Taste

Effects on Doshas

Madhura (sweet)

Increase kapha/decrease vata and pitta

Amla (sour)

Increase kapha and pitta/decrease vata

Lavana (salty)

Increase kapha and pitta/decrease vata

Katu (bitter)

Increase vata and pitta/decrease kapha

Tiktha (pungent)

Increase vata and pita/decrease kapha

Kashaya (astringent) Increase vata/decrease kapha and pitta

avoid talking or laughing while eating and focus solely on the food; one should take food in the prescribed manner, with due regard for oneself. Individuals are also advised to give thought to the effects that various foods may have their constitution in terms of their weight. For instance, foods classified as brahmana samanya have properties like heaviness, unctuousness, and coldness that can lead to increase in tissue and body weight. Foods called langana samanya, on the other hand, tend to reduce tissue and body weight. Other properties such as taste can have a profound impact on an individual’s dosha, dhatus, malas, and agni. Ayurveda delineates a total of six tastes. Table 1–3 shows the effects of the six taste on the three doshas.

1.2.12.2  Nidra (sleep) Proper sleep endows the individual with happiness, nourishment, strength, vitality, knowledge, and longevity. Improper sleep, untimely sleep, and excessive sleep cause various imbalances in the body. Ayurveda has described in detail the mechanisms of sleep and its qualities. It advises against sleep during the daytime in a season other than summer. Sleeping during the daytime in all seasons is recommended for only those people who are exhausted by singing, study, alcoholic drinks, sexual acts, elimination therapy, carrying heavy loads, walking long distances, suffering from wasting diseases, thirst, diarrhea, colic pain, dyspnea, hiccups, or psychosis, and for those who are very old or very young, weak, or emaciated, as well as for those injured by a fall or an assault, exhausted by a

History, Present and Prospect of Ayurveda  45

long journey in a vehicle or by anger, grief, or fear, and for those who are accustomed to daytime sleep.

1.2.12.3  Bramacharya (positive lifestyle) Ayurveda teaches that living a long and healthy life requires practicing restraint in regard to sex and worldly pleasures. Classical literature in Ayurveda also includes extensive discussion on the two other aspects of good conduct that promote health and happiness: Sadvritta (mental and social health), Swasthavrtta (healthy lifestyle).

1.2.13  Swasthavrtta (healthy lifestyle practice) Ayurveda proposes that swasthavritta (a healthy regimen) is the key to a balanced life. This regimen spans three categories of routines. The ancient Ayurvedic literature gives detailed instructions on how each of these should be conducted: Dinacharya (daily routine), Ratricharya (night routine), and Ritucharya (seasonal routine).

1.2.13.1  Dinacharya Ayurvedic instructions for a balanced daily routine are as follows: One should get up from bed before sunrise. He or she should attend to natural calls and should wash his face, hands, and excretory orifices properly with clean water. The individual should clean the mouth and teeth. The teeth should be cleaned with the help of fresh wooden stick with astringent, bitter or pungent taste (top portion is crushed) without damaging gums. After this, one should clean his tongue using tongue cleaner made of gold, copper, or silver, which should be about 10–15 cm long. Eyes should be cleaned with cold water. After drying the eyes, one must apply anajana (collyrium) to promote good vision. One should use nasal drops (anu tailam can be used) daily to protect the sensory organs and organs above the shoulder. Gargling with oil or decoction is beneficial for the strength of jaws and teeth and to protect the sensory organs. One must also put the oil drops in the ears to prevent the diseases due to vitiated vata and to protect the ears. One who applies oil on his head regularly won’t suffer from headache, baldness,

46  History, Present and Prospect of World Traditional Medicine

early greying of hair, and hair loss. It also helps to protect all the sensory organs. One must apply oil all over the body and massage the body to protect the body and to have healthy skin and happiness. One must engage in daily exercise to achieve body stability and physical and biological strength. One must pay attention to his own strength to decide on the intensity of the exercise. After exercise, one should take a bath. A bath should be taken twice a day and an attempt should be made to clean all of the body. Beard and nails should be cut thrice a fortnight. One should wear clean cloths and use natural perfumes and garlands. One should wear gems and ornaments to have a charming effect and happiness. One should use footwear while walking to protect the feet from attacks of reptiles, thorns, etc. One should eat in proper quantity, paying attention to agni. (The previous section includes detailed explanations about food.) One should engage in smoking the cigars that are made up of plant powders. It helps create a feeling of lightness in the chest and head and promotes the liquification of kapha.

1.2.13.2  Ritucharya The regimen of life in different seasons is described in this section of the text. This regimen will help the body to overcome the seasonal challenges and prevent the diseases that occur due to seasonal changes. According to the time factor, the whole year is divided into two parts: uttarayana, or adanakala (northward movement of Sun and its act of dehydration), which bring about three seasons (late winter, spring, and summer), and dakshinayana, or visargakala (southward movement of Sun) and its act of hydration that give rise to the other three seasons (rainy season, autumn, and early winter). The changes in the body that happen during these times influence the doshas, dhatus, agni, and malas. These practices aim to preserve the equilibrium of these biological energies.

1.2.13.3  Ratricharya Conduct during night is explained in this section. Ayurveda explains different types of sleep and measures to induce good sleep. Proper sleep endows the individual with happiness, nourishment, strength, virility, knowledge, and longevity. Improper sleep causes emaciation, weakness, ignorance, and

History, Present and Prospect of Ayurveda  47

even early death. Ayurveda recommends avoiding day sleep, and advises that only certain people can indulge in day sleep (please refer the previous section about sleep). Certain measures are explained to induce good sleep. Massage, bath, intake of soup of domestic marshy, aquatic animals, rice with curd, milk, unctuous substances, and alcohol, smell of fragrance, calming the mind, application of soothing ointment to the eyes, head, and face, and a comfortable bed and home, will help induce good sleep. Food should be taken as early as possible during night. One shouldn’t go to sleep immediately after a meal at night. Food should be light and easily digestible. Intake of curd during night is prohibited; it may affect digestion and metabolism.

1.3  Present status of Ayurveda in India 1.3.1  Introduction The traditional health systems that are officially recognized in India include Ayurveda, Yoga, Unani, Siddha, Homeopathy, and so on, which are represented by the acronym AYUSH. (Since Homeopathy is not indigenous to India, the acronym AYUSH in reference to the present article does not include Homeopathy.) AYUSH systems have been absorbed into the national healthcare delivery system in India and are integral parts of it. However, the mainstream healthcare system remains conventional biomedicine, known also as Western medicine, biomedicine, or allopathy. Although, all AYUSH systems run parallel to Western Medicine in terms of education and practice, some steps toward integration have been taken of late.[8]

1.3.1.1  Official incorporation of AYUSH systems into the national healthcare system Prior to Indian independence, vaidyas (Ayurveda practitioners) were largely unsanctioned by official governing boards, with the exception of a few provincial boards that recognized specific qualifications. Once Western Medicine received official recognition from the colonial rulers, and as its acceptance grew, Ayurveda had to reinvent itself in order to maintain its relevance. The home-based Ayurvedic pharmacies were slowly converted into bulk drug manufacturing units, and commercial

48  History, Present and Prospect of World Traditional Medicine

production of formulations started. Even after independence, it took more than 20 years to formally integrate Ayurveda, Unani, and Siddha into the national healthcare system. More than seven expert committees were formed by the government and were asked to furnish their reports. The committees’ reports represented different priorities and points of view. The important committees and their recommendations have been summarized in Table 1–4.[9]

Table 1–4    Summary of major recommendations of seven expert committees concerning the education and practice of ayurveda and other indigenous systems of medicine (ISM). Committee

Year

Recommendations and Actions

Bhore Committee

1946

Headed by Sh. Joseph Bhore: suggested the rapid expansion of biomedicine and recommended that the provincial governments be asked to determine the role of ISM in public health

Sokhey Committee

1946

Recommended integration of practitioners of Ayurvedic and Unani systems of medicine into state health organizations after providing them with further scientific training

Chopra Committee

1948

Proposed including concepts and methods of ISM in the education system; integrating standard research methods, production parameters, and biomedical techniques into ISM; and teaching ISM and Western Medicine together

Pandit Committee

1951

Finalized recommendations of Chopra Report: rejected proposed integration of ISM and Western medical training but strongly advocated adoption of standard research methods by ISM, resulting in establishment of the Central Institute of Research in Indigenous Systems of Medicine and the Postgraduate Training Center for Ayurveda, both in Jamnagar, Gujarat, in 1952

Dave Committee

1956

Recommended developing a single integrated syllabus model for colleges comprising five and a half years of coursework for ISM physicians; proposed establishing a council similar to Medical Council of India for ISM and a registration process for “hereditary physicians.” These proposals were not adopted, and each state continued to regulate education independently

History, Present and Prospect of Ayurveda  49 Table 1–4   (Continued) Committee

Year

Recommendations and Actions

Udupa Committee

1958

Considered issues surrounding the quality of education for ISM practitioners and the quality and standardization of Ayurvedic pharmaceuticals

Mudaliar Committee

1962

Rejected the integrated medical model and insisted on teaching and practicing traditional medicine in “pure” form. This eventually led to the establishment of Central Council for Research in Indian Medicine and Homeopathy in 1969

Vyas Committee

1963

Worked on framing a curriculum comprising four years of Ayurvedic training without any courses in modern medicine and science in keeping with recommendation to establish “shuddha” (“pure”) Ayurveda

Sampurnananda Committee

1964

Recommended development of Ayurveda-oriented syllabus and decided that eligibility criteria for Ayurvedic training should include intermediate pass of Sanskrit exam and satisfactory command of English; proposed that modern science course be made optional

The four non-allopathic systems of medicine — Ayurveda, Unani, Siddha, and Homeopathy — were legally recognized in the 1970s. Before the enactment of Indian Medicine Central Council (IMCC) Act in 1970, several state governments had passed various legislation establishing the requirements for Ayurvedic degrees and regulating the practice of indigenous medicine. The earliest statute appears to be the Board of Indian Systems of Medicine Act in 1947, Mysore State, followed by the East Punjab Ayurvedic and Unani Practitioners Act in 1949. Chennai, Maharashtra, Hyderabad, the Andhra area, enacted their own legislation. The Andhra Ayurvedic & Homeopathic Medical Practitioners Registration Act in 1956, was specifically introduced to regulate and recognize practitioners in the Andhra area. In 1964, a special chapter, Chapter IV A, was included under the Drugs & Cosmetics Act 1940.[10] At present, the education and practice of the Ayurveda, Siddha, and Unani (ASU) systems of medicine is regulated by the Central Council of Indian Medicine (CCIM), a statutory organization established by a central

50  History, Present and Prospect of World Traditional Medicine

enactment. The medicine system (popular in the Himalayan region), was included in the regulations of CCIM in 2011. The Central Council of Homeopathy (CCH) oversees the education and practice of Homeopathy. Yoga and Naturopathy are also taught throughout the country by different institutions, however, there is no central registry maintained for registration of the practitioners of these systems.[10] The Central Government established an independent Department for the Indian Systems of Medicine & Homeopathy in 1995. The Department of ISM & H was renamed AYUSH in 2003. The status of this department was upgraded to that of an independent ministry in 2014. Among AYUSH systems, Ayurveda currently dominates the healthcare scenario in terms of the number of educational institutions, practitioners, hospitals, pharmacies, and dispensaries.[8]

1.3.1.2  Central Council of Indian Medicine (CCIM) Under the IMCC Act, 1970, the Central Council of Indian Medicine (CCIM) was established to ensure a standard and uniform ASU medical education system. It adopted the same framework as that of the Medical Council of India (MCI) under the MCI Act in 1956. A system for membership and election to the General Body and the Executive Body of the CCIM was also introduced. In the list of changes that aimed to bring the standards for traditional medical systems up to par with those for Western Medicine, the CCIM recommended the requirements for MBBS/BAMS/ BSMS and BUMS degrees include five and a half years of training.[10]

1.3.1.3  The National Commission for Indian Systems of Medicine (NCISM) Recently, the National Commission for Indian System of Medicine (NCISM) Act 2020) has come into effect from 11 June 2021, replacing the provisions of Indian Medicine Central Council (IMCC) Act 1970 (48 of 1970). It proposes to introduce a paradigm shift in regulation of ASU education in INDIA. Functionally, it is set to take over the role of CCIM. One of the important features is a new regulatory hierarchy comprising a commission, an advisory council, and various autonomous boards with a

History, Present and Prospect of Ayurveda  51

mandate to operate within specified domains. It proposed the establishment of two boards: one charged with ensuring ethics in education and practice and overseeing regulation of the registration process, and another responsible for assessing and rating of educational institutions. Another prominent feature is the replacement of the current norm of “elections” with a transparent merit-based “selection” process. This new selection process would apply to key positions on the Commission and its constituent boards. It also has replaced the current input-based regulatory mechanism with an outcome-based one. Other significant provisions include the following: the inclusion of experts in fields such as botany, pharmacology, management, economics, and law in the framework of the Commission, introduction of a national entrance examination to ensure a transparent merit-based admission process, the development of an examination to certify the competency of graduates to practice professionally and to enter postgraduate programs, and ongoing collaboration with the NMC to ensure interaction between all branches of healthcare delivery.[11] One of the important features of this bill is the introduction of a new regulatory hierarchy comprising a commission, an advisory council, and various autonomous boards with a mandate to operate within specified domains. The bill proposes the establishment of two boards: one charged with ensuring ethics in education and practice and overseeing regulation of the registration process, and another responsible for assessing and rating educational institutions. Another prominent feature of the draft is a proposal to replace the current norm of “elections” with a transparent merit-based “selection” process. This new selection process would apply to key positions on the Commission and its constituent boards. The draft also calls for replacing the current input-based regulatory mechanism with an outcome-based one. Other significant provisions of the draft include the following: the inclusion of experts in fields such as botany, pharmacology, management, economics, and law in the framework of the Commission, introduction of a national entrance examination to ensure a transparent merit-based admission process, the development of an examination to certify the competency of graduates to practice professionally and to enter postgraduate programs, and ongoing collaboration with the NMC to ensure interaction between all branches of healthcare delivery.[11]

52  History, Present and Prospect of World Traditional Medicine

1.3.1.4  Present status of Ayurvedic education in India According to the 2017 data, there are 11 national institutes operating under various AYUSH councils.[12] The following is an abridged list of officially recognized degree programs for Ayurvedic physicians: Graduate-Level Programs These programs, which comprise five and a half years of coursework leading to a Bachelor of Ayurveda Medicine and Surgery, are currently operating throughout the country under IMCC Act in 1970. Postgraduate-Level Programs These three-year programs provide advanced training in various specialties. Currently available postgraduate programs for Ayurvedic physicians span 22 fields of specialization. Postgraduate Diploma Programs These two-year programs span 16 specialty fields. Table 1–5 lists the courses taught to students training to become Ayurvedic physicians during the first four and half years of a graduatelevel program.[13] Table 1–6 provides a statistical breakdown of the population of registered practitioners across the four categories of AYUSH systems as of January 2017.[14]

1.3.1.5  Differences in education and practice The Ayurvedic, Unani, and Siddha systems vary considerably in their approach to education and practice. Ayurveda is practiced countrywide, and there are several approaches that derive from either regional/traditional custom or university-based training. For instance, the use of panchakarma procedures and botanical preparations is popular in southern India, whereas rasa shastra-based practice is more popular in the northern states. Public trust also differs widely across regions. The Unani system is more dominant in the pradeshes of Uttar Pradesh, Bihar, Andhra Pradesh, Maharashtra, Delhi. The practice of Siddha Medicine is mostly confined to the state of Tamilnadu.[10]

History, Present and Prospect of Ayurveda  53 Table 1–5    Subjects taught to graduate students of Ayurveda during their first 4.5 years of professional training. 1st Year Professional

English Equivalent

Padartha Vigyan evam Ayurved Itihas

Philosophy and History of Ayurveda

Sanskrit

Sanskrit

Kriya Sharir

Physiology

Rachana Sharir

Anatomy

Maulik Siddhant evam Ashtanga Hridaya

Basic Principles and Ashtanga Hridaya (an ancient Ayurvedic text)

2nd Year Professional Dravyaguna Vigyan

Pharmacology and Materia-Medica

Roga Nidana

Diagnostics and Pathology

Rasa Shastra

Iatrochemistry and Ayurvedic Pharmaceutics

Charaka Samhita

Sutrasthana, Nidanasthana, Vimanasthana, Sharirasthana, and Indriyasthana

3rd Year Professional Agadtantra Vyavahar-Ayurved evam Vidhivaidyak

Toxicology, Forensic Medicine, and Medical Jurisprudence

Swasthavritta

Preventive and Social Medicine

Prasuti Tantra evam Stri Roga

Obstetrics and Genecology

Kaumarbhritya Parichaya

Introduction to Ayurvedic Pediatrics and Child Care

Charak Samhita (Uttarardha)

Chikitsa, Kalpa, Siddhi Sthana

4th Year Professional Kayachikitsa

General Medicine

Panchakarma

Five Basic Therapeutic Procedures

Shalya Tantra

General Surgery

Shalakya Tantra

Diseases of Eye, Nose, Ear, and Throat

Research Methodology and Medical Statistics

—

54  History, Present and Prospect of World Traditional Medicine Table 1–6    The number of registered practitioners of AYUSH systems in India. Registered Practitioners

Ayurveda

Unani

Siddha

Number

428,884

4,956

68,505

2,242

284,471

773,668

Percentage

55.40%

6.40%

1.10%

0.30%

36.80%

100%

3,221

372

64

17

2,136

5,810

Number Per Core Population

Naturopathy Homeopathy

Total

1.3.1.6  Central Council of Research in Ayurvedic Sciences: A Government Controlled Research Council The Central Council for Research in Ayurveda (CCRA) was set up as an advisory body in 1962, and the Central Council for Research in Indian Medicine and Homeopathy (CCRIM&H) was established in 1969. The Central Council for Research in Ayurveda and Siddha (CCRAS), an apex body charged with formulating, coordinating, and developing research in Ayurveda and Siddha along scientific lines, was established in March, 1978. The purpose of its efforts was to validate Ayurvedic knowledge in “scientific terms.” In 2011, the CCRAS was renamed the Central Council for Research in Ayurvedic Sciences. The Council has been executing its research programs across a network of 30 peripheral institutes/centers/ units and has assigned responsibility for oversight of these programs to its headquarters. The Council relies on more than 700 officers and staff, as well as on collaborative studies with various universities, hospitals, and institutes to conduct its research. CCRAS programs span a wide variety of research areas, including Clinical Research, Fundamental Research, Pharmacology (Pre-clinical Safety/Toxicity and Biological Activity Studies), Medicinal Plants (Medico-Ethno Botanical Surveys, Cultivation, Pharmacognosy), Drug Standardization, and Literature Reviews, and Documentation.[15]

1.3.1.7  National policy on Indian systems of Medicine and Homeopathy (2002) While the efforts to systematize the development and propagation of Ayurvedic, Unani, and Siddha Medicine gained momentum through the

History, Present and Prospect of Ayurveda  55

creation of an independent department, the first ISM health policy was announced only in 2002. It spoke of mainstreaming the AYUSH sector across all aspects of education, research, and practice.

1.3.1.8  The establishment of National Medicinal Plants Board (NMPB) In order to promote the medicinal plants sector, the Government of India set up the National Medicinal Plants Board (NMPB) on 24 November 2000. Currently the board is located in the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy), Government of India. The primary mandate of NMPB is to develop an appropriate mechanism for coordination between various ministries/departments/organizations in India and to implement support policies/programs for overall (conservation, cultivation, trade, and export) growth of medicinal plants sector at both the central/state and international levels.[16] To meet the increasing demand for medicinal plants, the NMBP focuses on in situ and ex situ conservation and on augmenting local medicinal plants and aromatic species of medical significance. The NMPB also promotes research and development, capacity building through training, and raising awareness through promotional activities like creation of home/school herb gardens. NMPB also supports programs for quality assurance and standardization through development of Good Agricultural and Collection Practices (GACPs), development of monographs laying down standards of quality, safety, and efficacy, and development of agro-techniques and credible institutional mechanism for certification of quality of raw drugs, seeds, and planting material. The NMPB’s overall aim is to develop the medicinal plants sector through strong collaboration between various ministries/departments/organizations charged with implementing policies/programs that address that sector’s concerns.[16]

1.3.1.9  Traditional Knowledge Digital Library (TKDL) Traditional Knowledge Digital Library (TKDL) is an initiative to prevent misappropriation of India’s traditional medicinal knowledge at International Patent Offices. In 2005, the TKDL expert group estimated

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that about 2,000 inappropriate patents related to Indian systems of medicine were being granted every year at the international level. Since India’s traditional medicinal knowledge is documented in languages such as Sanskrit, Hindi, Arabic, Urdu, and Tamil, it is neither accessible nor comprehensible to patent examiners in international patent offices.[17] With the help of information technology tools and the innovative Traditional Knowledge Resource Classification (TKRC) system, the Traditional Knowledge Digital Library has been able to translate about 0.29 million medicinal formulations documented in the ancient texts of Ayurveda, Siddha, Unani, and Yoga into five international languages (i.e., English, Japanese, French, German, and Spanish). The TKRC has organized traditional Indian medicinal knowledge into approximately 25,000 subgroups for Ayurveda, Unani, Siddha, and Yoga. Under A61K 36/00, the TKRC has enabled incorporation of about 200 subgroups into International Patent Classification, far surpassing the limited number of subgroups on medicinal plants available under A61K 35/00 and thus enhancing the quality of searches and examination of previously filed patent applications in the area of traditional knowledge. TKDL has also been able to establish international specifications and standards for setting up TK databases. The Committee adopted these standards in 2003 in the fifth session of the Intergovernmental Committee (IGC) of World Intellectual Property Organization (WIPO) on Intellectual Property and Genetic Resources, Traditional Knowledge, and Expression of folklore.[17]

1.3.1.10  Good Clinical Practices guidelines Poorly designed study protocols have attracted a lot of criticism when it comes to clinical trials pertaining to Ayurveda. To overcome these constraints, the department of AYUSH created a set of Good Clinical Practice guidelines in 2013 that span every stage of the clinical trial process from the design, conduct, termination, audit, and analysis of the trial to clinical study reports and the documentation of the trial’s participants. The guidelines describe in detail the most essential scientific and ethical steps a researcher needs to follow while conducting a clinical trial.[18]

History, Present and Prospect of Ayurveda  57

1.3.1.11  Good Manufacturing Practices Guidelines In 2014, the department of AYUSH published a manual entitled Good Manufacturing Practice (GMP) Guidelines that was based on the requirements for ASU drug manufacturing units laid down by the Drugs and Cosmetics Rule 157 in 1945. GMP guidelines comprise a series of general principles that ASU pharmaceutical establishments must be observed during manufacturing. These guidelines ensure that raw materials used in the manufacture of drugs are authentic, meet prescribed quality requirements, and are free from contamination, that the manufacturing process conforms to the prescribed standards, that adequate quality control measures are adopted, and that the drug released for sale is of acceptable quality.[19]

1.3.1.12  Pharmacovigilance program for ASU&H drugs In the era of globalization, concerns are being raised regarding the clinical safety of contemporary ASU formulations. There is a prevailing misconception that all drugs of natural origin are safe. Other false assumptions include the belief that natural medicines ensure both safety and efficacy and that there is a little or no chance of drug interactions. Contrary to these beliefs, an increasing number of published case reports document potentially adverse effects associated with AYUSH interventions. To tackle this issue, the Ministry of AYUSH has initiated the Pharmacovigilance Program for ASU & H drugs.[20] The All India Institute of Ayurveda, New Delhi, is the National Pharmacovigilance Coordination Center (NPvCC) for implementation of the pharmacovigilance program for ASU & H Drugs. The NPvCC receives input in terms of suspected ADRs from the Intermediary Pharmacovigilance Centers (IPvCs). The National Pharmacovigilance Coordination Center undertakes the pharmacovigilance activities under the guidance and technical support of Indian Pharmacopoeia Commission (the WHO Collaborating Centre for Pharmacovigilance), and the relevant program officers at WHO Country Office-India. If required, the National Pharmacovigilance Co-ordination Center, in consultation with the Pharmacopoeial Commission of Indian Medicine and Homeopathy (PCIM&H), conducts the Causality Assessment of the signals received

58  History, Present and Prospect of World Traditional Medicine

from the Intermediary Pharmacovigilance Centers and then reports confirmed cases of Adverse Drug Reactions and misleading advertisements to the Ministry of AYUSH to enable suitable action.[20]

1.3.1.13  Tribal Health Care Research Program The Central Council for Research in Ayurvedic Science has initiated Tribal Health Care Research Program (THCRP) in 14 states through 15 institutes that operate under it. This program aims to study the living conditions of tribal peoples, collecting health statistics on tribal populations and studying their dietary habits, the nature and frequency of prevalent diseases, and the use of common medicinal plants in the area. It also strives to provide medical aid at the doorsteps of tribal peoples while also propagating knowledge of the Ayurvedic concept of Pathyapathya (wholesome and unwholesome food), including hygiene habits and dietary practices. It also collects information pertaining to LHTs/folk medicines/traditional practices prevalent in the area. This study has been implemented under TSP (Tribal Sub Plan) and, as of 2018, has covered approximately 842,959 people from 1,003 villages.[21]

1.3.1.14  The Swasthya Rakshan (preventive and promotive healthcare) Program The Swasthya Rakshan Program was initiated through Central Council for Research in Ayurvedic Sciences (CCRAS), the Central Council for Research in Unani Medicine (CCRUM), the Central Council for Research in Homeopathy (CCRH), and the Central Council for Research in Siddha (CCRS) in selected districts/villages. The program aims to organize Swasthya Rakshan outpatient departments, Swasthya Parikshan camps (Health camps), and health/hygiene awareness programs and to raise awareness of the importance of cleanliness of domestic surroundings and environment. It also documents the demographics, dietary habits, hygiene conditions, seasons, lifestyle, and incidence/prevalence of disease associated with each district.[22]

History, Present and Prospect of Ayurveda  59

1.3.1.15  Ayurveda mobile health care program Initiated under the Scheduled Castes Sub Plan (SCSP), this program provides door-to-door healthcare services in areas with officially recognized castes pockets.[22]

1.3.1.16  National program for prevention and control of cancer diabetes cardiovascular disease and stroke This program has been undertaken by the Ministry of AYUSH and Ministry of Health and Family Welfare to promote prevention of noncommunicable diseases in three identified districts of three pradeshes: Bhilwara (Rajasthan), Surendra agar (Gujrat), and Gaya (Bihar).[22]

1.3.1.17  Physical and functional integration of AYUSH in NRHM This initiative of the Department of Health and Family Welfare and Ministry of AYUSH aims to strengthen healthcare facilities in remote areas.[22]

1.3.1.18  National AYUSH Morbidity and Standardized Terminologies Electronic Portal (Namaste Portal) The Ministry of AYUSH has recently developed a comprehensive web portal for Standardized Terminologies and National Morbidity Codes of Ayurveda, Siddha, and Unani Systems of Medicine and WHO-ICD-10 and ICD-11. This aims at pan-India implementation of ASU National Morbidity Codes for reporting morbidity and treatment outcomes along with ICD10/11 (Dual Coding System), and is expected to serve as reference repository of A-S-U terminologies and Morbidity Codes for further development of ASU international terminologies and ICD-11 Morbidity Codes.[23]

1.3.1.19  Ayur prakriti web portal A standardized prakriti assessment scale has been launched by the Ministry of AYUSH in April 2018. It has been developed by conducting

60  History, Present and Prospect of World Traditional Medicine

one year study by eight peripheral centers of CCRAS. It aims at solving the problem of assessment of prakriti at Oot Patient Department level, which helps to prescribe medicine, diet, and lifestyle to maintain one’s health.

1.3.1.20  AYUSH Hospital Management Information System (A-HMIS) A comprehensive IT platform has recently been developed to effectively manage all functions of healthcare delivery systems and patient care in AYUSH facilities. The Ministry of AYUSH has created AYUSH GRID to bring all the IT projects under one umbrella. The platform integrates all IT projects that are dedicated exclusively to the improvement and facilitation of AYUSH healthcare delivery across India.[24]

1.3.1.21  Central sector scheme for promotion of Information, Education and Communication (IEC) in AYUSH This plan has been implemented under Schemes for Public Health initiatives scheme of AYUSH. Its main objective is to spread awareness among the public about remedies available in AYUSH system of medicine. This scheme has five components focusing on spread of knowledge in public.

1.3.1.22  Voluntary certification scheme for AYUSH products A voluntary product certification scheme for selected AYUSH products aimed at enhancing consumer confidence has been initiated by the ministry of AYUSH. The Quality Council of India (QCI) is the partner institute in this initiative. It offers two levels of certification: AYUSH Standard Mark, which is based on compliance to the domestic regulatory requirements, and AYUSH Premium Mark, which is based on GMP requirements, WHO Guidelines, and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria.

History, Present and Prospect of Ayurveda  61

1.3.1.23  Scheme for acquisition, cataloging, digitization and publication of text book & manuscripts of AYUSH Due to emerging demands for natural medicine and the process of globalization, a few initiatives in the AYUSH sector have been made through electronic means. Use of such information technology can add dimensions to the domain and scope for modernization of the AYUSH sector for its better accessibility to the stakeholders. All major classical textbooks have been made available in digital format for free use by National Institute of Indian Medical Heritage, Hyderabad, an institution that is governed by CCRAS.

1.3.1.24  E-Charak This acronym stands for E-Channel for Herbs, Aromatic, Raw Material, and Knowledge, and is a platform for enabling information exchange between various stakeholders involved in the medicinal plants sector. E-Charak has been jointly developed by the National Medicinal Plants Board (NMPB) and the Centre for Development of Advanced Computing (CDAC).[25]

1.3.1.25  AYUSH sector skill council This initiative is aimed at preparing a skilled workforce in the AYUSH sector. Under this initiative, the All India Institute of Ayurveda has developed curricula for different courses leading to different levels of certification, such as AYUSH Sports Therapist.

1.3.1.26  Research trends in Ayurveda Until recently, there were virtually no good peer-reviewed journals dedicated exclusively to publishing AYUSH research. This gap has now been filled by several journals that are indexed in standard databases such as PubMed and Scopus. According to Scopus data, approximately 6,321 articles have been published to date that contain the keyword “Ayurveda.” Of those, 4,274 came out in the last decade alone. Most of the articles on

62  History, Present and Prospect of World Traditional Medicine

Ayurveda that have been published, appeared in the Journal of Ayurveda and Integrative Medicine (J-AIM). Bulletin of the Indian Institute of History of Medicine and the Journal of Ethnopharmacology are the oldest publications among the top five journals.[26] Not surprisingly, most of the articles on indigenous Indian Medicine that are being published and indexed, are authored by the Indian researchers. Out of the approximately 6,300 published, 4,417 — around 70% of the total number — originated in India. The next largest number of articles (705) came from the US, followed by the UK with 193, while Germany, the sole European contributor, published 138 articles. Researchers from Japan, Australia, Sri Lanka, and Canada have published 91, 86, 75, and 71 papers respectively.[26] The majority of the articles published (3,141) fell under the category of medicine. Around 2,873 dealt with pharmacology and pharmaceutics, 975 related to biochemistry, genetics, and molecular biology, and 521 of the articles published fell under the category of agriculture and biological sciences. While researchers in chemistry and the social sciences contributed 269 and 251 papers, respectively, those in the allied health professions and nursing categories published only 179 and 157, respectively.[26]

1.3.1.27  Quality of research and research publications The quality of research in Ayurveda has long been a concern. The fundamental difficulty of testing the effectiveness of Ayurvedic interventions is rooted in the complexities of Ayurvedic diagnosis and treatment. Of late, however, a few models for conducting clinical trials without compromising the Ayurvedic approach to disease have been proposed that look promising. The problem of poor quality research also appears to stem from the failure of college and university level courses in Ayurveda to sufficiently stress the importance of following standard research protocols. The same training deficiencies are reflected in the scarcity of high-quality Ayurvedic research publications. These challenges must be tackled so that Ayurvedic research can become more visible and earn wider respect from the mainstream scientific community.[27]

History, Present and Prospect of Ayurveda  63

1.3.1.28  Challenges ahead: Education A 2009 nationwide survey of students and teachers from more than 30 colleges of Ayurveda raised concerns about the field’s lack of high-quality educational standards. The study suggested the curriculums of Bachelor of Ayurvedic Medicine and Surgery (BAMS) programs failed to deliver the skills that practitioners need. Participants complained that college syllabi lacked sufficient information on certain relevant topics such as intellectual property rights, standardization of medicinal products, toxicity of medicinal products, healthcare management, and cultivation of medicinal plants. The study also suggested that the Ayurvedic academicians were not following the accepted standard methods of research and documentation, and that the educational institutions should be urged to do more to shore up the evidence base for Ayurveda. In addition, survey respondents noted that Ayurveda graduates need more exposure to basic clinical skills in order to be able to deal effectively with the challenges of primary healthcare delivery. Since that time, the Central Council of Indian Medicine has introduced a series of curricular reforms designed to address these deficiencies. To determine their success, a critical evaluation of the present situation is now required.[28,29] Exhaustive field work conducted by Shailaja Chandra, the former Secretary of the Department of AYUSH, resulted in the 2011 and 2013 publication of a two-volume report titled “Status of Indian Medicine and Folk Healing, with a Focus on Benefits the Systems Have Given to the Public.” Since the report’s publication, many changes have been implemented that warrant re-evaluation of the situation described in the report.[9] A major concern raised by all these reports was that the mushrooming growth of substandard colleges was diluting the rigor of Ayurvedic medical training. Other concerns included the presence of corruption in the educational system, which manifested in the emergence of many colleges whose resources existed only on paper, and the failure of AYUSH faculty to provide undergraduates with a strong foundation in the biomedical sciences and insufficient hands-on training in clinical settings.[10]

1.3.1.29  Outcome-based education model Teaching/learning methods in Ayurveda have received negligible attention in the contemporary literature on Ayurvedic education. While serious

64  History, Present and Prospect of World Traditional Medicine

research in this area has been minimal, a few promising studies have been published recently. One study that looked at various integrative approaches to teaching and another on problem-based learning modules, pointed to the potential benefits of implementing these innovative methods in Ayurvedic educational programs.[30] Based on the requirements, NCISM have now implemented the outcome-based education model to the graduation level Ayurvedic program.

1.3.2  Present status of Ayurveda outside India 1.3.2.1  Clinical practice The historical and cultural diversity of various countries is a key source of the wide disparities among them in regard to the evolution and adoption of traditional indigenous medical systems such as Ayurveda. Differences in economic conditions, religious beliefs, government healthcare policies, and scholarly opinions also help account for these disparities. The current status of Ayurveda in countries outside India is reflected in its increasing visibility in forms ranging from Ayurvedic cooking methods and massage therapies, panchakarma centers, Ayurvedic spas, and yoga retreats to products such as nutrition supplements, herbal remedies, and aphrodisiacs. While these traditional Indian wellness applications have been enthusiastically embraced in many Western countries, most Westerners have yet to realize the value of Ayurveda as a medical system whose scope encompasses the prevention, treatment, and management of a plethora of diseases. In the US, Ayurveda is, at best, relegated to the category of complementary and traditional medicine; yet unlike many better known alternative medical systems such as chiropractic and acupuncture, Ayurveda is ineligible for health insurance coverage. Another potential barrier to its official recognition as a healthcare discipline in the West, is the presence of heavy metals in some traditional Ayurvedic remedies. While the therapeutic use of heavy metals has been extensively documented in Ayurvedic texts, these formulations violate the stringent drug-manufacturing norms that prevail in most Western countries. Due to the risk of toxicity from heavy metals like mercury, arsenic, and lead, the US, Britain, and the EU have banned the importation and sale of these preparations.[31]

History, Present and Prospect of Ayurveda  65

The Ministry of AYUSH has set up information centers in more than 30 countries to disseminate authentic knowledge of AYUSH systems. The Ministry has also signed a number of memorandums of understanding (MoUs) with various countries to encourage productive communication and cooperation among ISM stakeholders. WHO has played a key role in spreading Ayurvedic knowledge worldwide. Along the same lines, it has recognized Morarji Desai National Institute of Yoga (MDNIY) and Institute for Post Graduate Teaching & Research in Ayurveda (IPGTRA) as its Collaborative Centers in Traditional Medicine. As an initiative to standardize its terminology according to contemporary needs, a Project Collaboration Agreement (PCA) has been signed between the Ministry of AYUSH and the WHO, Geneva, for developing WHO Terminologies for Ayurveda, Unani, and Siddha. Various associations and organizations in different countries, led primarily by eminent Indian scholars, have been involved in the development of Ayurveda abroad. They mainly offer Ayurvedic treatments and training. To gain an overview of the status of Ayurveda globally, the countries can be broadly classified into four groups: India and Other SAARC Countries Ayurveda is indigenous to India and enjoys a strong foothold in other member states of the South Asia Association for Regional Cooperation (SAARC). As SAARC countries recognize Ayurveda as an independent medical system, they regulate its trade and practice standards through various Acts and statutes. Other Asian Countries Ayurveda and Traditional Chinese Medicine are recognized in many other Asia countries. While each of these countries has its own traditional medical system, Ayurveda still plays a major role in delivery of primary healthcare services. Developed Countries This group includes America, Europe, and Australia, where Ayurveda is widely practiced as a form of wellness therapy, with no official recognition or regulation. The medicines are sold more often as food supplements and cosmetics, without the intervention of any Ayurveda practitioner, often as over-the-counter (OTC) products. There are many educational institutions that offer Ayurveda courses in these countries, some with and some without accreditation and recognition. Europe and Other Countries Approximately 70–80% of Ayurvedic drugs are banned from import into the EU. Per the EU Directive for

66  History, Present and Prospect of World Traditional Medicine

Traditional Herbal Medicines (In 2005, only those drugs being sold as OTC products with a minimum of 15 years of documented use within the EU can be marketed there). The directive restricts the sale of newly developed Ayurveda drugs and all drugs that use animal products such as milk products and honey, including formulations containing metals and minerals along with herbal components. The opinion expressed in the directive deems these drugs a potential threat to public health as well as to the reputation of the healthcare system. Despite these concerns about the safety of traditional medicines, the majority of medical tourists who visit India are Europeans with various chronic disorders seeking treatment with Ayurvedic therapies and medicines.[31] Other Countries A large number of consumers of Ayurveda treatment and services reside in Africa, Latin America, Russia, and other Commonwealth of Independent States (CIS). Ayurveda is recognized as an alternative system of medicine in these regions, and various Ayurvedic services are popular there.

1.3.2.2  Education Australia The evolution of Ayurveda in Australia dates back to 1970s when the First International Congress on Traditional Asian Medicine, known as ICTAM, was organized. This event initiated a dialogue between stakeholders in various traditional medicine systems around the globe. It was followed by the establishment of the International Association for the Study of Traditional Asian Medicine (ASTAM) by the Australian Ayurveda Association. Currently, the Australian Institute of Higher and Further Research (AIHFR) runs a nationally recognized program that leads to an advanced diploma in Ayurveda. The program delivers all the theoretical lectures online and requires a minimum of 400 hours of supervised clinical training. Europe In Europe, the European Institute for Ayurveda Medicine (EIFAM) provides a 12-month foundation course on Ayurvedic Medicine for healthcare professionals, as well as a collaborative program with the European University Viadrina that leads to a master’s degree in

History, Present and Prospect of Ayurveda  67

complementary medicine. The institute is also involved in Ayurvedic research and development, and is working toward a vision of integrative medicine. Another leading contributor to the advancement of Ayurveda is the European Ayurveda Association (EUAA), a network of organizations, hospitals, educational institutions, therapists, manufacturers, and suppliers and distributors of Ayurvedic products that extends across 16 countries in the European Economic Area (EEA). The group is actively involved in issues of major interest to the Ayurvedic community such as freedom of choice in medicine, health insurance reimbursement, the quality of Ayurvedic products and services and patient safety. It works in collaboration with European government health authorities, health insurance companies, professional associations, universities, training institutes, the Ministry of AYUSH, and the Ministry of Health and Family Welfare, Government of India. The Rosenberg European Academy of Ayurveda (REAA), a nonprofit organization funded by students’ tuitions and patients’ treatment fees and donations, runs various treatment and training centers in Germany, Switzerland, and Austria. It offers a number of courses for Ayurveda enthusiasts, including Ayurveda seminars for beginners, further training for doctors, Ayurveda as complementary medicine, and postgraduate studies in Ayurvedic nutrition, massage, and marma therapy. It also provides training for alternative practitioners, Ayurveda and yoga health coaches (IHKs), and Ayurvedic nutritionists, health consultants, cooks, and medical phytotherapists.[32] In addition, the academy is partnering with Middlesex University, the School of Health and Education (London, UK), and Charité University Medical Center Berlin (Master module) in a program that leads to the first recognized Master of Science degree in Ayurveda. The four-year university course is divided into three parts and features a flexible curriculum that meets the needs of graduate students. It includes clinical internships in India and Europe and home studies. United States In the US, Ayurveda is gaining ground through the efforts of the National Ayurvedic Medical Association (NAMA), a renowned organization dedicated to the growth of Ayurveda in the West. Founded in 2000, its primary goal is to support Ayurvedic education and professional practices.

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The Standards Committee surveys the Ayurvedic education system and is involved in setting standards for Ayurvedic professionals. There are currently around 30 NAMA-recognized schools of Ayurveda operating in various regions of the country. The organization strives to serve as an official spokesperson for and representative of the Ayurvedic profession in the United States. Its efforts are oriented toward regulating education, ethics, professional competency and licensing, and research. Along with establishing recognition and acceptance of the Ayurvedic profession and forging connections with government agencies, policymakers, and numerous Ayurvedic organizations and businesses, NAMA hosts yearly conferences that consistently attract a broad swath of the Ayurvedic community.[33] Russia Although there is no legal recognition of the Ayurvedic profession in Russia, the government and the public have acknowledged Ayurveda as a healing system. A large medical center in Moscow called NAAMI, that included a team of vaidyas from India on its staff in the late 1990s, has been successful in generating awareness of Ayurveda. NAAMI has also signed an MOU with the Indian government, agreeing to dedicate government aid from India to promote the development of Ayurveda in Russia. In addition, upcoming translations of works by Charaka, Sushruta, and Vagbhata will soon enable Russians to read the classics of Ayurveda in their native language. Japan Ayurveda in its present form, has a history of 30 years in Japan, where its traditions are perpetuated by respected institutions, including the Society of Ayurveda, founded by Osaka Medical School, the Japan School of Ayurveda (Tokyo), and the Institute of Traditional Oriental Medicine (Tokyo).

1.4  Ayurveda in future Balanced and sustainable growth needs to happen at the level of more standardized education, clinical practice, research, and pharmacy levels. Since few decades, there has been tremendous growth in Ayurveda happening globally. However, there is an urgent need for strategic planning to address certain challenges. Healthcare policy decisions in India are largely opinion-based and often fail to consider regional differences in culture, social-economic

History, Present and Prospect of Ayurveda  69

conditions, population characteristics, healthcare-seeking behavior, literacy levels, and other relevant factors. This “one-size-fits-all” approach falls short in the context of Ayurveda. This fact becomes obvious when one compares the model of Ayurvedic education that prevails in southern India with the one that predominates in the northern states. While many institutions in northern states, including Banaras Hindu University in Uttar Pradesh, have adopted an integrative model of Ayurvedic training, those located in southern states like Kerala have largely opted for a “classics-oriented” approach. Thus, the goal of promoting uniformity in training may be unrealistic.[34] Furthermore, advocates of these different approaches lack sufficient evidence to categorically state that either model (integrative or “pure” Ayurveda) is superior to the other. Most importantly, there is almost no research on Ayurvedic educational policy happening in India. Unlike most nations, India has yet to be found either government or university-based institutes dedicated to research on medical education policy. As a result of this research gap, huge disparities in training between different streams of healthcare professionals persist. A well-thought-out strategy is clearly needed to address this problem. Data from well-designed educational surveys and experiments is essential to policymakers’ ability to craft informed decisions. To date, only a handful of published papers that provide such data are available on the research databases such as PubMed. The establishment of an institution focused on medical education policy research and equipped with a mandate to guide the development of evidence-based policies in close collaboration with the Ministry of Health and Family Welfare and the Ministry of AYUSH would go a long way toward resolving these issues. Ultimately, the advancement of Ayurvedic Medicine both within and beyond India will require a multi-pronged effort to align it with modern science. Pharmacoepidemiological studies documenting its safety and effectiveness and new clinical processes, research protocols, and whole system treatment regimens are needed. Much remains to be done. Yet as a knowledge system that pioneered a holistic, personalized approach to medicine that has thrived for thousands of years, Ayurveda promises to play an innovative, dynamic, and highly valued role in the continued evolution of integrative healthcare.

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References   [1] Vidyanath R, NiṣṭēŚvar K. Hand Book of History of Ayurveda[M]. Gopal Lane: Chowkhamba Sanskrit Series Office, 2004.  [2] Varier, Krishnankutty NV. History of Ayurveda[M]. Arya Vaidya Sala: Kottakkal, 2005.   [3] Mukhopadhyaya G. History of Indian Medicine-3 Volume[M]. New Delhi: Munshiram Manoharla Publishers Pvt. Ltd., 2003.   [4] Sharma RK, Bhagwan Das. Charak Samhita (English translation)[M]. 6th ed. Varanasi: Chaukhamba Sanskrit series, 2003.  [5] Bramhanand Tripathi. Ashtanga Hridayam[M]. Varanasi: Chaukhambha Sanskrit Pratishthan, 2003.  [6] Rao, Rammohan V. Ayurveda and the Science of Aging[J]. Journal of Ayurveda & Integrative Medicine, 2017: S0975947617304114.   [7] Baghel MS. Researches in Ayurveda: A Classified Directory of All India P.G. and Ph.D. theses of Ayurveda[J]. Thesis’s of Ayurveda. Jamnagar: Mridu Ayurvedic Publication and Sales, 2005.   [8] Patwardhan K. Medical Education in India: Time to Encourage Cross-Talk between Different Streams[J]. Journal of Ayurveda and Integrative Medicine, 2013, 4(1).  [9] Chandra S. Status of Indian Medicine and Folk Healing: With a Focus on Integration of AYUSH Medical Systems in Healthcare Delivery[J]. AYU (An International Quarterly Journal of Research in Ayurveda), 2013, 33(4): 461–465. [10] Shailaja C, Kishor P. Allopathic, AYUSH and Informal Medical Practitioners in Rural India — A Prescription for Change[J]. Journal of Ayurveda & Integrative Medicine, 2018, 9(2): 143–150. [11] Patwardhan K, Patwardhan B. Ayurveda Education Reforms in India[J]. Journal of Ayurveda and Integrative Medicine, 2017, 8(2): 59. [12] Ministry of AYUSH [EB/OL]. https://www.ayush.gov.in/. [13] Curricula of Undergraduate and Postgraduate Ayurveda education [EB/OL]. [2019–02–17]. https://ncismindia.org/ayurveda-syllabus.php. [14] Ministry of AYUSH [EB/OL]. [2018–03–08]. https://cdn.ayush.gov.in/wpcontent/uploads/2021/03/4859684838-Medical_Manpower-writeup-6.pdf. [15] Central Council for Research in Ayurvedic Sciences [EB/OL]. [2018–03– 08]. http://ccras.nic.in/content/objectives-council. [16] National Medicinal Plants Board [EB/OL]. [2019–02–17]. https://www. nmpb.nic.in/.

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[17] Traditional Knowledge Digital Library [EB/OL]. [2019–02–17]. http:// www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng. [18] Good Clinical Practice Guidelines for Clinical Trials of ASU Medicine [EB/ OL]. [2020–03–25]. https://main.ayush.gov.in/acts-rules-and-notifications/ good-clinical-practice-guidelines-for-clinical-trials-of-asu-medicine/. [19] GMP Guidelines Book [EB/OL]. [2020–03–25]. https://main.ayush.gov.in/ tenders-vacancies/publications/gmp-guidelines-book/. [20] Pharmacovigilance [EB/OL]. [2020–03–25]. https://www.ayushsuraksha. com/. [21] Press Information Bureau, Government of India. AYUSH. CCRAS Initiated Tribal Health Care Research Programme in 14 States [EB/OL]. [2020–03–25]. https://pib.gov.in/newsite/PrintRelease.aspx?relid=177962. [22] Annual Report, 2015–2016. Ministry of AYUSH [EB/OL]. [2020–03–25]. https://www.ayush.gov.in/images/annualReport/ANNUAL-REPORT2015-2016_English.pdf. [23] National AYUSH Morbidity and Standardized Terminologies Electronic Portal (NAMASTE-PORTAL) [EB/OL]. [2020–03–25]. http://namstp. ayush.gov.in/. [24] AYUSH Hospital Management Information System (A-HMIS) — AYUSH Grid [EB/OL]. [2020–03–25]. https://ehr.ayush.gov.in/ayush/#&panel1-1. [25] E-Marketing of Medicinal Plant Products [EB/OL]. [2020–03–25]. https:// echarak.in/echarak/main.do [26] Data from Scopus [EB/OL]. [2020–03–25]. http://www.scopus.com/. [27] Patwardhan K, Prasad BS, Aftab A, et al. Research Orientation in Ayurveda Educational Institutions: Challenges and the Way Forward[J]. Journal of Ayurveda and integrative medicine, 2019. [28] Patwardhan K, Gehlot S, Singh G, et al. Global Challenges of Graduate Level Ayurvedic Education: A Survey[J]. International Journal of Ayurveda Research, 2010, 1(1): 1–5. [29] Patwardhan K, Gehlot S, Singh G, et al. Global Challenges of Graduate Level Ayurvedic Education: A Survey[J]. International Journal of Ayurveda Research, 2010, 1(1): 21–22. [30] More V R, Singh G, Patwardhan K. Introducing Hybrid Problem-Based Learning Modules in Ayurveda Education: Results of an Exploratory Study[J]. The Journal of Alternative and Complementary Medicine, 2019, 26(2): 100. [31] Association of Ayurvedic Professionals UK. Ayurveda Abroad [EB/OL]. [2020–03–25]. http://www.aapuk.net/ayurveda-abroad/.

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[32] Rosenberg M. The European Academy of Ayurveda: 20 Years of Ayurvedic Education in Germany[J]. Ancient Science of Life, 2013, 32(1): 63–65. [33] National Ayurvedic Medical Association [EB/OL]. [2020–03–25]. https:// www.ayurvedanama.org/. [34] Patwardhan K, Patwardhan B. Ayurveda Education Reforms in India[J]. Journal of Ayurveda and Integrative Medicine, 2017, 8(2): 59.

© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_0002

Chapter 2

History, Present and Prospect of Chiropractic Robb Russell, William F. Updyke, Bart N. Green

Abstract Chiropractic is a form of healthcare that originated in the United States of America (US) during the 1800s and is now practiced around the world. Chiropractic healthcare focuses on the diagnosis, treatment, and prevention of disorders of the musculoskeletal system. Chiropractors in the US complete a comprehensive four-year educational program, after completing undergraduate training, culminating in a clinical doctoral degree of doctor of chiropractic (DC). Outside of the US, the degree may be indicated by other acronyms, depending on the country wherein the degree is obtained, but the most common designation is DC. From the perspective that chiropractic originated in the US, it could be considered traditional medicine, but perhaps only loosely. While this may be perplexing, a brief explanation is all that is necessary to provide clarity. First, doctors of chiropractic do not prescribe medicine and do not perform surgery. Thus, they do not practice medicine. Second, in the US, the dominant form of medicine, Western Medicine (also referred to as orthodox medicine), has been considered “traditional medicine.” Chiropractic is a profession practiced around the world. However, this chapter will focus on the origins and development of chiropractic, and its future prospects, in its mother country. Keywords: chiropractic, manipulation, musculoskeletal system 73

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Introduction Chiropractic is a type of natural therapy widely popular in the United States. It is a medical and health profession concerned with the diagnosis, treatment, and prevention of diseases of the neuro-musculoskeletal system and their effect on overall health. This chapter discusses the past, present and prospect development of Chiropractic. The first part of this chapter discusses the history of chiropractic, mainly from the aspects of antecedents, origins, clinical elements, training, licensure, scope and practice, research, journals, and scientific conferences. The second part of this chapter is about the current situation of chiropractic profession. It provides a broad overview of the profession’s current status relative to training programs, general parameters regarding its practice, economic considerations, practice models, public perception, and emerging trends. The third part of this chapter discusses the potential futures for the Chiropractic profession, which includes healthcare, the Internet of Things (IOT), the training institutions, market, integration, Competition and Research.

2.1 The history of chiropractic (1880s through 1990s) 2.1.1  Antecedents to chiropractic The chiropractic profession began in the US in the late 1800s when the US was a developing nation. This was a rugged era when new American settlers pushed the boundaries of the US in a westerly direction from the colonial Eastern states toward California. These were the days of the “Wild West” from which the iconic images of cowboys and frontiersmen emerged during this dangerous and exciting period of expansion. At this time, many Americans became disillusioned with the rapid industrialization of the eastern part of the country from the late 1800s through the turn of the century. These Americans felt that times were better during when people were more in tune with the land. Thus, they advocated for a return to simpler times that involved rural living and the philosophical perspectives that came with it.[1] However, at this time, medicine was increasingly turning to large cities to locate large medical institutions and hospitals, not only in which to

History, Present and Prospect of Chiropractic  75

care for patients, but to train medical students.[2] Medical care during these times was limited and based greatly on practices passed down from one generation of doctors to the next. For context, the germ theory of disease, antisepsis, and many other standard medical practices had not been discovered. Medical science was crude and little research existed to validate medical procedures. In fact, the randomized controlled trial research design did not become used to test the effectiveness of various medical therapies until the 1900.[3] In the late 1800s and early 1900s, there were no standards or accreditation procedures in medical education. Thus, at that time, American medical education was essentially proprietary in nature, a fact criticized by many physicians. Various medical cures were often harsh and some critics suggested that patients survived medical therapies, rather than disease.[4] Given the lack of knowledge related to bacteriology or other infectious diseases, there were virtually no effective interventions for infection. Medical doctors of the period relied greatly upon the practice of heroic medicine.[5] Heroic medicine involved the draining of blood from sick patients, the use of purgatives, administration of mercury, and other treatments that are now known to be fatal.[4,6] Early American physicians had virtually no treatments in their therapeutic armamentarium for common disorders of the muscles, bones, and joints, particularly of the spine. In this nearly unregulated environment, in 1847, a group of medical doctors, who called themselves regular or orthodox doctors, created the American Medical Association (AMA).[7] The goal of the AMA was to control the healthcare industry and protect the benefits of its members. Thus, the AMA was against non-regular healthcare providers and created a code of ethics deeming non-regulars as anti-scientific and that any AMA member who collaborated with a non-regular, committed a breach of the code and would be sanctioned.[8] Due to the harsh nature of the medical treatments, people often sought the care of the non-regular providers, who also were known as alternative providers of healthcare.[9] Alternative healthcare practitioners were abundant in the 1800s. Since alternative practitioners offered conservative, and often less damaging, healing treatments, they might have seen positive results where orthodox heroic medicine practitioners did not. Alternative

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providers used natural healing agents such as diet changes, herbs and plants, exercise, bonesetting, manipulation, religious healing, magnetic healing, sunshine therapy, and baths. The most commonly known professions that arose towards the end of the century included homeopathy, osteopathy, naturopathy, and chiropractic.[5] It is important to understand the evolution of health professions that were contemporary with the begging of chiropractic in order to place the emergence of chiropractic into perspective. This section provides an overview of the common alternatives to emerge in the US. Thomsonism, founded by Samuel Thomson around 1800s, was considered the first medical alternative in the US.[10] Thomsonism was an herbal remedy system. Thomson’s goal was to provide the herbal remedies in a simple form so that the common layperson could prepare them and administer them to those who were ill.[10] This was considered to be safer than receiving heroic medicine offered by the orthodox physicians.[11] Thomsonism was popular amongst Americans. The Thomsonism movement was fragmented due to dissenting views from within, pertaining to the fundamental practices of Thomsonism. One faction, the eclectics, believed that formal education was required to practice Thomsonism. This group formed several eclectic medical schools in the US. These alternative medical schools persevered until the late 1930s when they were closed due to pressures from the AMA.[5] Homeopathy, a popular early alternative to orthodox medicine, was developed by Samuel Hahnemann, a German physician, who found orthodox medical cures unsuccessful and dangerous.[12] Hahnemann believed that diseases could be cured by using extremely dilute herbal remedies by producing symptoms similar to the disease.[13] Homeopathy was brought to the US in 1825 by Hans Gram after he received medical training in Europe.[12] The American public found homeopathy attractive because many homeopaths were trained in orthodox medical schools, yet, homeopathic methods were less intimidating and appeared more scientific than heroic medicine.[12] The number of homeopaths was large and they were successful in creating their own homeopathic medical schools and hospitals. Most American orthodox practitioners did not accept homeopathy and labeled it quackery.[13] This was probably compounded

History, Present and Prospect of Chiropractic  77

by many American MDs who perceived homeopathy as a threat to their business.[7] Homeopaths also created the word “allopath” for the orthodox practitioners. Allopath means to treat disease by inducing a pathological reaction that is antagonistic to the one being treated.[6] Relationships between homeopaths and allopaths deteriorated, becoming a significant reason that the allopaths formed the AMA.[5] By the early 1900s, homeopathy had largely been eliminated by competition from organized medicine in the US. Another US medical alternative, osteopathy, emerged during the 1870s.[14] Andrew Taylor Still founded osteopathy and believed that the body was a self-repairing mechanism that functioned best without impediments to the circulatory and nervous systems and that these impediments could be relieved using manual manipulation. Osteopaths manipulated joints in addition to other procedures and eventually expanded their scope of practice to include prescribing pharmaceuticals and performing surgery.[14] Despite more than 50 years of opposition by the AMA, osteopathy was eventually absorbed by orthodox medicine. Several authors have stated that in the US today, osteopathy and medicine are virtually indistinguishable in practice.[5,15,16]

2.1.2  Origins of chiropractic It was during this time that Daniel David Palmer, an Iowan teacher, gro­ cer, and farmer, began to develop what later became chiropractic.[17] The philosophical bases for DD’s embryonic chiropractic were spiritualism and vitalism.[18,19] Spiritualism was considered to be a belief that there was a spiritual life after death and that living people could communicate with the dead through the use of a state of trance.[20] Vitalism was a belief that living beings have a vital force, that the whole of a human is made up of more than the sum of its parts and a cause of life.[20] Vitalism served as an opposing philosophical concept to the highly mechanistic concepts of medicine and the industrial revolution. Thus, vitalism became popular in the US at the time that DD Palmer (Figure 2–1) was developing his new philosophy of chiropractic. DD Palmer believed that disease was related to the interruption of nervous impulses that influenced innate intelligence.[16] DD also believed that the body had inborn

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Figure 2–1    A photo of DD Palmer.

healing or homeostatic capacities.[21] This philosophy was compatible with the perspectives of rural Americans of the period.[16] DD Palmer’s early theories were that the vertebrae could become misaligned and that if the bones were manipulated this would improve the function of the circulatory and nervous systems to allow natural healing to take place.[22] Most people consider spinal manipulation, also known as spinal manipulative therapy (SMT), as the cornerstone of chiropractic treatment. Spinal manipulation has long been practiced in the world and DD Palmer acknowledged this fact. However, it was DD Palmer who claimed to develop specific spine manipulation procedures that used different parts of the vertebrae as levers. This manipulation alone was and is not chiropractic. Chiropractic consists of the use of manipulation with the hypothesis that the nervous system and other bodily functions can be improved by relieving such obstructions, known as vertebral subluxations, and then allowing the body to heal itself through its various homeostatic capacities. Thus, when a chiropractor manipulated the spine with this concept in mind, it was called a spinal adjustment.

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DD Palmer did not believe that chiropractic was subservient to medicine; he stated that it was an alternative to medicine.[16] Chiropractic was in contrast to medicine. DD said, “Our healing is done entirely by the hands; there are no drugs used.”[23] Many medical doctors left rural areas to develop practices, colleges, and hospitals in metropolitan areas. Chiropractors then began to fill the role of healthcare providers in these rural areas where the Populist movement was aligned with the philosophical ideals of chiropractic.[24] Chiropractic care became popular and common in these rural areas. With its new philosophy and practice, as well as the attempts of the AMA to eliminate chiropractic, chiropractic was attacked by medical licensing agencies and associations. Therefore, the young chiropractic profession had to clearly identify itself as different than medicine.[21] Thus, the distinctive identity of chiropractic was based on its philosophy and art. This approach was an important part of chiropractors being able to establish their own state licensing boards over a period of decades.

2.1.3  Clinical elements of practice Since chiropractic evolved as being separate and distinct from medicine, chiropractors fill provider roles in a wide variety of areas as drugless care providers. Some chiropractors solely address chiropractic vertebral subluxations. Others offer care that includes rehabilitation, nutrition, or procedures for helping with internal disorders.

2.1.4  Training Similar to American medical education in the 1890s, the earliest years of chiropractic education included student observation of teachers while they cared for patients.[25] When DD Palmer’s students graduated, he printed on their diplomas that they were qualified to “teach and practice” chiropractic.[26] Thereafter, graduates opened new chiropractic schools. Rivalries between schools and founders developed based upon differing opinions on chiropractic thoughts and procedures. Eventually, there became two main rivaling groups. Those chiropractors who agreed with Palmer’s

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assertion that chiropractic was done by hand only focused on the manual correction of vertebral misalignments and called themselves straight chiropractors.[22] The other group included other methods of healing, such as adjustive instruments, naturopathic techniques, and physiotherapeutic therapy devices, were dubbed mixers.[27] By the early 1920s, chiropractic college curricula were 18 months or longer.[28] Chiropractic schools continued to increase entrance requirements and lengthened curricula. By the 1970s, programs were modern with ever-increasing entrance requirements. Chiropractic educational programs continued to evolve to modernize entrance requirements and enhance curricula to the present day.[29] These high-quality chiropractic educational programs continued to improve and met with less resistance from the AMA. The chiropractic profession was recognized by the United States Office of Education with its own programmatic accrediting agency in 1974. This agency was called the Council on Chiropractic Education (CCE) and maintains the same name today.[30,31] When the profession had its own accrediting body, chiropractic students became eligible for federal student loans.[32]

2.1.5  Licensure In the early years, US licensing laws favored the established medical profession. Thus, the AMA lobbied strongly to continue its control over the marketplace and continued to oppose the development of chiropractic in an effort to make it subservient to organized medicine. In the states that did not legally recognize chiropractic, chiropractors were arrested and sent to jail, being accused of practicing “medicine” without a license.[33,34] Chiropractors battled many cases in court and continued to lobby for licensure in each of their respective states. Laws to govern and regulate the practice of chiropractic in the US were enacted slowly over many years and chiropractors eventually gained licensure laws in all the states. Even though laws were passed that allowed chiropractors to practice in their jurisdiction, organized medicine continued to oppose chiropractors. However, medicine lost the battle to prevent chiropractic from establishing licensing laws and it attempted to retard chiropractic with a new

History, Present and Prospect of Chiropractic  81

method called basic science laws. This approach involved getting laws passed in each of the states that required candidates eligible for licensure to pass prelicensure examinations on basic science topics. Medical doctors, osteopaths, and chiropractors were usually required to take these examinations. The basic science tests were mainly relevant to practicing medicine and created to keep chiropractors from obtaining eligibility for state licensure. Given the low relevance of the examinations to chiropractic practice, many chiropractors failed the tests and were unable to be licensed in their states.[35] Eventually, the chiropractic profession won the right to create its own national board examinations, which are now administered by the National Board of Chiropractic Examiners. These tests are required by most states to demonstrate that licenses meet the minimum qualifications for licensure.[36]

2.1.6  Scope and practice Chiropractors have developed many specialties related to clinical practice. Many of these specialties began during the 1930s through 1960s. Chiropractic specialties that are common today, such as radiology and orthopedics, began as lengthy specialty curricula offered after one graduated from chiropractic college.[37] Additional specialty programs, such as sports, nutrition, and pediatrics, began later. Today, many specialty programs are available, including topic areas such as rehabilitation, sports medicine, nutrition, pediatrics, geriatrics, women’s health, radiology, and others.

2.1.7  Research, journals, and scientific conferences Early attempts at research were mainly descriptive reports of human anatomy and physiology.[16] However, as the scientific method became an accepted practice in science, chiropractors adopted this approach to research.[38] However, continued improvements in chiropractic education and frequent distractions to battle organized medicine hampered early development of chiropractic research. Through 1960s, some groups of chiropractors that practiced certain kinds of chiropractic treatment and

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diagnostic procedures made observations of patient presentations and responses to treatment and communicated about their findings. For them, their observations on clinical outcomes were research.[39] Perhaps the largest attempt to conduct observational research in the 1930s through 1950s were the efforts of BJ Palmer. BJ Palmer was the son of DD Palmer and eventually became the owner of the Palmer School of Chiropractic (now the Palmer College of Chiropractic). In his research clinic, to avoid criticism that improvement under chiropractic care following unsuccessful medical treatment did not represent misdiagnosis by chiropractors, Palmer was said to have medical doctors evaluate the patients before and after care.[39] Hundreds of thousands of dollars were invested in this lengthy effort that included records of thousands of patients.[40] The level of reporting of methodologies for this observational data was superior to many other efforts of the period. Palmer referred to the studies as “controlled,” likely due to the inclusion of medical verification of patient outcomes, however it would be decades before controlled clinical trials, as they are known today, would be used in clinical studies.[24] One of the chiropractic profession’s first true scientists was Henry Higley, a trained chiropractor, engineer, and mathematician.[41] Higley developed structured research programs where investigators from various chiropractic colleges would input from college clinics into a central repository.[39] The first chiropractic research publication that was widely distributed within the greater scientific community was published in 1960.[42] Significant laboratory research in chiropractic topics began in the 1970s with the work done by Dr Chung Ha Suh, a biomechanist at the University of Colorado. Dr Suh spent many years studying the potential mechanisms behind chiropractic care and biomechanics of the spine, for which he received some of the profession’s first federal funding.[43] Also in the 1970s, fellowships and other funding for chiropractors to receive training in research methods and higher education evolved. Despite an increase in chiropractic research and science, there were few periodicals in which a chiropractic researcher could publish a paper. That changed in the 1978 with the inaugural issue of the profession’s first peer-reviewed journal, the Journal of Manipulative and Physiologic Therapeutics, began publication. Published by the National College of Chiropractic (now the National University of Health Sciences), the

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Journal of Manipulative and Physiologic Therapeutics was dedicated entirely to chiropractic and topics germane to chiropractic science and practice.[44,45] The Journal of Manipulative and Physiologic Therapeutics was the first chiropractic scholarly journal indexed in Index Medicus and remains the profession’s flagship scholarly peer-reviewed journal.[44,46] Within a few short years, other chiropractic journals began to be published and represented various specialties, countries, and procedures. Table 2–1 presents some of the chiropractic journals that started during this era. The first conference that brought chiropractic researchers together with medical, osteopathic, and other researchers was “The Research Status of Spinal Manipulative Therapy.” This conference was held by the National Institute of Neurological and Communicative Disorders and Stroke. It included interdisciplinary presentations of research papers by important spinal manipulation researchers. Chiropractic colleges began

Table 2–1    Chiropractic journals that started during 1990s. Chiropractic Journals American Journal of Chiropractic Medicine Annals of the Swiss Chiropractic Association Chiropractic Australia Chiropractic History Chiropractic Journal of Australia Chiropractic Pediatrics Chiropractic Research Journal Chiropractic Sports Medicine/Journal of Sports Chiropractic and Rehabilitation Chiropractic Technique European Journal of Chiropractic Journal of Chiropractic Education Journal of Manipulative and Physiological Therapeutics Journal of the Canadian Chiropractic Association Journal of the Neuromusculoskeletal System Topics in Clinical Chiropractic

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research collaborations in the 1980s. One early collaborative that focused on chiropractic research was the Pacific Consortium for Chiropractic Research. The Consortium fostered collaboration between the colleges and helped hold annual research conferences for chiropractors.[46] It was not long before scientific conferences became a regular part of chiropractic science. Publications and research conferences of the early 1990s set the stage for significant scientific growth within the profession by the year 2000.

2.2  The chiropractic profession today (2000 to the present) “Chiropractic was the original holistic medicine in that it focused on treating the whole person, not just the body part that hurt,” according to Michael Schneider, DC, PhD, an associate professor of health sciences at the University of Pittsburgh. His research on chiropractic suggests that cervical and lumbar manipulation can be an effective treatment for low back pain. A study published in April 2017 in the Journal of the American Medical Association supported this, finding that based on the latest research, spinal manipulation, the back and neck adjustments most people associate with a visit to a chiropractor, can modestly reduce a person’s lower back pain.[47] An in-depth summary of the chiropractic profession at present is far beyond the scope of this chapter. Even when looking primarily at its country of origin, the US, with its decentralized, some would say fractured, healthcare delivery system and laws governing the profession that vary from state to state, the task is challenging. The goal of this portion of the chapter is to provide a broad overview of the profession’s current status relative to training programs, general parameters regarding its practice, economic considerations, practice models, public perception, and emerging trends. Over the past two decades, as chiropractic has reached its current level of maturity in the United States, paradoxical forces have influenced the profession, some pushing it forward, others seemingly pushing it backwards or, at best, holding it in check. Small colleges and universities in the US are facing economic difficulties due to a combination of factors: rising tuition to cover rising costs

History, Present and Prospect of Chiropractic  85

(and a corollary, graduates’ debt load), decreasing or flat net tuition revenue and shifting enrollment trends.[48] As chiropractic degree programs are mostly offered at narrowly focused, small colleges and universities, they are subjected to these same forces. In addition, they face challenges associated with factors generally described as the US healthcare crisis. In spite of these dual challenges, the number of training programs and students enrolled has not changed appreciably. Laws governing the practice have remained intact but not without occasional challenges. In Texas, a protracted attempt by the medical establishment to limit the right of a chiropractor to make a diagnosis is reportedly ongoing.[49] In 2009 the scope of practice in New Mexico expanded to permit limited drug prescription privileges.[50] Beyond these two extremes, chiropractors across the county enjoy a relatively broad scope of practice to examine, diagnosis, and treat a range of health conditions but do not have prescribing rights nor do they perform most other invasive procedures such as surgery with one exception, Oregon, where minor surgery is permitted. The long-dominant model of private practice, with one or perhaps a few chiropractors working together, separate from larger, mainstream healthcare systems and facilities, persists but is beginning to wane. New models of practice, such as integrative, multispecialty practices, where chiropractors work with other healthcare practitioners, and employment opportunities, have emerged over the past 20 years and continue to grow. In some areas, particularly private practice, reimbursement from various sources has stagnated or shrunk. The new models of care and emerging employment opportunities, which were not present in the relatively recent past, are creating the possibility of enhanced earning capacity. Accessibility has been constrained by the design of private health insurance, particularly so-called managed care and government regulated healthcare networks, many of which require physician-approved referral or insurance company authorization. At the same time, entirely novel practice venues and arrangements are emerging that promise patients greater and more affordable access to chiropractic care. Public perception is favorable, and among actual patients, it is extremely high. Demand for access to chiropractic care is strong but

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several factors dampen the ability of many patients to access care directly or promptly.

2.2.1  Training Traditionally, chiropractic colleges in the US have been single degree focused institutions. The Palmer College of Chiropractic was founded in 1897 and, as noted earlier in this chapter, many others were founded in the early 1900s. Some of these legacy programs have added other professional degree programs such as acupuncture, naturopathic medicine or master’s degrees in nutrition or sport-related fields. Three currently accredited universitybased chiropractic institutions are notable exceptions, each offering training leading to bachelor’s and master’s degrees in liberal and applied arts, sciences, and health-related fields, such as physical therapy, nursing, occupational therapy, and psychology. Rather than beginning as chiropractic programs, these three institutions recently added a chiropractic degree program to the existing curricula. There are approximately 10,000 students in chiropractic programs in the US. This has been a fairly consistent number for decades except for the mid-1990s when there was an exceptionally large pool of students in college. Attracting new students has been a challenge historically as the US programs are all private institutions and have minimal to no government assistance for campus infrastructure, operations, or tuition. Demographic trends across the country have resulted in a shrinking number of students enrolled in undergraduate college today, lessening the number of potential chiropractic students. In addition, over the last decade, there have been hundreds of new programs that have opened, particularly schools of physical therapy and those granting Physician Assistant degrees, as well as several medical and osteopathic colleges. This has led to a reduction in the number of potential candidates for chiropractic college admission. The fact that enrollment in chiropractic programs has remained steady is remarkable given this reality. In the US, there are accredited programs on 18 campuses and the programs are represented by a common organization, the Association

History, Present and Prospect of Chiropractic  87

of Chiropractic Colleges. The Association is aware of prospective academic organizations exploring the creation of new chiropractic degree programs.[51] Programs leading to a chiropractic degree, designated as a DC in the US, are typically four academic years in length. Depending on the specific program, training is completed in approximately three and a half years as extended summer breaks, common in traditional college programs, are not incorporated. Entering students are not generally required to first obtain an undergraduate degree. Following is an example of what is considered for admission at one institution, the Los Angeles College of Chiropractic, a college within Southern California University of Health Sciences. A prospective student must have completed a minimum of 90 semester units or 135 quarter units at an institution(s) accredited by an agency recognized by the US Department of Education or an equivalent foreign agency. From the minimum 90-unit requirements: 24 of these units should be in the Life and Physical Sciences, half of the 24 science units must have a substantive lab component, Biology and Chemistry Course are mandatory course requirements, and science coursework must have been completed within seven years of admission.[52] As noted earlier in this chapter, since 1974 chiropractic degree programs in the US are accredited by the CCE which sets national standards for curricula. Additionally, students are required to pass a sequence of four tests, administered by the National Board of Chiropractic Examiners (NBCE) during the course of training. The NBCE tests include three written exams, one optional written exam, and one final practical exam. NBCE Part I Exam includes six basic science subjects: Anatomy, Spinal Anatomy, Physiology, Chemistry, Pathology, and Microbiology. NBCE Part II Exam includes six clinical science subjects: General Diagnosis, Neuromusculoskeletal Diagnosis, Diagnostic Imaging, Principles of Chiropractic, Chiropractic Practice, and Associated Clinical Sciences. NBCE Part III Exam addresses nine clinical areas: Case history, Physical examination, Neuromusculoskeletal examination, Diagnostic Imaging, Clinical laboratory and special studies, Diagnosis or clinical impression, Chiropractic techniques, Supportive interventions, and Case management.

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NBCE also conducts a Physiotherapy Exam which is an elective. A final, practical exam, Part IV, consists of three major sections and each of the sections is divided into stations. The three sections are: Diagnostic Imaging (DI), Chiropractic Technique, and Case Management. DI consists of 20 stations which are allotted two minutes per station. During the DI portion, candidates view diagnostic images on a monitor and answer questions related to the images. During the Chiropractic Technique portion of the exam, candidates are assessed in five stations with five minutes allotted to complete each station. During the Chiropractic Technique portion, candidates read instructions and subsequently set up for spinal and extremity adjustments while graded by a live exam proctor. The Case Management portion consists of 20 stations with five minutes allotted to complete each station. Candidates are asked to perform a case history, physical examination, or orthopedic or neurological test on a so-called standardized patient, an actor or actress who responds to questions and cues consistent with expected clinical responses, while graded by a live exam proctor.[53] Most US states accept completion of these four NBCE exams as sufficient for applying for licensure although a separate exam covering state rules and regulations is common. States may have specific requirements for training in addition to what the CCE prescribes but these are often minor and focused on state laws regulating practice in respective jurisdictions. Relative to curriculum, CCE does not prescribe specific classes but instead has guidelines that require students to acquire competencies in a number of areas.[54] Each chiropractic degree program creates curricula to meet those competencies as well as any state-mandated requirements. In light of CCE competencies and NBCE testing topics, curricula at the various chiropractic degree programs cover comparable material. As an example, an overview of the doctor of chiropractic curriculum from Northwestern Health Sciences University (NHSU) is offered. The NHSU program is comprised of 84 course offerings, organized by eight academic and clinical departments. Basic sciences: Biochemistry, Anatomy, Embryology, Histology, Immunology and Microbiology, Neuroscience, Pathology, and Physiology. Chiropractic studies: Chiropractic Principles and Philosophy (history of the profession and the nature of the chiropractic healthcare model) with lectures and labs, Physiological Therapeutics,

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Exercise, and Rehabilitation. Diagnostic and clinical sciences: six trimesters are devoted to diagnostic skills with courses in clinical skills (obtain a medical history and perform a physical exam), clinical pathology, diagnosis and management of a variety of health and chiropractic problems. Health promotion and wellness: courses regarding special populations (pregnant patients, infants and children, women, and the elderly), plus the role chiropractors play in public health, health promotion, and wellness. Diagnostic imaging: the role of imaging technology in diagnostic decision-making and specific courses in normal radiographic anatomy, interpretation of advanced imaging, and the diagnosis of chiropractic and medical pathologies. Clinical education: training in the university’s public clinic system and with chiropractors working in community-based private practices. In addition to the training in on-campus and related clinics, opportunities exist for students to rotate through facilities run by the Department of Defense (DoD) in military hospitals and clinics, at Veterans Administration (VA) clinics and hospital-based facilities, and in clinics for underserved patients, that is, those with limited financial means to pay for care and little or no health insurance coverage.[55] In comparison, medical school curricula have a similar breakdown but compared with medical students, chiropractic students spend more hours in anatomy and physiology, whereas fewer in public health. Both programs have similar hours in biochemistry, microbiology, and pathology. Chiropractic curricula provide relatively little instruction in pharmacology, critical care, and surgery but emphasize biomechanics, musculoskeletal function, and manual treatment methods. Medical education has more than twice as many hours in actual clinical experience but 1,000 fewer hours in didactic and workshop-like clinical courses.[56] A major distinction of training, however, are the two to four years of specialty residency training physicians pursue following acquisition of a medical degree. Comparable postgraduate training is available to only a tiny fraction of chiropractors.

2.2.2  Licensure There is no central agency that tracks the number of chiropractic doctors licensed nationally. Each state and territory have laws regarding licensure.

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There is no nationwide license issued. According to the Federation of Chiropractic Licensing Boards (FCLB), as of 2018, there are over 90,000 licenses issued for chiropractors in the 50 states, plus the US territories of Puerto Rico and Virgin Islands.[57] Some jurisdictions do not report to the FCLB yearly and there are chiropractic doctors with licenses in more than one state so the exact number is not known with certainty.

2.2.3  Scope and practice Chiropractic is licensed and regulated in all 50 US states. Each state’s statutes and regulations determine the scope of clinical procedures chiropractors may legally perform in their respective jurisdictions. Broadly speaking, chiropractors take a patient’s history, perform an examination and arrive at a diagnosis. Providing care for musculoskeletal conditions using manipulation is within the legal scope of chiropractic practice in all states. Application of other procedures and modalities varies. With one exception previously noted, all states except New Mexico exclude prescribing drugs. Chiropractors in Oregon may perform minor surgery but all states preclude performing major surgery. Performing other diagnostic or therapeutic procedures, such as obstetrics (delivering babies), venipuncture for diagnostic purposes, use of physiotherapy modalities, dispensing of vitamin supplements or provision of nutritional advice to patients, vary from state to state.[58] As part of the examination process, chiropractors may order or perform diagnostic X-rays. They may order other imaging, such as MRI, CT, electrodiagnostic or laboratory tests, such as blood tests. In some jurisdictions, chiropractors are restricted to a narrow range of diagnoses, either spinal or broadly musculoskeletal. In others, they may treat or manage a wide or even unlimited number of conditions, provided they do not use prohibited modalities or procedures, such as pharmaceutical products or performing surgery. In short, they may not practice medicine. Regardless of the scope of practice granted by a state or the clinical orientation of a particular chiropractor, that is whether seeking to treat patients for general health or pain, the vast majority of patients seek care for a few specific conditions. In the general population, musculoskeletal

History, Present and Prospect of Chiropractic  91

conditions, particularly low back pain or back conditions and neck conditions, are the predominant reasons for seeking chiropractic care. In the pediatric population, the most common reason for attending chiropractic care was musculoskeletal conditions. More telling, only 3.1% of the general population sought chiropractic care for visceral/non-musculoskeletal conditions.[59]

2.2.4  Spinal adjustments as the common thread The US-based International Chiropractors Association, in its description to the public regarding the educational courses taken by chiropractic students, refers to instruction in adjusting techniques, describing them as unique among healthcare professional education.[60] The American Chiropractic Association (ACA) describes spinal manipulation therapy (SMT or chiropractic adjustments, as previously noted) as one of the most common and well-known therapeutic procedures performed by chiropractors. The ACA adds that the purpose of spinal manipulation is to restore joint mobility by manually applying a controlled force into joints that have become hypomobile or restricted in their movement.[61] According to the World Health Organization, chiropractors are a health care profession concerned with the diagnosis, treatment, and prevention of disorders of the neuromusculoskeletal system and the effects of these disorders on general health. There is an emphasis on manual techniques, including joint adjustment and/or manipulation with a particular focus on subluxations.[62] Similarly, the definition offered by the World Federation of Chiropractic includes reference to spinal adjustment and other joint and soft-tissue manipulation.[63] It is clear from these definitions and descriptions that the spinal adjustment is central to the profession’s therapeutic approach and further, that the adjustment is a type of manual therapy, specifically a form of SMT. As described in the section on the profession’s past, the spinal adjustment is one of many interventions within the scope of practice of chiropractors, but it is the procedure most identified with the chiropractic profession. Medical and osteopathic physicians in the US are legally able

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to incorporate SMT in patient care and in some states, depending on legislation and regulation, so can physical therapists and acupuncturists. In the US, however, 94% of SMT is performed by chiropractors.[64,65] The integral association between chiropractic care and SMT has been a benefit to the profession as the public expects chiropractors to be the most proficient and experienced in this approach. Chiropractic advocates feel that this level of training is a benefit to patients as they can be assured a high degree of expertise in adjusting skills or SMT when consulting a chiropractor. Other professions that may be legally able to offer SMT do not have the same degree of training. However, the association between SMT and chiropractic has also led some to assume that it is the only tool chiropractors use. This may include the assumption that SMT or adjusting is a non-specific procedure applied absent of performing an examination or arriving at a diagnosis. SMT is a signature procedure used by chiropractors, in a sense it is a modality or therapeutic procedure, but does not define the totality of what training and licensure permit.[66,67]

2.2.5  Specialties As noted in the portion of this chapter that discussed the profession’s history, specialized practice in radiology, orthopedics, sports, nutrition, and pediatrics developed. Residency programs also exist in sports medicine, primary spine care and hospital-based integrated clinical practice. The latter residency is available for 10 trainees per year with the Veterans Administration. The others mentioned are offered by some chiropractic degree granting institutions. The current practice of two of these special areas of practice are illustrated below.

2.2.6  Diagnostic imaging A longstanding specialty in the profession is that of radiology which now incorporates training in other advanced imaging methods, such as MRI and, in some instances, diagnostic ultrasound. Following a three-year residency and passing an examination, chiropractors may recommend, supervise, and interpret radiologic studies as well as advanced imaging

History, Present and Prospect of Chiropractic  93

procedures. Those so trained may advise referring chiropractic colleagues on the necessity and appropriateness of radiologic services and whether to select or to avoid certain diagnostic or clinical procedures. The American Chiropractic Board of Radiology is the certifying agency for chiropractic radiologists.[68]

2.2.7  Athletic and sports-related care Gone are the days in the 1970s when pioneering sports chiropractor, Leroy Perry, DC, would see athlete patients against the advice of coaches in secret. Officially appointed to the Olympic medical team for Antigua in the 1976 Olympics, Dr. Perry saw patients from other countries, including those from the US.[69,70] In the modern era, chiropractors are increasingly becoming involved at all levels of sport from the club level to elite athlete. Both general practicing chiropractors and those with certificates of additional qualifications in sports medicine are more commonly engaged in the care of individual athletes and sporting teams. The American Chiropractic Board of Sports Physicians (ACBSP) produces Position Statements on important topics in sports medicine including concussion in athletics and participation examinations.[71,72] These position papers regarding the management of sportrelated topics are offered to the sports medicine community to guide and better define the role of qualifying doctors of chiropractic to make returnto-play decisions and clarify common concepts pertaining to evaluating and managing athletes. There are doctors of chiropractic involved at elite levels of sport including leadership level of the world’s largest Olympic National Organizing Committee, the United States Olympic Committee (USOC). At the USOC, the sports medicine division and clinics have been led by doctors of chiropractic with specialty certifications in sports medicine.[73] Even with a high level of representation in elite sport, doctors of chiropractic may have limits placed on their scope of practice in the management, evaluation, and return-to-play decision-making by athletic associations or governmental bodies. Common areas of special access or restriction include sports related concussion and the participation examination.

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Rule-making bodies are recognizing those doctors of chiropractic with ACBSP sports medicine certificates of additional qualifications as having the appropriate clinical skills for recognition to provide advanced practices in sports medicine.[74,75] There is increased interest to include conservative healthcare providers, including doctors of chiropractic, as a recognized part of the sports medicine team. The recognition of the determinate effects of opioid use in the sporting environment has served as a catalyst for sporting bodies to seek alternative non-pharmacological interventions, such as chiropractic and physical therapy, to manage athletes with pain.[76] Interventions for the management of pain in the athletic population using manual techniques should be expected to increase in the future. In order to continue the expansion of doctors of chiropractic at all levels of sport, the profession must continue to increase sports medicine acumen and identify their role within the framework of the sports medicine environment they have available to them.[77] Utilization of chiropractic within the professional sports world has also grown steadily. In 2002, 31% of National Football League teams used a chiropractor in an official capacity on their medical staff, and in 2006, a study analyzing Division I NCAA college athletes found that chiropractic usage was reported by 39% of respondents. Twelve years later, as of the 2014–2015 NFL season, all 32 NFL teams had an official team chiropractor, 27 of 30 Major League Baseball teams had an official team chiropractor, and almost every NBA team has an official team chiropractor as well.[78]

2.2.8  Economic considerations According to the US Bureau of Labor Statistics (BLS), the median annual wage for chiropractors was $68,640 in May 2017 for those working in chiropractic offices and $78,710 for those working in the offices of medical physicians. The lowest 10% of chiropractors earned less than $34,550, and the highest 10% earned more than $144,730. Earnings vary with the chiropractor’s number of years in practice, geographic region of practice, and hours worked. Geographic variations figure significantly in the earning capacity as illustrated in the following table (Table 2–2).[79]

History, Present and Prospect of Chiropractic  95 Table 2–2    Top paying states for this occupation. Employment (1)

Employment Per Thousand Jobs

Location Quotient (9)

Hourly Mean Wage

Annual Mean Wage (2)

80

0.18

0.75

$71.10

$147,900

Tennessee

480

0.16

0.69

$58.95

$122,620

Connecticut

190

0.11

0.48

$54.39

$113,130

Alaska

100

0.32

1.35

$51.25

$106,600

Colorado

980

0.38

1.62

$47.76

$99,350

State Rhode Island

Like most businesses, chiropractors tend to earn more as a patient base is built and become owners of or partners in a practice. BLS calculation of national median wages for chiropractors in 2012 was $79,550, considerably more than the most recent figure of $71,410.80. The experience of those in practice for many years, however, is that reimbursement for services or ability to bill for services, has fallen for most types of payment models, particularly in what is referred to as fee-for-service. Employment of chiropractors is projected to grow 12% from 2016– 2026, faster than the average for all occupations. According to the BLS, people across all age groups are increasingly becoming interested in integrative or complementary healthcare as a way to treat pain and improve overall wellness. Chiropractic care is appealing to patients because chiropractors use nonsurgical methods of treatment and do not prescribe drugs.[80]

2.2.9  Reimbursement Before discussing how chiropractic doctors are reimbursed for their services, it is helpful to summarize the healthcare system in the US. It is fractured into multiple reimbursement models, each of which differs as to whether chiropractic care is covered and if it is, to what extent. Table 2–3 illustrates the most common payment models and Table 2–4 is a summary of whether chiropractic care is considered and/or reimbursed under each model.

96  History, Present and Prospect of World Traditional Medicine Table 2–3    Varieties of healthcare system. Reimbursement System or Category

Primary Population(s) Served

Medicare

65 years old or older or younger if suffering from long-term or permanent disability

Medicaid

Low income (means-tested; varies by state)

Children’s Health Insurance Program (CHIP)

Children and families with low income but who do not meet Medicaid requirements

Employment-related healthcare plans

Employees and immediate family members

Corporate (on or near a jobsite)

Employees

Workers’ Compensation

Workers injured on the job (employer sponsored)

Casualty/Personal Injury

Injury from negligence or accident (e.g., vehicle accident or defective product); may require litigation

Indian Health Service

American Indians and Alaska Natives

Veterans Health Administration

Most Veterans of military service (exceptions apply)

Military Health System & TRICARE

Active military service and most dependent family members

Table 2–4    Chiropractic coverage of varieties of healthcare system. Reimbursement System or Category

Chiropractic Coverage

Medicare

Yes: Spinal adjustments (manipulation) only; examination, lab tests, imaging, and counseling are not covered

Medicaid

Yes: Varies by state with most offering coverage but it may be limited in number of visits permitted or scope of conditions permitted for care; typically very low reimbursement

Children’s Health Insurance Program (CHIP)

Varies by state, similar to Medicaid

Employment-related healthcare plans

Yes: Broadly but some plans may have limited or no coverage

Corporate (on or near a jobsite)

Variable/Emerging, depending on the employer

History, Present and Prospect of Chiropractic  97 Table 2–4   (Continued) Reimbursement System or Category

Chiropractic Coverage

Workers’ Compensation

Yes: Varies by state

Casualty/Personal Injury

Yes: Varies by state and, if litigation is involved, payment may not be awarded depending on legal settlement

Indian Health Service

Yes: Varies by tribe

Veterans Health Administration

Yes: Upon medical referral

Military Health System & TRICARE

Yes: Typically, upon medical referral

There are 28 million US residents who do not fit any of the categories noted in Table 2–3. They tend to be male, 19–64 years old, have less than a high school education and/or have lower incomes.[81,82] Private insurance is available to these residents but due to the high cost of individual plans, many have no meaningful healthcare insurance whatsoever. Healthcare practitioners, pharmaceutical companies, hospitals, and related service providers are paid relatively well when new technologies, advanced procedures or novel medications are involved. Time spent to talk to patients or deliver low technology, hands-on, direct care, is seldom well-reimbursed. Chiropractic care generally fits this latter category. Although chiropractic doctors earn an above average income, as previously noted, medical physicians and other healthcare practitioners typically earn more. Chiropractic care is reimbursed by most insurance schemes but at varying levels of payment, many of which are relatively poor when compared with comparable services provided by medical physicians or physical therapists.

2.2.10  Emerging models of practice As previously noted, chiropractic doctors in the US tend to practice solo or in small groups with other chiropractors. This is gradually changing, however, with a minority but growing trend of practices integrating with medical and other healthcare practitioners.[83] According to William

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Morgan, DC, current president of Parker University, the trend is for more integration of chiropractors into medical clinics and hospitals, and for more physicians to work within chiropractic offices. Morgan adds, “The Department of Defense and the Veterans Administration are both following directives to find safe alternatives to opiates and pain procedures. As a result, they are gradually expanding the chiropractic benefit.”[84] Indeed, hospital-based academic medical centers including, but not limited to, those at Dartmouth College, Duke University, University of Texas, Austin, and the Medical College of Wisconsin have chiropractors on staff at outpatient clinics. Other hospital-based medical centers and healthcare systems, such as Wisconsin-based Aurora Healthcare, Beth Israel Deaconess Hospital, Plymouth, Massachusetts and the Lehigh Valley Health Network in Pennsylvania, have chiropractors on staff. Chiropractic in-patient care is much less common but in at least one instance, Mercy Hospital St. Louis, chiropractors are part of integrative health offerings for patients within a hospital environment. In response to Public Law 107–135, the Veterans Health Administration established chiropractic clinics at 26 Veterans Administration (VA) facilities beginning late 2004.[85] Since that time, the use of chiropractic care and the chiropractic workforce in VA have grown without further mandate expansion or development seen from 2005 through 2015 represents the organic growth of this new service. This growth may be explained by multiple factors including patient demand, patient access, and the successful clinical outcomes of VA chiropractors. As little is known about the introduction of chiropractic services to other US hospital systems, there are no obvious comparators against which to gauge the manner, rate, and extent of penetration of these services in VA. The fact that these services have expanded consistently and substantially beyond the minimum mandated level may suggest that some VA decision-makers perceive value in providing chiropractic care. There are now approximately 200 chiropractors employed by the VA which is most probably the largest single employer of chiropractors in the US; a definitive statement on this matter is not possible due to a lack of centralized data on employment. The VA also offers a one-year chiropractic residency position at 10 of its hospital-based clinics. Five of these sites are the

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only CCE accredited residency programs in the US and the other five are expected to apply for such by the end of 2020. Active military personnel in the US also have access to chiropractic care since 1995, although employment of chiropractors may not be directly with the Department of Defense (DoD) or specific branch of the military. Rather, employment may be arranged through contracting agencies, not directly through the various branches of the military. As such, there is no central repository of information regarding employment or utilization although research has been conducted to assess various aspects of care with the DoD.[86] US employers, particularly those with large numbers of employees, have long offered on-site healthcare services. A full one-third (33%) of US employers with 5,000 or more employees offer general medical worksite clinics in 2017, up from 24% in 2012. Employers are starting to offer on-site wellness and healthcare services as well. As these clinics are established, employees are asking specifically for chiropractic care. Patients, healthcare administrators, and medical physicians recognize the value of adding chiropractic into multidisciplinary clinics.[87] On-site or near-site clinics, often referred to as health and wellness centers, typically offer numerous services to employees including first aid, occupational health, acute, primary, specialty, condition management, wellness and ancillary services, and increasingly, chiropractic care. Healthcare costs for employers were calculated to reach $15,000 per employee in 2019. Additionally, direct and indirect costs associated with low back pain, a malady often managed by chiropractors, are estimated between $85 billion and $238 billion, and expenditures for back pain are rising more quickly than overall health expenditures. To help stem that growth, as many as 65% of large corporations are expected to offer company healthcare clinics by 2020. According to a recent study conducted by the National Association of Worksite Health Centers, the majority of employers surveyed said their employees have expressed interest in chiropractic services at their clinics. Many worksite clinics are now offering integrative primary care services, including chiropractic care, as part of their on-site corporate clinic.[88]

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In the past 10 years, the trend of chiropractors at on-site clinics has grown. Starting with a few individuals working at Silicon Valley technology companies and Midwest manufacturing sites, there are now several hundred chiropractors working in the employer-driven model. One of the key drivers has been large medical group vendors hiring chiropractors as part of their teams such as Crossover Health, Premise, Stanford, and One Medical Group.[89] One such clinic, affiliated with California-based Crossover Health, found that an integrated physical medicine clinic, including chiropractors, physical therapists, acupuncturists, and medical physicians, resulted in favorable clinical outcomes, received fewer opioid prescriptions, and had high patient satisfaction, all at a reduced cost compared to what can be described as usual care, i.e., non-integrated care.[90] Employer-sponsored on-site clinics are unique and based on the employers’ specific needs and resources. As an example, a large Silicon Valley employer has what is considered the first fully integrated on-site holistic medical home. A medical home is a model of primary care that is patient-centered, comprehensive, team-based, coordinated, accessible, and focused on quality and safety.[91] In addition to multiple healthcare services, the facility also has a gym. In this on-site facility, chiropractic care is a part of the integrated front-line healthcare team, not merely a complementary, alternative option. According to a chiropractor who has worked at a Kansas City on-site clinic since 2009, medical providers in these integrated clinics have learned how chiropractic care can benefit patients with neuro-musculoskeletal conditions and complaints, and actively refer and involve chiropractic in treating the patients.[92] A 2013 study suggests that chiropractic services offered at on-site clinics may promote lower utilization of costly healthcare services, while improving musculoskeletal function.[93] Crossover Health and similar organizations have organized clinics that include chiropractic care for relatively smaller companies that do not have the option of operating a comprehensive, on-site clinic. This model is the near-site or shared-site clinic. A company can share costs with other similarly sized companies and offer employees attractive healthcare benefit without the overhead cost or providing the space on their campus to build the clinic.[92]

History, Present and Prospect of Chiropractic  101

In either scenario, whether on-site or shared-site models, employers are learning that corporate health and wellness clinics help with the retention of employees. Investing in the well-being of employees with workplace health and wellness benefits can help attract and retain employees — clinics are often viewed as the most popular benefit by workers.[91]

2.2.11  Public perception Among those who saw a healthcare professional for neck or back pain over a 12-month period, 62% saw a medical doctor and 53% saw a chiropractor. About one-third saw a physical therapist (34%) or massage therapist (34%) for care.[94] A 2014 market research study gauged consumer appetite for chiropractic care. Among the 1,000 consumers surveyed, 1 in 10 with chronic pain reported having back and/or neck surgery, 42.3% said surgery did not solve their pain, 65.8% of chronic pain respondents said they felt hopeless and 71.8% said they would consult with a chiropractor.[95] In the Gallup-Palmer College of Chiropractic Annual Report, Managing Neck, and Back Pain in America, patients who saw a chiropractor for significant neck or back pain over a 12-month period say their chiropractor often listens (93%), provides convenient, quick access to care (93%), demonstrates care/compassion (91%) and explains things well (88%), and 90% of chiropractic patients say that their chiropractor spends the right amount of time with them. These figures are higher than those reported by patients who consulted physical therapists, generally by 5% on the same parameters, and superior to the ratings of medical physicians, generally by a 20% margin.[94] The Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program is a multi-year initiative of the Agency for Healthcare Research and Quality to develop and promote the use of standardized surveys of consumers’ experiences with health care. Fulcrum Health Inc., a regional chiropractic healthcare network, uses Press Ganey Associates to administer the Clinician and Group (CG-CAHPS) survey type on a regular basis to assess patients’ experiences with healthcare providers and

102  History, Present and Prospect of World Traditional Medicine

staff throughout the offices within the network. Press Ganey Associates is a 2019 Merit-based Incentive Payment System (MIPS) approved survey vendor. Fulcrum’s provider network is a multi-year recipient of Press Ganey’s Guardian of Excellence Award. This award honors those who have reached the 95th percentile for patient experience, engagement or clinical quality performance. Guardian of Excellence Awards are awarded annually to those who sustain performance in the top 5% for each reporting period for the award year. This distinction demonstrates the network’s ability to excel in measures of patient experience when comparted to healthcare providers and medical staff among other medical specialties. In a recent survey, the overall percentile ranking for chiropractic services is 96.9, a figure that fares exceptionally well compared to medical specialties.[96] Simply stated, patient perceptions of the chiropractic profession are quite favorable.

2.2.12  Research, journals, and scientific conferences An overview of the profession’s development of research capacity through the 1990s was covered earlier in this chapter. At present, there are a few additional chiropractic journals that have come into existence but perhaps a more fundamental change is that chiropractic doctors now publish work in a broad number of medical scientific journals. Chiropractic researchers now routinely participate in making presentations at a variety of medical and scientific conferences in addition to those that are chiropracticspecific. There are also clinical and research collaborations between chiropractic colleges and academic medical institutions as well as similar ventures between chiropractors and hospitals, government health plans agencies. Changes such as these are due, in part, to an increase in government and private research dollars awarded to chiropractors and chiropractic institutions compared to that which historically occurred. Unfortunately, overall US government funding has declined for all types of research, pitting smaller chiropractic training programs against larger, more wellestablished, research-oriented universities and institutions. The latter are more likely to receive the benefits of grant money, leaving the chiropractic institutional funding at relatively low levels.

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2.2.13  The world view Although the profession began in the US, there are more chiropractic training programs outside of the US than inside the US today.[97] The World Federation of Chiropractic (WFC) is the global voice of the chiropractic profession and has national association members in over 90 countries globally. In terms of distribution, it remains the case that over 80% of the profession is located in North America, particularly the US and Canada, where over 90,000 chiropractors hold licenses to practice. This inequity in the provision of chiropractic services sees many countries with very sparse numbers or without representation at all. However, projected numbers are set to rise with the founding of new educational programs in Europe, Asia, Latin America, and the Eastern Mediterranean regions. Scope of practice varies from country to country and within countries. Some jurisdictions permit a wide scope, including rights to prescribe medication and refer for advanced imaging. In others, such as Austria and the Republic of Korea, chiropractic remains technically illegal, with chiropractors vulnerable to prosecution. Chiropractic is recognized as a health profession by the World Health Organization (WHO); indeed, the WFC has been a non-state actor in official relations with WHO since 1997 and remains the only chiropractic non-governmental organization afforded this status.[98]

2.3  Potential futures for the chiropractic profession 2.3.1  Introduction Writing about the future of anything is risky business. Putting a wager on where anything is going is certainly akin to gambling or betting a line on a sports game. Some approach this futuristic stuff by outright guessing, others with percentage odds of potential future scenarios based on data and trends. Others go about it by just asking those in the current know what they think. I’m going with a bit of a combination of both, because after almost 35 years of practicing chiropractic, I have learned that the more information you have to help you make decisions, the better your guesses.

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This section builds on the earlier sections of this chapter by my colleagues, Drs. Bart Green and Robb Russell, and will attempt to forge a bridge from that fact-based story about chiropractic into a theoretical one about what is coming to the chiropractic profession. In my story, I will be looking at the views of people that know our profession and because of each of their positions, they have their own special insight into a critical portion of the profession. They will be extrapolating to a degree based on what their perch over the profession has brought into their field of view. While there were a few with overlapping views, most gave a new and insightful perspective on where the chiropractic profession is going — and I owe each of them a deep level of gratitude. They are all listed in the reference section for this chapter. The obvious problem with my approach is that I am consulting people who are currently in the know. Change, however, in any endeavor often comes from people who are not thinkers that are confined by the boundaries of current way of doing things. The future often comes from those who look at what exists, see the flaws in the system, and then work out ways to carve out a niche or build a structural base of support for a new and possibly better or more efficient way to do the job, but might require destroying the current way of doing things. Disrupted, is the current way we describe this. We are all familiar with the history of many processes that have been transformed. Consider transportation or communication and how the initial innovators were displaced by those with new and typically ingenious ways to build on what was in existence in a transformed way. The domestication of the horse was revolutionary. It transformed the speed of our communication, trade, and transportation, how war was fought. and expanded food production along with many other things. Now, however, for most in the first world, horses are typically just a fabulous hobby. There is certainly only so much critical thinking that experts can do when they are really dealing with the known knowns and known unknowns. Just to put an even deeper blanket of haze over this whole forecasting thing, let us not forget that chiropractic is only one small part of the healthcare world. While we are not insignificant, we are small enough to mostly not be considered when healthcare policy makers go about their business. Certainly, we have done a good job of existing at the fringes of

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the models that exist in healthcare but from a structural standpoint, we have never had much of a chance of existing at the center of, in a spoke and wheel sort of way, the business of healthcare delivery. Moreover, those business models are certainly changing from those that have been built around relationships with hospitals to one designed more with the medical group as the spoke around which the other players exist. This trend may be an opening for the chiropractic profession. A final level of critical evaluation to this future prediction business is that it will be done through my eyes and the eyes of those I have come to know. Certainly, this is suspicious. Nonetheless, I have listened to those I interviewed and followed up, as best as I could, with other experts that were recommended to me. However, given all the reasons that this entire section of the manuscript might be just a “Boat of Foolish Smells,” we shall forge ahead regardless and hope that we can ask for forgiveness at some future date if our representations have been amiss. Avast! Let us sail forward into the unknown...

2.3.2  Healthcare landscape and trends It seems that a day does not pass with health-related information splashed across the news. Everything from new and better ways to treating specific diseases to new disease outbreaks to breakthroughs in care delivery and care processes. In the US, health delivery systems are constantly merging or divesting portions of their business or new models of care are being tried out in an effort to provide care that will drive efficiencies, profits, quality, or value to the care seeking public. Up to 25% of all US healthcare delivery are being considered wasteful and over 30% of lower back pain care are being discordant with guidelines, there is ample opportunity for new and innovative ways to improve efficiencies and provide value while cutting out healthcare delivery waste. Enter Big Data and maybe Big Brother. With the digitization of healthcare data, through electronic medical records and tracking healthcare encounters through billing, the opportunity to document and evaluate what has happened during a healthcare encounter grows with every new byte and bit of data entered into a healthcare provider’s computer. While data has been entered into computers for decades, it is the advent of the

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network and the cloud to store all of that data, combined with software to perform data analytics, that is leading to new and better data driven decision making and strategy. Eventually, with the advent of deep learning and large volumes of data collected over time, artificial intelligence will create opportunities to transform our understanding of healthcare and our ability to make impactful healthcare predictions. Starting with the tracking of the main reason for healthcare encounter (diagnostic codes, procedure codes, etc.), matched to any co-morbidities or related diagnosis, paired to the specific provider type seeing the patient and then the exact provider that is performing any procedures or giving prescriptions — everything is becoming known about what happens when caring for a health condition. What then becomes of all our very personal data in a medical record when that information gets woven into the data fabric of our electronic life? Meaning, consider the individual lifestyle choices and personal goals each person has along with their work and family requirements, where they live, and how long they commute along with their ethnic and religious background, and everything else. Much of that data will be entered into the medical record, evaluated, and tracked and then combined with data from every other patient healthcare encounter with similar clinical parameters. It will create a 360 degree view of an individual in the healthcare system and formulate that patient’s likely next best step forward in dealing with their health concerns. Pair that data with the historical data of each provider treating each patient in the healthcare system with their individual conditions and it is likely that the system is going to be able to eventually have the ability to predict outcomes for each patient by a specific provider or a category of providers. Meaning, recommendations may one day be made to each patient, by whomever is in control of the data, as to exactly which provider or group of providers will be best for a specific patient and/or the specific health concern of that patient. This is beyond centers of excellence — it will be truly personal and customized healthcare based on real data that will make actual predictions on what will be the best care pathway for each patient’s condition. So, everything will be measured and evaluated, right? Well, yes, except when there is no insurance carrier or other entity being billed or the data being collected is not shared within a larger healthcare system. This

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lack of participation, from an electronic data collection perspective within large healthcare systems, is relatively frequent in the chiropractic profession and other professions in the non-medical healthcare provider world. Additionally, medical providers in small practices, those still paper charting and concierge practices, likely constitutes a significant amount of care. If data is not being submitted by a subgroup of healthcare providers into the vast pool of patient data, in the new data gathering age we are in, will the care data being done by those providers who are off the grid be forever lost? That is very likely. Classical research on what those providers are doing can help but it appears to me that we are moving into a captured data driven decision-making era. Studying healthcare with traditional research methods (randomized controlled trials, etc.) in a welldesigned and organized fashion, which is how most healthcare research to date is done, for conditions treated by physical medicine practitioners, will likely be seen as less helpful and likely less accurate than the real data captured on millions of patient encounters over an extended period of time. In a world where every bit of healthcare data on those individuals is known, as it eventually will be, that information and the predictions that will be possible might be closer to the real truth as compared to what a controlled research study can tell us. So, will the non-participants in healthcare data capture become vestiges of healthcare? It makes one wonder if that is possible but, certainly, care decisions and best practices will be determined outside of what those non data providing providers, who are working in data deserts where healthcare information is noncapturable, are doing. At this point, a flaw in this line of thinking must be revealed — the regulatory environment. Currently, it is either not possible or uncommon to be able to take data captured by an electronic medical record (EMR) and blend it directly to all of the billing and coding data for an individual patient throughout their entire healthcare journey. Large at-risk organizations have the ability to do this because they have all of that data. In most situations though, there is the insurance entity data (billing and coding of every health encounter) that has encounter data and then the EMR that has data the healthcare provider is using to collect specific healthcare information on each patient, patient encounter, and everything associated with that patient including their individual lifestyle habits and preferences.

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There is too much to be gained for this data not to be joined seamlessly and this is what large data gathering organizations have been working to achieve and will likely achieve in the not-too-distant future, if the regulatory environment allows it. Also, what is the point of data analytics in healthcare? As described above, data will help with the understanding of exactly what is being done during a healthcare encounter for each individual patient. Which types of encounters and care pathways and maybe the specific provider that is most effective for each patient will become much easier to understand with big data. It will likely lead to training opportunities for providers who have less identified proficiency in caring for certain patient types which may revolutionize healthcare provider training. All of this will lead to new efficiencies in care delivery and more appropriate decision making. Given chiropractic’s success in neuro-musculoskeletal (NMSK) care, this new world of data gathering and data analytics will lead to data driven care pathways that will likely be favorable for the chiropractic profession. Where I work, we have already begun to put the positive data that has been gathered in physical medicine (physical therapy and chiropractic care) to work. Discussions have started about how to get nurse triage calls routing patients to the appropriate provider for the patient’s first encounter as opposed to the default practice of referring the patient to a medical doctor — which is the healthcare system standard. Other provider groups, such as Crossover Health, have already put the focus on physical medicine providers seeing the NMSK patients as the first point of contact to their clinics. This trend has the potential to be a huge boost for the chiropractic profession. All this data gathering is not without controversy. Will Big Data beget Big Brother, or more probable, Big Hackers? Data security is a wellknown concern to all of us. What will happen when all an individual’s health data becomes known to the hackers of the world? Other than putting individuals in a potentially compromised position if information about their health concerns are publicized, I’m not sure there are any concerns to the individual. That is not unimportant though — an employer or family member being made aware of health information could certainly create volatile situations with significant repercussions. Potentially more concerning is that patient identifiable hospital data is now being shared

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with technology companies. While many good things can happen when evaluating data, one must wonder if this will eventually lead to nothing more than marketing opportunities for our for-profit healthcare system, particularly the pharmaceutical industry. However, given that this data gathering has already been happening, it has generated very positive findings when comparing chiropractic care to others for spine care. And this has already resulted in positive changes. Optum (United Healthcare) has already announced benefit changes that allow three free visits to patients with a spine problem if they see a physical therapist or chiropractic provider. A positive event for the professions indeed. Again, given our history with data gathering so far, it is very likely that what comes out of any future healthcare data is going to be very positive for the chiropractic profession and will drive changes leading to growth in the number of patients being driven to chiropractic providers by the healthcare system. Prediction: By 2030, data analytics will be driving healthcare organizations to refer spine pain patients to doctors of chiropractic and the trend will be to send all NMSK patients to chiropractors or other providers with skills that are traditionally best handled by doctors of chiropractic. This could increase the number of patients being directed to seeing a doctor of chiropractic by the medical system to increase several times over what it is today. This has the potential to increase the total number of patients under chiropractic care by up to 50% a year. This means that instead of treating 10–15% of the US population, the percentage of the population under chiropractic care could be between 15–23% of the US population by 2030.

2.3.3  The Internet of Things (IOT) Next, consider all the devices connecting individuals to the internet and the implications to the chiropractic profession. All those things, those devices, those tiny computers, even just chips or wires that are collecting personal physiologic data, are connected to the internet. From smart watches to posture monitoring devices to everything else imaginable when monitoring body functions — the IOT, Internet of Things, has evolved and been subdivided into the internet of medical things (IOMT) and several other subcategories. These devices have the ability to significantly

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change the day-to-day activities of all healthcare providers and doctors of chiropractic included. Now that everyone is familiar with FitBit, smart phone, especially the iPhone and their abilities to monitor our activity and physiology, where will this take us? IOMT unleashed! I am not going to go into a complete review of all the devices available and other technology currently available or even everything that is on the horizon. At this point, smart clothing, E-textiles, and sensors in our attire are all available to monitor and potentially enhance our lives. What seems more prudent is to briefly review current technology that directly impacts the chiropractic profession and what is being discussed as coming in the near future. Here are a couple of established technologies that have direct implications to the practice of chiropractic. There are posture monitoring and training devices that patients are already ordering and trying in an effort to improve their posture. UpRight, based in Tel Aviv, has been in this space since 2015. At the clinic I work in, we initiated a trial program using the product, starting in 2016. Patients found them helpful, although a bit intrusive. At the time, they were promoted mainly for lumbar lordosis training when sitting. While we found that it was helpful, we decided not to fully integrate the product into our daily practice. Today I generally have a few patients a month trying the product and asking me about it. Generally, they are very happy with the product. They feel that it does help them work towards correcting their posture problems and for most of them, in my experience, it does. What has been missing is the ability of the device, which adheres to the spine and buzzes/vibrates to alert the individual when their posture is poor, to provide feedback to the provider and to integrate the data into the providers EMR. Sensors in our foot apparel are another IOMT component that has already been available for years and allows many of the mechanical components of walking and running to be evaluated and tracked. There are several examples of this in socks and shoes. Sensors are being woven into fabrics that measure the positional/postural issues of the body parts they cover as well as muscle activity and muscle fatigue. While currently most smart fabric technology is in the experimental stage, there are now garments available that monitor this. Will this data make it securely to the user’s cell phone and then be pushed to a healthcare provider’s EMR? It

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will be a major game changer in how the chiropractic and other physical medicine providers practice once it does. Tracking activity levels and posture over time will create a road map of a patient’s biomechanical activities. If integrated with pain measurements, imagine the ability to prevent the chronic problems, from poor posture or improper biomechanics, that will be possible. Since poor posture might be something that occurs only at a certain time of day, the unveiling of this data to the individual wearing it and the provider, when that happens, will facilitate communications that hopefully will help to pinpoint reasons for flare-ups and ultimately help to prevent problems. While I have been told that getting IOMT data from the user’s cell phone into the EMR is being worked on and that each IOMT company includes this as part of their roadmap, there are still many hurdles for actual patient data to get into the provider’s chart. Agreements between each IMOT company and each EMR company are needed and the technical issues of transferring data securely need to be worked out. Yet just imagine if it was possible to do this. A patient wearing the device all day, capturing a day’s worth of postural information and regional muscle activity. That alone, documenting any positive or negative situations and changes, would be incredibly helpful in managing a patient. What if they also input their level of region-specific pain into the system at regular intervals (say hourly). Then, it would be relatively easy to track their pain as mapped to their postural history. That data would obviously be very helpful in pointing out problematic situations and allowing the patient and provider to review how to avoid those moments. It would likely help in tailoring specific rehabilitation exercises for each patient based on a specific set of demonstrated biomechanical faults during their daily activities. Everything from ergonomic discussions, exercise choices, and reviewing sleeping positions, would all have actual hard data points and lead to less guessing as to how to best avoid the causative situations and activities that are likely driving the patient’s problems. This, if ever fully implemented, will likely lead to a significant improvement in the quality of people’s lives and create an entirely new desired skillset for chiropractic providers — remote communication and remote patient education. Now, what about devices listening in on patient encounters? With smart speakers in the home now, one would have to think that eventually

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Siri and Alexis will be electronically hovering over our every word during a patient encounter. At this point, I think we are very far from that being a reality that results in changing a patient encounter. However, one day, as technology advances, one would expect this to significantly change the healthcare provider and patient encounter. Imagine no typing into an EMR, being questioned about performing an additional orthopedic or neurologic test, or maybe advised to evaluate another potentially related body part or organ system. What if outcome assessments were populated automatically based on the verbal interaction of a patient encounter and red flag question lists and potential lists of differential diagnosis were verbally generated by the smart speaker? Automatic specialist referral recommendations, nutritional options as well as general exercise recommendations might be mentioned by the smart speaker and video’s demonstrating exercises might be cued up onto a screen. The list of potential new eventualities is pretty extensive. I believe all of this is coming but it is obviously a very long way off. What is certain is that humans will become more and more machinelike as we evolve to wear more devices to help us monitor our functioning and ultimately to help us perform better and for longer. Providers will need to stay aware of these changes and learn how to best incorporate them into the home care advice that they give patients. Prediction: By 2030, most people in modern society will have several monitoring devices connected to their body and that data will be shared with providers who will engage with the patients remotely on the findings of the IOMT device.

2.3.4  Training, licensing, scope of practice and regulations In the US, doctor of chiropractic programs are becoming more competency-based and are starting to steer away from teaching to specific requirements. When compared to the training of other healthcare professionals, we certainly stand alone, from an institutional standpoint in the US. We are not tethered to larger university systems since we grew independently of other educational systems. Chiropractic’s professional origins go back to a time when many of the medically affiliated professions

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(physical therapy, behavioral health, nutritionist) were not fully in existence or were not part of the medical profession or medical care paradigm. Having gone our own way from an educational standpoint, we have stayed independent for the most part and have not developed the type of training that most other US health education programs have done with hospital-based programs and internships. This may be to our advantage because we have had to learn to be independent, but it is possible that the future of our US-based training institutions will become more integrated along these lines. This would mean incorporating learning with not just other ancillary health professions, but also with the traditional medical aligned professions of medicine, nursing, podiatric, physical therapy, and all the others. I have heard that there are concerns trying to teach to the requirements of 50 different states, particularly a state such as California where licenses are based on an Initiative Act enacted in 1922. The concerns are with adhering to all the requirements of something voted into law nearly 100 years ago as well as newer requirements that come from states with different ideas about chiropractic. Is it possible that licensing changes around education will become less of a state regulatory requirement, with more of the educational requirements being federally mandated? That seems unlikely but there is a sense that some regulatory changes might occur to streamline the educational process. Residencies, which are the standard in many other healthcare training programs, are rare in chiropractic. The Veterans Administration is the only good example of using DCs in residencies and it only serves a very small percentage of the chiropractic graduate population. Any growth of that program will help to increase the job placement of the residents into integrated settings but will certainly only continue to involve few DCs. At the current time, there is no indication that an additional entity will appear to help train chiropractic residents. Accreditation standards have changed over time for chiropractic colleges and education delivery and assessment have and will continue to change, but towards what end? Federal agencies have looked at graduation rates and student loan default rates as potential indicators of how effective educational programs are. Is that data meaningful or will it drive any changes in how doctors of chiropractic are trained? That is difficult to

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know. Moreover, we really do not know what it actually should cost to train a DC and if rates of graduation or passing National Board of Chiropractic Examiner exams or success in practice have anything to do with this. As far as training goes, has the technological revolution done anything to revolutionize chiropractic training? Not much so far. There is certainly a huge opportunity to centralize the basic science portion of chiropractic education through the pooled use of technology. Will privately held colleges link together so that one lecturer with expertise in the basic sciences can lecture to the students of all or many of the chiropractic colleges with distance learning technologies? It has yet to happen or from my understanding, even been openly considered. If it did, it certainly would allow, in theory, the best teachers to teach and those that are not to explore their other talents. There is no doubt that this would start the process of bringing down the cost of delivering a DC degree. I can imagine that any group of administrators who started down this path might end up jobless themselves prior to this being implemented — but it does make sense when viewed through the lens of making education more affordable. Given the current high student loan burden of chiropractic graduates, it seems that the lack of implementation of a distance learning component to the doctor of chiropractic curriculum will certainly continue to burden the graduates in a financial way and negatively hinder their potential success. This alone, one would hope, might be impetus enough to have the process initiated on some campuses. The US standards, put forth by the CCE, require programs to establish their own mission, along with goals and objectives that define how they are going to measure their success. There are some common elements and some unique nuances that are defined and measured by each doctor of chiropractic program. If the measure of success of the educational program were made by looking at performance from the prospective of the end user of that program, the doctor of chiropractic, then maybe all the factors that ultimately lead to success would be considered. Certainly, passing tests and boards are important but so is the total time and cost of the program as well as the ability of a graduate to perform as a DC in a private office or in a healthcare delivery system. What is the importance of instituting the notion of life-long learning, or to be true to the history and principles of our profession? Should we measure the educational

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success by the ethical leanings of our graduates or the quality of care or value to the healthcare system provided by our practitioners? All of these are concerns and it will be up to each institution to decide its individual path. Let us hope that there are chiropractic training institutions that find commonality in their approach and are able to co-resource certain components of their educational training process to allow the end user to benefit financially from these efficiencies. If something along these lines does not happen, it will limit the number of students entering the profession and lead to shortages of skilled providers of badly needed services. It is possible though that if the income of graduates significantly accelerates it could easily offset the continuing increasing debt load of chiropractic college graduates. Eventually, if data continues to support the chiropractic profession as being a provider of high quality and high value care, it is certainly likely that the larger healthcare educational systems will want to incorporate chiropractic into their programs. This could, given the public support of these types of systems, result in a lowering of the total debt burden on the doctor of chiropractic graduates. Chiropractic has always been a service that is directly accessed by the public and this has continued being so, except in a few situations where the medical delivery system requires a medical doctor to initiate any specialist (non-primary medical doctor care) — such is the current case in the VA. The procedures, recommendations, and adjunctive therapies the profession performs have been based on a more natural and noninvasive approach to healthcare. The case has been made that medication prescribing should be added to a chiropractor’s scope of practice. It is possible that this has happened as there are examples of it now but imagining this as a growing component of the chiropractic scope of practice is difficult. There are advanced practice providers including physician’s assistant and nurse practitioners that are rapidly filling the need for these services. Currently, if the value of chiropractic services were fully realized, there would not even be close to enough doctors of chiropractic to fill the needs of the public. Additionally, any foray into this sort of increase in scope of practice will be costly and vigorously fought by other providers. Imagining the prescribing of medications as something that gains traction for the chiropractic profession in any significant way is very difficult at this point.

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When looking at accessing a doctor of chiropractic from the patients’ perspective, historically, a visit was one that required the patient to pay cash for the services. Through the 1970s and 1980s, chiropractic gained insurance coverage in most reimbursement settings and currently is covered by the vast majority of insurance plans. That coverage does not necessarily mean equal coverage as often times, the amount a patient must pay out of their pocket for a course of care with a conservative care provider, chiropractic included, is significantly greater than the cost to a medical doctor for a potentially dangerous and highly addictive medication. As of 2009, likely influenced by the aforementioned policies, the US has acknowledged that it has an epidemic regarding the abuse of opioids. Due to this, legislation to avoid the addiction, overdoses, and deaths that have followed opioid abuse are supporting conservative care for pain. It has created an interesting twist in the history of healthcare at this time. While access was granted to many conservative care approaches through reimbursement, those approaches were never put into the forefront of the care pathways that were used by the medically managed healthcare system. Now, it seems, in this world of data management, quality, and metrics, a path of conservative care seems to be the one currently enlightened by the literature. Individual state regulators are looking at ways to stop the opioid crisis as well. Legislation in West Virginia was signed into law in 2018 to require that any prescription for opioids also requires a prescription for an evidence-based form of conservative care that can include chiropractic. Other states in the US have or will be introducing similar legislation as well. With this as a backdrop, the American Chiropractic Association is supporting legislation that would increase access to services by chiropractors in the Medicare system and, if signed into law, would bring the current antiquated reimbursement system more in line with the way that population is cared for today. There are those in the reimbursement world who are looking to get ahead of this trend towards better conservative care and are basing their approach on what their many years of insurance data has shown. One large US insurance carrier is considering removing any out-of-pocket costs for patients with a spine problem if they see a conservative, nonMD, care provider first for their problem. The conservative care being considered will certainly include chiropractic care. Since it has been

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shown that chiropractic patients are very price sensitive, this would clearly incentivize many patients to choose chiropractic and create a very large influx of patients into the offices of doctors of chiropractic. This would be an amazing turn of events from the years of increasing deductibles and co-pay for chiropractic services. Prediction on chiropractic training: Within the next decade, it is likely that there will be at least some US chiropractic programs that will be merged together and others that will be joined with established healthcare training educational systems. There will also be a sharing of resources between some doctor of chiropractic programs which will help to decrease the debt burden on the graduating doctor of chiropractic. Prediction on scope of practice: Over the next decade, the scope of practice of chiropractic practitioners will be largely unchanged.

2.3.5  Market for chiropractic services and the practice of chiropractic It is now clear that spinal disorders are a serious and important problem in the world as evidenced by the series of papers published on “Global Spine Care” in the European Spine Journal. Spine problems, as of 2018, have become the 4th leading cause of disability-adjusted life years just after ischemic heart disease, cerebrovascular disease, and lower respiratory infections and that grew from spine problems being the 12th leading cause in 1990. Given the trajectory of this problem and its prevalence, it would appear that the opportunity for the services that chiropractic profession delivers is growing significantly. What is less clear, based on that same group of papers, is which category of healthcare professional will be the preeminent spine care provider. The importance of spine care and the specialty information required to be an effective spine care provider are becoming known and taught. One has to wonder who will control spine care given this current body of evidence. If healthcare policy continues to identify spine problems as a significant cost driver and producer of great disability, the need to move towards a more generalist approach to spine care will likely occur. It is not difficult to imagine, as many have suggested, that eventually, healthcare will treat the spine as a specific organ or body region, much like the way

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dental profession approaches teeth. In that scenario, who will fit into that professional role? There may be a need for some providers to re-tool or update their diagnostic skills, evidence-based knowledge, manual procedure skills, rehabilitation skills, communication skills, team-based integration, and inter-professional referral skills. There are many professions who all play in the spine care space and it may be that an integrated team will be the best approach to spine care, as this is now apparent in some areas. Imagine a doctor of chiropractic, doctor of physical therapy, medical or osteopathic doctor who possesses the skills to diagnose and treat with evidence-based procedures, all that has shown to be effective for spine care. Who would do the best job? Currently, the physical therapy and chiropractic professions would seem to have the largest numbers of providers currently able to implement most of the skills that the evidence seems to indicate as being effective. However, doctors of osteopathy, who have taken the time to acquire and then fully develop the appropriate skills, may become well equipped to be put into this role, given their ability to prescribe the few medications that have been shown to be effective for spine conditions. The medical field, with its inherent lack of focus on manual body work, currently does not seem to be the best fit for this portal of entry provider who can initiate care on the initial visit. Moreover, nobody should be so bold to think the book is closed on exactly who, or what skillset is best, to be the perfect spine care provider. At this point, it seems that a team-based approach is best, in utilizing several types of different providers. While it is possible that a team is needed, the scope of the team may vary based on the individual skills of the team members. As previously mentioned, we may need to start by taking a look at the outcomes from large sets of data to find practitioners, or specific groups of practitioners, who get great results that last the test of time. Some are concerned, as it has been discussed for decades, that the chiropractic profession is indeed heading for a split between those who want to be condition focused on patient care with less focus on wellness and those who want to be wellness focused with less focus on caring for conditions. Doctors of chiropractic are not the only provider type that has providers with significantly different focuses. The acupuncture profession and other professions have this same potential split between traditional

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holistic-only providers and those providers willing to care for regional conditions. I think that after well over 100 years, we are not going to split. This profession has many different flavors and two or more categories of providers. Will we continue to confuse the public because it will be difficult to find another provider like their prior doctor of chiropractic? Yup. However, that will not be a significant obstacle to success and growth of the chiropractic profession. Patients will gravitate towards the type of healthcare provider that resonates with them and tell negative stories about the providers who did not align with their expectations of what a doctor of chiropractic should be.

2.3.6  Integration Chiropractic has grown from virtually no integration at its inception, to now being integrated into the most multidisciplinary practice opportunities available. Included in the vast array of these types of practices are stand-alone practices that can include DCs with any of the following and more: massage therapists, acupuncturists, physical therapists, athletic trainers, behavioral health providers, and an array of traditional medical providers along with some of the newer advanced practitioners. Then there are the standard medical practices that can include DCs, hospital settings, specialist medical offices, community clinics, corporate clinics, the Department of Defense, the Veterans Administration hospitals and clinics, and others. The fact is that the growth of chiropractic in integrated clinics is significant and appears to be something that will continue for an extended period of time. The number of DCs employed in the VA has the potential to double or more than double over the next decade and the growth in onsite and near-site clinics will likely continue at a greater rate than that. Chiropractors practicing in a hospital setting might not experience significant growth, as the ability of a hospital to make a profit off a DC is limited. In the future, if there is significant growth in hospital based Accountable Care Organizations, the picture could change dramatically as chiropractic providers certainly would help to limit the cost of employing more expensive specialists. Between the Department of Defense and medical institutions generally, there is significant opportunity of growth for DCs who are

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effective at treating NMSK conditions to be employed. The problem is trying to gage a growth trajectory for integrated providers when we do not even have a good idea of how many DC’s are currently employed in these positions.

2.3.7  Competition from other provider types On the competitive front, physical therapists have been granted direct access to patients, often with restrictions on that access in the majority of states, and this enables them to directly compete in the public eye for those same patients that would typically walk into a chiropractic doctor’s office. Will this lead to a decrease in the number of patients seeing chiropractic practitioners? The indications are certainly not trending that way. After practicing with many different physical therapists over the last 12 years, many still have a way to be comfortable and competent in caring for patients without another provider’s referral. There are certainly physical therapists who are much better at this than others and those better prepared providers have the ability to make patients comfortable with them as their portal of entry NMSK provider. In my experience, those providers are not in the majority yet. Additionally, doctors of chiropractic have a different general approach to care compared to physical therapists, and the public can readily tell the difference. The other thing I have experienced is that we work very well together once we understand each other. We all learn from each other and come to understand our individual strengths and weaknesses. It would be perfect if the two professions can work together to help patients not only recover from a problem but to help that patient to better learn about avoiding a return of that problem in the future. Since our professions have similar skillsets regarding some practice styles, there will be the inevitable turf war scuffles. As the NMSK world is currently being so poorly managed, the number of patients with NMSK problems will continue to grow, therefore there will be significant growth opportunities for both professions. Prediction by 2030: I believe there will continue to be fewer providers practicing independently or in small group chiropractic-only practices and those practices will be in the minority. There will be a growing number of

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doctors of chiropractic providing care in larger integrated practices and in medial settings generally and this will be where the majority will be practicing.

2.3.8  Chiropractic research We must start the discussion of the future of chiropractic research by acknowledging that the business of going after research dollars to actually doing chiropractic research was easier in the prior decades than it has been of late. While there is no real data on this, there appears to be less money being spent by US chiropractic institutions on their research faculty and, as the older researchers approach and enter into retirement, there is not a significant group of chiropractic research focused on graduates in the US to continue their work. In the past, there was some work in the basic sciences looking at animal models and the underpinnings of what a subluxation is and how chiropractic works. The labs that provided those data are not in existence today to the degree they were in the past, if at all. Therefore, the future of gaining a better understanding of exactly what happens when an adjustment is delivered in an animal model is stalled. It is a discomforting statement to think that the future of US-based chiropractic research is not moving into a growth phase. There is some hope of US colleges partnering with larger institutions for research dollars but there are only a few colleges doing that now and the prospect of increasing or expanding that work is very unclear. While the number of researchers in the US seems not to be growing, outside of the US, the story is different. In Canada, there is a growing number of DCs who have continued education to acquire PhDs that will focus on research and the trend around the world seems to indicate the same but to a lesser degree. All this indicates that the future of chiropractic research will be funded outside of the country that was the birth of the profession, and that may just be an uncontrollable and appropriate evolution. On a positive note, studies conducted by international researchers that have looked at the neuroplastic changes that adjustments can have on humans and their relationship to controlling pain, the potential to increase muscle strength and/or muscle relaxation are exciting. This research is

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evaluating some of the core principles on which chiropractic was founded. Where this research leads us is an exciting question. Will chiropractic adjustments become an evidence-based component of athletic performance care? Will chiropractic care become an indicated or even required part of every orthopedic or neurologic rehabilitation program? All of this reminds me of when I heard Jerry Rice, named the greatest American football player of all time, speaking at Palmer College of Chiropractic West. He noted that throughout his career playing football he saw his chiropractor and was adjusted two times weekly. He said it allowed him to recover faster from games and his intense training regime. It was his ability to keep up an intense training schedule that he credited with ability to do so well during the game and particularly during the last quarter of play when the players he was going against tended to tire. While stories such as this have been a part of chiropractic since its inception, one never knows when or if the Jerry Rice approach to chiropractic will become mainstream. A new twist into the chiropractic research story is how research into what doctors of chiropractic do is expanding by other non-chiropractic researchers. Just take a look at the journals that are typical places for DCs to submit papers, such as Journal of Manipulation and Physiologic Therapeutics, Chiropractic and Manual Therapies and Journal of Chiropractic Medicine. You will see that the papers published are typically dominated by researchers with degrees outside of the chiropractic profession or from non-chiropractic institutions. The continuation of this trend into the future certainly looks likely. What this means for the future of the chiropractic profession, to have the majority of our research being published by researchers outside of chiropractic, may be a good thing but it remains to be seen. Truly, the professional impact of research depends on implementation of the research and just because the researchers are from other professions does not mean that DCs will not be the beneficiaries of that research. It does seem possible though, that the basic understanding of our profession might be moving out of our control and, given that the evidence is squarely supportive of what we do, particularly in relation to spine, it seems likely that researchers from all professions will be chasing those research dollars and looking deeper into what doctors of chiropractic do.

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As far as research into chiropractic professional practice goes, it has been dominated by research looking at cost of care for the condition being treated, overall utilization from a cost containment perspective, number of visits per condition, and the like. Hopefully at some point, research will start to focus on the total cost of all care when a DC is treating a patient or when no DC is treating a patient, including the cost of care for the adverse events caused by the healthcare system. As mentioned earlier, this is made much easier by the advent of data driven analytics. As this happens, I believe the financial incentives for which provider to a patient will be a significant shift and that shift will be towards conservative care providers, particularly doctors of chiropractic. Prediction: By 2030, research into the chiropractic profession will be more data analytics of care that has been provided and less traditional research as we know it today.

2.3.9  Public perception of the chiropractic profession It has been clearly demonstrated by Palmer College of Chiropractic’s Gallup polls, that the American public utilizes chiropractors for spine problems relatively frequently. The public is very satisfied with the care they receive and the perception of the safety of chiropractic care is very high. There is no sense that the public will lose faith in the profession in the years ahead. Given this, the public’s perception of the profession seems to be one that will continue to be favorable and will create demand for chiropractic services at a high level. Certainly, one negative that has been mentioned about public perception of the chiropractic profession is the issue of the lack of standardization. We are all aware that going into a doctor of chiropractic’s office might result in one of many different types of experiences. From the history taking to the examination, report of findings, informed consent, treatment, and imaging, there is no consistent approach taken by practicing doctors of chiropractic. Much of this is because we have many chiropractic techniques and practitioners of different techniques requiring different evaluation methods and care protocols. Many in the profession embrace the different approaches as demonstrating our uniqueness. Others complain that is confusing for patients to not be

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able to tell what they are going to get when the walk into the office of a doctor of chiropractic. Should we have basic standards of practice to allow patients to understand what will happen when they see a doctor of chiropractic? — Yes. Will that ever happen? It does not appear that it will anytime soon. Prediction 2030: The public perception of chiropractic will remain very positive but with a cautious eye, requiring each patient to find the brand of chiropractic that makes sense to them.

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[30] Keating JC, Callender AK, Cleveland CS. A History of Chiropractic Education in North America: Report to the Council on Chiropractic Education[M]. Davenport, Iowa: The Association, 1998. [31] Hidde O. Historical Perspective: The Council on Chiropractic Education and the Committee on Accreditation, 1961–1980[J]. Chiropractic History, 2005, 25(1): 49–77. [32] Senzon SA. Chiropractic Professionalization and Accreditation: An Exploration of the History of Conflict between Worldviews through the Lens of Developmental Structuralism[J]. J Chiropr Humanit, 2014, 21(1): 25–48. [33] Bower N, Hynes R. Going to Jail for Chiropractic: A Career’s Defining Moment[J]. Chiropractic History, 2004, 24(2): 1–5. [34] Callender A. BJ Palmer, the Universal Chiropractic Association, and Civil Disobedience[J]. Chiropractic History, 2004, 24(2): 1–5. [35] Derbyshire RC. Medical Licensure and Discipline in the United States[M]. Westport: Greenwood Press, 1978. [36] Johnson CD, Green BN. Chiropractic Care. In: Lavretsky H, Sajatovic M, Reynolds C, eds. Complementary, Alternative, and Integrative Interventions in Mental Health and Aging[M]. New York: Oxford University Press, 2015. [37] Green BN, Johnson CD. The Early Years of Organized Chiropractic Orthopedics, 1954–1973: A Social History[J]. J Can Chiropr Assoc, 2009, 53(2): 129–143. [38] Wiese G. Chiropractic’s Tension with the Germ Theory of Disease[J]. Chiropr Hist, 1996, 16(1): 72–87. [39] Keating JC, Jr. Green BN, Johnson CD. “Research” and “Science” in the First Half of the Chiropractic Century[J]. Manipulative Physiol Ther, 1995, 18(6): 357–378. [40] Killinger LZ. The Resurrection of the BJ Palmer Clinic Research: A Personal View[J]. Chiropr Hist, 1998, 18(1): 53–58. [41] Keating JC, Siordia L, Green BN. Henry G. Higley: Pioneer Chiropractic Scientist[J]. Chiropractic History, 2004, 24(1): 35–57. [42] Higley HG, Morgan C. The Intervertebral Disc Syndrome[M]. Webster City: National Chiropractic Association, 1960. [43] Suh C-H. A Progress Report on ICA-Sponsored Biomechanical Research[J]. International Review of Chiropractic, 1984, 40(2): 27–31. [44] Keating JC, Jr. Larson K, Stephens M, et al. Journal of Manipulative & Physiological Therapeutics: A Bibliographic Analysis[J]. J Manipulative Physiol Ther, 1989, 12(1): 15–20.

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[45] Hildebrandt RW. Why a Journal of Manipulative and Physiological Therapeutics[J]. Journal of Manipulative and Physiological Therapeutics, 1978, 1(1): 1–6. [46] Keating JC. Toward a Philosophy of the Science of Chiropractic: A Primer for Clinicians[M]. Stockton: Stockton Foundation for Chiropractic Research, 1992. [47] Paige NM, Miake-Lye IM, Booth MS, et al. Association of Spinal Manipu­ lative Therapy With Clinical Benefit and Harm for Acute Low Back Pain: Systematic Review and Meta-analysis[J]. JAMA, 2017, 317(14): 1451–1460. [48] Huffington Post. https://www.huffingtonpost.com/dr-brian-c-mitchell/ when-the-financial-crisis_b_7061176.html (Accessed December 19, 2019). [49] Texas Chiropractic Association. https://tcachiroblog.blogspot.com/2023/ 08/medicine-v-chiropractic-timeline.html (Accessed August 10, 2023). [50] Emery PC, Stuber KJ. Chiropractors’ Attitudes toward Drug Prescription Rights: A Narrative Review[J]. Chiro Man Therap, 2014, 22: 34. [51] Personal communication, David O’Bryon, president, Association of Chiropractic Colleges, June 2018. [52] Southern California University of Health Sciences. https://www.scuhs.edu/ academics/los-angeles-college-of-chiropractic/academic-requirements/ (Accessed January 2, 2020). [53] https://mynbce.org/basic/National Board of Chiropractic Examiners (Accessed May 5, 2018). [54] The Council on Chiropractic Education, CCE Accreditation Standards Principles, Processes & Requirements for Accreditation, 2018, Scottsdale, AZ. [55] Northwestern Health Sciences University. https://www.nwhealth.edu/ academics/chiropractic/curriculum-overview/ (Accessed August 6, 2023). [56] Meeker W, Haldeman S. Chiropractic: A Profession at the Crossroads of Mainstream and Alternative Medicine[J]. Ann Intern Med, 2002, 136 (3): 216–227. [57] https://fclb.org/files/publications/1668450956_us-licensure-statistics.pdf (Accessed August 6, 2023). [58] Sandefur R, Coulter I. Licensure and Legal Scope of Practice in: Chiropractic in the United States: Training, Practice, and Research[J]. Agency for Health Care Policy and Research, 1997. [59] Beliveau. The Chiropractic Profession: A Scoping Review of Utilization Rates, Reasons for Seeking Care, Patient Profiles, and Care Provided[J]. Chiropractic & Manual Therapies, 2017, 25: 35.

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[60] https://www.chiropractic.org/who-we-serve/patients/ (Accessed August 6, 2023). [61] https://handsdownbetter.org/about-chiropractic/(Accessed January 2, 2020). [62] World Health Organization. WHO Guidelines on Basic Training and Safety in Chiropractic, Geneva, 2005. [63] https://www.wfc.org/website/index.php?option=com_conte nt&view=artic le&id=90&Itemid=110&lang=en (Accessed January 2, 2020). [64] Dougherty PE, Katz P. Chiropractic Management of Musculoskeletal Pain in the Long-term Care Setting. [65] Adams J, Peng W, Cramer H, et al. The Prevalence, Patterns, and Predictors of Chiropractic Use Among US Adults: Results from the 2012 National Health Interview Survey[J]. Spine (Phila Pa 1976), 2017, 42(23): 1810–1816. [66] Hawk S. Chiropractic: More than Spinal Manipulation[J]. Journal of Chiropractic Humanities, 1998, 8: 71–76. [67] Hartvigsen J, French S. What is Chiropractic?[J] Chiropractic & Manual Therapies, 2017, 25: 30. [68] https://www.acbr.org/ (Accessed July 31, 2018). [69] Sports Illustrated, the Good-hands Man: Leroy Perry has Won Ardent Support among Top Athletes with Methods that Mystify and Annoy MDs. [1979–16–7] https://www.si.com/vault/1979/07/16/823797/the-goodhands-man-chiropractor-leroy-perry-has-won-ardent-support-among-topathletes-with-methods-that-mystify-and-annoy-mds (Accessed January 2, 2020). [70] https://www.chiroeco.com/chiropractic-included-at-vancouver-winterolympic-games (Accessed January 2, 2020). [71] Moreau W, Nabhan D. Development of the 2012 American Chiropractic Board of Sports Physicians Position Statement on Concussion in Athletics[J]. J Chiropr Med, 2013, 12(4): 269–273. [72] Moreau W, Nabhan D, Roecker C. The American Chiropractic Board of Sports Physicians Position Statement on Pre-participation Examinations: An Expert Consensus[J]. J Chiropr Med, 2015, 14(3): 176–182. [73] https://www.teamusa.org/Athlete-Resources/Medical-Services/Clinicsand-Staff (Accessed August 23, 2018). [74] http://aiaonline.org/ (Accessed January 8, 2020). [75] https://biacolorado.org/youth-sports-concussion-act/ (Accessed January 8, 2020). [76] http://chirobd.ohio.gov/Licensees/ConcussionManagement.aspx (Accessed January 8, 2020).

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[77] Philip Veliz, Quyen Epstein-Ngo, Elizabeth Austic, et al. Opioid Use among Interscholastic Sports Participants: An Exploratory Study from a Sample of College Students[J]. Research Quarterly for Exercise and Sport, 2015, 86: 2, 205–211. [78] http://www.chirotexas.org/index.php?option=com_content&view= article&id=1512:a-brief-history-of-sports-and-chiropractic&Itemid=179, Texas Chiropractic Association, A Brief History of Sports and Chiropractic (Accessed Oct 15, 2018), [79] https://www.bls.gov/oes/current/oes291011.htm#st, Bureau of Labor Statistics (Accessed October 13, 2018). [80] https://www.bls.gov/ooh/healthcare/chiropractors.htm#tab-1, Bureau of Labor Statistics (Accessed January 8, 2020). [81] https://www.census.gov/library/stories/2018/09/who-are-the-uninsured. html, United States Census Bureau (accessed 12/11/2019). [82] https://www.healthaffairs.org/do/10.1377/hblog20190911.805983/full/, Health Affairs Blog, Uninsured Rate Rose In 2018, Says Census Bureau Report (Accessed January 10, 2020). [83] https://www.acatoday.org/News-Publications/ACA-News-Archive/ ArtMID/5721/ArticleID/64/Why-DCs-Are-a-Perfect-Fit-for-IntegratedCare-Settings, Why DCs Are a Perfect Fit for Integrated Care Settings, ACA News (Accessed January 4, 2020). [84] Lisi AJ, Salsbury SA, Twist EJ, et al. Chiropractic Integration into Private Sector Medical Facilities: A Multisite Qualitative Case Study[J]. The Journal of Alternative and Complementary Medicine, 2018, 24(8): 792–800. [85] Lisi A, Brandt C. Trends in the Use and Characteristics of Chiropractic Services in the Department of Veterans Affairs[J]. J Manipulative Physiol Ther, 2016, 39: 381–386. [86] Green BN, Johnson CD, Daniels CJ, et al. Integration of Chiropractic Services in Military and Veteran Health Care Facilities: A Systematic Review of the Literature[J]. J Evid Based Complementary Altern Med, 2016, 21: 115–130. [87] https://tcachiroblog.blogspot.com/2023/08/a-brief-history-of-sports-and. html?m=1#more (Accessed August 24, 2023). [88] https://www.nawhc.org/resources/Documents/NAWHC%20Benfield%20 research%20release%20FINAL%202-4-19.pdf, Worksite Clinics on Rise per New Employer Survey from National Association of Worksite Health Centers and Gallagher (Accessed January 10, 2020).

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[89] Personal communication, Dan Lord, DC, Physical Medicine Program Manager, Crossover Health. [90] Lord Daniel J, Wright John R, Fung Rebecca, et al. Integrated Physical Medicine at Employer-Sponsored Health Clinics Improves Quality of Care at Reduced Cost[J]. Journal of Occupational and Environmental Medicine, 2019, 61 (5): 382–390. [91] https://www.pcpcc.org/about/medical-home, Patient-centered Primary Care Collaborative (Accessed November 28, 2018). [92] https://www.f4cp.org/package/home/viewfile/whicorporate-wellnessprint-version, Corporate Innovators Integrate Chiropractic Care into Healthcare Clinics: Chiropractic Yields Improved Outcomes, Reduces Costs, Absenteeism and Increases Employee Retention, The Foundation for Chiropractic Progress, 2018 (August 10, 2023). [93] Krause C, Kaspin L, Gorman K, et al. Value of Chiropractic Services at an onsite Health Center[J]. Value in Health, 2013, 16(3): A193. [94] http://www.palmer.edu/alumni/research-publications/gallup-report/managing-neck-and-back-pain-in-america/, Gallup-Palmer College of Chiropractic Annual Report, Managing Neck and Back Pain in America, Gallup, 2018 (Accessed December 10, 2019). [95] http://www.chirocare.com, Interest and Commitment Around Conservative Care, Q Market Research, December 18, 2014 (Accessed January 17, 2020). [96] Personal Communication, Vivi-Ann Fisher, Chief Clinical Officer, Fulcrum Health, Inc. (January 17, 2020). [97] Personal Communication, David O’Brian, President, Association of Chiropractic Colleges (September, 18, 2018). [98] Personal Communication, Richard Brown, Secretary-General, World Federation of Chiropractic (September 18, 2018).

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Chapter 3

History and Present of European Traditional Herbal Medicine (Phytotherapy) Hans Rausch (lchenhausen/Neu-Ulm), Sven Schröder (Hamburg), Thomas Friedemann (Hamburg), Silke Cameron (Göttingen), Kenny Kuchta (Göttingen), Marius Konrad (Neu-Ulm)

Abstract In this text contribution, a general overview of European Traditional Herbal Medicine was compiled by German experts under the leadership of Hans Rausch. Based on the historical development in the form of written documents from about 2100 BC as cuneiform writings and hyroglyphs from the Mesopotamian and ancient Egyptian cultures with fixed recipes and corresponding indications up to modern phytotherapy, the relevant market potentials, regulations, and developments are presented. In addition, a list of the important training and research centers as well as organizations, dosage forms, and evidence base are also general topics. Further contents include registration and marketing issues, “phytogenerics” and raw material supply of materia medica, and the on-site cultivation of needed herbals.

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An overview of typical phytotherapeutic applications in Europe, the used herbals, and the relevant herbal secondary constituent classes is also included in tabular form. Furthermore, internal (oral) and external (dermal) applications are discussed. Furthermore, the modern and classical applications (modern European phytotherapy versus traditional European Herbal Medicine) are distinguished in detail. Keywords: Phytotherapy, market potential, phytotherapeutic application, European Phytomedicine, market regulation and registration, cultivation, history, European health system, product variety, Western herbs, therapeutic fields, indication, application areas

Introduction European Traditional Herbal Medicine, also called Phytotherapy, encompasses applying herbal medicine to prevent, treat, and heal diseases. Due to the manifold effects of phytotherapeutics, its basic principles are often challenging to assess. This is compounded by the fact that the combined effects of its huge amount of constituents cannot yet be evaluated sufficiently through scientific studies for only a few master constituents. The term phytotherapy describes the use of plants and parts of plants, such as leaves, flowers, roots, fruits and others, and their preparations for preventing and treating diseases and health issues. Plants suited to this application have traditionally been referred to as medicinal plants. This fact resulted in the Latin Species name with the addition “officinalis”, which means typically used in the pharmacies of monasteries. Of key importance is the fact that the medicinal plant or its parts are used as a holistic substance. For the central registration process at the European Medicine Agency (EMA) one herb or part of herb or extract is seen as one active principle in such kind of remedies. Therefore, plant medicines always represent multicomponent mixtures corresponding to one active agent. In Germany and most developed European nations, their quality, efficacy, and safety must meet the requirements of the national drug legislation, e.g., the German Medicinal Products Act (AMG).

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3.1  Main concepts Phytotherapy is the central part of the comprehensive field of herbal medicine, which is based on phytochemistry, phytopharmacy, and phytopharmacology. Phytochemistry Phytochemistry exclusively studies plant ingredients (chemical-defined secondary products). Its mission is to identify the chemical composition of plants, verify or control their fingerprint and describe potential ingredients that can be examined pharmacologically for their effects. The view of phytochemistry is focused solely on the parts and not the whole. Phytochemistry provides the impulse to examine active ingredients for their potential to be synthesized to become independent from natural harvesting. Phytopharmacy Phytopharmacy focuses on the drug that provides the basis for a herbal medicinal product and its dosage forms, for example, in teas or various forms of pharmaceutically prepared extracts and products. Pharmacognosy Pharmacognosy, or drug identification through visual inspection, is an important part of phytopharmacy. Historically, pharmacognosists identified plants by looking at, touching, tasting, and smelling the plant. This approach to identifying and determining the quality of a medicinal plant can still be significant. However, in the meantime, highly specialized physiochemical analysis methods are preferred for identifying drugs. Now it is not unusual for a pharmacist to know and be able to differentiate the entire fingerprint of a medicinal herb. Phytotherapy Phytotherapy describes the possibilities and limitations of using medicinal plants or products derived from medicinal plants in the treatment of human disease. It belongs primarily in the hands of physicians or other therapists who are specialized in herbal medicine. Many phytopharmaceuticals are also suited for self-medication, especially in a preventive sense. Typically, phytotherapy is mostly focused on chronic diseases and not directly on acute problems.

3.1.1  Phytotherapy and mainstream medicine Most representatives of modern phytotherapy view it as part of sciencebased (mainstream) medicine. The aspiration to apply the same scientific

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methods to phytotherapeutics as to synthetic drugs and to view phytotherapy as an integral component of modern pharmacotherapy should be supported. In this context, it should be mentioned that phytotherapy, unlike homoeopathy and anthroposophical medicine, does not rely on its own epistemology or scientific method. It has been and continues to be a natural science in the truest sense of the word, although, in the past, it was viewed in a more comprehensive context than today. Most of its applications are derived from centuries or even millennia of experience with medicinal herbs.

3.1.2  Effect and efficacy One unique aspect of phytotherapy is its broad spectrum of indication areas. The medical use of the whole plant or “whole” parts of the plant, special mixtures derived through extraction, or isolated single components, all involve specialization that ranges from comprehensive therapeutic efficacy to pharmacologically definable effect. The more ingredients contained in a phytotherapeutic, the broader its indication area can be. The therapeutic effect of polychemical (multicomponent) mixtures is wider than that of certain ingredients in a standardized extract or a defined mono substance, usually in the form of a synthetic derivative. This gradation creates many indication possibilities especially, for phytopharmaceuticals for the treating physician. Any ideology that says that only holistic models provide healing is just a one-sided opinion and needs to be questioned as the dominant view today — that verifiable therapeutic results can only be achieved with chemically defined single substances.

3.1.3  Finding and feeling Opponents of herbal medicine often maintain that these medicines are only suitable for improving a disorder or discomfort. The denigration implied here shows the inability of these scientists to understand the reality of an ill person. Against a backdrop of ideological one-sidedness, the increasingly dogmatic field of medical science has constructed abstract assessments of therapies oriented solely towards objectively provable

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findings. In their daily practice, however, physicians continuously observe that people who are ill experience and suffer their discomfort much more directly than their pathological findings or diagnosis. However, modern medicine has gotten more and more patients to fixate on their findings or pathologies. They judge the value of therapy by these findings and seek out a different physician to alleviate their discomfort or lack of well-being. However, there is no doubt that everyone who is ill seeks to regain their health in both areas: finding and feeling. Strangely, scientific medicine has long criticized “cosmetic diagnostics.” For example, it has been shown that treatment of chronic hepatitis with glucocorticosteroids produced dramatic improvements in transaminase levels. However, histological assessments have demonstrated that disease progression and chronic destructive inflammation of the liver not only did not improve but often worsened dramatically during therapy. This was referred to as the “whitewash effect.” It led to cortisone therapy for chronic hepatitis becoming obsolete. European Traditional Medicine seems to primarily work in areas where the human organism experiences well-being that changes into discomfort due to disease. Well-being expresses an overall, holistic sense of health, ideally a sense of wellness. Conversely, feelings of comfort or discomfort are an expression of individual symptoms, for example, localized pain, sense of bloating in the upper abdomen, discomfort in the extremities or dysuria. The objectifiable level of findings or diagnostics is created by analytical thinking that starts with the whole and breaks it down into parts. It seeks to derive its knowledge from ever-greater differentiation. Assessing feelings of discomfort requires synthesizing thinking that directs the focus from symptoms as an expression of holistic beings to the whole being. The world of feelings of comfort or discomfort is an expression of the subjectiveness of the individual and is generally not provable. It can only be described and understood. Some disorders are entirely dominated by findings and show no symptoms or feelings of discomfort, such as hypertonicity or hypercholesteremia. Other disorders are entirely within the realm of feelings of discomfort, without the possibility of objectifiable diagnosis, for example, migraines. Both nosological units of a disease process cannot be differentiated according to which is more

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“correct,” worthy of recognition, or exists in a scientific sense. Disorders that combine discomfort and pathological findings are even more frequent. Physicians practising phytotherapy are often excited to observe that improvements on a diagnostic level do not coincide with primary improvements in well-being but do tend towards normalization after a significant delay. The worlds of finding and feeling exist in parallel and require different therapeutics, depending on which side of the disorder is dominant. Some diseases require treatment exclusively with synthetics. Some are only treatable with phytotherapeutics. Other diseases require both types of therapy and these therapies are complementary. This results in the following four categories, illustrated in Table 3–1. The holistic human being is characterized by the levels of finding and feeling as well as the criteria of mood and presence of mind. Findings indicate pathologies in the physiochemical dimension of the body. The feeling is an expression of the body’s functionality. Mood describes the psychosomatic level, the unity of body and soul. Today, “psyche” and “psychogenic” tend to be used loosely. Much of what is labelled with these terms is derived from the level of functionality or life, not directly from the connections between body and soul. These are holistically expressed in a wide range of moods. The fact that modern medicine is or Table 3–1    Therapeutic categories for phytotherapeutics (According to ref [1]). Characteristics Category 1 Indications for which phytotherapeutics are the drug of first choice and that have no synthetic alternatives, for example, toxic liver diseases Category 2 Indications for which phytotherapeutics may be used as an alternative to synthetics, for example, anxiety, mild to moderate depression, functional dyspepsia, and non-specific urinary tract infections Category 3 Indications for which phytotherapeutics are used as an adjunct to basic therapy, for example, adjunct treatment for heart, liver, and respiratory disorders Category 4 Indications for which the use of phytotherapeutics is not appropriate or viewed as malpractice because it prevents or delays rational therapy using synthetics

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at least was conscious of this fact can be deduced from the pathologically oriented use of the term “mood disorders.” Objective accessible areas of this psychosomatic dimension can primarily be found in endocrinology and immunology. Psycho-neuro-immunology is a scientifically accepted speciality and no physician, no matter how scientifically oriented, will be able to deny the high percentage of psychological symptoms associated with endocrine disorders.

3.2 The history of European traditional herbal medicine (European Phytotherapy) Recent anthropological research has led to the astounding conclusion that traditional medicine has most probably a longer history than humanity itself: Our closes non-human animal relatives, the apes, have demonstrated the use of medicinal plants for the treatment of diseases. Moreover, human populations that settle in the same region as these ape populations use the same plants with similar indications. The transfer of medicinal knowledge from animals to humans has been documented. E.g., For the plant Vernonia amygdalina Del., chimpanzees (Pan troglodytes) have been observed numerous times to chew on its bitter pith as self-medication in case of parasitic nematode infections. Traditional healers of the WaTongwe people of the Mahale Mountains in Tanzania, where the use of V. amygdalina by chimpanzees has also been observed, use this plant for intestinal parasites, diarrhoea, and stomach upset. Phytochemical research has demonstrated that sesquiterpene lactones in V. amygdalina possess anthelmintic, antiamoebic, antitumor, and antibiotic properties. Current understanding thus hints at a long-term co-evolution between man and his food and medicinal plants, resulting in the adaption of human biology to pharmacologically active plant metabolites. The fact that already Neanderthals 50,000 years ago used yarrow (Achillea millefolium) and camomile (Matricaria chamomilla) — two staple plants of European Phytotherapy still registered as medicinal plants in the European Pharmacopoeia — as well as poplar buds (Populus spec.)[2,3] as medicine, demonstrates that contemporary practice of European Phytotherapy goes

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back to the dawn of man and the earliest native inhabitants of the European Continent. In the 1950s, a 60,000 year-old grave was discovered in Iraq. The dead were laid out in tufts of plants. Laboratory analysis showed that the heaps of plants consisted of more than 25 different medicinal plants, which are still used today. These included plantain (Plantago), yarrow (Achilea), mugwort (Arthemisia), and flake flower (Centaurea). Even though this finding does not provide clear evidence of such an early dating of herbal medicine, it is a first indication of the use of medicinal plants. Since humans and their closest ape relatives are able to learn successful behaviors, such successful systems of information become transferable from person to person. The accumulated body of learned knowledge that has been established within a population can be referred to as the “tradition” or “culture” of the respective population. Through individual variation, innovation, and learning from other populations on the one hand and empirical selection on the other hand, the basic principles of Darwinian evolution apply to the “culture” of a population in the same way as they apply to the genome. The process of the improving and distributing of this knowledge can therefore be referred to as “cultural evolution.” Regarding traditional medicine, the evolutionary pressure that drives this cultural evolution is the survival benefit for tribes with knowledge of effective treatments. By 9000 BC, the cultural evolution of humans in Europe had resulted in the construction of the first archaeologically attested buildings of mankind, of temples of Göbekli Tepe.[4] Although the archaeological evidence indicates that hunter-gatherers still constructed these first ritual places, the development of agriculture followed soon afterwards, allowing the construction of the first permanently inhabited cities in Mesopotamia, especially in ancient Sumer, where in the late 4th millennium BC, Sumerian Cuneiforms were developed, making Sumerian the first written language in the world.[5] Whereas previously, in the earliest phase of the cultural development of anatomically modern humans, all cultural knowledge had to be passed down from the elder to the younger generation via direct personal instruction — as that process, to this day, forms the cultural basis of all medical knowledge of contemporary hunter-gatherer cultures but also of

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the so-called “folk medicine” of civilized nations. The process of cultural evolution was now greatly enhanced by the written word, as written knowledge could be stored and transmitted without personal contact with its originators. Even in the early Sumerian civilization, medicine had developed considerably. The Sumerian word for a medical doctor was “a-zu” or “ia’-zu” and first medicinal herbs were listed in 4000 BC. Much of our knowledge of ancient Sumerian medical practices comes from cuneiform clay tablets, many of which are prescriptions for medicine.[6] One of the oldest known ancient Mesopotamian medical texts is a collection of 15 prescriptions, written in Sumerian, on a clay tablet, which dates from the Ur III period, or Sumerian Renaissance (2112–2004 BC). Common ingredients of these prescriptions were sodium chloride (salt), potassium nitrate (saltpetre), milk, snakeskin, turtle shell, cassia (Senna alexandrina Mill.), myrtle (Myrtus communis L.), asafoetida (Ferula assa-foetida L.), thyme (Thymus vulgaris L.), willow (Salix purpurea L.), pear (Pyrus communis L.), fig (Ficus carica L.), fir [Abies cilicica (Antoine & Kotschy) Carrière], and date (Phoenix dactylifera L.).[7,8] Most of these plants, with almost 5,000 years of documented empirical knowledge of their therapeutic value, are commonly used in European Phytotherapy even now and found in many European Pharmacopoeias. The knowledge of medicinal plants was also woven deeply into Sumerian mythology. In the epic mythic narrative known to modern scholars as “Enki and Ninhursag” the god Enki strives to “know the hearts” and the “destiny” of each of the eight plants by ingesting them, naming the body part that each plant is associated with, and creates the gods that are each associated with the respective body part. The mythical eight triplets of plant, human organ, and deity illustrate how pharmaceutical treatments of physical afflictions may have been formulated based on the symbolic attributes of plants, and the empirical observation of ameliorative effects. The myth, in its most pragmatic sense, celebrates the collaborative production of a pharmacopoeia of herbal remedies by Ninhursag and Enki, at the very least. Their medical efficacy is ensured by the links that associate eight plants, eight pains, eight body parts, and eight deities in a homologous system partially underwritten by the proposal of etymological connections — even though none of these eight Sumerian plant

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names could be clearly identified as any specific species. In summary, the close similarity between the Sumerian myth of the creation of herbal medicine and the equivalent Chinese myth of Shen Nong is especially interesting: both the gods Enki and Shen Nong eat or taste plants and thereby determine their previously occult properties, both suffer sickness as a consequence, and both give rise by their efforts to a body of herbal lore that has eminently practical, medical use in their respective communities. Sumerian civilization, which had been mainly supplanted by Akkadians by the 19th century BC, functioned as a model for numerous subsequent civilizations in the ancient Near East (like Akkadians, Hurrians, Assyrian, Hittites, Urartians, Persians, etc.), who copied and adapted the Cuneiform writing system as well as much of Sumer’s mythology and cultural institutions, including its knowledge of herbal medicine. Amongst the other ancient civilizations of the Fertile Crescent, Egypt stands out as significantly more independent from Sumer than any other. Thus, whilst the idea of writing may have been transmitted to Egypt from Mesopotamia, the Hieroglyphs themselves, that first appeared almost in parallel with the first cuneiforms in the 31st century BC, are clearly an independent development and not an adaptation of the latter, in contrast to the writing systems of most other civilizations of the ancient Near East. Unlike Sumerian and later Mesopotamian traditional medicine, for which the archaeological record is rather fragmentary, several volumes of ancient textbooks on Egyptian medicine have survived. Amongst numerous surviving medicinal papyri, the Papyrus Ebers that has been dated to around the year 1550 BC, is both the most extensive and also the one most concerned with herbal medicine, containing already 877 specific prescriptions of mixtures of herbal drugs for specific indications in the same style as a typical European Phytotherapy prescription in our time. Common medicinal plants mentioned in these prescriptions are i.e. castor (Ricinus communis L.), olive tree (Olea europaea L.), pomegranate (Punica granatum L.), myrrh [Commiphora myrrha (T.Nees) Engl.], and frankincense (Boswellia sacra Flück.). In many cases, the traditional indications of these plants are still the same as in European Phytotherapy today.

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Together with neighboring Israel, Egypt should function as the major transmitter of medical knowledge from the Bronze Age civilizations of the ancient Near East to the Mediterranean Iron Age civilizations of classical antiquity. Especially in the case of Israel, the number of medicinal plants that were included in the Bible cannot be overstated. Although these plants are only rarely described in direct relation to their medical application — in a few cases, for example, the “Balm of Gilead,”[9] the labdanum resin of Cistus creticus L., or poultice of figs (Ficus carica L.)[10] their use for the treatment of wounds, boils, and abscesses are directly mentioned[11] — their inclusion is of high symbolic importance as these plants became meaningful due to their healing power being reminiscent of the holy power of god. This analogy becomes even more significant when one remembers that the words “healing” and “holy” in English and most European languages are derived from the same linguistic root. Regarding their medical proficiency, the Greek and Roman civilizations of classical antiquity can largely be regarded as one. Both were heavily influenced by Egyptian medical practice and knowledge, which was easily accessible on the opposing coasts of the Mediterranean. The Greek historian Herodotus visited Egypt around 440 BC and wrote extensively about their medicinal practice.[12] In the 5th century BC, Alcmaeon of Croton developed humoralism. This philosophical system which was further developed by Empedocles (c. 494–c. 434 BC) classifies not only the workings of the human body and the relevant medicines for its treatment but also the surrounding world, thus linking Macro- and MicroCosmos. This system should remain on European Phytotherapy and all forms of Western Medicine for all major ancient physicians and philosophers and for the entire West until the 18th century AD. Hippocrates of Kos (c. 460–c. 370 BC) is often referred to as the “Father of Medicine” in recognition of his lasting contributions to the field as the founder of the Hippocratic School of Medicine. His school revolutionized medicine in ancient Greece and established medicine as an independent science and profession distinct from theurgy and philosophy. The Hippocratic Corpus (Latin: Corpus Hippocraticum), is a collection of around 60 early Ancient Greek medical works strongly associated with Hippocrates and his pupils. The Hippocratic Corpus became the foundation

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for which all future medical systems of the West would be built. A significant portion of the Corpus is made up of case histories that were supposed to function as model cases later doctors to base their therapy. It further contains theoretical and methodological reflections in the framework of humoralism (Table 3-2), treaties on medical ethics and manners — the main guiding principle being “at least not to harm,” and theories on the formation of urinary tract stones, amongst numerous other topics. Most famously, this work contains the “Hippocratic Oath,” which later found application worldwide. The Romans built extensively on the work of their Greek forebearers. Based on Greek concepts and thought systems, Roman scientists accumulated knowledge from all parts of the vast Empire into extensive reference books that should remain the field standard for more than 1,500 years. Pedanius Dioscorides (c. 40–90 AD) was a Greek physician employed in the Roman army who authored a 5-volume Greek encyclopedia about herbal medicine and related medicinal substances (a pharmacopoeia) entitled “De Materia Medica” (Ancient Greek: Περὶ ὕλης ἰατρικῆς, On Medical Material). In summary, about 600 plants and some animals and mineral substances are covered and around 1,000 medicines made from them. This work became the precursor to all modern pharmacopoeias and formed the basis for European Phytotherapy drug therapy throughout the Middle Ages well into the 19th century, suggesting that “the timelessness of Dioscorides” work resulted from an empirical tradition based on trial and error, that worked for generation after generation despite social and cultural changes and changes in medical theory.”[13] Aelius Galenus (129 AD–c. 216 AD) was a physician and philosopher in the Roman Empire. Arguably the most accomplished of all medical researchers of antiquity, Galenus influenced the development of various scientific disciplines, Table 3–2    Relationship of humor to temperament. Humour

Season

blood

spring

Ages infancy

yellow bile summer youth

Element

Organ

Qualities

air

liver

warm and moist sanguine

fire

gallbladder

warm and dry

choleric

cold and dry

melancholic

black bile

autumn adulthood earth

spleen

phlegm

winter

brain & lung cold and moist

old age

Temperament

water

phlegmatic

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including anatomy, physiology, pathology, pharmacology, and neurology, as well as philosophy and logic. However, Galenus’ main field of excellence was surgery, and he accumulated a vast amount of clinical experience in the treatment of gladiators. Just as Dioscorides in the field of pharmacognosy, Galenus should remain the commonly accepted scientific standard for 1,500 years. After long scientific, cultural, and military progress, the Roman Empire entered a state of perpetuated crises in the 4th century AD. With all of the Mediterranean under Roman control and past conflicts with concurrent powers slipping from living memory in during the long “Pax Romana,” human desires for glory directed themselves inwards and slowly against the cultural foundations of the Empire. The “mos maiorum,” the “ancestral custom” that Roman social order had been based upon as an axiom, not provable but not requiring any proof, is more and more under scrutiny. The ability of the “mos maiorum” that had traditionally grown through cultural evolution to preserve and define a Roman identity even within changing circumstances permitted the expansionism of Rome from a city-state to a world power.[14] However, the preservation of the “mos maiorum” depended on consensus and moderation among the ruling elite whose competition for power and status threatened it.[15] When larger parts of the Roman elite began to convert from their ancestral religion to Christianity in the late 300s, the Consul Quintus Aurelius Symmachus argued that Rome’s continued prosperity and stability depended on preserving the “mos maiorum.” However, his “modern” critics dismissed this as blind adherence to a tradition as “the superstition of old grandpas” and inferior to the newly revealed truth of Christianity.[16] By the late 5th century, the Roman Empire had mainly disintegrated. Western Europe had fallen to Germanic tribes from the North, who established new kingdoms that soon came to be defined by their specific amalgamate of Germanic and Roman culture, thus laying the foundation for the later development of the current nations of Europe. Whilst the southern half of the Empire should soon fall to invaders from Arabia, in the Greek-speaking North-Eastern Portion of the Empire a continuous Roman government survived for more than 1,000 additional years. Commonly referred to as the “Byzantine Empire” after its capital city Byzantion, this state should serve as both a source for books, practical expertise in

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medicine and herbal raw materials as trade goods for many centuries. Latrosophia, “medical wisdom,” is a genre of Byzantine medical literature that comprises medical handbooks containing recipes or therapeutic advice, many of which were produced during this period.[17] In the kingdoms of the West, the Catholic Church established itself as the major guardian of the accumulated body of knowledge on the continent, which included most fields of science and medicine. In the scriptoriums of the monasteries, the medicinal works of Roman times were meticulously copied, serving as the foundation for the practice of Monk physicians in the hospitals that accompanied the monastery. This era and line of tradition of European Phytotherapy is therefore also referred to as “Monastery Medicine.”[18] In 800 AD, the Frankish king Charlemagne managed, for the first time in 400 years, to organize an imperial government that controlled a major portion of the continent. This Carolingian Empire is commonly considered the first phase in the history of the Holy Roman Empire, which lasted until 1806. It played a prominent role in the spread of both Christianity and Graeco-Roman based civilization to the north of Europe. The Carolingian monasteries’ gardens cultivated many medicinal plants from the Mediterranean that had previously not been found in the north, thus adapting these plants to the colder climate over generations. The surviving architectural plan of Saint Gall Monastery in Switzerland, dating from 820–830 AD, documents a dedicated cultivation area called “herbularius” for 16 species of medicinal plants. All plants listed in the plan are derived from the plant list of the “Capitulare de villis,” a royal decree of Charlemagne (c. 768–814) pertaining to the governance of his royal estates. This document contains a list of 73 herbaceous plants (mostly medical herbs) and 16 fruit trees, to be cultivated in all imperial estates. Many of these estates were located in the territory of present day Germany, to which many of these medicinal plants from the South and fruit trees like fig, almond, and sweet chestnut, were introduced. With the works of Dioscorides accessible in many monastery libraries, European Phytotherapy, as it had developed in Rome, had soon successfully been transplanted to the entire continent. It must, however, be emphasized that the spread of Monastery Medicine, northward through and beyond the Carolingian, did not enter a

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vacuum. Through the Northern European woodlands, Germanic and Celtic traditional healers possessed a vast knowledge of the medical properties of the native flora, but without a literary tradition, this knowledge could not a preserved and systematized in written form. However, after the establishment of Monastery Medicine, the stage was set for integration of these plants into the therapeutic framework provided by Dioscorides and Galenus. One of the most prolific contributors to this process was St. Hildegard of Bingen OSB (1098–1179), a German Benedictine abbess, writer, composer, philosopher, Christian mystic, herbalist, and polymath. Her books Physica (Liber simplicis medicinae) and Causae et curae, published c. 1160 AD, quotes not only Roman sources, e.g., Dioskurides, but also include much previously only orally transmitted Germanic folk medicine, adapted to the style of Roman herbals and the principles of humoralism.[18] Many plants that are staples of European Phytotherapy today first entered the written tradition in St. Hildegard’s works, e.g., Calendula officinalis L. which is still used today in many skin ointments, and Arnica montana L., which is generally in use for its analgesic and anti-inflammatory effects. In the subsequent centuries, European Phytotherapy remained largely set in the framework that had evolved in Monastery Medicine since the fall of the Roman Empire. However, as time went on, the practice of medicine shifted more and more from the monasteries to secular, commercial doctors who had studied medicine, mainly with the same texts as the monks, at secular medicine schools and universities. The most influential of these schools was the Schola Medica Salernitana, the medical school of Salerno in Southern Italy. Founded in the 9th century, the school, initially based in a local monastery’s dispensary, achieved its greatest celebrity between the 10th and 13th centuries, when it developed its own form of the Greek-Latin tradition supplemented by knowledge from Arabic and Jewish sources. Matthaeus Platearius, a professor at Salerno, wrote the Circa Instans (also known as The Book of Simple Medicines), an alphabetically listed textbook of simple herbal prescriptions that was based on Dioscorides and describing the appearance, preparation, and uses of various drugs. His contemporary Constantinus “Africanus” (died before 1099) contributed immensely, imparting medical knowledge from Arabic sources into European Phytotherapy. Born in

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Tunisia, where he received a profound education in the Arabic interpretation of Hippocratic Medicine, Constantinus later converted to Catholicism and became a professor at Salerno. Here he compiled a vast opus of textbooks, mainly translations from Arabic sources such as Razes, Ibn Imran, Ibn Suleiman, and Ibn al-Jazzar. His textbooks remained in active use until the 17th century. In Western civilization, the transformation from the Middle Ages to the Early Modern period is typically defined by two events: 1) The invention of the printing press with movable types by Johannes Gutenberg in 1439 and 2) the discovery of the Americas by Christopher Columbus in 1492. Both events had significant implications for the development of European Phytotherapy, as medical books could now be printed, and ideas could thus spread much faster throughout the population. These ideas also included numerous medicinal plants that were introduced to Europe from the Americas. One of the first herbals that found mass market in print was the 1542 De historia stirpium commentarii insignes (Notable Commentaries on the History of Plants) by Leonhart Fuchs (1501–1566). In contrast to previous areas, the printing press allowed the immediate work translation into the common German tongue as New Kreüterbuch. During Fuchs’ lifetime, the book went through 39 further printings in Dutch, French, and Spanish and was translated into English 20 years after his death. The work covers ca. 500 plants, over 100 of which were first descriptions and has woodcut illustrations for almost all plants.[19] It sets a new standard for accuracy and quality, as well as being the first known publication of plants from the Americas, such as chilli pepper (Capsicum annuum L.), pumpkin (Cucurbita pepo L.), or marigold (Tagetes erecta L./T. patula L.), all which were permanently integrated into European Phytotherapy. However, the Columbian exchange did not only bring new plants to Europe, but also new diseases. Although the presence of syphilis in Europe before Columbus has been theorized, at least the emergence of the most virulent strain coincided with the aftermath of the discovery of the Americas and was perceived to be causally connected.[20] Often, the cure for the disease from across the sea was also sought in imported drugs from the New World. The German knight and religious reformer Ulrich von Hutten (1488–1523), who suffered from syphilis of which

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he would later die for the final 15 years of his life, wrote the book De morbo Gallico in 1519 about his symptoms and his treatment with Guaiacum (Guaiacum officinale L.). His text is regarded as one of the first patient narratives in the history of medicine.[21] Today, Guaiacum is a common ingredient in European Phytotherapy cold medicines. The use of Guaiacum for syphilis therapy, however, was not without controversy. The Swiss alchemist, physician, and philosopher Paracelsus (1494–1541), born as Theophrastus von Hohenheim, was highly critical of its use and instead, recommended mercury compounds derived from Alchemy, which he used with much success. He is credited as the “father of toxicology.”[22] His school of medical thought (Paracelsianism), which was continued by his pupils long after his death, displayed a strong influence of Alchemy and a high respect for the herbal folk medicine of the ordinary people that was unusual for university-educated doctors of his time. Paracelsus, thus, emphasized the value of experimental observation in combination with traditional knowledge. This duality of Paracelsus’ work, alchemical medicines based on minerals and often heavy metals on the one hand and herbal medicines from folk medicine with much emphasis on the distillation of pharmacologically active volatile oils on the other, should later lead to a major schism in the history of medicine in Europe. After the works of Dioscorides and Galenus had stood for more than 1,000 years as state of the art in medical practice, their position was seriously challenged during the Renaissance. In his 1628 book Exercitatio Anatomica de Motu Cordis et Sanguinis in Animalibus (Latin for “An Anatomical Exercise on the Motion of the Heart and Blood in Living Beings”), the English physician William Harvey (1578–1657) demonstrated the circulation of blood through the human body by the pumping action of the heart. His experimental evidence disproved the views of the two ancient authors the new blood was constantly processed by the liver and waxed and waned through the arteries like the tides in the ocean. In the wake of the “Enlightenment,” a general crisis of belief in all European cultural traditions during the 17th to 19th centuries, this refutation of major basic assumptions of both Monastery Medicine and Alchemical Medicine called all traditional medicinal practice question in the eyes of many contemporaries. The Enlightenment included a

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range of ideas centred on the “sovereignty of reason” and the “evidence of the senses” as the primary sources of knowledge.[23] This mindset gave way to the vast variety of new forms of medicine — all based on the latest “scientific evidence” and “reasonable” theories about human physiology. However, as the latest “scientific evidence” and what seems “reasonable” were constantly changing, each decade brought a new “innovative” and “enlightened” school of medicine that was a few decades later as quickly forgotten as it had emerged. European Phytotherapy was thus increasingly replaced by diverse new forms of treatment that were not based on traditional knowledge but on purely theoretical speculation. Of the numerous medical systems developed in the Enlightenment, only chemical synthetic “scientific medicine” or “biomedicine” and homoeopathy have flourished up to this day. The latter forms the basis and precursor of a wide variety of today’s “alternative medicines” such as “anthroposophical medicine.” As “alternative medicines” are not based on traditional empirical knowledge, but on a “philosophical interpretation” of disease and medication, they must not be confused with European Phytotherapy, which is based on the written traditional empirical medical knowledge alone. The triumphs of “scientific medicine” or “biomedicine” over the past two centuries shall not be denigrated or denied. In contrast to infectious diseases, the non-plus-ultra-success of scientific biomedicine which scientific reductionism can easily be reduced to a singular cause, namely the causative microorganism. Chronic conditions have no single cause but result from a complex multitude of interconnected conditions and thus are almost untreatable with the synthetic single compound drugs of scientific medicine. This has resulted in the population’s renewed interest and popularity of European Phytotherapy since the post-war period. The conservation of European Phytotherapy in the present era, however, would not have been possible without the engagement of many traditional practitioners who fought for the preservation of the European medical tradition in an age when governments and large parts of the public had grown hostile to ancestral customs that were dismissed by “modern” critics as blind adherence to tradition and pseudoscientific superstition, inferior to the newly discovered truth of scientific materialism.

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Amongst those who fought preserving of European Phytotherapy in the 19th century, Sebastian Kneipp (1821–1897) is the most prominent. Kneipp was a Bavarian Catholic priest commonly associated with the “Kneipp Cure” form of hydrotherapy. The importance of Hydrotherapy in Kneipp’s medical work should also not be overvalued, as this approach only formed the 1st of five “columns of health” the others being Exercise (promoting the health of the body through physical training), Nutrition (a diet of whole grains, fruits, vegetables, explicitly including a however limited amount of meet), an Ordered Lifestyle (a health person needs a healthy mind, for Kneipp personally this meant traditional Catholic spirituality), and last but not least Phytotherapy (traditional botanical medicines was another of Kneipp’s fields of expertise). The integration of Catholic spirituality and a majority of its herbal drugs put the Kneipp school of European Phytotherapy thought into the direct line of tradition of earlier Monastery Medicine. As a Catholic priest, Kneipp did not have a medical license that a modernist government could have taken away. With the increasingly prominent success of his practice, many universityeducated medical doctors joined his school of thought, which led to a much higher acceptance of European Phytotherapy in the medical community of German-speaking Europe than in most other areas of the continent.[24] This higher acceptance of European Phytotherapy in German universities later facilitated scientific research into the pharmacological effects of its prescriptions and practices with the aim of a general scientific understanding and further practical improvement of traditional practice.[1] The fact is that European Phytotherapy is accepted today in German and European law as one of three “particular therapeutic systems” — the other two being homoeopathy and anthroposophical medicine.[25] According to AMG (German drug law), these traditional medicinal products distinguish themselves from other medicinal products in that their efficacy is exclusively based on traditional use. Provided with this secure legal framework, European Phytotherapy is in a good position to take place among the great traditional medicine systems of humankind, just like Traditional Chinese Medicine on the opposing coastline of the Eurasian Continent.

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3.3 Traditional European Herbal Medicine in the health system 3.3.1  Phytotherapeutic products in Germany and Europe in the last 100 years Up to the Second World War, there was a harmonious coexistence of phytotherapeutic agents and the “highly effective” synthetic “miracle weapons” of modern medicine, i.e., a large number of established synthetic active ingredients and pharmaceutical products. In the reconstruction phase after the Second World War, attempts were made to establish a fast, inexpensive, and effective medicine that was as comprehensive and standardized as possible, focusing primarily on new and better synthetic active ingredients. The result was a significant loss of old knowledge about the targeted use of phytotherapeutic products and their technical implementation. Phytotherapeutic products were only manufactured by a limited number of pharmaceutical companies. However, a large number were also produced and distributed by pharmacists within the scope of their legal options as formulation and small batch productions (“Defektur”). At that time, it was relatively easy to obtain drug approvals, so many pharmacists and small pharmaceutical companies, could get a large number of drug approvals and establish themselves in this market segment. Due to various scandals in the pharmaceutical sector, but not in the phytomedicine sector, politicians were forced to start a new quality offensive to protect German export interests, also because of the advancing globalization. As part of this structural change, more and more small and medium-sized companies in the pharmaceutical industry disappeared. This process has continued until today. The basis for improving and increasing transparency in the pharmaceutical segment was a massive expansion of the legal requirements, especially in the European environment. The creation of a common pharmacopoeia and an alignment of the requirement profiles to the AngloAmerican market and the Japanese requirements resulted in a harmonization with their pharmacopoeias.

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The introduction of Good Manufacturing Practice (GMP) in the pharmaceutical industry to minimize risks also affected phytopharmaceuticals at the end of the 1980s. The parallel establishment of the so-called “approval processes” and the “registrations as “traditional “herbal medicinal products” (tHMP’s),” resulted in two independent market segments, which were nevertheless at least largely financed by the health insurance companies. While the “approval process” was typically characterized by complex synthetic new active substances, the effectiveness, mechanisms of action, toxicity potentials, and side effects have to be proven through preclinical and clinical studies, whereas the “registrations as traditional “herbal medicinal products” (tHMP’s)” did not need clinical proofs of effectiveness. Phytotherapeutic products with registration as tHMP, not to be confused with the German divisional term “medical devices” according to the German pharmacopoeia, did not need extensive clinical and toxicological studies. For the easier registration process, it has to be proven if such products have been in the market for at least 30 years without becoming aware of adverse effects and 15 years of usage without encountering any problems in the scope of the European Pharmacopoeia. This scope includes not only the countries of the European Union (EU) but also countries such as Switzerland, Turkey, and Israel, to name just a few. In the 1970s, the pressure on the pharmaceutical industry increased massively, but the phytopharmaceutical industry, with its mostly smallscale production method, remained unaffected for a long time. In the 1980s, there was a drastic change in political acceptance, characterized by two processes. As a first step, the German competent authority “Bundesinstitut für Arzneimittel und Medizinprodukte” (BfArM) launched a so-called “step-by-step program” for post-approval, in which all approved products were analyzed again and the approval holder of phytotherapeutic products had to adapt their approval documents to the “state of the art” in science and technology. To take this into account, a committee of experts called “Monograph Commission E” was established, which dealt with the “rationalization” of phytotherapeutics. In the long-term work of these specialists, rationallybased data and mechanisms of action and potential drug candidates, but mostly only marker compounds, were defined, and modern chromatographic

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methods were proposed for quality assurance, which had to replace the mostly “Stone Age” procedures in old approvals. Simple gravimetric methods, unspecific spectrophotometric quantifications and, in some cases, questionable chemical test methods without any validation were common before these changes. As part of these post-approval procedures, the same or similar requirement profiles for synthetic products were suddenly placed on phytotherapeutics. However, to bring products that had never been considered critically for decades to the new requirements, it was necessary for the pharmaceutical companies to either set up new, highly-qualified test laboratories with personnel that were not easy to obtain or to commission external service providers in this segment. Due to the highly diverse structure with many small and tiny companies (primarily pharmacies) without any test experience with modern chromatographic processes (HPLC, GC, IC, etc.), the crucial question was how high the respective sales would be in relationship to the resulting registration costs. With many products, economical production with the same quality standards as the rest of the pharmaceutical industry in this small-scale production was not feasible for cost reasons. In the time frame of the post-approval phase, which had even been extended several times, all products which remain in the market in the future had to be produced, analyzed, and documented according to these new criteria under GMP and according to the procedures documented in the improved approvals, from the raw material up to the pharmaceutical product. According to unconfirmed estimates by various experts, around 80% of all phytopreparations that were still on the market at the time disappeared during this period. Only a few companies acquired such old approvals very costeffectively and brought these products to the new requirement profiles or left them in their portfolio with little effort and without much economic exhaustion. A further decisive turning point in the market for phytotherapeutic agents began with the removal of health insurance reimbursement. In the Japan’s industrialized society, for example, the legislation has recognized the cost-saving effects of phytotherapeutics and approved about 150 formulations (not products) from various manufacturers as fully reimbursable medicines, thus contributing to a consolidation of health costs.

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In contrast, phytotherapeutic agents in Germany were almost exclusively excluded from reimbursement by political decisions, which did not improve the market climate. Many products that had survived the first cuts in the post-approval process were suddenly put to the test again due to the onset of market consolidation. Economic production was now only possible to a limited extent with the small-scale manufacturers in the context of intense market competition, whereby several modern contract manufacturers were able to establish themselves. Here, cost-effective production was only possible if the corresponding sales figures could be generated. As a result of this massive cut, the phytopharma market has changed again. In addition to the closure of companies, there have been significant mergers in this consolidation process. From this time, many approved phytotherapeutics have been preserved, but their production has been more or less reduced. An amendment to the law stipulated that a market authorization without its use would expire after several years. Companies create at least one production batch each year to preserve their product for the future. The authorities generally only monitor production but not the real marketing of these products. As a result of this further limiting criterion, several still existing approvals, which largely remained unused beyond this period, expired again. As explained in the previous sections, the number of phytotherapeutics on the market has further decreased, although the market volume has developed positively regarding sales. This development is currently going in the same direction so that in addition to the expiration of “old” approvals/registrations and trading with them, the variety of products on the market is disappearing.

3.3.1.1  Future viability of phytopharmaceuticals The fundamental question remains regarding which possible rational paths can be taken to expand the phytopharmaceutical market. Looking at the market development not only regionally/nationally but at least in the area of the European internal market, the possible development potential must be considered.

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The European market alone is not homogeneous concerning the acceptance of phytopharmaceutical products on the one hand and the development of purchasing power on the other. On closer inspection, the German-speaking countries Germany, Austria, and Switzerland, as well as the neighboring Benelux countries, tend to have a higher affinity for nature-based pharmaceuticals. The market in France is already considerably more complex, and a rather inhomogeneous market can be observed in the Mediterranean countries. In contrast to the rest of the country, the Catalan part of Spain has a much higher affinity for accepting these products and purchasing power. A relatively inconsistent purchasing behavior can be observed in Italy. The United Kingdom is no longer considered here due to the politically motivated exclusion from the common EU market and the unclear legal boundaries (Brexit). Due to historical developments, the eastern member states of the EU are to be regarded more as a future market concerning their purchasing behavior of nature-based products. However, there is still no extensive pharmaceutical nature-based product portfolio there. The difficulty in this segment has been exacerbated by the relatively uncontrolled expansion of the food supplement market. The awareness of the buyer that, on the one hand, quality products have to be reasonably priced, but on the other hand, apparently comparable food supplements are massively advertised as health-friendly alternatives despite legal regulations has not led to rationalization and harmonization of the market. The main problem for expanding the classic phyto-pharmaceutical market is the lack and incorrect knowledge of consumers, doctors, and pharmacists regarding this problem in the EU. The entire market segment lives from the argumentation of the sustainability of nature-based products and positive consumer/patient response to high-quality phytopharmaceuticals of the past, such as the much-vaunted alleged freedom from side effects that increases the willingness to buy. On the one hand, acceptance of nature-based products in all application areas, not only in medicine, is steadily rising. On the other hand, modern patients and medical professionals are not sufficiently informed about the necessary delimitation, despite or probably even because of the large amount of information available.

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Doctors who advise their patients to order their therapy “preparations” from the internet solely due to cost considerations run the risk of many people being unable to distinguish between products from reliable mailorder pharmacies and often dubious “dietary supplements.” Especially since the effects of such “dietary supplements” have not undergone thorough critical examination and assessment, as they are legally classified only as food. As a result of ineffective “dietary supplements,” consumers lose their confidence in high-quality phytopharmaceuticals because there is no genuine differentiation. Unless a reevaluation occurs, the higher-priced phytopharmaceuticals will remain confined to existing target markets, leading to a decline in the longer-term numbers of potential consumers who possess phyto-affinity and quality awareness. Moreover, there is growing awareness of the environment and sustainability among the younger generation, although some individuals’ decisions may be swayed by prices, cheap internet offers, and the influence of “social media personalities”.

3.3.1.2  Market potential for phyto-products in Europe To get back to the European market, there is still enough market potential for new phytopharmaceuticals. The crucial question of positioning in a market characterized by ostensibly “inexpensive” but mostly “cheap” phyto-products on the retail store shelves has to be addressed in addition to the classic dispensing in pharmacies. The ever-increasing idea of direct marketing via the Internet or even viral structures using apps and other new concepts should also be considered and legally examined. Where should positioning take place? – – – – –

Dietary supplements and food additions. “Functional foods” with the right to apply health information on use. OTC products. Traditional Herbal Medicinal Products (tHMP’s). Approved remedies of modern character but based on nature.

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The problem of unauthorized health-related advertising of food supplements, legally classified as food, and the lack of prevention by the responsible country-specific food surveillance authorities seems to be a ubiquitous problem of the entire pharmaceutical industry — not just the phytopharmaceutical industry — especially in Germany.

3.3.2  Policies and regulations specific to this traditional medicine The popular phrase is “one herb has been grown for everything,” but this has to be put into perspective. Phytopharmaceuticals offer a reasonable alternative to chemically-defined preparations for weaker diseases and mainly chronic diseases. Since consumer attitudes are increasingly tending towards naturebased products and herbal therapeutic agents are considered to be lowsideeffect or side-effects-free alternatives to classic synthetic preparations, basic acceptance has shifted in favor of phytotherapy. The question now arises of which therapeutic interventions phytotherapeutic agents are primarily suitable. To get a first overview, available market data from Germany and Europe as a pointer market for phytotherapeutic preparations are added in the following sections. The basis for phytopharmaceuticals are medicinal plants from local cultivation and, to a large extent, from imports. In the context of discussions about renewable raw materials and ecological balances, European medicinal plant cultivation is also faced with new tasks. The dependencies on problems in the various countries of origin have led to an inevitable rethinking of raw material procurement in the industry. The cost of medicinal plants has not proven to be an overly critical cost factor. The following market figures illustrate the considerable sales volume for the pharmaceutical market in Germany (Fig. 3–1). Suppose one now looks at the two pharmaceutical areas (prescription versus over-the-counter sales). In that case, there are somewhat different increases in both the packs sold (corresponds to treatment units) in the 2017 and 2018 observation period. One reason for this is that there are a

History and Present of European Traditional Herbal Medicine (Phytotherapy)  157

number of very costly drugs in the area of prescription — mainly synthetic-chemical drug products (e.g., tumor therapeutics). At the same time, however, the overall increase in the trend, in terms of volume for over-the-counter products, is recognizable (Figure 3–2 to Figure 3–5). The WHO also compiled summary data for Europe as a whole regarding traditional and complementary medicine and compared the years 2005 and 2018 to show a trend (Table 3–3). The two definitions of the WHO for these therapy concepts are the basis for this. – Complementary Medicine: The terms “complementary medicine” and “alternative medicine” refer to a broad set of healthcare practices

Figure 3–1    Trend of pharmacy market since 2014 in Germany (Sales in Mio. Euro). Note: It shows the market figures for the period 2014–2018 as a representative overall development.

Products

Mio

%

Change to 2017

Prescription of medicines

744

50

+ 0.8 %

OTC of medicines

752

50

+ 1.7 %

1.496

100

+ 1.2 %

Total

Prescription of medicines

OTC of medicines

Figure 3–2    Sales in Mio. Euro 2018 in Germany.

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Products

Mio

%

Change to 2017

Prescription of medicines

48.873

88

+ 4.4 %

6.958

12

+ 3.4 %

55.831

100

+ 4.2 %

OTC of medicines Total

Prescription of medicines

OTC of medicines

Figure 3–3    Sales in Mio. Packaging units 2018 in Germany.

Figure 3–4    Sales in Mio. Euro.

that are not part of that country’s own traditional or conventional medicine and are not fully integrated into the dominant healthcare system. They are used interchangeably with traditional medicine in some countries. – Traditional Medicine: Traditional Medicine has a long history. It is the sum total of the knowledge, skill, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the

History and Present of European Traditional Herbal Medicine (Phytotherapy)  159

Figure 3–5    Value in Mio. Packaging units.

prevention, diagnosis, improvement, or treatment of physical and mental illness. Source: WHO global report on traditional and complementary medicine 2019. Phytopharmaceuticals, a New Dynamic in Therapy in Germany The German phytopharmaceutical market is on the rise — around every 12th pharmaceutical packaging sold in pharmacies contains a phytopharmaceutical product. – Since 2010, the share of phytopharmaceuticals in the over-the-counter market (OTC) has been growing steadily. In 2017, phytopharmaceuticals accounted for approximately 44% (around EUR 1.6 billion) of sales in the OTC market. Phytopharmaceuticals thus cover a large part of the over-the-counter medicines (OTC products). Between 2015 and 2017 inclusive, sales of phytopharmaceuticals rose by 6.8%. Thus, the increase in sales in the comparative period was slightly above the growth of the German OTC pharmaceutical market (6.3%). The main sales drivers for phytopharmaceuticals 2017 were cold preparations, antacids, and immune stimulants. The high demand for cold-relieving phytopharmaceuticals is due to the increasing interest of the German population in herbal medicines and the growing selfmedication for colds (Figure 3–6).

160  History, Present and Prospect of World Traditional Medicine Table 3–3    WHO development of traditional and complementary medicine (T&CM). WHO European Region, Development of T&CM, 2005–2018

Category

Regional Regional Number of Number of Member States Member States with Affirmative with Affirmative Responses in Responses in 2005 2018

Regional % Global % of of Member Member States with States with Affirmative Affirmative Responses in Responses in 2018 2018 (N = 53) (N = 194)

National Policy on T&CM

7

11

21

51

Laws or Regulations on T&CM

14

21

40

56

National Program on T&CM

3

7

13

41

National Office for T&CM

9

15

28

55

Expert Committee on T&CM

10

15

28

48

National Research Institute for T&CM or Herbal Medicines

10

11

21

39

Regulation of Herbal Medicines

36

45

85

64

Registration of Herbal Medicines

32

45

85

64

47

89

88

Population Using T&CM

—

Note: The 2018 data set includes 1) 2012 data and 2) additional Member States who responded “Yes” to the update survey, but either replied “No” or did not reply to the first and second surveys or responded “Yes” through additional data sources (e.g., regional reports and data verification during 2016–2018). There may be Member States in which the T&CM situation has changed, and therefore are not accounted for here.

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Figure 3–6    Sales distribution of phytopharmaceuticals 2017. Note: It shows the typical percentage market distribution in relation to the most common areas of application.

In the further course of this chapter, more detailed assignments will be made. – The German market for phytotherapeutics is divided into two parts. On the one hand, the “big five” large companies dominate, but on the other hand, many small and medium-sized companies are responsible for the complexity and flexibility. In 2017, the five leading phytopharmaceutical manufacturers, with a combined turnover of around EUR 800 million, achieved a market share of approximately 50% in Germany. The following five companies in the top 10 together achieved additional sales of around EUR 230 million and thus represent only a further 14% of the German market. The top five products [Sinupret (Bionorika SE), Iberogast (Bayer GmbH), Tebonin (Schwabe GmbH), Gelomyrtol (Pohl-Boskop GmbH and Co. KG), and Prospan (Engelhard AM GmbH and Co. KG)] achieved a total turnover of approximately EUR 500 million in 2017. While 85% of phytopharmaceuticals are acquired through self-medication, only 15% are based on prescriptions.

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– For over-the-counter medicines, customers mostly make their own decision to buy. In contrast to the manufacturers of prescription drugs, phytopharmaceutical manufacturers must encourage end users to consume them. In addition to classic advertising measures such as print, outdoor, and television advertising, online marketing has become increasingly important. Company websites, display advertising, search engine marketing, and social media presence are increasingly integrated into the marketing strategy. As a result of the advancing digitalization, online trade is also of increasing interest for pharmaceutical products. In 2015–2017, a steady increase in the sales of all pharmaceuticals sold by mail-order pharmacies could be determined. In the over-thecounter medicinal products market, mail-order sales accounted for 13% of total sales in 2017. The mail-order business achieved a growth of 9.3% compared to the previous year, while in-store pharmacies were only able to increase sales of over-the-counter medicines by 2.7%. The mail-order business with over-the-counter medicines is the fastest-growing sales channel in the German pharmaceutical market. Sales of phytopharmaceuticals from self-medication in the mail-order segment have been constant, at around 99% in the past three years. – Therefore, self-medication is almost entirely responsible for the growth in sales of phytopharmaceuticals in the mail-order business. Internationalization In 2016, Germany ranked fourth among the largest pharmaceutical markets worldwide, behind the USA, China, and Japan. Germany is the largest sales market in Europe and number one in the phytopharmaceutical segment. Despite the relatively low per capita sales in the German OTC segment, Germany is of great interest due to the total size of the OTC market, the high proportion of phytopharmaceuticals in total OTC sales, and the increasing popularity of natural medicines. The per capita revenue in Germany shows that there is still considerable potential for improvement. Research and Development Due to socio-demographic trends and greater health awareness, the phytopharmaceutical market has considerable

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growth potential and, at the same time, places high demands on the development of new products. The innovation and growth potential of the phytopharmaceutical market is reflected in the expansion of the product range of most suppliers in recent years. Homoeopathy in Germany is the second therapy that is often not correctly delimited for the patient besides phytotherapy. The following graphic shows the sales volume in the packs. If homoeopathy is considered as part of the sales market of phytopharmaceuticals, the following picture emerges (Figure 3–7 to Figure 3–9).

Figure 3–7    Phytopharmaceuticals value in Mio. Packaging units.

Figure 3–8    Homoeophatic value in Mio. Packaging.

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Figure 3–9    Sales in Mio. Euro.

Typically, however, the fewest phytotherapeutic agents are administered in clinics. Phytotherapy clinics, similar to TCM clinics in China or KAMPO clinics in Japan, are not common in Germany. German and European clinics mainly use synthetic chemical products from modern Western medicine. The following picture emerges from the total amount of phytopharmaceuticals (in a million packaging units) for 2018 (Figure 3–10). Product Variety If the European consumer/patient is asked about their subjective perception of phytotherapeutic products, astonishing evaluations will appear. Phytotherapeutics are considered to have no side effects in patient circles. Through media discussion of petroleum-based contaminations in various products of general life, clothing, food, cosmetics, and much more — synthetic chemistry in the meantime has massively slipped in its emotionally-based assessment by consumers from originally “very valuable”. According to the buyers’ assessment, the general “insurance

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Figure 3–10    Value in Mio. Packaging units.

policy” of pharmaceutical companies, with regard to possible side effects, has also done something else. The now “enlightened” consumer perceives synthetic preparations subjectively as critical with concerning synthesis-based contaminants and interprets the potential side effects listed by the companies as a threat to health. Startled by the permanent media presence of negative statements and the patient’s fears, for years now, more and more doctors have been using private prescriptions to prescribe seemingly harmless alternatives in the form of phytotherapeutic products and increasingly homoeopathic medicines. In the past 10 years, several alternative medical approaches that should not be underestimated have also been established, also affirming phytotherapeutic support, at least in many cases.

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In the eyes of the patients, a higher cost factor is also accepted to a certain extent since, in their view, valuable products must also represent a certain cost factor. On closer inspection, the costs are not only somewhat but are usually well above the prices of synthetic products, which are usually reimbursed by health insurance companies. Product Alternatives In addition to phytotherapeutics, i.e., legal products according to the rules of the German Medicines Act, a “dark grey” parallel market of herbal “pseudo-therapy products” with so-called nutritional supplements has become increasingly popular, established in the legal framework of food law in recent years. Since many of these products are not sold in the pharmacy, an average patient/consumer cannot assess the massive difference in quality. Ordinary consumers perceive plant-based dietary supplements, plant-based functional foods, and plant-based medicines as a single product family without knowing the legal basis and the resulting consequences.

3.3.3  Clinical management The application of herbal-based phytotherapy is typically not implemented in the clinical treatment of patients. Only lighthouse products like IberogastR and a few others are used as supplementary opportunites in clinical practice. Specific herbal clinics, like for TCM, are not included in the European health system because the typical insurances do not cover these treatment. One of the most significant challenges in dealing with phytotherapeutics is the strongly negative attitude towards conventional medicine. It is based on a critical examination of how therapeutic agents work in general. By turning away from the holistic view in therapy towards an extremely specialized organ-specific idea in modern medicine with precise demands for monocausal relationships. Hence, the multicomponent mixtures of herbal products could hardly meet the expectations of today’s medicine. Monopreparations with high doses in a suitable dosage form can be documented very well utilizing relatively simple structured clinical

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studies concerning their effects based on concentration determinations in blood and tissues as well as by selective binding assays. The side effects resulting from this effect-related “maximum dosage” are accepted with approval. Without appropriate clinical studies, a rationally-based medicine is no longer imaginable. The limiting factor is the analytical determinability of effective components and parameters. With this forced construct, in the form of classic studies, the frequently observed synergistic effects of plant extracts and, even more, of mixtures of several extracts made from them cannot be recorded. Furthermore, and there is even the possibility in extreme cases that critical ones, focusing on an “active ingredient” examined in isolation as a result of the simplified study of the finished product with its specified dosage, can then lead to adverse effects on the product. Although it is now a matter of obtaining more profound and more advanced knowledge, only simple or extremely simplified test systems are still used to identify biological/pharmacological effects. On this basis, pharmacological principles are often postulated prematurely without further post-examination and exclusion testing and are described as valid only. Likewise, lead substances are too hastily named which hinder and even prevents the further search for other active substances that may be present in smaller quantities but at least (also) determine them. Real targets must therefore be identified, and their pharmacological relevance also be confirmed with suitable in vivo experiments. For in vitro experiments, for example cellular test systems, effects appear immediately. To this day, it is common that these examination methods, which are intended to identify immediate effects, are only used to clarify the effects that start after administering of plant extracts after weeks. The current state of the art in science and technology also allows a much more precise elucidation of the multi-component/multi-target principles prevailing in phytopharmaceuticals and the determi­na­tion of their bioavailability and pharmacokinetics in the human organism.

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3.3.4  Standardization 3.3.4.1  Dietary supplements — an alternative? From a purely legal point of view, a food supplement is considered as food and, therefore, only has to meet the criteria of the underlying food law. The HACCP concept applies in the manufacturing process of food and never meets the GMP requirements for medicinal products. To fulfill the legal situation regarding potential consumer deception in the context of food law, it is sufficient for the manufacturer to have processed traces of a potentially effective plant in the product. Since there is no technical examination regarding the suitability of these plant raw materials, which are generally classified as uncritical, the legislator has ensured within the European framework that the legal health effects of such products could not be advertised with “health-related statements”. However, the reality in the market shows an opposite picture. Through clever, legally ambiguous word capers and skilful implementation of effects, various providers have successfully managed to conquer massive parts of this market segment or to establish an entirely new parallel market segment. Since the formerly typical pharmaceutical dosage forms are now allowed for the food technology manufacturer, an average patient usually cannot recognize the supposedly cheaper alternative as such. Even declarations such as “food supplements with a pharmaceutical character” have become common in the industry. The lower price can be easily implemented for the manufacturers by eliminating any regulatory restrictions imposed by pharmaceutical law and other options for cost reduction with even higher profit margins. Effective implementations that systematically influence the market undermine the general advertising ban with “health-related statements.” This procedure gives the consumer the eloquent promising glossy promises regarding potential therapeutic effects “legally in the grey area,” that real product quality and variety do not exist.

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3.3.4.2  Panacea — functional food In addition to the classic food supplements, European legislation introduced a new product group in addition to nature-based medicines in 2007. The original basic idea of making vitamin preparations and minerals in terms of their safety and quality better available to European consumers in high quality, was established within the European Food Safety Agency (EFSA) in Parma, Italy, for functional foods. The aim was to raise effective nutritional supplements with known functionality to a solid level without having to immediately meet the requirements of a drug. However, it took years (until 2012 in Germany) until the legal basis was transposed into national law. In contrast to food supplements, it is entirely legal for functional foods to advertise with permitted health-related statements. Thus, the “functional foods” are intermediate level to nature-based medicines. In addition to the effective statement, it is mandatory for the manufacturer to put a clear note on the packaging that the use of these products is not necessary for a healthy consumer (it is legally food). However, many companies see this as a constraint damaging to sales, hence would rather these products be sold without EFSA’s legitimacy as a dietary supplement and without this “warning.” Suppose one now looks at the prerequisites necessary to obtain registration as a functional food with EFSA. In this case, it also quickly becomes clear that this set of instruments, which is well-intentioned by politicians, is unrealistic in practice. To register a product as functional food and receive a so-called “health claim,” the respective manufacturer must submit not only extensive documentation but also clinical studies and higher-level metastudies on the pharmacological effects. Since it is generally a matter of natural products (often analogous to phytotherapeutics), the classic way of registering as a traditional medicinal product (tHMP) appears in many cases to be much easier, faster and, above all, more cost-effective because no clinical studies are necessary for this drug registration. Therefore, the legal situation places considerably higher demands on functional food, which should typically only contain 10% of a

170  History, Present and Prospect of World Traditional Medicine

phytotherapeutic agent’s current active ingredient content, than on a drug with higher potency. Hence, it is not surprising that the market prefers to sell “illegal” food supplements with implied health effects without any official monitoring to be able to handle this bureaucratic hurdle (EFSA registration) with all its requirements. However, as long as the sanctioning of this circumvention strategy is not consistently implemented, more and more untested and sometimes unsuitable products will be sold as “pseudo-natural medicines” and unintentionally be used as a boomerang against the established and highquality phytopharmaceuticals, if the therapy is unsuccessful. The consumer/patient does not have the understanding and expertise to distinguish “pseudo products” from effective therapeutic agents (Table 3–4). With a food supplement, it is never guaranteed that an active ingredient is contained at all and whether it is present in the appropriate form or the necessary amount.

Table 3–4    Quality control of food here functional foods and food supplements compared to nature-based pharmaceuticals. Phytopharmaceuticals

Food

Legal Norms

drug law, drug manufacturing regulation, pharmacopoeias

food and commodities law

Quality Management

GMP

HACCP

Raw Material

manufactured under GMP or GACP (good agricultural or collecting practice)

no binding requirements

Goods Receipt

incoming goods inspection according to the pharmacopoeia of each batch including complete documentation

visual inspection

Storage

under GMP surveillance

—

In-process Control

batch-specific, fully documented, in accordance with specifications

—

Monitoring

external monitoring and auditing audits also for “suppliers”

self-monitoring hygiene control

Reaction after Deviations

product destruction

rectification

History and Present of European Traditional Herbal Medicine (Phytotherapy)  171 Table 3–4  (Continued) Phytopharmaceuticals

Food

Final Product Control

batch-specific, test methodology by admission according to the state of the art in science and technology documented at the registration documents

no definition of criteria of the HACCP concept individual decided by each producer

Release

batch-specific by “competent person” on the basis of the batch-specific test data

free choice

Validation

method validation process validation cleaning validation

not mandatory

Scope of Testing

all with every batch heavy metals pesticides microbiology aflatoxins identity purity salary

one batch, once a year nutritional value fat content carbohydrates protein salt as well as microbiology and fiber content

dosage content homogenity

no, except efficacydetermining components with regard to correctness, quality, and quantity

For example, in the case of a magnesium preparation, it is imperative to determine and declare the nutritional value, fat, protein, and sugar content, as well as the salt content once the magnesium content is rarely checked. So, can dietary supplements have any therapeutic effect? According to experts, over-the-counter natural products with a presentation similar to phytotherapeutics present a considerable risk potential for users. Since typical dietary supplements, approved as functional foods, only contain approximately 10–20% of the active substance concentration of a phytotherapeutic with comparable or other active substances, a reliable and reproducible therapeutic effect in the classic sense cannot be assumed.

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The suitability of a specific extract extraction process, the use of the right source drug, or the right part of the drug is never checked. No “qualified person” or any specialist expertise is required for approval. The enlightened customer cannot distinguish between medicinal products (here phytotherapeutic agents) and foods (here food supplements) due to a lack of professional qualifications with the same make-up and similar or identical plant components. The problem is exacerbated because pharmacies offer these products as an inexpensive alternative to their customers.

3.3.5  Education and training Unfortunately, as EU regulations have made registering Herbal Medicinal Products in the Nations of Europe more difficult, teaching European Traditional Herbal Medicine at universities has also declined. Nevertheless, there are still several university courses available, e.g., at the following institutions: University of Münster, Germany (Prof. Dr. Andreas Hensel) At the Institute for Pharmazeutical Biology and Phytochemistry (IPBP) courses, seminars, and lectures are given for students of Pharmacy and Food Chemistry. Botanical excursions are offered as well, based on the legal requirements for pharmaceutical studies in Germany (AAppO 2000). University of Rostock, Germany (Prof. Dr. med. Karin Kraft) The course “naturopathy” consists of both an introduction into and practical training of the use of phytotherapy and other naturopathic methods including naturopatic devices used in the doctor’s office, basic knowledge of medicinal herbs used in Europe, including examples of recent research and practical instructions in the ambulance for naturopathy in small groups. Georg August University of Göttingen, Germany (PD. Dr. Silke Cameron, Dr. Kenny Kuchta) The Research Station for Traditional East Asian Medicine (Forschungsstelle für Fernöstliche Medizin) in cooperation with the Department of Botany and the University Medicine engaged in the establishment of courses on Herbal Medicine that also include plants and applications from European Phytotherapy. HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg-Eppendorf. The institute covers research, treatment, and education. Besides classes for students of Western medicine, the center offers postgraduate education in Traditional Chinese Medicine for Western medicine physicians. The three-year education courses

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include Chinese herbal medicine and Western herbal medicine. The students can receive an additional qualification in acupuncture and natural medicine recognized by the German Chamber of Physicians and, in cooperation with the Shanghai University of TCM, the “Master of Chinese Medicine.” Zurich University of Applied Sciences (ZHAW), Switzerland (Dr. Evelyn Wolfram) Courses are offered in the subjects “Pharmacology and Toxicology” and “Biotechnology of Natural Products” at the Section Natural Product Chemistry and Phytopharmacy of the ZHAW School of Life Sciences and Facility Management. University of Geneva, Switzerland (Prof. Jean-Luc Wolfender) Courses at the School of Pharmaceutical Sciences, at the University of Geneva, are designed to allow the student to obtain general knowledge of the main medicinal plants, their botanical classification, chemical composition, therapeutic uses, and dangers. This practical work complements and illustrates the courses in pharmaceutical analytical chemistry and pharmacognosy-phytochemistry. University of Innsbruck, Austria (Prof. Dr. Hermann Stuppner) The teaching activities of the Institute of Pharmacognosy Innsbruck include lectures, seminars, and excursions pertaining to topics like biogenic drugs, compound classes and biosynthesis of natural products, and the phytochemical analysis of medicinal and agricultural plants. University of Szeged, Hungary (Prof. Dr. Judit Hohmann) The courses “Herbal and Drug Knowledge” and “Phytotherapy” are offered as one of the professional majors in pharmacy training, introducing uses of traditional and modern medicine to pharmacy students. This course provides general information on plant primary and secondary metabolites, details the biosynthesis of each group of compounds, and the physical and chemical characteristics and analytics of the compounds. It also deals with the critical evaluation of herbs and agents that are now in vogue and whose medical use in European Medicine is not adequately documented. Other Pharmaceutical Institutes in European Universities: Germany Würzburg University: Julius-Maximilians-Universität Würzburg https://www.uni-wuerzburg.de Tübingen University: Eberhard Karls Universität Tübingen https://uni-tuebingen.de

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Saarbruecken University: Universität des Saarlandes https://www.lsf.uni-saarland.de Regensburg University: Universität Regensburg https://www.uni-regensburg.de München University: Ludwig-Maximilians-Universität München https://www.lmu.de/en/ Marburg University: Philipps-Universität Marburg https://www.uni-marburg.de Mainz University: Johannes Gutenberg-Universität Mainz https://www.pharmazie.uni-mainz.de Leipzig University: Universität Leipzig https://www.uniklinikum-leipzig.de/einrichtungen/pharmazie/en Kiel Universität: Christian-Albrechts-Universität zu Kiel https://www.pharmazie.uni-kiel.de Hamburg University: Universität Hamburg https://www.chemie.uni-hamburg.de Erlangen-Nürnberg University: Friedrich-Alexander-Universität Erlangen-Nürnberg https://www.fau.de Greifswald University: Universität Greifswald https://pharmazie.uni-greifswald.de Braunschweig University: Technische Universität Braunschweig https://www.tu-braunschweig.de Frankfurt am Main University: Goethe Universität Frankfurt am Main https://www.uni-frankfurt.de Bonn University: Rheinische Friedrich-Wilhelms-Universität Bonn https://www.pharma.uni-bonn.de

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Düsseldorf University: Heinrich Heine Universität Düsseldorf https://www.pharmazie.hhu.de Jena University: Friedrich Schiller Universität Jena https://www.pharmazie.uni-jena.de Regensburg University: Universität Regensburg https://www.uni-regensburg.de Berlin University: Freie Universität Berlin https://www.bcp.fu-berlin.de Freiburg University: Universität Freiburg https://www.pharmazie-web.uni-freiburg.de Heidelberg University: Universität Heidelberg und molekulare Biotechnologie Lehrstuhl-Bezeichnung. Lehrstuhl für Pharmazie https://www.bio.uni-heidelberg.de Austria University: Universität Graz https://www.uni-graz.at Universityt: Universität Innsbruck https://www.uibk.ac.at University: Universität Salzburg, Paracelsus Medizinische Privatuniversität https://www.pmu.ac.at University: Universität Wien https://www.univie.ac.at Switzerland University: Lausanne https://www.Unil.ch University: Universität Basel https://www.unibas.ch University: Universität Bern https://www.unibe.ch/index_eng.html University: ETH Zürich https://www.ethz.ch

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France University: Université de Franche-Comté Besançon https://www.univ-fcomte.fr/ University: Université d’Aix Marseille II https://www.univ-amu.fr Spain University: Universitat de Barcelona. Facultad de Farmacia https://www.ub.edu/farmacia University: Universidad del País Vasco. Facultad de Farmacia https://www.ehu.eus University: Universidad de Granada. Facultad de Farmacia https://farmacia.ugr.es University: Universidad de La Laguna. Facultad de Farmacia https://www.ull.es/la-universidad/facultades-escuelas University: Universidad Complutense de Madrid. Facultad de Farmacia https://farmacia.ucm.es University: Universidad de Navarra, Pamplona. Facultad de Farmacia https://www.unav.edu/ University: Universidad de Salamanca. Facultad de Farmacia https://facultadfarmacia.org University: Santiago de Compostela. Facultade de Farmacia https://www.usc.es/gl/centros/farmacia University: Universidad de Sevilla. Facultad de Farmacia https://www.farmacia.us.es University: Universidad de Valencia. Facultad de Farmacia https://www.uv.es/farmacia

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Netherlands University: University of Groningen https://www.rug.nl University: Utrecht University https://www.uu.nl University: Leiden University https://www.universiteitleiden.nl University: Vrije Universiteit Amsterdam https://www.vu.nl Italy University: University of Padova https://www.unipd.it University: University Of Genoa (Università Degli Studi Di Genova) https://unige.it University: University of Bologna https://www.unibo.it/en/homepage Outside of established universities, several of the Organizations offer privately organized courses, e.g., the following representative examples: Gesellschaft für Phytotherapie (GPT) (Society for Phytotherapy) Offers a modularized training course for doctors and pharmacists, in which expert speakers present a large number of medicinal plants with their ingredients and their effect on the human organism at seminars in order of indication areas, as well as give concrete tips for the practice. The aim is to provide new insights, including clinical studies on phytopharmaceuticals and their use in medical practice and pharmacy. The participants learn that science did not stop before phytotherapy and that the effects of many herbal medicines are now very well documented. https://phytotherapie.de Schweizerische Medizinische Gesellschaft für Phytotherapie (SMGP) (Swiss Medical Society for Phytotherapy) The SMGP Phytotherapy Skill Program offers doctors, pharmacists, and natural scientists interested in pursuing further education in phytotherapy (course program with 11 courses, excursions, and conferences in a 3-year cycle). These courses are strongly oriented towards practice but in the training style “postgraduate” with an open discussion about different therapeutic approaches and textbook opinions. They are offered in two languages (German and French). The training cycle is completed with a final thesis and then leads to the receipt of the “Phytotherapy Certificate SMGP.” Only SMGP members can obtain this certificate.

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Österreichische Gesellschaft für Phytotherapie (ÖGPhyt) (Austrian Society for Phytotherapy) The ÖGPhyt offers a Diploma for phytotherapy. The aim of the phytotherapy training of ÖGPhyt is to enable doctors to use herbal medicines in the sense of a scientifically-based phytotherapy by acquiring in-depth knowledge. According to the definition of the Austrian Society for Phytotherapy, phytotherapy is the therapy direction that uses herbal medicinal products (phytopharmaceuticals) for therapy and prophylaxis, which is based exclusively on medical and scientific principles. Training is designed to provide knowledge that also includes herbal medicines, whose use has not (yet) been proven by scientific methods (e.g., herbal medicines of traditional European medicine, dietary supplements, etc.). The target group is doctors for general medicine and specialists from different disciplines. Società Italiana di Fitoterapia (S.I.Fit.) (Italian Society of Phytotherapy) The Italian Society of Phytotherapy (S.I.Fit.) offers courses on phytotherapy in cooperation with the universities of Padua and Siena. They promote post-graduate courses in phytotherapy of the highest level, continuing the tradition of the oldest school in Italy, which regards professional training on the subject. Besides courses at universities and private organizations, one of the most important teaching organizations are various journals and periodicals that publish articles on research and theory of the application of traditional European medicinal plants. The following examples give a representative overview on these publications: Planta Medica [Journal of the Gesellschaft für Arzneipflanzen — und Naturstoff — Forschung (GA)] Planta Medica is one of the leading international journals in the field of natural products — including marine organisms, fungi, as well as micro-organisms — and medicinal plants. Planta Medica accepts original research papers and reviews from researchers worldwide. The journal publishes 18 issues per year. The following areas of medicinal plants and natural product research are covered: Biological and Pharmacological Activities, Natural Product Chemistry & Analytical Studies, Pharmacokinetic Investigations, Formulation and Delivery Systems of Natural Products. The journal explicitly encourages the submission of chemically characterized extracts. Zeitschrift für Phytotherapie [Journal of the Gesellschaft für Phytotherapie (GPT)] This Journal publishes primarily original manuscripts with reports on medical and pharmaceutical sciences as well as

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practice after acceptance by the editors. The contents of manuscripts include reports on preparations from natural products, preferably plants and their ingredients, including proprietary medicinal products: Therapeutic Applications, Presentation/Search of New Ways to Prove Effective and Effective, Pharmacology and Toxicology, Medicinal Use in Non-European Regions, and Overview articles that present the state of knowledge about certain phytopharmaceuticals or groups with emphasis on therapeutic use. PHYTO Therapie Austria [Journal of the Österreichische Gesellschaft für Phytotherapie (ÖGPhyt)] PHYTO Therapie focuses on herbal medicines in Austria. The possibilities and the limits of the therapy with herbal medicinal products in Austria are presented with a focus on herbal proprietary medicinal products authorized or registered in Austria. Particular emphasis is given to the demarcation of herbal medicines from dietary supplements. In addition, PHYTO Therapie is to report regularly on the activities of the ÖGPhyt and promote contact between the members of the ÖGPhyt. Nederlands Tijdschrift voor Fytotherapie [Journal of the Nederlandse Vereniging voor Fytotherapie (NVF)] The Dutch Magazine for Phytotherapy (NTvF) is a quarterly publication of the Dutch Association for Phytotherapy for publications concerning scientific research into the safety, quality, and efficacy of medicinal plants and phytotherapeutics, as well as other subjects deemed relevant in connection with the application of phytotherapeutics, for example, developments in legislation and regulations, phytotherapy education, and the exchange of clinical experiences in the (different contexts of) phytotherapy. Fitoterapia This is a Journal dedicated to medicinal plants and bioactive natural products of plant origin. It publishes original contributions in seven major areas: 1) characterization of active ingredients of medicinal plants, 2) development of standardization methods for bioactive plant extracts and natural products, 3) identification of bioactivity in plant extracts, 4) identification of targets and mechanism of activity of plant extracts, 5) production and genomic characterization of medicinal plants biomass,

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6) chemistry and biochemistry of bioactive natural products of plant origin, 7) critical reviews of the historical, clinical, and legal statuses of medicinal plants, and accounts on topical issues. Journal of Ethnopharmacology [Journal of the International Society for Ethnopharmacology (ISE)] The Journal is dedicated to the exchange of information and understandings about people’s use of plants, fungi, animals, microorganisms, and minerals and their biological and pharmacological effects based on the principles established through international conventions. The empirical knowledge of these medicinal substances and their toxic potential was passed on by oral tradition and sometimes recorded in herbals and other texts on materia medica. In recent years, the preservation of local knowledge, the promotion of indigenous medical systems in primary healthcare, and the conservation of biodiversity have become even more of a concern to all scientists working at the interface of social and natural sciences, especially to ethnopharmacologists. Accordingly, today’s ethnopharmacological research embraces the multidisciplinary effort in the documentation of indigenous medical knowledge. The Journal of Ethnopharmacology publishes original articles concerned with the observation and experimental investigation of the biological activities of plant and animal substances used in the traditional medicine of past and present cultures. Other common forms of teaching European Phytotherapy are conferences, that offer lectures from distinguished scientists. The following is a short list of some of the most popular annual conferences in the field: International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA), Congress of the Society for Phytotherapy (Gesellschaft für Phytotherapie GPT), International Congress Phytopharm, International Congress of the International Society for Ethnopharmacology, and Bernburg Winter Seminar for Medicinal and Spice Plants (Bernburger Winterseminar für Arznei- und Gewürzpflanzen).

3.3.6  Organizations in the field of European Phytopharmaceuticals In the following table, the organizations in the field of European Phytopharmaceuticals are listed with their topics and web-address for further detailed information (Table 3–5).

Table 3–5    Organizations in the field of European Phytopharmaceuticals.

International Title (National Title)

Author: Silke Cameron Topics

Web Address

Society for Medicinal Plant and Natural biochemistry, biosynthesis, biotechnology, plant cell and tissue Product Research [Gesellschaft für culture, breeding, cultivation, pharmacognosy, metabolomics, Arzneipflanzen- und Naturstoffchemistry and analytics, biological and pharmacological Forschung (GA)] clinical studies, formulation, quality control, extracts and preparations, phytotherapy

https://www.ga-online.org/

Society for Phytotherapy [Gesellschaft für Phytotherapie (GPT)]

scientific society for physicians, pharmacists, and scientists, fundamental pharmaceutical and pharmacological research, clinical research, evidence-based medicine, information on self-medication

https://phytotherapie.de/de/

Swiss Medical Society for Phytotherapy [Schweizerische Medizinische Gesellschaft für Phytotherapie (SMGP)]

medicinal plant research, quality, safety and efficacy, training in phytotherapy, medical studies training

https://www.smgp.ch/

Austrian Society for Phytotherapy [Österreichische Gesellschaft für Phytotherapie (ÖGPhyt)]

collection of medical and pharmaceutical experience; initiation and promotion of chemical-pharmaceutical, pharmacological and clinical research; evaluation of research results, international exchange of experience; therapy

https://www.phytotherapie. at/

Dutch Association for Phytotherapy [Nederlandse Vereniging voor Fytotherapie (NVF)]

scientific association, quality and reliability of natural products, pharmacology; interactions between regular medicines and natural products and side effects. members: pharmacists, doctors, researchers, therapists, growers, producers, etc.

https://fyto.nl/

(Continued)

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Organizations

Organizations International Title (National Title)

Author: Silke Cameron Topics

Web Address

Phytochemical Society of Europe (PSE)

assist young researchers, conferences, chemists and biologists

http:// phytochemicalsociety. org/

Francophone Association for Teaching and Research in Pharmacognosy [Association Francophone pour l’Enseignement et la Recherche en Pharmacognosie (AFERP)]

development and coordination of teaching and research in pharmacognosy, exchange of information; national and international contacts; medicinal plants and natural substances; therapeutic interest

https://aferp.fr/

Italian Society of Phytotherapy [Società scientific experiments; phytotherapy in modern medicine; Italiana di Fitoterapia (S.I.Fit.)] scientific research on medicinal plants; main national media, serious information

http://www.sifit.org/ societa.html

International Society for Ethnopharmacology (ISE)

medicinal, food and toxic plants; traditional drugs/medicine; cultural settings in daily health care, nutrition, veterinary, hunting, pest control etc.; emic and ethic perspective; future use; research transdisciplinary, link between the social and the natural sciences

https://www. ethnopharmacology.org/

Non-profit Research Association Saluplanta (JRC); Association for Medicinal and Spice Plants [Gemeinnützige Forschungsvereinigung Saluplanta (GFS); Verein für Arznei- und Gewürzpflanzen]

promote science and research in the field of medicinal, spice, aromatic, and dye plants, medicinal and spice plant producers; scientific knowledge on medicinal, spice, aromatic and dye plants

https://www.saluplanta.de/

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Table 3–5  (Continued)

Organizations International Title (National Title)

Author: Silke Cameron Topics

Web Address

non-profit association, wild collection, growing, first processing steps and quality assurance of medicinal and aromatic plants; association of European national organizations of herb growers; perfumery, aromatic and medicinal plants; defining quality criteria; collaboration; members are Austria, Bulgaria, France, Germany, Greece, Hungary, Italy, Latvia, Poland, Portugal, The Netherlands, United Kingdom; Switzerland, applied research

http://www.europam.net/

German Technical Committee for Medicinal, Spice, and Aroma Plants [Fachausschuß für Arznei-, Gewürzund Aromapflanzen (DFA)]

interests of the producers of medicinal, spice and aromatic plants in Germany; cultivation, industry, commerce, research institutions and public authorities; agricultural production and the first stage of processing of plants with special ingredients

https://www.dfa-aga.de/

Association for the Promotion of Medicinal and Spice Plant Cultivation in Bavaria (Verein zur Förderung des Heil- und Gewürzpflanzenanbaus in Bayern)

intermediary role between growers, customers, and researchers; promote local quality cultivation; supports the experimental activity, effect on the market

https://kraeuteranbau.de/

Ökoplant e.V.; Supporting Association for Organic Medicinal and Spice Plant Cultivation (Ökoplant e.V.; Förderverein ökologischer Heilund Gewürz-pflanzenanbau)

exchange of information and experience; interaction between https://oekoplant-ev.de/ science and practice; breeding, cultivation, processing, quality and marketing of organically produced medicinal and spice plants; education in the field of organic medicinal and spice plant cultivation; represents the interests of organic medicinal and spice plant cultivation; various specialist groups (plant protection, seed ordinance, plant breeding, etc.) (Continued)

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European Herb Growers Association (EUROPAM)

Organizations International Title (National Title)

Author: Silke Cameron Topics

Phytopharmaceutical Cooperation [Kooperation Phytopharmaka (KOOP)]

phytopharmaceuticals as an integral part of the supply of medicinal products; scientifically-based medicines in medical therapy (i.e. evidence-based medicine); self-medication; safety of the products; intensive research and extensive expertise in medical, preclinical, regulatory and health policy; active link between patients, doctors, pharmacists, researchers, societies, associations and authorities; direct advisors for specific scientific and medical questions to institutions, regulatory authorities, companies, national and European bodies such as HMPC and ESCOP as well as scientific societies; therapy on a scientific level through publications, lectures and symposia

Research-Station for Traditional Asian Medicine Göttingen (Forschungsstelle für Fernöstliche Medizin Göttingen)

collection of literature and materials; supports the translation of knowledge about medicinal plants and herbal formulations into products and their use in medical therapy; relations with the authorities and decision makers in the field of health policy; cooperation between German and European manufacturers

Federal Institute for Drugs and Medical BfArM is an independent federal authority as an institute in the Devices [Bundesinstitut für division of the Federal Ministry of Health. The main task of Arzneimittelund Medizinprodukte the BfArM is the approval of ready-to-use medicinal products. (BfArM)] This also includes the medicines of the three officially recognized “Particular Therapeutic Systems” according to the “German Medicines Act” (AMG): 1) Phytotherapy, including East Asian Traditional Medicine; 2) Homeopathy; and 3)

Web Address https://www.koop-phyto. org/

https://www.bfarm.de/EN/ Home/home_node.html

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Table 3–5  (Continued)

Organizations International Title (National Title)

Author: Silke Cameron Topics

Web Address

European Scientific Cooperative on Phytotherapy (ESCOP)

ESCOP was founded as an umbrella organization representing national herbal medicine or phytotherapy societies across Europe and to determine its role in discussions with European medicines regulators. In particular, it produces reviews of the therapeutic use of leading herbal medicinal products or herbal drug preparations based on scientific evidence and on the leading expertise across Europe. ESCOP aims to advance the scientific status of herbal medicinal products and to assist with the harmonization of their regulatory status at the European level and to promote the field of “phytotherapy” defined as: “Phytotherapy is the science-based medicinal use of plants and preparations derived from them, in the treatment, alleviation and/or prevention of disease or injury, according to recognized standards of quality, safety and efficacy.”

https://escop.com/

(Continued)

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Anthroposophical Medicine. It further arranges the registration of homeopathic and traditional herbal medicinal products, the detection and evaluation and prevention of drug risks (pharmacovigilance), the central recording and evaluation of risks in medical devices, the monitoring of the (legal) traffic of narcotics and raw materials. The legal framework for these tasks includes the Medicines Act (AMG), the Medical Devices Act (MPG), the Narcotics Act (BtMG), the Basic Substances Surveillance Act (GÜG) and the regulations adopted for this purpose. The office of the German Pharmacopoeia Commissions is also located at the BfArM.

Organizations International Title (National Title)

Author: Silke Cameron Topics

Web Address

Its further objectives are to develop a coordinated scientific framework to assess herbal medicinal products, to promote the acceptance of herbal medicinal products especially within general medical practice, to support and initiate clinical and experimental research in phytotherapy, to improve and extend the international accumulation of scientific and practical knowledge in the field of phytotherapy, to support all appropriate measures that will secure optimum protection for those who use herbal medicinal products, to produce reference monographs on the therapeutic use of plant drugs, and to further cooperation among national associations of phytotherapy to advance these Aims and Objectives. European Medicines Agency (EMA) [Committee on Herbal Medicinal Products (HMPC)]

HMPC is the European Medicines Agency’s (EMA) committee responsible for compiling and assessing scientific data on herbal substances, preparations, and combinations, to support the harmonization of the European market. The Committee was established in accordance with Regulation (EC) No 726/2004 and the Herbal Directive, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States. The HMPC is composed of scientific experts in the field of herbal medicines. The HMPC prepares the Agency’s opinions on herbal substances and preparations, along with information on recommended uses and safe conditions.

https://www.ema.europa. eu/en/committees/ committee-herbalmedicinal-productshmpc

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Table 3–5  (Continued)

Organizations International Title (National Title)

Author: Silke Cameron Topics

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This work supports the harmonization of the European market: national competent authorities are able to refer to one unique set of information on herbal substances or preparations when evaluating marketing applications for herbal medicines. To support EU Member States, the HMPC focuses on two main tasks: 1) Establishing EU monographs covering the therapeutic uses and safe conditions of well-established and/or traditional use for herbal substances and preparations; 2) Drafting an EU list of herbal substances, preparations, and combinations thereof for use in traditional herbal medicinal products.

Web Address

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3.3.7  Seven scientific research and evaluation for efficacy, quality and safety As previously mentioned, there are several ways to develop new phytotherapeutics. Reactivation or Purchase of Existing Approvals (Registrations) As briefly stated above, the historical development in Europe, especially in Germany, has led to a pool of currently unused or only niche-like products with old approvals. The easiest and fastest way to position new phytotherapeutic products as pharmaceuticals on the market is to reactivate currently inactive approvals. If anybody now starts to convert an existing post-approval into a new product, the following must be observed. The combination of drugs (many approvals concern typical combination products) can be modified in terms of their quantitative composition but cannot be restructured. The consequence of this is that although constituents (usually due to a lack of verifiable effects) can be omitted, a substitution or addition of a new drug or an extract made from it is no longer legally possible within the scope of this existing authorization. If a substantial change in the active ingredients is nevertheless necessary, this can only be achieved by a new registration or approval. Such a modernized product, therefore, requires a new, complete approval/registration procedure, which is now processed centrally at the EMA for total Europe. The impact of the so-called Brexit currently cannot be assessed. This means that existing approvals/ registrations cannot necessarily be converted into modern phytotherapeutic products. In many cases, a completely new start is more promising, since the restrictions due to the traditional composition can be critical or problematic in terms of marketing or technology. It is common in the industry to check the potential availability of such an approval in addition to determining the market potential and the competitive situation before completely reworking. The general questions are: – Which country should the product be marketed? – What is the overall competitive situation including synthetic products?

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– – – –

Which target group can be reached with it? Which marketing strategy must be used for this target group? Which dosage form is really convenient for this target group? How can mediators (doctors and e.g., alternative practitioners) be convinced? – Does a possibility of positioning the product in a clinical environment exist? In many cases, it can be assumed that the topicality of both the quality control approval documentation as well as validations and stability studies are usually rated as below average for such inactive or only minimally active approvals. If such a product is inexpensively produced by a company using largescale processes with acceptable raw material costs and is not only marketed nationally but also internationally in an existing close-knit marketing network, it can become an attractive driving force with high returns at any time. Intensive communication with potential customers should also be favored here, whereby the long-standing tradition of these products often offers positive buying incentives as a quality criterion for the customer and thus represents a counterpoint to the prevailing “avarice is cool” mentality. When viewed critically, older products often contain a large number of herbal raw materials, which is both a curse and a blessing. So, if there is already an active approval, these products could also be adapted relatively quickly, provided that there is a positive economic implementation opportunity in the overall market. Modification of Existing Approvals There is the possibility of creating a new product in a simplified process by reducing the number of herbal ingredients, which can also be communicated with the customer/ patient. However, there are also corresponding expenses for any work with regard to the new formulation, the galenics, but also stability tests, and above all, the complete analysis and quality control. In most cases, however, the advantage increases in a simplification of the analytical expenditure, if additional plant drugs with their specific analytical marker compounds are eliminated.

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Here is the highest chance for a fast and reasonably inexpensive market penetration, provided if the remaining market-relevant requirements are met. At the same time, the possibility of varying the dosage of individual components also offers new opportunities. Here, the compliance for the user can be improved and any supplementary similar therapeutic fields can be communicated within the broad framework of the old approval. Expansion of the Fields of Application As an alternative, the current trend in synthetic drug development, due to the lack of availability of novel drug concepts, can lead to interesting new markets due to the massive expansion of therapeutic applications for identical drugs and drug combinations. However, it must be borne in mind that this can only be implemented with a higher administrative expenditure in terms of admission/ registration. If the effort is almost comparable to a new registration, this variant can only serve as a faster solution in special cases. “Phyto Generics” as a New Market Field Alternatively, there is the potential to also implement the marketable alternative in the form of “generics” in the phytotherapeutic field. Here, however, the market volume and the market coverage of the original preparations on the market must also be taken into account. The difficult patent situation with existing ones is advantageous here. Phytochemical drugs have recently been mostly not circumvented through creative patent law strategies. In most cases, in contrast to the synthetic pharmaceutical market, there are more or less no patent protection scenarios for old products, so that it is possible to position a comparable “copycat preparation” within the framework of a relatively simple “phyto-equivalence test,” established also from the author. It is even possible to secure this new “phyto-generic” under patent law with a corresponding “slight” modification of the manufacturing process. This requires the creativity of a good registration department and a good patent department. In the context of global trade, the current restriction of many companies to products with fewer symptom circles is no longer appropriate. The assignment of products and the associated manufacturers to a

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certain therapeutic area may historically represent a growing, but by no means cemented structure. In the past, the physician who used the diagnosis was able to assign the prescribed therapeutic agents to the respective manufacturers due to the structure of the market. Something similar can also be found with some synthetic pharmaceutical manufacturers but has survived in a market economy. Complete New Drug-Focused Development With this variant, which requires a certain amount of financial resources for the company, the alignment also begins with the assessment of the target markets. In addition to the market volume, the potential area of targeted therapy is used as the basis here. To achieve a simplified Herbal Medicinal Product (HMP) registration, it would be necessary to use the medicinal plant treasure in the western hemisphere or on drug materials from Asian documented medicine. As previously discussed, around 700 known medicinal plants can currently be assumed in Europe alone, but experts see a much higher number of those without use in the last 100 years. Of the estimated 200,000 plant species worldwide, approximately 7,000–10,000 plants of East Asian flora alone are considered to be long-known and traditional medicinal plants. Suitable candidates for product development should be identified here, which can then also be provided economically. The approaches currently being implemented by the large pharmaceutical industry with regard to their search for new active ingredients, i.e., usually single components, meanwhile, in addition to the global flora, also extend to increasingly exotic raw material resources, such as marine sponges of the deep sea or blood factors of reptiles or sharks. In terms of marketing technology, the sustainability of natural active ingredients is currently not being sufficiently emphasized, which in turn has led to considerable growth in many industries. Completely New Drug-Focused Development Another alternative with less sustainability but extremely high, rather short-term chances of success is the “fashion drug-focused” phytotherapeutics development. The findings of the market observation for the dietary supplements to be differentiated clearly show a higher acceptance to use products with

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plant drugs of high media relevance in order to achieve a corresponding differentiation from alternative products. This approach is still unknown in the more conservatively structured European phytotherapeutic market, which of course can also be due to the delay in market entry due to the approval or registration process. As the examples of aloe and noni, or also pomegranate (punica granatum sp.), etc. show plants (not only medicinal plants) that are positively rated by the general public are suddenly made available to consumers, but also patients, with an unmanageable variety of products. This also works with only smaller advertising budgets, since the media attention is directed not to the product but to the “fashion drug.” This media interest is fueled by more or less serious scientific and popular scientific publications. Likewise, resourceful entrepreneurs in the US have already extensively and successfully implemented the so-called brassica ingredients of Broccoli or the “phytosterols” from Soy and recently also Rapeseed in the dietary supplement market. This is often done in the form of so-called “specialist books” on these individual topics. This methodology has recently been used to creatively circumvent the ban on advertising with health claims for food supplements within the EU. A “freelance researcher” who is not integrated in the company reproduces his personal “pseudo experiences” with the specific product in the form of a paperback. No violation of the application ban can be proven to the company concerned, although the overall market effect remains pretty much the same. It should be noted, that a more “fashion drug-based” phytotherapeutic product has a priority market presence of approximately three years, which should nevertheless be of considerable economic interest compared to the food sector without approvals with a period of approximately one year. International marketing has great advantages here, since the products do not achieve corresponding sales figures in all high-priced target markets around the world, so that the decline in sales in one target market is compensated for by the increase in another. Overall global sales can be kept fairly constant over several years. Complete New Development Focused on Impact The variant of a completely new development with a focus on specific and clearly delineated effects appears to be the most sensible way to generate sustainable

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and long-term economic success with regard to its market relevance and its market potential. The question of why there is actually relatively little innovation potential in the market is clearly due to the structuring of the phytopharmaceutical industry in Europe with mainly limited resources. The synthetic-chemical pharmaceutical industry is characterized by a mix of large international companies and medium-sized structured manufacturers. In contrast, the grown structure in the phytochemical area is typically small to medium-sized. This results in a massive restriction of financial scope for possible new developments and a prevailing fear of counterfeiting by imitators, since the influence of patent law strategies in these companies is usually not too high due to lack of experience. Through the well-known practice of a so-called “duplicate economy,” consortia of actual competitors have created joint approvals, which are then viewed as competitive products by the customer using different brand names and packaging. It even comes to the point that license holders have the production carried out jointly by a single contract manufacturer in order to reduce costs and only the blister packaging and secondary packaging is designed depending on the manufacturer. In such a climate, an innovative potential is only fragmentary and it looks more like a certain stable market structure. Only through a restructuring can greater economic accents be set here again. However, this requires considerable financial investments which, as a rule, the companies in the market may not be able to make on their own. This has resulted in a situation in which the variants described in the other previous chapters were implemented. The number of really new products is therefore extremely modest. Natural Product-Based Substitution of Synthetic Long-Term Preparations Substitution of only synthetically manufactured therapeutics in the therapy environment of chronic diseases (e.g., with rheumatoid symptom fields), aftercare of severe illnesses (e.g., aftercare of infarct), and interventions can be a great potential for new products of any kind, whether traditional or modern, which should not be underestimated (e.g., after highly invasive surgery, etc.) as well as other long-lasting symptom improvements currently incurable diseases (e.g., autoimmune diseases). In addition, gentle supportive products represent a secure market potential in cancer therapy.

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The reduced side effects and the usually better tolerability represent the marketing technical all-round features for the market intervention. When viewed critically, approximately 30% of the population can be classified as at least “phyto-affine,” although the proportion of selfdeciding chronic patients is likely to be significantly higher. Current European Research Landscape in the Field of Phytopharma­ ceuticals. The current research landscape is roughly divided into university institutes in the following fields: – – – – – – – – –

History of medicine and pharmacy (historian) Botanical institutes Cultivation research and phytopathology (including plant protection) Departments of organic chemistry with a certain focus on natural products Genetic engineering institutes with a focus on medicinal plants Phytomedical research Pharmacy and pharmaceutical biology with focus on natural products Clinical medicine with focus on herbal treatments Bioinformatics for data processing

The second column of research is based on the research activities of the players in the phytopharmaceutical market in Europe. Based on the structure of the phytoindustry with small and middlesized companies with limited financial resources, there are only small dynamic processes for new products. This result also comes from very limited experienced personal resources for research and development. Most of these experts are implemented in the massive growing field of quality restrictions and for the more and more growing quality control work. But What is Today? Since government-funded research at German and European universities in the context of phytomedicine has been massively reduced in recent decades, efficient product-oriented development should no longer be generated from this research environment. In addition to the company’s own development departments, only a few contract- financed research and development institutes and laboratories are active in this area, as is the author’s company.

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To be able to reasonably estimate the innovative strength and the resulting performance potential, the available national as well as international development resources must be identified and optimized. In the US, there is considerable innovative potential for natural-based products in the industry, also at universities, which provide a large number of scientific accompanying research activities for the dietary supplement market. In Europe, this development was not recognized by the education policy and so an opposite development, characterized by a massive reduction of existing research capacities, has manifested itself here. The consequence of this is — the total number of researchbased pharmaceutical companies, research and development companies as well as academic research groups working on the development of new herbal medicines is very small in Europe.

3.3.8  Products and trading 3.3.8.1  Market fields Data modified from BAH (Bundesverband der Arzneimittelhersteller) (Table 3–6): Only through an intensified and targeted development policy, in the field of natural substance-based therapeutics, can not only regional but above all global markets be expanded into an economic success model in the medium and even better in the long term, if, as already mentioned, in addition to the gentle efficacy in chronic diseases. Both the sustainability character in addition to the advantage of little or no side effects are linked to modern marketing activities: Combination of effects versus mono-preparations. The hope for pure natural substance-based mono-preparations in this connection, i.e., products based on a single specific extract of a single medicinal plant, as has been favored globally in recent years, actually contradicts the basic concept of phytotherapy with its proven efficacyenhancing synergy effects from “combination of several matching natural materials.” The work of leading scientists shows that the suitable composition of several medicinal plants, i.e., according to the traditional approach, can not only achieve additive, but in many cases even multiplicative physiological/pharmacological effects in the therapeutic area.

196  History, Present and Prospect of World Traditional Medicine Table 3–6    Market fields. Market Development

Rating

Phytopharmaceuticals for Human Use

Three quarters of the medicinal plants in demand are used for the production of phytopharmaceuticals for human medical applications; this is the traditional area of application for medicinal plants

Market growth expected, good sales opportunities for German medicinal plants (documented quality)

Health Food

Still small market, but growing Strong market growth rapidly; second most important expected sales market for medicinal plants; today, almost a fifth of all medicinal plants used in Germany are sold in this market

Cosmetics

Only 7% of medicinal plants have so far been used in the cosmetic industry; rising demand is due to changing customer preferences, to which the cosmetic industry is increasingly responding with a “green” product range

Moderate to strong market growth; very price sensitive on the procurement side

Phytopharmaceuticals for Veterinary Use

Future market due to changes in the legal framework; today the market is still insignificant; medicinal plants as animal food supplement to increase performance in growing; phytotherapy has also been increasingly used in veterinary medicine now for some years

The market has not yet been significantly developed due to the high price sensitivity of the manufacturers

It would therefore make sense, to focus precisely on these old and yet new strengths and not consider the expected regulatory difficulties as a decisive negative criterion for product development. This combinatorial way of thinking has almost completely disappeared in Europe in modern medicine and therapy with its departure from “holism.” This medical-theoretical demarcation in combination with a small potential for side effects creates the marketing-technical demarcation

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from the classic synthetically based modern conventional medicine, the reputation of which has suffered greatly due to scandals. Traditional European phytotherapy with its original roots in the early Arab period and its permanent improvements in ancient Greece and later in the Roman period, flourished in the European Middle Ages where the existing European healing knowledge of its time was preserved. When composing effective herbal mixtures for therapeutic treatment, concepts similar to those in Asian Medicine were very well implemented with regard to mutual compatibility on the one hand and an improvement in effectiveness on the other. It can be assumed that even at these times, there was always a certain intellectual exchange of therapeutic know-how even before the time of Marco Polo. Corresponding documents in Asia testify to a mutual intercultural exchange of herbal therapy with European-style medicine. However, in order to be able to implement such tasks in product identification and implementation in a meaningful and efficient way in a future-oriented manner, there are two basic ways of thinking to complement the currently limited development activities.

3.3.8.2  Decentralized, relaxed scientific cooperation To meaningfully fill this first variant with life, it would be necessary to identify all potential resources, bring them together, and integrate them into a joint research network. It would therefore be necessary, starting with the raw material supply, to integrate the cultivation research, which would then also have to be supplemented by technological competence in cultivation, crop protection, and improved harvesting in the efficient and optimized extract production. In the causal consequence, it should then still be necessary to obtain innovative medical professionals, best at renowned clinics, with regard to targeted application research in the therapy area, which can then make meaningful product optimization possible due to their observation values in individual therapy.

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Preclinical development and implementation can very well be realized with plant-based products with appropriate affinity (particularly difficult since conventional medicine dominates here). If we now look at completely different fields of technology, we can see completely different, more modern structures there, which in the rather conservative way of looking at the phytopharmaceutical industry in Europe are still often regarded as absolute “no-go’s.” Using the example of aerospace technology, the market has consolidated in recent decades to the extent that, in addition to the economic “top dogs” and some medium-sized structured providers, a not inconsiderable number of highly innovative but financially limited small companies have been established. In the meantime, however, it was recognized in this technology field that despite the competition, the disclosure of individual research results in the limited community did not lead to an economic disadvantage, but rather to an innovation initiative that massively accelerated the development potential. A loosely coordinated synergy network has developed from original competitors.

3.3.8.3  How is contract research evaluated socially? A few years ago, the European Commission commissioned an opinion poll. Citizens should comment on whether they believe the results of science. The conclusion: “Europeans are very firm in their belief that scientists cannot be trusted to tell the truth about controversial scientific and technical problems because they are increasingly dependent on industrial funding.” In the meantime, industry-funded research at German universities is only under “general suspicion” with regard to its influence only among the population, while politicians currently see no reason for intervention.

3.3.8.4  Central structuring of an own development center Through intelligent structuring, in addition to our own core competences, research and development partnerships with commercial and therefore success-oriented laboratories and institutes can be efficiently integrated or

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fully integrated if relevant. The expected synergy effects create new opportunities here. The restructuring of the research landscape in the natural sciences has also led to a massive shift in the direction of gene-based molecular biology in the field of biology and natural product chemistry as well as pharmacology. Genetic technology as the gravedigger of phytopharmaceuticals? However, completely different control and regulatory mechanisms are required for gene technology intervention in the therapy area, which cannot be implemented directly with the classic phytochemistry and the resulting phytotherapy. To limit research funding, evaluation criteria regarding potential future orientation have been shifted away from old traditions towards new technologies, which is by no means wrong. However, the sociopolitical reorientation towards more “nature” and sustainability was not considered sufficiently. However, it is precisely the original broadly structured and often productor technology-oriented European research landscape with a high level of rationally based research, that makes US competition thinking with a high publication rate (less content-oriented) and the striving for high “impact factors” in with an inflationary publication density as the new way. The research landscape, which has grown over decades and focuses on natural products, has also been systematically replaced by genetic engineering departments in the past 10 years. For this reason, there are currently only a few institutes at German universities, that deal intensively with phytotherapeutic and phytochemical issues.

3.3.8.5  Monastery medicine as the basis of new active concepts Starting from the University of Würzburg, a specific working group has been formed around a pharmacy historian who has been active in phytochemical research for several years and also has had a positive impact on the research of Western monastic medicine but has so far not been too target- as well as company-oriented. A real product orientation is also not clearly recognizable.

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3.3.9  Dosage forms of herbal medicinal products Dosage forms of herbal medicinal products Designate, on the one hand, the finished preparation containing the plant extract which is administered to the patient, while on the other hand, the pharmaceutical form does not correspond to the final preparation and the dosage form must be transferred for use, e.g., in the case of decoction pieces by decoction. Dosage forms are how herbal drugs are delivered to the site of action in the body and must therefore always be adapted to the route of administration intended for use and optimized for this purpose. The most commonly used routes of administration for herbal dosage forms are oral, rectal, topical, parenterally, respiratory, nasal, and ophthalmic. Herbal medicinal products can be categorized into different groups by their dosage forms. Different categories are subjected to different regulations regarding their legal status, quality control requirements, distribution, and market approval/registration. Nevertheless, all herbal medicinal products in Europe, regardless of their pharmaceutical form, must be sold to patients through pharmacies or therapists. Herbal products such as food supplements or herbal health teas are not sold through pharmacies, they are freely available in internet shops or drugstores. However, they are not medicinal products and are not allowed to have any therapeutic effect. Therefore, for these products, the regulations of the food law count and it is illegal to sell herbal medicine as food supplement in whatever dosage form it is sold. The most basic dosage form which is traded as medicine are the decoction pieces. They are regarded as raw material, after the pharmacist or therapist has mixed the raw drugs according to a prescription, the mixture acquires the status of a medicinal product. As this dosage form is not really practical, it has increasingly disappeared in the last decades in the field of European phytomedicine. Nowadays, mainly drugs from traditional Asian Medicine are given to patients as raw drugs. To make it easier for patients to use herbal medicines, many manufacturers of herbal medicine in Europe started decades ago to extract the plants before they are given to patients. The simplest dosage forms developed from the extracts are decoctions, tinctures, granules, or compactates.

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As long as the pharmacist or therapist is producing the decoction or tincture out of the herbal raw material, the finished medicinal product does not need to be registered or get a market approval to be sold legally. The same accounts if the pharmacist is mixing single herbal granules or compactates together to produce a medicine. It is even allowed in some European countries that the pharmacy produces further developed and easier- to use dosage forms like capsules, tablets, creams, and suppositories without the need to register the product or get a market approval as long as they produce those mixtures in small amounts. However, if a company is producing more modern dosage forms like a tincture, a mixture of granules, capsules, and tablets and wants to sell it as herbal medicine, they need (since 2004) to register their herbal product as medicine or get a market approval. In former days, all dosage forms of herbal medicinal products could be sold freely on the European market. Due to large quality and safety concerns and the huge differences in the regulation of herbal medicine in different European countries, the European Medicine Agency (EMA) decided that the European market must be harmonized and that all finished herbal medicinal substances and herbal preparations produced by pharmaceutical companies need to be registered. The rules on herbal medicinal products and the routes of authorization were first established in 2001, in the Directive 2001/83/EC. To advance the implementation of this directive, the EMA established the Committee on Herbal Medicinal Products (HMPC) in 2004. The HMPC introduced a simplified registration procedure in 2004 for traditional herbal medicinal products through Directive 2004/24/EC (which amends the Directive 2001/83/EC), this directive is also called Traditional Herbal Medicinal Product Directive (THMPD). The THMPD which came into force in April 2011, aimed to protect the health of the customers and, at the same time, it should secure the free movement of herbal medicinal products within the EU. According to the THMPD, modern dosage forms of herbal medicine can get the market approval through three different regulatory pathways: Traditional Use Registration No clinical studies on safety and efficacy are required. Only the safety data and efficacy of the product must be demonstrated by evaluating the literature published for the product. In addition, it must be demonstrated that the product has been used

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worldwide for a total of 30 years and at least 15 years within the EU. The only dosage form that is excluded are injections. Well-Established Use The product is required to be used in the EU for 10 years. In addition, high-quality scientific data in the literature on the safety and efficacy must be available and evaluated by an expert for approval. Stand-Alone or Mixed Application The applicant company is required to submit its own studies relating to safety and efficacy of the product. The application can also be submitted with bibliographic data in combination with the company’s own study data. After the directive came into force, the cost of bringing a new product onto the market rose significantly, which also pushed up prices for the consumer. In the eyes of the consumer, however, a price increase also goes hand in hand with an increase in quality. In recent years, companies have responded to consumers’ increased quality demands and developed increasingly better dosage forms and drug delivery systems by the use of appropriate additives or excipients in the formulation. In modern phytopharmaceuticals, various excipients that perform different pharmaceutical functions such as solubilizing, suspending, thickening, emulsifying, modifying dissolution, and improving compactability and flavoring, are combined with the active ingredients to form various drugs or dosage forms. The aim of developing new formulations for herbal medicinal products is to develop a bioactive stable and optimized dosage form for a specific route of administration. This includes the use of excipients that ensure the therapeutic performance, safety parameters, and stability of the active ingredient are not compromised. The most common dosage forms on the phytopharmaceutical market in Europe are at the moment capsules, tablets (mostly coated to cover the taste and make the tablets easy to swallow), creams, gels, ointments, tinctures, suppositories, and even some novel forms such as extended release, sustained release, and microencapsulating. Some companies even invented special dosage forms for children, which often refuse to take herbal medicine because they cannot or do not want to swallow capsules or tablets, or they cannot drink herbal medicine because of the taste. An example for children is straws in which the dried plant extract is applied to a suitable carrier material. The children drink a good-tasting drink with the straw and the active ingredient dissolves in the drink and is absorbed relatively unnoticed by the children. Due to the high competitive

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pressure in the phytopharmaceutical market, it can be assumed that in the coming years, the dosage forms will be further improved, which will increase the quality and reputation of herbal medicinal products in Europe.

3.3.10  Overseas communication WHO has divided the globe into different regions (Table 3–7). Table 3–7    Overseas communication. WHO Region

Africa

Purchasing Power

low

Therapy Preference

1) confidence in western modern synthetic chemical products 2) numerous domestic nature-based products of different quality 3) little to no European phytotherapy

WHO Region

America: USA + Canada

Purchasing Power

high

Therapy Preference

1) therapy only with western modern synthetic chemical products 2) food supplements with, among other things, nature-based products

WHO Region

America: South and Central America

Purchasing Power

low to limited

Therapy Preference

1) therapy only with western modern synthetic chemical products 2) partially domestic nature-based products 3) hardly any European phytotherapeutic agents

WHO Region

Eastern Mediterranean

Purchasing Power

limited

Therapy Preference

1) therapy mainly with western modern synthetic chemical products 2) partially domestic nature-based products 3) hardly any European phytotherapeutic agents

WHO Region

WHO Europe

Purchasing Power

high to low

WHO Region

Southeast Asia + West Pacific

Purchasing Power

high to low

Therapy Preference

1) therapy only with western modern synthetic chemical products 2) many nature-based domestic products 3) hardly any European phytotherapeutic agents

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3.3.11  Current challenges: Synergism the new concept? If we summarize all these findings, there is currently hardly any research group that adequately addresses the classic concept of medicinal plants with synergistic effects in a traditional recipe. The focus is clearly on the identification and testing of materially definable individual components, which is a direct continuation of the work of the Monography Commission E. The rational basis of modern phytotherapeutic agents was laid here, which is the basis of legal recognition. Besides, it partially supplanted the traditional and experience-based targeted composition of active compounds. Since the complex product focus is usually lacking, the opportunity to protect complex mixtures from imitation was completely neglected. In addition to the increased effectiveness of the holistic human system through synergistic effects, there is also potential protection against imitation. It quickly becomes clear why the previous work on the rationalization of phytotherapy relatively rigidly selected those parts that could not immediately be classified as relevant for the effect. A modern review with newer knowledge is missing so far. With a targeted approach, traditional knowledge can serve as a valuable basis for new products without transferring its dusty image to the new product. In contrast to state-funded basic research, commercial developments are a dynamic process that builds on the knowledge of others and must lead effectively and stringently to a product. The recent invention of the “wheel” may be academically interesting, but ineffective from an economic point of view. Only through success-triggered research economic success can be achieved by establishing new products in new markets.

3.3.11.1  Is this concept sustainable in any other way? The holistic approach of phytotherapy to healing and keeping people healthy is gaining more and more popularity worldwide. The sustainability, biological harmlessness and apparent independence from the petrochemical industry with its perceived disadvantages,

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which have meanwhile reached every consumer in terms of media policy, can score with a certain “bio and nature image” of nature-based products so that the cost- technical disadvantages to a certain extent can be compensated.

3.3.11.2  Typical areas of application of phytotherapeutic intervention The most diverse areas of application come into consideration for phytotherapy: Medicinal plants are particularly popular in the classic self-treatment sectors such as colds (coughs), gastrointestinal problems, injuries, and skin diseases. There is also a wide range of extracts for cardiovascular diseases and for strengthening the constitution or defense. Phytotherapy can also score for liver, biliary, and digestive problems. Problems such as cystitis, prostate problems, or menopause symptoms can be alleviated in the urogenital area. Effective classics are also available for the treatment of psychosomatic complaints, sleep disorders, and moderate depression. Pharmaceutical knowledge about the ingredients from a laboratory, cell culture, and animal experiments is increasing. Clinical studies are available on some medicinal plants, which prove their effect on humans. The facts of the most important medicinal plants were and are summarized in detailed evaluations by official commissions (Commission E, ESCOP, WHO, HMPC).

3.3.11.3  Evidence-based phytotherapy In Germany, phytotherapy has only been paid by the health insurance fund in exceptional cases since 2004. This does not apply to children up to the age of 12 and adolescents up to the age of 18 with developmental disorders. Only a few remedies are not affected, for example, certain St. John’s wort preparations for moderate depression (not for mild depression). In certain special cases, ginkgo for the treatment of dementia, psyllium husks for the intestine, and mistletoe preparations are also reimbursed. Since 2012, some health insurance companies have been offering optional tariffs

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that also include phytotherapy. Individual statutory health insurers, currently around 25%, are also prepared to take over limited amounts of phytotherapeutics on medical prescriptions. For example, benign prostate enlargement usually prescribes chemical-synthetic substances such as alpha-receptor blockers (tamsulosin) and alpha-reductase inhibitors (finasteride). However, studies show that in stages one and two, i.e., with irritating symptoms in the prostate in particular, treatment with products from saw palmetto or a nettle root extract can achieve equivalent results. There are different forms of phytotherapy: – Traditional phytotherapy is a folk medicine procedure that is mainly based on traditional experience. – The rational phytotherapy (also called allopathic phytotherapy) takes advantage of the traditional knowledge from traditional herbal medicine but claims to meet scientific standards in the treatment of diseases.

3.3.12  Cultivation and origin of medicinal drugs Medicinal plants are also counted among the renewable raw materials since their use is outside the food and feed sector. Together with Dyer’s plants, the cultivation area in Germany is about 12,000 ha (approx. 0.5% of the total area under cultivation for renewable raw materials). About 90% of the medicinal plants used in Germany are imported. However, only 30% of the medicinal plants are cultivated and about 70% come from wild collections. From about 440 native medicinal plants, 75 species are cultivated in Germany, with 24 species alone accounting for 92% of the supply. The main areas of cultivation in Germany are Thuringia (Erfurt Basin), Bavaria (Upper Bavaria, Erdinger Moos, Middle Franconia), Saxony (loess areas of Central Saxony), Saxony-Anhalt (Central German arid region), Hesse, North Rhine-Westphalia, and East Frisia. Many of the medicinal drugs in the market still come from wild collection but more than half of them are grown in the fields. This is currently increasing in almost all parts of the world, with China, Indonesia, Thailand, India, Egypt, Sudan, South Africa, Argentina, Chile, Brazil,

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Costa Rica, Tasmania, the US, Canada, and various European countries as the most important producers. Traditionally, the cultivation of medicinal plants has been widespread in Eastern Europe, but in the last two decades, it has established itself in almost all countries of the European Union. Besides the Netherlands, France, Spain, Italy, Austria and Germany are particularly noteworthy. The most important species are chamomile, milk thistle, coneflower, peppermint, valerian, and St. John’s wort. However, there are also cultivations of e.g., arnica, celandine, mallow, goldenrod, yellow gentian, and artichoke. About 72,000 plant species are used as medicinal plants worldwide. However, only 4,000 to 7,000 of these species are traded internationally. In Germany, there are about 1,500, of which only 50 to 100 species are exclusively cultivated. About 15,000 species of medicinal plants are threatened with extinction worldwide, mostly due to uncontrolled wild collection. Before a plant is completely extinct, it is threatened with “commercial extinction.” This means that the stocks decline to such an extent that they can no longer be used. If harvested nevertheless, this is uneconomical and/or illegal. According to expert opinion, about 14% of the plant species have been extinct since and 1,600 have disappeared due to overuse. The wild collection of medicinal drugs does not require long-term planning and investment and causes relatively low running costs. In addition, many traders have the opinion that these plants have a higher efficacy. Yet there are considerable disadvantages: The risk of contamination and adulteration is high, the active ingredient content often fluctuates, and quality control is difficult. In addition, there are species protection problems.

3.3.12.1  Breeding and cultivation of medicinal plants The quality and reproducibility required for medicinal products, therefore, presuppose that all the factors influencing the course and result of medicinal plant production are known as precisely as possible and that they can be controlled in order to keep the natural residual variance low. The most important influencing factors in this context are:

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– the genetic make-up of the plant material (genetic variation), – the distribution of the ingredients on the plant organs (morphogenetic variability), – the changes in the content of the active ingredient during the vegetation cycle (ontogenetic variability), – the modification by environmental conditions, – the influence of cultivation measures such as choice of variety, location, crop rotation, cultivation date, care measures including the use of herbicides and pesticides with the corresponding residue problems, as well as harvesting and processing. Many of the medicinal plants widely used today, such as St. John’s wort (Hypericum perforatum), stinging nettle (Urtica sp.), coneflower (Echinacea sp.), milk thistle (Silybum marianum), sage (Salvia officinalis), etc. are still in the stage of just-cultivated wild plants, only a few species like the old-cultivated plants opium poppy (Papaver somniferum) or peppermint (Mentha piperita) are systematically cultivated. The genetic variability is therefore still correspondingly high in many cases. In addition, the level of secondary compounds is based, as far as genetic, on polygenic conditional quantitative characteristics. For the purpose of quality assurance of herbal medicinal products, the breeding of medicinal plants has therefore been started in several places. In 1996 the German Federal Plant Variety Office published for the first time a “Descriptive Variety List” of about 50 registered medicinal plant varieties. The breeding objectives of medicinal plants can be summarized in two groups: – From a pharmaceutical point of view, the type and quantity of active ingredients or lead substances are the most important characteristics. In terms of crop cultivation and production technology, the main objectives are yield and yield security, broad site adaptation, but also resistance to pathogenic organisms. For the majority of medicinal plants, the natural genetic variability is so high that simple selections already bring great progress in breeding. In individual selection, single plant offspring are tested and propagated, in mass

History and Present of European Traditional Herbal Medicine (Phytotherapy)  209

selection, the seeds of all selected plants are propagated together and evaluated. A special form of selection is clone selection, where selected individuals are propagated conventionally or vegetatively by in vitro methods. – Crossbreeding is necessary to unite valuable traits of different individuals or lines. This is followed by readout and, if necessary, backcrossing. If the first generation of offspring shows performance beyond that of the parent plants, this is called the heterosis effect of F1 hybrids. To extend the natural diversity of traits and to create new variants, mutations are triggered by chemicals or high-energy radiation. Both point (gene) and genome mutations (polyploid forms) have gained practical significance. Transgenic medicinal plants produced by genetic engineering methods do not play a role yet, because of the natural variability and selection possibilities mentioned above.

3.3.12.2  Environmental influences and cultivation measures The scheduled cultivation of medicinal plants serves to obtain and secure the required quantities of the most uniform and high-quality drugs possible. As part of the quality assurance of herbal medicinal products, it is reflected in the guidelines for good agricultural practice (GAP), which covers all specifications from the starting material, cultivation, and treatment to harvesting and processing. In addition to basic knowledge of plant cultivation, planned cultivation requires information on the growing conditions and vegetation cycle of the individual species. Important external factors are the cultivation location or its climate and the plant nutrition, whereby variety, development stage, etc. are interrelated. The water and nutrient supply primarily determine the mass yield but can also accelerate or slow down plant development and thus influence the formation of active ingredients. A direct correlation between fertilization and secondary nutrient content has so far been found mainly in the case of alkaloids — such as the increase in Chelidonin in celandine after nitrogen fertilization.

210  History, Present and Prospect of World Traditional Medicine

Each plant and the drug derived from it is surrounded by its own typical microflora, which depends on the soil, fertilization, microclimate, and plant part. The assessment of microbiological contamination by natural, apathogenic germs based on pharmacopoeia limits and therefore often raises problems. In principle, it is necessary to work cleanly already in the field and during harvesting when extracting medicinal drugs and to avoid contamination with soil in above- ground plant parts. The subsequent drying and processing must also be carried out hygienically, which is not always guaranteed in many producing countries. For germ reduction and “disinfestation” (killing insects), various physical processes with steam or in CO2 pressure chambers are suitable, since most chemical processes (fumigation) are no longer permissible due to toxic reaction products.

3.3.12.3  Harvest and preparation The harvesting of medicinal plants is done according to the state of technical development: – manually or with simple harvesting aids (e.g., flower picking combs, bark peeling knives, root digging forks), – partially mechanized, (e.g., swath mowers, plows, stationary threshing machines) or – fully mechanized (e.g., combine harvester, root harvester, flower picking machines). The advantages of mechanical harvesting methods in terms of labor economy are counterbalanced by the greater mechanical stress and the usually necessary post-cleaning of the harvested material as restrictions. It is important to have a uniformly maturing field crop, which requires homogeneous varieties and suitable cultivation conditions. Herb and leaf drugs are generally harvested shortly before or during flowering, flower drugs in full bloom, bark in spring and roots towards the end of the growing season. The fresh crop must be processed and preserved quickly. In individual cases, this includes washing and cleaning processes (e.g., in the case of underground plant parts) as well as the separation of leaf and stem parts or crushing. Unless pressed juices or fresh plant extracts are

History and Present of European Traditional Herbal Medicine (Phytotherapy)  211

produced or the raw material is used for distillation of essential oils, the harvested material is preserved by dehydration. The most important drying processes are: – Natural drying in the sun or in the shade, which is mainly used in warmer countries. Here it is important to ensure that no increased microbiological contamination, e.g., by dust or pets occurs. – Artificial drying by means of cold, warm, or hot air. This includes chamber and tray drying as discontinuous and drum and belt drying as continuous processes. Oil, gas, or solid fuel burners with heat exchangers are used as heat sources; solar collectors have proven themselves in sunny locations. – The drying temperatures are between 4–100℃, depending on the stability of the ingredients. Drugs may only have a residual moisture content of less than 15% to prevent the growth of microorganisms. Drugs are stored in a cool, dark, dry, and clean place, i.e., protected from sunlight, moisture, oxygen, dust, and storage pests.

3.3.12.4  Quality assurance of the plant source material through cultivation The production of the plant starting material for phytopharmaceuticals is a complex bio-/technological process, which can only meet today’s quantity and quality requirements with appropriate management. For this purpose, it is necessary to integrate agricultural production into a quality assurance system in the same way as it already exists for industrial processing to the final product (industrial drugs). In addition to the GMP guidelines (Good Manufacturing Practice), the European Association of Medicinal and Aromatic Plant Producers (EUROPAM), and the Society for Medicinal Plant Research (GA) have therefore drawn up guidelines for Good Agricultural Practice in Medicinal Plant Cultivation (GAP = Good Agricultural Practice) in coordination with other associations. The aim of the guidelines is to set standards for cultivation and processing to the extent that these are suitable for identifying critical production steps and ensuring that the plant’s raw material meets consumer expectations and

212  History, Present and Prospect of World Traditional Medicine

meets high-quality standards. In particular, this includes that the plants are produced hygienically in order to keep microbiological contamination low and that they are carefully produced to minimize negative influences during cultivation, harvesting and storage. The guidelines contain basic information on seeds and propagating material, cultivation including soil and fertilization, irrigation, crop care and plant protection, harvesting and the post-harvest procedures to be used, packaging, storage, and transport, but also on machinery, equipment, and personnel, including training. Documentation of all measures plays an important role but an audit system must be set up to monitor them. The CAP guidelines are to be understood as a supplement to the European Directive “Good Manufacturing Practice for Starting Materials of Medicinal Products.”

References   [1] Fintelmann V, Weiss RF, Kuchta K. Lehrbuch Phytotherapie [M]. Stuttgart Karl F: Haug Verlag, 2017.   [2] Hardy K, Buckley, et al. Neanderthal Medics? Evidence for Food, Cooking, and Medicinal plants Entrapped in Dental Calculus[J]. Naturwissenschaften Dusseldorf, 2012, 99(8): 617–626.   [3] Weyrich LS, Duchene S, Soubrier J, et al. Neanderthal Behaviour, Diet, and Disease Inferred from Ancient DNA in Dental Calculus[J]. Nature, 2017, 544(7650): 357–361.   [4] Schmidt K. Sie Bauten Die Ersten Tempel: das rätselhafte Heiligtum der Steinzeitjäger; die archäologische Entdeckung am Göbekli Tepe[M]. California: Beck, 2006.  [5] Walker CB, Chadwick J. Reading the Past: Ancient Writing from Cuneiform to the Alphabet[M]. Oakland: Univ of California Press, 1990.   [6] Borchardt JK. The Beginnings of Drug Therapy: Ancient Mesopotamian Medicine[J]. Drug news & perspectives, 2002, 15(3): 187–192.   [7] History M, Frank J, Anderson. An Illustrated History of the Herbals[M]. New York: Columbia University Press, 1977.  [8] Inskeep RR. Health Hazards and Healing in Antiquity[J]. The South African Archaeological Bulletin, 1969, 24(93): 21–29.

History and Present of European Traditional Herbal Medicine (Phytotherapy)  213

  [9] Herrmann S. Jeremia[M]. Deutschland: Neukirchener Verlag, 1986. [10] Cohn RL, Cotter DW, Walsh JT, et al. 2 Kings[M]. Collegeville: Liturgical Press, 2000. [11] Zohary M. Pflanzen der Bibel[M]. Calw: Calwer, 1983. [12] Jouanna J. Egyptian Medicine and Greek Medicine[M]. Leiden: Brill, 2012. [13] Vos PD. European Materia Medica in Historical Texts: Longevity of a Tradition and Implications for Future Use- ScienceDirect[J]. Journal of Ethnopharmacology, 2010, 132(1): 28–47. [14] Luce TJ, Erich S, Gruen. The Last Generation of the Roman Republic[M]. Berkeley and Los Angeles: University of California Press, 1974. [15] Hölkeskamp, Karl Joachim. Reconstructing the Roman Republic[M]. Princeton: Princeton University Press, 2010. [16] Ando C. The Palladium and the Pentateuch: Towards a Sacred Topography of the Later Roman Empire[J]. The Phoenix, 2001: 369–410. [17] Andreas L, PG José, Michael H. Resins and Gums in Historical Iatrosophia Texts from Cyprus — A Botanical and Medico-pharmacological Approach[J]. Frontiers in Pharmacology, 2011, 2: 32. [18] Mayer JG, Uehleke B, Saum K. Das große Buch der Klosterheilkunde: neues Wissen über die Wirkung der Heilpflanzen; Vorbeugen, behandeln und heilen[M]. München: Zabert Sandmann, 2013. [19] Classen A, Meyer FG, Trueblood EE, et al. The Great Herbal of Leonhart Fuchs. De Historia Stirpium Commentarii Insignes, 1542[J]. German Studies Review, 2001, 24(3): 595. [20] Farhi D, Dupin N. Origins of Syphilis and Management in the Immunocompetent Patient: Facts and Controversies[J]. Clinics in Dermatology, 2010, 28(5): 533–538. [21] Riccomi G, Giuffra V. First Portrait of a Syphilitic Patient: Ulrich Von Hutten[J]. American Journal of Medicine, 2018: S0002934318300925. [22] Borzelleca JF. Paracelsus: Herald of Modern Toxicology[J]. Toxicological Sciences, 2000(1): 2–4. [23] Zafirovski M. The Enlightenment and Its Effects on Modern Society[M]. New York: Springer, 2011. [24] Roloff, Eckart. Göttliche Geistesblitze: Pfarrer und Priester als Erfinder und Entdecker[M]. New Jersey: John Wiley & Sons, 2012. [25] Bundestag D. Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz — AMG)[J]. Jahrbuch Für Wissenschaft Und Ethik, 2005, 10(1): 433–440.

214  History, Present and Prospect of World Traditional Medicine

Appendix — Short Overview of Typical Phytochemical Applications In the following section, a small selection of about 60 typical medicinal plants common in Europe are listed in Table 3–8 with regard to their secondary substance composition, which are used in phytopharmaceuticals. Table 3–9 lists both the typical areas of application of these medicinal drugs for oral administration with regard to modern phytopharmaceuticals and the traditional herbal medical applications. From a European perspective, the name of the organ clearly corresponds to the respective organ. These compilations are supplemented by the respective indications or areas of application. In addition to internal application, European phytotherapy also uses a wide range of applications over the skin for both local and systemic interventions. This is where modern European phytotherapy, which is based on herbal medical experience that is thousands of years old, differs considerably from the Asian healing tradition of TCM, as well as the systems of KAMPO, KOM and others derived from it. In Table 3–10, examples of typical medicinal plants for topical applications are summarized in analogy to Table 3–9 and differentiated with regard to modern applications and herbal medical use and supplemented by their indications.

Volatile Oils Flavonoids Polyphenols and Acids Lipids Plant Acids Proteins/ Enzymes Saponins Polysaccharides Terpenes Mucilage Naphtoquinones Anthraquinones Alkaloids Bitter Substances Capsaicinoids Sterols Coumarins Lignans Anthracenes Salicylates Iridoids Tannins Silicic Acids org. Sulphur derivatives Phenylpropanes

Table 3–8    Pharmacologically relevant secondary substances and their distribution in typical European medicinal plants as the basis of modern phytotherapeutic agents.

Absinthii Herba

x x

Agni Casti Fructus

x x x

x

x

x x x

History and Present of European Traditional Herbal Medicine (Phytotherapy)  215

Volatile Oils Flavonoids Polyphenols and Acids Lipids Plant Acids Proteins/ Enzymes Saponins Polysaccharides Terpenes Mucilage Naphtoquinones Anthraquinones Alkaloids Bitter Substances Capsaicinoids Sterols Coumarins Lignans Anthracenes Salicylates Iridoids Tannins Silicic Acids org. Sulphur derivatives Phenylpropanes

Table 3–8  (Continued )

Agrominiae Herba

x x

Alchemillae Herba

x

Allii Sativi Bulbus

x

Allii Ursini Herba

x

x

x x x x

Aloe Bar­baden­ sis

x

Althaeae Folium/ Radix

x x

Angelicae x Arch­angel­ ica Radix

x

x

x

x x x x

x x

Artemisiae Herba

x x x x x

x

Balsamum Peru­vi­ anum

x

x x

x

x

x x

Basilici Herba

x

x

Arnicae Flos

x

x

x

x

Bardanae Radix

x

x

x

Anisi Fructus x x x Anserinae Herba

x

x

x

x x

x

x x (Continued)

216  History, Present and Prospect of World Traditional Medicine

Volatile Oils Flavonoids Polyphenols and Acids Lipids Plant Acids Proteins/ Enzymes Saponins Polysaccharides Terpenes Mucilage Naphtoquinones Anthraquinones Alkaloids Bitter Substances Capsaicinoids Sterols Coumarins Lignans Anthracenes Salicylates Iridoids Tannins Silicic Acids org. Sulphur derivatives Phenylpropanes

Table 3–8  (Continued )

Betulae Folium

x x x

x

Boldi Folium x x Bursae Pastoris Herba

x x

Calendulae Flos

x x

Capsici Fructus

x

Cardui Mariae Fructus

x

x

x

x

x

x

x

x

x

x

Carvi Fructus x x Centaurii Herba

x x

Chelidonii Herba

x

x

x x x x

x

x

Cnici Benedicti Herba

x x x

x

Crataegi Folium cum Flore

x

x

Crataegi Fructus

x

Cynarae Folium

x

x

x

x

x

x

x

History and Present of European Traditional Herbal Medicine (Phytotherapy)  217

Volatile Oils Flavonoids Polyphenols and Acids Lipids Plant Acids Proteins/ Enzymes Saponins Polysaccharides Terpenes Mucilage Naphtoquinones Anthraquinones Alkaloids Bitter Substances Capsaicinoids Sterols Coumarins Lignans Anthracenes Salicylates Iridoids Tannins Silicic Acids org. Sulphur derivatives Phenylpropanes

Table 3–8  (Continued )

Droserae Herba

x

x

Eleuthe­ro­ cocci Radix

x

Equiseti Herba

x

Farfare Folium

x

x x x

x x

x

x

x

x

x

x x x

x

Frangulae Cortex

x x

Gentianae Radix

x x

Gingko Folium

x

x x x

x x

x

x

Hama­me­lidis x x Cortex/ Folium Harpagophyti Radix Hederae Folium

x

x

x

x x

x x

x

Hibisci x x Sabdariffae Flos

x

Hip­pocastani x x Semen Hyperici Herba

x x

x

x

x x

x

x x

x x x

x x (Continued)

218  History, Present and Prospect of World Traditional Medicine

Volatile Oils Flavonoids Polyphenols and Acids Lipids Plant Acids Proteins/ Enzymes Saponins Polysaccharides Terpenes Mucilage Naphtoquinones Anthraquinones Alkaloids Bitter Substances Capsaicinoids Sterols Coumarins Lignans Anthracenes Salicylates Iridoids Tannins Silicic Acids org. Sulphur derivatives Phenylpropanes

Table 3–8  (Continued )

Ipecacuanhae Folium

x

Juglandis Folium

x x

Lavendulae Flos

x x

Leonuri Cardiacae Herba

x x

Lichen Islandicus

x

x

x x

x

x

x

x

x

x x

x

x

Lupuli Flos

x x

x x

x

x

Lupuli Glandula

x x

x x

x

x

Matricariae Flos

x x

Melissae Folium

x x

Millefolii Herba

x x x

Passiflorae Herba

x x

Plantaginis Ovatae Semen

x x

x

x

x

x

x x

x

x

History and Present of European Traditional Herbal Medicine (Phytotherapy)  219

Volatile Oils Flavonoids Polyphenols and Acids Lipids Plant Acids Proteins/ Enzymes Saponins Polysaccharides Terpenes Mucilage Naphtoquinones Anthraquinones Alkaloids Bitter Substances Capsaicinoids Sterols Coumarins Lignans Anthracenes Salicylates Iridoids Tannins Silicic Acids org. Sulphur derivatives Phenylpropanes

Table 3–8  (Continued )

Primulae Flos x x cum Calyce

x

x

Rauwolfiae Radix

x

Rubi Fruiticosi Folium Rusci Rhizoma

x

x

x

Salicis Cortex

x x

x

Sambuci Flos x x

x

Sarothamni Scoparii Herba

x

x x

Symphyti Radix

x

Taraxaci Radix cum Herba

x

x

x x x

x

x x

Tiliae Flos

x x x

x

Valeriannae Radix

x

x x

x x

x x

x x

Visci Herba

x

x

x

x x

x

x x

x x

x x

220  History, Present and Prospect of World Traditional Medicine

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9    Indications and areas of application of typical European medicinal plants as the basis of modern phytotherapeutic agents as well as for folk medical applications with oral application.

Absinthii Herba

Agni Casti Fructus

Agrominiae Herba

Alchemillae Herba

M

x x

x x

lack of appetite, disorder of the digestive tract, gastritis, choleretic, cramps in bowel and gall bladder, dyspeptic disorders, dyskinesia of the bile tract

T x

x

menstrual disorders, anemia

M

x

menstrual disorders, premenstrual disorders, mastodynia

T

x

M

x

x

T

x

M x

x

M x

T x

x anaphrodisiac, menopausal symptoms, reduced lactation amounts

x

mild astringent, complaints of diarrhea, gastroenteritis, intestinal cathartic, inflammations of mouth and throat x liver disorders, viral infects, diabetes

T Allii Sativi Bulbus

Indications/Application Areas

x

x

x

non-specific complaints of diarrhea, astringent for bleeding

x

gynecological for conditions of flaccidity of the abdomen x lipid reducer, mycoses, vascular stabilizing, thrombocyte aggregation inhibiting effect x

—

History and Present of European Traditional Herbal Medicine (Phytotherapy)  221

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Allii Ursini Herba

Indications/Application Areas

M x

x

digestive disorders, circulatory and circulatory disorders

T

x

x gastro-intestinal disorders, bacterial infections, carminative

Aloe M Bar­baden­ sis

x

x

strong laxative, intestinal stimulating, antiphlogistic

T x Althaeae Folium

M

reduces blood sugar and blood fat x x

x

x

dry cough, irritation of mucous mem­ branes, inflammation of mouth, throat, stomach, and intestines

T Althaeae Radix

M

— x

x

T

x

x

Angelicae M Archan­gel­ ica Radix

x

T

x

x

x

antitussive, slight inflammation of the stomach mucosa diarrhea, cystitis x

x

x lack of appetite, slight gastrointestinal cramps, feeling of fullness, flatulence, stimulating stomach and pancreatic juice, antimicrobial diuretic, antitussive, neuralgia, rheumatic complaints, nervous insomnia x (Continued )

222  History, Present and Prospect of World Traditional Medicine

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Anisi Fructus M

x

x

x x

x

x

T Anserinae Herba

M

T Arnicae Flos M

x secretolytic, expectorant, catarrh of the respiratory tract, spasmolytic, antiseptic, antimycotic, antibacterial emmenagogue, milk-forming, aphrodisiac x

x

x

x x

x

Bardanae Radix

x

x analgesic, antiseptic, antiphlogistic, inflammation of the mouth and throat mucosa

x x x

T

x x

gastritis, gastrointestinal diseases, stimulation of blood circulation, hysteria, epilepsy x

x

M

T

x lack of appetite, flatulence, anthelmintic, women’s suffering x x complaints in gastrointestinal tract, gout and rheumatism, blood purification, stimulation of perspiration and urination

T Basilici Herba

inflammation of the mouth and throat mucosa, non-specific diarrhea, dysmenorrhea

varicose veins

M x

M x

x

calming tea

T x Artemisiae Herba

Indications/Application Areas

— x x

x

x

stimulates digestion, lack of appetite, flatulence, feeling of fullness, diuretic, inflammation of the throat —

History and Present of European Traditional Herbal Medicine (Phytotherapy)  223

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Betulae Folium

M

x

x

T x x x

T

x

gastrointestinal disorders, dyspeptic complaints, digestive disorders, disorders of the bile system, cholagogue

x x

x diuretic, stomachic, sedative, anthelmintic

M x

x

T x Calendulae Flos

M

x x x

x

M

T

hemostasis, dysmenorrhea antiphlogistic, spasmolytic

x

x diuretic, for liver damage, antispasmodic, anthelmintic

M T

Cardui Mariae Fructus

nosebleeds, excessive menstrual bleeding x

T Capsici Fructus

bacterial and inflammatory drainage of the urinary tract, rheumatic complaints

x x gout, rheumatism, hair loss, blood purification

Boldi Folium M

Bursae Pastoris Herba

Indications/Application Areas

— x

x x x

x

gargle water, arthritis toxic liver damage, chronic inflammatory liver diseases, disorders of the bile system, liver cirrhosis, digestive disorders — (Continued )

224  History, Present and Prospect of World Traditional Medicine

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Carvi Fructus M

T Centaurii Herba

x

x

x

gastrointestinal remedy, digestive disorders, feeling of fullness, flatulence, light cramps x

M

x x x

M

lactagogic, mouthwash x lack of appetite, increase of gastric juice secretion, antiinflammatory, analgesic, antipyretic, antimutagenic

T Chelidonii Herba

Indications/Application Areas

x tonic x x x

x

cholagogue, disorders of the bile system, disorders of the gastrointestinal tract, spasmolytic, analgesic

T Cnici Benedicti Herba

M

T Crataegi M x Folium cum Flore T Crataegi Fructus

—

M x

T

x

x

lack of appetite, increase of gastric juice secretion bile remedies decreasing efficiency of the heart (stage II according to NYHA) bradycardic cardiac arrhythmia — cardiovascular disorders, high blood pressure, arteriosclerosis, promotion of blood circulation in the coronary arteries, use in cases of cardiac insufficiency —

History and Present of European Traditional Herbal Medicine (Phytotherapy)  225

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Cynarae Folium

M x

x x

Indications/Application Areas dyspeptic disorders, liver and bile therapeutics, cholesterol and triglyceride lowering

T Droserae Herba

Eleu­thero­ cocci Radix

—

M

x

T

x

x

asthma

M

x

x stress-reducing, strengthening and invigoration in cases of fatigue and weakness, convalescence, immune modulation, adaptogen

T Equiseti Herba

x substitution of ginseng

M

x

x

T x x Farfare Folium

M

x urinary, bacterial, and inflammatory diseases of the urinary tract, post-traumatic and static edema hemostatic, tuberculosis

x x

x

T x Frangulae Cortex

x bronchyolytic, secretolytic, against spasmodic and dry cough, spasmolytic, bacteriostatic

catarrh of the respiratory tract, coughing, hoarseness, irritable cough, inflammation of mouth and throat mucosa cough medicine

M

x

laxatives, stimulation of the peristalsis

T

x

laxatives (Continued )

226  History, Present and Prospect of World Traditional Medicine

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Gentianae Radix

M

Gingko Folium

M x

x

digestive disorders, lack of appetite, feeling of fullness, flatulence, promotion of gastric juice and saliva production, influence on the gastric mucosa

T

— x

Alzheimer’s disease, dementia, antidepressant, hearing and vision disorders in elderly patients, improvement of memory performance, balance disorders, neuroprotective, improved blood circulation

T Hamamelidis M Cortex

— x

x

T Hamamelidis M Folium

x

acute non-specific diarrhea, inflammation of the gums and oral mucosa

x x

x

x

Harpagophyti M Radix

x x

x x

x x neuralgia, muscle rheumatism, tonic x

T

T

Indications/Application Areas

acute non-specific diarrhea, inflammation of the gums and oral mucosa x x neuralgia, muscle rheumatism, tonic x

x

antirheumatic, analgesic, degenerative diseases of the locomotory system

x x metabolic diseases, arthritis, liver, gall, kidney and bladder diseases, allergies

History and Present of European Traditional Herbal Medicine (Phytotherapy)  227

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Hederae Folium

M x x

x x

expectorant, catarrh of the airways, chronic inflammatory bronchial diseases, spasmolytic

T

x

Hibisci Sab­ M x x dariffae Flos

x

x

gout, rheumatism lack of appetite, laxative, colds, expectorant, circulation problems, diuretic

T

x

Hippocastani M x Semen

Indications/Application Areas

x

x

gout, rheumatism x chronic venous insufficiency, pain and heaviness of the legs, leg swelling, nightly calf cramps, itchiness

T Hyperici Herba

—

M

x x

T Ipeca­cu­an­hae M Folium

Juglandis Folium

x x

x

gastritis, gall bladder diseases

x

expectorant, chronic bronchitis, stimulation of bronchial secretion, emetic

T

x

emetic

M x

x

T

x

psychovegetative disorders, depressive moods, fear and anxiety, dyspeptic disorders

x

x gastrointestinal catarrh, blood purification, astringents, anthelmintic — (Continued )

228  History, Present and Prospect of World Traditional Medicine

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Lavendulae Flos

M

x x

T

x

x x

x

Leonuri M x x Cardiacae Herba

T Lupuli Flos

x x

lung disorders, kidney, and bladder disorders x

x

sedative, restlessness, overexcitability, anxiety, stress, nervous insomnia x

x

x

spasmolytic, sedative, blood pressure lowering, uterus contracting, climacteric disorders, amenorrhea irritation of mucous membranes in mouth and throat, dry irritated cough, lack of appetite

x

M

T

x x

x

M

T Lupuli Glandula

x

x

spasmolytic, carminative, stomachic, diuretic, insomnia medication nervous heart problems, bronchial asthma

T x

Lichen M Islandicus

Indications/Application Areas restlessness, difficulty falling asleep, lack of appetite, nervous irritable stomach, nervous intestinal disorders

cystitis sedative, restlessness, overexcitability, anxiety, stress, nervous insomnia cystitis

History and Present of European Traditional Herbal Medicine (Phytotherapy)  229

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Matricariae Flos

M

x

x

T Melissae Folium

M x

calming

x x

M

x

x

x

sedative, spasmolytic, colds, poor circulation, migraine, hysteria, melancholy

x

lack of appetite, dyspeptic disorder, mild gastrointestinal cramps x

M

insomnia, functional gastrointestinal disorder, psychovegetative heart disorder, dysmenorrhea

x

T x Passiflorae Herba

Indications/Application Areas gastrointestinal spasms, inflammation of gastrointestinal tract, inflam­mation and irritation of the respira­tory tract, inflammation of mucous membranes in mouth and throat

x

T x x

Millefolii Herba

x x

x

hemorrhoids, menstrual disorders anxiety medication, sedative

T Plantaginis Ovatae Semen

—

M

x

laxative

T Primulae Flos cum Calyce

M

T x

— x

mild secretolytic and expectorant, for cough, bronchitis and colds x

x

neuralgia, headaches, trembling limbs, cardiac tonic (Continued )

230  History, Present and Prospect of World Traditional Medicine

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Rauwolfiae Radix

M x

x

Indications/Application Areas mild essential hypertension, sinus tachycardia, anxiety and stress, psychomotoric restlessness

T Rubi Fruiticosi Folium

—

M

x

x

x

non-specific acute diarrhea, astringents, mild inflammation of the mouth and throat mucosa

T Rusci Rhizoma

M x

Salicis Cortex

M

— x

x

x chronic venous insufficiency, pain and heaviness in the legs, nightly calf cramps, hemorrhoids, itchiness, oedema

T

— x x

x

feverish diseases, rheumatic disorders, headaches

T Sambuci Flos M

— x

T Sarothamni Scoparii Herba

x

gargle water

M x

cardiovascular disorders, low blood pressure

T Symphyti Radix

x activates perspiration, colds

x

x oedema, diuretic

M T

— x

x

x

rheumatism, bronchitis, pleuritis

History and Present of European Traditional Herbal Medicine (Phytotherapy)  231

Heart, Circuit, Blood Respiratory Tract, Lung Mouth, Throat Kidney, Urinary Tract Liver, Bile Tract Stomach, Bowel Head, Nerves, Pains Inflammations Muscles, Cramps Women’s Suffering Gout, Rheumatism, Arthritis Other

Table 3–9  (Continued )

Taraxaci M Radix cum Herba

x x x

T x Tiliae Flos Valerianae Radix

M

Indications/Application Areas disturbances of the bile flow, stimulation of diuresis, loss of appetite, dyspeptic disorders

x

x

x

blood purification, gout, rheumatism, laxative, eczema colds, coughs

T

x

sedative

M

x

restlessness, nervous insomnia

T Visci Herba

—

M

x

T

x

x x inflammatory joint diseases, malignant tumors x

vertigo, amenorrhea

(M = modern medicine, T = traditional medicine)

Table 3–10    Indications and areas of application of typical European medicinal plants as the basis of modern phytotherapeutic agents as well as for folk medical applications with dermal application. Insect Skin, Wounds, Bites, Mucosa Eczemas Vermin Itchiness Other

Indications/ Application Areas

Absinthii Herba

T

x

x

eczema, poorly healing wounds

Agrimoniae Herba

M

x

x

slight superficial inflammation (Continued )

232  History, Present and Prospect of World Traditional Medicine Table 3–10  (Continued ) Insect Skin, Wounds, Bites, Mucosa Eczemas Vermin Itchiness Other Alchemillae Herba

T

x

Aloe M Barbadensis

x

Althaeae Radix

x

M

x

Arnicae Flos

x

x

Balsamum M Peruvianum

x

x

T

x

M

x

x

Basilici Herba M

x

x

Betulae Folium

T

x

x

Bursae Pastoris Herba

M

x

x

Calendulae Flos

M

x

x

re-epithelizing, erythema dissipating, moisture-binding inflammations and burn injuries

x

M

Bardanae Radix

wound healing agents x

Anisi Fructus T

Indications/ Application Areas

vermin

x

x

consequences of injuries and accidents, hematomas, bruises, distortions, contusions, fracture oedemas, rheumatic muscle and joint disorders, insect bites, furuncles

x

x

infected poorly healing wounds, burn injuries, decubitus, frostbite, ulcer, hemorrhoids, antiparasitic

x

itchiness

x

psoriasis, skin diseases, itchiness poorly-healing wounds x

hair loss, skin eczema bleeding skin injuries

x

inflammation of skin and mucous mem­branes, ruptures, bruises and burns, poorly healing wounds

History and Present of European Traditional Herbal Medicine (Phytotherapy)  233 Table 3–10  (Continued ) Insect Skin, Wounds, Bites, Mucosa Eczemas Vermin Itchiness Other Capsici Fructus

Indications/ Application Areas

M

x

x

rheumatic disorders, muscle tension, pain, neuralgia, diabetic neuropathy

T

x

x

frostbite

Carvi Fructus T

x

embrocations

Chelidonii Herba

T

x

warts

Droserae Herba

T

x

warts

Equiseti Herba

M

x

x

Hamamelidis M Cortex

x

x

x

slight skin injuries, local inflammations, varicose veins, hemorrhoids, astringent

Hamamelidis M Folium

x

x

x

slight skin injuries, local inflammations, varicose veins, hemorrhoids, astringent

Hederae Folium

T

x

x

x

lice, scabies, ulcers, burn injuries

Hippocastani Semen

M

x

x

traumatic swelling (sport injuries, bruises, hemorrhoids and chronic venous insufficiency)

Hyperici Herba

M

x

x

x

sharp and blunt injuries, myalgia, minor burn injuries

Juglandis Folium

M

x

x

x

acne, eczema, ulcers, superficial inflammation of the skin, excessive perspiration (Continued )

poorly-healing wounds

x

234  History, Present and Prospect of World Traditional Medicine Table 3–10  (Continued ) Insect Skin, Wounds, Bites, Mucosa Eczemas Vermin Itchiness Other

Indications/ Application Areas

Lichen Islandicus

T

x

x

poorly-healing wounds

Lupuli Flos/ Glandula

T

x

x

skin injuries, ulcers

Matricariae Flos

T

x

Melissae Folium

M

x

x

T

x

x

Symphyti Radix

M

Valerianae Radix

M

x

x

skin inflammations, diseases in the genital area herpes simplex

x

inflammation of the skin and genital organs

x

x

contusions, swellings, sprains, joint inflammation, gout, bone fractures, tendonitis, arthritis, hematomas

x

x

as bath calming, muscle relaxant

(M = modern medic, T = traditional medicine)

© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_0004

Chapter 4

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine Bashar Saad Arab American University Palestine

Abstract Despite the great achievements of the evidence-based modern medicine and pharmacology, traditional Greco-Arab and Islamic Medicine-based herbal remedies are currently becoming more popular in Arab and Islamic world. Historical circumstances and the belief that these remedies are prepared according to the principles of Greco-Arab and Islamic Medicine, which was developed during the Golden Age of Arab-Islamic civilization. This medical system has influenced the fates and fortunes of countless human beings all over the world and it formed the roots from which modern Western Medicine and pharmacology arose. There is no doubt that the earlier Greco-Roman scholarly medical literature was the stem from which much Arab-Islamic Medicine grew, just as, several centuries later, Arab-Islamic Medicine was the core of late middle ages and early European medical system. To compete with the growing pharmaceutical market, there is an urgency to utilize scientifically validated herbal products. Therefore, 235

236  History, Present and Prospect of World Traditional Medicine

policy-makers in the Arab and Islamic world are forced to establish standardization and regulatory measures that regulate the quality, availability, and preservation of these products. Public demand has also grown for evidence on the safety and efficacy of herbal products as well as for national regulations for traditional healers and caregivers. This chapter provides a comprehensive overview on Traditional Arab-Islamic Herbal Medicine including the historical background, medical innovations introduced by Arab physicians, methods of therapies, and a state of the art and prospect description of Traditional Arab Herbal Medicine. Keywords: Arab-Islamic Herbal Medicine, medicinal plants, diabetes, obesity, cardiovascular diseases

Introduction Herbal Medicines have been used since the dawn of civilization to maintain health and to treat diseases. Currently, they represent a central component of all alternative medical systems and are becoming even more popular as people prefer the use of natural remedies rather than synthetic drugs. To compete with the well-established and highly sophisticated pharmaceutical products, there is an urgency to utilize scientifically validated and clinically tested herbal products. Therefore, the study of pharmacological and biological effects of herbal-based medicines is becoming more competitive and complex, with the involvement of experts belonging to different scientific fields, including botany, chemistry, biochemistry, immunology, molecular biology, and bioinformatics. According to recent surveys, there are about 450 medicinal plants in the Eastern region of the Mediterranean and about 230 medicinal plants in the coastal Mediterranean region in Egypt. These plants are used by healers all over the Arab and Islamic world for the treatment and prevention of almost all types of human disease, such as overweight, infertility, diabetes, cardiovascular diseases, impotence, cancer, skin, respiratory, digestive, liver diseases, and others. Most of these plants and their products are sold or traded in marketplaces in the Arab-Islamic world as well as internationally without any pharmacological or medical validations. In many cases, leaves, flowers, stems, roots, seeds, and berries are prepared into a mixture.[1–9]

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  237

According to the principles of Greco-Arab and Islamic Medicine, which was developed during the Golden Age of Arab-Islamic civilization (7th–15th century) all components of the body are treated with equal importance; both spiritual and physical health are of equal importance. Already at that time, many Arab and Muslim physicians recognized that there are individual differences in the severity of disease symptoms, and in the individual ability to cope with disease and healing. Rhazes (864– 930 AD), one of the famous Muslim physicians, laid the foundation of this concept by a statement, “The physician, even though he has his doubts, must always make the patient believe that he will recover, for state of the body is linked to the state of the mind.” Later on, Avicenna (980–1037 AD) supported Rhazes’s recommendation in his Canon of Medicine, where he stated, “We have to understand that the best and most effective remedy for the treatment of patients should be through the improvement of the power of the human body in order to increase its immune system, which is based on the beauty of the surroundings and letting him listen to the best music and allowing his best friends to be with him.” Evidence-based research now shows that the mind and the body influence each other and regulate each other. Accordingly, stress can lead to the production of “stress hormones,” as well as products of the immune system. These “stress hormones” act in a feedback pathway to modulate their own production as well as of other immune mediators. These immune mediators act on the brain to modify behavior and the ability to perceive and to respond to stressful challenges by inducing lethargy, fever, and nausea. Based on the above-mentioned concepts of Rhazes and Avicenna, Greco-Arab and Islamic physicians treated patients through a scheme starting with physiotherapy and diet; if this failed, drugs were used. Rhazes’s suggested a treatment scheme that starts with diet, he noted that, “If the physician is able to treat with foodstuffs, not medication, then he has succeeded. If, however, he must use medications, then it should be simple remedies and not compound ones.” Drugs were grouped in two classes, simple and compound drugs. Physicians were aware of the interaction between drugs, and thus, they preferred to use simple drugs first. If these failed, compound drugs (consisting of two or more extracts) were used. If these conservative measures failed, surgery was undertaken.[1–4]

238  History, Present and Prospect of World Traditional Medicine

4.1  A brief history of Arab medicine The currently used Arab-Islamic Herbal Medicines has historical origin in Greco-Arab and Islamic Medicine. In the history of medicine, Islamic Medicine, Arabic Medicine, or Greco-Arab and Islamic Medicine refer to a medical system developed during the golden age of the Islamic civilization (7th–15th century AD). Medicine in general is considered to be one of the most illustrious and best-known facts of Arab-Islamic civilization in which Muslims most excelled. Although it was written in Arabic, the lingua franca of that time, it became influential in Western medical circles to such an extent that it built an essential part of the curriculum of medical schools for many centuries in Europe (Figure 4–1).[1–4]

4.1.1  Early Arab and Islamic medicine Most Arabs and Muslims believe that the first Muslim physician is the Prophet Mohammad (PBUH, 570–632 AD), as a significant number of Hadith (statements by the Prophet) concerning diseases and their cure are attributed to him. For example, “Allah has sent down both the disease and the cure, and He has appointed a cure for every disease, so treat yourselves medically,” “The one who sent down the disease sent down the remedy,” and “For every disease, Allah has given a cure.” These Hadiths encouraged early Muslims to engage in seeking out a cure for every disease known to them and hence, initiated the foundations of Arab-Islamic Medicine. Accordingly, early Muslims began to use herbs as well as animal products mentioned in the Holy Quran and recommended in Hadiths for health care. These included dates, black seeds, olive leaf and olive oil, honey, and camel milk. Later on, these products formed the basis for the Prophet’s Medicine (Al-Tibb al-Nabawi), which includes prescriptions for medical treatment and disease prevention, health promotion, and spiritual aspects that were recommended by Prophet (PBUH) to his followers. It is important to mention that the Prophetic Medicine was not based on medical experiments but rather on inspiration and experience from previous culture and tradition. According to a Hadith, the stomach is the central basin of the body and origin of many diseases, “The stomach is the central basin of the body, and the veins are connected to it. When the stomach is

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  239

Figure 4–1    Development of traditional medical systems. Note: The Babylonians and ancient Egyptians laid down the foundations of medicine upon which this field progressed. Later on, Mesopotamian Medicine was transmitted in part to the Greeks, and together with Egyptian Medicine, it paved the way for the great Greek Medicine 5th century B.C. Then, during the rise of the Arab-Islamic Empire, large parts of available Greek medical scripts were translated to Arabic. The Arab and Muslin scholars improved the Greek Medicine as well as made new discoveries over several centuries. In the 14th century Greco-Arab Medicine was disseminated to Europe again from Arab capitals, such as Cordoba in Andalusia and Baghdad in Iraq.

240  History, Present and Prospect of World Traditional Medicine

healthy, it passes on its condition to veins, and in turn the veins will circulate the same and when the stomach is putrescent, the veins will absorb such putrescence and issue the same.” Indeed, the Prophet (PBUH) recommended the use of diet even more than herbs or animal-based medicines. He used everything from barley soup to honey to camel milk to heal his followers and advised them to eat certain foods to prevent or cure diseases. Honey, camel’s milk, dates, olive oil, and black seeds were the favored foods by the Prophet who regarded food as part of an overall holistic approach. Concerning olive oil, he said, “Eat olive oil and massage it over your bodies since it is a holy tree.” Black seeds were regarded as a medicine that cure all types of diseases. He once stated, “The black seed can heal every disease, except death.” Dates are mentioned in 20 places in the Quran and the Prophet mentioned them in a Hadith, “If anyone of you is fasting, let him break his fast with dates. In case he does not have them, then with water. Verily water is a purifier.”[1–9]

4.1.2  Greco-Arab and Islamic medicine The translation of Greek as well as available Persian and Indian medical scripts characterized the first phase in the development of Greco-Arab medical system. The Abbasid Caliphs (ruler of the Arab-Islamic World) Harun al-Rashid (786–809 AD) and his son, al-Ma’mun (813–833 AD), established a translation unit in Baghdad, the Bait al-Hikmah (House of Wisdom). Hunayn ibn Ishaq al-Ibadi (809–873 AD) was the chief translator who managed by the end of the 9th century to translate the entire body of Greek medical texts into Arabic. Hunayn reputed to have been paid for his translated manuscripts by an equal weight of gold. These translations build the foundations of a uniquely Arab Medicine. The attitude of Muslim rulers and scholars toward learning from foreign civilizations is clearly obvious in a statement by the philosopher Al-Kindi (Alkindus in Latin, 800–873 AD), who wrote in the 9th century in Baghdad, “We should not be ashamed to acknowledge truth from whatever source it comes to us, even if it is brought to us by former generations and foreign peoples.” Al-Kindi was one of the hundreds of Arab scholars employed to translate, analyze, and develop Greek learning by the Caliphs.[10–16]

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  241

Galen of Pergamon, a Greek physician, developed the theory of humors that formed the roots from which early Arab-Islamic Medicine grew. In brief, Galen believed that the human body consists of earth, air, fire, and water. These elements, that comprise the world, can be mixed in various proportions and the differing mixtures give rise to the different temperaments and “humors.” Correctly balanced bodily humors is a prerequisite for health. Sickness is due not to supernatural forces but to humoral imbalance and such imbalance could be corrected by the doctor’s healing arts. Rhazes was the first physician to criticize Galen’s theory of humor in his book Doubts about Galen. He carried out an experiment, in which he disturbed the humoral balance by inserting a liquid with a different temperature into the body. This treatment resulted in an increase or decrease of bodily heat, which resembled the temperature of that particular fluid. Rhazes noted particularly that a warm drink would heat up the body to a degree much higher than its own natural temperature, thus the drink would trigger a response from the body, rather than transferring only its own warmth or coldness to it. Later on, Ibn Zuhr (Avenzoar) (1091–1161 AD) was one of the earliest physicians known to have carried out human dissection and postmortem autopsy. He proved that parasites are responsible for scabies (a skin disease). This discovery contradicts Galen’s theory of humors. The removal of the parasite from the patient’s body did not involve purging, bleeding, or any other traditional treatments associated with the four humors.[9–14] The second phase or the innovation period in the development of Greco-Arab medical system began when the scholars started to develop and promote their own medical theories and practices that were highly influential in the development of Western Medicine. Arab-Muslim physicians developed the first scientific methods in the field of medicine. This included the introduction of quantification, experimental medicine, evidence-based medicine, animal testing, clinical trials with human experimentation, and postmortem autopsy by Muslim physicians. As we will see later on in this chapter, Harun al-Rashid established the first hospital at Baghdad around 805 AD. Within two decades, hospitals had sprung up in most large cities of the Islamic world. These hospitals featured drug tests, drug purity regulations, and competency tests for doctors.[1,9]

242  History, Present and Prospect of World Traditional Medicine

The third phase, or Arabic to Latin period, of the Greco-Arab and Islamic Medicine started in the 12th century, when Europeans came to appreciate how much they needed to learn from the Muslims. As such, scholars started to translate the most important medical Arab manuscripts into Latin. As aforementioned, the most outstanding writers on medicine in Arabic were Avicenna and Rhazes. Avicenna wrote on many subjects and his vast Canon of Medicine is highly considered as the “culmination and masterpiece of Arab systematization.” It was translated into Latin in the 12th century, and continued to play a central role in the study of medicine in Europe until the end of the 16th century. There were 16 editions of Avicenna’s work in the 15th century, 20 editions in the 16th century, and several more in the 17th century.[1–16]

4.1.3  Prominent Arab and Muslim physicians As aforementioned, it is important to highlight that the Greek and Persian medical manuscripts built the imperatives sources of development ArabIslamic Medicine, just as several centuries later, the innovative GrecoArab and Islamic Medicine formed the stem from which late medieval and early European medical education grew. While Galen indeed used logic, Arab and Muslim scholars were responsible for giving medicine its formal scientific structure. They translated the voluminous writings from Greek and Persian into Arabic and then created new theoretical and practical medical system based on the translated Greek manuscripts. Later on, in the 9th century, famous innovators in the Arab and Islamic world, namely Al Tabbari (838–870), Al Razi (Rhazes, 846–930), Al Zahrawi (Albucasis 936–1013), Al-Biruni (973–1050), Ibn Sian (Avicenna, 980–1037), Ibn Al Haitham (960–1040), Ibn al-Nafis (1213–1288), Ibn Khaldun (1332– 1395), and Ibn Zuhr (Avenzoar, 1091–1161) discovered the existence of the immune system and introduced microbiological science. Furthermore, they separated medicine from pharmacology, introduced animal testing, and combined different sciences such as chemistry, medicine, pharmacology, agriculture, and plant science in order to develop new treatments. Arab physicians were also aware of the contagious qualities of diseases. Furthermore, every major city of the Arab-Islamic Empire had a hospital;

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  243

the hospital at Cairo had separate wards for fevers, ophthalmic, dysentery, and surgical cases.[11–20] Concerning herbal medicine, Arab physicians introduced many new ideas and upgraded the existing knowledge about herbs and their potential medical uses. For instance, the Gerber and others extracted different anesthetic compounds from indigenous plants for local and general anesthetization. Daoud al-Antaki used different plant extracts to treat patients and published a book on medicinal plants, summarizing the knowledge of his predecessors. Ibn al-Baitar, in Andalusia, Spain, introduced around 350 new medicinal herbs for treating human diseases. Abu al-Abbas and other herbalists published several books and dictionaries on the use of medicinal herbs describing the botanical origin, the parts used, the preparation procedure used for each remedy, and the treatment procedure of certain diseases. Avicenna’s Canon of Medicine and Rhaze’s Comprehensive were translated from Arabic into several different languages. Until a few centuries ago, these two books were the focus of medicinal literature and they are still in use in different libraries in Europe. In the following sections, we will try to summarize the sophisticated framework of medical theory and practice developed by the most prominent Arab and Muslim physicians.[2,7,8,10]

4.1.4  Rhazes (Al-Razi, 864–930 AD) Rhazes, Avicenna, and Albucasis were considered to be the greatest of all Arab and Muslim scientists. Rhazes was born in Persia in the town of Rayy. After completing his medical studies, he was appointed to build a new hospital in the capital city, Baghdad. He approached the question of where to put the new facility by a simple technique. He hung pieces of meat in various locations of the city and observed the rate at which they spoiled. He then decided to build the hospital at the site where the meat showed the least putrefaction. According to Rhazes, disease is not a punishment inflicted upon people by God; it has specific physical causes. He rejected superstition dogma, which is not based on observable physical origins. He was the first who dared to criticize some of the foundations of Galen in his Doubts

244  History, Present and Prospect of World Traditional Medicine

about Galen, “I prayed to God to direct and lead me to the truth in writing this book. It grieves me to oppose and criticize the man, Galen, from whose sea of knowledge I have drawn much. Indeed, he is the Master and I am the disciple. Although this reverence and appreciation will and should not prevent me from doubting, as I did, what is erroneous in his theories. I imagine and feel deeply in my heart that Galen has chosen me to undertake this task, and if he were alive, he would have congratulated me on what I am doing. I say this because Galen’s aim was to seek and find the truth and bring light out of darkness. I wish indeed he were alive to read what I have published.” In his Al-Kitab al-Mansuri, a 10-volume book, he dealt with such varied subjects as general medical theories and definitions, diet and drugs and their effect on the human body, mother and child care, skin disease, oral hygiene, climatology and the effect of the environment on health, epidemiology and toxicology. His book, The Diseases of Children, has led some medical historians to regard him as the father of pediatrics. The identification of hay fever and its cause and his work on kidney stones were considered as classic for many centuries. Rhazes was a strong supporter of experimental medicine in the development of new medicines and therapies. He called for high professional control and standards for practitioners. He also insisted on continuing education for already licensed physicians. Rhazes was the first to emphasize the value of mutual trust and consultation among skilled physicians in the treatment of patients, an unknown practice at that time.[18,19] In his book, The Book of Smallpox and Measles, Rhazes was the first physician to clinically distinguish between smallpox and measles, “The eruption of smallpox is preceded by a continued fever, pain in the back, itching in the nose and nightmares during sleep. These are the more acute symptoms of its approach together with a noticeable pain in the back accompanied by fever and an itching felt by the patient all over his body. A swelling of the face appears, which comes and goes, and one notices an overall inflammatory color noticeable as a strong redness on both cheeks and around both eyes. One experiences a heaviness of the whole body and great restlessness, which expresses itself as a lot of stretching and yawning. There is a pain in the throat and chest and one finds it difficult to

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  245

breath and cough. Additional symptoms are dryness of breath, thick spittle, hoarseness of the voice, pain and heaviness of the head, restlessness, nausea and anxiety (Note the difference: restlessness, nausea, and anxiety occur more frequently with “measles” than with smallpox. At the other hand, pain in the back is more apparent with smallpox than with measles). Altogether one experiences heat over the whole body, one has an inflamed colon, and one shows an overall shining redness, with a very pronounced redness of the gums.” The Comprehensive was the most supreme work by Rhazes. This 25-volume medical encyclopedia is known as the Liber Continens of Rhazes’s in Latin translations. Rhazes spent a lifetime collecting data for the book, which he intended as a summary of all the medical knowledge of his time, augmented by his own experience and observations. Rhazes highlighted the need for physicians to pay careful attention to patient history, rather than merely consulting the authorities of the past. In a series of diagnosed case histories entitled “Illustrative Accounts of Patients” he discussed this important principle.[1,6,18,19]

4.1.5  Avicenna (Ibn Sina, 980–1037 AD) Avicenna was born in Bukhara in Uzbekistan. His superiority was not only in medicine, but also in philosophy, science, music, poetry, and leadership. At the age of 16, he began to study medicine and by the age of 20, he was appointed as court physician. Later on, he served as Vizier (Prime minister) to Shams al-Dawlah, the prince of Hamadan, in western Persia. The Canon of Medicine was his highly impressive and respected book. Over one million words long, it was nothing less than an excellent review of all existing medical knowledge. It summarized Hippocratic and Galenic theories and practices, describing Arab-Islamic and Indo-Persian knowledge and practice and including notes on his own experimental observations and innovations. The Canon made its first appearance in Europe by the end of the 12th century and its impact was dramatic. Copied and recopied, it quickly became the standard European medical reference work. In the last 30 years of the 15th century, just before the European invention of printing, it was issued in 16 editions; in the century that followed more than

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20 further editions were printed. From the 12th to the 17th century, its materia medica was the pharmacopoeia of Europe, and as late as 1537, The Canon was still a required textbook at the University of Vienna. Taken overall, it is hard to describe Avicenna in anything other than superlatives or as his contemporaries called him “the prince of physicians.”[20] In his Canon, Avicenna was the first who gave medicine its formal scientific structure. He transformed the human body into something that can be understood in terms of causal chains of events that lead to various states of health and disease. Elucidation of diseases and their causes became the main objective of medical training and education. He distinguished four kinds of causes for diseases, namely, material, efficient, formal, and final. In this regard, he wrote in his Canon, “Therefore in medicine we ought to know the causes of sickness and health. In addition, because health and sickness and their causes are sometimes manifest, and sometimes hidden and not to be comprehended except by the study of symptoms, we must also study the symptoms of health and disease. Now it is established in the sciences that no knowledge is acquired safe through the study of its causes and beginnings, if it has causes and beginnings; nor completed except by knowledge of its accidents and accompanying essentials. Of these causes there are four kinds: material, efficient, formal, and final.”[20] The Canon also discusses the role of diet and the impact of climate and environment on human health. It discusses rabies, breast cancer, tumors, labor, and poisons and their possible treatments. Avicenna distinguished between meningitis and meningismus of other acute diseases, and described chronic nephritis, facial paralysis, ulcer of the stomach, and the various types of hepatitis and their causes. He also elaborated on the dilation and contraction of the pupils and their diagnostic value, described the six motor muscles of the eye, discussed the functions of the tear ducts, and noted the contagious nature of some diseases, which he attributed to “traces” left in the air by a sick person. In parallel with Alhacen, who was carrying out his experimentations in Cairo at the same time, but from a more detailed anatomical and medical perspective, Avicenna searched deeply into the anatomy of the eye, including the cornea, iris, retina, aqueous humor, and optic nerve. He enlarged on Galen’s theories in describing much more esoteric and remote optical organs, such as the optic chiasma, a structure in the brain formed by the partial intersection or crossing of the optic nerve fibers on the

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underside of the hypothalamus. He also confirmed that nerves are responsible for forwarding signals for virtually all physical functions, in particular muscular contractions, concluding that pain is transmitted from its source via the nerves. Avicenna further studied how the aorta works, demonstrating that its three valves prevent blood from rushing back into the heart after the heart completes contracting.[12,13,20] Avicenna’s contributions to anatomy and physiology are of great importance. Galen, like Chinese physicians, was convinced that there was a unique type of pulse for every organ of the body and for every disease. Galen also believed that “every part of an artery pulsates simultaneously” and that the motion of the pulse was due to natural motions (the arteries expanding and contracting naturally) as opposed to forced motions (the heart causing the arteries to either expand or contract). Avicenna gave the first correct explanations of pulsation, “Every beat of the pulse comprises two movements and two pauses. Thus, expansion, pause, contraction, pause. The pulse is a movement in the heart and arteries... which takes the form of alternate expansion and contraction.” Avicenna also pioneered the modern approach of examining the pulse through the examination of the wrist, which is still practiced. His reasons for choosing the wrist as the ideal location is due to it being easily available and the patient not needing to be distressed at the exposure of his/her body. Other contributions of Avicenna to physiology include the introduction of systematic experimentation and quantification into the study of physiology in The Canon of Medicine. In addition to the classification, symptoms, and complications of diseases, the Canon also elaborates on hygiene, simple and complex medicines, and functions of various organs of the body. Avicenna even asserted that tuberculosis was contagious, which was later disputed by Europeans but turned out to be true. Even before the discovery of contagious diseases by Avicenna, Rhazes recognized the origin of smallpox and that one could only acquire it once in one’s life. These findings built the basis for building hospitals with separate wards for specific diseases, so that people with contagious diseases could be separated from other patients. With regard to herbal medicine, the Canon also included a description of some 760 medicinal plants, their uses, and the preparation of medicines that could be prepared from them. At the same time, Avicenna laid out the basic rules of clinical drug trials, principles that are still followed today.[1,12,13,20]

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4.1.6  Alhacen (Ibn al-Haitham, 965–1040 AD) Through his extensive studies on optics, Alhacen is regarded as the founder of modern optics. He managed to write more than 200 books, very few of which have survived. In his books, he described and discussed scientific methods comprising the systematic observation of physical phenomena and their linking together into a scientific theory. This was a major breakthrough in scientific methodology, as distinct from guess and gesture, and placed scientific pursuits on a sound foundation comprising systematic relationships between observation, hypothesis, and experimentations. His outstanding treatise on optics survived in its Latin translation. The Latin translation of his main work, Kitab-at-Manazir, exerted a great influence upon Western science e.g., on the work of Roger Bacon and Kepler. In this book, he dealt in depth with the theory of various physical phenomena like shadows, eclipses, the rainbow, and speculated on the physical nature of light. He is the first to describe the anatomy of the eye and give a scientific explanation of the process of vision. He disapproved Ptolemy’s and Euclid’s theory of vision that objects are seen by rays of light emanating from the eyes; according to him the rays originate in the object of vision and not in the eye. Alhacen made a thorough examination of the passage of light through various media and formulated the laws of refraction. He also carried out the first experiments on the dispersion of light into its constituent colors. His contribution to mathematics and physics was extensive. In mathematics, he developed analytical geometry by establishing linkage between algebra and geometry. He studied the mechanics of motion of the body and was the first to maintain that the body moves perpetually unless an external force stops it or changes its direction of motion. This would seem equivalent to the first law of motion.[1–8]

4.1.7  Ibn al-Nafis (1213–1288 AD) Ibn al-Nafis has been considered as one of the greatest cardiologists of the Arab-Islamic civilization and pre-modern time. Ibn al-Nafis was born in a small town near Damascus, where he studied medicine. He spent most of his life in Cairo as the chief physician of al-Mansuri hospital and head of its school of medicine. He made his earthshattering discovery around

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1284 AD, when he described the true anatomy of the heart and the circulatory system. He was the first scholar who dared to contradict the predominate Galen’s theory that blood could pass through the cardiac interventricular septum, and in keeping with this, Galen was convened that all the blood that reached the left ventricle passed through the lung. Ibn al-Nafis clarified all that when he studied the heart-lung blood circulation, observed through many surgeries and possibly dissection. He mapped the network of vessels supplying blood to the heart and described the pulmonary circulation, coronary circulation, and capillary circulation, which form the basis of the circulatory system, for which he is considered as one of the greatest physiologists in history. In his Commentary on Anatomy in Avicenna’s Canon, Ibn al-Nafis completely rejected the Galenic theory of pulsation after his discovery of the pulmonary circulation. He developed his own Nevisian theory of pulsation after discovering that pulsation is a result of both natural and forced motions, and that the “forced motion must be the contraction of the arteries caused by the expansion of the heart, and the natural motion must be the expansion of the arteries.” He notes that the “arteries and the heart do not expand and contract at the same time, but rather the one contracts while the other expands” and vice versa. He also recognized that the purpose of the pulse is to help disperse the blood from the heart to the rest of the body. Ibn al-Nafis briefly summarizes his new theory of pulsation, “The primary purpose of the expansion and contraction of the heart is to absorb the cool air and expel the wastes of the spirit and the warm air. However, the ventricle of the heart is wide. Moreover, when it expands it is not possible for it to absorb air until it is full, for that would then ruin the temperament of the spirit, its substance and texture, as well as the temperament of the heart. Thus, the heart is necessarily forced to complete its fill by absorbing the spirit.”[21,22] Of all the branches of Islamic Medicine, ophthalmology was one of the foremost. Ibn al-Nafis detailed in The Polished Book on Experimental Ophthalmology his discovery that the muscle behind the eyeball does not support the ophthalmic nerve, that it does not come into contact with it, and that the optic nerves transect but do not come into contact with each other. He also discovered many new treatments for glaucoma and the weakness of vision in one eye when the other eye is affected by disease.[1,21,22]

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4.1.8  Abulcasis (Al-Zahrawi, 936–1013 AD) Abulcasis, born in Zahra in the neighborhood of Cordova (Spain), is regarded as one of the most renowned surgeons of that era. He is best known for his original innovations in surgery as well as for his 30-volume Medical Encyclopedia, Al-Tasrif, which covers different aspects of medicine. Three volumes of Al-Tasrif were devoted to surgery, in which he described in detail various aspects of surgical treatment as based on the operations performed by Abucasis. These include cauterization, removal of stone from the bladder, dissection of animals, midwifery, and surgery of the eye, the ear, and the throat. He optimized several delicate operations, including removal of the dead fetus and amputation. In addition, Al-Tasrif contains numerous schematic illustrations of surgical instruments, in use or developed by him, and comprised a part of the medical curriculum in European countries for many centuries. Abulcasis was the inventor of several surgical instruments, of which three are notable — an instrument for internal examination of the ear, an instrument for internal inspection of the urethra, and an instrument for applying or removing foreign bodies from the throat. He specialized in treating diseases by cauterization and applied this technique to 50 different operations. Al-Tasrif also described the preparation of various herbal-based drugs and described in detail the application of techniques such as sublimation and decantation. Abulcasis was also an expert in dentistry and his book contains sketches of various instruments used therein, in addition to a description of various important dental operations. He discussed the problem of nonaligned or deformed teeth and how to rectify these defects. He developed the technique of preparing artificial teeth and using them to replace defective teeth.[1,23]

4.1.9  Alkindus (Al-Kindi, 800–873 AD) Alkindus, known as the philosopher of the Arabs, was born and educated in Kufa (Iraq). He was a pioneer in medicine, physics, psychology, chemistry, music theory, music therapy, and the philosophy of science. Alkindus became a prominent figure in the House of Wisdom where he was appointed to supervise the translation of Greek scientific and

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philosophical scripts into the Arabic. This contact with “the philosophy of the ancients” (Greek and Hellenistic philosophy) had a far-reaching effect on his intellectual development and led him to write original works on subjects ranging from Islamic ethics and metaphysics to Islamic mathematics and pharmacology. Alkindus was the first to systematically determine the doses to be administered for all known drugs at the time. This resolved the contradictory views predominated among physicians on the dosage that caused difficulties in writing prescriptions.[1–4]

4.1.10  Avenzoar (Ibn Zuhr 1091–1162 AD) Avenzoar was born in Seville, Spain. Contrary to the general habit of scholars of that time, he confined his work to only medicine. He was regarded as one of the greatest physicians of the medieval Arab-Islamic Medicine who produced works of everlasting fame and importance. In his books, Avenzoar emphasized the importance of observation and experiment and his contribution greatly influenced medical science for several centuries both in the East and the West. His contributions were chiefly contained in his monumental works. The book of Simplification Concerning Therapeutics and Diet (Kitab al-Taisir fi al-Mudawat wa al-Tadbir), written at the request of Ibn Rushd (Averroes), is the most important work of Avenzoar. The book gives details of pathological conditions and their therapy. His Book of the Middle Course concerning the Reformation of Souls and the Bodies (Kitab al-Iqtisad fi Islah al-Anfus wa al-Ajsad) gives a summary of diseases, therapeutics, and hygiene. Its initial part is a valuable discourse on psychology. Book on Foodstuffs (Kitab al-Aghziya) describes different types of diet and drugs and their effects on health. His books were translated into Latin and remained popular in Europe as late as the advent of the 18th century.[1–4]

4.1.11  The role of Arabs and Muslims in the development of pharmacology The separation of medicine from pharmacology in Baghdad in the 8th century resulted in a huge development in pharmaceutical science and

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standardization of drug development process. Pharmacy was developed to a profession practiced by highly skilled specialists. Pharmacists were required to pass examinations in order to get an official license and were then monitored by the state. At the start of the 9th century, the first private apothecary shops opened in Baghdad. Pharmaceutical preparations were prepared and distributed commercially, then dispensed by physicians and pharmacists in a variety of forms: ointments, pills, elixirs, confections, tinctures, suppositories, and inhalants (Figure 4–2). The advances made in medicine, botany, and chemistry by medieval Arab and Muslim physicians stimulated the development of pharmacology. Arab pharmacists (Saydalaneh in Arabic) and ethnopharmacologists began to search for different ingredients and extracts as new sources for

Figure 4–2    Preparations methods of herbal medicines. Note: Several techniques were developed in Greco-Arab and Islamic Medicine and are still used by traditional herbalists to prepare herbal-based medicines. The majority of herbal medicines are consumed orally in the form of tea or other drink containing either diluted or concentrated plant extracts. Essential oils, salves, oils, balms, creams and lotions, or poultices and compresses are used for topical applications.

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drug development. They even started to study the physicochemical properties of the materials used in the preparation of the different forms of drugs (Figure 4–2). For the first time scholars, such as the Gerber, who is considered the father of Arab-Islamic alchemy, invented new extraction and purification methods for different chemicals and solvents including alcohol, nitric acids, sulfuric acids, and royal acid. The latter was used to dissolve gold. As aforementioned, Avicenna devoted a whole volume to simple drugs in The Canon of Medicine. He introduced systematic experimentation and quantification into pharmacology and the study of physiology. He also introduced the use of clinical pharmacology, experimental medicine, clinical trials, randomized controlled trials, and testing of drug’s efficacy. Furthermore, he wrote a precise description for experimentation in the process of discovering and proving the effectiveness of new drugs. Avicenna described about 700 preparations, their medical properties, mode of action, and their possible indications. Rhazes initiated the clinical uses of chemical compounds. Abulcasis introduced the preparation of drugs by sublimation and distillation. His Liber Servitoris is of particular interest; it contains a large number of recipes and explains how to prepare the simple as well as complex drugs. Al-Biruni (973– 1050) wrote one of the most valuable Islamic books on pharmacology, The Book of Drugs (Kitab al-Saydalah), in which he described in detail the properties of drugs and outlined the role of pharmacy and the functions and duties of the pharmacist. Al-Kindi was a renowned 9th century physician who introduced the application of mathematics into medicine, particularly in the field of pharmacology. This includes the development of a mathematical scale to quantify the strength of drugs and a system that would allow a doctor to determine in advance the most critical days of a patient’s illness, based on the phases of the Moon. Later on, Saydalaneh managed to develop a large number of new drugs to clinical practice, including senna, camphor, sandalwood, musk, myrrh, cassia, tamarind, nutmeg, cloves, aconite, ambergris, and mercury. They used syrups, juleps, and pleasant solvents such as rose water and orange-blossom water as means of administering drugs. They were familiar with the anesthetic effects of Indian hemp and henbane, both when taken in liquids and inhaled (Figure 4–2).[1–16]

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4.1.12  Poisons and their antidotes in Greco-Arab and Islamic herbal medicine In parallel with the development of pharmacy and pharmacology, there was also a similar development in alchemy and toxicology. The origins of these developments date back to the Greeks and Indians as well as to the empiric knowledge of the indigenous population. Alchemy was commonly practiced during the 9th century and many works have been written on this field. For instance, there is a five-volume, independent manual on toxicology by Kitab al-Sumum that is attributed to Shanaq the Indian. It was translated into Arabic by Al-Jawhari for Caliph al-Mamun and was a compilation from Greek and Indian sources of the 9th century. It discusses poisons and their detection by sight, touch, taste, or by the toxic symptoms they cause. Descriptions are provided of poisoned drinks, foods, clothes, carpets, beds, skin lotions, and eye salves, as well as narcotics and universal antidotes. A similar approach can be found in the book on poisons and their antidotes by the famous Arab alchemist, the Gerber. In the six chapters, he identified poisons by their traits, natural origins, modes of action, dosages, and methods of administration, choice of drugs, and target organ. Another, equally important example is found in an early 10th century book on toxicology by Ibn Wahshiyyah, who also discussed general human anatomy and the four humors, detailing how they are affected by lethal drugs. He even warned against poisonous or poisoned matter and prescribed antidotes. His discussion of body principles and subordinate organs and their function is similar to the previously mentioned Greek classification. Many of the antidotes described by the Gerber, Ibn Wahshiyyah, and Avicenna are still used nowadays by herbalists in the Islamic world.[1,24]

4.1.13  Hospitals in the Greco-Arab and Islamic herbal medicine The development of hospitals was one of the great achievements of ArabIslamic civilization. They were called bimaristans, from the Persian word bimar (ill person), and Stan (place). The earliest documented hospital established by an Islamic ruler was built in Baghdad in the 9th century. In Egypt, the first hospital was built in the south-western quarter of

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present-day Cairo in 872 by Ahmad ibn Tulun, the Abbasid governor of Egypt. It is the earliest for which there is clear evidence that care for the insane was provided. By the end of the 9th century, two additional hospitals were also said to have been built in Cairo (Fustat), though the evidence on this point is questionable. In the 12th century, Saladin founded the Nasiri hospital in Cairo, but it was surpassed in size and importance by the Mansuri, completed in 1248 after eleven months of construction. It remained the primary medical center in Cairo through the 15th century. The Nuri hospital in Damascus was a major one from the time of its foundation in the middle of the 12th century well into the 15th century, by which time the city contained five additional hospitals. Besides those in Baghdad, Damascus, and Cairo, hospitals were built throughout Islamic world. In al-Qayrawan in Tunisia, a hospital was built in the 9th century and early ones were established at Mecca and Medina in Saudi Arabia. Ottoman hospitals flourished in Turkey in the 13th century, and there were hospitals in the Indian provinces as well as in Islamic Spain. The style and location of hospitals were carefully determined and much attention was given to the climate with regard to the health conditions. Harun Al-Rashid asked Rhazes to build the first general hospital, so Rhazes selected the place after putting a few pieces of meat in different places in Baghdad to check which spoiled the least, thus identifying the place with the freshest air. In general, hospitals were built on a cruciform plan with four central Iwans or vaulted halls, with many adjacent rooms including kitchens, storage areas, a pharmacy, some living quarters for the staff, and sometimes a library. Each Iwan was usually provided with fountains to provide a supply of clean water and baths. There was a separate hall for women patients and areas reserved for the treatment of conditions prevalent in the area, e.g., eye ailments, gastrointestinal complaints, and fevers. There was also an area for surgical cases and a special ward for the mentally ill. Some had an area for rheumatics and cold sufferers. There were frequently outpatient clinics with a free dispensary of medicines. The staff included pharmacists and a roster of physicians who were required at appointed times to be in attendance and make the rounds of patients, prescribing medications. These were assisted by stewards and orderlies, as well as a considerable number of male and female attendants who tended

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the basic needs of the patients. In addition to the promotion of health and the curing of disease, hospitals served as a place for the expansion and dissemination of medical knowledge. Therefore, medical schools and libraries were attached to the larger hospitals, and senior physicians taught students, who were in turn expected to apply in the men’s and women’s wards what they had learned in the lecture hall. Hospitals set examinations for their students and issued diplomas. By the 11th century, there were even travelling clinics staffed by the hospitals that brought medical care to those too distant or too sick to come to the hospitals themselves. There were also instructors, possibly aspiring medical students, who trained the non-professional staff. The budget of such institutions must have been considerable, and in fact the budget of the Mansuri hospital was the largest of any public institution in Cairo. An administrator, who was not usually trained in medicine, was responsible for the entire staff and the management of the hospital. In most instances, this was a political appointment, subject to the unpredictable fluctuations of political favor, as the position of controller of a hospital was very lucrative. Conversely, the chief of staff was a medical officer. The first psychiatric hospitals were built in Baghdad at the beginning of the 8th century, Fes (Morocco) in the early 8th century, and Cairo in 800. Additional psychiatric hospitals were established in Damascus and Aleppo (Syria) in the late 13th century. Medieval Arab-Muslim physicians relied mostly on clinical psychiatry and clinical observations on mentally ill patients. They made significant advances to psychiatry and were the first to provide psychotherapy and moral treatment for mentally ill patients, in addition to other new forms of treatment such as baths, drug medication, music therapy, and occupational therapy. The Bimaristan was, in short, the cradle of Arab Medicine and the prototype upon which the modern hospital is based.[1,12,14,25]

4.1.14  Current status of Greco-Arab and Islamic herbal medicine Herbal Medicine represents a central component in all known traditional medical systems (e.g., Greco-Arab, Ayurveda, Chinese, and European) (Figure 4–3). The use of Herbal-derived treatments and supplements has increased tremendously over the past four decades with no less than 80%

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Figure 4–3    Therapy methods developed in the Greco-Arab and Islamic medicine still used by traditional healers.

of people worldwide relying on them for some part of primary healthcare. In Asia, Africa, and Latin America, people continue to use the system as a result of historical circumstances and cultural beliefs. In China, traditional medicine accounts for around 40% of all healthcare delivered and in Africa, up to 80% of the population uses herbal traditional medical system to help meet their healthcare needs.[26–37] Despite the great achievements of modern school medicine, GrecoArab Medicine has always been practiced in the Arab-Islamic world. Herbal Arab-Islamic Medicine finds a widespread use in all Arab and Islamic countries, which build about one fifth of the world’s population. Arab-Islamic community is spread across many different nations and ethnic groups connected only by religion. The 25% of Muslims live in the Indian subcontinent, 20% in sub-Saharan Africa, 17% in Southeast Asia, and 18% in the Arab world. Turkey, Iran, and Afghanistan build the majority of the non-Arab Middle East. Traditional Medicines have been favored over synthetic medicines by people who trust spiritual healers and herbalists for treatment of diseases such as diabetes, obesity, cardiovascular diseases, infertility, impotence, and psychosomatic troubles. Growing public interest in herbal-based remedies is mainly based on disappointments from synthetic drugs and their associated side effects as

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well as cultural and religion’s beliefs and practices. These factors have often led to self-care or home remedies in rural areas and consultation with traditional healers. Therefore, growing interest in these remedies is supported by the belief that they are prepared according to the principles of Greco-Arab and Islamic Medicine. As a result, many merchants and health caregivers of the Arab-Islamic Herbal Medicine are named after the aforementioned famous physicians: Avicenna, Rhazes, Ibn al-Baitar, Al-Zahrawi, or Al-Antaki.[26–37] Fortunately, parallel to the increase in the use and popularity of herbal-based preparations, there has been much recent research into efficacy, safety, quality control, and standardization of medicinal plants and derived medicines, particularly in the Middle East. Researchers have published numerous articles, review papers in peer reviewed international journals on this subject. These articles highlight the importance of traditional Arab-Islamic Medicine and indicate that the eastern region of the Mediterranean is outstanding from other regions by a rich inventory of herbal-based medicines. Due to this recent revival evidence-based herbal medicine, various medicinal plants have been investigated and their bioactive ingredients extracted to treat various human diseases. Several herbalbased preparations have been evaluated in cooperation with physicians and have started to be routinely prescribed in Mediterranean countries. [38–64]

Regarding quality, standardization, and preservation of endangered medicinal plants, ethnopharmacological studies conducted by different groups in the Middle East support the necessity of proper handling of herbal medicine, which requires both national regulation and licensing in order to ensure the supply of appropriate and safe products. Nowadays, there are increasing activities toward the preservation of rare medicinal plant resources in the Middle East, through an increasing emphasis on conservation by way of botanical gardens, greenhouses, herbariums, tissue culture propagation and seed banks. Furthermore, several national and international conferences on the current state of research and practice of herbal medicine were organized during the last few years. For instance, the author of this chapter organized the several regional conference on Arab-Islamic Medicine. These conferences were designed for research scientists, local and regional traditional healers, international

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pharmaceutical and medical research companies, physicians, ethnopharmacologists, and other parties interested in the study of traditional Arabic and Islamic Herbal Medicine. Discussions touched on the historical and cultural aspects of Arabic Islamic Medicine and its contribution to modern medicine and to human well-being. The latest scientific research on medicinal and aromatic plants, pharmaceutical research, clinical trials, as well as international legislation and intellectual property rights on Arabic and Islamic medicinal plants of the region were also discussed. These conferences highlighted the importance of exploring the economically sustainable aspects of Arab-Islamic medical heritage and encouraged investment to develop pharmaceutical products based on this medical system.[26–37] The above-mentioned surveys and studies, carried out by the group of authors of this chapter, show that although most herbalists in the Mediterranean claim to have expertise in traditional herbal medicine, the majority of them are not licensed as herbalists and many are not welltrained in herbal medicine or health care. For example, the survey discussed above by Abu-Irmaileh and Afifi revealed that over 70% of the interviewed Jordanian herbalists do not have a high school degree, and a considerable percentage had no schooling at all. Hence, the scientific background of these herbalists is clearly insufficient to comprehend the etiology of diseases, to perform diagnoses, and to prescribe herbal medication. Nevertheless, Abu-Irmaileh and Afifi noticed that some practitioners are highly successful in treating conditions such as hysteria, neurotic cases, madness, and other psychotic disorders using the abovementioned herbal medicines. Abu-Irmaileh and Afifi, where the widespread use and popularity of medicinal plants and their products, which as aforementioned are freely available at Attarah shops, have raised concern regarding the professionalism of practitioners, as well as fears about the quality, efficacy, and safety of “natural” products available on the market. Many herbalists sell the plants they have in their shops regardless of the appropriateness of the disease. In some cases, the herb is recommended to the patient by a community member who had received the same treatment. The plant and herbal-based remedies are sold as single plant, pre-packed mixtures, or as freshly mixed preparations. An additional observation by Abu-Irmaileh and Afifi was that

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unsuitable storage conditions for plant materials exist in some Attarah shops. In a few cases, plant materials were stored in inadequately ventilated stores, with poor hygiene conditions where they are liable to rodent attack and similarly, some plant material was found to be rotten or infested with insects.[30] In 2002, similar observations were reported by the group of Omar Said who conducted an extensive ethnopharmacological survey among the most well-known 31 Arab herbalists in the Israel-Palestine region and the Golan Heights in order to evaluate the potential of local plants used in treating different diseases and illnesses. As in the Jordanian survey, Said and his colleagues also found that surveyed practitioners and herbalists were not licensed for this particular purpose. Their scope of experience varied greatly, depending upon their location. In the Golan Heights, there is only one practitioner who works part-time, in comparison to the West Bank and Galilee region, in which more practitioners mentioned that they depend on their practice as a sole source of income. The status of the Arab herbalists according to this survey is: – Most practitioners have very limited knowledge of the identification of species and procedures for preparing medicinal remedies. They buy ready-made or partially prepared remedies from Attarah shops and do not collect plants from natural sources. – The level of education of practitioners is in decline, where many practitioners often rely on shepherds for knowledge, identification, and collection of plant materials. – Younger practitioners were even less experienced than their older counterparts, indicating that traditional knowledge is being partially lost with new generations. – Many practitioners are turning to “mystical” or “magical” methods of healing, indicating a loss of the rich knowledge of practical plant medicine. – Plant mixtures are of poorer quality and less variety in comparison to the past. – A very limited exchange of information takes place between healers in the same area. Furthermore, medicinal plants used in one region are not used in others. For example, local healers from the Negev region

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use only plant species found in the desert. The occupation of the traditional healer is a family trade and is passed on by inheritance, so when the present generation of healers die, their expertise may die with them because children of the practitioners have no or little interest in the subject.[26–37] Herbal Medicines have gained enormous popularity in the Mediterranean and across the Arab-Islamic world over the past 30 years. According to a survey conducted by the group of Saad and Said study (2010), three of the main factors that explain the current popularity in the Mediterranean are: – The conviction that herbs are natural products and therefore are safe. About 30% of the asked people in our survey believed that all medicinal plants are safe. While 65.5% believe that not all plants are safe. – The belief that synthetic medicines are often accompanied by side effects. Therefore, 87% of the surveyed persons prefer herbal-based medicines over synthetic drugs. – Herbal-based Medicines are presumed to be safe and effective in the treatment and prevention of diseases because they are prepared according to the principles of the great Arab and Muslim physicians. – Herbal products are superior to manufactured products. – High cost and side effects of most synthetic drugs. – Movement toward self-medication. Fortunately, in contrast to the above mentioned surveys and in parallel with the observed increasing popularity of herbal-based medicines, the qualifications and training of traditional Palestinian herbalists seem to be improving during the last decade. According to recent surveys, almost all interviewed people as well as traditional healers do support scientific research into the safety and efficacy of medicinal plants. About 53% of the herbalists claim to have an academic education and 50% of them have more than 10 years’ experience. The majority of the herbalists (62.5%) are highly successful in treating cases with medicinal plants. About 70% of the attendant healers and herbalists claim that they are able to identify the plants they use in nature and to identify different parts of the plant used to

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treat different diseases. Furthermore, most of them consider diet as part of the treatment.[26–37] The majority of the participated herbalists and healers in Saad and Said study (2010) mentioned internet links and media programs as the primary source for their knowledge of herbs and their preparations. Other healers consider books as their main source of knowledge. Unfortunately, there are many books on herbal medicine on the market written by authors without medical background, who often use books by Muslim physicians and herbalists such as Ibn al-Baitar and al-Antaki. These books are then used by current practitioners in selecting treatment and prescribing herbal medicines. One serious mistake in using these books is the possible misnaming of the herb in question. Presumably, misidentification of the intended plant could subject the patient to harmful effects. In addition, in these texts, herbs were identified only by their local, common names. Based on the fact that one plant can have many names, both locally and regionally, recognition of the correct species can be very doubtful. Additionally, different plant species in many cases share the same common name. For example, Rosemarinus officinalis is known by two different local names “Hasalban” and “Iklil jabal.” The name “Hasalban” is also known for the resin produced from the plant Boswellia carterii. Another example is the use of the Arabic name “Rijl El hamameh” for Paronychia argentea and for the less commonly used plants Verbena officinalis and Anchusa officinalis. Neither the consumers nor the herbalists were aware of the fact that these plants have different uses.[37] Approximately 93% of the interviewed people in Saad and Said study (2010) do believe that herbal-based remedies are effective. About 95% of them were content with the result of medicinal plant treatments and 53% confirm that the herbal treatment did indeed alleviate their ailment. Noteworthy, 72% do regularly use medicinal plants at home, about 30% of the asked people in our survey believe that all medicinal plants are safe since they are natural products. While 65.5% believe that not all plants are safe. Almost all interviewed people as well as traditional healers do support scientific research into the safety and efficacy of medicinal plants. In addition, 87% of the surveyed persons prefer herbal-based medicines to synthetic drugs (mainly due to side effects associated with synthetic drugs).[37]

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Saad and Said’ study also interviewed Palestinian physicians who were asked about their attitudes toward herbal-based medicines in general and their knowledge regarding these therapies. The majority (83%) believe that herbal-based drugs can complement synthetic drugs and 85% think that some medicinal plant remedies should be integrated with modern medicine. Noteworthy, 91% support scientific research to develop herbal medicines and 43.8% would like to learn more about medicinal plants and their traditional applications. Furthermore, 54.2% think that their patients are interested in medicinal plants and 77.1% believe that this interest relates to serious diseases. However, only one fifth of the physicians are willing to recommend such therapies to patients with intractable or chronic diseases. Whereas 39.6% think that medicinal plants only treat very simple diseases. This study highlights the need for educational intervention and the importance of providing physicians with ready access to evidence-based information regarding medicinal plants[37.

4.2 Commonly used medicinal plants in the mediterranean Currently, despite the fact that Greco-Islamic Herbal Medicine continues to be the prevailing traditional healing system, particularly in Middle Eastern societies, where the foundations of modern Western Medicine were laid, Western and Chinese phytotherapies have become another important source of therapy. There are more than 2,600 known plant species in the eastern region of the Mediterranean. About 350–450 of them are still in use for treatment and prevention of all known types of diseases. Plant parts used included leaves, flowers, stems, roots, seeds, and berries. A comprehensive survey that was conducted on practitioners and herbalists in Israel, the West Bank, and the Golan Heights, evaluated the number and types medicinal plants that are currently used by herbalists and practitioners. Results revealed that 129 plant species were in use in Arabic Traditional Medicine for the treatments of various diseases. Among these plants, 40 species were used for treating skin diseases, 27 species for treating diseases of the kidney and urinary system, 26 species

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for treating diabetes, 23 species for treating the digestive system including stomach and intestinal pain and inflammation, 22 species for treating liver diseases, 16 species for treating respiratory system and coughing, 13 species for treating forms of cancer and nine species for treating weight loss and cholesterol reduction. Each interviewed practitioner has his own methods of preparation, following the tradition of his parents or teachers. The process of transmitting knowledge from one generation to the next is complex one, and the end result is not always identical.[28–34] Another comprehensive ethnopharmacological study published in 2000 by Lev and Amar, covered selected medicinal plants markets in Israel belonging to various religious and ethnic communities, and included a survey of dealers and consumers concerning the healing properties of the herbal-based preparations. The survey revealed data on 310 medicinal materials, of which: 264 species of plants, 20 species of animals, 19 kinds of minerals, and seven remedies of other or mixed origin. About 50% of the used materials were of local origin whereas the others were imported from other countries. Similar findings were reported in 2003 by Omar Said who conducted a survey on the practice of Traditional Palestinian Medicine, in which herbal-based medicines comprise a significant and essential segment of public healthcare. Similar observations were obtained in another ethnopharmacological survey conducted in Jordan in which more than 100 herbalists were interviewed. More than 150 medicinal plants were mentioned by herbalists for the preparation of traditional medicines. Another recently published ethnopharmacology study by the group of Jaradat surveyed the use of herbal remedies by herbalists and traditional healers for treatment of various urological diseases in the West Bank regions of Palestine. Results obtained here revealed that 57 medicinal plants were used by the interviewed 144 herbalists and traditional healers for treatment of various urinary tract diseases in Palestine. Of these, Paronychia argentea, Plantago ovata, Punica granatum, Taraxacum syriacum, Morus alba, and Foeniculum vulgare were the most commonly used plant species in the treatment of kidney stones, while Capsella bursa-pastoris, Ammi visnaga, and Ammi majus were the most recommended plants for treatment of urinary tract infections and Portulaca oleracea used for renal failure. In addition,

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Curcuma longa and Crocus sativus were used for enuresis while Juglans regia, Quercus infectoria, Sambucus ebulus, and Zea mays were used for treating symptoms of benign prostate hyperplasia. Fruits were the most common parts used and a decoction was the most commonly used method of preparation.[28–34] Abu-Irmaileh and Afifi surveyed the situation of herbal medicine sales in Jordan. They interviewed more than 100 herbalists throughout the country. The data included the types of medicinal plants present in the market, recommendations made by herbalists for the treatment of specified disease, the education and training of the herbalists, and other observations. More than 150 herbal-based preparations were available in natural products shops (Attarah). Twenty-seven medicinal plants were found to be common and are sold in most Attarah shops in Jordan. Nine medicinal plants were revealed as most prevalent. They are regarded as safe without reported side effects, except when misused, or not properly handled. The remaining 17 medicinal plants, which are available in Attarah shops, are sold to certain extent less than those considered as commonly used plants. This group includes some plants which contain harmful compounds. Included among them are Peganum harmala and the seeds of Ricinus communis. The seeds of Peganum harmala are traditionally used in the form of a decoction in treatment of male impotence. Overdose of the decoction can be harmful as the plant contains many potent alkaloids such as harman, harmalan, and harmalin, which are highly toxic and may accumulate to dangerous concentrations in the body of the patient; in most cases of traditional medicine, the recommended treatment period spans for 3–12 months. The seeds of Ricinus communis contain the toxic polypeptide ricin, a heat labile compound that is removed from the medicinally used Ricinus communis fixed oil, which is very well known for its laxative properties. Furthermore, oral intake of the seeds is recommended by some traditional healers in Jordan as a female contraceptive despite the fact that five to eight seeds may be lethal to an adult person.[30] Another survey on the uses of medicinal plants in the coastal Mediterranean region of Egypt recorded 230 plants from which 89% have multipurpose medicinal uses. These plants belong to four major families;

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Compositae (17%), Leguminosae (11.4%), Gramineae (10.5%), and Chenopodiaceae (7.9%). In Morocco, the pharmacopoeia dates to the time of the Arab-Islamic expansion into Europe (711 AD). Later on, the pharmacopoeia was further enriched to include knowledge introduced by various ethnic groups that migrated to Morocco from the Arabian Peninsula, the Andalusians and Jews from Europe, and the black Africans from Sudan, Senegal and Niger. Notably, the Greco-Arab and Islamic medical system was taught at the Quarawin University in Fez until 1893, when it was stopped by the French colonialists. According to botanical studies, there are approximately 42,000 plant species in Morocco (715,000 square kilometers), consisting of 150 families and 940 genera, spread throughout the entire country. Several ethnopharmacological studies revealed that the various traditional medicine are still popular and relatively well preserved by the different Moroccan ethnic groups, such as the Arabs, Sahraouis, Soussis, and Rifains. In recent years, there have been remarkable research activity in the field of herbal-based medicines that takes place at institutions of higher education in Morocco. As a result, numerous medicinal plants and their traditional uses have been investigated and their safety and efficacy have been published in international scientific journals. An ethnopharmacological study published in 2007 by the group of Lyoussi, surveyed the main medicinal plants used in folk medicine to treat arterial hypertension and diabetes mellitus in the Errachidia province in south-eastern Morocco. Four hundred herbals and heath traditional medicine partakers were interviewed throughout different regions of the province. Results obtained indicate that 64 medicinal plants belonging to 33 families are used. Of these, 45 are used for diabetes, 36 for hypertension, and 18 for both diseases. About 34% of the reported plants were wild plants, 44% are cultivated plants, and 22% of the plants are not indigenous to the area and are brought from other parts of Morocco or from outside the country. In addition, results showed that 78% of the patients regularly use these medicinal plants. In this region, the most frequently used plants to treat diabetes include Ajuga iva, Allium cepa, Artemisia herba- alba, Carum carvi, Lepidium sativum, Nigella sativa, Olea europaea, Peganum harmala,

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Phoenix dactylifera, Rosmarinus officinalis, and Zygophyllum gaetulum, and those used to treat hypertension include Ajuga iva, Allium cepa, Allium sativum, Artemisia herba-alba Asso, Carum carvi, Nigella sativa, Olea europea, Rosmarinus officinalis, Origanum majorana, Peganum harmala, and Phoenix dactylifera. The local people recognize which plants are toxic and are very careful in using such plants, which are Citrullus colocynthis, Datura stramonium, Nerium oleander, Peganum harmala, and Zygophyllum gaetulum. Another earlier ethnobotanical survey, published in 2003 by the group of Lyoussi, found that 102 medicinal plants belonging to 48 families grow in Northern Morocco. The majority of them grow in the wild (61%), while others are cultivated (37%), and some (1.9%) are domesticated. In addition, herbal-based preparations are widely used in indigenous pharmacopoeia to alleviate the common symptoms of cardiovascular (5.8%), gastrointestinal (24.9%), bronchopulmonary systems (9.8%), urogenital (12.2%) and skin diseases (9.2%). Among the 102 herbs, 13 medicinal plants are widely commercialized in the region and exploited outside of the province. Centaurium erythraea and Rosmarinus officinalis, Zea mays and Foeniculum vulgare are found to be useful in renal disease and have been shown to have a diuretic effect in experimental studies. Trigonella foenum-graecum, Ammi visnaga, Nigella sativa, and Ajuga iva were reported to have antidiabetic and hypoglycemic properties.[28–34] According to aforementioned ethnopharmacological surveys, all rare species, most of the occasional species and even certain common species, face potential extinction as a result of habitat loss, habitat degradation, overharvesting due to the increased trade of herbal-based preparations, ongoing destruction of their natural habitat, and detrimental climatic and environmental changes. As a result, it is predicted that in semi-arid regions such as the Middle East, a number of species will disappear within the next decade, particularly in deserts or dry areas.[28–34,65] Based on results obtained in our recent survey and other ethnopharmacological potential studies, the following sections of this chapter provide an overview of medicinal plants and their preparations in the Mediterranean (Table 4–1).

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√

Ammi visnaga

Others

Anti-obesity

Nervous system

Hepatoprotective

Cardiovascular

Vasoconstrictive

Hypolipidemic

Antiallergic

Anticancer

Antimicrobial

Antidiabetic

Hypotensive

Immunomodulatory

Anti-inflammatory

Medicinal Plant

Antioxidant

Table 4–1    Most commonly used medicinal plants in the mediterranean region and their evidence-based medical effects.

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Conium maculatum √

Cyperus rotundus

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Asafoetida asafoetida

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Ruscus aculeatus Inula viscose

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Portulaca oleracea

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Ruta chalepensis

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Trigonella foenum-graecum

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Cuminum cyminum Atriplex halimus

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Cichorium intybus

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Eruca sativa

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Melissa officinalis

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Origanum majorana

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Salvia fruticosa

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Silybum marianum

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Capparis spinosa

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Foeniculum vulgare

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Hypericum triquetrifolium

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Urtica dioica

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Nigella sativa

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Olea europaea

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Punica granatum

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History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  269

4.3 Medicinal plants used in the treatment of diabetes, obesity, cardiovascular diseases The prevalence of type 2 diabetes mellitus (T2DM) has increased dramatically during the last two decades, a fact driven by the increased prevalence of obesity, which is the primary risk factor for T2DM. According to WHO, more than 220 million people worldwide were diabetic in 2010 and this number is estimated to be doubled in 2040. The figures for diabetes in the Arab world are particularly alarming as the prevalence of diabetes is estimated to increase by about 100% by 2035. Obesity and diabetes have become a major public health problem throughout the world because of their high prevalence, causal relationship with serious diseases, adverse effect on quality of life, and considerable economic consequences. These two chronic diseases are closely associated with our modern lifestyle that requires minimal daily physical activity and provides an abundance of pleasurable foods. These factors contribute to an adverse gene-environment interaction with harmful consequences. Diabetes and obesity are closely linked with the development of serious complications. Large number of scientific publications in recent decades have indicated that abnormal high accumulation of body fat is associated with increase in the prevalence of metabolic disorders, collectively known as obesityrelated disease or metabolic syndrome. It includes insulin resistance, hypertension, diabetes, hyperinsulinemia, and dyslipidemia characterized by elevated levels of triglyceride and low-density lipoprotein (LDL) and low levels of high-density lipoprotein (HDL). Progression in these diseases can eventually cause atherosclerosis, and thus, metabolic syndrome constitutes a significant risk for coronary heart disease (CHD).[66–71] Despite the great progress in Western Medicine in the treatment and prevention of obesity and diabetes, herbal medicine has continued to be preferred over synthetic drugs by people in most Arab and Islamic countries. In general, anti-obesity medicinal herbs are known to exert their weight-reducing effects through five basic mechanisms: controlling appetite, stimulating thermogenesis and lipid metabolism, inhibiting pancreatic lipase activity, preventing adipogenesis, and promoting lipolysis. Whereas antidiabetic medicinal herbs are classified according to the route,

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Figure 4–4    Possible action mechanisms of medicinal plants and their mixtures.

through which they induce their normoglycemic effect. Natural products having antidiabetic potential, which acts through either insulinomimetic, secretagogues properties, affecting signalling cascades involved in glucose homeostasis, or through the modulation of sugar absorption, distribution, metabolism, and elimination routes (Figure 4–4).

4.3.1  Olea europaea (olive tree) Olive leaves and olive oil have been widely used in Arab and Islamic traditional medicine as well as a main component of the Mediterranean diet. Olive leaf products are currently marketed as having wide-ranging

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pharmacological benefits, such as treatment of hypertension, atherosclerosis, cancer, diabetes, and cardiovascular diseases (Figure 4–4). Both olive leaves and olive oil contain several active compounds, with health beneficial effects, collectively known as olive biophenols. Oleuropein, followed by verbascoside, luteolin, rutin, catechin, and hydroxytyrosol are the most abundant biophenol. Several in vitro animal model and clinical investigations have confirmed the traditionally claimed therapeutic effects of olive leaves-based products. For example, the weight-reducing properties of a well-defined olive leaf extract was investigated in high fat diet-induced mice. Olive leaf extract significantly decreased the gain of body weight, visceral fat-pad weights, and plasma lipid levels in the test mice. These beneficial anti-obesity effects in mice appear to be mediated, at least in part, through downregulating the expression of molecules involved in adipogenesis and upregulating the expression of molecules involved in thermogenesis in the visceral adipose tissue of mice fed with high-fat diet.[3,42,43,47,72–76] In a recent randomized, double-blinded, placebo-controlled, crossover trial in New Zealand investigated the effects of oleuropein and hydroxytyrosol on insulin sensitivity as well as on cardiovascular risk factors. In this study, overweight middle-aged men (n = 46) [BMI (28.0 ± 2.0) kg/m2] at risk of developing the metabolic syndrome were asked to take capsules with olive leaf extract or placebo for 12 weeks, crossing over to other treatments after a 6-week washout. Olive leaf intake led to a 15% improvement in insulin sensitivity and a 28% improvement in pancreatic b-cell responsiveness compared to placebo. In addition, olive leaf extracts also led to increased fasting levels of interleukin-6, IGFBP-1, and IGFBP-2.[1,3,42,43,47,72–76] Many scientific reports have indicated that many herbal-based active phytochemicals exert their preventive/therapeutic effects via synergistic or additive mechanisms of two or more compounds affecting single or multiple target cells and tissue (Figure 4–4). These phytochemicals exert their beneficial health effects by reducing side effects associated with the use of synthetic drugs consisting of a single compound. A synergistic effect of different anti-obesity herb-mixtures containing olive leaf extracts. For instance, “Weighlevel” is a mixture of extracts from leaves of Alchemilla vulgaris, Olea europea, and Mentha longifolia L., as well as seeds of

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Cuminum cyminum. These four herbs are used in traditional Greco-Arabic and Islamic herbal medicine as well as in traditional European herbal medicine. Weighlevel showed significant antioxidant effects (at 10 μg/ mL) and induced significant weight loss in chickens fed with this mixture for four weeks. In addition, a 300% increase in the thermogenesis was seen in rat interscapular brown adipose tissue following exposure to different concentrations of Weighlevel. Furthermore, a clinical study was carried out among 80 human volunteers with a body mass index (BMI) of (30.67 ± 2.14) kg/m2. The volunteers were asked to continue their usual diet but to eat only three main meals daily and to take one Weighlevel tablet 30 minutes before each meal for three months. A progressive and significant weight loss was measured in these volunteers during the whole study period. Higher levels of weight loss were found in overweight people with BMI of 25 –30 kg/m2 compared to obese people with BMI >30 kg/m2. The BMI was reduced after three months from (28.5 ± 1.2) kg/m2 and (32.1 ± 1.8) kg/m2 to (24.5 ± 1.4) kg/m2 and (27.5 ± 2.2) kg/m2 in overweight and obese group, respectively.[3,43,47] Olive leaf extracts are also found in many polyherbal preparations that are utilized to treat obesity-related diseases such as, hyperlipidemia and diabetes. For example, “Cholevel” is a fixed combination of dry extracts of Loquat (Eriobotrya japonica) and olive leaves. Hypolipidemic properties of Cholevel were investigated in a double-blinded, randomized clinical study carried out among 41 human volunteers with hyperlipidemia. The volunteers were asked to continue their usual diet and medications, unchanged. Efficacy and tolerability of Cholevel were evaluated for three months. Group one included 12 persons who were given a fixed dose of statins therapy without fully responding to their medications; they consumed Cholevel tablets 1 × 3 daily. Group two included 20 volunteers who consumed only Cholevel tablets 1 × 3 daily. Group three (control group) included nine volunteers who consumed placebo tablets 1  ×  3 daily. Cholesterol levels were significantly reduced in groups one and two by 24% and 14.3% after three months of treatment with Cholevel, respectively. Parallel reductions in both LDL and triglycerides levels and increments in HDL levels were observed.[45] Olive leaf extracts are also found in an antidiabetic polyherbal preparation “Glucolevel.” In addition to olive leaf, the mixture contains extracts of dry leaves from Juglans regia L., Urtica dioica L., and Atriplex

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  273

halimus L.. Hypoglycemic effects of Glucolevel were evidenced by the augmentation of glucose uptake by yeast cells and by inhibition of glucose intestinal absorption in a rat gut segment. Furthermore, treatment with Glucolevel of Streptozotocin-induced type 2 diabetes mellitus rats for 2–3 weeks showed a significant reduction in glucose levels to normal levels. Furthermore, the glucose levels were tested in 16 human volunteers with recent onset of type 2 diabetes mellitus who received Glucolevel tablets 1 × 3 daily for a period of four weeks. Within the first week of Glucolevel consumption, baseline glucose levels were significantly reduced from (290 ± 40) mg/dL to (210 ± 20) mg/dL. At baseline, a subgroup of 11 of these subjects had glucose levels below 300 mg and the other subgroup had levels ≥300 mg. Clinically acceptable glucose levels were achieved during the second to third week of therapy in the former subgroup and during the fourth week of therapy in the latter subgroup. No side effect was reported. In addition, a significant reduction in hemoglobin A1c values were found in six patients treated with Glucolevel.[42] Research on the impact of consumption of olive oil and olive leaves extracts on cholesterol-lowering action, hypotensive effect, and other cardiovascular diseases, has expanded over the last four decades. For example, a stable olive leaf extract “EFLA®943” was tested in a pre-clinical study carried out in 20 monozygotic adult twin pairs with mild hypertension in Germany. An eight-week daily treatment with 500 or 1,000 mg of EFLA®943 resulted in a significant reduction of patients’ systolic blood pressure and diastolic blood pressure compared to untreated control group. At a dose of 1,000 mg, the extract was clearly superior to recommendations for lifestyle changes in reducing mean blood pressure levels from baseline. The study showed that the extract induced a significant reduction of LDL-cholesterol level. Based on these positive preclinical results, a recent double-blind, randomized, parallel, and active-controlled clinical study was carried out to evaluate the hypotensive effects as well as the tolerability of EFLA®943 in comparison with Captopril (an angiotensin-converting enzyme inhibitor used for the treatment of hypertension and some types of congestive heart failure) in patients with stage-1 hypertension. It consisted of a run-in period of four weeks continued subsequently by an eight-week treatment period. EFLA®943 was given orally at the dose of 500 mg twice daily in a flat-dose manner throughout the eight weeks. Captopril was given at the dosage regimen of 12.5 mg twice daily

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at the start. Results obtained here indicate that the mean systolic blood pressure at baseline was (149.3 ± 5.58) mmHg in olive group and (148.4 ± 5.56) mmHg in Captopril group, and mean diastolic blood pressure were (93.9 ± 4.51) mmHg and (93.8 ± 4.88) mmHg, respectively. After eight weeks of treatment, both groups experienced a significant reduction of systolic blood pressure as well as diastolic blood pressure from baseline while such reductions were not significantly different between groups. Means of systolic blood pressure reduction from baseline to the end of study were (−11.5 ± 8.5) mmHg and (−13.7 ± 7.6) mmHg in Olive and Captopril groups, respectively, and those of diastolic blood pressure were (−4.8 ± 5.5) mmHg and (−6.4 ± 5.2) mmHg, respectively. Triglyceride level were significantly reduced in olive group, but not in Captopril group[78–80] (Figure 4–5).

Figure 4–5    Cellular and biochemical targets of olea europaea.

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  275

Many prospective studies demonstrated that olive oil consumption attributes largely to the well-known beneficial health effects of the Mediterranean diet, in particular, on lowering the risk of cardiovascular diseases. Most of the biggest studies on the role of the Mediterranean diet in lowering the risk of cardiovascular diseases were conducted in Southern European countries. For example, the association between olive oil intake and all-cause as well as cause-specific mortality was evaluated in a Spanish population. A gradual increased consumption of olive oil was associated with lowering the cardiovascular diseases (CVDs) mortality. In two recent prospective studies, the incidence of coronary heart disease (CHD) was compared with the consumed amount of olive oil. In a Spanish cohort study taken from the European Prospective Investigation into cancer study, a 22% reduction of CHD was observed in the upper quartile consumers of more than 28.9 g of olive oil/day. In the Three-City Study conducted in France, participants who consumed olive oil intensively had a 41% lower risk of stroke than those who never consumed it. Another multicenter trial in Spain was carried out among participants (men 55–80 years of age and women 60–80 years of age) with no CVD at enrollment, though at high cardiovascular risk. They had either T2DM or at least three of the following major risk factors: smoking, hypertension, elevated LDL levels, low HDL levels, overweight or obesity, or a family history of premature CHD. The participants were assigned to one of three diets: a Mediterranean Diet supplemented with extra-virgin olive oil, a Mediterranean Diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). Based on the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. Results obtained in this study revealed that an energy-unrestricted Mediterranean diet, supplemented with extra-virgin olive oil or nuts, resulted in a substantial reduction in the risk of major cardiovascular events among high-risk persons. The results support the benefits of the Mediterranean Diet for the primary prevention of CVD.[27,42,43,45,80] The polyphenol fraction of extra-virgin olive oil may be partly responsible for its cardioprotective effects. A recently published systematic review and meta-analysis evaluated the effect of high versus low

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Figure 4–6    Health beneficial effects of the traditional mediterranean diet. Note: This diet is characterized by a high intake of olive oil, vegetables, nuts, fruit, grains, a moderate intake of fish, and a low intake of red meat or processed meats. Beneficial cardiovascular properties are mediated through reduction of the blood pressure, improvement of lipid profile, reduction of oxidative stress, and weight loss.

polyphenol olive oil on CVD risk factors in clinical trials. Twenty-six studies were included. Compared to low polyphenol olive oil, high polyphenol olive oil significantly improved measures of malondialdehyde, oxidized LDL, total cholesterol, and HDL cholesterol. Subgroup analyzes and individual studies reported additional improvements in inflammatory markers and blood pressure[81] (Figure 4–6).

4.3.2  Punica granatum (the pomegranate) Punica granatum (the pomegranate) is a shrub cultivated throughout the Mediterranean countries, Iran, India, Malaysia, and tropical Africa. Over recent decades, consumption of the pomegranate has increased

History, Present and Prospect of Greco-Arab and Islamic Herbal Medicine  277

Figure 4–7    Different cellular and biochemical targets of punica granatum.

tremendously because of its many health benefits. Pomegranate extracts (juice, seed oil, and flower extracts) have been found to exert numerous therapeutic properties, such as antitumor, antibacterial, antidiarrheal, astringent, and anti-obesity properties (Figure 4–7). The pomegranate contains very high levels of antioxidants, polyphenols, and flavonoids, compared with any other known vegetable or fruit. It contains an array of compounds that are potentially useful in treatment of obesity, diabetes, and cardiovascular diseases. The most abundant active compounds in pomegranate juice are the hydrolyzable polyphenols called punicalagins. Punicalagins are absorbed into the human body and may have dietary value as antioxidants; other phytochemicals include beta-carotene, and polyphenols catechins, gallocatechins, and anthocyanins such as prodelphinidins, delphinidin, cyanidin, and pelargonidin. The fruit contains also Vitamin C at 0.47 mg/100 g.[82–87]

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Regarding the anti-obesity properties of pomegranate, various cellular and molecular action mechanisms have been suggested to explain the weight reducing activities of the different phytochemicals found in the pomegranate. These range from decreasing energy intake, inhibition of the intestinal absorption of dietary fats by inhibiting pancreatic lipase, to antioxidant and anti-inflammatory effects. Several studies have suggested that pomegranate exerts its anti-obesity activity through suppressing energy intake and the inhibition of lipase activity (digest diary triacylglycerol). The anti-obesity effects of the pomegranate extract on energy intake were found to be similar to orlistat, a clinically proved drug that inhibits pancreatic lipase, decreasing the absorption of dietary fat in the blood and increasing fat excretion in the feces. In addition, pomegranate-derived ellagic acid and tannic acid were reported to decrease hyperlipidemia through inhibiting the pancreatic lipase activity in vitro and increasing fecal fat excretion in animal tests. Several animal studies have found that pomegranate extract also acts like sibutramine, an appetite-reducing drug. The mechanisms of the observed appetite-reducing effects in obese animals are not known and need further elucidation. Similar observations were observed in different animal models. For instance, the consumption of pomegranate seed oil (61 mg/day) for 14 weeks and a high fat diet resulted in decreases of body weight, leptin, insulin, and increased adiponectin compared with untreated animals. The weight reduction seems to be mediated through the leptin-adiponectin pathway because leptin and adiponectin — these cytokines, are closely linked to the regulation of the body weight.[82–87] Punicalagin, ellagic acid, and anthocyanins antioxidant capability have been the subject of several in vitro and animal studies. These phenolic molecules are known for their free radical-scavenging activities and the inhibition of lipid oxidation.[1,27,43,82–87] A significant increase in vascular endothelial nitric oxide synthase and plasma nitric oxide contents was seen because of pomegranate extract consumption. Furthermore, they were found to increase the response to acetylcholine in a resistance artery in vitro, thus suggesting a clinical application in the metabolic syndrome. In addition, a one-year consumption pomegranate juice decreased oxidation of HDL and LDL in humans. In a randomized control clinical trial conducted in 2008, 30 adolescents, aged 12–15 years, with the metabolic

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syndrome; one group consumed natural grape juice and the other group consumed pomegranate juice for one month. This study showed daily consumption of diets rich in antioxidant, such as pomegranate juice, might improve endothelial function in adolescents with metabolic syndrome. Such beneficial effects should be considered in dietary recommendations for the pediatric age group, notably in obese individuals.[82–87] In general, obesity is associated with the development of low-grade chronic inflammation and oxidative stress, which contribute to the development of obesity-related diseases. Thus, the combination of hypocaloric diets with high antioxidant contents represents a highly valuable and potent diet to treat overweight and obesity and their related diseases. Several in vitro studies have reported that pomegranate-derived compounds are highly potent anti-inflammatory agents. Obesity has been associated with the production of increased levels of adipocyte-derived inflammatory cytokines; among these, interleukin-6 (IL-6) has a primary effect on metabolism through several pathways. Pomegranate compounds decrease IL-6 production and thus modulate the expression of various adipose tissue-specific genes, insulin sensitivity, triacylglycerol release, and lipoprotein lipase downregulation.[82–87] Pomegranate-derived active compounds were demonstrated to prevent/treat obesity through modulation the gut microbiota. Nowadays there are increasing evidence that link the human gut microbiota with the development of various metabolic diseases. Beneficial bacteria, known as probiotics, such as lactobacilli and bifidobacteria exert their beneficial health effects though building a barrier that inhibit pathogen infiltration, prevention of food allergies, inhibition of carcinogenesis, stimulation of the innate immune system, production of various vitamins, increasing mineral bioavailability, and metabolizing cholesterol and lipids. Thus, the manipulation of the gut microbiota using probiotics may provide potential prevention and treatment for different diseases, including obesity. Moreover, an imbalance between beneficial and deleterious bacteria has been linked to the development of diabetes, obesity, cancer, and various neurological diseases. Most health benefits of the pomegranate are known to be caused by the presence of ellagitannins, mainly punicalgins and ellagic acid. These components were found to favor the growth of beneficial to “bad” gut microbiota. Punicalagins are hydrolyzed in the small intestine to yield

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ellagic acid. The consumption of pomegranate products was found to elevate the concentration of ellagitannins in the large intestines, where they interact with complex gut microflora. Pomegranate by-products and punicalagins inhibit in vitro the growth of pathogenic Clostridia species, Pseudomonas aeruginosa, and Staphylococcus aureus. It was also observed that probiotic lactobacilli and most bifidobacteria were not affected, whereas the growth of Bifidobacterium breve and Bifidobacterium infantis were significantly elevated after treatment with pomegranate by- products, as was the production of short-chain fatty acids in media inoculated with human fecal microflora. Thus, the manipulation of the gut microbiota using probiotics may provide potential prevention and treatment for different diseases, including obesity.[1,27,43,82–87] Over the two decades, many scientific publications have linked pomegranate with T2DM prevention and treatment. Recent findings from cell culture and animal studies as well as clinical human research have shown that pomegranate fractions (peels, flowers, and seeds) and some of their active components exhibit favorable hypoglycemic effects. One key mechanism by which pomegranate fractions affect the T2DM condition, is by reducing oxidative stress and lipid peroxidation. Fasting blood glucose levels were decreased significantly by punicic acid, methanolic seed extract, and pomegranate peel extract. Other compounds in pomegranate, such as punicalagin and ellagic, gallic, oleanolic, ursolic, and uallic acids, have been identified as having anti-diabetic effects. In addition, the juice sugar fraction was found to have unique antioxidant polyphenols (tannins and anthocyanins), which could have beneficial effects on T2DM. These findings provide evidence for the anti-diabetic activity of pomegranate fruit, however, before pomegranate or any of its extracts can be medically used for the management of T2DM, controlled clinical studies are needed. [1,27,43,82–88]

4.3.3  Black seeds (Nigella sativa) Black seeds (Nigella sativa) have been widely used in Arab-Islamic Medicine since centuries. The prophet Mohammed (peace be upon him) stated 1,400 years ago in a Hadith, “The black seed can heal every disease, except death.” Therefore, they are regarded as the seed of blessing

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(Habbatul barakah). Avicenna made mentioned to black seed in his Canon, for their stimulation of the body’s energy. In the Unani medical system, seeds are regarded as a useful remedy in the treatment of a large number of diseases.[89–91] Over the recent decades, the pharmacological activities and safety properties of black seeds have been extensively evaluated. A Google Scholar and Medline search on “Nigella sativa” or “Black seed” reveals more than 850 citations. These include anti-inflammatory, antioxidant, anti-diabetic, hypotensive, anti-nociceptive, anti-histaminic, immunomodulatory, anticancer, and anti-microbial (Figure 4–8).[1,27] Thymoquinone, the active principle of the black seed, has also been found to exhibit a variety of therapeutic effects. Thymoquinone, one of the active components of Nigella sativa, exhibited many biological effects. Several

Figure 4–8    Nigella sativa therapeutic effects. Note: Different cellular and molecular targets of Nigella sativa and thymoquinone in inflammatory, cancer, and antimicrobial activities. GSH: reduced glutathione; GST: lutathione-S-transferase; SOD: superoxide dismutase; CAT: catalase.

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beneficial effects of thymoquinone such as its antidiabetic, antioxidant, anticancer, hypolipidemic, and anti-inflammatory activities have been recognized. Both black seed and thymoquinone have been found to reduce the negative effects of obesity and its related disease by a variety of mechanisms, including the stimulation of natural killer cell activity and proliferation, monocyte function, T cell-based immunity, and macrophage activity. For example, in rat models, black seeds were shown to reduce the allergic inflammatory reaction. They significantly reduced nitric oxide production and serum levels of inflammatory mediators including IL-4, IL-5, IL-6, IgE, IgG1, and OVA-specific IgG1 in rats sensitized to and treated with ovalbumin. Rats treated with black seeds experienced an attenuated T cell response and reduced T cell proliferation in the spleen. Control, untreated rats with black seed exhibited a thickening of the alveolar wall and increased numbers of goblet cells. These results indicate that black seeds inhibit Th-2-induced T cell growth and differentiation, thereby attenuate the inflammatory reaction. In other studies, pretreatment with thymoquinone reduced lung inflammation mediated by an inhibition in Th-2 cytokines production, lung eosinophilia, and goblet cell hyperplasia. Furthermore, thymoquinone-treatment downregulated the expression of COX-2 expression, PGD2 production, and a slight inhibition in COX-1 expression and PGE2 production in rats. COX-2 converts arachidonic acid into pro-inflammatory prostaglandins, whereas COX-1 mediates constitutive or “housekeeping” inflammation. Long-term increased COX-2 levels is associated with many chronic inflammatory disorders, thus inhibition of COX-2 is favorable in cases of chronic inflammatory conditions, for instance, rheumatoid arthritis. Thus, thymoquinone exerts its anti-inflammatory effects primarily through downregulation of COX-2 and PGD2 production.[89–91] Thymoquinone improved diabetes and hyperlipidemia through increasing antioxidant and decreasing lipid peroxidation in serum and pancreatic tissue. The most protective properties of thymoquinone against cardiovascular diseases may be related to its antioxidant and anti-inflammatory activities. Cardioprotective effects of thymoquinone have been showed in vivo and in vitro, however, these protective effects have not been confirmed by clinical trials yet and more safety assessments are necessary to determine the toxic properties of thymoquinone in humans for long-term

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application. In addition, more studies should be conducted to confirm its traditional use as treatment against cardiovascular diseases. Thymoquinone has been reported to have anticancer properties in cell culture systems and animal models. There are studies that link the anticancer effects of thymoquinone with its pro-oxidant activities. For example, it induced a significant production of reactive oxygen species (ROS) and inhibited the activity of aconitase, an enzyme sensitive to superoxide anion generation in human colon cancer cells and in isolated rat liver mitochondria. Furthermore, many multidrug-resistant variants of human leukemia, pancreatic adenocarcinoma, and uterine sarcoma were found to be sensitive to thymoquinone. In addition, thymoquinone induces apoptosis through modulation of multiple targets and hence is a promising anticancer compound that could be useful for the treatment of many types of cancers. Thymoquinone was found to inhibit angiogenesis in vivo, through preventing tumor angiogenesis in a xenograft of human prostate cancer model in mouse and blocking human prostate tumor growth with almost no side effects. Thymoquinone inhibited the growth of prostate and colon tumors implanted in nude mice with no noticeable side effects. The observed effects in colon xenografts seem to not be the result of decreased proliferation but rather a significant induction of apoptosis. However, in androgen-independent prostate tumor xenografts, the inhibition of tumor growth was accompanied with a marked decrease in E2F-1 and induction of massive apoptosis. These findings indicate that the anti-tumor activity or anti-mitotic effects could in part be due to the ability of thymoquinone to arrest cell cycle at various phases.[1,27,89–91]

4.3.4  Curcuma longa rhizomes (Turmeric) Curcuma longa rhizomes (Turmeric) is a rhizomatous herbaceous perennial plant widely cultivated in the tropical and subtropical regions of the world and is a commonly used medicinal plant in the Indian and Chinese medical systems. Turmeric has been long used for its anti-inflammatory and other health-promoting effects. Its pharmacological properties have been attributed to curcumin, the active compound (Figure 4–9). Curcumin is one of the hundreds of components isolated from turmeric, and it has been studied intensively in recent years for its potential therapeutic

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Figure 4–9    Different cellular and biochemical targets of curcuma longa.

effects. These include anti-inflammatory, anti-angiogenic, antioxidant, wound healing anti-cancer, anti-obesity, and obesity-related metabolic diseases. Accumulating experimental evidence indicate that curcumin is effective in promoting weight loss and reducing the incidence of obesityrelated diseases. As mentioned above, obesity is characterized by chronic low-grade metabolic inflammation. Hence, phytochemicals like curcumin, which exhibit anti-inflammatory effects, are being intensely studied as potential therapeutic agents. With regard to anti-obesity effects of curcumin, much recent scientific research has revealed that it can directly interact with white adipose tissue to inhibit chronic inflammation, to inhibit preadipocyte differentiation, and to activate potent cellular antioxidants. There are multiple cellular and molecular mechanisms by which curcumin mediates its

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anti-inflammatory effects. These include, but are not limited to, transcription factors (NF-jB, AP-1), growth and differentiation factors (Wnt10b), pro-inflammatory cytokines (TNFa, IL-1b, and IL-6), AMP-activated protein kinases which suppress the expression of pro-inflammatory adipokines including TNFa, MCP-1, and PAI-1 and induces the expression of adiponectin, and the principal anti-inflammatory mediators produced by adipocytes. Curcumin also inhibits the differentiation of preadipocyte to mature adipocytes. The underlying molecular mechanisms of this inhibition may be the preservation of active canonical Wnt signaling within white adipose tissue with b-catenin- dependent suppression of C/EBPa and PPARc, transcription factors essential for adipocyte differentiation. In other tissues, curcumin induces the nuclear translocation and activation of Nrf 2, a key regulatory transcription factor essential for the expression of multiple antioxidants. Curcumin also acts to influence the longevity of the intracellular regulator of energy metabolism SIRT1 in adipose tissue. SIRT1 functions in adipose tissue to protect from inflammation.[1,27,92,93]

4.3.5  Cumin (cuminum cyminum L.) Cumin belongs to the family umbelliferae. Cumin and its products are used as food spices. Cuminaldehyde, the major active principle of cumin, exhibit anti-allergic, anti-obesity, antioxidant, anti-platelet aggregation, and hypoglycemic effects. A double-blind randomized placebo-controlled clinical trial among 78 overweight subjects aged 18–60 years, tested the effects of cumin on weight loss and metabolic profiles. The subjects were randomly divided into three groups and were asked to take either cumin capsule, orlistat 120 capsule (a drug designed to treat obesity), or placebo three times a day for eight weeks. Both cumin and orlistat 120 treatment resulted in a similar significant reduction in weight [(1.1 ± 1.2) kg and (0.9 ± 1.5) kg versus (0.2 ± 1.5) kg, respectively] and BMI [(0.4 ± 0.5) kg/m2 and (0.4 ± 0.6) kg/m2 versus (0.1 ± 0.6) kg/m2], respectively compared with placebo. These results indicate that cumin has the same effects of orlistat 120 on weight and BMI and beneficial effects on insulin metabolism compared with orlistat 120 and placebo.[1,27,94–96]

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Cumin was also found to improve glucose utilization, reduce raised blood sugar, and promote digestion by stimulating gastrointestinal mucosa and pancreatic digestive enzymes.[4,6,12,65–71] For example, Cumin used in the preparation “Weighlevel,” a mixture of extracts from four plants used in traditional Greco-Arabic and Islamic Medicine. This polyherbal mixture consists of leaf extracts of lady’s mantle (Alchemilla vulgaris), olive tree, and mint, as well as seeds of cumin. Weighlevel exhibited significant antioxidant effects and induced significant weight loss in chickens fed with Weighlevel for four weeks. In addition, Weighlevel caused a threefold increase in the rate of thermogenesis in rat interscapular brown adipose tissue as determined by measurement of increased oxygen intake. Furthermore, Weighlevel was tested in a clinical trial carried out among 80 subjects with a body mass index (BMI) of (30.67 ± 2.14) kg/m2. The subjects were asked to continue their normal diet but to eat only three main meals daily and to take one Weighlevel tablet 30 minutes before each meal for three months. This treatment caused a progressive and significant weight loss in these subjects. Peak effects were seen in people with BMI of 25–30 kg/m2 (overweight) compared to people with BMI higher than 30 kg/m2 (obese), where the BMI values were reduced from (28.5 ± 1.2) kg/m2 and (32.1 ± 1.8) kg/m2 to (24.5 ± 1.4) kg/m2 and (27.5 ± 2.2) kg/m2 in overweight and obese group, respectively.[43] A recent meta-analysis has evaluated the efficacy of cumin supplementation on plasma lipid concentration in adult population. Analysis of data from six eligible randomized controlled trials with 376 participants showed a significant reduction in plasma concentration of total cholesterol and LDL cholesterol after supplementation with cumin compared with control treatment, and plasma concentration of HDL cholesterol were seen to be increased.[97]

4.4 Prospect of Greco-Arab and Islamic herbal medicine The fact that many of the currently used drugs are derived from medicinal plants (e.g., digitalis from foxglove leaves, salicylates from willow bark, quinine from cinchona) proves that traditionally used medicinal plants

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may be effective remedies for treating diseases. Nowadays, it is well accepted that there is no such thing as an “alternative” medicine, but only that for which effectiveness has been confirmed using biological, chemical, pharmacological accurate tests. The scientific criteria for causal associations include biological credibility, consistency of research results, dose-response effects, reproducibility of the research in different contexts using different methodologies, the strength of the association, and a correct temporality between cause and effect (Figure 4–10).

Figure 4–10    Research strategies in herbal-derived trials. Note: A single medicinal plant may contain hundreds of natural constituents and a mixed herbal medicinal product may contain several times that number. Therefore, the requirements as well as the research protocols, standards, and methods needed for the evaluation of the safety and efficacy of herbal medicines are much more complex than those required for conventional or orthodox pharmaceuticals.

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The above-mentioned ethnopharmacological surveys from the Mediterranean region as well as other studies from other regions of the world, highlight the necessity for proper regulations and licensing of medicinal plants and their derived products. The increasing popularity of these products as well as of other natural sources indicates that the public is not satisfied with modern school medicine. Public demand has also grown for evidence on the safety, efficacy, and quality of herbal products and Greco-Arab practices. Public demand that, like new synthetic drugs, herbal remedies must fulfil international requirements on quality, safety, and efficacy. In certain simple to mild diseases, herbal medicine could be useful, independent of diagnosis, but this is unlikely in the majority of cases which require a complex history of the patient, a thorough physical examination, and proper laboratory data for the correct diagnosis and adequate treatment. As we have seen in our surveys, all those surveyed would like to see more research activities in the field of medicinal plants in order to ensure the quality, safety, and efficacy of herbal-based remedies. Concerning the safety, despite the fact that many herbal-based medicines are safe and effective, there are many precautions regarding their use, especially in view of the recent rise in the sale and administration of herbal medicine in Attarah shops by non-experienced herbalists. Several surveys showed that, due to a lack in proper education, traditional healers prescribe herbal medicines symptomatically rather than because of a full and holistic determination of the underlying disease. Standardization and regulatory measures of herbal medicinal products are other important issues in the development of evidence-based herbal medicine. Standardization of herbal medicines is often a very difficult task because of the quantity and complexity of their diverse secondary metabolites. Both quantity and diversity of the active compounds of medicinal depend largely on age, genetic factors, and geographical location of the plant species. Variability in chemical composition and concentration can result in significant differences in safety and therapeutic effects. Additionally, the harvesting process and period, coupled with incidents of adulterations due to the presence of microorganisms and pesticides have profound impact on achieving uniform standards of herbal medicines worldwide.

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Aside from the use of scientific methods to ensure the quality and safety of herbal remedies, the integration of control measures during the course of production, storage, and sale, which conforms to extant rules and regulations should be officially and legally applied using established government institutions and legislative instruments. Unfortunately, in the absence of stricter regulatory controls the production and sale of herbal medicines in developing countries is a major drawback for traditional medicine. For instance, if not properly stored, the pharmaceutically active compounds in plants could degrade by hydrolysis or oxidation to rather toxic compounds or degradation products. Also, many cultivated medicinal herbs went through different breeding procedures throughout the years with the aim of increasing their yield. Presumably, the newly cultivated and hybridized strains of the same species may not correspond to the plants described in the old books. Despite potentially harmful information, herbalists in the Arab and Islamic world rely on these books, which could be the source of differences among the documented and recommended uses of commonly used medicinal plants. Such books often did not provide clear descriptions of preparation methods accompanying the herbalists’ recommendations. Such findings support the necessity of regulations concerning the proper handling of herbal medicines, which requires proper oversight and licensing. WHO regulations can be considered a good basis for such regulations. Therefore, improvement in the quality of herbal medicines could be achieved by deliberate implementation of good agricultural practices (GAPs) at the point of cultivation of medicinal plants and good manufacturing practices (GMPs) during the process of manufacture and packaging of finished herbal products, as well as post-marketing quality assurance surveillance. In parallel with the currently observed increasing use and fastgrowing market of herbal medicines and other herbal healthcare products, in both developing and developed countries of the world, policy-makers, health professionals, and the public are increasingly expressing concerns about the safety, efficacy, quality, availability, preservation, and further development problems of these herbal products. Public demand has also grown for evidence on the safety, efficacy, and quality of herbal products and Greco-Arab practices. In order to allay these concerns and to meet

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public demands, it provides and aims to explain different kinds of herbal medicine. Therefore, there is no doubt that future trends in the development of herbal-based medicines must include a powerful and deep assessment of their pharmacological qualities and safety issues. It is clear that the currently observed widespread use of herbal-derived substances all over the world cannot rely only on the tradition or supposed millenarian beliefs. Explanatory and pragmatic studies here are useful and complementary in the acquisition of reliable data both for health caregiver and patients. Current and future trends in the characterization of the pharmacological and biological effects of herbal-based medicines have to involve experts belonging to different scientific fields, including botany, chemistry, biochemistry, immunology, molecular biology, and bioinformatics. These fields are becoming of great interest for several high-impact scientific journals. In parallel, ethnopharmacological surveys from the Mediterranean as well as from other regions of the world emphasize the necessity for the proper handling and licensing of herbal medicines. The increasing popularity of herbal-based medicinal products or other natural sources indicates that the public is not satisfied with modern medical treatment. It is necessary that not only new synthetic drugs, but also herbal remedies must fulfill international requirements on quality, safety, and efficacy. Current and future trends in evaluating the efficacy and safety of Greco-Arab-based traditional herbal remedy have to focus on adequately standardized replicable extracts and on the need to definitively identify relevant active components, understand their cellular and molecular action mechanisms and their synergistic effects. As aforementioned, the body of existing phytopharmacology knowledge has led to great developments in healthcare and led to the development of many synthetic drugs, either in their original or semi-synthetic form. Indeed, many of the currently used pharmacological groups of drugs include an herb-derived prototype. Aspirin, reserpine, taxol and tubocurarine are a few examples of drugs that were originally discovered through the study of traditional uses and knowledge of indigenous people. Currently, there is a revival of interest in herbal medicine-based remedies in the Arab-Islamic world as well as at a worldwide level and the conventional medicine is now beginning to accept the use of medicinal

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plants and their products once they are scientifically validated. Black seeds, ginger, ginkgo, pomegranate, milk thistle, and St. John’s Wort are a few examples of medicinal plants that are gaining popularity amongst modern physicians and researchers, and this trend is likely to continue partly due to high cost involved in the development of patentable synthetic drugs. There is growing evidence that pharmacological effects of these medicinal plants are potentiated through synergistic mechanisms and/or side effect-neutralizing combinations. In parallel to the currently observed growing interest in medicinal plants and their products, there is an increasing demand for more in-depth research on biochemical and molecular action mechanisms of phytochemicals. However, it is important to mention that the vast majority of the voluminous research relating to the topics briefly reviewed above is conducted in entirely in vitro or in animal test models. Therefore, future trends in the field of medicinal plants research must include more clinical trials (Figure 4–10). With the rapid industrialization of the planet and the loss of ethnic cultures and customs, some of this information will no doubt disappear. An abundance of ethnomedical information on plant uses can be found in the scientific literature but has not yet been compiled into a usable form. As a vast proportion of the available higher plant species have not yet been screened for biologically active compounds, drug discovery from plants should remain an essential component in the search for new medicines, particularly with the development of highly sensitive and versatile analytical methods. Therefore, teamwork amongst ethnobotanists, ethnopharmacologists, physicians, and chemists is essential for the fruitful outcome on medicinal plants research. The above mentioned ethnopharmacological surveys in the Mediterranean region warns that many plants are being lost through the destruction of their natural habitats. This trend will affect the discovery of new drugs, according to these reports. This gives an added sense of urgency to the task of recording their identity and use, as well as initiating programs of preservation of the genetic resources of medicinal plants in the region. This is especially relevant due to the growing interest in herbal medicines globally, accompanied by increased laboratory investigation into the pharmacological properties of the bioactive ingredients used to treat various diseases. The aforementioned surveys suggested various sets

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Figure 4–11    Conservation strategies for endangered medicinal plants.

of recommendations regarding conservation of endangered medicinal plants, including the establishment of coordinated conservation practices based on both in situ and ex situ strategies (Figure 4–11). For medicinal plants with increasingly limited supplies, sustainable use of wild resources can be an effective conservation alternative.

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[24] Saad B, Azaizeh H, Abu-Hijleh G, et al. Safety of Traditional Arab Herbal Medicine[J]. Evidence-Based Complementary and Alternative Medicine, 2006, 3(4): 433–439. [25] Ageron CR. A History of the Maghrib in the Islamic Period[M]. Cambridge: Cambridge University Press, 1987. [26] Said O, Zaid H, Saad B, et al. Greco-Arab and Islamic Herbal Medicine and Cancer Treatment/Prevention[J]. Bioactive Foods and Extracts: Cancer Treatment and Prevention, 2009: 49–66. [27] Saad B, Zaid H, Shanak S, et al. Anti-diabetes and Anti-obesity Medicinal Plants and Phytochemicals: Safety, Efficacy, and Action Mechanisms[M]. Berlin: Springer International Publishing, 2017. [28] Ali-Shtayeh MS, Yaniv Z, Mahajna J. Ethnobotanical Survey in the Palestinian Area: A Classification of the Healing Potential of Medicinal Plants[J]. Journal of Ethnopharmacology, 2000, 73(1–2): 221–232. [29] Said O, Khalil K, Fulder S, et al. Ethnopharmacological Survey of Medicinal Herbs in Israel, the Golan Heights and the West Bank Region[J]. Journal of Ethnopharmacology, 2002, 83(3): 251–265. [30] Abu-Irmaileh BE, Afifi FU. Herbal Medicine in Jordan with Special Emphasis on Commonly Used Herbs[J]. Journal of Ethnopharmacology, 2003, 89(2–3): 193–197. [31] Azaizeh H, Fulder S, Khalil K, et al. Ethnobotanical Knowledge of Local Arab Practitioners in the Middle Eastern Region[J]. Fitoterapia, 2003, 74(1–2): 98–108. [32] Lev E. Reconstructed Materia Medica of the Medieval and Ottoman alSham[J]. Journal of Ethnopharmacology, 2002, 80(2–3): 167–179. [33] Lev E, Amar Z. Ethnopharmacological Survey of Traditional Drugs Sold in Israel at the End of the 20th Century[J]. Journal of Ethnopharmacology, 2000, 72(1–2): 191–205. [34] Lev E, Amar Z. Ethnopharmacological Survey of Traditional Drugs Sold in the Kingdom of Jordan[J]. Journal of Ethnopharmacology, 2002, 82(2–3): 131–145. [35] Tahraoui A, El-Hilaly J, Israili Z H, et al. Ethnopharmacological Survey of Plants Used in the Traditional Treatment of Hypertension and Diabetes in South-eastern Morocco (Errachidia province)[J]. Journal of Ethnopharma­ cology, 2007, 110(1): 105–117. [36] El-Hilaly J, Hmammouchi M, Lyoussi B. Ethnobotanical Studies and Economic Evaluation of Medicinal Plants in Taounate Province (Northern Morocco)[J]. Journal of Ethnopharmacology, 2003, 86(2–3): 149–158.

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[37] Saad B, Said O. Greco-Arab and Islamic Herbal Medicine: Traditional System, Ethics, Safety, Efficacy and Regulatory Issues[M]. Washington, DC: Wiley, 2011. [38] Saad B, Dakwar S, Said O, et al. Evaluation of Medicinal Plants Hepatotoxicity Using Co-cultures of Hepatocytes and Monocytes[J]. Evidence-based Complementary and Alternative Medicine, 2006, 3: 93–98. [39] Azaizeh, Hassan, Saad, et al. Traditional Arabic and Islamic Medicine (TAIM) Now Joins TCM CAM, Kampo and Ayurveda[J]. Evidence Based Complementary & Alternative Medicine, 2008. [40] Azaizeh H, Kobaisy M, Dakwar S, et al. Botanical Pesticides as a Source of Safe Bioacaricides for the Control of Tetranychus Cinnabarinus[J]. Acta Phytopathologica Et Entomologica Hungarica, 2007, 42(1): 143–152. [41] Ghareeb B, Arteen M, Farha AA, et al. In Vitro Evaluations of Cytotoxicity of Crozophora Tinctoria (Ghbeira) and Antidote Effects of Silybum Marianum (Khurfeish) Applied Aspects for Grazing in Palestine[J]. An Najah University Journal for Research Natural Sciences, 2007. [42] Said O, Fulder S, Khalil K, et al. Maintaining a Physiological Blood Glucose Level with “Glucolevel,” a Combination of Four Anti-Diabetes Plants Used in the Traditional Arab Herbal Medicine[J]. Evidence-Based Complementary and Alternative Medicine, 2010. [43] Said O, Saad B, Fulder S, et al. Weight Loss in Animals and Humans Treated with “Weighlevel,” a Combination of Four Medicinal Plants Used in Traditional Arabic and Islamic Medicine[J]. Evidence-based Complementary & Alternative Medicine, 2011, 8(1): 1–6. [44] Saad B, Abou Atta BS, Basha W, et al. Hypericum Triquetrifolium — Derived Factors Downregulate the Production Levels of LPS-induced Nitric Oxide and Tumor Necrosis Factor-a in THP-1 cells[J]. EvidenceBased Complementary and Alternative Medicine, 2011. [45] Said O, Saad B, Fulder S, et al. Hypolipidemic Activity of Extracts from Eriobotrya Japonica and Olea Europaea, Traditionally Used in the GrecoArab Medicine in Maintaining Healthy Fat Levels in the Blood[J]. Open Journal of Pathology, 2009, 5(3): 73–83. [46] Kassis E, Fulder S, Khalil K, et al. Efficacy and Safety Assessments of Ferula assa-foetida L. Traditionally Used in Greco-Arab Herbal Medicine for Enhancing Male Fertility, Libido and Erectile[J]. The Open Complementary Medicine Journal, 2009, 1: 102–109. [47] Said O, Khalil K, Fulder S, et al. A Double Blinded-randomized Clinical Study with “Weighlevel,” a Combination of Four Medicinal Plants Used in

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Traditional Greco-Arab and Islamic Medicine[J]. The Open Complementary Medicine Journal, 2009, 1: 100–115. [48] Hadieh H, Said O, Massalha M, et al. Anti-inflammatory Effects of Herbalderived Factors are Mediated by Down Regulation of Pro-inflammatory Cytokines[J]. Jamia, 2010, 14: 1–13. [49] Ben-Arye E, Cassileth B, Heusser P, et al. Complementary and Integrative Oncology in the Cross-Cultural Region of the Middle East and South Asia[J]. Evid Based Complement Alternat Med, 2015, 2012: 940961. [50] Kadan S, Saad B, Sasson Y, et al. In Vitro Evaluations of Cytotoxicity of Eight Antidiabetic Medicinal Plants and their Effect on GLUT4 Translocation[EB/OL]. Evidence-based Complementary and Alternative Medicine, 2013. http:// dx.doi.org/10.1155/2013/549345. [51] Ben-Arye E, Massalha E, Bar-Sela G, et al. Stepping from Traditional to Integrative Medicine: Perspectives of Israeli-Arab Patients on Complementary Medicine’s Role in Cancer Care[J]. Annals of Oncology Official Journal of the European Society for Medical Oncology, 2014, 25(2): 476–480. [52] Mahajna S, Azab M, Zaid H, et al. In Vitro Evaluations of Cytotoxicity and Antiinflammatory Effects of Peganum Harmala Seed Extracts in THP-1derived Macrophages[J]. European Journal of Medicinal Plants, 2015. [53] Ben-Arye E, Dagash J, Silbermann M, et al. Modeling Integrative Oncology Care Program for Arab Patients in North Israel: Towards Quality of Life Improvement during Chemotherapy[J]. Harefuah, 2015, 154(154): 26. [54] Eran BA, Elad S, Kamer M, et al. Integration of Complementary Medicine in Supportive Cancer Care: Survey of Health-Care Providers’ Perspectives from 16 Countries in the Middle East[J]. Supportive Care in Cancer, 2015, 23(9): 2605. [55] Abed AH, Harb J, Khasib S, et al. In Vitro Assessment of Cytotoxic, Antioxidant and Antimicrobial Activities of Leaves from Two Grape Varieties Collected from Arid and Temperate Regions in Palestine[J]. QScience Connect, 2015, 2015(4). [56] Kadan S, Saad B, Sasson Y, et al. Cytotoxic, Antidiabetic and Chemical Composition and of Ocimum Basilicum[J]. Food chemistry, 2015. [57] Kmail A, Lyoussi B, Zaid H, et al. In Vitro Assessments of Cytotoxic and Cytostatic Effects of Asparagus Aphyllus, Crataegus aronia, and Ephedra Alata in Monocultures and Co-Cultures of Hepg2 and THP-1-Derived Macrophages[J]. Pharmacognosy Communications, 2015.

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[58] Daragmeh, Jamila, Barriah, et al. Analysis of PI3K Pathway Components in Human Cancers[J]. Oncology letters, 2016, 11(4 Pt.B): 2913–2918. [59] Ben-Arye E, Samuels N, Goldstein LH, et al. Potential Risks Associated with Traditional Herbal Medicine Use in Cancer Care: A Study of Middle Eastern Oncology Health Care Professionals[J]. Cancer, 2016, 122(4): 598–610. [60] Saad B, Wh E. Hypericum Triquetrifolium Extracts Modulate IL-6, IL-10 and TNF- ± Protein and mRNA Expression in LPS-Activated Human Peripheral BloodMononuclear Cells and THP-1-Derived Macrophages[J]. Medicinal & Aromatic Plants, 2016, 1(s3). [61] Kmail A, Lyoussi B, Zaid H, et al. In Vitro Evaluation of Anti-inflammatory and Antioxidant Effects of Asparagus Aphyllus L. Crataegus azarolus L. and Ephedra Alata Decne. in Monocultures and Co-cultures of HepG2 and THP-1- derived Macrophages[J]. Pharmacognosy Communications, 2017, 7(1): 24–33. [62] Ben-Arye Eran, Bonucci M, Daher M, et al. Refugees in Conflict: Creating a Bridge Between Traditional and Conventional Health Belief Models[J]. The Oncologist, 2017, theoncologist: 490. [63] Sleman K, Yoel S, Bashar S, et al. Gundelia Tournefortii Antidiabetic Efficacy: Chemical Composition and GLUT4 Translocation[J]. Evidencebased Complementary and Alternative Medicine, 2018: 1–8. [64] Kadan S, Sasson Y, Abu-Reziq R, et al. Teucrium Polium Extracts Stimulate GLUT4 Translocation to the Plasma Membrane in L6 Muscle Cells[J]. Advancement in Medicinal Plant Research, 2018. [65] Jaradat NA, Zaid AN, Al-Ramahi R, et al. Ethnopharmacological Survey of Medicinal Plants Practiced by Traditional Healers and Herbalists for Treatment of Some Urological Diseases in the West Bank/Palestine[J]. Bmc Complementary & Alternative Medicine, 2017, 17(1): 255. [66] Visscher TL, Seidell JC. The Public Health Impact of Obesity[J]. Annu Rev Public Health, 2001, 22: 355–375. [67] Billington CJ, Epstein LH, Goodwin NJ, et al. Overweight, Obesity, and Health risk[J]. Archives of Internal Medicine, 2000, 160(7): 898. [68] Atkinson, Richard L. Current Status of the Field of Obesity[J]. Trends in Endocrinology & Metabolism Tem, 2014, 25(6): 283–284. [69] Ng M, Fleming T, Robinson M, et al. Global, Regional, and National Prevalence of Overweight and Obesity in Children and Adults during 1980–2013: A Systematic Analysis for the Global Burden of Disease Study 2013[J]. The Lancet, 2014, 384(9945): 766–781.

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[70] Goldstein DJ. Beneficial Health Effects of Modest Weight Loss[J]. Int J Obes Relat Metab Disord, 1992, 16(6): 397–415. [71] Hassan HA, El-Gharib NE. Obesity and Clinical Riskiness Relationship: Therapeutic Management by Dietary Antioxidant Supplementation — A Review[J]. Applied Biochemistry & Biotechnology, 2015, 176(3): 647–669. [72] Ying S, Jin SS, Narae K, et al. Olive Leaf Extract Attenuates Obesity in High-Fat Diet-Fed Mice by Modulating the Expression of Molecules Involved in Adipogenesis and Thermogenesis[J]. Evidence-Based Complementray and Alternative Medicine, 2014, 1(1): 971890. [73] Bock MD, José GB, Derraik, Brennan CM, et al. Olive (Olea europaea L.) Leaf Polyphenols Improve Insulin Sensitivity in Middle-Aged Overweight Men: A Randomized, Placebo-Controlled, Crossover Trial[J]. Plos One, 2013, 8(3): e57622. [74] Saad B, Greco-Arab and Islamic Herbal Medicine, A Review[J]. European Journal of medicinal plants, 2014, 4(3): 249–258. [75] Said O, Saad B, Fulder S, et al. Hypolipidemic Activity of Extracts from Eriobotrya Japonica and Olea Europaea, Traditionally Used in the GrecoArab Medicine in Maintaining Healthy Fat Levels in the Blood[J]. Open Journal of Pathology, 2009, 5(3): 73–83. [76] Susalit E, Agus N, Effendi I, et al. Olive (Olea Europaea) Leaf Extract Effective in Patients with Stage-1 Hypertension: Comparison with Captopril[J]. Phytomedicine International Journal of Phytotherapy & Phytopharmacology, 2011, 18(4): 251–258. [77] Said O, Saad B, Fulder S, et al. Hypolipidemic Activity of Extracts from Eriobotrya Japonica and Olea Europaea, Traditionally Used in the GrecoArab Medicine in Maintaining Healthy Fat Levels in the Blood[J]. Open Journal of Pathology, 2009, 5(3): 73–83. [78] Diedrich K, Ludwig M, Fel Be Rbaum RE. Blood Pressure Lowering Effect of An Olive Leaf Extract (Olea europaea) in L-NAME Induced Hypertension in Rats[J]. Arzneimittelforschung, 2002, 52(11): 797–802. [79] Perrinjaquet-Moccetti T, Busjahn A, Schmidlin C, et al. Food Supplementation with an Olive (Olea Europaea L.) Leaf Extract Reduces Blood Pressure in Borderline Hypertensive Monozygotic Twins[J]. Phytotherapy Research Ptr, 2010, 22(9): 1239–1242. [80] Bock MD, José GB, Derraik, Brennan CM, et al. Olive (Olea Europaea L.) Leaf Polyphenols Improve Insulin Sensitivity in Middle-Aged Overweight Men: A Randomized, Placebo-Controlled, Crossover Trial[J]. Plos One, 2013, 8(3): e57623.

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[81] George ES, Marshall S, Mayr HL, et al. The Effect of High-Polyphenol Extra Virgin Olive Oil on Cardiovascular Risk Factors: A Systematic Review and Meta-Analysis[J]. Critical Reviews in Food Science and Nutrition, 2018: 1–138. [82] Al-Muammar MN, Khan F. Obesity: The Preventive Role of the Pomegranate (Punica Granatum)[J]. Nutrition, 2012, 28(6): 595–604. [83] Lei F, Zhang XN, Wang W, et al. Evidence of Anti-obesity Effects of the Pomegranate Leaf Extract in High-fat Diet Induced Obese Mice[J]. International Journal of Obesity, 2007, 31(6): 1023. [84] Mousavinejad G, Emam-Djomeh Z, Rezaei K, et al. Identification and Quantification of Phenolic Compounds and their Effects on Antioxidant Activity in Pomegranate Juices of Eight Iranian Cultivars[J]. Food Chemistry, 2009, 115(4): 1274–1278. [85] Fadavi A. Physicochemical Composition of Ten Pomegranate Cultivars (Punica Granatum L.) Grown in Iran[J]. Food Science & Technology International, 2005, 11(2): 113–119. [86] Larrosa M, A González-Sarrías, MT García-Conesa, et al. Urolithins, Ellagic Acid-Derived Metabolites Produced by Human Colonic Microflora, Exhibit Estrogenic and Antiestrogenic Activities[J]. Journal of Agricultural & Food Chemistry, 2006, 54(5): 1611–1620. [87] Dobroslawa, Bialonska, Sashi, et al. The Effect of Pomegranate (Punica Granatum L.) Byproducts and Ellagitannins on the Growth of Human Gut Bacteria[J]. Journal of Agricultural and Food Chemistry, 2009, 57(18): 8344–8349. [88] Banihani S, Swedan S, Alguraan Z. Pomegranate and Type 2 Diabetes[J]. Nutrition Research, 2013, 33(5): 341–348. [89] Salem ML, Hossain MS. Protective Effect of Black Seed Oil from Nigella Sativa Against Murine Cytomegalovirus Infection[J]. International Journal of Immunopharmacology, 2000, 22(9): 729–740. [90] Gilani AUH, Qaiser J, Khan MAU. A Review of Medicinal Uses and Pharmacological Activities of Nigella Sativa[J]. Pakistan Journal of Biological Ences, 2004, 7(4). [91] Salem ML. Immunomodulatory and Therapeutic Properties of the Nigella Sativa L. Seed[J]. International Immunopharmacology, 2005, 5(13–14): 1749–1770. [92] Peter G, Bradford. Curcumin and Obesity[J]. Biofactors, 2013. [93] Aggarwal BB. Targeting Inflammation-Induced Obesity and Metabolic Diseases by Curcumin and Other Nutraceuticals[J]. Annual Review of Nutrition, 2010, 30(1): 173–199.

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[94] Abdel-Sattar E, El Zalabani SM, Salama MM. Herbal and Microbial Products for the Management of Obesity[J]. Anti-Obesity Drug Discovery and Development, 2014, 2: 130–210. [95] Taghizadeh, Mohsen, Asemi, et al. Effect of the Cumin Cyminum L. Intake on Weight Loss, Metabolic Profiles and Biomarkers of Oxidative Stress in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial[J]. Annals of Nutrition & Metabolism, 2015, 66(2/3): 117–124. [96] Saad B. Greco-Arab and Islamic Diet Therapy: Tradition, Research and Practice[J]. Arabian Journal of Medicinal and Aromatic Plants, 2015, 1: 1–24. [97] Hadi, A, Mohammadi, et al. Cumin (Cuminum Cyminum L.) is a Safe Approach for Management of Lipid Parameters: A Systematic Review and Meta-analysis of Randomized Controlled Trial[J]. Phytother Res, 2018, 32(11): 2146–2154.

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Chapter 5

History, Present and Prospect of Homeopathy To Ka Lun

Abstract Homeopathy is one of the most well-established medical systems in traditional and complementary medicine. In this chapter, we will introduce homeopathy with its history, including its definition, origin, basic principles, and its specific concepts of health and disease. Afterward, we will describe the current status of homeopathy around the world, not only its integration into different national health systems, but also the policies, regulations, clinical management, standardization, education, scientific research, trading, and overseas communication. Lastly, we hope to share the main areas of concerns on the global development of homeopathy in the future. Keywords: Homeopathy, complementary medicine, history, global development

Introduction The word “Homeopathy” is formed from two Greek words “Homoeo” meaning “similar” and “Pathos” meaning “suffering.” In other words, the 301

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core principle of Homeopathic treatment is “like cures like.” At around 400 BC, Hippocrates (460–377 BC), the father of modern medicine, had first advocated a notion much alike, “Through the like, disease is produced, and through the application of the like it is cured.” Since then, it had been a long time that this concept of medical treatment was brought into attention. It was until the 16th century, the German doctor Paracelsus (AD 1493–1541) proposed a similar treatment theory. He proposed the “doctrine of signatures” (“signa naturae”) according to which the therapeutic properties of different remedies were “similar” to and could be deduced from the external appearance of plants and minerals. Paracelsus’s proposal was to match the color and the appearance of the medication with the therapeutic target. For example, since the color of celandine juice is similar to human bile, it is used to treat hepatobiliary diseases. Although his observation of the above treatment was proven to work out, his proposed theory was too over-simplified. In 1790, the theory of “like cures like” was rediscovered from the ancient publications by a German doctor known as Dr. Christian Frederich Samuel Hahnemann (AD 1755–1843). After years of research and experiments, he finally established the theory of this medical treatment and also set up a new system of medicine diluted medicinal doses. He named this system of medicine as Homeopathy.

5.1  History and philosophy of homeopathy 5.1.1  Definition of homeopathy According to the International Council for Homeopathy (ICH),[1] Homeopathy is system of medicine which is based on natural laws which have always existed. The way of similars, the homeopathic way, is to give the suffering patient who has a set a of particular symptoms which characterize their condition, a minute dose of a substance which in larger doses causes similar symptoms of an artificially inflicted disturbance in a healthy person. The symptom expression of each remedy is discovered primarily through a standard procedure called a “proving,” where a substance is tested on a group of healthy volunteers for its effects and the symptoms

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are recorded and compared to produce the information that defines that particular remedy. Each homeopathic medicine has its unique symptom expression recorded in the homeopathic “materia medica.” The practice of classical homeopathy involves a detailed case-taking by the homeopath where the patient is examined and listened to while they explain in as much detail as possible their present symptoms, thoughts, and feelings and the history which has led up to the present reason for consulting the homeopath. After recording the patient’s case, the homeopath will analyze the whole picture and by comparing the symptoms to the known remedies in the “materia medica,” seek to find the single remedy which best covers the patient’s expressed mental, emotional, and physical symptoms.

5.1.2  Origin of homeopathy Homoeopathy is a system of healing that was founded by a German physician, Dr Samuel Hahnemann. He actively began his work on his new system in 1790 and continued to his death in 1843, aged 88. Hahnemann coined the term homoeopathy from two Greek words meaning similar (homois) suffering (pathos). He used “similar suffering” because homoeopathy is based on a Law of Nature which Hahnemann called the Law of Similars. Hahnemann acknowledged that the Law was not discovered by him but ancient healers such as Hippocrates. And the idea of “similia similibus curantur” was also introduced by Paracelsus, “the father of toxicology.” Moreover, Hahnemann was the first to develop an accessible medical system that applied the Law as its foundation. Hahnemann rediscovered the Law of Similars through his medical studies, and personally experienced it in 1790. At that time, he had almost given up the practice of medicine and was making a living by translating medical texts into one of the seven languages in which he was fluent. When he was translating Cullen’s Materia Medica (of herbal medicines) from English into German, he disagreed with Cullen’s description of the action of cinchona bark. Hahnemann decided to take some of the bark twice daily for some days until he developed symptoms. There he

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found the bark produced in human body the symptoms of fever with thirst, chilliness, flushing of the face, and weariness. The symptoms disappeared when he paused taking the bark but returned when he resumed it. Hahnemann knew that the symptoms he had developed were similar to symptoms of malaria. He also knew that cinchona bark was the source of quinine which is used to treat malaria. Hahnemann realized that he had experienced the Law of Similars in practice — i.e., a substance that is capable of producing symptoms in a healthy person, is capable of removing similar symptoms in an unwell person. The Law of Similars was then established as the pillar of homeopathic medicine. The onion example is commonly used to help explain the Law. Due to its vapors, most people struggle with watery eyes and a running nose when slicing onion. If these symptoms occur during an episode of hay fever, a dose of Allium cepa, the homeopathic preparation of red onion, will relieve them. What the onion is capable of producing in the healthy, it is capable of removing in the unwell. After the first experience with cinchona bark, Hahnemann began conducting similar experiments of different substances on himself and also a few dedicated colleagues. These experiments were called provings. Through the provings, Hahnemann and his colleagues gradually collected an interesting set of mental, emotional, and physical symptoms for each substance, and these are the foundation of the Materia Medica in Homeopathy. Hahnemann stopped practicing as an allopathic doctor because he disagreed with the damaging and suppressive effects of the allopathic medicines. He insisted to find the lowest possible dose of each medicine sufficient to produce a therapeutic effect, and at the end in the new medicinal system, Hahnemann made another very important contribution — the discovery of “potentization.” At the beginning, he tried to dilute doses. The toxic side effects reduced without a loss of therapeutic benefit during the initial diluting process. However, as the medicine became more and more dilute, there would be a point where the medicine no long carried any therapeutic effect.

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It was at this time when Hahnemann believed that he had made another a breakthrough discovery, while transporting his products in a horse drawn carriage. From his observations in daily life, he suspected that the vigorous shaking during the transport, in fact, increased the potency of his remedies even further beyond the dilution effect. He then started to do experiments on agitating (or potentizing) the dilutions by succussion, a specific type of vigorous tapping at each dilutional stage. He found that the therapeutic power did not only pass from the less diluted stage to the more diluted stage but also become more potent in the process. At each stage of dilution, Hahnemann violently shook the remedy container against a firm surface. This process was named as potentization. Compared with simple dilutions, he found that potentization not only removed the toxic side effects of the initial substance, the therapeutic action also began to reach the mental and emotional aspects of each case. Potentization has been questioned and discredited by many in pharmaceutical medicine as unscientific nonsense. However, not all scientists believe homeopathy is impossible.[2] Professor Luc Montagnier, who won a Nobel prize in 2008 for his role in discovering HIV, says homeopaths are right to use these high dilutions. In an interview for Science magazine,[3] when asked, “Do you think there’s something to homeopathy...?,” he replied,”... What I can say now is that the high dilutions are right. High dilutions of something are not nothing. They are water structures which mimic the original molecules.” The present orthodox paradigm does not cope well with concepts involving “energy” rather than physical substance. Fortunately, this is changing and eventually quantum physicists may produce an explanation which satisfies a growing awareness of the full spectrum of life. Hahnemann then began using his new potencies, giving each patient only as much as they needed to produce a therapeutic effect. This method of dosing is based on another Law of Nature — the Law of Minimum Dose. Therefore, homoeopathy may be defined as a system of healing which selects remedies using the Law of Similars and administers remedies using the Law of Minimum Dose.

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In the 1800’s, Hahnemann devoted the rest of his life to proving new remedies, experimenting with methods of preparing remedies, as well as investigating the true nature of disease. The most important milestones of Hahnemann’s era include: The first of six editions of Hahnemann’s Organon of Medicine were published in 1810. This is the bible of homeopathy for both the philosophical basis of homoeopathy and the practice guideline for new homoeopaths. Hahnemann’s Materia Medica Pura was published in 1821. This is the collection of symptom pictures of 62 remedies after the trial of proving. Hahnemann’s Chronic Diseases was published in 1828. After 12 years of concentrated work in looking for the true cause of chronic disease, Hahnemann finally came to a conclusion — the concept of miasms, which we shall examine in latter sections. Homeopathy is a medical system built on known yet well utilized Laws of Nature. It is a method that could improve our health of all levels — mental, emotional, and physical, in a structured way and without damaging toxic effects.

5.1.3  Basic principles Homeopathy is a system of medical practice based on three pillars: the similia principle, the use of potentized medicines or remedies, and the homeopathic methodology.

5.1.3.1  The similia principle This principle states that substances or remedies that cause symptoms when applied to healthy biological systems can be used to treat the same symptoms in diseased biological systems.[4] The similia principle, which forms the fundamental basis of homeopathy, is specific to homeopathy in the sense that it has not been fully recognized, accepted, or studied by mainstream medicine. The idea that a substance can be damaging in large amounts, but beneficial in small amounts is not new to science, in fact, this concept (“hormesis”) has been around for decades and is increasingly well

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documented in fields such as biology and toxicology. In pharmacology, paradoxical reactions are known,[6] i.e., opposite biological effects observed for different doses of a given agent or opposite reactions observed in different individuals. There are examples of “like cures like” in conventional medicine, for example: Digitalis in high doses causes arrhythmias but this drug is used routinely in low doses to treat this condition. The stimulant amphetamine-based drug Ritalin is used to treat Attention Deficit Hyperactivity Disorder (ADHD). Small doses of allergens such as pollen are used to de-sensitize allergic patients. However, an important difference in homeopathy is that the medicinal doses given are so small that toxic side-effects are avoided. Low potency homeopathic medicines (up to 12c or 24x potencies) will contain molecules of the original substance they are made from. For this reason, in most countries, remedies made from toxic substances are only available in higher potencies, from the “first safe dilution” upwards. It is the higher potencies that do not contain molecules, which are most controversial as we do not yet fully understand their mechanism of action. Till now, these paradoxical reactions are not studied enough. This phenomenon could be a bridge between sciences. Homoeopathy is the only healing modality that intentionally and systematically uses the Law of Similars as the foundation of its method. Other therapies occasionally use the Law of Similars either deliberately or unintentionally [for example, pharmaceutical medicine uses Ritalin (amphetamines or “speed”) to slow down hyperactive children]. The great advantage of basing the entire healing system on an unchanging law is that the implementation of the method remains the same over time.

5.1.3.2  The use of potentized medicines A Homeopathic Medicine (“remedy”) is made into different strengths by a process of dilution and succussion (the application of energy through vibration) (Figure 5–1).[5]

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Figure 5–1    Concept of matter and energy in dilution and succussion.

Homeopaths call this the “potency” of the medicine. In keeping with homeopathy’s individual approach, we match the potency of the medicine to the healing energy the individual has to respond with. The process of serial dilution was developed by Hahnemann as mentioned in the previous chapter. He found that whilst his medicines were helping people, they often produced side effects as many of them were poisonous. To minimize these effects, he diluted the medicines into weaker and weaker doses (serial dilution). Then, between each stage of dilution, he succussed them, vibrating the vessel containing the dilution to release the energy of the medicine. He found that the higher the potency of the medicine, the more it stimulated healing ability. Homeopaths are regularly challenged on the issue of potency as we are unable to provide a fully satisfactory explanation. However, scientists cannot provide an explanation for many phenomena, including the most basic of forces — gravity. Albert Einstein spent the better part of his life attempting to create a unified field theory that could integrate electromagnetism and gravity. He did not succeed in this endeavor. However, he brilliantly and famously demonstrated to the scientific community that matter is simply another form of energy. This equivalence implies that matter is inter-convertible with other forms of energy. This is the basic principle behind atom bombs and the production of energy in nuclear reactors and stars. Or, to put it in another way, “We may therefore regard matter as being constituted by the regions of space in which the energy field is extremely intense.” — Albert Einstein. In homeopathic pharmacy, an equivalent process is acted out but on a micro-scale. Through serial dilution and succussion, matter is successively imbued with the power to heal by becoming accessible to the

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regenerative capacity all living things possess. Thus, remedies start off in the form of matter but are translated into energy, which in turn can influence the energetic regenerative field everywhere in the body. Today, we like to think of a medicine as being information (information: deriving from the form within). This is similar to an instruction, in that it is without physical substance but has the power to exert an influence. Imagine reading that you have won a huge amount of money. The chances are high that you would leap out of the chair, your arms up, and your voice excited. All that has actually happened is that you have read some words on a piece of paper, and then your emotions, mind, and body have followed. The words on the paper are comparable to the new level of energy flowing into the individual from a Homeopathic Medicine. Homeopathic Medicines, some of which in their crude state are potentially toxic, are prepared according to a specific process of successive dilution and succussion (for liquid preparations) and successive trituration (for solid preparations) — potentization process, in such a way as to nullify their toxic properties. A number of variations exist for both dilution steps and the way in which succussion is performed. The Pharmacopoeia Convention adopts the decimal, centesimal, and fifty millesimal systems as the standard scales of attenuation and notation, under which each successive attenuation or trituration contains just 1/10, 1/100 or 1/50,000 as much of the drug substance as the preceding attenuation or trituration. By far the most common one in use is the centesimal system. One milliliter (1.0 mL) of the first centesimal liquid attenuation (1C) or one gram (1.0 g) of the first centesimal trituration (1C), represents 0.01 gram (10.0 mg) of the dry crude medicinal substance. One milliliter (1.0 mL) of the 2nd centesimal liquid attenuation (2C) or one gram (1.0 g) of the 2nd centesimal trituration (2C), represents 0.0001 gram (0.1 mg) of the dry crude medicinal substance. Subsequent liquid or solid attenuations are made by serial progression, succussing, or triturating one (1) part of the preceding attenuation to 99 parts of the vehicle, and represent the following proportions of active principle (i.e., dried medicinal substance): 2C = 10−4, 3C = 10−6, 4C = 10−8, and so on. The potency used in this RCT will be 12C, 30C, or 200C, which are all beyond the Avogadro’s constant.

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Main controversy about homeopathy is the plausibility of remedies which hardly contain a molecule of the original source. Its mechanism of action is actually evolving through advanced physics research in recent years (refer to the session of “current status of homeopathy” — i.e., “mechanism of action of potentized substances”). Due to this property, homeopathic remedies are commonly agreed to be a safe kind of treatment. This unique method of preparing medicines allows for treatment on all levels, i.e., physical, emotional, and mental levels. It also enables a significant retracing of symptoms. For example, if a 50 year old patient was traumatized since the age of five, this old wound can be treated using highly potentized medicines. Minimum & Single Dose In homeopathy, two important principles are employed when prescribing potentized medicines — the minimum dose and the single dose. Minimum dose: The principle that only “the minimum dose” should be employed is based upon the understanding that the minimum and single dose stimulus of the medicine triggers the intrinsic healing response. Following this principle, we give only enough medicine to initiate this healing response. This response then carries on, driven by the body’s need to maintain health and balance. The use of the minimum dose has the advantage that it does not produce the gross side effects so often caused by conventional treatments. The concept of the minimum dose is similar to Arndt-Schultz law (named after the pharmacologist Hugo Schultz and the psychiatrist Rudolf Arndt, who formulated the law). Arndt stated, “Weak stimuli accelerate vital activity, medium stimuli raise it slightly, strongones suppress it and very strong ones halt it.” This is usually simplified as follows: small doses stimulate, medium doses inhibit, and large doses kill. Thus the minimum, potentized dose is employed by homeopaths. Single dose: When seeing a homeopath for the first time you may be surprised if you are prescribed just a single pill, particularly so if you have been used to receiving bags full of medications from your doctor. This is because a Homeopathic Medicine stimulates your own internal healing

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mechanisms, and while these are in action, there is no need to give more (Figure 5–2). Then, we wait and watch while the healing process takes place. There may be a slight worsening of symptoms (aggravation) at the start, but this should be followed by an improvement as your vitality and immune system are stimulated by the medicine. During the healing of chronic disease, old symptoms (that might once have been suppressed) may re-emerge. This phenomenon will be described in the section “direction of cure.” Other reasons for giving only one medicine at a time are as follows: – If you give more than one medicine, one might cancel out the action of another. – If you give more than one medicine, it is not possible to know which is having an effect. – The possible interactions between simultaneously given remedies are not known.

Figure 5–2    A homeopathic medicine stimulates your own internal healing mechanisms.

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Our mission is to treat the whole person, not individual symptoms, so homeopath will try to find the one medicine that corresponds to the whole case.

5.1.3.3  The homeopathic methodology: Individualization More than most other healing modalities, homoeopathy requires a very high level of individualization in order to select the most appropriate remedy. There are over 4,000 remedies in the homoeopathic Materia Medica, allowing for precise remedy-patient matching. There is a down-side to this need for individualization — if the remedy selection is not accurate, the remedy will not work. The key to successful homeopathic treatment is identifying the similarity between the effects of the original substance in healthy people and the pattern of the illness in the individual who is ill.[6] Homeopathic treatment is highly individualized — the patient’s personal physical and psychological characteristics, his/her clinical picture, diagnosis, aetiology, constitution, and present, past, and family illnesses are all relevant and significant. Homoeopathy recognizes that there are certain personality characteristics which appear to be unchanging over life. These characteristics form what is called the constitution of the patient and can assist in finding a remedy that eventually will assist the patient to improve every aspect of their life. Hahnemann’s ground-breaking research into the true cause of chronic diseases allows the trained practitioner to understand many of the reasons why a patient is suffering their health problems and then to do something about it by using special remedies which can remove these chronic impediments to health.

5.1.4  Specific concept of health and disease The basis of homeopathic thought is that health is not a static condition but a dynamic process that tends to maintain a state of optimum equilibrium. This concept presupposes a built-in self-regulation mechanism, which protects against a loss of balance. Disease reflects an intensified

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attempt to restore an out-of-balance state, resulting from disturbing physical, chemical, biological, and emotional factors.

5.1.4.1  A holistic view of health Plato wrote almost 2,400 years ago, “As you ought not to attempt to cure the eyes without the head, or the head without the body, so neither ought you to attempt to cure the body without the soul; and this is the reason why the cure of many diseases is unknown to the physicians of Greece, because the parts can never be well unless the whole is well” (Figure 5–3). Although current medical practice recognizes that there are connections between mental, emotional, and physical conditions, the dominant approach is to break the whole down into parts with separate diagnostic labels. Different drugs are then prescribed for each seemingly unrelated symptom. Most medicines have side effects which add to the patient’s troubles — a search on the Internet will reveal pages of them. To counteract these side effects, a new set of drugs may be given. Thus, suffering is not ultimately decreased at all but actually increased. Homeopaths use specially prepared, potentized medicines from which toxic effects have been removed. Homeopaths look at the big picture — all the patient’s symptoms are grouped together and understood to

Figure 5–3    Holistic view of health — Uniqueness of each patient.

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represent the whole disease. When making an individual assessment, homeopaths look at ancestral health, family issues, conception and gestation, birth, and childhood, whilst at all times noting the ways in which the patient manifests uniqueness. Job and family life, hobbies and holidays, relationships, responses to life’s challenges, and everything that denotes individuality are used to add to the picture of health and its breakdown into disease. One of the reasons that homeopathy is the second largest system of medicine in the world today, aside from bringing health benefits without side effects or the dangers inherent in major interventions, is that it offers this holistic approach to health and healing. Holism implies that the parts in a system relate interactively; that body, mind, and spirit are all aspects of a whole being, and that all individuals are involved in a web of interrelationships with the world — its mineral, plant, and animal constituents. Apropos of which, the healing agents used in homeopathy derive from mineral, plant, and animal sources and are used according to the principle of “like cures like.” When a person is treated as a whole, the symptoms presenting in different parts of their body will naturally be cured because their overall health has been addressed, that is to say their mental, emotional, and physical symptoms have all been taken into account and treated by the homeopath.

5.1.4.2  A homeopathic view of health Many people are becoming increasingly disillusioned with the outcomes of contemporary Western Medicine, its many side effects, its close relationships with big pharmaceutical companies, and its inability to do more than treat the results of disease. Often the primary aim of treatment is to remove the physical symptoms. On the face of it, this makes sense because symptoms may cause pain or interfere with normal functioning. Homeopathy, treating like with like, gets to the root cause of symptoms. The idea of curing like with like may seem counter-intuitive. Why should that which can cause symptoms to arise in a healthy person, cure them when applied in ill health?

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An example of current medical wisdom is provided by the first aid treatment of burns, i.e., putting the affected part under the soothing influence of cold, running water. The heat of the burn may be temporarily extinguished. However, healing of the burn is not aided by this. A homeopathic treatment for a burn might be to apply a cream medicated with naturally occurring substances such as Urtica urens or Cantharis, which in higher concentrations produce a reaction similar to burning. This excites a reaction within the body that mimics its usual response to a burn, thus speeding up healing. Under the action of such a medicine, the sensation of burning will momentarily increase then easing of the pain and natural healing will follow. The idea is that the body knows how best to respond and the best help we can provide is to encourage it in its healing efforts — to work with it, not against it. The homeopathic definition of health can be covered in six words: “The freedom to adapt to change.” A healthy person is able to adjust freely according to changing circumstances. The long-term aim of homeopathic treatment is not only to alleviate the immediate presenting problem but also to address the underlying causes. A bacterium itself is not a problem, it is the weakness in the person who becomes sick because of it that needs to be treated. Every day, bacteria and viruses enter our bodies, but only some of us become ill, some of the time. The question is why? A person’s susceptibility to disease can arise from psychological imbalance, stress, physical weaknesses, and heredity. A well-chosen Homeopathic Medicine strengthens a person’s self-curative response. When this is working at an optimum level, the naturally protective mechanisms will follow suit and weaknesses will be overcome (Figure 5–4). Disease is conditioned by susceptibility and it manifests itself through symptoms in the mental/intellectual, emotional, and physical plane. The self-regulation mechanism is regarded as responsible for protection against the loss of balance as well as for its restoration. All that a doctor can do is to assist the process of restoration, to stimulate this selfregulation, or self-recovery mechanism. Homeopathic Medicines are supposed to induce a process of reorganization of vital functions by stimulating this self-regulation mechanism. This reorganization can result in complete cure in cases where only

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Figure 5–4   Disease susceptibility in mental/intellectual, emotional and physical plane.

functional derangement had caused the symptoms. Of course, the therapeutic possibilities depend on the extent to which the organism is able to recover. The more structural changes that have been caused by the deregulation, the more partial a recovery will be. Limitations are specific surgical indications, deficiency diseases, and very serious diseases in which gross anatomical changes have evolved. If a disease process has come to an end and the tissue damage has become irreversible, homeopathy may only have a palliative or relieving effect. Homeopathy is used to treat a wide range of disorders. A review in 1991 of the research literature[7] found the following main areas had been scientifically investigated: trauma and pain, respiratory infections, mental and psychological disorders, pollinosis, and rheumatology. Homeopathy can even offer therapeutic options where other treatments have failed or plateaued, where conventional treatments do not exist for the problem or where they are contraindicated or not tolerated.

5.1.4.3  Direction of cure In an acute situation, where the complaint is of recent onset and the person has no previous history of chronic disease, homeopathic treatment invariably works with great success (provided the medicine is accurately chosen) (Figure 5–5).

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Figure 5–5    Direction of cure.

Recent symptoms abate and the afflicted individual is returned to their previous state of good health. The storm that may have been lifethreatening passes without a trace. In the case of chronic diseases, the story of how health is restored is more complex and the duration of recovery is usually in direct proportion to the length of time that the illness was present. There is no way of predetermining what this will be as each one of us differs, however, we can say that long-term illnesses require time to heal. We can also make observations about how cure proceeds, for example, the first symptoms to appear will be the last to resolve, while the most recent symptoms will be the first to disappear. The original symptoms may have manifested a very long time ago! Cure tends to proceed from more recent to older symptoms; from vital organs to less vital organs; from the center to the circumference; from above downwards.

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As well as symptoms disappearing in the reverse order of their appearance, healing often proceeds from within the organism and extends outwards. Improvement may occur on the mental or emotional levels before the physical level. For example, we may be relating in better ways to our partner or job before our inflamed joints improve. Healing often progresses from more important organs to less important organs, thus the health of the heart or brain improves before that of less vital organs like the stomach or joints, or someone’s asthma clears up before their itchy skin does. Healing often follows a downward course, from head to foot. This pathway of symptom movement may be understood by remembering that the head houses the brain, arguably the most important organ, so this will be protected above all else and the first to heal. If a disease is left untreated it moves in the opposite direction, progressing from surface to center and from less important to more important organs. New symptoms are seen as it progresses. This allows a clear distinction to be made between disease and healing processes. Using these principles, the homeopath can track the progress of the disease and the health of the patient and can recognize when treatment is progressing successfully.

5.1.4.4  Susceptibility & suppression Each of us has certain triggers or situations to which we are highly sensitive and vulnerable and to which we are most likely to react. This is known as “susceptibility” and is an important factor for homeopaths to consider, especially when prescribing at a constitutional level. Susceptibility is one of the things that makes us unique, because sensitivity to situations is different for each of us. We do share some susceptibilities, however, this is best demonstrated in epidemic situations where we are overwhelmed by a contagion and produce similar reactions and symptoms. Susceptibility can be linked to certain events, such as always getting ill after being exposed to harsh cold wind, or suffering a stomach upset after being embarrassed about something. Or it may be the result of our living conditions — anyone living in a damp house is likely to experience

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Figure 5–6    Suppression of symptoms.

upper respiratory tract symptoms after a while, although for some of us, it will be sooner rather than later. Susceptibilities can manifest on any level: mental, emotional, or physical. Good homeopathic treatment can change our core susceptibility (or to a lesser degree address some of the effects of our susceptibility), strengthening us so that we are not affected by an “attack” on our vulnerabilities (Figure 5–6). Another factor that affects our reactions to situations is suppression. Suppression means stopping or limiting an action. Frequently, we limit the vital energy in our body by the use of conventional “cures.” How often do we use a cream to “remove” a rash, a pill to take away a pain, a medicine to calm our nerves? The main action of these medicines, however, is to palliate the symptom and to moderate its expression rather than to address the susceptibility behind it. They can never constitute a longterm cure. If we keep palliating a symptom long enough, we may not be able to continue to externalize the illness. As a result, the untreated internal state will be forced to find another outlet in order to re-balance itself. While we may suppress, or apparently “remove” a symptom from a particular part of the physical body, the next available vent may be anywhere on the mental, emotional, or physical level. A simple example of this is when someone indulges in many “flu cures” to fix their cold and then becomes irrationally bad-tempered as the discharge dries up. Many more examples of the effects of suppression exist, from the development of asthma in children whose eczema has been suppressed by steroid creams, to breast lumps which are believed to correlate directly

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with the use of antiperspirants, to childhood inoculations resulting in a chronically sick adult population.

5.2  Current status of homeopathy 5.2.1  Overview of national health service system and integration of homeopathy into national health system 5.2.1.1  According to the World Health Organization There was a global study conducted by the World Health Organization (WHO) about all the medical modalities, apart from the mainstream. The results were published in the WHO Global Atlas — of Traditional, Complementary and Alternative Medicine.[7] Results showed that Homeopathy is the second largest system of medicine in the world. And it is even more popular in countries which are wealthier (i.e. higher Gross Domestic Product (GDP)).[8] The World Health Assembly (WHA) resolution on Traditional Medicine (WHA62.13) adopted in 2009, requested the WHO DirectorGeneral to update the WHO Traditional Medicine Strategy 2002–2005. Across the world, Complementary and Alternative Medicine (CAM) or Traditional Medicine (TM) is either the mainstay of healthcare delivery or serves as a complement to it. Thus, the WHO Traditional Medicine Strategy 2014–2023 reappraises and sets out the course for TM and CAM (T&CAM) in the next decade. According to the WHO, Homeopathy is the second largest system of medicine. Owing to the historical background, Homeopathy is considered as traditional medicine in the Western countries and India, similar to how we categorize Traditional Chinese Medicine in China. The Strategy aims to support Member States in harnessing the potential contribution of T&CM to health, wellness, and people-centered healthcare and to promote the safe and effective use of T&CAM through the regulation of products, practices, and practitioners.[9] In the chapter “Different Stages of Traditional and Complementary Medicine Integration,” Swiss healthcare system was quoted as an example for illustration. “In many other countries, traditional and complementary

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medicine is partially integrated into the national health system. Switzerland became the first country in Europe to integrate traditional and complementary medicine into its health system.” “In Switzerland, the average prevalence of traditional and complementary medicine use was 49% after 1990. In 1998, the Federal Department of Home Affairs (DHA) decided that, from 1999 to 2005, five complementary therapies — anthroposophical medicine, homeopathy, neural therapy, phytotherapy, and TCM, would be covered by the compulsory health insurance program (KLV) if the service was provided by a physician certified in CAM. Meanwhile, the Swiss government also set up a comprehensive program to evaluate CAM (PEK), which was playing an ever-increasing role in the Swiss medical system in order to determine its role and effectiveness. According to the PEK evaluation result, CAM practitioners can be distinguished from physicians providing conventional healthcare in respect of the nature, location, and technical resources of their practice. In 2009, more than 67% of national voters opted for a new constitutional article on CAM, with the result that certain complementary therapies have been re-instated into the basic health insurance scheme available to all Swiss citizens.” In the chapter “Universal Health Coverage and Integration of T&CM,” French and Belgium were also quoted as examples. “In many countries, T&CM has been partially covered by public and private insurance companies since the 1990s […] many French doctors are specialists in homeopathy, which are reimbursed by the Social Security when performed or prescribed by a doctor. Since 1997, the Socialist Mutual Insurance of Tournai-Ath in Belgium partially reimburses specific complementary/ alternative treatments such as homeopathic remedies.” “In Belgium, detailed information is available for homeopathy, acupuncture, osteopathy and chiropractic including scientific literature reviews, population surveys, product consumption patterns, sociological aspects, practices, legal frameworks, training, professional organizations, patients’ associations and reimbursement policies.” In the chapter “Types and Qualifications of T&CM Practitioners,” it is mentioned that in India there are two categories of TM practitioners, with 785,185 registered as non-conventional practitioners. Among them,

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the number of Homeopaths rose from 105,000 in 1980 to 246,000 in 2010. The number of homeopathic hospitals also rose from 1,686 in 1980 to 7,000 in 2010. In India, all traditional systems of medicine with official recognition have institutionalized education systems. Colleges can only be established with the permission of the central government and the prior approval of their infrastructure, syllabi, and course curricula. Annual and surprise inspections ensure that educational and infrastructural standards are met. Central Government has the power to recognize or rescind any qualification and college.

5.2.1.2  According to the European Central Council of Homeopaths (ECCH) In the Legal report by ECCH in 2006, Homeopathy is found to be available within the public healthcare system in 10 countries — Armenia, France, Germany, Israel, Lithuania Luxembourg, Netherlands, Poland, Romania, and United Kingdom. In Israel, homeopathy is offered within the setting of the national healthcare system but it is not subsidized. Although homeopathy is not available within the public healthcare system in Austria, homeopathic remedies are being prescribed in acute cases in some hospitals. In the ECCH report, it was also shown that Homeopathy is available free of charge (partially or fully) through the national healthcare system in five countries — France, Germany, Netherlands, Poland, and United Kingdom. In France, the cost for treatment and 35% of the costs for Homeopathic Medicines are reimbursed through the national healthcare system. In Germany, homeopathic treatment is available free of charge when provided by medical doctors who are within the national healthcare system. In the Netherlands, homeopathy is available free of charge through the national healthcare system, provided the patient has additional health insurance. In Poland, homeopathy is available free of charge through the national healthcare system, provided the patient is treated by a homeopathic doctor working within the national healthcare service. Homeopathic treatment may be free of charge if provided by a homeopathic doctor in a

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hospital. In the United Kingdom, homeopathy is available free of charge through the national healthcare system, provided it is given directly by or on referral from a general practitioner. The expenses for both the consultations and Homeopathic Medicines are covered. Costs for homeopathic treatment and/or medicines are partially or fully reimbursed in 14 countries — Austria, Belgium, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Luxembourg, Malta, Netherlands, Switzerland, and United Kingdom. This includes both state insurance in seven countries — Belgium, France, Germany, Italy, Luxembourg, Netherlands, and United Kingdom, and private insurance in 11 countries — Austria, Belgium, Germany, Hungary, Ireland, Israel, Italy, Latvia, Malta, Switzerland, and United Kingdom. In Germany, private insurance companies refund expenses for homeopathic treatment provided by both medical doctors and Heilpraktikers. State insurances partly pays for homeopathic treatment in certain circumstances, including expenses for Homeopathic Medicines in treatment of children under the age of 12, provided treatment is given by a medical doctor with a special education in homeopathy. Funding for research in homeopathy has been granted in 16 countries, including 11 EU member countries and two EEA member countries — Austria, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Switzerland, Ukraine, and United Kingdom. In eight countries, funding has been granted from the Government — Austria, Denmark, Germany, Italy, Norway, Romania, Switzerland, and United Kingdom, and in 14 countries, funding has been granted from other sources — Austria, Denmark, France, Germany, Ireland, Israel, Netherlands, Norway, Poland, Portugal, Sweden, Switzerland, Ukraine, and United Kingdom.

5.2.2  Policies and regulations specific to homeopathic practice According to the legal report by the ECCH in 2006, where 42 countries have been included — Albania, Armenia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic,

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Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of Macedonia, Romania, Russia, Serbia and Montenegro, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, and United Kingdom: – Patients have access to homeopathic treatment in all the countries. – It is legal to practice as a homeopath in 21 countries, including the majority (14) of all EU member countries, and all four EEA member countries. It is illegal for someone who is not a medical doctor or recognized healthcare professional to practice in 17 countries, including nine EU member countries. – In Germany, homeopathy may only be practiced by medical doctors or Heilpraktikers. A Heilpraktiker is a CAM practitioner who has passed a local health authority exam. Heilpraktikers must use the title “Heilpraktiker” and may also inform which therapies they offer, such as homeopathy. – There are legal restrictions in 24 countries, including 14 EU member countries and three out of four EEA member countries. Restrictions are, with one exception, not for homeopathy specifically, but for any practitioner of CAM therapies. – Governmental regulation of some sort has been introduced in 14 countries, including seven EU member countries and three out of four EEA member countries. – In 17 countries, the practice of homeopathy is restricted to some sort of statutorily regulated healthcare practitioner. Only medical doctors and/or dentists may practice in 12 countries. In one country, medical doctors, dentists, and physiotherapists may practice. In one country, medical doctors, dentists, nurses, midwives, physiotherapists, and pharmacists may practice. In one country, only medical doctors and Heilpraktikers may practice. In yet another country, any legally regulated healthcare practitioner may practice. – Seven countries have introduced protected titles; it is illegal for people who have not fulfilled the accredited professional training to use the titles. These countries include Germany, Norway, Switzerland, and Denmark.

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– The title “Homeopath” is legally protected in Belgium. The title “Registered Homeopath” is legally protected in Norway. The title “Doctor Homeopath” is legally protected in Lithuania. In the revised report in 2011, the legal situation for homeopathy was further categorized into seven types: – – – – –

Practice under the absence of specific legislation. Statutory voluntary self-regulation of non-conventional practitioners. Statutory regulation of non-conventional practitioners. Practice under legislation and regulation for employment. Statutory regulation where homeopathy practice is limited to conventional practitioners. – General restrictions where all treatment of patients is limited to conventional practitioners. – Unregulated or unclear.

5.2.2.1  Voluntary self-regulation under the absence of specific legislation In 14 countries, homeopaths who are non-conventional practitioners can practice homeopathy under the absence of specific legislation. The absence of legislation, which specifically restricts the practice of homeopathy to any particular type of practitioners, means that anyone may practice. This is also a reason why homeopaths have taken it on themselves to self-regulate the profession in these countries. As part of this process, homeopathy associations, which are members of ECCH, have agreed to ECCH’s guidelines for voluntary self-regulation. Homeopaths who are non-conventional practitioners can practice homeopathy under the absence of specific legislation in: Croatia, Estonia, Finland, Greece, Ireland, Israel, Malta, Montenegro, Netherlands, Republic of Macedonia, Spain, Sweden, and the United Kingdom. In the United Kingdom, an Act of Parliament was established in 1950, recognizing the role of the homeopathic doctors’ association (Faculty of Homeopathy) in regulating education, training, and practice of homeopathy carried out by their members. Over the years, the Faculty’s role has

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been extended to include other statutorily regulated healthcare practitioners practicing homeopathy, such as veterinarians and dentists. Practitioners who are not statutorily regulated healthcare practitioners can practice homeopathy and most other CAM therapies under the absence of specific legislation. Voluntary regulation is supervised by the government under the Professional Standard Authority, and the homeopathic profession is represented by the Society of Homeopaths (SoH).

5.2.2.2  Statutory voluntary self-regulation of non-conventional practitioners Statutory voluntary self-regulation of non-conventional practitioners implies that individual practitioners may choose whether they want to apply to be accepted into a public register of CAM practitioners or choose to remain a non-registered practitioner. There are certain criteria which practitioners must fulfil in order to be accepted into such a register. The main intention of such a system is to contribute to the safety of patients. Statutory voluntary self-regulation has been introduced in Denmark, Iceland, and Norway. All three countries have established such regulation by Act of Parliament, and all three countries have: – A public register for CAM practitioners. – Introduced this register to contribute to ensuring patient safety. – Set criteria for practitioners who want to be accepted onto the register. Protected titles linked to the CAM modality practiced “Registered Alternative Practitioner (RAB)” in Denmark, “Healer” in Iceland, and using the word “Registered” in Norway. In order for a practitioner to be accepted into one of the three registers, he/she must belong to an association which has been officially recognized by the register (exceptions may be made in Iceland). For an association to be officially recognized by the register, it must fulfil a number of criteria, including having:

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– – – –

Registration criteria, with criteria for undergraduate education. Criteria for professional, responsible, and ethical behavior. Code of ethics, complaints, and disciplinary procedures. The power to expel members on specified grounds.

Regulation in Denmark and Iceland also specifies the minimum amount of education and training practitioners must have completed: – Denmark: 660 hours, whereof the person is to practice a minimum of 250 hours specifically related to the therapy. – Iceland: Minimum of six credits in anatomy and physiology, five in pathology, two in ethics and health legislation. While the Danish law solely focuses on criteria for the public register, the laws in Iceland and Norway address various aspects of CAM treatment, and also relate to practitioners who are not registered. This includes provisions stating that a practitioner: – Cannot carry out interventions which entail serious health risks to patients. – Cannot treat serious communicable diseases or any other serious disease, except when: In Iceland, the patient requests the services of the practitioner after consultation with a physician; in Norway, treatment takes place in cooperation or consultation with the patient’s physician, or when the health service has no curative or palliative treatment to offer, or when the sole purpose is to alleviate/moderate symptoms/consequences of disease, or when the sole purpose is to treat side effects of conventional treatment, or when the sole purpose is to strengthen the body’s immune system/its ability to heal itself.

5.2.2.3  Statutory regulation of non-conventional practitioners Statutory regulation for non-conventional practitioners has been introduced in Belgium, Germany, Liechtenstein, and Portugal. All four countries have established such regulation by Act of Parliament. Legislation in

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these countries states that in order for someone to practice homeopathy, a practitioner must be registered through the Government established system. The practitioner does not have to have a background as a practitioner of conventional medicine. Although the basic principle is the same for these countries, there are some variations, including: Three countries have specified therapies that have been recognized: – Belgium: Homeopathy, acupuncture, chiropractic, and osteopathy. – Liechtenstein: Homeopathy, naturopathy (Traditional European Medicine), and Traditional Chinese Medicine (TCM). – Portugal: Homeopathy, acupuncture, chiropractic, osteopathy, naturopathy, and phytotherapy. In order for applicants to be registered they must: – Belgium: Complete a course with sufficient numbers of hours of theory and practice, in accordance with guidelines developed by ECCH. – Germany: Pass a public exam organized by local healthcare authorities in order to prove that they possess sufficient knowledge in medicine and healthcare legislation. – Liechtenstein: Provide documentation to prove they have carried out education which enables them to practice the therapy in question. Two countries have introduced protected CAM titles: – Germany: Heilpraktiker. – Liechtenstein: Naturheilpraktiker.

5.2.2.4  Practice under legislation and regulation for employment In Poland, only medical doctors and dentists can state that they treat patients. Homeopaths do not have a background as a medical doctor or dentist, however, they may practice under the regulation established by the Ministry of Employment and Social Affairs, as long as they do not claim to treat patients. The practice is defined as “paramedical activity.” A law published in April 2010 defines “practitioners of unconventional or complementary methods of therapy” and the title “homeopath” is specifically mentioned.

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In Greece, where practitioners can practice under Common Law, the homeopathy profession is registered with the Ministry of Economics.

5.2.2.5  Statutory regulation where homeopathy practice is limited to conventional practitioners Ten countries have introduced legislation or regulation which limits the practice of homeopathy to practitioners with a conventional medical background. The countries include Belarus, Bosnia and Herzegovina, Bulgaria, Hungary, Latvia, Lithuania, Serbia, Slovenia, Romania, and Ukraine. Where can Homeopathy be Practiced and by Whom? Legislation varies considerably from country to country with regard to the therapies that may or may not be practiced by medical doctors and other practitioners: – Bulgaria: Homeopathy by medical doctors only. Additional requirements for practitioners include: European Union, European Economic Area or Swiss member citizen, mentally healthy, no criminal record, educational requirements. – Bosnia & Herzegovina: Homeopathy may be practiced only by nurses, dentists, or medical doctors. – Hungary: Acupuncture, Anthroposophic Medicine, Ayurvedic Medicine, Chiropractic, Homeopathy and TCM by medical doctors only; Acupressure, Kinesiology, Shiatsu, and Reflexology by others. – Latvia: CAM therapies such as acupuncture, homeopathy, and phytotherapy are regulated and supervised by the Medical Society. – Lithuania: Homeopathy, manual therapy, and reflexology by medical doctors only. The Ministry of Health provides state accreditation of practitioners. – Serbia: Medical doctors, dentists, pharmacists, and nurses may practice homeopathy. The Ministry of Health issues working licenses for such practitioners. – Slovenia: Any CAM therapy by medical doctors only. Medical doctors practicing any CAM therapy (except acupuncture) must hand in their medical license and are therefore no longer able to practice conventional medicine.

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– Ukraine: Homeopathy by medical doctors only. It is unclear whether any other CAM therapies are restricted to medical doctors, but aromatherapy, massage, and phytotherapy may be practiced by other practitioners. For these therapies, the law refers to treatment methods which involve diagnosis, prevention and treatment of disease, based on experience gained over several generations. Regulation of education Five countries specify requirements for education: – Belarus: Requirements for homeopathic education exist, but specific requirements are unclear. – Bulgaria: To practice homeopathy a person must at least hold a Master Degree in medicine, for any other CAM therapy the practitioner must have at least a Bachelor Degree in healthcare or four semesters of education at a medical school. – Hungary: Medical doctors must carry out a two-year university education at master’s level in the therapeutic modality they wish to practice; for some other CAM therapies, a two-year education (not necessarily at a university) including general medicine and CAM modalities must be completed; several other CAM therapies are not regulated. – Lithuania: Medical doctors must first complete a specialization in another field of medicine before they can practice homeopathy, and must then do an 80-hour post-graduate university level education on homeopathy over a five-year period in order to retain their right to practice homeopathy. – Romania: Medical doctors must complete a three-year long homeopathy training program, at the end of which they must pass an exam.

5.2.2.6  General restrictions where all treatment of patients is limited to conventional practitioners Eight countries have not specifically mentioned homeopathy in their legislation but have stated that only medical doctors (Austria, Cyprus, Czech Republic, France, Slovakia, Russian Federation) or other conventional practitioners (Armenia, Luxembourg) may treat patients.

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5.2.2.7  Unregulated or unclear The practice of homeopathy is unregulated in Italy and Montenegro. There is no law that legalizes the practice of homeopathy, nor is there a law that prohibits the practice. The situation is unclear in Albania.

5.2.3  Regulation of Homeopathic Medicinal Products (HMP) 5.2.3.1  Regulations in European countries The first steps towards EU harmonization of national pharmaceutical law were taken in the 1960s with the adoption of Directive 65/65/EEC. Homeopathic medicinal products were explicitly excluded (see recital 8 and Article 34 of Directive 75/319/EEC) until 1992 when Directive 92/73/ EEC on homeopathic medicinal products was adopted.[10] Directive 92/73/EEC on homeopathic medicinal products came into force on the 1 January 1994. Its primary aim was the completion of the internal market. The second recital of the preamble indicates another essential aim of the Directive, that is to safeguard public health. It was introduced to harmonize national rules on homeopathic medicinal products for human use and to facilitate free circulation of safe and high quality homeopathic medicinal products. The intention was to eliminate the differences between national rules and administrative practices, which were impeding the free movement of homeopathic medicinal products, distorting competition between manufacturers and depriving patients of access to the medicinal products of their choice. The European Coalition on Homeopathic and Anthroposophic Medicinal Products (ECHAMP) summarized the history of the regulation of HMP as follows[11] (Figure 5–7). The Directive intended to take account of the specific characteristics of homeopathic medicinal products which have been produced in accordance with a homeopathic manufacturing procedure. However, the Commission stated in its report on the application of Directive 92/73/EEC in 1997, that the introduction of a Directive that harmonizes the registration regime of homeopathic medicinal products

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Figure 5–7    50 Years of regulations for homeopathic products in the European union.

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did not remove the disparities between the national regimes in the Member States. In 2001, the rather fragmented EU pharmaceutical legislation was codified in Directive 2001/83/EC, including the existing legislation on homeopathic medicinal products without any changes. Once all EU pharma legislation was brought together into a single legal act, subsequent revisions of Directive 2001/83/EC in 2003 and 2004 brought about some substantive modifications for homeopathic medicinal products. Firstly, Annex I of the Directive, also known as Directive 2003/63/EC, inserted specific provisions on the proof of quality and safety of homeopathic medicinal products, providing more clarity for the assessment of quality and safety of applications for simplified registration. Secondly, the adoption of Directive 2004/27/EC opened up the possibility of using the Mutual Recognition Procedure/Decentralised Procedures for products eligible for simplified registration. A third modification made the implementation of a simplified registration procedure mandatory in all EU Member States. Directive 2001/83/EC The Directive 2001/83/EC on medicinal products for human use outlines two procedures for market access of homeopathic and homeopathically produced anthroposophic medicinal products: – Special Simplified Registration Procedure (Article 14). – Marketing Authorization (Article 16). The Special Simplified Registration Procedure (simplified registration) applies to homeopathic medicinal products that comply with the following criteria: – They are administered orally or externally. – No specific therapeutic indication appears on their labeling. – There is a sufficient degree of dilution to guarantee their safety; in particular they may not contain more than 1 part per 10,000 of the mother tincture or more than 1:100 of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription.

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Those products which do not comply with these criteria need to be authorized in accordance with Article 16. As a consequence, the general marketing authorization procedures for allopathic medicinal products are in principle applicable to homeopathic medicinal products, which are not eligible for a simplified registration. However, Member States have the competence under Article 16(2) to retain or introduce specific rules for pre-clinical tests (pharmacological and toxicological tests) and clinical trials in accordance with the principles and characteristics of homeopathy as practiced in that particular Member State. Thus, they are able to adopt special rules to make an assessment of safety and efficacy. The reason for failing to make the authorization mandatory all over the EU is described in Recital 25 of 2001/83/EC, “In particular, those Member States which have a homeopathic tradition should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products provided that they notify them to the Commission.” The main reasons for creating a solid European legislation were to safeguard public health, eliminate disparities which affect the functioning of the internal market, not hinder the development of the pharmaceutical industry or trade of medicinal products in the community, and remove the hindrances to approximate relevant provisions. These are fully put aside and regarded as homeopathic medicinal products subject to an Article 16.2 marketing authorization, despite the fact that homeopathy is a European tradition practiced and used in all the EU Member States. In 2017, the Homeopathic Medicinal Products Working Group (HMPWG) under The Heads of Medicines Agencies (HMA), published a report on the regulatory status of Homeopathic Medicinal Products in European Union (EU) and European Free Trade Association (EFTA) countries.[12] HMA is a network of the heads of the National Competent Authorities (NCA) whose organizations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. It cooperates with the European Medicines Agency (EMA) and the European Commission in the operation of the European Medicines regulatory network, and it is a unique model for cooperation and work sharing on statutory as well as voluntary regulatory activities.

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The 2017 HMPWG report provided more updated information about the implementation and management of EU legislation in this field. It includes data from 27 countries — the EU Member States excluding Estonia, Spain, Poland, UK, Switzerland, Lichtenstein, and Norway. The data was collected between March and December 2016 and adopted by HMPWG in February 2017. Before of the Directive Regulatory status varied a lot from country to country in Europe before the Directive (amended by Directive 2004/27/EC). In Ireland, homeopathic products were on the market and had been covered by legislation since 1998 but there was no system for licensing in place before 2002 and so homeopathic products were unregulated before that. In Norway, all homeopathic medicinal products registered in at least one other EEA/EU country may be sold according to the Norwegian law. In Sweden, before 1994, when a registration procedure was first implemented, the homeopathic products were considered as food supplement. In Netherland, based on National Regulation for homeopathic medicinal products from 1992, if they were labeled as “homeopathic medicinal product,” the products were not registered nor notified. Switzerland has a unique policy of its own. In 1934, one of the first registration of homeopathic products with indication was given, mandatory authorization was only needed for pharmaceutical specialities (specific brands and indication). Then in 2002, the Law on Therapeutic Products enacted. Since then, Switzerland has had a mandatory authorization for Homeopathic products without indication. A special guidance for the homeopathic products was provided in 2002. In 2006, the Ordinance on Complementary and Herbal medicinal products enacted. Implementation of the Directive The Directive was implemented in majority of the EU countries in 2003–2007, with or without a transition period. If we take Norway as an example, the Directive was implemented into the Norwegian law in 2010, however there was a transition period until 1 December 2017, where all homeopathic medicinal products that are registered in at least one country within the EEA/EU can be sold in Norway without any registration. As of 1 December 2017, all homeopathic medicinal products on the Norwegian market must be registered. In contrast, in Belgium, the Directive was immediately implemented with the publication of the Royal Decree on 14 December 2006.

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In Sweden, Directive 2001/83/EC was implemented through LVSF 2003:2 that came into force in May 2003. Before that, 234 HMPs were registered, after the implementation, 1,250 HMPs were registered. In Netherlands and Germany, 2,632 and 3,470 homeopathic medicinal products were registered respectively. The implementation of the Directive has been quite successful as all the countries reported that there has been no major obstacle for the registration of homeopathic medicinal products in the country. Simplified Registration Procedure In all countries where the Directive is implemented, the simplified registration procedure is available for those homeopathic medicinal products which are: – Placed on the market without therapeutic indications. – In a pharmaceutical form and dosage which do not present a risk for the patient. In Switzerland, where the Directive is not implemented and a unique national policy was introduced, there are “special simplified authorization procedures” for homeopathic and medicinal products without indication. A full documentation is required only for a small number of products. Normally, it is either possible to get a simplified authorization based on a reduced dossier or an application procedure. The applicable procedure depends on a risk assessment which was made by Swissmedic. The outcome was the “list of homeopathic and anthroposophic substances (HAS List).” The HAS list consists of substances for which Swissmedic has the proof that their use can be seen as traditional within homeopathy and potencies for which safety has been proven to the extent that all or certain documentation on quality and security does not need to be submitted. Application procedure is also simple, based on the HAS list for each substance and dosage form only basic information, i.e., declaration of manufacturing method and starting material, must be submitted electronically. Some documents must be submitted for each product (“reduced dossier”). However, the number of the quality and safety documentation is reduced to a minimum.

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An additional documentation (master dossier) is only required for certain substances of animal or human origin, for medicinal products administered parenterally or applied either on or in the eye. There are no efforts for Switzerland to change this system. On the contrary, currently they are working on changes of the Law on Therapeutic Products. The aim of the new law is to enable simplified procedures for more medicinal products. Old and Existing Homeopathic Medicinal Products For existing homeopathic medicinal products marketed before 1993, the policies vary among countries. For example in Italy, registration procedure is not mandatory for all the old and existing products. All the products on the domestic market before the implementation of Directive (National Decree) are notified products. The notification consisted in an ope legis authorization that permitted these old products to be still on the market even without a formal authorization under transitional provisions. These products are without the scope of the procedure outlined in article 14.1 but under domestic procedure and must be formally authorized before the deadline of 31 December 2018. In Finland, no renewal procedure is planned for those homeopathic medicinal products registered before 1993, when all other requirements are identical for all old and existing products. On the contrary, in Germany, the old market has been completely reviewed. In Belgium, all the homeopathic medicinal products on the market had to be notified to the FAMHP in 2003. Based on this list of notified homeopathic products, the applicants had to submit an application for a demand of registration (art. 14) or authorization (art. 16). In 2003, an additional 18,000 products were notified. After an update of the list in 2014, around 5,600 products remained notified. In Czech Republic, the first homeopathic products were registered in 1992 according to the Czech legislation in force at the time of registration. Homeopathic preparations had to fulfil the definition of the homeopathic product according to the legislation, nosodes were not accepted, and the route of administration was limited to oral and external use. In France, all medicinal products, which have been authorized and marketed prior to 18 January 1994, have been subjected to a registration.

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The dossiers have been submitted according to a calendar running from 2001 to the end of 2015. A lot of them were still currently under assessment in 2016. In Switzerland, there are no specific rules for products marketed before 1993. All products which are actually on the market are treated in the same way. Renewal of Product Registration According to Article 24(4) to (6) of Directive 2001/83/EC and Article 14(4) to (6) of Regulation (EC) No 726/2004, when an authorized product previously placed on the market in the authorizing Member State or in the Union is no longer actually present on the market for a period of three consecutive years, the authorization for that product will cease to be valid. The article is implemented in the same way except France and Germany, where the authorization is valid for a period of five years instead of three years, and the renewal is unlimited afterwards. Marketing Authorization There are currently 12 Member States which have established Article 16(2), including the publication of specific rules for preclinical tests and clinical trials. In six Member States, Article 16(2) has not been implemented at all. In these countries, Article 16(1) (full marketing authorization in accordance with Articles 8, 10, 10a, b, c and 11) applies for homeopathic medicinal products. In 10 Member States, the optional Article 16(2) is given in the national drug law but no specific rules for pre-clinical and clinical testing are provided. This means that in practice in these countries, Article 16(2) cannot be considered as fully implemented. We can go into the details in Austria, France, Bulgaria, and Germany for illustration. In Austria, no preclinical or clinical data is required, but toxicological evaluation, justification of homeopathic use, and evidence on the specific homeopathic efficacy are required. In France, for a homeopathic medicinal product subject to a marketing authorization, considering its specificities, the applicant is exempted from producing all or part of the pharmacological, toxicological, and clinical results, if he can demonstrate, by thoroughly referring to accepted publications in the traditional medicinal use in France, that the homeopathic use of this product or its composing stocks are well established and provide all guarantees of safety. The documentation needed are as shown:

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Non-clinical information, Module 4 must include all data on animals, in vitro or in vivo, allowing to define the safety. These data must contain information on herbal drug, stock, or compound(s) of stock regarding: – – – – –

Pharmacology (efficacy) and pharmacokinetics, if applicable. General toxicology after single and repeated administrations. Genotoxicity and carcinogenicity. Reprotoxicity (in pups, males, and females). Local tolerance. Clinical information, Module 5 must include:

– A compiling of references (mostly from Materia Medica) for each stock. – An assessment of the provided bibliographic references proving the homeopathic use of the stocks in the claimed indication. – An assessment of the bibliographic references regarding safety mentioned in the Clinical overview. In Bulgaria, for homeopathic medicinal products under Art. 16 (marketing authorization with indications), the Marketing Authorization Holder (MAH) does not submit results from preclinical and clinical trials for homeopathic medicinal products if MAH can prove the indications, using bibliographic data from scientific literature, and establish safe homeopathic use of the medicinal product or of the homeopathic stocks within its composition concerned. In these cases, bibliographic data must indicate: – The homeopathic nature of the raw materials and their traditional administration, in the presence of the indication applied for. – The non-harmful nature of the homeopathic medicinal product, in terms of the level of dilution of each of its ingredients. In Germany, according to Section 22(3) of the German Medicinal Products Act, specific scientific documents may be presented for homeopathic medicinal products. Furthermore, the medical experience gained by

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the homeopathic school of therapy must also be taken into consideration. These are: – Monographs of Commission D. – “Criteria for cognition-based data on clinical indications in homeopathy” (2002). – Scientific literature. – Opinions of expert associations. – Reports from authorized homeopathic medicinal products. Restriction on Therapeutic Indications For some, but not all, countries, there are restrictions on therapeutic indications. For example, in Bulgaria, therapeutic indications of severe diseases such as cancer and AIDS are not allowed; in Lithuania, homeopathic medicinal products could be used only for light (self-passer) symptoms and conditions. This includes symptoms or the condition, whose prevention can be safely facilitated or taken without medical supervision or intervention. In Switzerland, while there is no restriction related to the therapeutic indication, the applicant must provide the evidence for it. However, depending on the indication, the products will be only available on prescription. There is no restriction in Netherlands, Sweden, Greece, Italy, Hungary, Austria, and so on. Labeling of Homeopathic Medicinal Products Packaging and labeling of homeopathic medicinal products is regulated by Articles 68 and 69 of Directive 2001/83/EC. Article 68 lays down the legal basis for packaging and labeling of these products and Article 69 the specific requirements. The package/label should contain the following information: – The scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5); if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labeling may be supplemented by an invented name; – name and address of the registration holder and, where appropriate, of the manufacturer,

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– – – – – – – – –

method of administration and, if necessary, route, expiry date, in clear terms (month, year), pharmaceutical form, contents of the sales presentation, special storage precautions, if any, a special warning if necessary for the medicinal product, manufacturer’s batch number, registration number, “homeopathic medicinal product without approved therapeutic indications,” – a warning advising the user to consult a doctor if the symptoms persist. These articles apply to Article 14 products only, which are mostly put on the market as over-the-counter medicines. They are required to be sold with a disclaimer, without indications and with restricted information. In fact, patients may not be given adequate information on the safe and correct use of these products. Specifically, the requirement to include a disclaimer, “homeopathic medicinal product without approved indication,” is misleading since these products do have indications but are simply registered without indication. Furthermore, no information can be provided on contra-indications or side effects linked to specific ingredients, or on contra-indications linked to allergies or dosage instructions. The legislation is not good for patients; the situation is further complicated by the fact that the translation and interpretation of Article 69 in the Members States has resulted in differences of implementation, with different Member States allowing more or less restricted patient information. This fosters a high degree of uncertainty for manufacturers, dependent on individual interpretations of the licensing authorities. The non-harmonized implementation is also an obstacle for Mutual Recognition. The regulation in Germany is more homeopathy friendly in the aspect of giving advice for possible aggravation (the initial reaction of homeopathic medicinal products indicates the improvement in vitality and remedy should be withheld until the instruction by homeopaths). What they

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ought to include in the label should be: “When using a HMP, the existing symptoms can initially aggravate. In this case, you should stop taking the medicine and ask your doctor.” In Switzerland, they must be labeled as homeopathic medicinal products. There are also requirements concerning the specific declaration of the active components etc. The rules of labeling of homeopathic medicinal products are defined in the AMZV — an ordinance which is not available in English.

5.2.3.2  Regulations in the USA In 1938, Senator Royal Copeland of New York, a physician trained in homeopathy and a principal author of the FDCA, included within the law’s definition of “drugs” articles monographed in the HPUS.[13] Whether Congress’s acceptance of this definition was a personal concession to Copeland or an attempt by reformers to regulate homeopathic drugs more closely is not clear.[14,15] The effect was to include homeopathic drugs as a formal component of food and drug law in the United States. Current Regulation[16,17] Under the Federal Food, Drug, and Cosmetic Act, homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the enforcement policies in FDA’s Compliance Policy Guide (CPG) 400.400 since 1988. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section.

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There are distinct regulatory differences in the regulations of allopathic drugs, homeopathic drugs, and dietary supplements. Table 5-1 compares the regulation of the three categories of medications.[17] In the table, we can see the comparison of the three kinds of regulations in different aspects: premarket approval, manufacturing, advertising, and labelling. Homeopathic drugs are subject to the FDCA and regulations issued by FDA. Unlike the new-drug-approval process as in the conventional drugs, premarket approval for homeopathic medicinal products is by way of monograph approval by HPCUS.[13] In other aspects, there are FDA compliance rules for the manufacturing, marketing, labeling and sales of homeopathic drugs, and the majority

Table 5–1    Regulation of allopathic drug, homeopathic drugs, and dietary supplements. Regulatory Control Medication Enabling Premarket Type Legislation Approval GMPs Allopathic drugs

FDCA

Dietary supple­ ments

DSHEA

Homeo­ pathic drugs

FDCA

NDA (21 21 C.F.R. C.F.R. 300 210 & et seq.) 211

None

Proposed

HPCUS 21 C.F.R. Monograph 210 & 211

Labeling

Indication on Advertising Labeling

21 C.F.R. Prescription: 201 FDA Nonpre­ scription: FTC

Required

DSHEA

“Structure function” claims only

FTC

21 C.F.R. Prescription: 201, FDA FDA Compliance Nonpre­ Policy scription: Guide FTC 400.400

Required

Note: GMPs = good manufacturing practices, FDCA = Food, Drug, and Cosmetic Act of 1938, NDA = new-drug-application process, 21 C.F.R. = Title 21 of the Code of Federal Regulations, FDA = Food and Drug Administration, FTC = Federal Trade Commission, DSHEA = Dietary Supplement Health and Education Act of 1994, HPCUS = Homeopathic Pharmacopoeia Convention of the United States.

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of the rules are almost identical to the rules for their conventional medicinal products counterparts, with just a few exceptions like expiration dating, tablet imprinting, and finished product testing. Homeopathic medicinal products have to follow the identical GMP standards as the convention drugs. Advertising oversight and reimbursement for homeopathic and allopathic drugs are also identical. The Homeopathic Pharmacopoeia Convention of the United States (HPUS) The HPUS is a non-governmental, non-profit scientific organization composed of experts in the fields of medicine, arts, biology, botany, chemistry, and pharmacy who have had appropriate training and experience and have demonstrated additional knowledge and interest in the principles of homeopathy. The Convention is an autonomous body which works closely with the Food and Drug Administration (FDA) and homeopathic organizations notably the American Institute of Homeopathy and the American Association of Homeopathic Pharmacists. The HPUS is “written” by a group of pharmacists, physicians and lay people who meet 3–6 times a year to review monographs (information about specific drugs) and pharmacy procedures. Currently, there are about 1,350 drugs in the Pharmacopeia. For a drug to be included in the HPUS, it needs to have sufficient clinical data or proving to show efficacy. The process for review is very formal as are the criteria for acceptance. The main difference between homeopathic and conventional medicinal products regulation is in the procedures for premarket approval. The HPUS is not only officially recognized by the FDCA, but also a standardsetting organization that focuses on the regulatory approval of official homeopathic drug products and the development and publication of general pharmacy practices and standards. Criteria for Eligibility of HPUS According to the instruction by the HPUS, The Board of Directors recognizes the following: – that homeopathy has a strong historical basis in theory and practice which was systematized by Samuel Hahnemann in the late 18th century, but which can be referenced to ancient medical writings and traced throughout its subsequent development to the present day;

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– that although the theoretical basis of its scientific methodology has remained constant, its format and documentation have evolved, and will continue to do so; – that as medical knowledge and the understanding of the nature of health and disease evolve, so medical treatment will evolve; – that for a medical treatment to be considered homeopathic, it must reference or be referenceable to the traditionally accepted principles of homeopathy. Such referencing will form the “bridge” that will allow for the scientific evolution of homeopathy. The principles and doctrine of homeopathic practice include but are not limited to the following: the Law of Similars, traditional homeopathic provings, cured symptoms, toxicologic data, and Hering’s direction of cure; – that the adoption of these principles and subsequent criteria will protect the integrity of homeopathy as it has been known until now, and also protect, without limiting, the possibility of its future development. To be eligible for inclusion in the Homeopathic Pharmacopeia of the United States, the drug must meet criteria 1, 2, 3, and at least one of 4, 5, 6, or 7 as set forth below: – The HPCUS has determined that the drug is safe and effective. – The drug must be prepared according to the specifications of the General Pharmacy and relevant sections of the Homeopathic Pharmacopeia of the United States. – The submitted documentation must be in an approved format as set forth in the relevant sections of the Homeopathic Pharmacopeia of the United States. – The therapeutic use of a new and non-official homeopathic drug is established by a homeopathic drug proving and clinical verification acceptable to the HPCUS. During the period of clinical verification, the drug will be accepted for provisional review and should be available on a monitored basis. Refer to the guideline for Homeopathic Drug Provings and the guideline for Clinical Verification for further information.

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– The therapeutic use of the drug is established through published documentation that the substance was in use prior to 1962. This documentation must include the symptom picture, including subjective and any available objective symptoms. Such use and documentation may include but are not limited to the medical literature of the following homeopathic authors: S Hahnemann, C Hering, TF Allen, HC Allen, JH Clarke, and JT Kent. – The therapeutic use of the drug is established by at least two adequately controlled double-blind clinical studies using the drug as the single intervention. The study is to be accompanied by adequate statistical analysis and adequate description of the symptoms picture acceptable to the HPCUS, which includes the subjective symptoms and where appropriate, the objective symptomatology. – The therapeutic use of the drug is established by 1) data gathered from clinical experience encompassing the symptom picture, pre- and posttreatment, including subjective and any available objective symptoms or 2) data documented in the medical literature (all sources of medical literature may be considered on a case-by-case basis) subjected to further verification (statistical and/or other forms of verification). The fifth criterion of old remedies used prior to 1962 was used to ensure the Traditional Homeopathic Medicines used during the 1970s and 1980s were accepted in the HPUS. This criterion is now rarely used, and HPCUS is re-reviewing many monographs accepted under this approach. Specific to homeopathy, homeopathic drug proving has its roots directly in the principle of similars. Traditionally, a dose of a pharmacologically-active substance is administered to a healthy volunteer and the developed symptoms are observed and recorded. A homeopathic dose of the same substance is then given to an individual with similar symptoms in their sickness to determine if the symptoms improved. Modern provings are similar but a control group and the use of placebo may be involved. Placebo is administered for a pretrial run-in period, followed by a study period of exposure to a homeopathic level of the test substance. Self-reported symptoms are entered into a subject’s diary for the entire period, and subjects are followed by a supervisor, who is typically

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an experienced prover. At the conclusion of the active period, symptoms are aggregated and analyzed using both qualitative and quantitative methods. Validity errors are expected with self-reporting but proper controls can mitigate this limitation. After analysis and acceptance by HPCUS, the data is subject to clinical verification, which involves clinical use of the drug to mitigate symptoms while capturing outcome data using conventional case-series methods. Overall, adequately designed and well-controlled clinical trials have become the norm for Homeopathic Medicine as they are for most allopathic medicines. The approval process begins with the submission of a monograph to the HPCUS monograph editor, either by private sponsors or by HPCUS itself. After review for completeness and formatting, the monograph file is forwarded to the monograph review committee (MRC) for a first review (Figure 5–8).

Figure 5–8    HPCUS monograph evaluation process.

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The MRC is composed primarily of scientists and pharmacists, the main focuses are the technical aspects of monographs, including substance characterization, quality analysis and controls, assay techniques, reference reagents, and technical aspects of drug production. After review, the MRC may return the submission to the sponsor for more data or clarification, reject or accept the monograph and recommend publication for a 90-day comment period in journals (e.g., Homeopathy Today) related to the professional practice of Homeopathic Medicine. After publication for comment, the monograph and comments are presented to the pharmacopeia revision committee (PRC) for a second review. The PRC consists primarily of clinicians and concerns itself with the proving or clinical trials data and with a second review of technical information. Like the MRC, the PRC may request more data on a drug, reject or accept it. If a monograph is accepted and differences exist between the MRC’s and PRC’s opinions, a joint MRC-PRC meeting may be called to resolve them. After preliminary approval by the MRC and the PRC, the monograph, along with recommendations, is forwarded to the HPCUS board of directors, which makes the final decisions. If the board accepts the monograph, the sponsor is advised and clinical outcomes data are requested. HPCUS collaborates with the monograph sponsor to determine the sample size for these data based on standard criteria of effect size, clinical indications for use, and potential toxicity or adverse effects. Once these data are collected and forwarded to HPCUS, the combined MRC and PRC committees review the clinical outcomes data. If acceptable, the monograph is granted final approval for inclusion in HPUS and the drug becomes an official approved drug within the meaning of the FDCA. The new conventional drug-approval process of Phase 1–3 clinical trials that start with early dose — response studies are not applicable in homeopathy. The clinical history of homeopathic drugs and the datacollection techniques are specific to the therapy, and therefore the premarketing approval process cannot be the same. Randomized controlled trials are only applicable when we are determining the efficacy of homeopathic drugs. For data collection, the

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homeopathic specific pathogenic trials, provings, are much more valuable in developing a more complete remedy picture that provides homeopath with insight into the specific clinical effectiveness — it is somehow similar to the use of qualitative data to enrich the data collected in a randomized controlled trial. The HPCUS monograph process, which has evolved over the past 150 years, produces only a few new homeopathic drugs every decade but carefully reviews those new drugs for safety based on clinical evidence. Recent actions by the FDA: The homeopathic industry has experienced expansive growth since the issuance of the CPG in 1988, which has compounded the FDA’s concerns about homeopathic medicinal products. FDA held a public hearing in April 2015 and drafted a guidance that proposes to substitute the CPG with a “risk-based enforcement approach” to drug products labeled as homeopathic. However, this new move was commented on by the national association of homeopathy as “less effective, less comprehensive” than the old CPG.[18] FDA’s proposed approach prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic that pose the greatest risk to patients. FDA intends to focus its enforcement authorities on the following kinds of products: – with reported safety concerns; – that contain or claim to contain ingredients associated with potentially significant safety concerns, such as controlled substances; – with routes of administration other than oral or topical, e.g., for use as an injection or taken nasally; – that claim to treat or prevent serious and/ or life-threatening diseases and conditions, such as cancer; – marketed to vulnerable populations, including children, pregnant women, and the elderly; – that do not meet regulatory standards of quality, strength, or purity as required under the law. FDA claimed that, under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers.

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However, the National Center for Homeopathy expressed serious concerns about the draft because: – Risk Assessment is designed for and essential to the oversight of chemically-based medicines but not for low-risk, highly-diluted Homeopathy Medicines. – Homeopathic Medicines are unique and are not the equivalent of chemically-based conventional drugs. They are prepared and manufactured differently and are used based upon a distinct set of principles. They should not be shoehorned into a category intended to increase the safety of chemically-based medicines but completely unsuited for Homeopathic Medicines. – The proposed Risk Assessment categories overlook the characteristic preparation and dilution of Homeopathy Medicines, which are in the nanoscale range and remove the potential for toxicity from the sourced substances. – The CPG 400.400, created by the FDA and used by manufacturers for 30 years, has ensured the manufacturing of Homeopathy Medicines up to high standards and has resulted in an exemplary safety record for Homeopathic Medicines. – Removal of the CPG 400.400, which specifically identifies Homeopathy Medicines within the HPUS protocols, opens the door for hybrid products to be sold improperly as homeopathic medicines. – Removal of the CPG 400.400 takes away the standardized production of Homeopathy Medicines, which may jeopardize safety. – The CPG 400.400 has guided the manufacturers and protected the consumers of homeopathy for 30 years. It is a comprehensive document and contains all the needed solutions to the challenges raised by the FDA in the Draft Guidance.

5.2.4  Clinical management Homeopathic treatment is aimed at methodically improving the level of health of an organism by the administration of proven-potentized medicines, which are individually selected in accordance with the similia

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principle. The symptoms of a diseased organism, the so-called disease picture, are classified and interrelated in such a way as to trace patterns that match the “remedy picture,” i.e., the symptoms provoked by a remedy in a healthy organism. The more detailed, peculiar, and individual the pictures are, the more chance that they fully match for a specific remedy, which implies that a deep and prolonged curing response is likely to follow. In case of incomplete similarity, only partial or temporary effects are noticeable. Homeopathic treatment is compatible with other medication but a homeopathic doctor seeks to reduce medication to a minimum. Practical experience has shown that a hierarchy of functions plays a role in the application of the similia principle. Symptoms and signs that arise from higher functions (like emotional symptoms or individual patterns of responding to environmental factors) appear to be more indicative within the frame of reference of the similia principle. Even if the patient seeks help for somatic complaints (like headache or gastritis), all hierarchical levels of the patient — mental, emotional, and physical, are methodically screened and the highest level of disturbance — from a hierarchical point of view, is detected. Both human beings and animals may successfully respond to a homeopathic treatment. However, since mental, emotional, and individual symptoms are more difficult to elicit in animals, in veterinary practice, symptoms lower in hierarchy often lead to the most appropriate remedy. Homeopathy is often referred to as the Art of Healing because the clinical outcome depends on the accuracy of prescription. The more similar the remedy is, the more penetrating the treatment result we have. Patients see the simillimum as “magic pills,” no matter what their sickness is, headache or vertigo, diarrhea, or constipation, it can be treated with the simillimum. However, remedies not similar to the patient are no different from pure sugar pills. Homeopaths are artists, we contribute our life on continuous education after they graduated from the practitioner training, refine their skills, and aim at the simillimum. The Law of Similars requires us to find a remedy whose symptoms are very similar to the symptoms of the patient. In practice, a number of remedies will be closely similar. In theory, one remedy should stand out as being the most similar — and it is called the simillimum.

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The ideal is to find the simillimum, but we know in practice that a number of similar remedies can also assist the patient to heal. To find an effective similar remedy we need to match the symptoms that are most significant in the patient, with similar symptoms in the remedy picture. There are in fact four different types of simillimum. They are: – The Symptom Simillimum. This is the remedy that most closely matches the simple listing of individual symptoms. – The Aetiological Simillimum. Aetiology = cause. So, this is the remedy that most closely relates to a stress that has caused the patient’s symptom picture to permanently change. Some common aetiologies are loss of a loved one, a relationship break up, major financial loss, being sacked from work, a severe infectious disease, vaccination, and so on. Homoeopathy has special remedies which assist in the removal of the unresolved stress or trauma, and allow the Vital Force to resume the healing process. – The Constitutional Simillimum. This is the remedy that most closely matches the constitutional symptom picture. – The Miasmic Simillimum. This is the remedy that most closely matches the patient’s active miasm. There are also different levels of clinical practice around the world. They are:

5.2.4.1  Use of a disease-specific complex remedy The analysis here is relatively superficial. The “name” of the disease is noted, the remedy for the disease is looked up in a product manual and the remedy given. For example, if a patient presents with acne, the prescriber looks up “acne” in the product manual and prescribes the remedy listed under that disease. It is usually a remedy which contains a number of related homoeopathic medicines mixed together and patented under a specific product name (such as “pimpleclear,” or something similar). Homoeopaths believed that such prescribing is not true homoeopathy. The individualizing symptoms of the case are not considered, no attempt

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Figure 5–9    Algorithm-based prescribing software.

is made to find the most similar remedy, and the symptom profile of the combination remedy (usually referred to as a complex) is rarely proved. This method is seen as being a “shotgun” approach — i.e., if enough bullets (remedies) are fired, one is sure to have some effect. At times, the combination remedy brings symptomatic relief to the patient. Some homoeopaths believe that this relief is only superficial and the remedy is almost certainly not going to heal the disease.

5.2.4.2  Analysis using an algorithm- based prescribing software to select a disease- specific single remedy In this method, a single remedy is used rather than a combination remedy. The remedy is selected by choosing between a number of single remedies, all of which are known to be indicated in many cases of the condition affecting the patient. This method does utilise the Law of Similars by using proved remedies. The method works reasonably well in simple conditions provided that deeper method is used if the remedies listed in the algorithm-based prescribing software do not fit the patient’s symptoms well. A sample for algorithm-based prescribing software is as shown (Figure 5–9).

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5.2.4.3  Analysis of mainly physical symptoms using repertorial analysis In this approach, we are concentrating on the physical complaints of the patient. We are now using a more sophisticated method of choosing the most similar remedy, which involves the following: The patient’s main symptoms are listed. They are looked for in a book of symptoms called a Repertory. If the symptom is present, it is listed in a matrix or grid (in the Repertory, the symptom is called a rubric). The matrix shows how many rubrics each remedy covers and the weight (or relative importance) of the remedy as it relates to each symptom. From the repertorial matrix, a short-list of remedies that appear to have a degree of similarity to the patient’s symptoms is prepared. The short-listed remedies are examined in the Materia Medica, and the most similar is chosen. The potency and frequency of administration is then decided. This approach clearly relies on the Law of Similars, however, it generally limits the analysis to the main physical symptom(s) of the patient. A case example of repertorization of physical symptoms of cough was as shown (Figure 5–10): Ms W, 42/F, begins homeopathic treatment since March 2011. Chief complaint: Eczema.

Figure 5–10    Before treatment.

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Onset: Intermittent eruption of eczema since childhood, suppressed with steroid cream during episodes of eruption. This episode had begun 4–5 months ago, since the release of the poor exam results of her son, she then ran around looking for schools for her son. Due to the eruptions, the sites (especially lower limbs) “stiffened” up; now she cannot not run around anymore. Position: At first it was only on the bilateral legs, suppressed by steroid during eruptions, but then it also extended up to the upper limbs and trunk in recent eruptions. Quality: Constant itching and burning, worse at the right lower limb. Inflammation was so severe that it was swollen. Patient feels stiff, numb, and immobilized. Relieving and aggravating factors: Better from warm bath, worse from wet and cold weather. Severity: It got more and more serious in recent years, especially during this episode; so stiff that she could not walk. Time: Irregular, this episode had lasted for around five months now and it was getting worse. In this case, the description of “stiffness” of the eczema is a very peculiar point to note. Illness brought to her “stiffness” and “immobility” which contrasted interestingly with her “must run around” status, this is what we call the tension of polarity, it represented the patient’s flow of vitality. Eczema is red, dry, itchy, or evening burning, it is common, and these are what we call the diagnostic criteria for “eczema” in allopathic medicines. However, in homeopathy, we are not looking for these “common symptoms” which are representing the disease but not the patient. For prescription, peculiar symptoms are listed out, respective rubrics are picked from repertory, and the most similar remedy is chosen (Figure 5–11). The Prescription given to the patient was Rhus Toxicodendron 30C. After the remedy, the stiffness first decreased, the restlessness during the itch decreased as well, then the itchiness and inflammation improved, and finally gone completely in half a year. Patient is well till now (2022) (Figure 5–12).

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Figure 5–11    Repertorization.

Figure 5–12    After treatment.

5.2.4.4  Complete analysis of mental, emotional and physical symptoms using repertorial analysis This method uses the same analytical structure as Method 3, except that in this case, not only the physical symptoms are considered, but the mental/emotional, or personality symptoms of the patient as well. As before, the Repertory provides a guide into the Materia Medica, which

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is where the final decision is made, based on the comparison of all of the patient’s symptoms with all of the symptoms of the short-listed remedies.

5.2.4.5  Constitutional analysis In this method, we are looking beyond the simple listing of individual symptoms, to an essence that can be perceived in the totality of symptoms. We call this essence of the patient their constitution. This represents the personality profile of the patient — their characteristics as a unique individual. In depth knowledge of many remedies and remedy groups is needed to make an accurate constitutional prescription.

5.2.4.6  Miasmic analysis This method requires the homoeopath to once again see behind the simple listing of individual symptoms and to perceive the presence of the miasmic disease entity, which Hahnemann saw as the true cause of chronic disease. It takes many years of study and experience to fully understand how to recognize the miasms, and how to treat them appropriately. The purpose of all these analyzes is to find the most similar remedy — the simillimum. In acute (non-professional) prescribing, method ii — the algorithmbased software or a similar book is usually used. Basic level professional training involves the use of repertories and Materia Medica. The use of the more sophisticated methods (iv-vi) requires practitioner level of professional training. Our eventual aim should be to find a single remedy that fits the symptoms, the constitutional, as well as the miasm. This is indeed possible, so that all the suppressed traumas that the patient has suffered over their life can be fully resolved or healed. In ideal cases, we have a remedy that is able to take the patient to their core, achieving the highest possible level of health. This is a form of prescribing that requires great skill and experience, and this is our ultimate goal.

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5.2.5 Standardization Manufacturing processes for homeopathic medicinal products are standardized in the European Pharmacopoeia and in specific national Pharmacopoeias, such as Pharmacopée Francaise (FHP), the German Homeopathic Pharmacopoeia (GHP), the Homeopathic Pharmacopoeia of the United States (HPUS), Homeopathic Pharmacopeia of India (HPI), Brazil-Brazilian Homeopathic Pharmacopoeia (Brz HP), and Mexican Homeopathic Pharmacopoeia (MHP). Quality standards are important, as they bring recognition and help to create a legal framework for homeopathic medicinal products. This gives a solid basis on which to submit dossiers for a marketing authorization or registration and gives the authorities a legal instrument by which to review the quality. Europe is the center of pharmaceutical expertise in these products. The pharmaceutical processes, including quality monographs for both starting materials and manufacturing methods, are developed in the industry, further developed with academics, and confirmed by regulation. The countries which do not have an official pharmacopeia use the pharmacopeia of other countries for their reference standards.

5.2.5.1  Starting materials Manufacturers of homeopathic medicinal products use a wide diversity of natural starting materials. The materials are mainly fresh and dried plants, minerals, chemical substances (salts and metals), or animal materials. The larger manufacturers may have as many as 1,500 –2,000 starting materials. The companies with the widest range of products process over 4,000 different starting materials, so as to ensure the full range of products required for the proper practice of the therapies. Many of the small or medium-sized companies have around 700–800 different starting materials and even the smaller companies or those with a limited range have between 100–200 different starting materials. According to information provided by the European Coalition on Homeoapthic and Anthroposophic Medicinal Products (ECHAMP), more than 50% of starting materials are of botanical origin; for some companies, this number can be as high as 80–90%.

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In many cases, this wide variety of starting materials is sourced from multiple suppliers to ensure stability of production. The larger companies can have over 100 different suppliers, up to as many as 350 different suppliers. Even the smaller companies or those with limited ranges can have 20 or more different suppliers. In view of the high number of starting materials, flexibility of the choice of suppliers is essential to guarantee availability. In Europe, the companies maintain quality documentation for each different starting material. The quality of the raw material is guaranteed by a routine evaluation, that takes account of all the information from the harvesting protocol or certificate of origin, the analytical controls to show conformity with the release specification and, if required, additional risk-based considerations and tests. In that way, independently from the supplier, the companies ensure that the starting material is of consistently good quality. ECHAMP supports the practice of manufacturers of homeopathic medicinal products to not fix suppliers of certain raw materials in registration dossiers for these products. This is not practical, feasible, or desirable from a scientific or regulatory perspective as flexibility of supplier is essential to guarantee quality and availability of these products.

5.2.5.2  Viral safety Since Hahnemann’s time preparations of materials of animal origin have played an important role in homoeopathy, such as snake venoms (Lachesis), honeybee (Apis), or cuttlefish (Sepia), as well as parts of slaughtered animals such as cattle or pigs. These preparations are therapeutically used in homoeopathy medicine. Due to their natural origin, it is possible that such preparations of animal raw materials could be contaminated with pathogens from the animal and potentially harmful by transmitting these infectious agents to man. Therefore, the safety of such preparations is of great concern. The European Pharmacopoeia monograph on “Homoeopathic Preparations” requires pharmaceutical companies to take steps to minimize the risk of infection, e.g., by the choice of the raw material or the preparation method. In particular, the question of how to demonstrate viral safety of animal raw materials was and is still a great challenge to pharmaceutical companies as well as to the authorities.

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In this context, the “Viral Safety Group” was established, a working group of German pharmaceutical companies, supported by the two major German pharmaceutical associations. All manufacturers have to follow the same legal regulations and use the same raw materials and production methods, so by combining efforts, the companies were able to share their pharmaceutical, veterinary, and regulatory expertise and avoid the costly challenge of meeting the pharmacopoeial requirements alone. The aim of the collaboration was to elaborate a viable strategy on how to demonstrate the viral safety of homeopathic preparations of animal origin as required by the Monograph “Homoeopathic Preparations” of the European Pharmacopoeia. Specifications were developed for each animal or human raw material, derived from detailed assessment reports about the risk of contamination with and transmission of pathogens by the material and/or its preparations. The assessments identify the risk associated with the various materials. The specifications cover the animals’ origin and living conditions, e.g., breeding conditions, housing, food, and applicable slaughtering conditions. Animals that are usually intended for human consumption must meet the EU food hygiene regulations (“fit for human consumption”). In order to show how different homeopathic methods of preparation can minimize or remove a potential virus load, as identified in the assessment reports, the working group initiated a validation study of the homeopathic manufacturing processes of mother tinctures and dilutions in terms of virus reduction or removal in accordance with the relevant European Medicines Agency Guidance on Virus Validation Studies.

5.2.5.3  Manufacturing processes The first step in the preparation of a Homeopathic Medicine from plant or animal starting material is the preparation of the “mother tincture” (Ø). From chemical or mineral starting material, a first dilution is made. It can be a liquid dilution with ethanol/water or a solid dilution (a “trituration”) with lactose. All procedures, both the preparation of the mother tincture and the preparation of the first dilution or trituration, are performed

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according to a homeopathic manufacturing method given in the European Pharmacopoeia or other Pharmacopoeia. The second step is a process of systematic serial dilution and “succession” (vigorous, rhythmic shaking with impact) known as “potentization,” during which the most concentrated homeopathic preparation is “potentized” with a dilution agent (usually ethanol, water, or lactose). The potentization steps in a potency row can be performed in different dilution ratios: – D or X: 1:10 – C or CH: 1:100 – LM 1:50,000 So, for example, D4 means potentized four times in the ratio 1:10. The higher the number of potencies, the lower the concentration. The dosage forms comply with the European Pharmacopoeia or other national Pharmacopeia.

5.2.6  Education and training In order to bring the benefits of high quality homeopathic treatment to all members of the public, homeopathy education must be of sufficient quality to facilitate students’ development to become practitioners who are able to contribute positively to patients’ health and healthcare, while at the same time ensuring their safety. The International guidelines for Homeopathy Education was published by the European Central Council of Homeopaths (ECCH) and International Council for Homeopathy (ICH) in 2011. These guidelines outline a framework for the education and training of a competent, autonomous homeopath. The homeopath should ideally be competent to work in a variety of roles, ranging from an independent consultant in private practice through to being an integrated member of a team of healthcare practitioners working in a clinical setting. Practitioners from other healthcare disciplines studying homeopathy are expected to complete the full homeopathy content of these guidelines, including the clinical requirements, in order to become competent homeopaths.

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Homeopathy Education: – Needs to fulfill certain minimum requirements as to quality and content. – Needs to be sufficiently long for the content of the study outlined in these guidelines to be covered and assimilated. – Needs to include a range of educational experiences, preparing students for a broad range of potential experiences they are likely to meet in practice. The homeopathy education process recognizes the student as an individual and creates an environment that enables students to realize their potential. Homeopathy education should therefore preferably be studentcentered. In order for students to learn how to become skilled practitioners, clinical experience and deep approaches to learning are central elements of their education. Learning activities and opportunities in the course and the assessment of student progress, are designed in such a way that all the study topics are covered and students can show evidence that: – they know at a basic understanding level, – they comprehend through understanding relationships of ideas in concepts and procedures, – they can apply the material in a practitioner role, integrating understanding, and refining knowledge. In addition, throughout the course, students are encouraged to develop independence and autonomy, showing evidence that: – they are able to analyze existing information or situations, – they can synthesize new ideas themselves from their own observation and experience, – they can evaluate their progress through use of reflective practice. Study areas should include:

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5.2.6.1  Anatomy, physiology and pathological processes A thorough knowledge of anatomy, physiology, and pathological processes enables the homeopath to differentiate between pathognomonic and individualizing symptoms in a patient’s case. It also enables the homeopathy practitioner to communicate with other health care professionals and to practice within each national health care system upon graduation.

5.2.6.2  Principles of homeopathy To become a competent homeopath, it is essential to have a strong grounding in the principles and concepts of homeopathy. To restore patients to health, one needs to understand the fundamental principles of health and disease. Samuel Hahnemann’s writings are the foundation of this.

5.2.6.3  History and development of homeopathy In order to understand homeopathy and develop it further, it is essential to place Hahnemann’s theories and those of his successors in the context of medical history.

5.2.6.4  Homeopathic pharmacology In order to understand the healing potential of a homeopathic remedy, it is essential to have good knowledge and an appreciation of its sources and methods of preparation. The quality of the remedy will affect clinical results. It is important to be aware that there is more than one pharmacopoeia.

5.2.6.5  Homeopathic materia medica Two-hundred years of homeopathy have produced a wealth of Materia Medica derived from homeopathy provings and other sources. This treasury deserves a deep and critical approach.

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The intensive study of original homeopathy proving symptoms is the basis of every remedy study. Toxicology and clinical experience are other important sources of homeopathy information. Clear acknowledgement of the various sources for Materia Medica knowledge is essential.

5.2.6.6  Research Research is vital to the development of homeopathy. As an empirical and phenomenological science, there is a strict coherence in its principles between the knowledge acquired from the provings and the final application in clinical practice. Research provides the context for dialogue within the homeopathy community and with the wider scientific community. Advances in communications technology make it easier to search for, exchange, and increase knowledge and understanding of homeopathy through research.

5.2.6.7  Practice methodology Students need to learn how to synthesize homeopathy theory, philosophy, and Materia Medica learning and apply it in clinical practice.

5.2.6.8  Patient health awareness The goal of homeopathic treatment is improved health. As the patient’s health improves from effective homeopathic treatment, there is often a need to explore and facilitate appropriate lifestyle changes, in order to support the movement towards health. Students are taught how to explore and explain maintaining causes or obstacles to achieving good health in a sensitive manner. The importance of respecting the patients’ dignity, autonomy, and rights regarding any decisions around their lifestyle and an acknowledgement of their power to heal themselves is stressed. It is also essential for students to be aware of their own potential biases when they make any judgment regarding a patient’s health, lifestyle, etc. Students should have the skills, when requested, to help patients

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become aware of how social contexts and family dynamics, personal beliefs, self-images, preferences, and the choices they make affect their lives and how their psychological and emotional functioning influences their health and well-being.

5.2.6.9  Clinical training Comprehensive clinical education and training is an essential requirement in the education of homeopaths. While much homeopathy theory, history, and Materia Medica can be learned from books, it is impossible to gain clinical competence without practical clinical training and experience. Clinical training should be a main focus of homeopathy teaching program and should run concurrently with theoretical studies throughout the entire course. The skills and attitudes needed in order to become a competent homeopath are acquired by the rigorous application of an experiential and reflective process throughout the student’s training. Clinical training allows the student to develop the ability to observe and communicate with the patient, as well as to learn how to acquire relevant information from the patient and identify their particular healthcare needs. It is essential that students are actively involved in clinical training in order to make the most of teaching and learning experiences. Teachers should be aware that students engaged in casework might be at different levels of study and/or understanding. It is essential that students are actively involved in the supervised case taking and management of individual patients before being considered eligible for graduation. These cases should cover a range of conditions and include the initial consultation, plus a number of follow-up consultations.

5.2.6.10  Practitioner and practice development Practitioner and practice development are essential components of a homeopathy course curriculum. Their inclusion facilitates students in establishing and managing a successful practice capable of meeting the diverse needs of their patients.

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5.2.6.11  Ethics of healthcare practice Ethical values are involved in all areas of healthcare practice. Therefore, the development of relevant ethical values runs throughout the whole study of homeopathy, reflecting day-to-day practice. In line with developments within the Higher Education Community in Europe via the Bologna Process, this guideline does not recommend a specific number of hours, or course length, or stipulate the number of clinical hours. The Bologna process proposes the introduction of a modular system and the awarding of points per module. Each course can then map its curriculum and allocate points for each module. Course completion and fitness to practice is then measurable and transparent. The onus is on the course to show that its curriculum is at the required level for homeopaths to enter professional practice. According to the Society of Homeopaths (SoH) in UK,[19] the academic level of a fully accredited homeopathic practitioner course of is equivalent to that of a first degree — Higher Education Level 6. According to the standard of higher education in UK, it equals to 360 credits (10 hours teaching for each credit), so the practitioner course is equivalent to a 3-year full time degree course or 4-year part time degree course. For the clinical training, students should practice under supervision for at least 18 months before graduation and they should be able to fulfill the requirement of the National Occupational Standard before registration.

5.2.7  Scientific research and evaluation for efficacy, quality, and safety (if available) Both the European Parliament and the Council of Europe have encouraged the development of research programs for nonconventional medicines.[13,18] The first systematic research on homeopathy was conducted at the end of the 18th century.[19] Since then, there has been a continuous research tradition within homeopathy. Of all so-called “complementary” or “nonconventional” therapies, homeopathy is probably the one in which there is the largest established research base of past and present activity. In 1997, the Homeopathic

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Medicine Research Group, which was established by Directorate Commission X11 E of the European Union Commission two years earlier, published a comprehensive report of its findings into the status of homeopathic research together with a Dictionary of Homeopathy and database of homeopathic trials.[2] The report concluded that there was sufficient evidence to continue to develop more effective research into homeopathy and its effectiveness but that, as most of the trials surveyed, was of low methodological quality. Much work was needed to improve trial quality before any truly definitive statements could be made. This statement supports the findings of two separate meta-analyzes of homeopathic clinical research trials in 1992[20] and 1997,[21] which both concluded that there is sufficient evidence to suggest that the effects of homeopathic treatment cannot be explained by calling them mere placebo effect but that more research of greater quality needs to be carried out before final proof can be established. The type of research which has become best known outside homeopathic circles, has been conducted using methodologies based on conventional science. This type of research has resulted in a focus on determining whether homeopathy works due to a placebo response or not. To an increasing extent research is being carried out in order to determine what the treatment can actually do for patients. The integration of homeopathy into the conventional health system is a burning topic recently as highlighted by a recent article at BMJ titled as “Should Doctors Recommend Homeopathy?”[22] A major problem in homeopathic research has been the lack of funding. Single homeopathic medicines cannot be patented. This fact, plus the relatively low turnover in sales, has meant that manufacturers of homeopathic medicinal products have only contributed to a minor degree to funding research on homeopathy. In recent years, some money for research has been granted by national authorities in eight European countries. The countries are: Austria, Denmark, Germany, Italy, Norway, Romania, Switzerland and UK.[23] This is in line with the recommendations from the European Parliament and the Council of Europe.[13,18]

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5.2.7.1  Mechanism of action of potentized substances Critics of homeopathy point to the fact that Homeopathy Medicines are so highly diluted that there is “nothing in them” and it is “impossible.” This comes from the fact that the liquids used to make some Homeopathy Medicines are diluted beyond the threshold known as Avogadro’s number (dilution 10–23). This means that the liquid is so highly diluted that you would not expect any molecules of the original substance to remain. It is these “ultra-high dilutions” (Homeopathy Medicines above 12c or 24x potency) which attract controversy, because they clearly cannot work in the same way as conventional medical drugs i.e., through molecules interacting directly with the body’s biochemistry. Science is a constantly evolving field and what the scientific establishment declares to be “impossible” in one era, is often proved to be “fact” in another.[2] To take just one famous example of medical U-turns, in 1982, when Dr Barry Marshall and Dr Robin Warren first put forward their theory that bacterial infection was an underlying cause of stomach ulcers, their idea was ridiculed.[20] Scientists said it was impossible for bacteria to survive the acidic environment in the stomach, let alone thrive there, but years later Marshall and Warren were vindicated when it was finally accepted that they were right — Helicobacter pylori infection is indeed the most common cause of stomach ulcers. In 2005, they were awarded the Nobel Prize for Physiology. In the Nobel citation, the doctors were praised for their “tenacity, and willingness to challenge prevailing dogmas.” While scientists continue to investigate how homeopathic medicines have a biological effect, perhaps we should be more cautious about using the word “impossible” when it comes to any facet of medical science. It has been suggested that potentization changes the characteristics of the substance in such a way that the information content of the remedy is more relevant than its material content, especially in high potencies. Researchers around the world are investigating the mechanism of action of these medicines, which is likely to be based in physics rather than chemistry. Although there are various theories being explored, as yet, we do not fully understand how exactly Homeopathy Medicines work.

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Current research points towards the likely existence of water structures which, although being largely unexplored, in principle have the necessary characteristics to explain the mechanism of action of homeopathic medicines. Current fundamental research projects aim to investigate these new water structures using a multidisciplinary approach involving theoretical physics, mathematical modeling, and experimental exploration. In the field of the physics of high dilutions, which has immediate relevance to homeopathy, many research groups have reported interesting findings. In particular, Prof Luc Montagnier (who won the Nobel Prize for discovering the HIV/AIDS virus), has shown homeopathic dilutions to have electromagnetic properties which differ from those of normal water.[24,25] In 2009, Nobel Prize winner, Prof Luc Montagnier and his team reported the results of a series of experiments investigating the electromagnetic (EM) properties of highly-diluted biological samples. They found that pathogenic bacteria and viruses show a distinct EM signature at dilutions ranging from 10–5 to 10–12 and that small DNA fragments (responsible for pathogenicity) were solely accountable for the EM signal. The EM signature changed with dilution levels but was unaffected by the initial concentration and remained even after the remaining DNA fragments were destroyed by chemical agents. They observed that the EM signal was destroyed by heating or freezing the sample. Also, a “cross-talk” effect was found whereby a sample interacted with one another when left together overnight in a shielded container. It was also noted that the samples needed be vortexed (a shaking process akin to succussion) for the EM effects to be present. They propose that specific aqueous nanostructures formed in the samples during the dilution process and are responsible for the EM effects measured. With this initial paper, Prof Montagnier and his team have started a very promising line of enquiry, which has direct relevance to homeopathy as they continue to investigate the characteristic physicochemical properties found in high dilutions of biological material. Research interests are centered around repeating the famous basophil degranulation experiments of the late Dr Jacques Benveniste (1935–2004),

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with the aim of making the experiment more easily reproducible in standard laboratory setting and of studying important physical parameters crucial to the phenomenon. In particular, researchers aim to study the influence of electromagnetic fields on the system, in line with Prof Luc Montagnier’s recent results. Benveniste was an eminent French immunologist, adviser to the French government. He was the director of INSERM unit 200, directed at immunology, allergy, and inflammation. In a seminal paper published in the prestigious journal Nature in 1988, Dr Benveniste’s team reported their results investigating the effects of high dilutions on human basophils (a type of white blood cell). They diluted a solution of human anti-IgE antibodies in water to such a degree that there was virtually no possibility that a single molecule of the antibody remained in the water solution. They reported, human basophils responded to the solutions just as though they had encountered the original antibody (part of the allergic reaction). The effect was reported only when the solution was shaken violently during dilution. This publication led to a large controversy around “the memory of water.” Since then, 28 scientific papers have been published in this area, 23 of which reported positive results. Of the 11 publications judged to be of high quality, 8 (72%) reported positive results.[21] In July 2018, a major research conference took place at London’s Royal Society of Medicine, titled “New Horizons in Water Science — The Evidence for Homeopathy?” The conference confirmed the therapeutic effects of extremely small doses (nanodoses) of homeopathic medicines. Two Nobel Prize-winning scientists and other esteemed researchers from across the world presented compelling evidence that medicinal agents not only persist in water but they retain therapeutic effects in these nanodoses. Unsurprisingly, our bodies’ hormones and cell-signaling systems also operate at this super small nanodose level. Professor Vladimir Voeikov from Lomonosov Moscow State University asserted that Russian scientists had known for decades that tiny doses of medicines have dramatic effects on biological systems. Professor Jerry Pollack of the University of Washington is one of the leading experts on water who reported in his research, which confirms that water has the capacity to store huge amounts of medicinal information, enabling homeopathic nanodoses to fully impact a person’s physiology. Presentation by Cambridge

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Professor Emeritus Brian Josephson at the conference[22] is now available freely on web, with introduction by Lord Kenneth Ward-Atherton.

5.2.7.2  Homeopathic pathogenetic trials: Proving Homeopathic pathogenetic trials or “provings” are a type of research in which compounds are tested on healthy human volunteers in order to observe as many effects as possible, at a non-toxic level. Such careful experimentation is a prerequisite for identifying the true pathogenetic picture of a Homeopathy Medicine, i.e., its capacity to alter the state of health. Homeopathic pathogenetic trials can in fact be considered as a type of pilot study. Testing potential remedies on selected volunteers and describing the induced symptoms in order to establish the “remedy picture” has been carried out since homeopathy’s inception. Healthy and sensitive persons have been recruited for remedies proving since the time of Hahnemann. Human provers can report and record the holistic effect after taking the remedies, which make it possible for us to understand the totality of symptoms that different remedies pose on human beings. This unique method of testing and quantifying the healing potential of a substance can reveal all aspects (mental, emotional, and physical) of the remedy, and it provides immensely valuable data for the practitioner. Without provings, the systematic use of the Law of Similars would not be possible. Hahnemann performed the first systematic study of drug action in the history of medicine, and this method, essential for evaluating the indications for homeopathic remedies, has continued ever since, although over time the procedures have changed. New protocols are currently under development which are in accordance with modern pharmaceutical and Good Medical Practice (GMP) procedures for testing new substances or retesting incompletely tested old substances. It is essential that Homeopathy Medicines are tested on human beings rather than animals. The reason for this is that a disease has two distinct forms of expression, namely tissue changes or objective signs, and subjective symptoms which include types of pain, emotions, and other sensations. These subjective symptoms are of particular importance because they help to characterize the patient’s individual illness and allow the selection of a homeopathic remedy that matches this personalized state of illness. A review of

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homeopathic pathogenetic trials has revealed that nearly 150 such trials, 3,326 of a wide range of substances, have been conducted in Europe since 1945.

5.2.7.3  Clinical efficacy As any other kind of traditional and complementary medicine, evidence at different levels is the main area of concern. DNA-microarrays provided useful suggestions about the behavior of human organisms treated with Homeopathy Medicines. The results reviewed suggested that the action of drugs proceeds through modulation of gene expressions. Moreover, the different gene expression profiles showed consistent concentration-dependent inversion of gene expression, which can justify at a molecular level the concept of simile adopted in homeopathy.[26] In animal studies, homoeopathic preparations can produce a clear trend of metamorphosis inhibition in amphibians.[27] This was observed by seven independent researchers from Austria, Germany, Switzerland, and the Netherlands.[28] Informative controlled animal experiments were also done on alloxan-induced diabetes in rats.[29] The results were also reproduced by other workers.[30,31] At an observation study level, the EPI3 survey,[32] which is a nationwide cohort study of primary care practice, was conducted in a representative sample of GPs from across France and their patients between 2007 and 2008. A total of 518 adults and children with URTI were included. As opposed to conventional treatment group, patients in the homeopathic treatment group showed significantly lower consumption of antibiotics and antipyretic/anti-inflammatory drugs (OR = 0.54, 95% CI: 0.38–0.76) with similar evolution in related symptoms (OR = 1.16, 95% CI: 0.64–2.10). By the end of 2014, 189 randomized controlled trials of homeopathy on 100 different medical conditions had been published in peer-reviewed journals.[24] Of these, 104 papers were placebo-controlled and were eligible for detailed review: 41% were positive (43 trials), i.e., finding that homeopathy was effective, 5% were negative (5 trials), i.e., finding that homeopathy was ineffective, and 54% were inconclusive (56 trials). The percentages of positive, negative, and inconclusive results are similar in homeopathy and conventional medicine.[25] Below are some examples of positive high-quality randomized controlled trials in homeopathy:

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– Individualized homeopathic treatment for diarrhea in children. A meta-analysis of three placebo-controlled randomized trials by Jacobs et al. (2003) showed that homeopathic treatment reduced the duration of diarrhea (P = 0.008).[33] – Individualized homeopathic treatment for ear infections (otitis media) in children.[34,35] – Individualized homeopathic treatment for moderate to severe depression in menopausal women.[36] The randomized placebo-controlled trial compared homeopathy with Fluoxetine, showing that Homeopathy caused greater clinical improvement in symptoms of depression than fluoxetine and also improved the patients’ menopausal symptoms, whereas fluoxetine did not. Over the past few decades, encouraging results have been obtained in performed clinical trials supporting the efficacy of homeopathy, as was shown in recent meta-analyzes.[20,21,29,30] Recent meta-analysis[37] of randomized controlled trials revealed that although the overall quality of the evidence was low or unclear, preventing decisive conclusions, there is a statistically significant treatment effect of individualized homeopathic treatment that was robust to sensitivity analysis based on reliable evidence. Findings are consistent with sub-group data available in a previous global systematic review of homeopathy RCTs. At a National level, Health Technology Assessment report[38] was commissioned by the Swiss health authorities to inform decision-making on the further inclusion of homoeopathy in the list of services covered by statutory health insurance. The report confirms that there is sufficient evidence for the preclinical effectiveness and the clinical efficacy of homeopathy and for its safety and economy compared with conventional treatment. Contradictory result was found by the Australian National Health and Medical Research Council (NHMRC) a few years later,[74] the Australian Homeopathic Association (AHA) made a formal complaint to the Commonwealth Ombudsman aimed to hold NHMRC accountable for bias and misconduct because the existence of a positive first report was not disclosed to the public.[75] The seven-year investigation was closed in 2023 in the absence of independent expert scientific expertise.[76] Since the NHMRC report on homeopathy has been widely quoted, it is profoundly regrettable that the scientific misconduct case remains unanswered.

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For more information on clinical researches, CORE-Hom (The Clinical Outcome Research in Homeopathy Database) is the most comprehensive and academically rigorous database of its kind in the world, and the only homeopathy database providing information about the quality of the studies it contains. CORE-Hom contains all types of clinical outcome studies, from randomized controlled trials to observational studies. At present, it comprises over 1,200 clinical studies on homeopathy but this number will change as the database is continually improved and updated with newly published trials.

5.2.7.4  Placebo effect?[39] It is frequently argued that Homeopathy Medicines are “just sugar pills” that do not Contain any active ingredients, so any benefits that patients report are due purely to the placebo effect, i.e., people believe the pills are going to help and this belief alone triggers a healing response. With any medical treatment, there is likely to be some degree of “placebo effect” and in this respect homeopathy is no different, but the theory that homeopathy’s effects are only a placebo response is not supported by the scientific evidence. If homeopathy is really just a placebo effect, how does one explain: – The existence of positive high-quality placebo-controlled trials? These trials are designed specifically to separate out the placebo effect from the real clinical effect of the treatment being tested. * Individualized homeopathic treatment for diarrhea in children. A meta-analysis of three placebo-controlled randomized trials by Jacobs et al. 2003 showed that homeopathic treatment reduced the duration of diarrhea (P = 0.008).[33] * Individualized homeopathic treatment for ear infections (otitis media) in children.[34,35] * The homeopathic medicine Galphimia glauca for hay fever (allergic rhinitis).[40] * The isopathic medicine Pollen 30c for hay fever.[41]

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Critics may comment on the examples of high-quality positive trials as “cherry picking.” In fact, “cherry picking” is the practice of publishing or quoting only the positive trials on a given treatment, whilst ignoring conflicting negative trials. This can lead to distortion of the evidence, which is why there has been a recent drive to force research institutions and drug companies to disclose all trial results — both positive and negative, so that the balance of evidence can be considered in its entirety. When strong positive studies are presented to critics of homeopathy, they often say that this is cherry picking because there are other negative trials on homeopathy. However, those negative trials are only relevant if they were testing the same homeopathic treatment for the same condition. In the case of the studies listed above, to our knowledge, there are no other repetitions of these trials which had negative results, so the evidence is unrefuted. – Homeopathy Medicines having effects in laboratory experiments? Many laboratory studies have shown that ultra-high dilution Homeopathy Medicines have biological effects; effects have been seen on white blood cells, frogs, and wheat plants to name just a few examples. Here, we present some of the highest quality and most replicated experiments. Basophil degranulation experiment: 28 scientific papers have been published on this topic, 23 of which reported positive results. Eleven publications were judged to be of high quality, of which eight reported positive results.[21] As the people who originally designed this experiment explain, “When human polymorphonuclear basophils, a type of white blood cell with antibodies of the immunoglobulin E (IgE) type on its surface, are exposed to anti-IgE antibodies, they release histamine from their intracellular granules and change their staining properties. The latter can be demonstrated at dilutions of anti-IgE that range from 10–2 to 10–120; over that range, there are successive peaks of degranulation from 40–60% of the basophils, despite the calculated absence of any anti-IgE molecules at the highest dilutions.”

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The earliest study using this model reported inhibition of degranulation with ultra-molecular dilutions of anti-IgE,[42] but these experiments proved to be unreproducible.[43,44] However, subsequent studies using a modified method (using ultra-molecular dilutions of histamine instead of anti-IgE), have shown positive results. These findings have been reproduced in several independent laboratories,[45,46] as well as in a multi-center series of experiments.[47] Effects of homeopathic thyroxine on tadpole development: In amphibians, the hormone thyroxine stimulates metamorphosis. Over almost 20 years, various teams have tested homeopathic dilutions of thyroxine on frogs by adding it to the bathing water tadpoles are kept in. Although exact results varied, all 22 experiments have found the same trend — that Thyroxine 30x (diluted beyond Avogadro’s limit using the homeopathic manufacturing process) inhibits metamorphosis. An independent meta-analysis of these studies identified 22 experiments — 15 carried out by the original team in Austria and 5 by independent researchers.[48] This effect has now been observed by seven individual researchers from Austria, Germany, Switzerland, and the Netherlands. The challenge of reproducibility: Although these laboratory studies demonstrate that Homeopathy Medicines can exert biological effects, so far, no positive result has been stable enough to be reproduced by all researchers every time. Close to 75% of in vitro experiments on ultra-high dilutions show the substance having an effect and nearly 75% of replications have been positive.[49] As scientists gain more experience experimenting on ultra-high dilutions, they are gradually understanding what factors are influencing the results and consequently, reproducibility is improving.[50] The basophil and frog experiments described above have proved the most repeatable so far and progress is also being made in finding the most repeatable plantbased experiments.[51] However, until an experiment is achieved, in which every team gets exactly the same effect every time, this field will remain controversial. This is the ongoing challenge for basic science researchers in homeopathy. – The fact that homeopathy can work in animals?

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Two recent reviews by Mathie and Clausen investigated the evidence in veterinary homeopathy.[52,53] The first review looked at the evidence from randomized placebo-controlled trials and found weak evidence that homeopathy treatment is different from placebo (P = 0.01 for N = 15 trials and P = 0.02 for N = 2 most reliable trials).[54] The second review looked at the evidence from randomized trials controlled by other means than placebo (e.g., usual care) and found the quality of the trials in this category to be too low to provide any meaningful answer.[53] Prevention of diarrhea in piglets: A rigorous research study found that a Homeopathy Medicine can prevent E. coli diarrhea in piglets — a big problem in commercial farming. It is one of the high-quality placebo-controlled trials identified by Mathie and Clausen, and it was carried out by Wageningen University in the Netherlands.[55] In this triple-blinded RCT, 52 pregnant sows were treated with either Coli 30K (a homeopathic medicine made from E. coli bacteria) or placebo. The sows gave birth to 525 piglets and those in the group treated with Coli 30K had six times less diarrhea than the piglets in the placebo group. This result was statistically significant (P < 0.0001) meaning that it is extremely unlikely to be a false positive result due to chance alone. The Homeopathy Medicine used in this study was made from E. coli bacteria, alternately diluted, and succussed to produce an ultra high dilution of 10–60, meaning that it should no longer contain any molecules of the original bacteria. The particular technique used, where the medicine used is made from the same substance which causes the disease being treated, is a sub-type of homeopathy called “isopathy.” As the only existing way of preventing this disease in livestock is by using antibiotics, this study should be repeated to confirm its findings, as it may provide an effective way to help reduce overuse of antibiotics. Wound healing disorder and antimicrobial resistance in a horse: Case reports play a valuable role in documenting the direct experience of individuals, especially when recorded in systematic detail and independently verified. In this recent case report by homeopathic equine veterinarian, Dr Petra Weiermayer (Vienna), a 4-year old horse with delayed wound healing associated with antimicrobial resistant bacteria was treated successfully with homeopathy.[56]

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After surgical treatment of a deep lacerated wound to the right foreleg, the horse failed to respond to appropriate antibiotic treatment. A deep wound swab identified infection with antimicrobial resistant bacteria. Subsequent treatment with homeopathic medicine Silicea Terra resulted in complete resolution of the clinical signs of delayed wound healing (putrid inflammation, edema and seroma) and full closure of the wound within five weeks; the improvements were maintained for over a year with no relapses. Importantly, the case was also documented by the attending independent veterinary surgeon, the horse owner and other horse owners at the same stable, providing valuable external validation. Considering the global threat of antimicrobial resistance, welldocumented cases such as this can form the basis of large-scale clinical studies to assess the potential impact of homeopathy on antibiotic stewardship and treatment of resistant infections. Amelioration of pain and distress in tail-ringed lambs using homeopathy: It should be noted that not all “veterinary” homeopathy research and treatment is actually carried out by vets; some of it is carried out by farmers such as David Eyles who use homeopathy with their own livestock. He describes his research as reducing pain and distress in lambs.[57]

5.2.7.5  Safety Twenty observational studies found no cases of serious adverse events or serious adverse drug reactions. 0 –11% of homeopathy patients report side effects during homeopathic clinical trials (including children trials), they are all “mild and transient,” e.g., headaches, tiredness, skin eruptions, dizziness, and diarrhea.[58] The report from European Council for Classical Homeopathy (ECCH) published in 2009, provided an overview of the evidence on the safety of homeopathy. The report covers four main areas of concern: – the safety of homeopathic medicinal products (HMPs) as a result of manufacturing methods; – research evidence on reported adverse events and adverse drug reactions;

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– the safety of treatment provided by practitioners; and – the safety of patients self-administering HMPs. Results concluded that: – Current evidence seems to support the claim that adverse drug reactions (ADR) resulting from HMPs are rare and where they occur, are only mild or moderate. No evidence was found to support the claim that HMPs may cause serious adverse events (AE) or ADR. HMPs seem to lack the potential for life-threatening side effects. – Current evidence appears to show a very low incidence of cases of unethical practice or malpractice by homeopaths. A number of precautionary measures have been put into effect, through national legislation, for regulation and through self-regulation by the profession, to ensure the safety of patients. – Concern had been raised about patients self-administering HMPs, in particular as they may thereby arrive too late for treatment provided by a health professional and because it may be difficult for someone to consider how to proceed with self-treatment using HMPs without advice provided by a well-educated and trained homeopath. In summary, current evidence seems to confirm the claim that HMPs are safe to use and homeopathic treatment provided by statutorily regulated or self-regulated homeopaths is safe.

5.2.8  Homeopathic medicines Homeopathy Medicines, mostly called remedies, are of botanical, chemical, mineral, zoological, or microbiological origin. In EU countries, they are prepared from products, substances, or compositions, called homeopathic stocks, in accordance with a homeopathic manufacturing procedure described by the pharmacopoeias currently used officially in the EU Member States. They are obtained from stocks by the process of potentization, i.e., successive dilutions and succussions for liquid preparations and successive triturations for solid preparations. In more simple words, the original material is diluted, then agitated vigorously (succussed). The number of times this is repeated determines

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the strength or “potency” of the remedy, e.g., a “6c” remedy will have been diluted 1 part in 100 then succussed, six times over. If you only dilute the substance over and over, of course you are eventually left with an inactive sample which is “just water”; it is the added succussion between each step of dilution which appears to imprint information from the original substance, into the water/alcohol it is diluted in. This idea is supported by experiments which show that unsuccussed dilutions are inactive but succussed dilutions can cause biological effects, suggesting that this aspect of the manufacturing process is essential in creating homeopathic medicines. Exactly what physicochemical changes succussion causes and how this enables water to capture information about the substances diluted in it are the big questions researchers are trying to answer.

5.2.9  Trading According to different surveys and comparisons, it is estimated that across Europe, the percentage of the various populations that have used complementary or alternative medicine (CAM) at least once in their lifetime is between 20% and 70%.[59] Homeopathy is one of the most used CAMs in Europe: 36% of the French, 32% of the Belgian, 31% of the Dutch, and 20% of the British public reported taking homeopathic medicines in recent public opinion surveys, and its popularity is increasing. In the HWPWG report 2017, Homeopathic medicinal products are marketed in all the 27 EU member states except Cyprus, Malta. In US, homeopathic medicinal products are among the top 10 best-selling nonprescription drugs in the specialty analgesics, oral analgesics for children, and cough-cold-flu categories.[60] In Belgium, CAM treatments are one of the fundamental rights of patients (law passed in 2002 regarding patients’ rights). In UK, the market for homeopathy is continually growing; growth is more rapid in some southern countries, while in countries with well-developed markets (such as France and Germany) the growth rate is slower. The total European market for Homeopathy Medicines in 2001 was €1,612 million; the largest markets are Germany and France, with 36% and 33% respectively of the total market.[61,62]

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In US, industry estimates suggest sales of homeopathic drugs in 2003 of between $300 million and $450 million, with a compound average growth rate of approximately 8% per year.[63] Recent data from the National Health Information Survey indicate that 74.6% of Americans have used CAM as the Centers for Disease Control and Prevention (CDC) defines it, while 3.6% of Americans have used homeopathy.[64] This level of use is roughly double that reported in 1990 by Eisenberg and colleagues,[65] who may have underestimated the extent of use.

5.2.10  Overseas communication The International Council for Homeopathy (ICH) was established in 2007. It is the international professional platform representing professional homeopaths and the practice of homeopathy around the world. ICH presently consists of 31 professional associations of homeopaths from 28 countries in five continents, and aims to eventually have member associations in all continents. Through networking and dialogue, members of ICH engage in the promotion and evaluation of the status of homeopathy in every part of the world, with emphasis on the development of international guidelines promoting freedom of access to the highest possible standard of homeopathic care. The members of ICH have to follow the guidelines for practice, education, and ethics for the highest standard of homeopathic care, their members include Australia, New Zealand, Canada, America, Kenya, Japan, Macao (SAR of China), and Hong Kong (SAR of China). The Hong Kong Association of Homeopathy (HKAH) and Macao Association of Homeopathy (MAH) are both member associations of the ICH, advocating proper legislation and regulation of homeopathy.

5.3  Prospect of homeopathy 5.3.1  The need for water research Homeopathy will remain controversial until its mechanism of action is understood. Although water is molecularly simple, it has 12 known ice phases on top of the liquid and vapor phases we encounter in everyday

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life. Moreover, mixtures of such water phases are known to occur, yielding a very rich and complex physicochemistry. The complexity of water fuels much research in this highly active field. Current investigations suggest there may be a great deal yet to discover about its properties. Water continues to surprise us. The more we explore its characteristics, the more properties we discover. The Water Research Lab (WRL)[66] aims to investigate the full potential of water using a multidisciplinary approach involving theoretical physics, mathematical modeling, and experimental exploration. The WRL project is a flagship fundamental research project in homeopathy. The aim is to establish a center of excellence for exploring the physics of water using state of the art experimental techniques. The expected findings from this project will have a wide range of potential applications, but the 5-year research program may well uncover the mode of action of homeopathic medicines. Moreover, the findings may also be the future direction for identification, fingerprinting, quality assurance, and regulation of homeopathic medicinal products. Techniques such as Near-Infrared spectroscopy, Nuclear-Magnetic Resonance, Conductivity measurements and Mass-spectrometry will be used to probe the underlying physics of the properties of water, potentially telling us how homeopathic high-dilutions (beyond Avogadro’s number) can contain information and be biologically active. The research team is led by Dr Alexander Tournier, collaborating at an international level with world experts in the various techniques being used. The laboratory, located in Heidelberg, Germany, was officially launched and began conducting experiments in June 2018. “Confirming the presence of multiple phases of water co-existing at room temperature could lead to a completely novel understanding of solution chemistry and hence biochemistry potentially leading to new therapeutic and diagnostic techniques.” — Dr Alexander Tournier PhD.

5.3.2  The need for good research strategy Conducting poor quality research is a waste of time and money. Investment in research should be well allocated by qualified Scientific Advisory

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Committee like the Homeopathy Research Institute. Projects should first pass a peer review process conducted by experts in the field. This “quality control” system enables us to confidently channel donations and expertise to only the most promising projects. Besides, it is also essential for the profession to identify projects with research priorities. Prioritized research should meet all of the following criteria: – Investigating an area of significant clinical need, i.e., medical conditions for which even the best existing treatments are unsatisfactory or there is no existing treatment (so called “effectiveness gap conditions”). – Existing evidence suggests that homeopathy has the potential to be effective. – It is feasible to design and carry out a suitable trial or experiment which is both ethical and likely to produce useful results. Through the experience and networks of experts, we should be able to continually review the status of homeopathy research at a global level. In such a rapidly evolving field, both the research questions being asked and the way we conduct research studies, may need to be adjusted in light of new information being discovered by teams around the world.

5.3.3  The need for targeted research into specific medical conditions Homeopathy will probably still be controversial until the body of evidence showing that homeopathy works for a specific clinical condition becomes indisputable. There are a number of high quality, suitably blinded, randomized, placebo-controlled trials in homeopathy and they are positive. However, to provide definitive evidence acceptable to decision-makers, more research is needed. When one considers the general scarcity of research funding in homeopathy it is vital that resources be targeted to areas with maximal potential

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impact. In practical terms, this means targeting common “effectiveness gap” conditions for which conventional treatments are unsatisfactory. What is emerging is the idea that it makes little sense to continue putting a whole system of medicine on trial by point-scoring; what does make sense is to concentrate our research efforts on a small number of the most promising clinical areas. The Homeopathy Research Institute is currently providing financial and/or academic support to a range of projects which meet these criteria, e.g., attention deficit hyperactivity disorder (ADHD), depression, and irritable bowel syndrome (IBS). For the reasons outlined above, childhood ear infections — aka acute otitis media, is an additional target for our future efforts. Furthermore, if we can open up discussion between those on both sides of the debate to clarify the most appropriate research questions and trial designs before projects commence, then generating meaningful results — being able to resolve the current impasse, becomes a realistic possibility.

5.3.4  The need for international awareness of national policies which are not T&CM friendly In some countries where conventional medicine industry is politically powerful, there are increasingly barbaric movements towards T&CM despite the clear instruction in the WHO Traditional Medicine Strategy 2014–2023. The instruction to the member states are: – harnessing the potential contribution of T&CM to health, wellness, and people centered healthcare; – promoting the safe and effective use of T&CM by regulating, researching, and integrating TM products, practitioners, and practice into health systems, where appropriate. Besides the NHMRC issue in Australia, we mentioned in the section “Current Challenges” about the recent cut on the funding to homeopathy by the NHS in UK is also against the WHO strategy.

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Some people take the position that public money should not be spent on homeopathy because “there is no proof that it works” or “tax-payers money shouldn’t be spent on placebos.”[67] This is not an argument limited to the UK but is repeated across the world — especially in Europe, where homeopathy funding or rebates are available from national health budgets. Yet very few people have access to the facts needed to weigh up this argument effectively. While NHS funding of homeopathy has now stopped in the UK, the points below highlight more general issues with the argument against public funding of homeopathy. How much does homeopathy cost? In 2016, just £92,412 was spent on 40,000 homeopathy prescriptions from a total expenditure of £9.2 billion.[68] Out of the total NHS budget of £100 billion a year, roughly £4 million (0.004%) is spent annually on Homeopathy if you include everything from running the hospitals departments to paying the doctors. When considering value for money, it should be remembered that if homeopathy patients were not treated with this service, they would have to be treated by other departments using more expensive conventional drugs. To be fair, homeopathy should be considered in the same way as all other NHS treatments. Some people argue that the NHS should not pay for homeopathy because we do not know that it works, whereas conventional medical drugs are “tried and tested.” Surprisingly this issue is not actually as clear-cut as one might think. Analysis by the British Medical Journal’s (BMJ) Clinical Evidence[69] shows that just 11% of 3,000 commonly used NHS treatments are known to be beneficial. This data clearly indicates that the NHS pays for many treatments, besides homeopathy, for which the evidence is still unclear. The evidence that homeopathy helps NHS patients is in fact available but ignored. Five published observational studies carried out from 1999 to the present day have tracked the outcome of patients being treated at NHS homeopathic hospitals. These studies consistently show that patients improve clinically following homeopathic treatment (often from chronic, difficult to treat conditions); some also highlight areas of potential

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economic benefit for the NHS as a whole in terms of reduced prescribing of conventional drugs. For example: – The largest observational study at Bristol Homeopathic Hospital followed over 6,500 consecutive patients with over 23,000 attendances in a 6-year period.[70] The 70% of follow-up patients reported improved health; 50% reported major improvement. – The results of this 2005 Bristol study have been confirmed by a more recent observational study published in 2016, involving an audit of just under 200 patients. The audit demonstrated that patients with long-term conditions who come under homeopathic care, experience statistically significant improvements in their presenting symptoms and well-being.[71] – A 500-patient survey at the Royal London Homeopathic Hospital showed that many patients were able to reduce or stop conventional medication following homeopathic treatment.[72] When assessing these clinical results, it is important to remember that NHS patients were usually referred for homeopathy because conventional medicine had failed to give satisfactory results or conventional treatment was contra-indicated in their case. One has to ask, now that these homeopathy services are not available, who will treat these 40,000 people instead? How ethical was it to remove a service valued by patients, without being able to offer them a viable alternative treatment? The British Homeopathic Association (BHA) has reacted to the ban by legal challenge, trying to get NHS England’s decision to stop funding homeopathic medicines overturned. Without a wide-enough international awareness and support, the brave legal bid failed in June 2018.[73] “That NHS England attracted fewer than 3,000 responses from patients to a national consultation that ran for three months highlights its failure to genuinely engage with the public on important decisions about healthcare provision,” said Margaret Wyllie, BHA Chair, “It appears NHS England can fail to engage with patients properly on removing services and getaway with it. That is not good enough, for it is important to remember that the real losers in this case are the patients who are now being refused a treatment on which they have come to depend.”

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Figure 5–13    Scientific evidence regarding commonly used treatments.

5.3.5  The possibility of supranational collaboration Whilst the potential benefits of regulatory collaboration for both national and global markets are significant, supranational collaboration is advancing only slowly due to highly disparate national situations. The potential benefits and pitfalls of bilateral/multilateral collaboration and advance global cooperation on a synergistic basis should be explored. There are countries (especially in Europe) with a long-standing homeopathic tradition, while other countries have only a short homeopathic tradition. Harmonization may be more practical if we start with international convergence on minimum legal and regulatory standards. The importance of a regulatory framework which does justice to core homeopathic principles is essential for the profession to advance.

References   [1] International Council for Homeopathy [EB/OL]. http://www.homeopathyich.org/.  [2] Scientists Say Homeopathy is Impossible[EB/OL]. https://www.hriresearch.org/resources/homeopathy-faqs/scientists-say-homeopathyis-impossible/.  [3] Enserink M. Newsmaker Interview: Luc Montagnier. French Nobelist Escapes “Intellectual Terror” to Pursue Radical Ideas in China. Interview by Martin Enserink[J]. Science, 2010, 330(6012): 1732.

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  [4] The Idea of Like Cures Like Makes No Sense [EB/OL]. https://www.hriresearch.org/resources/homeopathy-faqs/the-idea-of-like-cures-likemakes-no-sense/.  [5] Remedies in Homeopathy[EB/OL]. https://www.homeopathyschool.com/ why-study-with-us/what-is-homeopathy/remedies/.   [6] Gaier HC. Jeremy SwayneHomeopathic Method: Implications for Clinical Practice and Medical SciencePrice 22.50 (pbk)1998 Churchill LivingstoneForres, Scotland0 443 05926 8[J]. Complementary Therapies in Medicine, 1998, 6(1): 53–54.   [7] Kleijnen J, Knipschild P, ter Riet G. Clinical Trials of Homoeopathy[J]. BMJ (Clinical research ed.), 1991, 302(6772): 316–323.   [8] Bodeker G, Burford G, Grundy C, et al. WHO Global Atlas of Traditional, Complementary and Alternative Medicine[M]. Tehran: Iranian Journal of Pharmaceutical Research, 2005.   [9] World Health Organization. WHO Traditional Medicine Strategy: 2014– 2023[M]. Geneva: World Health Organization, 2013. [10] A Strong Foundation in EU Law[EB/OL]. https://www.echamp.eu/eupolicy-and-regulation/eu-legislation/. [11] EU Timeline for HAMP [EB/OL]. https://echamp.eu/eu-policy-and-regulation/eu-legislation/timeline-of-activity. [12] Homeopathic Medicinal Product Working Group (HMPWG) [EB/OL]. http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_ HMA/Working_Groups/HMPWG/2017_04_HMPWG_Report_ Regulatory_status_Homeopathic_Medicinal_Products.pdf. [13] Lush MJ, Hinton V, Food F. Drug, and Cosmetic Act[J]. Cal West Med, 1938, 49(2): 172–174. [14] Junod S W. An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation[J]. Food & Drug Law Journal, 2000, 55(1): 161–183. [15] Copeland. Copeland’s Cure: Homeopathy and the War between Conventional and Alternative Medicine[J]. Knopf, 2005, 294: 1829–1829. [16] The Regulation of Homeopathic Medicines [EB/OL]. https://www.hpus. com/document/the-legal-standard-for-homeopathic-drug-products/. [17] Borneman JP, Field RI. Regulation of Homeopathic Drug Products[J]. Am J Health Syst Pharm, 2006(1): 86–91. [18] Americans For Homeopathy Choice [EB/OL]. https://homeopathychoice. org/

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[19] Society of Homeopaths [EB/OL]. https://homeopathy-soh.org/trainingand-events/become-a-homeopath/. [20] Pincock S. Nobel Prize Winners Robin Warren and Barry Marshall[J]. Lancet, 2005, 366(9495): 1429–1429. [21] The in Vitro Evidence for an Effect of High Homeopathic Potencies — A Systematic Review of the Literature[J]. Complementary Therapies in Medicine, 2007, 15(2): 128–138. [22] Homeopathy New Evidence — “Memory of Water and Ordering Mechanisms in Nature” (Brian D Josephson)[EB/OL]. https://youtu.be/ PsPN0Sc4owo. [23] Dantas F, Fisher P, Walach H, et al. A Systematic Review of the Quality of Homeopathic Pathogenetic Trials Published from 1945 to 1995[J]. Homeopathy, 2007, 96(1): 4–16. [24] Faculty of Homeopathy[EB/OL]. https://www.facultyofhomeopathy.org/ pages/50-research. [25] There is No Scientific Evidence Homeopathy Works [EB/OL]. https:// www.hri-research.org/resources/homeopathy-faqs/scientific-evidencefor-homeopathy/. [26] D O’Connor, Lester W, Willoughby S, et al. Hormetic Effects of Extremely Diluted Solutions on Gene Expression[J]. Homeopathy the Journal of the Faculty of Homeopathy, 2015, 104(2): 116–122. [27] Graunke H, Endler PC, Scherer-Pongratz W, et al. Treatment of Lowland Frogs from the Spawn Stage with Homeopathically Prepared Thyroxin [10(-30)][J]. Scientificworldjournal, 2015, 7(1): 1697–1702. [28] Harrer B. Replication of an Experiment on Extremely Diluted Thyroxine and Highland Amphibian[J]. Homeopathy, 2013. [29] Rastogi DP, Nagpaul VM, Kumar S. Demonstration of Anti-Diabetic Activities of Alloxan In Potentized Diluent State-An Experimental Approach[J]. 1991. [30] Sharma RR. Homœopathy Today: A Scientific Appraisal[J]. British Homoeopathic Journal, 1986, 75(4): 231–237. [31] Walfel B, Weingertner O, Altenburg HP, et al. Auswirkungen Eines Homöopathischen Komplexmittels (Diabetes-Gastreu R 40) auf den Blutzuckerspiegel[J]. Ärztezeitschrift für Naturheilverfahren, 1984, 25: 1–5. [32] Lamiae GB, Bernard B, Michel R, et al. Management of Upper Respiratory Tract Infections by Different Medical Practices, Including Homeopathy, and Consumption of Antibiotics in Primary Care: The EPI3 Cohort Study in France 2007–2008[J]. Plos One, 2014, 9(3): e89990.

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[33] Jacobs J, Jonas WB, Jiménez-Pérez M, et al. Homeopathy for Childhood Diarrhea: Combined Results and Metaanalysis from Three Randomized, Controlled Clinical Trials[J]. Pediatric Infectious Disease Journal, 2003, 22(3): 229. [34] Jacobs J, Springer DA, Crothers D. Homeopathic Treatment of Acute Otitis Media in Children: A Preliminary Randomized Placebo-Controlled Trial[J]. Pediatric Infectious Disease Journal, 2001, 20(2): 177–183. [35] Nassau E. Randomized Controlled Pilot Study to Compare Homeopathy and Conventional Therapy in Acute Otitis Media[J]. Homeopathy, 2012, 101(1): 5–12. [36] Macías-Cortés, Emma del Carmen, Llanes-González, et al. Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP Study): A Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Trial[J]. Plos One, 2015, 10(3): e0118440. [37] Robert Mathie. Randomized Placebo-Controlled Trials of Individualized Homeopathic Treatment: Systematic Review and Meta-Analysis[J]. Syst Rev, 2014,6(3): 142. [38] Bornhoft G, Matthiessen PF. Homeopathy in Healthcare: Effectiveness, Appropriateness, Safety, Costs[M]. Berlin, Heidelberg: Springer Science & Business Media, 2011. [39] The Best Studies Have Shown Homeopathy is Just Placebo [EB/OL]. https://www.hri-research.org/resources/homeopathy-faqs/benefitsbeyond-placebo/. [40] Wiesenauer R. A Meta-Analysis of the Homeopathic Treatment of Pollinosis with Galphimia Glauca[J]. Complementary Medicine Research, 2009, 3(5): 230–234. [41] Reilly DT, Mcsharry C, Taylor M, et al. Is Homoeopathy A Placebo Response? Controlled Trial of Homoeopathic Potency, with Pollen in Hayfever as Model.[J]. Lancet, 1986, 328(8512): 1272–1272. [42] Davenas, Beauvais, Amara, et al. Human Basophil Degranulation Triggered by very Dilute Antiserum Against IgE[J]. Nature, 1988, 333: 30. [43] Ovelgnne JH, Bol AWJM, Hop WCJ, et al. Mechanical Agitation of Very Dilute Antiserum against IgE has no Effect on Basophil Staining Properties[J]. Experientia, 1992, 48(5): 504–508. [44] Hirst SJ, Hayes NA, Burridge J, et al. Human Basophil Degranulation is not Triggered by very Dilute Antiserum against Human IgE[J]. Nature, 1993, 366(6455): 525–527. [45] Belon P, Cumps J, Ennis M, et al. Inhibition of Human Basophil Degranulation by Successive Histamine Dilutions: Results of a

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European Multi-Center Trial[J]. Inflammation Research, 1999, 48(1): 17–18. [46] Lorenz I, Schneider EM, Stolz P, et al. Sensitive Flow Cytometric Method to Test Basophil Activation Influenced by Homeopathic Histamine Dilutions[J]. Forschende Komplementärmedizin/Research in Complementary Medicine, 2003, 10(6): 316–324. [47] Belon P, Cumps J, Ennis M, et al. Histamine Dilutions Modulate Basophil Activation[J]. Inflammation Research, 2004, 53(5): 181–188. [48] Harrer B. Replication of an Experiment on Extremely Diluted Thyroxine and Highland Amphibian[J]. Homeopathy, 2013, 102(1): 25–30. [49] Witt CM, Bluth M, Albrecht H, et al. The in Vitro Evidence for an Effect of High Homeopathic Potencies — A Systematic Review of the Literature[J]. Complementary Therapies in Medicine, 2007, 15(2): 128–138. [50] PC Endler. Repetitions of Fundamental Research Models for Homeopathically Prepared Dilutions beyond 10–23: A Bibliometric Study[J]. Homeopathy, 2010, 99(1): 25–36. [51] Use of Plants in Basic Research in Homeopathic Potentization [EB/OL]. https://www.hri-research.org/wp-content/uploads/2014/08/HRI_ ResearchArticle_16_Baumgartner_PlantModels.pdf [52] Mathie RT, Clausen, Jürgen. Veterinary Homeopathy: Meta-Analysis of Randomized Placebo-Controlled Trials[J]. Homeopathy the Journal of the Faculty of Homeopathy, 2015, 104(1): 3–8. [53] Fischer O, Weise W. Homeopathy as Replacement to Antibiotics in the Case of Escherichia Coli Diarrhoea in Neonatal Piglets[J]. Homeopathy, 2010, 99(1): 57–62. [54] Mathie RT, Clausen J. Veterinary Homeopathy: Meta-Analysis of Randomized Placebo-Controlled Trials[J]. Homeopathy the Journal of the Faculty of Homeopathy, 2015, 104(1): 3–8. [55] Mathie RT, Clausen J. Veterinary Homeopathy: Systematic Review of Medical Conditions Studied by Randomized Placebo-Controlled Trials.[J]. Veterinary Record, 2014, 175(15): 373–381. [56] Weiermayer, Petra. Wound Healing Disorder in a Horse, Associated with Antimicrobial Resistant Bacteria, Resolved with a Homeopathic Medicine — A Case Report[J]. Journal of Equine Veterinary Science, 2018: S0737080618300431. [57] Eyles D. Amelioration of Pain and Distress in Tail-Ringed Lambs Using Homeopathy[J]. Homeopathy, 2014, 103(1): 1–5. [58] European Council for Classical Homeopathy. Safety of Homeopathy [R]. Information Resources Inc., 2009.

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[59] Vincent C, Furnham A. Why do Patients Turn to Complementary Medicine — An Empirical Study[J]. British Journal of Clinical Psychology, 2011, 35(1): 37–48. [60] IRI Data Report. 12 Months Trailing December 31, 2004[R]. Information Resources Inc., 2004. [61] Jenny S, Monckton J, Schulze-Pillot T, et al. Supplement to the Final Report of the Management Committee COST B4 1993–1998[J]. Approved March, 1999. [62] Moncton J. European Comission COST Action B4, Unconventional Medicine Final Report of the Management Committee 1993–1998[J]. Office for Official Publications of the European Communities, 1998. [63] Santa Rosa. Report of Survey for the U.S. Homeopathic Industry [R]. American Association of Homeopathic Pharmacists, 2002. [64] Barnes PM, Powell-Griner E, McFann K, et al. Complementary and Alternative Medicine Use among Adults: United States, 2002[C]. Seminars in Integrative Medicine. WB Saunders, 2004, 2(2): 54–71. [65] Eisenberg DM, Kessler RC, Foster C, et al. Unconventional Medicine in the United States Prevalence, Costs, and Patterns of Use[J]. N Engl J Med, 1993, 328(4): 246–252. [66] Water Research Lab [EB/OL]. https://www.wrl-lab.org/. [67] NHS Homeopathy in the Spotlight [EB/OL]. https://www.hri-research.org/ resources/essentialevidence/homeopathy-within-the-national-healthservice-uk/. [68] Prescription Cost Analysis [EB/OL]. https://www.hri-research.org/ resources/essentialevidence/homeopathy-within-the-national-healthservice-uk/. [69] Smith QW, Street RL, Jr Volk RJ, Fordis M. Differing Levels of Clinical Evidence: Exploring Communication Challenges in Shared Decision Making. Introduction[J]. Medical Care Research and Review: MCRR, 2013, 70(1 Suppl): 3S–13S. [70] Spence DS, Thompson EA, Barron SJ. Homeopathic Treatment for Chronic Disease: A 6-Year, University-Hospital Outpatient Observational Study[J]. Journal of Alternative & Complementary Medicine, 2005, 11(5): 793. [71] Thompson E, Viksveen P, Barron S. A Patient Reported Outcome Measure in Homeopathic Clinical Practice for Long Term Conditions[J]. Homeopathy the Journal of the Faculty of Homeopathy, 2016: 309–317. [72] Sharples F, Haselen RV, Fisher P. NHS Patients’ Perspective on Complementary Medicine: A Survey.[J]. Complementary Therapies in Medicine, 2003, 11(4): 243–248.

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[73] Homeopathy UK [EB/OL]. https://www.britishhomeopathic.org/mediacenter/bhas-brave-legal-bid-overturn-nhs-decision-homeopathy-fails/. [74] Homeopathy is Bunk, Study Says [EB/OL]. https://www.theguardian.com/ world/2014/apr/08/homeopathy-is-bunk-study-says. [75] The Australian Report [EB/OL]. https://www.hri-research.org/resources/ homeopathy-the-debate/the-australian-report-on-homeopathy/. [76] HRI Statement on Closure of Commonwealth Ombudsman Investigation [EB/OL]. https://www.hri-research.org/2023/08/hri-statement-on-closureof-commonwealth-ombudsman-investigation/.

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Library of Congress Control Number: 2023035280 British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library. Jointly published by World Scientific Publishing Co. Pte. Ltd. and Shanghai Scientific & Technical Publishers International edition © World Scientific Publishing Co. Pte. Ltd. 2024 China edition © Shanghai Scientific & Technical Publishers 2022 HISTORY, PRESENT AND PROSPECT OF WORLD TRADITIONAL MEDICINE Copyright © 2024 by World Scientific Publishing Co. Pte. Ltd. All rights reserved. This book, or parts thereof, may not be reproduced in any form or by any means, electronic or mechanical, including photocopying, recording or any information storage and retrieval system now known or to be invented, without written permission from the publisher.

For photocopying of material in this volume, please pay a copying fee through the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA. In this case permission to photocopy is not required from the publisher. ISBN 978-981-12-8710-7 (set_hardcover) ISBN 978-981-12-8217-1 (set_ebook for institutions) ISBN 978-981-12-8218-8 (set_ebook for individuals) ISBN 978-981-12-8695-7 (vol. 1_hardcover) ISBN 978-981-12-8696-4 (vol. 2_hardcover) For any available supplementary material, please visit https://www.worldscientific.com/worldscibooks/10.1142/13565#t=suppl Desk Editor: Vanessa Quek ZhiQin Typeset by Stallion Press Email: [email protected] Printed in Singapore

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Informative Abstract

Traditional medicine plays a significant role in health maintenance as well as disease diagnosis and treatment. Available in almost every country in the world and in a growing demand for its services, traditional medicine contributes to the goal of ensuring universal access to health care through its accessibility, safety, and effectiveness. This book reviews and summarizes the history, present, and prospect of mainstream traditional medicine around the world. It aims to promote the integration of traditional medicine and conventional medicine, to contribute to Universal Health Coverage as a reference for policy makers, academies, and stakeholders. This book consists of nine chapters, involving Ayurveda, chiropractic, European Traditional Herbal Medicine, Greco-Arab and Islamic Herbal Medicine, Homeopathy, Japanese Kampo, Korean Medicine, Traditional Chinese Medicine, and Thai Medicine.

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List of Editors

Chief Editor Shen Yuandong Associate Editors Sang Zhen Xu Xiaoting Editorial Board Anupama Kizhakkeveettil Robb Russell Hans Rausch Bashar Saad To Ka Lun (Aaron) Toshihiro Togo Byungmook Lim Yan Shiyun Anchalee Chuthaputti Editorial Assistant Huang Yiran

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Preface

Traditional medicine has become an important part of the world healthcare system. It has made outstanding contributions to human health and disease prevention and treatment. According to WHO Global Report on Traditional and Complementary Medicine 2019, more countries are recognizing the role of Traditional and Complementary Medicine (T&CM) in their national health systems. For instance, by 2018, 98 Member States had developed national policies on T&CM, 109 had launched national laws or regulations on T&CM, and 124 had implemented regulations on herbal medicines. Available in almost every country in the world and in a growing demand for its services, traditional medicine contributes to the goal of ensuring universal access to healthcare through its accessibility, safety, and effectiveness. The inclusion of traditional medicine into the International Classification of Diseases (WHO ICD11-ICTM) symbolizes the WHO recognition of its value and widespread use. It is also a milestone for traditional medicine to be incorporated into the WHO International Health Care System. As the President of Shanghai University of Traditional Chinese Medicine, I am delighted to know that more than 39 countries around the world offer higher education programs in T&CM (including bachelor, master, and doctoral degrees at university level). In recent years,

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an increasing number of countries have facilitated training programs in traditional medicine, and some have included traditional medicine into academic curriculum for health profession students. As a WHO Collaborating Center for Traditional Medicine since 1983, our University has been cooperating with WHO headquarters and the West Pacific Region for a long period of time. We have provided technical support and advisory services on Traditional Chinese Medicine (TCM) terminology standards, guidelines, medical service standards, safety of Chinese Medicine, and training programs in traditional medicine for WHO member states. Every year, more than 3,000 international students come to our University to study Traditional Chinese Medicine. We have established an international exchange network system covering more than 50 partners in over 20 countries and territories. In 2009, International Organization for Standardization established a technical committee for Traditional Chinese Medicine (ISO/ TC 249), whose Secretariat was based in our University. Since then, this platform has been playing an important role in improving the quality and safety of TCM and other traditional medicine. To better strengthen international exchange and cooperation in the field of traditional medicine and maximize its role in global health governance and benefit public health and well-being, we hosted the Shanghai Forum for World Traditional Medicine in 2017 and 2019. The forum has facilitated international academic exchanges in the field of traditional medicine. For the purpose of promoting academic ideas among traditional medicine experts, the Organizing Committee of the Forum invited guest speakers of the forum to compile a book named “History, Present and Prospect of World Traditional Medicine.” The book consists of nine chapters, involving Ayurveda, chiropractic, European Traditional Herbal Medicine, GrecoArab and Islamic Herbal Medicine, Homeopathy, Japanese Kampo, Korean Medicine, Traditional Chinese Medicine, and Thai Medicine. It is with great pleasure to witness the publication of History, Present and Prospect of World Traditional Medicine. I sincerely hope that the

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Shanghai Forum for World Traditional Medicine will become an important academic platform for international cooperation and contribute more to the further development of traditional medicine.

Prof. Xu Jianguang, M.D., Ph.D. President, Shanghai University of Traditional Chinese Medicine May, 2022

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Preface

I am not a traditional medicine practitioner. My interest in Traditional Medicine arose from working as a regulator for ensuring the quality, safety, and efficacy of marketed therapeutic products (medicines and medical devices), being involved in the development of international standards for traditional therapeutic products derived from ancient Chinese medicine and ensuring the educational standards and professional services of Chinese Medicine practitioners. All forms of medical services have been derived from medical products and techniques which evolved through observation and experience, in some cases, over thousands of years. These original products and techniques provided accessible and affordable healthcare to their communities, were aligned with, as well as influencing, the culture and values of those communities and provided a holistic approach to the well-being of individuals. Many of those practices have carried on to the present day and are classified as Traditional Medicine. More recently, scientific approaches to investigation, extraction, and the gathering of evidence are now able to increasingly explain the biological effects and demonstrate the efficacy of treatments. Traditional Medicine is also evolving and has incorporated some of these advances such as the use of electrical medical devices. The availability of newer scientific methods for assessing efficacy has often caused tension between Traditional Medicine and what is generally

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referred to as Western Medicine. From the point of view of public safety there is a legitimate expectation that these scientific methods should be used, as far as possible, to validate the efficacy of traditional treatments. This is occurring and is now a very active area of research. At the same time, it is very important not to lose other benefits provided by Traditional Medicine: remaining true to the underlying paradigm, the holistic approach to wellbeing, the level of involvement of patients in their own treatment, affordability, and ease of access to health care. In many countries, the educational and practice standards of Traditional Medicine practitioners have also become much more sophisticated. Many national governments and regulators have been in a quandary about how to recognize and then regulate the services and practitioners of Traditional Medicine, for example some classifying traditional medicines as foods. However, with consumers universally being active users of traditional products and techniques, health regulators are increasingly recognizing these important components of health care and the practitioners who deliver them. This book is a very important collection of descriptions of several Traditional Medicine systems that have evolved to meet the needs of their own communities and, in many cases, now provide health services much more widely. It includes the philosophy of these systems, the increasing standards of education and practice of practitioners and the advances in ensuring the quality, safety, and efficacy of treatments. Traditional Medicine continues to be a very important component of healthcare, both in developing and developed countries.

Dr. David Graham Past National Manager of the Therapeutic Goods Administration, Australia Past chair, ISO TC 249 Traditional Chinese Medicine Past vice chair, Chinese Medicine Board of Australia May, 2022

© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_fmatter

Foreword

Traditional Medicine (TM) is the collection of skills and practices based on people’s life experiences or observations. With strong historical and cultural roots, it has long been used in health maintenance and in disease prevention and treatment. Thanks to the progress in modern science and civilization, TM has undergone and is still undergoing an evolutionary process to “keep what’s good and remove what’s bad.” TM has a long history. It is defined by the World Health Organization (WHO) as “the sum total of the knowledge, skill, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.” In some countries or territories, TM or non-conventional medicine may be termed alternative or complementary medicine. The social development and changes in the spectrum of human diseases have resulted in the medicine’s paradigm shift from the biomedical to the biopsychosocial model. At the same time, population aging, advances in rehabilitation medicine, and emerging contagious diseases brought new challenges and opportunities for TM. TM is found in almost every country in the world and the demand for its service is increasing. It has been used for thousands of years and has made great contributions to human health. According to the newly released WHO Global Report on Traditional and Complementary Medicine 2019, as of 2018, 170 WHO Member xv

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States (88%) acknowledged their use of Traditional and Complementary Medicine (T&CM), 107 had a national office for T&CM, 98 had developed national policies on T&CM, 75 reported the presence of a national research institute for T&CM, and 109 reported the presence of a legal or regulatory framework for T&CM. In addition, 124 Member States had implemented regulations on herbal medicines, 45 reported the coverage of T&CM by health insurance [public and (or) private], and 34 included traditional or herbal medicines in their national essential medicines lists (NEMLs). TM, with its availability and accessibility, is playing a key role in implementing the idea of people-centered health service and ensuring that all people have access to care. Thanks to the national policy of placing equal emphasis on Traditional Chinese Medicine (TCM) and Western Medicine in China, TCM is a key component in national healthcare system. It makes up 16.4% of the National Health Service and 23% of medical visits in grass-root medical institutions. The total output value of TCM pharmaceutical industry was approximately RMB 800 billion and the total value of international trade value reached $80 billion. Over 100 million Europeans are current users of T&CM, most (86%) Koreans have used traditional Korean Medicine at some point in their lives, and 76% of Singaporeans are regular users of TM. In the United States, more than 65% of the population use alternative and complementary medicine. In India, there are over 500,000 registered T&CM practitioners. In Western countries, there has been an increasing demand for health service of TM, along with the rapid increase in chronic disease, intractable conditions, and rehabilitation medicine. In some developing countries, TM plays a major role in primary healthcare service and TM practitioners remain the sole or main health providers for people living in rural areas. Globally, TM is playing a significant role in health maintenance as well as disease diagnosis and treatment. However, the current status of TM varies greatly from country to country due to the imbalance of economic-social development and differences in health system and policies. TM, as pointed out in the WHO Traditional Medicine Strategy 2014– 2023, “is an important and often underestimated part of health services.” Despite the fact that more and more countries have launched laws or regulations on TM, not so many countries reported the integration of TM

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within national health care system. There is still a gap between TM practitioners, skills and products and medical doctors, technologies, and pharmaceutical drugs. In addition, there are many challenges for TM in healthcare delivery, education, research, and pharmaceutical industry to meet the demand for health maintenance as well as disease prevention and treatment. In 2009, a new technical committee entitled “Traditional Chinese Medicine” (TCM) and coded “249” was established in the ISO family. It focuses on the TCM safety and quality. I was honored to serve as the secretary general and worked with the chairman Dr. David Graham (the former chairman of TGA, Australia) for nine years. I’ve served as the chairman of ISO/TC 249 since 2019. The ISO/TC 249 offers a work platform for top experts in the field of TM. We are making every effort to develop TM and improve the TCM safety and quality. We have organized two forums on world TM in Shanghai, once in 2017 and once in 2019. Inspired by the information exchanged among experts during the forum on the past, present, and future challenges of TM, I came up with the idea of compiling a book entitled History, Present and Prospect of World Traditional Medicine which received very positive feedback from TM scholars. After over two years of hard work from senior experts in different countries, we are now ready to publish this book, which involves Ayurveda, chiropractic, European Traditional Herbal Medicine, Ancient Greco-Arab and Islamic Herbal Medicine, Homeopathy, Japanese Kampo Medicine, Traditional Korean Medicine, Traditional Chinese Medicine, and Traditional Thai Medicine. We hope this book can serve as a useful reference for TM regulators and practitioners and thus contribute to human health and global development of TM. We will continue to gather more information on other types of T&CM across the world. Shen Yuandong Prof. Shen Yuandong Institute of TCM International Standardization, Shanghai University of Traditional Chinese Medicine April, 2022

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© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_fmatter

Contents Informative Abstract List of Editors Preface Preface Foreword

v vii ix xiii xv

Chapter 6  History, Present and Prospect of Kampo Medicine

395

Togo Toshihiro, Makino Toshiaki Introduction396 6.1  History of Kampo Medicine 397 6.1.1  Ancient era 397 6.1.2  Medieval age 399 6.1.3  Meiji restoration 408 6.1.4  After the World WarII  415 6.2  Current status of Kampo Medicine 426 6.2.1 National healthcare system and integration of traditional medicine into national healthcare  426 6.2.2 Insurance coverage of kampo medicine/acupuncture and moxibustion426 6.2.3  Licensure system, training, and education 427 6.2.4  Trade and Product 429 6.2.5 Academic societies and research centers for Kampo Medicine430 6.2.6 Overseas Communication: Academic Symposium and Conference 436 6.2.7 Japan’s contribution to international standardization of traditional medicine 439 xix

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6.3  Challenges and prospect of Kampo Medicine 442 References444 Chapter 7  History, Present and Prospect of Korean Medicine

447

Byungmook Lim, Byunghee Koh, Yongsuk Kim, Yunkyung Kim, Youngju Yun Introduction448 7.1  History of Korean Medicine 451 7.1.1  Ancient times to unified silla era 451 7.1.2  Goryeo dynasty 452 7.1.3  Early and mid-Joseon dynasty period 453 7.1.4  Late Joseon dynasty to Japanese colonial period 455 7.1.5  1945 to present 457 7.2  Components of Korean Medicine 460 7.2.1  Acupuncture therapy 460 7.2.2 Moxibustion 464 7.2.3 Cupping 465 7.2.4  Herbal medicine therapy 465 7.2.5  Herbal acupuncture therapy (pharmacopuncture) 466 7.2.6  Chuna manual therapy 467 7.2.7  Sasang Constitutional Medicine 468 7.3 Legal status and administration of Korean Medicine 471 7.3.1  Overview of the healthcare system in Korea 471 7.3.2 Legal status and administrational body for Korean Medicine 474 7.3.3  National development plans for Korean Medicine 476 7.3.4  Policies on Korean Medicine services 477 7.3.5  Policies and regulations on herbal medicines 487 7.4  Resources and utilization of Korean Medicine 492 7.4.1  Human resources 492 7.4.2  Hospitals, clinics, and pharmacies, etc. 494 7.4.3  Usage of Korean Medicine services 495 7.5  Education in Korean Medicine 498 7.5.1 Overview 498 7.5.2  Education system for Korean Medicine doctor 500

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7.5.3  Education system for herbal pharmacist 503 7.5.4  Clinical specialist education 504 7.5.5  Continuing medical education in Korean Medicine 506 7.5.6 Accreditation and evaluation of education for Korean Medicine institutions 507 7.6  Korean Medicine in health security system 508 7.6.1  National health insurance and Korean Medicine 508 7.6.2  Other medical guarantees and Korean Medicine 515 7.6.3  Patient classification system in Korean Medicine 516 7.7  Industry and R&D of Korean Medicine 517 7.7.1 Overview 517 7.7.2  Korean Medicine industry 519 7.7.3  Research & development of Korean Medicine 522 7.8  Future directions for Korean Medicine 526 7.8.1 Improving reliability of Korean Medicine through scientific evidence accumulation 527 7.8.2  Innovating Korean Medicine education 527 7.8.3 Expanding health insurance coverage for Korean medicine528 7.8.4 Enhancing the Korean Medicine-Western Medicine co-practice529 7.8.5  Promoting Korean Medicine industry and R&D 530 References531 Appendix533 Act on the Promotion of Korean Medicine and Pharmaceuticals (Act No. 15910) 533 Chapter 8 History, Present and Prospect of Traditional Chinese Medicine

543

Yan Shiyun, Chen Liyun, Zhou Min, Xu Shuang, Zhang Huaiqiong, Zhao Zhiping, Su Jinying, Nie Aiguo, Han Chouping Introduction544 8.1  The sprouting, formation, and development 544 8.1.1  The origin of Traditional Chinese Medicine 544

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8.1.2 TCM in the pre-Qin and Han Dynasties (221 BC–220 AD) 8.1.3  TCM in the Wei, Jin, Southern & Northern, Sui, Tang, and five dynasties (220–960) 8.1.4  The Song, Jin, and Yuan dynasties (960–1368) 8.1.5  TCM in the Ming and Qing Dynasties (1368–1912) 8.1.6  TCM in modern times 8.2  The Fundamentals and Concepts of TCM 8.2.1  Yin-Yang theory 8.2.2  The five-element theory 8.2.3  The zang-fu theory 8.2.4  Qi, blood, and body fluids 8.2.5 Meridians 8.2.6  Characteristics and practice of TCM clinical thinking 8.3  TCM healthcare skills and practices 8.3.1  Acupuncture therapy 8.3.2 Tuina 8.3.3  Qigong and Daoyin 8.3.4  Cupping therapy 8.3.5  Chinese herbal medicine 8.3.6  Health preservation 8.4  Current status of TCM 8.4.1  Policies and measures on TCM development 8.4.2  Regulations on TCM service 8.4.3  TCM service 8.4.4  Education and training for TCM professionals 8.4.5  TCM research and innovation 8.4.6  TCM pharmaceutical industry 8.4.7  Seven TCM standardization and cultural development 8.4.8  International exchange and cooperation in TCM 8.5  Future directions for TCM 8.5.1  Improving TCM service system 8.5.2  Giving play to the unique role of TCM in maintaining and promoting people’s health

549 552 556 564 570 579 580 582 583 586 590 592 593 593 598 600 603 604 608 613 614 616 617 621 624 626 627 628 630 630 631

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8.5.3  Promoting TCM quality enhancement and high-quality TCM industry development 631 8.5.4  Strengthening the building of TCM professionals 632 8.5.5  Facilitating the TCM inheritance, openness, and innovative development 632 8.5.6  Reforming and improving the TCM management system and mechanism 632 References632 Appendix I Traditional Chinese Medicine In China

635 635

Appendix II Law of the People’s Republic of China on Traditional Chinese Medicine

653 653

Appendix III 669 Traditional Chinese Medicine Treatment COVID-19 Diagnosis and Treatment Protocol (the 9th Edition)669 Appendix IV WHO Expert Meeting on Evaluation of Traditional Chinese Medicine in the Treatment of COVID-19

680 680

Chapter 9 History, Present and Prospect of Thai Traditional Medicine703 Benjama Boonterm, Yenpat Kamdangyodtai, Anchalee Chuthaputti Introduction704 9.1  The Principles of Thai Traditional Medicine 705 9.1.1 The four elements (dhatu) of the body and the causes of illnesses 705 9.1.2  Examination and diagnostic procedures of TTM 706 9.1.3  Treatment modalities in TTM 707 9.2  History of Thai Traditional Medicine 710 9.2.1 History of the development of Thai Traditional Medicine710

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9.2.2  The Revival of Thai Traditional Medicine 713 9.2.3 Milestone of major events, changes, and achievements in TTM after the establishment of DTAM 719 9.3 Current situations and status of Thai Traditional Medicine (2020–2021) 724 9.3.1  Current situation of the 4P of TTM 725 9.3.2 The current situation of ongoing agenda-driven projects on TTM based on the government policies and the national strategy (2020–2021) 740 9.4 Future development of Thai traditional medicine 751 9.4.1  TTM practice and provision of TTM service 751 9.4.2  TTM practitioners and TTM educational system 752 9.4.3  TTM products and herbal products for economy 752 9.4.4  Protection and promotion of TTM knowledge 752 9.4.5  Medical cannabis service 753 Acknowledgements753 References753 Index761

© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_0006

Chapter 6

History, Present and Prospect of Kampo Medicine Togo Toshihiro, Makino Toshiaki

Abstract The history of Kampo Medicine in Japan began with the introduction of continental medicine through the Korean Peninsula in the 5th and 6th centuries. Since then, Kampo Medicine, having its origins in ancient Chinese Medicine, has made its unique progress to this day. There are several reasons for its uniqueness of development, and the biggest one is geographical isolation. There were few opportunities to study continental medicine directly, except for some cases, such as envoys and priests who travelled to the continent, and physicians who learned medicine from foreign physicians from the Korean Peninsula and China. Most Japanese physicians indirectly learned through shipped manuscripts. Also, medical knowledge was often transmitted to Japan along with the Buddhism view of the universe, and the knowledge of Chinese Medicine was sometimes integrated with Buddhist knowledge. Another unique tendency in Japan is to attach importance to findings obtained by palpation; palpation of the abdomen is especially emphasized. Furthermore, the transmission of anatomical knowledge to Edo Japan prepared the foundation for accepting the Western medical view of the body, even among the physicians practicing traditional medicine.

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On one hand, the rapid modernization has brought Japanese Kampo Medicine to a state of discontinuation from tradition, but on the other hand, chemical and pharmacological studies of crude drugs used in Kampo medicines and the studies of the effects of acupuncture on the autonomic nerves have been conducted. Research methods on the therapeutic effect of traditional medicine have diversified even after the war. However, the best research methods are still being sought that match traditional medicine, which is characterized by the provision of individualized treatment for patients. Keywords: Kampo Medicine, acupuncture, Kampo extract formulation, international standard, scientific research, traditional medicine

Introduction Since ancient times, human beings have used medicinal plants to treat several diseases. Before human beings developed from anthropoids, they had been using medicinal plants when they felt sickness.[1] As civilization progressed, the usage of specific medicinal plants for the treatment of certain diseases were being discovered by the process of trial and error, and the theory of traditional medicine using crude drugs that were produced from medicinal plants, animals, and minerals had emerged in ancient civilizations such as Egypt, Mesopotamia, Greece, India, and China.[2] In ancient China, Shennung’s Bencaojing, written by mythical emperor Shen Nung circa 2500 BC, treats 365 crude drugs, many of which have been used nowadays as components in Kampo medicines such as Rhei rhisoma (dried rhizome of Rheum species), Ginseng (dried root of Panax ginseng), Ephedra herba (dried stem of Ephedra species), licorice (dried root and stolone of Glycyrrhiza species), and so on.[3] Japan experienced modernization the earliest in East Asia in the middle of the 19th century, and Japanese physicians who practiced Kampo Medicine at that time were forced to face the challenge of Western Medicine. That meant throwing away the knowledge that had long been accumulated up to that point. Still, it could be said that Japanese physicians and acupuncturists gained a new perspective on traditional medicine.

History, Present and Prospect of Kampo Medicine  397

Looking back at the history of Kampo Medicine and acupuncture and moxibustion in modern Japan, we can find scientists who found the significance of traditional medicine as a therapeutic science while keeping a distance from both Western Medicine and traditional theory. What is needed now is the reconstruction of Kampo Medicine from the perspective of “therapeutic science.”

6.1  History of Kampo Medicine 6.1.1  Ancient era Geographically located east of China, Japan, like other East Asian countries, had been under the influence of China. It is considered in the 5th to 6th century that medical knowledge, along with Buddhism, was transmitted to Japan via the Korean Peninsula. From the 7th to the 9th century, despite the danger in sea travel, the Japanese court dispatched missions to the Sui and the Tang Dynasty to accumulate the advanced administrative system and culture of the continent which brought a great deal of Buddhism, medical texts, and crude drugs. In the 7th century, the Japanese court, following the administrative system of Sui and Tang Dynasties, formed domestic systems including education on medicine. Though Ishituryo (医疾令), the first regulation of the medical system in Japan was lost, its restored manuscript shows that those texts such as Suwen 《 ( 素問》), Jiayi Jing 《 ( 甲乙経》), Xiaopinfang 《 ( 小品方》), Ming Tang 《 ( 明堂》), were used for medical education. Xiaopin Fang, which also had been adopted as the main text for medical education in the Tang Dynasty court, was lost before the Song Dynasty. However, a manuscript remains today at Maeda Sonkeikaku Library, Japan. The facsimile of the manuscript was published by Kitasato University Oriental Medicine Research Center in 1992.[4] In the mid of the 8th century, the famous Tang monk, Jian Zhen (鑑真), arrived in Japan after his ship was being wrecked many times and brought not only religious precepts but medical knowledge. In the Shosoin Repository Todaji Temple in Nara, many kinds of crude drugs were

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preserved along with the treasures brought from West Asia via the “Silk Road.” In 1948 and 1994, the pharmacognosists entrusted by the Imperial Household Agency, Japan, investigated these drugs. They found that 40 kinds of crude drugs such as Ginseng and Rhei rhisoma have been kept as the original substances in Shosoin from the 8th century up to the present age for more than 1,200 years. Due to the political instability in the Tang Dynasty, the Japanese court decided, in 894, to discontinue dispatching mission to the continent, and the inflow of medical texts also ceased. Nihonkoku Kenzaisho Mokuroku 《 ( 日本国見在書目録》), the book catalog of the court compiled in 891, shows that over 15,000 kinds of manuscripts had been brought to Japan before the end of the 9th century. Tamba Yasuyori (丹波康頼, 912–995), who was at the position of Hari Hakase (Doctor of acupuncture) of the court, compiled and dedicated to Emperor Enyu, in 984, a medical text, Ishinpo 《 ( 医心方》). Though Ishinpo consists of quotations from many medical manuscripts that had been shipped to Japan, it refers very little to pulse diagnosis, meridians, and five- phase theory, which are now considered the essence of Chinese Medicine. This suggests that Tamba Yasuyori had put more importance on the practical aspect of Chinese Medicine rather than the theoretical aspect. Ishinpo, wealthy in the old description transcribed from original texts that were lost in Chinese texts compiled in post-Song Dynasty, was prized not only by the Japanese physicians, but also by Chinese philologists in the 19th century. Another important medical manuscript that remains in Japan is Huangdi Neijing Taisu 《 ( 黄帝内経太素》), long preserved in Ninnaji Temple (仁和寺) in Kyoto. Huangdi Neijing Taisu, one of the oldest versions of Huandi Neijing with Yang Shangshan’s (楊上善) detailed annotations, is considered to have been brought to Japan in the 8th century and was long designated as the main text for medical education. The manuscript that remains in Ninnaji Temple is a text transcribed by Tamba Yorimoto (丹波頼基) in the 12th century. Since the Song Dynasty, Huangdi Neijing Taisu was already lost and was replaced by Suwen 《 ( 素問》) as the standard text for Huangdi Neijing. Thus, Ninnnaji Huangdi Neijing Taisu, like Ishinpo, attracted philologists of Edo Igakukan (江戸医学館, Edo Institute of Medicine) in the 19th century.

History, Present and Prospect of Kampo Medicine  399

The high quality of their bibliographical studies owed to the discovery of those manuscripts.

6.1.2  Medieval age As the samurai replace the noble and gained power in the 12th century, direct trade between Japan and the Southern Song Dynasty started. In the Northern Song Dynasty, from the 10th century, the revision project of the medical manuscript had been promoted under the leadership of the court. The outcome of those revisions was printed using the newly developed wood printing technology. It was widely distributed in China, followed by numerous amounts of annotations on those texts by individual physicians. In the Kamakura period, Zen priest, who was also engaged in people’s healthcare, travelled to the Southern Song Dynasty and brought back those medical texts together with Buddhist scripture. The manuscripts wood-printed in Song Dynasty are often prized for its beautiful printing. In Japan, medical manuscripts such as Waitai Miyao 《 ( 外台秘要》) and Beiji Qianjin Yaofang 《 ( 備急千金要方》) printed in Song Dynasty remain. Ashikaga Shogunate (足利幕府), opened in 1333, positively promoted mutual trade with the Ming Dynasty, resulting in transmission of the Ming Dynasty culture in various aspects. Not only numerous printed medical texts were brought, but also the newest printing technology was introduced to Japan, which caused a revolutionary change to the domestic propagation of medical knowledge. Japanese physicians, through the texts that had been compiled and printed in the Ming Dynasty, assimilated in a short period of time the theory or prescriptions preceding the Jin or Yuan Dynasties period.

6.1.2.1  Manase Dosan and his achievement Manase Dosan (曲直瀬道三, 1507–1594), who was active in the second half of the 16th century and was involved in the treatment of many powerful people such as Oda Nobunaga and Emperor Ohgimachi, raised many disciples at his private school (Keitekian 啓迪庵). He conducted a detailed analysis of many Chinese medical texts and especially had a deep interest

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in the theory of Zhu Danxi (朱丹渓). Inspired by Zhu’s theory, he created his own diagnosis and treatment system. His book, Keitekishu 《 ( 啓迪 集》) was entitled Satsusho Benchi 《 ( 察証弁治》) which represented his diagnosis-treatment system under which he prescribed medicine individually for each patient. The system can be compared to Bianzhen Lunzhi 《 ( 弁証論治》), the diagnosing system of modern Traditional Chinese Medicine (TCM). The diagnosis-treatment system developed by Manase Dosan was epoch-making and marked the highest peak of Japanese Medicine at that time. However, it did not seem to be inherited.[5] One reason for this is that the system required a great deal of knowledge and clinical experience. Dosan was able to create a prescription suitable for each of his patients with little reliance on existing prescriptions but it was difficult for all physicians to do this. Instead of developing prescriptions on a bespoke basis, his successors improved the existing prescriptions that were found in the well-read medical texts such as Wanbinghuichun 《 ( 万 病回春》). The group of physicians who assimilated medical theory and prescriptions through Ming Dynasty’s medical texts were later called Goseihoschool, contrasted to the Koho-school who put importance on the prescription in medical texts compiled by Zhang Zhongjing (張仲景).

6.1.2.2  Fukushin — development of abdominal diagnosis and dashin (hammer needle technique) Another thing that cannot be overlooked when considering medieval Japanese acupuncture and moxibustion is the widely believed existence of Mushi ( 虫 insect) that was considered as a causative factor of a disease. It is considered that from the Kamakura period to the 20th century, due to the wide use of human dung as a fertilizer for agricultural crops, the existence of a kind of parasite had come to be well known. In Japan, each Mushi, associated with the traditional concept of organs or pathological substance, was considered to cause a variety of diseases. The 63 humorously depicted Mushi in Harikikigaki 《 ( 針聞書》), compiled in 1568 by Ibaraki Gengyo (茨木元行) and now preserved in Kyushu National Museum, shows how closely people felt the existence of Mushi in their daily life.[6] The concept of a Mushi as a causative factor can also be found in ancient Chinese

History, Present and Prospect of Kampo Medicine  401

medical texts such as Suwen 《 ( 素問》) or Zhubingyuanhoulun 《 ( 諸病源 候論》) but it did not play a central role as a causative factor. Since those Mushi were considered to inhabit in Hara (Fuku), the abdominal area, thus, palpation to this area (Fukushin) is considered to give proof for the exact place of the pathogen. Acupuncture to the abdomen was also thought to help eliminate the pathogen, Mushi, and regulate the flow of qi. The idea also provided the rationale for one of the Japanese characteristic acupuncture method, Dashin (打鍼). Dashin, also referred to as “hammer needle method” or “strike mallet needling method,” is the method in which a practitioner strikes an acupuncture needle on the body surface with a small mallet and inserts the needle tip into the body. The method, invented by Mubun and disseminated by Misono Isai (御薗意斎, 1557–1616) was commonly practiced throughout Edo period (Figure 6-1 and Figure 6–2).

6.1.2.3  Early transmission of acupuncture and moxibustion knowledge to the West In the Age of Discovery, from the 15th to the 16th century, many Westerners rushed to Asia for both Christianity propagation and spice trade. During the Age, the knowledge of acupuncture and moxibustion were also introduced to the West and Japan played a significant role in the transmission. One of the typical examples of this type of

Figure 6–1    Wood Mallet and Needles. Note: Wood Mallet and Needles used for Dashin (hammer needle technique or tapping needle technique). Owned by Harikyu Museum (Museum of Traditional Medicine), Morinomiya Iryougakuen.

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Figure 6–2    Harishi (Acupuncture practitioner). Note: Illustration of acupuncturist giving Dashin treatment to a patient of Edo period. Owned by Harikyu Museum (Museum of Traditional Medicine), Morinomiya Iryougakuen.

knowledge transfer is the dictionary “Vovcabvario da Lingoa de Iapam (Japanese-Portuguese dictionary)” compiled by Portuguese Jesuits missionaries. The dictionary, along with those terms of daily use, included many terms from medicine in Japan, such as “Guinxin (silver needle),” “Vchibari (hammer needle),” and “Chizaxi (bloodletting).” “Moxibuston,” now a popular term for the remedy in which moxa cone or moxa stick are used, comes from Japanese term “mogusa,” which represents moxa floss. The first use of the term “Moxa” can be found in the Herman Buschof’s booklet in which he recorded his own experience of moxibustion treatment against his “Podagra (gout).”[7] He received the treatment from woman practitioner in Batavia and never had been to Japan. Thus, his usage of the term “Moxa” is considered to show how widely Japanese moxa floss is distributed in Southern East Asia at the time. The booklet, written in Dutch and published in 1675, attracted many European readers who suffered from Podagra, followed by the publication of German and English translation. Even after adopting a policy of seclusion in the first half of the 17th century, limiting the commercial intercourse with the Western country to only Holland, Japan continued to play a vital role in the transmission of acupuncture knowledge to the West. The Dutch physicians who were

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engaged in the healthcare of their colleagues in Dejima Island, Nagasaki, left the detailed record of Japanese traditional medicine in their itineraries. Willem ten Rhijne, who stayed in Edo Japan in the 1670s, published a book introducing the concept of meridians and remedy in which fine needles were inserted in the body. The term “acupunctura,” the combination of “acu” representing needle and “punctura” meaning “to punch,” first appeared in Rhijne’s 10th book, Dissertatio de arthritis: Mantissa schematic: de Acupunctura, published in London in 1683. The travelogues written by those physicians are valuable record of the society, culture, and medicine of Edo Japan. The practice of acupuncture and moxibustion in Japan were also introduced to the West throughout Edo period with detailed illustrations of a variety of needles.

6.1.2.4  Sugiyama Waichi’s achievements — acupuncture education for the blind and Sugiyama Shindenryu Sugiyama Waichi (杉山和一, 1610–1694), a blind acupuncturist who was active in Japan during the Genroku era (1688–1704), has two other major achievements. He contributed to the establishment of an acupuncture training center for the blind and introduced his various acupuncture techniques to his posterity through the famous book Sugiyama Shindenryu 《 ( 杉山真傳流》). The establishment of the acupuncture training school was promoted by Shogun Tokugawa Tsunayoshi, who highly evaluated Sugiyama’s treatment. Sugiyama Shindenryu was compiled by his disciple, Shimaura Wadaichi (島浦和田一) after Sugiyama’s death. This book describes many methods of slight stimulation to acupuncture and became an important source of Japan’s unique acupuncture techniques.

6.1.2.5  Traditional medicine and the transmission of anatomical knowledge to Japan in the 17th and the 18th century Tokugawa Yohimune (徳川吉宗, 1684–1751), the 8th Shogunate, relaxed the import restriction of Dutch written books, limiting the field to practical science such as astronomy, medicine, mathematics, physics, and

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agriculture, resulting in the inflow of medical texts including anatomy. Not only physicians but also intellectuals, showed strong interest in anatomical structure of human body and were eager to affirm the accuracy of traditional knowledge on body they are familiar with in traditional medical texts. One of the good examples to show Japanese intellectual’s interest in anatomy is the translation work Oranda Zenku Naigai Bungouzu 《 ( 和蘭全躯内外分合図》) produced by Motoki Ryoui (本木良意, 1628– 1697) in 1682. This work is translated from Dutch translation of Johann Remmelin’s anatomical chart, Pinax microcosmographicus, which contains layered illustrations of internal organs. Though Motoki served as an interpreter and had little medical knowledge, he completed this work after strenuous efforts. In this era, a lot of crude drugs were imported from the Qing Dynasty by silver produced in Japan. In order to save silver, Tokugawa Yoshimune let the local governments in Japan develop the cultivation of medicinal plants that was the origin of crude drugs used in Kampo Medicine. Then, some crude drugs such as the root of Panax ginseng had been able to be domestically produced. Whereas some crude drugs were replaced with products derived from domestic plants that were different from original Chinese ones. For example, the origin of Saiko (柴胡) was replaced from the root of Bupleurum chinense or B. scorzonerifolium in China to the root of B. falcatum in Japan. In Japan, the dissection of human body had also long been prohibited. Yamawaki Toyo (山脇東洋, 1706–1762), a Koho-school physician in Kyoto, applied for permission to observe the dissection of an executed criminal in 1754. Five years later, he published Zoshi 《 ( 蔵志》), a record of his observation in which he pointed out traditional anatomical knowledge did not match the real body structure. Started by the dissection performed at Kyoto in 1754, dissection and observation gradually became popular in Japan. Sugita Genpaku (杉田 玄白, 1733–1817) and Maeno Ryotaku (前野良沢, 1723–1803) who had purchased Anatomiche Tabellen, a Dutch anatomical text translated from Kulms’s German text, observed in 1772 the dissection conducted in Edo and were excited to find that the description and illustration of the Dutch text was quite accurate. They decided to translate it into Japanese resulting

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in the publication of Kaitaishinsho 《 ( 解体新書》) in 1774. The inflow of Western anatomical texts in the 17th and the 18th century Japan thus provided relativistic standpoint to the traditional idea of human body.[8]

6.1.2.6  The rise of Koho-school-reversionism movement and Yoshimasu Todo (1702–1773) In the mid-18th century, there was a reversionism movement in Kampo Medicine, emphasizing Zhang Zhongjing’s two major medical texts, Shanghanlun and Jinguiyaolue compiled in the 3rd century. The group of physicians who supported the reversionism was later called Koho-school, which meant “Old Medicine” school. In contrast, physicians whose practice was mostly based on medical texts written in the Ming period, were generally called Goseiho-school, which meant “Later Generation’s Medicine” school. Amongst the Koho-school physicians, Yoshimasu Todo (吉益東洞, 1702–1773) had the greatest influence not only over physicians at his time, but also over those in modern Japan. Yoshimasu’s approach to Kampo Medicine formed foundation of modern Kampo of the 20th century. Yoshimasu advocated Manbyo-Ichidokusetsu (万病一毒説) that insisted all the diseases result from “one poison in body,” denying ancient Chinese philosophical and pathological concepts such as Yin-Yang and five phase theory. He put importance on the findings gained from abdominal diagnosis which he considered to represent the “one poison.” The findings were also used for the rationale in his deciding prescription. He not only used the prescription of Shanghanlun in his clinical practice, but tried to analyze the structure of Zhang Zhongjing’s text to produce his style of therapeutics. His representative works were Ruijuho 《 ( 類聚方》, 1764) and Yakucho 《 ( 薬徴》, 1785). Yoshimasu Todo’s therapeutic approach was so radical that his son, Yoshimasu Nangai (吉益南涯, 1750–1813) gave modification to Todo’s idea, creating his own pathological theory of “Qi, Blood, Fluid (気血水).” Yoshimasu Todo’s idea, despite its extreme approach, was widely approved in Edo Japan along with more moderate theory of Yoshimasu Nangai.

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6.1.2.7  Philological research in Edo Igakukan and its transmission to Qing China in 1880s The rise of Koho-school caused controversy in the world of Kampo Medicine in Japan. Yoshimasu Todo’s extreme approach urged the physicians at the time to reconsider their clinical ground, resulting in the formation of the group of physicians who took an eclectic approach. Wada Tokaku (和田東郭, 1744–1803), one of the leading physicians of the Edo period, initially studied under Yoshimasu Todo but later became a physician representing the eclectic school. Another notable movement was the philological research into the medical texts. Medical practice was based on the text in which experience of predecessors is described. Arbitrary interpretation of medical texts might lead physicians to improper diagnosis and treatment. Under these recognitions, physicians who belonged to Edo Igakukan, an institute for medicine of Tokugawa Shogunate, started philological study on medical manuscript preserved in Japan. The physicians among this institute were Taki Motoyasu (多紀元簡, 1755–1810), Taki Mototane (多紀元胤, 1789–1827), Izawa Ranken (伊沢蘭軒, 1777–1829), Shibue Chusai (渋 江抽斎, 1805–1858), Kojima Hoso (小島宝素, 1797–1848), and Mori Tatsuyuki (森立之, 1807–1885). They conducted bibliographical research on the medical manuscripts collected from all over Japan with their profound understanding on philological research method developed in the Qing Dynasty. As mentioned before, Japan had a lot of medical manuscripts which had been lost in China, which enabled physicians of Edo Igakukan to pursue the “real” practice of Chinese Medicine in ancient times. Especially the discovery of Huandi Neijing Taisu and Ishinpo enthused and motivated them to produce numerous annotations on Chinese medical texts. Despite the high quality and huge amount of their annotation works, they drew little attention after Meiji restoration as Western Medicine replaced Kampo Medicine as mainstream medicine. Yang Shoujing (楊守敬, 1839–1915), a well-known Chinese philologist in the Qing Dynasty, made a visit to Meiji Japan during 1880–1884 as a member of Ambassador of Qing Dynasty. He was astonished by the high quality of bibliographical research achieved by Japanese members of Edo Igakukan. Most of their research had been conducted using newly discovered manuscripts such as Huangdi Neijing Taisu or Ishinpo, in

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which old description style of ancient medical manuscripts remained. Yang purchased printed manuscripts and a large number of printing woodblocks through Mori Tatsuyuki, one of the hold-over from philologists’ group of late Edo period. In 1884, the year of his return to the Qing Dynasty, Yang printed from those woodblock a Isshuudo series 《 ( 聿修堂 叢書》), consisting of 13 commentary texts which included Somonshi 《 ( 素問識》), Shokanron Shugi 《 ( 傷寒論輯義》), Nangyo Sosho 《 ( 難経疏 証》), Iryakusho 《 ( 医略抄》), and Keiketsu Sanyo 《 ( 経穴纂要》). Though both Kampo and acupuncture lost their leading positions in Japan’s national healthcare system soon after Meiji restoration in 1868, the above philological accomplishment by Japanese physicians was thus transmitted to Qing Dynasty and contributed to the development of the philological research of medical texts in China.[9]

6.1.2.8  Physicians from the Dutch East India company stationed in Dejima After 1639, the Edo Shogunate cut off exchanges with Western countries other than the Holland to prevent the increase of Christians in the country. Dutch merchants were also required to live on Dejima island in Nagasaki and were basically not allowed to leave there except during trade. Physicians in charge of disease treatment for Dutch merchants were also stationed on Dejima. Some of these physicians were interested in Japanese Medicine and plants and wrote down what they had seen in Japan after returning to Europe. Among these physicians were Willem ten Rhijne (1649–1700), Engelbert Kaempfer (1651–1716), Carl Peter Thunberg (1743–1828), and Philipp Franz von Siebold (1796–1866). Of these four, only ten Rhijne was Dutch, and the others were German or Swede. They were medical physicians and well-versed in natural history and energetically collected plants in Japan. Willem ten Rhine, in Dissertatio de Arthritide: Mantiffa Schematica: De Acupunctura, published in London in 1682, introduced Japanese acupuncture and meridian ideas with detailed illustrations. Engelbert Kaempfer had an audience with the 5th Shogun Tsunayoshi twice during his stay in Japan (1690–1692). After returning to Lemgo, Kaempfer wrote two travelogues. One is Amoenitates Exoticarum, written in Latin and published in 1712, in which Kaempfer presents a diagram of

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Japanese plants and moxibustion. The other is the History of Japan, translated into English by Sir Hans Sloane (1660–1753) after Kaempfer’s death and published in 1727. Kaempfer compared Japanese moxibustion treatment with the treatment of using a roasting iron that was performed in Persia. In this book, he praised that Japanese moxibustion treatment does not cause fear to patients. Kaempfer was also amazed that Japanese physicians performed acupuncture and moxibustion in remote areas rather than in symptomatic areas during treatment. Carl Peter Thunberg, an “apostle” of Carl Linnaeus, a renowned botanical taxonomist, arrived in Dejima in 1775 after energetically collecting plants at the Cape of Good Hope. During his two-year stay, he gave lectures on Western Medicine for Japanese physicians while collecting plants in Japan and sending the specimens to his master in Uppsala. Many of the specimens he collected in Japan, are still stored in the Herbarium at the University of Uppsala. After returning to Sweden, Thunberg wrote books such as Flora Japonica (1784) and Resa uti Europa, Africa, Asia, förrätled åren (1794), which fascinated young Phillipe Franz von Siebold and prompted him to travel to Japan. Phillipe Franz von Siebold, a German physician from Wurzburg, visited Japan in 1823, deeply inspired by Kaempfer and Thunberg’s travelogues. During his six-year stay in Japan, he interacted with many Japanese physicians including Ishizaka Sotetsu (石坂宗哲, 1770–1842), who specialized in acupuncture. Siebold described what he had seen in Japan in his great book Nippon (1833). He also brought many artefacts back to Holland, many of which are in the National Museum of Ethnology in Leiden. It is noteworthy that the diagrams of the guide tube and hammer (mallet) used in acupuncture needling in Japan were always included in the travelogue written by those foreign physicians who visited Japan in Edo period.

6.1.3  Meiji restoration 6.1.3.1  Meiji restoration (1868) and traditional medicine in Japan — decline of Kampo medicine In 1868, the Edo Shogunate set the stage for 260 years of history. In the same year, Meiji government determined the policy for introducing Western Medicine. In 1874, the government enacted Isei (医制), the first

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legislation on medical administration under which physician’s license was issued only to those who acquired Western medical knowledge. In contrast to Kampo Medicine, Isei permitted practice of acupuncture and moxibustion, limiting it under the control of Western Medicine trained physicians or surgeons. Japan has had a long history of acupuncture practice by visually impaired practitioners. In 1877, Miyake Hiizu (三宅秀, 1848–1938), a professor at the Tokyo Imperial University and his colleague, submitted to the government a document Shinchi Saiyou Ikensho 《 ( 鍼治採用意見書》) in which they concluded that acupuncture can be safely practiced by visually impaired, which enabled them to be engaged in the practice.[10] After Isei, physicians had to have the license of Western Medicine, but pharmacists could sell crude drugs used in Kampo Medicine as over-thecounter (OTC) medicines. To maintain the quality of crude drugs in the markets in Japan, Japanese Pharmacopoeia has been published by the government and registered as not only chemical drugs but also as crude drugs derived from plants, animals, and minerals since 1886. Though Kampo physicians, already in practice at the time, were permitted to continue their work under Isei, they initiated from a deep sense of crisis a movement for continuance of Kampo Medicine. They formed several societies such as Onchikai. It was Asada Sohaku (浅田宗伯, 1815–1894), who served as a physicians of Emperor Meiji and was successful in treating French envoy Léon Roches (1809–1900) that played the leading role in Kampo survival movement. In 1895, one year after the death of Asada Sohaku, Kampo physicians finally submitted a bill to revise the physician’s license at the 8th Imperial Congress, but the proposal was rejected by 27 votes, bringing Japanese Kampo Medicine to its Dark Age. It was second-class drug sellers that underpinned Kampo Medicine at this time.

6.1.3.2  Revival of Kampo Medicine in 1910s to 1930s Japan In 1910, 15 years after the rejection of physician license reform bill at the Imperial Congress, Wada Keijuro (和田啓十郎, 1872–1916) published a devastating book titled Ikai No Tettsui 《 ( 醫界之鐵椎》), which literally meant “A Crack on Medical Community.” It emphasized Kampo’s

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superiority over Western Medicine as clinical medicine and became the first indication of Kampo Medicine’s restoration after 1895. Its impact was so big that not only Japanese Kampo physicians but also Chinese physicians were moved. Ding Fubao (丁福保, 1874–1952) published Chinese translation in the same year of its publication in Japan and it attracted the attention of Chinese physicians searching for significance of traditional medicine in Qing Dynasty. Yumoto Kyushin’s (湯本求真, 1876–1901) work, Kokan Igaku 《 ( 皇 漢医学》) published in 1927, also encouraged those hoping for the revival of Kampo Medicine. The book, insisting on Kampo Medicine’s superiority over Western Medicine attracted not only physicians, but also pharmacists. Amongst these physicians was Otsuka Yoshinori (大塚敬節, 1900–1980), who played the leading role for the revival of Kampo Medicine and its academic improvement after the World WarII. Kokan Igaku, like Ikai No Tettsui, was also translated into Chinese and reprinted so many times (Figure 6–3). In 1936, nine years after the publication of Kokan Igaku, a society named Kaiko Gakuen was formed for promoting the spread of Kampo Medicine. The members of the society included physicians (Otsuka Yoshinori; Yakazu Domei, 矢数道明, 1905–2022; Yakazu Yudo, 矢数 有道, 1908–1946; Kimura Chokyu, 木村長久, 1910–1945), pharmacist

Figure 6–3    The First Edition of Kokan Igaku. Note: The first edition of Kokan Igaku (《皇漢医学》) by Yumoto Kyushin, published in 1927–1928.

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(Shimizu Tohtaro, 清水藤太郎, 1886–1976), acupuncturist (Yanagiya Sorei, 柳谷素霊, 1906–1959), and historian (Ishihara Yasuhide, 石原 保秀, 1877–1943). Otsuka Yoshinori, a high-caliber disciple of Yumoto Kyushin, played the leading role of the society. In 1936, Kaiko Gakuen held academic seminar on Kampo Medicine at Takushoku University, which was integrated into university’s curriculum in 1937. Though the Kampo seminar at Takushoku University enjoyed a good reputation, the members of Kaiko Gakuen aspired toward establishment of national research institute for Kampo Medicine, including acupuncture. In 1941, Hashida Kunihiko (橋田邦彦, 1882–1945), the Minister of Education, had a counsel with the members for the establishment of medical college specializing in Kampo. Though the plan was not realized, Institute of Clinical Medicine of East Asia (東亜治療医学研究所) was set up in Doai Hospital in 1943. Itakura Takeshi (板倉武, 1888–1958), the director of the institute, promoted scientific research of both Kampo Medicine and acupuncture. Primary research for developing Kampo extract was also conducted under Itakura’s leadership. Unfortunately, the institute was burnt down in the air raid of 1945.

6.1.3.3  Scientific research on Kampo and acupuncture by medical doctors before 1945 As already mentioned, Kampo Medicine and acupuncture and moxibustion lost its position of mainstream medicine in Japan since Meiji restoration. Though the practice of acupuncture and moxibustion were not the subject of extinguishment, they were required to be practiced under the supervision of physicians of Western Medicine. Those situations, however, did not mean that traditional medicines had not been attracting academic interest at universities or medical colleges. Nagai Nagayoshi (長井長義, 1845–1929), a chemist at Tokyo Imperial University succeeded in the isolation and the chemical identification of ephedrine from Ephedrae Herba (麻黄), the dried stem of Ephedra species, in 1885. Asahina Yasuhiko (朝比奈泰彦, 1881–1975), the professor of pharmacy department in Tokyo University also devoted himself in the research on chemical composition of Japanese ethnomedicines and Kampo medicines.

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It is worth noting that “modernized” acupuncture and moxibustion were the subject of scientific research in modern Japan, attracting physiologists intense interest. Ohkubo Tekisai (大久保適斉, 1840–1911), the principal of the medical school at Gunma prefecture, presented in his book Shinchi Shinsho 《 ( 鍼治新書》, new book on acupuncture effect) published in 1892, the idea that part of the acupuncture effect is associated with the function of autonomic nerve. Ohkubo’s work played a pioneering role in Japan in the scientific research of acupuncture related to the autonomic nervous system.[11] Amongst the physiologists attracted by the acupuncture effect were Ishikawa Hidetsurumaru (石川日出鶴丸, 1878–1947) and Hashida Kunihiko, both of whom are distinguished researchers in the field of physiology. Ishikawa was born in Toyama prefecture. After graduating from Tokyo Imperial University, he started his academic career in 1904 at the department of physiology of Kyoto Imperial University. He studied at Gottingen University during 1908–1912, while he communicated with Russian physiologist Ivan Pavlov (1849–1936). After his return, he started with Komai Kazuo (駒井一雄, 1898–1982) the research on the physiological mechanism of acupuncture effect. He was skeptical about meridian or five organ systems that traditional medical text referred to but had a strong interest in the relation of disfunction of the internal organ system and response detected on the body surface. Ishikawa, after retirement from Kyoto Imperial University, was appointed as principal of Mie College of Medicine (三重医学専門学校). In 1945 Ishikawa, with other professors of the college, he established an academic society for acupuncture research and set up in the college hospital the department of acupuncture treatment. It can be said that his was a pioneer of the medical system that we call integrative medicine today. In July 1947, two years after the end of the World WarII, Ishikawa was called by a surgeon of the General Head Quater (GHQ) Mie department for inquiry of the current situation of acupuncture treatment in Japan. GHQ had pushed forward reform of the Japanese healthcare system and collected information on any practice regarding healthcare. Ishikawa made a visit to GHQ Mie branch on the 2 July 1947 and explained to Dr. Wiseman, the GHQ surgeon officer, the relation between

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therapeutic mechanism of acupuncture and autonomic nerve system. Impressed by the cogent explanation by the old professor, the young surgeon demanded a demonstration of acupuncture treatment on the second meeting. Five days later, Ishikawa, followed by Higuchi Etsunosuke (樋口鉞之助) who had worked for Ishikawa for many years, revisited Wiseman and demonstrated acupuncture treatment for the woman patient. The demonstration was successful, and the typists and other office workers desired the treatment. Dr. Ishikawa’s explanation both to GHQ and the Ministry of Welfare contributed to the continuation of acupuncture practice in Japan. Hashida Kunihiko (橋田邦彦) was born in 1882, as the son of of Fujita Kenzo (藤田謙造, 1845–1903), a Kampo physician in Tottori prefecture. After graduating from Tokyo Imperial University in 1908, he started his academic career at the university. Returning from his study in Europe (1914–1918), he became an associate professor of the physiology department (1922). Hashida’s specialty was experimental physiology, but he was also known for his profound understanding of Zen, especially Dogen’s (道元) and Buddhism texts, Shohogenzou 《 ( 正法眼蔵》). Hashida, from his research on Zen, derived the concept of Zenkisei (全機 性), in which he considered the human body and its function as a whole. While his concept was quite similar to what is known as Holism, he felt the need to reconstruct medicine from this perspective. He found the same approach in traditional Kampo Medicine and acupuncture. Thereafter, he founded the Society of Japanese Medicine (日本医学 研究会) in 1935, which was joined by researchers, physicians, acupuncturists, and historians such as Itakura Takeshi, Yanagiya Sorei, Shirota Bunshi (代田文誌, 1900–1974), and Anzai Yasukane (安西安周, 1889– 1969). Hashida, after becoming Minister of Education in 1940, interested himself in the establishment of a national institute or medical college, which was not realized. Though he died in 1945, many of his disciples played a significant role in scientific research of acupuncture and its education after the war. Sugi Yasusaburo (杉靖三郎, 1906–2002), one of Hashida’s disciple, introduced to the Japanese medical community Hans Selye’s theory of General Adaptation Syndrome. Selye’s theory represented “Zenkisei” that Sugi’s master, Hashida pursued through his life. Serizawa Katsusuke (芹沢勝助,

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1915–1998), the first Japanese acupuncturist who received a Ph. D. degree in 1961 was also Sugi’s student at Tokyo Educational University. Itakura Takeshi, born in Chiba prefecture, famous for his pharmacological research of digitalis, was a physician at Tokyo Imperial University. In his youth, when visiting France on the university’s overseas training system, he found in a French textbook of therapeutics a description from Shanghanlun, which awakened him to the potential of Kampo Medicine as clinical medicine. He first had been expected to establish a department of clinical pharmacology at the university, but after his return to Japan, despite the opposition from his colleague, he devoted himself to the scientific research of Kampo Medicine. His pioneering attempt to develop Kampo extract which was essential for objective evaluation of medical efficacy, led to the post-war innovation of Kampo Medicine. He also contributed to the continuance of acupuncture practice, persuading Crawford F. Sams (1902– 1994) of GHQ, who tried to discontinue the practice in 1947.

6.1.3.4  Hara Shimetaro’s research on moxibuston and moxafrica Hara Shimetaro (原志免太郎, 1882–1991) was born in Fukuoka prefecture. After graduating from Kyoto prefectural medical college, he started his academic career in 1924 at the hygienics department of Kyushu Imperial University under Professor Miyairi Keinosuke (宮入慶之助, 1865–1946). In the next year, he began the research of moxibustion therapy as a preventive intervention. He put moxa to Zusanli every day and lived to over 100 years old. He conducted a variety of experiments to examine the effect of moxibustion treatment, but his most important work was the research on the preventive effect of direct moxibustion against tuberculosis (1929). He allocated rabbits, which were infected with tuberculosis, into the four groups with different duration of moxibustion treatment: 1) start moxibustion intervention one month before infection of tuberculosis and continue to give the treatment after infection, 2) start moxibustion intervention 20 days after infection, 3) start moxibustion intervention 67 days after infection, 4) giving moxibustion treatment for one month only before infection. He compared the survival span of the above four groups and concluded that moxibustion treatment is quite

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effective for tuberculosis when it was applied as a preventive and continuous intervention. After the war, with the spread of antibiotics, moxibustion therapy was seldom applied to tuberculosis in Japan. However, Moxafrica, a UK based Nonprofit Organization (NPO), started their activity for the spread of moxibustion therapy for tuberculosis treatment in Uganda. They introduced direct moxibustion therapy based on Hara’s research to people in Uganda as a self-care intervention Moxafrica’s activities are giving strong proof to Hara’s experimental insisted nearly a century ago. Information of Moxafrica can be obtained at the following website: https://www.moxafrica.org/.

6.1.4  After the World WarII 6.1.4.1  End of war (1945) and GHQ’s recommendation on the prohibition of acupuncture Following the end of the war, Japan went under the rule of GHQ until 1951 and several administrative reforms in the field of medicine were conducted under the leadership of Crawford F. Sams. The physician licensure system followed the pre-war system. Medical doctor’s license is issued only to those who completed the educational program of Western Medicine. As for the practice of acupuncture, GHQ issued in 1947 a recommendation to the members of the medical council on the discontinuation of acupuncture and moxibustion practice for the reasons such as 1) the lack of scientific rationale, 2) unhygienic and unsafe practice, 3) lack of a standardized educational program, 4) practice by the visually impaired. The recommendation caused strong opposition from both academic researchers and practitioners, which was later named “MacArthur Whirlwind.” Owing to their tenacious persuasion to GHQ and the Ministry of Health, “Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxibustion (Legislation No. 217)” passed the diet in December of that year.

6.1.4.2  Formation of academic societies — Kampo Medicine and acupuncture/moxibustion Following the enactment of the law, two major academic societies on acupuncture were formed. The first one was the Japan Society of Medical

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Acupuncture (日本鍼灸学会) formed in 1948. Another academic society, Japan Acupuncture and Moxibustion Society (日本鍼灸治療学会) was established in 1951 based on the Japan Acupuncture & Moxibustion Association, the practitioner’s association. The association’s first president was Higuchi Etsunosuke, who had worked under Dr. Ishikawa Hidetsurumaru. These two societies were integrated into the Japan Society of Acupuncture and Moxibustion, JSAM (全日本鍼灸学会) in 1980, which is now Japan’s leading society of academic research of acupuncture. Those societies obligated themselves to improve educational systems and the pursuit of scientific research on the mechanism of acupuncture effect. As for the academic society on Kampo Medicine, medical doctors who practiced Kampo Medicine formed the Japan Society of Oriental Medicine (日本東洋医学会) in 1950, with Tatsuno Kazuo (龍野一雄, 1905–1976) as the first president.

6.1.4.3  Development of Kampo extract formulations and its listing in National Health Insurance (NHI) drug price standard It is no exaggeration to say that the most important feature of modern Japanese Kampo Medicine is the use of stable, high-quality Kampo extract formulations. The history of the development of Kampo extract formulations dates back to 1943, when Itakura Takeshi, the president of the Institute of Clinical Medicine of East Asia (東亜治療医学研究所), tried to conduct a clinical trial for the purpose to examine the efficacy of Kampo medicines. Kampo extract formulations with uniform quality were required for ensuring the accuracy of the trial. Unfortunately, Itakura’s attempt for developing extract formulations was discontinued due to the deterioration of the war situation. After the war, a physician Hosono Shiro (細野史郎, 1899–1989) and Kotaro Pharmaceutical Company started manufacturing Kampo extracts. In 1957, 35 items of Kampo extract formulations had been manufactured and sold as OTC medicines from Kotaro Pharmaceutical Company, and in 1959, the number of Kampo extract formulations had increased to 59 items. In 1960, crude drugs registered in Japanese Pharmacopoeia were listed in NHI Price

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Standard by the Ministry of Health and Welfare (at that time). Then, physicians could prescribe crude drugs under health insurance. In 1967, four items of Kampo extract formulations among the OTC medicines were listed in NHI Drug Price Standard. In 1975, the Ministry of Health and Welfare had approved Kampo products derived from 210 Kampo formulations as OTC medicines. In 1976, Takemi Taro (武見太郎, 1904–1983), who had long been the president of Japan Medical Association (日本医師 会), despite the strong opposition from most of the members, bulled through expanding the number of Kampo formulation items in NHI Drug Price Standard list, and 148 kinds of Kampo formulations have been listed and covered by health insurance since 1987. In 2013, the number of OTC Kampo formulations approved by the government expanded from 210 to 294 items. Now crude drugs listed in NHI Drug Price Standard are 243 items. Since Japanese Pharmacopoeia had registered crude drugs by 1886, the number of crude drug items registered had been increased along with the expansion of Kampo formulations approved by the government. Japanese Pharmacopoeia 18th Edition, 2nd Supplement, published in 2021, registers 327 items of crude drug-related items including 37 items of Kampo extracts. Furthermore, The Japan Kampo Medicines Manufacture Association (JKMA), which consists of the major manufacturers treating crude drugs and Kampo medicines, voluntarily defines Good Manufacturing Practice (GMP) for Kampo products. Thus, the pharmaceutical manufacturers and the Ministry of Health, Labor and Welfare in Japan have put in a lot of effort to maintain the quality of crude drugs and Kampo formulations that have uniform active ingredients.

6.1.4.4  Standardization of acupuncture points in Japan The national standardization of acupuncture points in Japan dates back to the “revision of acupuncture points” conducted under control of the Ministry of Education in 1913. In Edo Japan, there had been a huge amount of research on Shisijing Fahui 《 ( 十四経発揮》) produced by Hua Shou (滑壽) in Yuan Dynasty that brought a profound understanding of meridian and meridian point to Japanese physicians at the time. After Meiji government adopted Western

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Medicine, the concepts of meridian or five-phase theory became obsolete, meridian points (経穴) came to be described just as acupuncture points (孔穴), the effect of acupuncture and moxibustion also were explained as stimulation of the nerve system or improvement of blood circulation. Ministry of Education set up in 1913 “the Meridian Point Committee” consisting of six specialists from those fields of medical history, massage practice, medicine, and anatomy. The committee, after five years’ consideration, compiled a report, “acupuncture points revision (改正孔穴)” which stipulated 120 acupuncture points as standard points frequently used in clinical practice. The location of each point was described using anatomical description, not associated with meridians or Zang-fu system. After the war, the need for standardization of acupuncture points was strongly recognized among acupuncturists belonging to the academic society. Japan Acupoint Committee was formed in 1965. In 1974, the meeting of the International Committee for Meridian and Meridian Points, of which the members were Australia, Philippine, and Korea, was held. In 1978, Japan Acupoint Committee started research on acupuncture points using over 50 medical texts. The research gave rise to the publication of Keiketsushuusei 《 ( 経穴集成》) which listed the source and description of each of 365 acupuncture points. In the 1980s, as the momentum for international standardization of acupuncture points increased, Japan began to play a leading role in international standardization of acupuncture points. Nakajima Hiroshi (中嶋宏, 1928–2013), who was in the position of Secretary-General at the WHO Western Pacific Regional Office (WHO/ WPRO) at the time, prepared the stage for international standardization. WHO/WPRO held Working Group meetings for standardization of basic terms three times in 1982, 1985, and 1986. In 1989, representatives from 20 countries gathered in Geneva to discuss the basic terms of acupuncture and moxibustion, and decided the number of acupuncture points be standardized, names and English notation of each acupuncture point and ancient nine acupuncture needles were decided, and the results were announced as Standard Acupuncture Nomenclature. Although the location of the acupuncture point was not decided at the conference, the Japan Acupoint Committee compiled their research results so far and published it as Standard Meridian Points 《 ( 標準経穴学》) in the same year (1989),

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Figure 6–4    Standard Meridian Points. Note: Ed. by the Japan Acupoint Committee, Ishiyaku Publication, 1989.

which later contributed as one of the important documents to international standardization project of WHO/WPRO starting in 2003 (Figure 6–4).

6.1.4.5  The re-evaluation of the classical medical texts and the development of meridian therapy in 1940s in Japan Yanagiya Sorei was born in 1906 in Aomori prefecture. In the 1920s and 1930s, early Showa period, acupuncture and moxibustion were completely separated from the tradition of the Edo period and were explained from the perspective of Western Medicine. “Revision of acupuncture points” (改正孔穴), conducted under the control of the Ministry of Education in 1913–1918 was the typical example of reinterpretation of traditional acupuncture by Western medical knowledge. Yanagiya, from his youth, started working towards reforming and rebuilding Japanese acupuncture and moxibustion. He joined Kaiko Gakuen and served as a lecturer at the seminar on Kampo Medicine held at Takushoku University since 1936, along with Otsuka Yoshinori and Yakazu Domei. He also joined the Japanese Medicine Institute (日本医学研究会) of which the president was Hashida

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Kunihiko and contributed articles to its journal, Nihon Igaku 《 ( 日本医 学》, Japanese Medicine). Yanagiya had doubts about the reinterpretation of acupuncture and moxibustion from a scientific point of view which started since the Meiji era and thought that classical medical texts should be reviewed and acupuncture and moxibustion reconstructed on the basis of those texts. He purchased a large number of medical books that had been neglected since the Meiji era and tried to reconstruct acupuncture and moxibustion through a comprehensive re-evaluation of those texts. Due to his broad knowledge and charismatic charm, Yanagiya gained the support of many disciples and played a key role in the innovation of post-war Japan acupuncture. Amongst those disciples who left great influence were Okabe Sodo (岡部素道, 1907–1984) and Inoue Keiri (井上恵 理, 1903–1967), who created Meridian Therapy (経絡治療) in Japan based on Nanjing 《 ( 難経》). Meridian Therapy is based on the idea that all the diseases were caused by the imbalance of the meridians and its adjustment should be the key point of treatment. They adopted a six-position pulse diagnosis for identifying the abnormal meridian and selected treatment points from five phase points in the forearm and lower limb. Meridian Therapy gained popularity due to its simplicity and clinical usefulness, and the group grew into one of the leading acupuncture and moxibustion societies in Japan, but since its establishment, many ideas had existed within the society in terms of theory and technique, which caused the formation of many branch schools.

6.1.4.6  The legacy of Meridian Therapy — Pursue of soft needling technique and research on classical texts It can be said that the development and practice of meridian therapy brought two major by-products to Japanese acupuncture. One is the development of various techniques. In Japan, the needling technique with soft stimulation for children had been popular since the early Showa era. These techniques, often conducted without insertion, were redeveloped into more elaborate methods in the practice of meridian therapy. Various styles of shallow acupuncture and contact needling have been developed, which later formed a major feature of Japanese acupuncture. The major

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Japanese acupuncture groups such as Toyohari Igakukai (Toyo Hari Medical Association) and Tohokai, which have promoted soft stimulation acupuncture styles, have a root in Meridian Therapy. Hokushinkai, adopting modern TCM theory, emphasized observation and palpation to the body surface, which has a root in Japanese tradition. The group is also well known for its unique practice of Dashin method (打鍼法). The Dashin method, despite its common practice in the Edo period, had been obsolete since the Meiji period. However, it was rediscovered by Renpu Fujimoto, the leader of Hokushinkai, and reconstructed as a new acupuncture method that does not involve needle insertion into the body. Although these groups had been working individually, the Japan Meridian Society (now the Japan Traditional Acupuncture-Moxibustion Society, JTAMS, 日本伝統鍼灸学会), was established in 1973 and has provided a platform for mutual communication among those groups. At present, 10 groups are participating in JTAMS as a supporting member, exchanging information on traditional acupuncture and moxibustion, and promoting academic research. The other is the rise of research in classical medicine literature. In the early stage development of meridian therapy, the emphasis was placed on a relatively small number of texts, such as Nanjing 《 ( 難経》), Huangdi Neijing 《 ( 黄帝内経》), and Ifa Dachenglun 《 ( 医法大成論》), but many practitioners felt a strong need to analyze medical textbooks other than these texts. They later formed their research groups of classical medical texts of acupuncture. Amongst the groups are Kotenshinkyu kenkyukai (古典鍼灸研究会), Nihonshinkyu kenkyukai (日本鍼灸研究会), Nihon Daikei Igakukai (日本内経医学会). The model for their research is the philological work carried out by the physicians of the Edo Institute of Medicine in the Edo period.

6.1.4.7  Japan’s contribution to the operation of the World Congress of Acupuncture and the establishment of WFAS (the 1960s to the 1980s) From the 1960s to the 1980s, Japan contributed to the establishment and operation of two international societies on acupuncture and moxibustion. In the 1950s, Japanese acupuncture and moxibustion became active in

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personal exchanges with their European counterparts. Dr. Herbert Schmidt visited Japan in 1953 from Germany and learned Japanese style acupuncture from Yanagiya Sorei, Okabe Sodo, and Kinoshita Haruto (木下晴都, 1915–1997) during his stay for about a year and a half. From Japan, Sakaguchi Hiroshi (坂口弘, 1921–2003), Yanagiya Sorei, and Manaka Yoshio (間中喜雄, 1911–1989) traveled to Europe in 1954, 1955, and 1959 respectively, and interacted with the European physicians who practiced acupuncture. In Europe at the time, Société Internationale d’Acupuncture (SIA) which was founded in France in 1945, regularly held international conferences on acupuncture in Europe. In order to collect information of the status in Europe, the Japan Acupuncture and Moxibustion Association set up in 1961 the International Division, and dispatched members to attend SIA’s international conferences. The association also began to envision the formation of a global acupuncture and moxibustion society centered on East Asia, including China.[12] In this context, Japan hosted The First World Congress of Acupuncture in 1965. The conference was held with simultaneous interpretation in three languages, Japanese, English and French, and it was agreed that the congress would be held once every four years as international acupuncture and moxibustion-related academic society that integrates societies in Asia Table 6–1    Japan’s Contributions to World Congress of Acupuncture (1965–1985). Number of Countries/Regions

Number of Participants

Participants from Japan

Year

Place

1

1965

Tokyo, Japan

19

800

700

2

1969

Paris, France

27

300

57

3

1973

Seoul, Republic of Korea

22

700

95

4

1975

Las Vegas, US

17

700

115

5

1977

Tokyo, Japan

32

1,600

1,250

6

1979

Paris, France

54

1,100

150

7

1981

Colombo, Sri Lanka

40

1,200

170

8

1982

Wien, Austria

25

700

100

9

1985

Montreal, Canada

20

600

9

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and Europe. Table 6–1 outlines the history of the World Congress of Acupuncture and Moxibustion held since then. From Japan, members of the Japan Acupuncture and Moxibustion Association and the Japan Acupuncture and Moxibustion Society participated actively. While playing the leading role in these international conferences, Japan paid tribute to China and was looking for ways for the representative from Mainland China to participate in international conferences. In the early 1980s, WHO/WPRO began international standardization of acupuncture nomenclature, and meetings were held for promotion. At the Manila meeting held in 1982, Kurosu Yukio from the Japan Acupuncture and Moxibustion Association, proposed the establishment of the World Federation of Acupuncture and Moxibustion. As a result, the Steering Committee was organized. Takagi Kentaro (高木健太郎, 1910–1990), then President of the Japan Society of Acupuncture and Moxibustion, was appointed as the Chairman. The committee’s proceedings, which were conducted several times after the Manila meeting, were often very difficult due to the language barriers and cultural differences among the participants, but thanks to the enthusiastic efforts of Takagi, who chaired the committee, the World Federation of Acupuncture-Moxibustion Societies (WFAS) celebrated its founding in November 1987.[13]

6.1.4.8  Japan’s achievement of basic research in acupuncture (the 1970s to 2000s) In postwar Japan, innovations related to clinical rationale or technique such as the development of meridian therapy and the creation of various contact acupuncture methods were promoted, while the academic societies established after the war was strongly required to scientifically elucidate the therapeutic effects of acupuncture and moxibustion. One of the important features of research in the field of acupuncture and moxibustion in Japan is the enhancement of basic research. As already mentioned, in the early Meiji era, Ohkubo Tekisai made an early point in his book about the relationship between acupuncture stimulation and the autonomic nervous system. Before the war, Ishikawa Hidetsurumaru researched on the autonomic nerves that convey visceral perception, which led to the research on Viscero-Cutaneous reflex after the war.

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Ishikawa Tachio (石川太刀雄, 1908–1973), a son of Ishikawa Hidetsurumaru, thought that lesions in the internal organs would be projected through the spinal cord to the epidermal arterioles in the corresponding cutaneous segment of the same ipsilateral spinal cord resulting in histological changes at the site. Ishikawa called this minute point, Hidenten (皮電点), where the electrical resistance was significantly lower and the electric capacity was higher than in normal skin in terms of electrophysiology. Ishikawa further explored how epidermal points appeared for each disease. He developed a device for measuring the electrical resistance of the skin, and published Naizo Taiheki Hansha (Visceral Wall Reflex) in 1962, which consisted of a pictorial record of the electrodermal points observed for each disease. Nakatani Yoshio (中谷義雄, 1923–1978), who had been engaged in oriental medicine research since 1950s at the Department of Physiology, Kyoto University, found that plotting points with low electrical resistance on the skin surface showed lines that closely resembled meridians. He named the highly conductive points “Ryodo points” (良導点) and thought that those points were more clearly observed when the patient had an illness or some ataxia. He developed his own method to adjust the imbalance of 12 Ryodoraku, and in 1960 he established the Japanese Society of Ryodoraku Medicine for promoting the method. In 1971, NY Times reporter Reston’s coverage of acupuncture anesthesia caused a worldwide sensation. To confirm the actual condition of acupuncture and moxibustion, not only acupuncturists but also many researchers such as physiologists and anesthesiologists visited China and started research in their own fields. Hyodo Masayoshi (兵頭正義, 1927–1994) of Osaka Medical University performed surgery with acupuncture anesthesia in more than 140 cases and confirmed that it was successful in 80% of the cases.[14] In a review published in 1978, Kumazawa Takao (熊澤孝朗, 1933– 2010), a professor at the Physiology Department of Nagoya University, stated, “We have reached a working hypothesis that the pain-relieving mechanism of acupuncture is regarded as a kind of negative feedback to pain by a nociceptive system with a polymodal receptor as an entrance.”[15] Sato Akio (佐藤昭夫, 1934–2006), who had long worked as vicedirector at the Tokyo Metropolitan Institute of Gerontology Geriatrics Institute, conducted a pioneering research in the field of somatic

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autonomic reflexes. He pointed out that the electrical stimulation input to the somatosensory nerve induces a sympathetic nerve reflex. It was also pointed out that there are two types of reflexes, one that was observed when only the myelinated nerve is stimulated and the other that appeared when the unmyelinated nerve was also stimulated. In a series of studies conducted from the 1970s to the 1980s, Sato also found that in anesthetized animals, physical stimuli to the limbs caused systemic reflexes, and stimuli in the trunk appeared as localized reflexes. Since the 1990s, it has been demonstrated that acupuncture stimulation activates nerves in the skin and muscles and causes visceral reflexes in anesthetized animals. The research by Sato et al. shows that stimulation of the skin by acupuncture and other physical therapies may cause a reaction to internal functions via the efferent path of autonomic nerve, providing an important step in the development of basic research on acupuncture and moxibustion.[16,17] Many years of research by Sato and his colleagues have provided a scientific basis for how interventions, such as acupuncture, physiotherapy, and manual therapy, affect the autonomic nervous system. The Impact of Somatosensory Input on Autonomic Functions (Springer, 1996), coauthored by Sato Yuko and Robert Franz Schmidt, is a great compilation.

6.1.4.9  Reproduction of classical medical texts in Japan In the 1970s, it was widely recognized among the acupuncturists and physicians, who practice Kampo Medicine, that collecting original texts and possessing a profound knowledge of the ancient Chinese language was indispensable for the accurate understanding of medical texts. In this trend, the reproduction of classical medical texts began in the late 1970s. In particular, the series of Toyoigaku Zenpon-sosho 《 ( 東洋医学善本叢 書》), published by Orient Publishing Co., Ltd., is a reproduction of valuable manuscripts such as the Huangdi Neijing Taisu long preserved in the Ninnaji Temple 《 ( 仁和寺 本黄帝内経太素》) and Ishinpo 《 ( 医心方》) compiled in the 9th century, both of which contain descriptions already lost in China. The publisher’s other publication includes a reproduction of rare medical texts produced in Song and Yuan period China and numerous texts produced in Edo period Japan, providing essential material for reading classical medical texts (Figure 6–5).

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Figure 6–5    Reproduction of Rare Medical Texts (Orient Publishing Co., Ltd.).

6.2  Current status of Kampo Medicine 6.2.1  National healthcare system and integration of traditional medicine into national healthcare According to statistics conducted in 2016 by the Ministry of Health, Labour and Welfare (MHLW), the total number of medical doctors in Japan was 304,759, which means that there were 240 doctors per 100,000 population. The number of dentists was 101,551, the number of nurses was 1,660,100, and the number of pharmacists was 230,186. In Japan, acupuncturists and moxibustionists are legally divided into two qualifications, both of which were approximately 115,000 in 2016. There are no special qualifications for Kampo Medicine. According to a survey conducted by the Japan Kampo Medicines Manufacture Association statistics in 2011, more than 80% of Japanese medical doctors were reported to have used Kampo medicines in their daily clinical practice.

6.2.2  Insurance coverage of Kampo Medicine/acupuncture and moxibustion Japan has adopted universal insurance since 1961, and insurance cards are issued to all citizens and foreigners with a status of residence of more than three months. If you bring your health insurance card, NHI can be applied at the insurance medical institution.

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6.2.2.1  Kampo medicines As already mentioned, in the 1970s, many Kampo formulations were added to the NHI Drug Price Standard list. Now, 148 Kampo formulations for ethical use are covered by health insurance and 243 crude drugs are listed on the NHI Drug Price Standard list, then raw materials for decoctions also can be covered by health insurance.

6.2.2.2  Acupuncture & moxibustion In Japan’s current medical insurance system, in principle, acupuncture treatment for the following six diseases are covered by insurance and a written consent from a medical doctor is required: 1) neuralgia, 2) rheumatism, 3) cervicobrachial syndrome, 4) frozen shoulders, 5) low back pain, and 6) sequelae of cervical sprain.

6.2.3  Licensure system, training, and education 6.2.3.1  Kampo Medicine Though many Kampo formulations came to be included in NHI Drug Price Standard list in 1970s, most medical colleges did not have educational programs on Kampo Medicine in their curricula, which resulted in an increase of physicians with little knowledge and experience on how to use Kampo formulations to patients. It was since 2001, when model core curriculum of medical education was revised by Ministry of Education, Culture, Sports, and Technology, the entry “can explain wakan-yaku (Japanese folk medicines and Kampo medicines)” was added so that medical universities were obliged to set up classes on Kampo Medicine in its six years’ education. Now, medical students of all the 82 medical universities in Japan receive Kampo education as well as Western Medicine education. In 2002, model core-curriculum of pharmacy universities was also revised to include the entry of “acquisition of crude drugs and Kampo medicines.”

6.2.3.2  Acupuncture/moxibustion Unified National Examination System The acupuncturist qualification was a license issued by the prefectural governor for a long time after the

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war, but with the amendment of the Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxibustion, etc. in 1978, it became a nationwide unified examination, and the license began to be issued by the Minister of Health, Labor and Welfare. The first national examination was conducted in 1993, and so far, approximately 87,000 people have acquired the qualifications of acupuncturists and moxibustionist under this system. Education (4-year University, 3-year Acupuncture School, Schools for the Blind) With the recognition of the need for scientific research on acupuncture and moxibustion after the war, the establishment of a 4-year university with research facilities had become a strong demand for the acupuncture field. It is in 1983 that Meiji University of Acupuncture and Moxibustion (Meiji University of Integrative Medicine) was established as the first 4-year University of Acupuncture in Japan. The university has a hospital with over 100 beds and an acupuncture center which enabled students to learn both the Western and the Oriental Medicine approach. Nine years after its establishment, the university added a graduate school and started master’s and Ph. D. courses in 1994 and 1996, respectively. To date, 418 graduates have obtained a master’s degree and 96 have obtained a Ph. D. Institution of higher education. Increased in the 21st century, now there are 11 universities. The number of 3-year acupuncture and moxibustion schools has continued to increase since 1999, and now it is 99. The Japan College Association of Oriental Medicine is responsible for the development of textbook and implementation of training aimed at improving the qualifications of teaching staffs in the 3-year acupuncture schools. Acupuncture education for the visually impaired is currently provided at 54 schools.

6.2.3.3  Aiming to further improve education-creation of Textbook of Traditional Japanese Medicine (2013) As the momentum for international standardization in the field of traditional medicine has increased, the demand for high-level textbooks in both the fields of Kampo Medicine and acupuncture and moxibustion has increased in Japan. The Textbook of Traditional Japanese Medicine

History, Present and Prospect of Kampo Medicine  429

was created in this context. This text is research products of Research on the Standardization of Traditional Japanese Medicine Promoting Integrated Medicine (Principal Investigator, Arai Makoto) subsidized by the Health and Labour Sciences Research Grant 2010–2011. The members from the Japan Society for Oriental Medicine (JSOM), the Japan Society of Acupuncture and Moxibustion (JSAM), and the Traditional Acupuncture and Moxibustion Society (JTAMS) were in charge of editing. The preface was written by Ishino Shogo, who was the chairman of the Japan Liaison Oriental Medicine (JLOM) at that time. Both the Kampo edition and the acupuncture and moxibustion edition not only outlined the basic topics such as diagnosis, prescription, and safety, but also a wide range of traditional Japanese Medicine such as historical background, current situation, and future prospects. The PDF file of these textbooks can be downloaded from the website: http:// kampotextbook.sakura.ne.jp/.

6.2.4  Trade and Product 6.2.4.1  Market and product in Kampo area The market of Kampo and other products derived from crude drugs in 2018 was worth 1.81 billion USD. Among them, 93% was Kampo products, 2% was crude drugs, and 5% was the products used in Western Medicine or based on folk medicine. By another classification, 79% was for ethical use and 21% was for OTC. Japan Kampo Medicines Manufactures Association is responsible for the steady supply of Kampo products.

6.2.4.2  Japan Kampo Medicines Manufactures Association (JKMA) JKMA was established in 1983. Its member manufacturers contain 63 companies in 2020. They aim was to contribute to the development of the pharmaceutical industry and people’s health by continuously and stably supplying, disseminating, establishing, and developing high-quality Kampo products, and its derivative products crude drugs.

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6.2.4.3  Products in acupuncture area Definition of Medical Device In Japan, as for the definition of medical devices, the MHLW has adopted the definition by the Global Harmonization Task Force and that of ISO 13485. Acupuncture needles for single use are classified as Class II (managed medical devices), which has certification standards and certification by a third party is required. Electroacupuncture stimulator is also classified as Class II and certification standard was created in 2013. Manufacture Association There is no manufacture association that specializes in the product used in acupuncture and moxibustion. Manufacturers of acupuncture needles belong to the Japan Industries Association of Physical Therapy Device. Outstanding Technical Capabilities that Support Delicate Clinical Practice Seirin, the first manufacturer of sterilized single-use acupuncture needles and the world’s leading manufacture to date, uses its advanced technology to make acupuncture needles that can withstand the rigorous demands of acupuncturists who make full use of delicate techniques. The J-type is a conventional acupuncture needle with a sharp needle tip, but the company recently developed J SEIRIN Point (JSP) type with a round needle tip, which makes the patient feel easy and enable the practitioner’s delicate needling technique (Figure 6–6 and Figure 6–7). Though Moxa floss is not classified as medical device, Japan has a long history of producing high quality moxa floss with high degree of purification (Figure 6–8).

6.2.5  Academic societies and research centers for Kampo Medicine Establishing a research institute had long been the earnest wish for the physicians who practice Kampo Medicine and acupuncture. Kitasato University Oriental Medicine Research Center and Department of Japanese Oriental Medicine, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama are both designated as WHO Cooperation Centre for Traditional Medicine in the 1980s, as well as a research center for the 21st Century COE (Center of Excellence) Program promoted by the Ministry of Education, Culture, Sports, Science,

History, Present and Prospect of Kampo Medicine  431

Figure 6–6    Acupuncture Needle with Sharp Tip (J-Type, Seirin Cooperation).

Figure 6–7    Acupuncture Needle with Round Tip (JSP type, Seirin Cooperation).

Figure 6–8    Moxa Floss. Note: The highly refined moxa floss with the minimum amount of impurities in the manufacturing process (Yamasho Co. Ltd.).

and Technology domestically. Both institutes actively promote research towards the integration of Kampo Medicine and Western Medicine.

6.2.5.1  The Japan Society for Oriental Medicine (JSOM) The largest academic society of Kampo Medicine with a total number of 8,118 members (2019), consisting of physicians, researchers, pharmacists,

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nurses, and acupuncturists. The society was established in 1950 by the core members of Kaiko Gakuen, who had led the survival movement of Kampo Medicine since the 1930s, such as Otsuka Yoshinori, Tatsuno Kazuo, and Yakazu Domei. In 1991, the society became a member of the Japanese Association of Medical Sciences. It is also the leading society in JLOM. Publication of Journal The society publishes its official journal Kampo Medicine four times annually. It also publishes its online journal Traditional and Kampo Medicine. Meeting Kampo Activities Academic conference is held annually. Accreditation of Specialist System The Society qualifies those physicians who are already accredited specialists in an academic society that belong to the basic area defined by the Japan Specialist Accreditation organization and who meet all the requirements of the Society as Kampo specialist. The system started in 1989 and up to 2022, 2,009 physicians have been accredited as Kampo specialists. Evidence Reports of Kampo Treatment (EKAT) The society set up in 2000 the committee for evidence based medicine (EBM) and started the evaluation program of randamized controlled trial (RCT) research of Kampo Medicine in which structured abstracts were developed to each of the clinical trial conducted in Japan since 1986. The collected abstracts which are compiled and published under the name of EKAT are available at the JSOM’s website: http://www.jsom.or.jp/ medical/ebm/index.html.

6.2.5.2  The Japan Society of Acupuncture and Moxibustion (JSAM) This society was established in 1980 by the integration of two societies established shortly after the war. One is Japan Acupuncture and Moxibustion Society (JAMS), established in 1951 and led by Higuchi Etsunosuke. The other is Japan Society of Medical Acupuncture (JSMA) established in 1948 and chaired by Sasagawa Kyugo (笹川久吾, 1984– 1968) of Kyoto University JSMA was an academic society composed mainly of physicians, while JAMS was a society mainly composed of acupuncturists. The mission of the society is to promote scientific research on acupuncture and moxibustion from diverse perspectives and to

History, Present and Prospect of Kampo Medicine  433

contribute to the well-being of the people. The number of registered members is 3,697 (2022). Publication of Journals They publish official academic journals The Journal of the Japan Society of Acupuncture and Moxibustion (JJSAM) four times annually and provides online journal The Journal of Acupuncture and Moxibustion (JAM), which is available on the following site: http:// jsam.jp/en/journals/ database/. Meeting Activities Academic conference is held annually. Accreditation of Certificated Acupuncturist The Society started a certification system in 1999 with the aim of improving the qualifications of academic members and training acupuncturists who can contribute to the society. At present, there are 302 certified acupuncturists. 2011 Tokyo Declaration In 2011, JSAM, along with its academic partner JTAMS, published 2011 Tokyo Declaration on Japanese Acupuncture — Toward Better Healthcare in Japan and the World in the 21st Century. In this declaration, the history and the current status of Japanese acupuncture are described and the solutions to the challenges are presented. The content of the declaration can be found on the website: http://jsam.jp/en/about/declaration.

6.2.5.3  Japan Society of Medical and Pharmaceutical Sciences for Traditional Medicine The Wakan-yaku symposium (1967–1983) focused mainly on research into Wakan-yaku (Japanese ethnomedicines and crude drugs serving as material for the preparation of Kampo medicines) was the parent organization for the establishment of this society in 1984. The society holds one annual national conference. While the Japan Society for Oriental Medicine primarily publishes clinical research results, publications pertaining to crude drugs, preparations, and basic research are the primary focus in this society. There are 613 members (2019), consisting of physicians, pharmacists, research scientists, and students. Publication of Journal They publish official academic journal Traditional and Kampo Medicine (jointed with JSOM) regularly. Meeting Activities Academic conference is held annually. Website: https://www.wakan-iyaku.gr.jp/eng/.

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6.2.5.4  The Japanese Society of Pharmacognosy (JSP) The Japanese Society of Pharmacognosy was founded in 1947. It aims to promote research in pharmacognosy and its related fields to provide the members with opportunities for presentations, exchange of knowledge, and cooperation/coordination among relevant societies. The primary scope of JSP lies in the chemical, biochemical, and biological properties of medicinal natural products and their derivatives. Research topics include the search for novel medicinal sources, structure elucidation, chemotaxonomy, genetic analysis, pharmacology, and biosynthesis. There are 1,345 members (2019), consisting of research scientists, engineers, and students. Publication of Journal They publish official academic journal Journal of Natural Medicines regularly. Meeting Activities Academic conference is held annually. Website: http://www.jsphcg.or.jp/index-e.html.

6.2.5.5  The Japan Traditional Acupuncture-Moxibustion Society (JTAMS) The society was established in 1973 and has provided a platform for mutual communication among groups of practitioners who practice traditional styles of acupuncture/moxibustion. At present, 10 groups are participating in JTAMS as a supporting member. Publication of Journal They publish official academic journal The Journal of the Japanese Traditional Acupuncture and Moxibustion (JJTAMS) regularly. Meeting Activities Academic conference is held annually.

6.2.5.6  Kitasato University Oriental Medicine Research Center It was in 1972, under the strong support of Takemi Taro, the president of Japan Medical Association, that a research institute of Kampo Medicine was established in Kitasato Institute (Kitasato University Oriental Medicine Research Center). The first director of the institute was Otsuka Yoshinori who started in the 1930s his activity towards the revival of Kampo Medicine and played a significant role in the movement. The

History, Present and Prospect of Kampo Medicine  435

institute included many research facilities such as laboratories for chemical research on Kampo formulas, clinics providing both Kampo and acupuncture treatment and a library. Since the successive directors were all book collectors, the institute boasts a library with a great collection of medical manuscripts in the field of traditional medicine, which enabled historians to conduct in-depth research in the medical history of East Asia. Amongst the historians who worked in this institute are Kosoto Hiroshi ( 小曽戸洋), Mayanagi Makoto (真柳誠), and Yasui Hiromichi (安井廣 迪). With notable academic achievements in its clinical research and medical history study, the institute was appointed in 1986 as a WHO Collaboration Centre for Traditional Medicine. This center, since 2014, also has functioned as a satellite research center for COI (Center of Innovation) program “Innovative Food and Healthcare Master,” promoted by the Ministry of Education, Culture, Sports, Science, and Technology and Japan Science Technology Agency. Website: https://www.kitasato-u. ac.jp/toui-ken/index.html.

6.2.5.7  Department of Japanese Oriental Medicine, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama Toyama Prefecture is famous for its long history of drug manufacturing in Japan. When the Toyama Medical and Pharmaceutical University Hospital opened in 1979, the department of Japanese Oriental Medicine was established at the same time, which is the first clinical department in a national university hospital specializing in Kampo Medicine. In 2005, when the three national universities in Toyama Prefecture were integrated into the University of Toyama, in the following year, the department of Japanese and Oriental Medicine was established in Graduate School of Medicine of the university. Terasawa Katsutoshi (寺澤捷年) became the first professor of the department. Since its establishment, the department has played a leading role in Japanese Kampo Medicine in all aspects of clinical practice, education, and research. In 2016, it was designated as a research center of the Ministry of Education, Culture, Sports, Science and Technology’s COE program “Advanced Approach to Personalized Medicine Based on Oriental Philosophy” and achieved great results. It

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was also designated as a WHO Collaboration center in 1988 and continues to disseminate information on the safety and efficacy of Kampo Medicine. Website: http://www.med.u-toyama.ac.jp/wakan/english/index.html.

6.2.5.8  Institute of Natural Medicine, University of Toyama The University of Toyama has another institute related to research in traditional medicine, the Institute of Natural Medicine, which has a root in Research Institute for WAKAN-YAKU established in 1963 in the Faculty of Pharmaceutical Sciences of Toyama University. Now the institute has broadened its scope to include scientific research on natural medicine in general, not limited to Kampo Medicine. It has two major departments. One is the Research Department consisting of the four divisions: 1) Dep. of Medicinal Resource, 2) Dep. of Bioscience, 3) Dep. of Clinical Science, and 4) Dep. of Translational Research. The other department consists of the Division of International cooperative study and Research Center for Ethnomedicine. Division for International Cooperative Research is promoting international cooperative study with overseas institute such as China, Thailand, and Egypt. Another division, Museum of Materia Medica is responsible for developing a database on wakan-yaku. It has a long history of collecting crude drugs from all over the world including those used in Ayurveda, Yunani medicine, and developed a database of sample data and information of about 29,500 crude drugs. The database, ETHMED is available on the following website:https://www.u-toyama. ac.jp/academics/inm/index.html; http://www.inm.u-toyama.ac.jp/index-e .html.

6.2.6  Overseas Communication: Academic Symposium and Conference 6.2.6.1  Japan-Korea Workshop on Acupuncture and EBM (2006–present) To facilitate the academic exchange of scientific acupuncture research in the East Asia, JSAM, and two Korean academic societies, “Korean Acupuncture and Moxibustion Medical Society (KAMMS)” and “Society

History, Present and Prospect of Kampo Medicine  437

of Korean Medicine (SKOM)” agreed on a memorandum in February 2004. Following this memorandum, JSAM and KAMS formally started a collaborative research program, “Japan-Korea Workshop on Acupuncture and EBM” in Chiba in 2004. Since then, series of the “Japan-Korea Workshop on Acupuncture and EBM” has been held. The workshops were held 10 times before the COVID-19 outbreak.

6.2.6.2  The JSAM International Symposium on Evidence Based Acupuncture In 2006, JSAM hosted “The International Symposium on Evidence Based Acupuncture Now” at Kyoto, Japan. The purposes of this symposium were 1) to present the latest research on evidence of effectiveness and safety of acupuncture treatment for “osteoarthritis of the knee” and 2) to introduce detailed information on Japanese acupuncture and moxibustion regarding history, educational programs, national licensure system and various diagnostic and therapeutic techniques. The symposium had a great success with more than 200 participants including eight special speakers from abroad. The JSAM held the 2nd International Symposium in 2009 and 3rd in 2012.

6.2.6.3  Traditions Crossing Borders, Enhancing Different Cultures, History of Medicine in the Cultural Sphere of Chinese Characters (the 2nd Joint Symposium of Japan, China and Korea Societies for the History of Medicine, 2010) In June 2010, Japanese Society for the History of Medicine held an international symposium, “Traditions Crossing Borders, Enhancing Different Cultures, History of Medicine in the Cultural Sphere of Chinese Characters” in which the discussion was made on the process of how ancient Chinese Medicine was transmitted and assimilated in the countries that belonged to the cultural sphere of Chinese Characters. Distinguished researchers from Japan, Korea, and Vietnam had intensive discussions about the impact of Chinese medical texts to the surrounding countries

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Figure 6–9  The 2nd Joint Symposium of Japan, China, and Korea Societies for the History of Medicine. Note: The proceeding of the 2nd Joint Symposium of Japan, China, and Korea Societies for the History of Medicine “Crossing Borders, Enhancing Different Cultures, History of Medicine in the Cultural Sphere of Chinese Characters.”

and the formation of medical culture rooted in the traditions of each of these countries (Figure 6–9).

6.2.6.4  World Federation of Acupuncture-Moxibustion Societies (WFAS Tokyo/Tsukuba 2016) In 2016, JSAM and JTAMS hosted the congress of World Federation of Acupuncture-Moxibustion Societies (WFAS Tokyo/Tsukuba 2016) which was held in Tsukuba and Tokyo, Japan. The congress was a grand one, with 1,727 participants from 31 countries. The theme of the congress was “The Art of Acupuncture,” and its purpose was to dynamically present the ideal way of acupuncture and moxibustion as a part of the

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sustainable healthcare in the future. In addition to the seven-keynote lectures, a scientific session and seven demonstration sessions were provided. In the scientific session, Kurosawa Mieko (黒澤美枝子), from International University of Health and Welfare, introduced the latest research on the relationship between tactile stimulation and the reward system of the brain. Chae Younbyoung, from Kyung-hee University, presented that the excitement of unmyelinated tactile receptors during acupuncture treatment might play a role in the development of therapeutic effect.[16]

6.2.7  Japan’s contribution to international standardization of traditional medicine 6.2.7.1  Establishment of JLOM (2005) WHO/WPRO, under the leadership of Dr. Choi Seung-hoon, launched several international standardization projects on traditional medicine. At first, Japanese experts were invited as temporary advisors for informal consultation as an individual, thus, there came a need for establishing a national platform for policy decisions for international standardization. In 2005, four major academic societies of Kampo Medicine and Acupuncture/ Moxibustion and two WHO collaboration centers for traditional medicine in Japan formed a liaison. It was named JLOM. As the range of standard projects expands, JLOM was added to the member societies and now consists of 12 member societies. The Japan Society for Oriental Medicine has played the leading role and the successive presidents of JSOM were inaugurated as the chair of JLOM (Table 6–2).

6.2.7.2  JLOM’s major contribution to international standardization — WHO/WPRO projects (2002–2008) Standardization of Acupuncture Points Location The project started as the first standardization project of traditional medicine after Dr. Choi Seung-hoon’s inauguration as traditional medicine officer of WPRO in 2002. Starting with the first informal consultation meeting held in Manilla in 2003, six informal consultations and three task force meetings had been held before

440  History, Present and Prospect of World Traditional Medicine Table 6–2    Member Societies of the Japan Liaison of Oriental Medicine. Member Societies/ Association

Year of Affiliation

 1

The Japan Society for Oriental Medicine (JSOM)

2005

 2

The Japan Society of Acupuncture and Moxibustion (JSAM)

2005

 3

Japan Society of Medical and Pharmaceutical Sciences for Traditional Medicine

2005

 4

The Japanese Society of Phamacognosy (JSP)

2005

 5

Kitasato University Oriental Medicine Research Center (WHO CC for Traditional Medicine)

2005

 6

Department of Japanese Oriental Medicine, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama (WHO CC for Traditional Medicine)

2005

 7

The Japan Tradition Acupuncture and Moxibustion Society (JTAMS)

2016

 8

Japan Dental Society of Oriental Medicine (JDSOM)

2016

 9

Japan Acupuncture & Moxibustion Association

2018

10

Japan College Association of Oriental Medicine

2018

11

All Nippon Acupuncture & Moxibustion Massage Association

2019

12

Japan Society of Acupuncture Course in Universities (JSACU)

2019

Note: JLOM’s website: http://jlom.umin.jp/.

the finalization meeting in 2006. Japan, with its history of research on acupuncture points which dates back to 1960’s, contributed to the standardization in this field. The standard point location was approved and finalized at the Meeting on the Development of Acupuncture Points Location held at Tsukuba, Japan in 2006. The outcome was published as WHO International Standard Acupuncture Point Locations in the Western Pacific Region in 2008. Standardization of Terminologies on Traditional Medicine (2005– 2007) The project started in 2004 as WPRO’s second international standardization project and Japan hosted the second informal consultation meeting 2005 which was held in Center for Oriental Medicine, Kitasato

History, Present and Prospect of Kampo Medicine  441

University. The outcome was published in 2007 as WHO International Standard Terminologies of Traditional Medicine in the Western Pacific Region. ICD-11 Chapter 26 “Traditional Medicine Module 1” (2010– 2019) Inclusion of disease/ pattern classification of traditional medicine into International Classification of Disease (ICD) was first raised in WPRO’s Informal Consultation of Information Standardization held in Beijing in 2005. Later it became one of WHO’s projects, and in May 2010, the First WHO Meeting of International Classification of Traditional Medicine was held in Hong-Kong. The Japan Society for Oriental Medicine, JLOM’s leading society, and Institute of Kampo Medicine of Kitasato University provided financial support to this project. The beta version classification was released in 2018 and the final document was approved in WHO General Assembly in 2019.

6.2.7.3  The Tokyo Forum on International Standardization of Natural Medicine (17–19 January 2011) In January 2011, JLOM hosted the Tokyo Forum on International Standardization of Natural Medicine in which 21 distinguished research professionals and administrators from eight countries and regions (China, Republic of Korea, US, Mongolia, Netherlands, Vietnam, and Japan) participated. The aim of this forum was to share the knowledge of each country’s contemporary issues and status of safety and quality control of natural medicines and to promote the development of standardization in the field. The forum consisted of the following four symposiums: – Symposium 1: Current situation of safety and quality control on natural medicines. – Symposium 2: Variation among China, Republic of Korea, Japan, and Vietnam on natural medicines (naming, original species, etc.). – Symposium 3: Existing international standardization activities on natural medicines. – Symposium 4: Strategy to establish safety and quality control on natural medicines.

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6.2.7.4  ISO/TC249, TC215 (2010–present) Following the establishment of ISO/TC249 in 2009, JLOM was appointed by The Japanese Industrial Standards Committee (JISC) as the national mirror committee for the Technical Committee. Since health informatics standards regarding traditional medicine are developed in TC215, JLOM also dispatches experts to TC215. In 2014, Japan hosted the 5th Plenary Meeting of ISO/TC249 at Hyatt Regency Kyoto. The Kyoto meeting, with 212 participants, was one of the most memorable meetings in the history of ISO/TC249. The following are the major international standards (Including TS and TR) in which the Japanese experts participated as project leaders. – ISO 18746 Sterile intradermal acupuncture needles for single use. – ISO 19614 Pulse graph force transducer. – ISO 20487 Test method of single-use acupuncture needles for electrical stimulation. – ISO/TS 20498 Computerized tongue image analysis system Part 3: Color chart. – ISO/TS16843–1 Categorial structure for representation of acupuncture Part 1: Acupuncture points. – ISO/TS18062 Health informatics — Categorial structure for representation of herbal medicaments in terminological systems. – ISO/TR 23021 Controlled vocabulary on Japanese Kampo crude drugs. – ISO/TR 23022 Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products.

6.3  Challenges and prospect of Kampo Medicine History is always a mirror that reflects the future. Looking back on the history of Japanese Kampo Medicine, we can say that it was a history of hardships on how to adapt foreign medicines, from ancient Chinese Medicine and Western Medicine, to Japanese traditions. Especially since the mid-19th century, when Western Medicine gained its position as mainstream medicine, traditional medicine has been repeatedly forced to build

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an “interpretation model” that could be explained from the biomedical perspective. Harmonization of traditional medicine and Western Medicine is an ongoing issue even today in the 21st century. It is a common challenge not only in Japan but in all countries that practice traditional medicine. It will be necessary to continue to promote the reconstruction of Kampo Medicine from the perspective of therapeutics. The following is a sketch of the challenges and prospects of Kampo Medicine in Japan. – Evidence has been presented for some Kampo medicines such as Daikenchuto (大建中湯), Rikkunshito (六君子湯), and Yokukansan (抑肝散), but further evidence for the therapeutic effects of Kampo medicines are needed. – Up to now, basic research has been accumulated in both areas of Kampo and acupuncture in Japan. Especially in the field of acupuncture and moxibustion, the relationship between acupuncture and moxibustion stimulation and the autonomic nervous system has been of interest since the Meiji era, with a history of nearly 140 years. However, basic research requires facilities and human resources, and requires a huge research budget. In Japan, in recent decades, MHLW and Japan Agency for Medical Research and Development (AMED) have been investing research budgets for traditional medicine as well but there is still a lack of funding to carry out research by an interdisciplinary team. – Since the establishment of the Meiji University of Integrative Medicine in 1983, 11 acupuncture and moxibustion universities have been established as institutions of higher education, of which eight universities have a graduate school. Unfortunately, few universities have large hospitals resulting in limited institutions that can provide training in both modern medicine and oriental medicine. – In order to provide a stable supply of high-quality crude drugs, industry-government- academia collaboration is attempting to 1) cultivate medicinal plants to produce crude drugs and 2) establish a traceability system as a countermeasure against agricultural chemicals, heavy metals, and microbial contamination. Companies are seeking new procurement sources such as Southeast Asia and attempting resource development in these regions.

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– Kampo Medicine is a property of Japan and is of great interest to the general public and academia. In addition to history and philology, researchers in the field of social sciences such as sociology, economics, and anthropology are also very interested in traditional medicine. However, in spite of individual research, there is almost no interdisciplinary research that integrates them. When considering the future development of Japanese traditional medicine, Kampo Medicine, interdisciplinary research in collaboration with not only biological science but also social science and humanities is essential. In Japan, while the high-quality extract and advanced needling technique are being developed, the standardization of terms and information technology in the field of traditional medicine is still insufficient, resulting in immature infrastructure for creating a database of the medical record. In the future, it will be necessary to promote standardization in these fields and build infrastructure for large-scale clinical research. – It can be said that the research environment for Kampo Medicine and acupuncture and moxibustion improved significantly after the war. In the 1970s, the Institute of Oriental Medicine was established at the Kitasato Institute, and now many national university hospitals are providing both Kampo Medicine treatment and acupuncture treatment. However, unfortunately, there is no national research institute specialized in traditional medicine, which has long been expected since the 1930s. In order to solve the problems mentioned above, the existence of a national research institute with a stable financial base and human resources is indispensable.

References  [1] Huffman MA, Wrangham RW. Diversity of Medicinal Plant Use by Chimpanzees in the Wild[J]. Chimpanzee cultures, 1994: 129–148.  [2] Lemonnier N, Zhou G, Prasher B, et al. Traditional Knowledge-Based Medicine: A Review of History, Principles, and Relevance in the Present Context of p4 Systems Medicine[J]. Progress in Preventive Medicine, 2017, 2(7): e11.   [3] Wang BY. Rpt. Shennongbencaojing[M]. Beijing: Beijing Yanshang Press, 2010.

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  [4] Kosoto H. A History of Kampo Medicine-Traditional Medicine of China and Japan[M]. Tokyo: Taishukan, 1999: 84–85.  [5] Endo J. Keitekishu and Independence of Japanese Medicine, in the Proceeding of Traditions Crossing Borders, Enhancing Different Cultures History of Medicine in the Cultural Sphere of Chinese Characters: The 2nd Joint Symposium of Japan, China and Korea Societies for the History of Medicine[C]. Bunkyo Mito Ibaraki: The 111th Japan Medical History Society Secretariat, 2010.  [6] Museum KN. See More Insects in the Collection Gallery “Acupuncture Book”[EB/OL]. [2022–03–06]. https://www.kyuhaku.jp/collection/ collection_harikiki-2.html.   [7] Wolfgang M. Japanese Acupuncture and Moxibustion in 16th–18th Century Europe[J]. Journal of the Japan Society of Acupuncture and Moxibustion, 2011, 61(2): 150–163.   [8] Ishida H. Why Traditional Chinese Medicine did not Assimilate Anatomical Knowledge from the West at the Earlier Stage[M]. Kyoto: Kyoto University, 1998: 715–737.   [9] Kosoto H. A History of Kampo Medicine-Traditional Medicine of China and Japan[M]. Tokyo: Taishukan, 1999: 170–172. [10] Katai S. History of Acupuncture in Japan. Japanese Tradtional Medicine, Acupuncture edition [J]. Health and Labour Sciences Research Grant, 2010–2011: 8–9. [11] Noguchi E, Ohsawa H. Autonomic Nerve in Textbook of Traditional Japanese Medicine, Acupuncture Edition [J]. Health and Labour Sciences Research Grant, 2010 – 2011: 75–87. [12] Japan Acupuncture & Moxibustion Association. Record of Japan Acupuncture & Moxibustion Association for 40th Anniversary of the Foundation[M]. Tokyo: Japan Acupuncture and Moxibustion Association, 1990: 69–82. [13] Tsutani K. NGO as a Partner in the Field of Healthcare[J]. Gendai Toyoigaku, 1993, 14(4): 117–128. [14] Hyodo M, Kitade T. Low Frequency Acupuncture Treatment-Application of Acupuncture Analgia to Treatment[M]. Bunkyo-ku, Tokyo: Ishiyaku Publishers, Inc, 1974: 161. [15] Kumazawa T. Mechanism of Acupuncture Analgia 2; Central Mechanism, Jpn J Clin Physiol[J]. Japanese Journal of Clinical Physiology, 1978, 8(6): 505–516. [16] Sato Y, Uchida S, Noguchi E, et al. Memorial Symposium in Honour of Professor Akio Sato[J]. Journal of the Japan Society of Acupuncture and Moxibustion, 2010, 60(4): 672–692.

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[17] Noguchi E, Ohsawa H. Autonomic Nerve in Textbook of Traditional Japanese Medicine, Acupuncture Edition, A Product of “Research on the Standardization of Traditional Japanese Medicine Promoting Integrated Medicine” [C]. Subsidized by the Health and Labour Sciences Research Grant 2010–2011, 2013: 75–87. [18] Wakayama I, Ishizaki N, Saito M, et al. Report on WFAS Tokyo/Tsukuba 2016 — First WFAS Conference in Japan in 23 Years was Concluded Successfully[J]. Journal of the Japan Society of Acupuncture and Moxibustion, 2017, 67(1): 4–14.

© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_0007

Chapter 7

History, Present and Prospect of Korean Medicine Byungmook Lim, Byunghee Koh, Yongsuk Kim, Yunkyung Kim, Youngju Yun

Abstract Korean Medicine is a collection of medical techniques and theories that have been used and developed over a long period of time on the Korean Peninsula. With an established legal and qualification system, Korean Medicine has maintained an independent and competitive position alongside Western Medicine. There are government departments and government-funded institutes on Korean Medicine, and Korean Medicine doctors are officially recognized in the fields of public health and military medicine. National plan for promoting Korean Medicine has been established every five years, and the National Health Insurance has covered most Korean Medicine procedures and herbal medicines. In conclusion, Korean Medicine is one of the most successful examples of traditional medicine being integrated into the modern healthcare system while maintaining its essential characteristics. Keywords: Korea, Korean Medicine, traditional medicine, healthcare policy

447

448  History, Present and Prospect of World Traditional Medicine

Introduction Korean Medicine is a collection of medical techniques and theories that have been used and developed over a long period of time on the Korean Peninsula. Traditionally, acupuncture, moxibustion, cupping, and herbal medicines have been used, and pharmacopuncture (herbal acupuncture) and Chuna Manual therapy, which have been improved to modernized forms based on traditional techniques, are also widely used. Sasang constitutional medicine theoretically represents the uniqueness of Korean Medicine. In the early 20th century, when Korea became a colony of Japan, Korean Medicine lost its official status and went through a process of decline, but liberation from Japan gave an opportunity for Korean Medicine revival. With the enactment of the National Medical Service Act in 1951, the license for and the education of Korean Medicine was legalized, and since then, Korean Medicine has maintained an independent and competitive position alongside Western Medicine in the Republic of Korea. The National Health Insurance coverage of Korean Medicine procedures and herbal medicines, which started in 1987, became an important opportunity for the expansion of the use and the institutional development of Korean Medicine afterward. Korean Medicine doctors have been officially recognized in the fields of public health and military medicine. The departments in charge of Korean Medicine were established under the Ministry of Health and Welfare, and the government began to support Korean Medicine research institute. In 2000s, the Act on the Promotion of Korean Medicine and Pharmaceuticals was enacted, and in accordance with the Act, the National Development Plan for Korean Medicine has been established every five years. As of 2019, 25,592 Korean Medicine doctors are working at 353 Korean Medicine hospitals 14,442 clinics, and about 1,335 long-term care hospitals.[1] Almost all public health centers across the country provide Korean Medicine services. The usage of Korean Medicine by Koreans is maintained frequent. A national survey in 2014 revealed 92% of Koreans had experience receiving Korean medical service in their lifetime and 27.1% received care within three months of the survey.[2] The proportion

History, Present and Prospect of Korean Medicine  449

of reimbursement for Korean Medicine treatments is about 7% of total National Health Insurance claims. As shown above briefly, Korean Medicine has been successfully integrated into and developed in the modern healthcare system of the Republic of Korea. This chapter introduces the modern development process of Korean Medicine, and the details of the current Korean Medicine system. First, the history of Korean Medicine was described in terms of academic, technical, and institutional aspects. In the pre-modern history, the old way of existence of Korean Medicine was explained, but in terms of technology and theory, the unique aspects of Korean Medicine which contrasted with traditional medicines of China and Japan were emphasized and summarized. The history of modern Korean Medicine focused on institutional aspect rather than technical aspect. Korean Medicine achieved modern development thanks to the government’s support, but there has been a lot of effort and struggles of Korean Medicine doctors to bring it forward. The next part introduces representative Korean Medicine procedures used by Korean Medicine doctors to help readers understand what modern Korean Medicine is like. Since this book is not a clinical book, the basic principles and methods of each procedure have been briefly explained. For additional knowledge on all the categories of treatments used by Korean Medicine doctors, please refer to the list of benefits covered by the National Health Insurance in the part on the health insurance and Korean Medicine in this chapter. As for the Korean Medicine system, it starts with a description of the legal status and administration. It introduced the Medical Service Act, which regulates Korean Medicine personnel, services, and facilities, and the Pharmaceutical Affairs Act, which regulates the production, distribution, and quality control of herbal medicines. The legal status of Korean Medicine was compared with that of Western Medicine, and the Act on the Promotion of Korean Medicine and Pharmaceuticals, which specifically supports the establishment and execution of Korean Medicine policy, was explained. The present status of various human resources and facilities related to Korean Medicine was presented, and the extent of the use of Korean Medicine in Korea was described through the results of a recent nationwide survey.

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The next part deals with the education system for Korean Medicine, the most developed of its type in the world. It explains the undergraduate programs that produce Korean Medicine doctors and Herbal pharmacists and the continuing medical education system for clinicians. The evaluation system for Korean Medicine colleges and schools were also described. In the part on Korean Medicine Service Policy, the roles and functions of Korean Medicine in the public health sector are described, and various policies for improving the quality of Korean Medicine service were introduced; Korean Medicine specialists, specialized hospitals, hospital accreditation system, development and distribution of Clinical Practice Guideline, and the collaboration between Korean Medicine and Western Medicine. Since the Korean medical system is mainly financed through the National Health Insurance, coverage in the health insurance is of great importance in Korean Medicine. With the purchase of Korean Medicine in health insurance, the status of Korean Medicine was solidified in the healthcare system and the use of Korean Medicine also increased rapidly. The part on health security system describes the development process of Korean Medicine coverage in the health insurance, the current benefit category, and the fee for each procedure, and includes Korean Medicine benefits for other public insurances such as Industrial Accident Compensation Insurance and Motor insurance. Herbal medicine is the main therapeutic method of Korean Medicine, so the quality control and regulatory policy of herbal medicine is described in a separate part. The standards for quality management of herbal medicinal materials and manufactured herbal medicines, policies to protect indigenous herbal resources, and policies to support the modern use of herbal medicines were included. In the Korean Medicine Industry and Research and Development (R&D) part, first, the composition and size of the current Korean Medicine-related industry were described based on the latest survey results, and the current status and major projects of the National Institute of Korean Medicine Development, whose main function is to support the Korean Medicine industry, were introduced. In the second half, the status of government-supported R&D was comprehensively described, and the research support project of the Ministry of Health and Welfare and the

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research activities of the Korea Institute of Oriental Medicine under the Ministry of Science and ICT were described. Finally, this chapter concludes by presenting the tasks for the future development of future Korean Medicine. It is hoped that this chapter will help readers to have a clear picture of the present and future of Korean Medicine, and that it will be used as a model and reference for the modernization of traditional medicine in countries around the world.

7.1  History of Korean Medicine 7.1.1  Ancient times to unified silla era The oldest record of traditional medicine dates to the Gojoseon period, over 4,000 years ago in Korean Peninsula.[3] According to the founding myth of Korea in a historical book, Memorabilia of the Three Kingdoms (《三國遺事》), compiled by the Buddhist monk, Il-yeon in the 1300s, “Hwanwung” descended from the kingdom of heaven and ruled the northern part of the Korean Peninsula. One day, a bear and a tiger visited Hwanwung and said they wanted to be human. Hwanwung told them not to look at the sun for 100 days in a dark cave, eating mugwort and garlic. The tiger came out of the cave without completing 100 days, but the bear succeeded in transforming into a woman by fulfilling 100 days. Hwanwung named the woman “Woongnyeo (Bear woman)” and married her. Their son was “Dangun,” and he was known to the founder of Gojoseon. From this story, it is presumed that the residents of the Korean Peninsula thousands of years ago used garlic or mugwort for medical purposes in their daily lives. After the collapse of Gojoseon, the Korean Peninsula was divided. During BC 1C–AD 7C, each kingdom had an organization in charge of treating diseases for each royal family, and deployed royal doctors and herbal collectors. Old history books and medical books contain records of diseases such as frostbite, strokes, swelling, carbuncle, and infectious diseases at the time, as well as records of use of medicinal herbs such as Ginseng, Mint, Asaroum, Schizandra seed, Milkvetch root, and Evodia fruit.[4] During the Unified Silla Era, the medical education and healthcare system of Tang Dynasty were introduced. In addition, Indian Buddhist

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medicine was introduced by monks who had studied abroad in India, and monks who dealt with both Buddhist and medical affairs appeared. Unified Silla had royal doctors, established the Yakjeon (《藥典》), an institution in charge of medical administration, where medical theory, herbalism, and acupuncture were taught.[5]

7.1.2  Goryeo dynasty During the Goryeo Dynasty (AD 10C–14C)a, the medical system included a medical policy hub called the Taeuigam (太醫監), and the Office of Superior Physicians was established to manage overall state healthcare. In addition, the Sangyakguk (尙藥局), which corresponds to the National Medical Center of today, was established, and policies installed medical education institutions in the capital and provinces. In the royal court there were doctors who treated the king, prince, and high-level bureaucrats exclusively. There were also positions for military doctors, veterinarians, and prison doctors. Doctors were also put in charge of the food within the royal court. The most important medical policy in Goryeo was the introduction of an official exam system to evaluate practitioners. Examination was divided into two sections, one for the general physicians and one for surgeons. General physician candidates were judged in terms of overall medicine while surgeons were assessed by their skill in acupuncture and the treatment of sores.[5] During this period, medical texts such as Effective Prescriptions for Relieving Public (《濟衆立效方》), Essential Prescriptions Collected by Royal Physician-New Edition (《新集御醫撮要方》), and Eastern Doctor’s Experience Prescription (《東人經驗方》) were published and used for medical education and disease treatment. In addition, the doctors of Goryeo deepened their understanding of medical theory through Yellow Emperor’s Inner Canon (《黃帝內經》), Canon of Difficult Questions (《難經》), and AB Canon (《甲乙經》) which were introduced from China, and based on this, they compiled an interpretation of these books.[4] After the Song Dynasty’s Classified Materia Medica (《證類本草》) and other books on herbs were introduced, knowledge of medicinal herbs a

 Goryeo is also written as Koryeo, which is the etymology of Korea.

History, Present and Prospect of Korean Medicine  453

was accumulated, which, on the other hand, increased interest in indigenous medicinal herbs. The term, Hyangyak (鄕藥, homeland herbs) was created and used to distinguish the medicinal herbs produced in Korean Peninsula from those imported from China. As the awareness that diseases that have occurred in Korea can be treated with drugs from Korea has grown, search and use of homeland herbs were encouraged. Some of the most representative books that collected prescriptions for treating diseases using homeland herbs include Formulas using Homeland Herbs for Emergencies 《鄕藥救急方》 ( ) and Samhwaja Formulas using Homeland Herbs 《三和子鄕藥方》 ( ). During this period, as clinical technology developed, pulse diagnosis was also used, but it remained at the level of symptomatic therapy using herbs rather than systematic combinations of diagnosis and treatment.[4]

7.1.3  Early and mid-Joseon dynasty period The medical policy of the Joseon Dynasty (1392–1897) was directed toward fostering a workforce trained to maintain national healthcare services and to build a medical database that would be used in clinical practice and education. Following the Goryeo Dynasty, Joseon Dynasty continued the policy of recommending homeland herbs. In 1398, Joseon government published the《鄕藥濟生集成方》, which described how to identify, collect, and use homeland herbs, and in 1433 under King Sejong (世宗, reigned 1418–1450), published Compendium of Formulas Using Homeland Herbs (《鄕藥集成方》), adding prescriptions from Joseon and China and the theory of each disease. King Sejong also supported a national project for compiling medical texts of Korea and China, and in 1445, Classified Collection of Medical Formulas (《醫方類聚》, Uibangryuchui) was compiled. It is the compilation of the various formulas in accordance with the disease conditions, and in which almost all the medical textbooks available in East Asia were collected and reorganized. The knowledge gained through the publication contributed significantly to the birth of the symbol of Korean Medicine, the Treasured Mirror of Eastern Medicine (《東醫寶鑑》, Donguibogam), published in 1613. It is a medical masterpiece compiled by Heo Jun

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(許浚, 1539–1615), that offers a faithful and systematic arrangement of contemporary medical achievements in an easy-to-use format.[6] The Donguibogam is the most widely known textbook of traditional medicine to come out of Korea. The book was renowned in both China and Japan, and saw publication 20 times in other countries. After the publication of the Donguibogam, Korean Medicine was restructured around the book’s contents. Since 1613, Korean Medicine has concentrated on internalizing the contents of the Donguibogam and, more importantly, focusing itself on the circumstances distinct to Korea rather than looking to China for its direction. This book is still widely utilized by Korean Medicine doctors in their clinical practices. In the field of acupuncture, acupuncture medicine books imported from China were widely used. As the use of acupuncture was expanded, indigenous acupuncture skills were also developed, and the first representative example is Heo Im’s work, Experiential Prescriptions Acupuncture (《鍼灸經驗方》). Heo Im was a famous doctor in the mid-Joseon period and served as a royal doctor and as a local administrator. Based on his many clinical experiences, Heo Im had developed a “tonifying-sedating method” of acupuncture based on his many clinical experiences. “Tonifying-sedating method” is a method of enhancing the therapeutic effect by tonifying or sedating Qi energy when stimulating acupuncture. In addition, he created many effective prescriptions of acupuncture points for various diseases, which are still used in clinical practice by Korean Medicine doctors in modern times. The second case is Lee Hyung-ik’s “burnt acupuncture (燔鍼術).” “Burnt acupuncture” is also called “quenching acupuncture” or “fire acupuncture,” which is a method of quickly inserting and removing a needle after heating it. It was criticized as a witchcraft by other doctors, but under the auspices of King Injo, who trusted the treatment effect, Lee Hyung-ik worked as a royal doctor. The third case was “Sa-am acupuncture (舍岩鍼),” which was created by Master Sa-am who was known as a monk and Taoist. Sa-am acupuncture is based on the five phases’ engendering and restraining theory and the methods of tonifying and sedating. This technique was introduced to Japan about the time of Japanese invasion of Korea in late 16th century,

History, Present and Prospect of Korean Medicine  455

and was popularized as five elements acupuncture with some modifications, including the use of gold needles for the tonification method and silver needles for the sedation method. Details will be described in the next chapter. During the Joseon Dynasty, Confucianism was the ruling ideology, but in the medical field, Taoism-based curing methods and prescriptions for longevity were popular. Many aristocrats in Joseon studied medicine as well as Confucianism and considered prescribing medicines as a culture. They were called “Confucian doctors,” and their basis of philosophy and standard of life were the principles of Confucianism, while they used Taoist regimen for the health of themselves and their families. Forensic medicine was used at that time. In 1438, the A Record of No Chagrin-New Annotation (《新註無冤錄》), affixed with commentary on Chinese forensic science books, was published to provide guidelines for corpse examination, and the optometrist was used in criminal trials. The field of veterinary medicine developed from the Goryeo Dynasty was further developed during the Joseon Dynasty. The government assigned doctors in “Saboksi (司僕寺),” a government office in charge of raising livestock owned by government to educate breeders on horse medicine, and published a veterinary book titled Collections of Prescriptions for Cattle and Horse-New Edition (《新編集成牛馬醫方》). One of the peculiarities of the medical system in the Joseon Dynasty was the “Ui-Nyeo (medical lady)” system. While working at a government medical institution after learning pulse detection diagnosis, acupuncture, and herbal remedies, Ui-Nyeo mainly treated women in the royal palace. Local administrative agencies selected women and sent them to central medical institution for medical education, and then returned to local government offices to engage in medical work.[5]

7.1.4  Late Joseon dynasty to Japanese colonial period In the later period of Joseon Dynasty, a significant medical theory is introduced, the Sasang Constitutional Medicine proposed by Dr. Lee Jema (李 濟馬, 1837–1899). It states that people are categorized into four types and each type is different in physiology and pathology, and that treatment should also be different. According to Sasang constitutional medicine,

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there are suitable medicinal herbs and food for each type, and when unsuitable herb of food is taken, the person will suffer from adverse effects. Sasang constitutional medicine is widely utilized in clinics up to date, and differentiation of Sasang type and respective advices for everyday life is still attractive to the public. Western Medicine introduced in the late 19th century by American missionary was only utilized for the royal family. In April 1885, a modern Western hospital was established in Korea for the first time. The role of Western Medicine in medical administration increased, and in the private sector, missionaries established modernized hospitals all over the country. In 1899, a modern public medical school based on Western Medicine was established. Even though Western Medicine had spread, the roles of doctors defined in the Rules of Physicians enacted in 1900 was that of traditional doctors. Inspired by the establishment of a Western Medicine school, Korean Medicine doctors asked Emperor Gojong to establish an educational institution for Korean Medicine. In 1905, Emperor Gojong sponsored, at his own expense, the foundation of “Dongje Medical School (同濟醫學校),” the first modern educational organization for Korean Medicine. However, it was closed in three years, and the education of Korean Medicine was charged by small private institutions. After 1910, when Japanese imperialism colonized the Korean peninsula, Korean medical system was reformed into Western medicine-oriented system, and Korean Medicine lost the status of mainstream medicine. Korean Medicine doctors from public hospitals and armed forces hospitals were driven out. By the new Rules of Physician enacted in 1914, Korean Medicine doctors were degraded to medical apprentices (醫生).[7] In addition, the Governor-General of Japan issued a medical license with very low standards to compensate for the insufficient medical personnel in colonial management policy. Even those without formal education, who had been in the herbal medicine business for a certain period of time, could obtain qualifications. So about 5,800 medical apprentices were licensed in 1914, and the number of medical apprentices decreased naturally without additional discharge during the Japanese colonial period. Japan abolished traditional medicine doctor system in its own country in the mid-19th century, allowing western doctors to use herbal medicines and acupuncture to be used by newly established

History, Present and Prospect of Korean Medicine  457

acupuncturists. The Japanese governor-general implemented acupuncturist system the same way as in Joseon to separate the use of herbal medicine and acupuncture.

7.1.5  1945 to present Liberation from colony in 1945 gave Korean Medicine a chance of revival. The Joseon Doctors Association, an organization of Korean Medicine doctors, was formed to respond to changes in the new era. The private Eastern Medicine Institute, which maintained Korean Medicine education during the Japanese colonial period, was reorganized into a 4-year “Dongyang (Eastern) College” in 1946. During the Korean War, in September 1951, a new National Medical Act was enacted, which legalized the licensing of Korean Medicine doctors who were equivalent to medical doctors, formal Korean Medicine education in university, and opening of Korean Medicine clinics by Korean Medicine doctors. There was a fierce controversy among law makers about the revival of Korean Medicine system at that time. While some argued that Korean Medicine was an old-fashioned medicine and did not need to be legally revived, others argued that Korean Medicine had been used by the people for a long time and should be revived and developed. Finally, Korean Medicine was legally restored and after that, the Republic of Korea has been maintaining a dual healthcare system where western medical doctors and Korean Medicine doctors coexist. With the enactment of National Medical Act which re-established Korean Medicine doctors, production of new acupuncturists was stopped. In 1952, the Association of Korean Medicine was founded as a new organization of Korean Medicine doctors, and began to promote the rights of Korean Medicine doctors, publicize externally, and establish internal professional ethics. In education, the existing “Dongyang College” became “Seoul Korean Medicine College” in 1953 and expanded to “Dongyang Medical and Pharmaceutical College” in 1955. “Dongyang Medical and Pharmaceutical College” was promoted to a 6-year college in 1964, but was merged into “Kyung Hee University” the following year. Since the 1970s, an additional 6-year colleges has been established, and 11 colleges and one school of Korean Medicine (4 years or over undergraduate

458  History, Present and Prospect of World Traditional Medicine

+ 4 years medical education system) are currently in charge of teaching Korean Medicine. With the implementation of Korean Medicine education at regular universities, Korean Medicine began to systematize and standardize as an academic discipline, and the study of Korean Medicine using modern scientific methodologies began to increase. As the number of Korean Medicine doctors increased, they could become one of the major healthcare professionals.[8] In the 1970s, the rapid growth of the Republic of Korean economy also improved the income level of the people. As the standard of living improved, people became more interested in healthcare and the use of oriental medicine increased as herbal medicine for health promotion became popular. However, when public medical insurance was introduced to the Western Medicine sector in 1977, patients began to flock to Western hospitals and clinics, which came as a crisis for Korean Medicine doctors. The Association of Korean Medicine requested the government to include Korean Medicine services in medical insurance and the government implemented a pilot project for Korean Medicine insurance from 1984 to 1986. Based on the successful results of the two-year pilot project, from 1987, the fees of acupuncture, moxibustion, cupping, and herbal medicines were reimbursed in public health insurance, and the number of patients going to Korean Medicine institutions increased significantly.[9] In 1980s, although the number of Korean Medicine doctors and the utilization of Korean Medicine services increased, Korean Medicine doctors had a perception that the existence of Korean Medicine was at stake. The reasons were that the Western medical community, whose political power is stronger than that of Korean Medicine doctors, has continuously tried to abolish Korean Medicine and promoted to unify the medical system. While the acupuncturists, whose production had ceased, tried to revive the acupuncturist system by mass-producing private qualified persons, and the number of pharmacists who provided herbal medicines increased, Korean Medicine doctors felt that their professional monopoly was threatened. The fiercest conflict over the professional monopoly on Korean Medicine was the so-called “herbal medicine dispute” in 1993 and 1996. In the Enforcement Rules of the Pharmaceutical Affairs Act in the Republic of Korea (the Minister’s Decree), there was an article that said,

History, Present and Prospect of Korean Medicine  459

“In addition to the traditional medicine cabinet, the medicine should be kept clean,” which was deleted by the Minister of Health and Social Affairs in 1993, judging it invalidated. Korean Medicine doctors argued that the article was kind of basis that the (western pharmacy-based) pharmacist were not able to handle the herbal medicines, so it should be restored again. On the other hand, pharmacists argued that availability of the traditional medicine cabinet was irrelevant to use of the herbal medicines and that herbal medicines could be handled by the pharmacist because it was also medicines. The issue of restoring the sentence of Rules expanded to a controversy over the authority to prescribe and dispense herbal medicines between Korean Medicine doctors and pharmacists. Korean Medicine doctors and pharmacists closed their clinics and pharmacies in protest, respectively, and Korean Medicine students and pharmacy students also took collective actions by refusing to attend classes and take tests. The conflict, which lasted nearly a year without the government even being able to resolve it, ended after an NGO called the Citizens’ Coalition for Economic Justice (CCEJ), stepped in to mediate with the main three points of final agreement. “First, prescribing and dispensing herbal medicines shall be separated in the Korean Medicine area. Second, new Herbal pharmacist shall be established to be in charge of herbal medicines’ production, distribution, and preparation. Third, existing pharmacists who want to provide herbal medicines shall pass an additional license examination for herbal medicines.” Based on this agreement, the department of herbal pharmacy was newly established to train herbal pharmacists, and 25,000 pharmacists received a license for herbal medicine preparation. Separation of prescribing and dispensing of herbal medicines was postponed on the premise that it would be implemented when conditions were formed. Instead, Pharmaceutical Act was revised to implement separation of prescribing and dispensing of western drugs, which had been delayed for a long time.[10,11] On the conflict of herbal medicines, Korean Medicine doctors believed the cause of the dispute was the government’s neglect of Korean Medicine and strongly demanded the government to promote Korean Medicine. The herbal dispute raised the status of Korean Medicine to the public’s interest, and aside from the solution of dispute, several promotion policies for Korean Medicine were introduced.

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First, Department of Korean Medicine was established in 1993 and was expanded to the Bureau of Korean Medicine in 1996 within the Ministry of Health and Welfare, national research institute for Korean Medicine was built in 1994, and programs for supporting research and development (R&D) on Korean Medicine were introduced in 1997. After 2000, Korean Medicine doctors could also take part in the army as medical officers and public health centers as public health doctors, and specialist system for Korean Medicine doctors was introduced for the first time in the world. In 2004, Act on Korean Medicine and Pharmaceutics Promotion was enacted, which is the legal basis for systemic development of Korean Medicine. According to this law, the Ministry of Health and Welfare establishes new plans for Korean Medicine every five years.[12] Since the 1980s, through the expansion of the institutional infrastructure, Korean Medicine has become one of the major areas in the Korean healthcare system and has played a role in the health of the Korean people.

7.2  Components of Korean Medicine Korean Medicine is a collection of medical techniques and theories that have been used and developed over a long period of time on the Korean Peninsula. Traditionally, acupuncture, moxibustion, cupping, and herbal medicines have been used, and pharmacopuncture (herbal acupuncture) and Chuna Manual therapy, which have been improved to modernized forms based on traditional techniques, are also widely used. Sasang constitutional medicine theoretically represents the uniqueness of Korean Medicine. A brief introduction to the features of each tool and theory of Sasang constitutional medicine is as follows.[13]

7.2.1  Acupuncture therapy Acupuncture treatment is a preventive, alleviative, or therapeutic act against disease in which a needle is inserted into one of many specific points on the exterior of the body known as an acupoint. Practiced in East Asian regions for 2,500 years, acupuncture is a remedial method representative of Korean Medicine. Acupuncture treatment is known to have

History, Present and Prospect of Korean Medicine  461

originated from early human experiences in which disease was ameliorated after instinctively stimulating particular regions of the skin with sharp stones or other simple implements. After centuries of practical experience and the development of the East Asian system of thought, Korea has developed unique acupuncture theories and techniques. The representative acupuncture methods developed in Korea are Sa-am acupuncture and Constitutional Acupuncture (Taeguk acupuncture).

7.2.1.1  Sa-am acupuncture therapy Sa-am acupuncture therapy (舍岩鍼法) is an original acupuncture technique that is widely used in Korean clinical practice. Founded by the ascetic Sa-am (舍岩道人), a monk who lived four centuries ago, Sa-am acupuncture has a theoretical background in the Five Elements Theory and the supplementation-draining method of acupuncture. The five transport points (well point, brook point, stream point, river point, and sea point) in the 12 meridians at the end of limbs such as hands and feet are arranged into five phases (五行配屬) in the order of wood (木), fire (火), earth (土), metal (金), and water (水) for yin meridians (陰經) and in the order of metal, water, wood, fire, and earth for yang meridians (陽經). Combinations of these 60 acupoints result in a maximum efficacy with minimum needling (Table 7–1). After pattern identification (辨證) of the state of the patient by the viscera-bowels, the meridians and five elements (臟腑經絡五行) and deficiency-excess and cold-heat (虛實寒熱), the acupoints are selected under the principle of “supplement the mother if deficient (虛卽補其母) and drain the child if excessive (實卽瀉其子)” for self-meridian supplementation-draining (自經補瀉) and other meridian supplementationdraining (他經補瀉). The mother-child (母子) is determined by engendering and restraining (相生相克) the five elements. The deficiency-excess supplementation-draining method (虛實補瀉 法) is as follows. In the deficiency syndrome of yin-wood (陰木), water, which is the mother of wood, should be reinforced, and metal, which restrains wood, should be reduced. Thus, the Gokcheon (LR08) of the liver meridian, the water point of the relevant meridian, and the Eumgok (KD10) of the

462  History, Present and Prospect of World Traditional Medicine Table 7–1    The five transport points in the 12 meridians. Yin Meridian (陰經) Well (Wood)

Brook (Fire)

Stream (Earth)

River (Metal)

Sea (Water)

Lung Meridian

Sosang (LU11)

Eoje (LU10)

Taeyeon Gyeonggeo Cheoktaek (LU09) (LU08) (LU05)

Spleen Meridian

Eunbaek (SP01)

Daedo (SP02)

Taebaek (SP03)

Heart Meridian

Sochung (HT09)

Sobu (HT08)

Sinmun Yeongdo (HT07) (HT04)

Sohae (HT03)

Kidney Meridian

Yongcheon (KI01)

Yeongok (KI02)

Taegye (KI03)

Buryu (KI07)

Eumgok (KI10)

Pericardium Meridian

Jungchung (PC09)

Nogung (PC08)

Daereimg (PC07)

Gansa (PC05)

Goktaek (PC03)

Liver Meridian

Daedon (LR01)

Haeggan (LR02)

Taechung (LR03)

Jungbong (LR04)

Gokcheon (LR08)

Yang Meridian Well (metal) (陽經)

Brook (water)

Stream (wood)

River (fire)

Sea (earth)

Large Intestine Sangyang Meridian (LI01)

Igan (LI02) Samgan (LI03)

Yanggye (LI05)

Gokji (LI11)

Stomach Meridian

Yeotae (ST45)

Naejeong (ST44)

Hamgok (ST43)

Haegye (ST41)

Joksamni (ST36)

Small Intestine Meridian

Sotaek (SI01)

Jeongok (SI02)

Hugye (SI03)

Yanggok (SI05)

Sohae (SI08)

Bladder Meridian

Jieum (BL67)

Joktonggok Sokgol (BL66) (BL65)

Gollyun (BL60)

Wijung (BL40)

Triple Energizers Meridian

Gwangchung Aengmun (TE01) (TE02)

Jungjeo (TE03)

Jigu (TE06)

Cheonjeong (TE10)

Gallbladder Meridian

Jokgyueum (GB44)

Jogimeup Yangbo (GB41) (GB38)

Hyeopgye (GB43)

Sanggu (SP05)

Eumneungcheon (SP09)

Yangneungcheon (GB34)

kidney meridian, the water point of the water meridian, should be supplemented. The Jungbong (LR04) in the liver meridian, the metal point of the pertinent channel, and the Gyeonggeo (LU08) in the lung meridian, the metal point of the metal meridian, should be drained. In the excess

History, Present and Prospect of Korean Medicine  463

syndrome of yin wood, fire, which is the child of wood, should be drained, and the metal point of the metal meridian that restrains wood should be supplemented. This indicates that the Haenggan (LR02) in the liver meridian, the fire point of the pertinent meridian, and the Sobu (HT08) in the heart meridian, the fire point of the fire meridian, are drained. The Jungbong (LR04) in the liver meridian, which is the metal point of the self-meridian, and the Gyeonggeo (LU08) in the lung meridian, which is the metal point of the metal meridian, are supplemented. In the cold-heat supplementation-draining method, fire is reinforced and water is reduced in the cold pattern. In addition, water is reinforced and fire is reduced in the heat pattern. For example, in the lung cold pattern, the Eoje (LU10) in the lung meridian and the Sobu (HT08) in the heart meridian are supplemented, and the Gyeonggeo (LU08) in the lung meridian and the Eumgok (KD10) in the kidney meridian are drained.

7.2.1.2  Constitutional acupuncture therapy Constitution (體質) is first mentioned in Huangdi’s Internal Classic (《黃帝內經》), while Lee Jema developed the concept into Sasang constitutional medicine, which is a system original to Koreab. There is a distinctive physiology and pathology for each constitution, and people are categorized as a Taeyang-in (太陽人, greater yang person), a Taeum-in (太陰人, greater yin person), a Soyang-in (少陽人, lesser yang person), or a Soeum-in (少陰人, lesser yin person). Constitutional acupuncture is an acupuncture therapy that complies with the theory of the visceral five elements created by Lee Byeonghaeng based on Lee Jema’s Sasang constitutional medicine. This form of acupuncture is also called Taegeuk acupuncture (太極鍼法), with Taegeuk referring to the heart. Among the five viscera, the heart is excluded from the four constitutions and governs the other viscera and bowels. The heart is the basis for the differentiation of constitution. Constitution is differentiated by acupoints of the heart meridian based on the differences in excessive qi in each constitution. For example, a b

 For more information on Sasang constitutional medicine, please refer to 7.2.7 “Sasang Constitutional Medicine.”

464  History, Present and Prospect of World Traditional Medicine Table 7–2    The diagnosis of constitution by Taegeuk acupuncture. Organ Functionality

Excessive

Constitution Diagnosis

Basis for Constitution Diagnosis

Taeyang-in

Greater Lung Lesser Liver

Metal

Supplement Sobu (HT08)

Fire Restrains Metal

Taeum-in

Greater Liver Lesser Lung

Wood

Supplement Yeongdo (HT04)

Metal Restrains Wood

Soyan-gin

Greater Spleen Lesser Kidney

Fire

Supplement Sohae (HT03)

Water Restrains Fire

Soeum-in

Greater Kidney Lesser Spleen

Water

Supplement Sinmun (HT07)

Earth Restrains Water

Taeyang-in exhibits greater lung and less liver, and it has an excessive metal qi. Following the principle that fire restrains metal, which supplements Sobu (HT08), the fire point of the heart meridian controls the excessive metal qi, and this instantaneous effect aids in identifying the patient as Taeyang-in. After the diagnosis of constitution, constitution-appropriate acupoints from the source points of the 12 meridians are selected for treatment. For example, if the patient is diagnosed as a Taeyang-in, to reinforce the recessive qi and reduce the dominant qi, Taechung (LR03), the source point of the liver meridian, is supplemented, and Taeyeon (LU09), the source point of the lung meridian, is drained (Table 7–2).

7.2.2  Moxibustion Moxibustion therapy is a preventive, remedial, and curative technique that is based on acupuncture theory and uses moxa, which are various medicinal items or instruments that target specific areas on the body surface to exert burning, scorching, fuming, ironing, and stimulation. Using fire, the experience of disease alleviation after receiving a thermos-stimulus, such as the warming or searing of particular body parts, seems to aid in the establishment of moxibustion therapy. Moxibustion shares its roots with acupuncture. However, while the acupoint is physically stimulated by needle insertion in acupuncture

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therapy, thermal stimuli is applied at acupoints in moxibustion therapy. According to the Introduction to Medicine, moxibustion will boost the source qi through the addition of fire qi in a deficiency syndrome, disperse excessive pathogens along with the excessive fire qi, recover warmth in centralized heat syndromes, and centralize and disperse the amassed heat in heat syndrome. Ancient moxibustion typically involves direct moxibustion [myeongddeum in Korean (明灸)], in which the moxa cone is directly burnt over the acupoint on the skin. In later generations, indirect moxibustion was developed utilizing medicinals or instruments between the acupoint of the skin and moxa cone. We shall examine procedures, indications, and adverse effects regarding direct and indirect moxibustion.

7.2.3  Cupping Cupping therapy uses negative pressure from suction by a vacuumized cup or jar on the skin surface to various internal elements. The origin of the therapy is unclear, but use of the term Gak (角) in the literature has been conjectured to be the equivalent of cupping. The fundamental principle of the therapeutic effect in cupping is to relax the sinews and activate collaterals (舒筋活絡). Cupping removes stagnated bodily wastes from the skin to expedite systemic or local circulation, diffuse and communicate qi-blood by congestion from negative areas, and is useful for various paralytic syndromes and muscular diseases. In addition to applying suction, pus drainage and bloodletting are performed to cleanse the bodily fluid around the lesion to achieve an antiinflammatory analgesic effect and thus become beneficial to arthropathy. In addition, internal injuries, stomach disorders, hypertension, and cough can be treated by cupping through the regulation of qi-blood circulation. Cupping therapy is classified as flash cupping (閃罐法), retained cupping (留罐法), and bloodletting (刺絡法, wet cupping) according to the method employed. The cup material varies from an artificial synthetic cup to a glass cup, bamboo cup, conduit jar, or copper cup.

7.2.4  Herbal medicine therapy Herbal medicine (韓藥) is defined as that is processed and prepared from a raw herbs under the principles of Korean Medicine. Herbal medicine is

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a therapy that is prescribed under the principle of the sovereign, minister, Assistant, and courier (君臣佐使), and it is based on Qi and Flavor Theory (氣味論) as well as meridian tropism (歸經) of the raw herbal drugs. Herbal medicine therapy is a medical practice performed by Korean Medicine doctors and officially sanctioned by the Republic of Korean medical system, and its indications are not limited to predetermination. Herbal medicine prescriptions are highly diverse and it is impossible to mention all of them. Korean Medicine doctors frequently use four categories of clinical prescriptions that are handed down from classic textbooks. That includes “antiquity prescriptions” founded by Zhang Zhongjing’s Treatise on Cold Damage Diseases (《傷寒論》) and Synopsis of Prescriptions of the Golden Chamber (《金匱要略》) from ancient China, “warm disease prescriptions” that have been developed since the Qing Dynasty, “Posterity prescriptions” based on the Treasured Mirror of Eastern Medicine (《東醫寶鑑》) and Compilation of Formulas and Medicinals (《方藥合編》) from mid-Joseon Dynasty, and “constitutional prescriptions” based on Sasang constitutional medicine from lateJoseon Dynasty.

7.2.5  Herbal acupuncture therapy (pharmacopuncture) Herbal acupuncture therapy, or pharmacopuncture, is a combination of acupuncture and herbal medicine. The pharmacopuncture is a therapeutic technology that treats diseases by injecting a drug that has been refined and extracted from herbal medicine into an acupoint, the response point on the body surface after pattern identification of the patient’s constitution and disease. Pharmacopuncture applies physical stimulation through the meridian and an acupoint associated with the pathogenic organ or region, and it also applies chemical stimulation via the selection of an herbal drug according to the Qi and Taste theory of herbal medicine therapy. In contrast to conventional injection therapy during which the doctor injects 1 mL to tens of milliliters allopathically or according to the test results, in pharmacopuncture therapy, 0.1 mL to a few milliliters of herbal extraction are injected into an acupoint or relevant region based

History, Present and Prospect of Korean Medicine  467

on the pattern of identification. Currently, various therapies such as bee venom acupuncture, Hominis Placenta acupuncture, Cervi Cornu Parvum acupuncture, Ginseng acupuncture, and distilled herbal drugs are used in practice.

7.2.6  Chuna manual therapy Chuna is a therapeutic modality that addresses biomechanical function, pathology, diagnostics, and theories related to treatment in order to create a balance in orthopedic structure and function. Chuna techniques include stimulation of the meridian system, correcting displacement of the osteoarticular structure, and prescribing exercises based on patientreported symptoms and the results of a functional anatomical assessment.[14] Chuna treatment encompasses a wide range of ideas and concepts spanning biomechanics and sports biomechanics to functional anatomy. Neuromusculoskeletal structures, the craniosacral system, and viscera are all subjects of Chuna manual treatment. Representative techniques of Chuna are thrust, mobilization, distraction of the spine and joints, soft tissue release, visceral manipulation, craniosacral therapy, and the diaplasis technique. These techniques were developed by combining aspects of Chinese Tuina, Japanese Shiatsu, and chiropractic and osteopathic medicine from the United States. Most Korean Medicine doctors use Chuna to treat imbalances of the human body, relieve various types of pain, and increase relaxation in patients by manipulating specific body parts (e.g., acupoints on the skin, myofascial trigger points, the spine and joints).[14] In 1994, modernized Chuna was officially recognized by the Ministry of Health and Society by the authoritative interpretation. Since 1995, Chuna has been accepted as an official part of the curriculum in Korean Medicine education. Eleven Korean Medicine colleges and one national school of Korean Medicine offers Chuna education. In 2005, Chuna was approved for coverage by automobile insurance, and in 2019, Chuna began to be reimbursed in the National Health Insurance after 2-year pilot coverage project.[15]

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7.2.7  Sasang Constitutional Medicine Sasang Constitutional Medicine (SCM) is a medical tradition that studies the physiological and pathological traits of the four constitutional types, namely the Taeyang (TY), Soyang (SY), Taeeum (TE), and Soeum (SE). The concept that constitution can be “typed” is the most basic underlying paradigm evident in the Dongui Suse Bowon 《東醫壽世保元》, ( Longevity & Life Preservation In Eastern Medicine) written by Lee Jema in 19C Korea.[16] In SCM, the three most important factors in differentiating constitutions are external appearance, mental characteristics, and patterns of pathology. External appearance is viewed in terms of the shape of the body and its countenance. Since each constitution has its own particular body shape, in many cases a constitution can be determined simply by looking at the shape of the body. Identifying constitutions by examining mental characteristics includes observing a person’s temperament, talents, natural mental state, personality, and personal tastes. Each constitution has its own particular characteristics. Therefore, observing mental characteristics plays a great role in constitutional differentiation. Just as normal, healthy physiological conditions vary across each constitution, so do disease signs and symptoms. These patterns of pathology can therefore be used to identify a particular constitution. The disease symptoms are first divided into mild and severe, but this division is not sufficient. Each constitution has a typical pattern of pathology, but some constitutions show symptoms only when a disease is severe.[17] Departing from the visceral theory in TCM where viscera are assigned in pairs, Zang and Fu, SCM assumes a theory of visceral groups: the lung, kidney, liver, and spleen groups. The lung group includes lungs, tongue, esophagus region, ears, brain, and skin. The spleen group consists of spleen, stomach, breasts, eyes, and tendon. The constituents of the liver group are the liver, small intestine, nose, lumbar region, and muscles. The kidney group has the kidney, large intestine, urethra, bladder, mouth, and bones. Among these groups, it is believed that specific inter-regulatory relations are present between specific pairs of visceral groups. As such, visceral groups are classified into two pairs: one consists of the spleen and

History, Present and Prospect of Korean Medicine  469

the kidney group and the other is composed of the lung and the liver group. Each constitution has its own strong and weak viscera. If the function of the lungs is stronger than the other three organs and the function of the liver is weaker than the spleen and kidneys, it’s called TY. If the function of the spleen is strong and the function of the kidneys is weaker than the lungs and the liver, it’s called SY. If the function of the liver is strong and the function of the lungs is weaker than the spleen and the kidneys, it’s called TE. If the function of the kidneys is strong and the function of the spleen is weaker than the function of the lungs and liver, it’s called SE. TY has well developed upper part of the body including the chest, neck, face, and the head, and has a relatively the broad forehead and a muscleless face with high cheekbone. This type excels more than others in thinking power and his quick judgement. SY has developed chest which belongs to the region of the spleen, has upper-strength and lower-weakness. This type likes to do outer work; on the contrary, he neglects his own domestic life. TE has developed lower back and the waist which belong to the region of the liver, but the head and the nape which belong to the region of the lungs are less developed. This type seems gentle in appearance, wicked and treacherous in mind, and never says what is on his mind. SE has a weak function of the spleen and a strong function of the kidneys, so the upper and the lower parts of the body are well balanced. SE looks generous, tender and weak in appearance but has a persevering mind, strong will power, strong sense of responsibility and a systematic and business-like manner[16] (Table 7–3). The principle of SCM treatment is based on the reinforcement of the hypoactive visceral groups. Thus, medicinal herbs of SCM are divided into four groups that correspond to the four constitutions. Under this rule, medicinal herbs and herbal remedies belonging to a certain constitution cannot be used for others; otherwise, this can result in no effect or an adverse effect. For example, in comparison with the classification of TCM, medicinal herbs for the SE type belong to the categories of Qi-tonifying medicine, blood-tonifying medicine, and interior warming medicine. Almost all SE herbs have warm properties and digestive stimulation effects, therefore, they are helpful in strengthening the process of

470  History, Present and Prospect of World Traditional Medicine Table 7–3    Characteristics of four Sasang constitutions.

Constitutions Items

太陰人 Taeum-in (Macro-yin type)

太陽人 Taeyang-in (Macro-yang type)

少陰人 Soeum-in (Micro-yin type)

少陽人 Soyang-in (Micro-yang type)

Type of Illness

Cardiorespiratory Hepatic

Digestive

Renal

Function of Internal Organs

liver system: strong lung system: weak

liver system: weak lung system: strong

kidney system: strong spleen system: weak

kidney system: weak spleen system: strong

Properties of smell the Sensorial Nerves

hearing

taste

sight visual

Character

imposing

neat

wise

gay

Behavior

dynamic

heroic

pensive

rash

Careers lawyer, Appropriate businessman, to brave Character

ingenious patriot, tradesman, inventor, educator, practical man, strategist monk or nun, soldier revolutionary scientist

Frequent Illnesses

hypertension, ocular troubles, gastric illnesses, malfunction of the hepatic digestive chronic kidney, chronic illnesses, troubles, acid abdominal lower back pain cough, chronic eructations pains constipation (belches)

Proper Food

beef, large radishes, peas

Proper Medicines

deer antler, acanthopanax, ephedrae fruits or herba, rhubarb berries

buckwheat, chicken, grapes, clams cabbage, honey

pork, oysters, cucumber, green peas, melon

ginseng, monk’s rehmania, hood plant glutinosa, hood, kibosch, lycium cinnamon Chinese (Mill)

Note: Offered by the Korean Society of Constitutional Medicine.

raw material intake and providing more material to produce Qi. Almost all the medicinal herbs for the SY type belong to categories of medicine for clearing heat, enriching Yin, and inducing dieresis.

History, Present and Prospect of Korean Medicine  471

In contrast to SE herbs, SY herbs, which have cooling or cold properties, are able to strengthen the shortcoming of the SY type, the waste discharge process. SE herbs should not be applied for SY type individuals and vice versa; otherwise, it may cause remarkable adverse effects. Radix panax ginseng is commonly known as a high-level herb for tonifying Qi but this herb can cause headache, rashes, and allergic reactions in SY individuals. Radix Rehmanniae Glutinosae is an effective herb for SY type but it may cause serious indigestion for SE type individuals. Medicinal herbs of the TE type are present in various categories in the herbal medicine classification of TCM, but these are generally characterized by strong dispersing effect and eliminating dampness effect. Dispersing medicine is used to promote perspiration and eliminating dampness medicine is used to resolve dampness, a pathogenic factor characterized by its impediment to the Qi movement and its turbidity, heaviness, stickiness, and downward flowing properties.[16] Eating foods that are appropriate for the constitution will suppress the strength of organs that have excessive energy and will strengthen organs that are deficient. This will result in harmonious balance. Yang types will be moved toward Yin tendencies and Yin types will be moved toward Yang tendencies so that both types can achieve balance. This does not mean that you cannot have foods that are not appropriate for your constitution. It only means that you should eat more foods that are appropriate for your constitution. Your diet should also be regulated if you habitually eat too many foods that are inappropriate to your constitution. SCM does not deal with specific diseases per se, instead it discusses the proper method for regulating and balancing one’s constitution.[17]

7.3 Legal status and administration of Korean Medicine 7.3.1  Overview of the healthcare system in Korea Figure 7–1 depicts the resource flows among government, consumers, corporations, and service providers, covered by National Health Insurance, Private Health Insurance, and Public Health Program (public health centers). A conspicuous feature of the Republic of Korea’s healthcare delivery

472  History, Present and Prospect of World Traditional Medicine

Figure 7–1  Healthcare system of Korea.

is that patients are given a choice of providers (hospitals, clinics, Korean Medicine doctors, public health centers, and even emergency wards) and localities (anywhere within the Republic of Korea) when sick. Providers, who are mostly private, are paid by fee-for-service (FFS) in return for providing services that are covered by insurance. For a limited number of inpatient services (seven inpatient services, including normal delivery), hospitals are paid by K-DRG (Korea-DRG). Total

History, Present and Prospect of Korean Medicine  473

expense is reimbursed in part by the National Health Insurance Service (NHIS) for insurance-covered services and the rest by patients’ out-ofpocket (OOP) payments for copayment and non-insured services[18] (Figure 7–1). National health insurance finances the Republic of Korea’s health system. The NHI covers about 97% of the population and the remaining 3% is covered by the Medical Aid Program, a tax-funded program to ensure access to healthcare for low-income citizens. In contrast to the public sector-dominant financing, healthcare delivery relies heavily on the private sector. As of 2018, almost all clinics and about 94% of hospitals were privately owned.[19] Public health facilities provide medically necessary services not only for the general public but also targeting populations at the central, regional, and municipal levels. They include national hospitals, special corporatized public hospitals, regional medical centers, public health centers, health center branches, and primary healthcare posts. Some national hospitals are accountable to the Ministry of Health and Welfare while others are accountable to other ministries. The former includes special hospitals such as the National Rehabilitation Center, five psychiatric hospitals, two hospitals for tuberculosis, and one for leprosy. The latter include hospitals targeting specific groups, for example, the National Police Hospital and several hospitals for armed forces. Special 15 corporatized public hospitals, established based on special laws for the public interest, include the National Medical Center, the National Cancer Center, and National University Hospitals.[19] As of 2019, there were 34 regional medical centers directly under regional governments and 256 public health centers accountable to municipalities. Public health sub-centers and primary healthcare posts, numbering 1,340 and 1,904 respectively as of 2019, provide basic health services in the areas where public health centers do not exist or are not easily accessible. There are also hospitals owned by regional governments that provide health services for specific populations such as children, the elderly, and the mentally ill.[1] The role and function of health providers is not well differentiated, particularly between clinics and hospitals. Some clinics have inpatient beds while all general hospitals provide outpatient services. There is no

474  History, Present and Prospect of World Traditional Medicine

gatekeeper in the healthcare system. Citizens are not required to register with any healthcare provider even though there are many local clinics. Thus, patients have the freedom to choose healthcare provider at any level according to their preference as long as they can afford to pay higher out-of-pocket (OOP) payments in general hospitals and tertiary hospitals. Korean Medicine has the same legal and institutional recognition as Western Medicine. With an established legal and qualification system, KM has maintained an independent and competitive position alongside Western Medicine.[19]

7.3.2  Legal status and administrational body for Korean Medicine The primary laws related to Korean Medicine are the Medical Service Act, Pharmaceutical Affairs Act, and Act on the Promotion of Korean Medicine and Pharmaceuticals. Through the Medical Service Act and its subsidiaries, the definition and category of Korean Medicine services, standards for the licensing of Korean Medicine doctors, establishment of Korean Medicine institutions, and the qualifications for Korean Medicine specialists are regulated. The definition and category of herbal medicine, standards concerning its production, distribution and manufacture, and the role and authority of herbal medicines related personnel, are regulated by the Pharmaceutical Affairs Act and its subsidiary acts. The following table is a comparison of the legal and administrative status of Korean Medicine with that of Western Medicine (Table 7–4). The table shows that Korean Medicine now shares an almost equal legal status with Western Medicine, having a public system of education and licensing along with government departments, participation in the military and public health sectors, reimbursement by national health insurance, and official positions for the Presidential physician. However, there is a difference in the use of medical technology and devices in that Korean Medicine doctors are prohibited from the use of Western drugs and modern medical devices. There is currently a conflict between Korean Medicine and Western Medicine communities regarding the partial use of modern medical devices by Korean Medicine doctors. Legally, the use of

History, Present and Prospect of Korean Medicine  475 Table 7–4    Comparison of the Institutional authority and role of western medicine and Korean Medicine. Western Medicine

Korean Medicine

Existence of Related Laws and Acts

O

O

Existence of Formal Education System

O

O

Existence of National School

O

O

Existence of Licensing System

O

O

Existence of Governmental Body

O

O

Existence of Governmental Funding

O

O

Military Service Participation

O

O

Public Health Service Participation

O

O

Health Insurance Coverage

O

O

Existence of Presidential Physician

O

O

Modern Medical Devices Use

O

under conflict

Western Drugs Use

O

X

Raw Herbal Drugs Use

X

O

Acupuncture Use

X

O

acupuncture is authorized only to Korean Medicine doctors and not to Western doctors. However, controversy arose as IMS (intra-muscular stimulation) was developed in North America and approved for use by Western doctors. Authority for prescription of drugs is also mutually exclusive between Korean Medicine doctors and Western doctors, and the rights to use recently developed natural drug products also created conflict between the two medical communities. The Act on the Promotion of Korean Medicine and Pharmaceuticals was implemented in 2004 to foster the development of Korean Medicine in a more systematic and stable manner. The enactment of an independent specialized law to support traditional medicine was globally unprecedented at the time. The principal framework of the Act is 1) the government ministries come together every five years to establish and enforce a

476  History, Present and Prospect of World Traditional Medicine

mid-to-long-term plan for the promotion of Korean Medicine, 2) research and development on Korean Medicine should be supported and promoted, 3) the Korean Medicine industry should be fostered, and 4) quality control of herbal medicine should be enforced. The Act on the Promotion of Korean Medicine and Pharmaceuticals was amended several times. The second revision in 2011 was especially significant because the legal definition of Korean Medicine and pharmaceutics was altered. The phrase “Korean Medicine and Pharmaceuticals” should be defined as any medical treatment service based on Korean Medicine that was “traditionally handed down from the nation’s ancestors and Korean Medicine pharmaceutical affairs,” as the law had previously stated was changed to add “scientifically applied and developed Korean Medicine services,” emphasizing not only the traditional inheritance of Korean Medicine but that the medicine is an assembly of modern knowledge and technology. In June 1993, the Division of Korean Medicine was installed temporarily under the Bureau of Medical Policy in the Ministry of Health and Social Affairs. The division was subsequently elevated to the status of the Office of the Director General for Korean Medicine, with the Division of Korean Medicine Policy and the Division of Korean Medicine Industry; and so can now facilitate both the medical affairs and the Korean Medicine industry. When the Ministry of Food and Drug Safety (originally known as the KFDA) was founded in 1998, the Division of Herbal Preparation was instituted for screening herbal medicine. The Herbal Medicine Management Team established in 2006 was later reorganized into the Division for Herbal Medicine Policy in 2009, administering policies for medicinal materials and herbal preparations. In addition, the Division of Herbal Medicine Research was established under the National Institute of Food and Drug Safety Evaluation for technical support on the safety management of herbal medicine and other products.

7.3.3  National development plans for Korean Medicine Based on the Act on the Promotion of Korean Medicine and Pharmaceu­ ticals, the government is obliged to set up a mid-to-long-term plan to foster Korean Medicine every five years. Korean government

History, Present and Prospect of Korean Medicine  477

implemented the first plan (2006–2010) in 2006, and recently established the fourth plan (2021–2025) in 2021. The fourth plan was established with the participation of many ministries, including the Ministry of Health and Welfare, Ministry of Education, Ministry of Science and Technology, and Ministry of Food and Drug Safety. The plan contains strategies and tasks to promote public health and welfare and to enhance industrial competitiveness through Korean Medicine development. In the fourth plan, four major objectives were determined: 1) promotion of local health and welfare using Korean Medicine, 2) improvement of Korean Medicine utilization system, 3) innovative growth of Korean Medicine industry, and 4) global promotion of Korean Medicine.

7.3.4  Policies on Korean Medicine services 7.3.4.1  Korean Medicine in public health sector Korean Medicine, which was expelled from the government and the public sector during the Japanese colonial era in the early 20th century, was only used in private hospitals and clinics even after the Korean Medicine system was legally revived in 1951. In order to play a certain role in the public field and to contribute to the public health, Korean Medicine doctors had demanded the government to use Korean Medicine in the public sectors. Since the introduction of Korean Medicine coverage in the National Health Insurance in 1987, the use of Korean Medicine in the public health sector has expanded. In 1989, Korean Medicine military doctor system was introduced. Korean Medicine military doctors are selected from among Korean Medicine specialists and appointed as lieutenants after a certain military education. As of 2015, out of a total of 2,480 military doctors, 73 were Korean Medicine doctors which accounted for 2.7% of the army doctors, 1.6% of the navy doctors, and 5.4% of the air force doctors.[24] In 1990, the Division of Korean Medicine was established at the National Medical Center, the highest organization among the national and public hospitals. The Division consisted of two departments — the Korean Medicine Department and the Acupuncture Department, and 35 beds were

478  History, Present and Prospect of World Traditional Medicine

allocated. From then on, Korean-Western medicine cooperation began to be provided within public hospitals. In 2019, 91 of the 224 public medical institutions nationwide had Korean Medicine departments; 1 in a tertiary general hospital, 11 general hospitals, 5 hospitals, 2 Korean Medicine hospitals, and 72 long-term care hospitals. Pusan National University Korean Medicine Hospital is the only national hospital in Korean Medicine. The following table shows the representative public hospitals that have established Korean Medicine[23] (Table 7–5). Since 1998, Korean Medicine public health doctors have been allocated at public health centers and branches in each city, county, and district across the country, providing Korean Medicine treatments and health promotion services. Public health doctor system, introduced in 1983, is a system that requires medical doctors and dentists to work at rural public health centers for about three years in substitution of mandatory military Table 7–5  National and public hospitals providing Korean medicine services. Type

Hospitals

Number

Tertiary Hospital Pusan National University Hospital

1

General Hospital National Medical Center

1

Hospital

Korean Medicine Hospital

Seoul Medical Center

1

Provincial General Hospitals

5

Veterans Hospitals

4

National Rehabilitation Center

1

Sorokdo National Hospital

1

Provincial Hospitals

3

Long-term Care Hospital

72

Pusan National University, Korean Medicine Hospital

1

Jangheung Integrative Medical Hospital

1

Source: Publication Committee for Korean Medicine Yearbook, 2019 Yearbook of Traditional Korean Medicine, Korea Institute of Oriental Medicine, 2021.

History, Present and Prospect of Korean Medicine  479 Table 7–6  Number of Public Health Centers and Doctors providing Korean Medicine (2019). Public Health Centers

Public Health Sub-centers

254

1,335

KM Doctors 59

Public Health KM KM Doctors Doctors 246

3

Public Health KM Doctors 716

Note: Public health KM doctor: KM doctors who are working at public health centers in substitution of mandatory military service. Source: Publication Committee for Korean Medicine Yearbook, 2019 Yearbook of Traditional Korean Medicine, Korea Institute of Oriental Medicine, 2021.

service. Korean Medicine doctors have been selected as public health doctors since 1998. In the beginning, only a small number of Korean Medicine doctors who were qualified as specialist were selected, but from 2002, they have been expanded to general Korean Medicine doctors. As of 2019, 254 public health centers provided Korean Medicine services and provided regular visiting healthcare services for senile patients who have difficulty in ambulation. Including public health doctors and employed doctors, 304 Korean Medicine doctors were working at public health centers and 709 at public health sub-centers[20,23] (Table 7–6). Korea is the only country in the world where a Korean Medicine doctor is appointed as the physician to the President together with a western doctor. In 2003, President Roh Moo-hyun appointed a Korean Medicine physician, who was equivalent to the vice minister level, for the first time. Although not appointed during President Lee Myung-bak, currently, President Moon Jae-in is using a Korean Medicine doctor.

7.3.4.2  Public health promotion service using Korean Medicine As mentioned above, local public health centers provide health promotion service using Korean Medicine in addition to Korean Medicine treatment service. In 2001, nine public health centers introduced Korean Medicine based health promotion programs on a trial basis, and they became regular

480  History, Present and Prospect of World Traditional Medicine

programs from 2002 when the deployment of public health Korean Medicine doctors were expanded. This program aimed to contribute to improving the health and quality of life of local residents, especially the elderly and low-income families, by providing Korean Medicine treatment and health promotion services. In order to facilitate the program operation, Association of Korean Medicine developed and distributed the standard manuals of health promotion programs, including Qigong program, Korean Medicine Stroke prevention program, Korean Medicine infant care program,Sasang Constitutional Medicine based health promotion, Smoking cessation program, etc.[23] Since 2005, the Korean Medicine health promotion program has been greatly expanded. With a large budget, each health center was supported to discover and implement a new health promotion project for Korean Medicine, and departments of Korean Medicine were established in three public hospitals in the provinces. It also supported the purchase of medical equipment and the improvement of facilities of each health center. The total supported budget was about 24.9 million USD from 2005–2012.[23] From 2013, the functions of public health centers was reorganized to focus on health promotion and disease prevention rather than medical treatment, and various sectors of health promotion projects in each public health center have been integrated. Accordingly, Korean Medicine health promotion projects have been reorganized from individual program-oriented to target-oriented and are integrated or linked to other health promotion projects. For target-oriented programs, Korean Medicine health promotion aimed to improve the health of the vulnerable population by life cycle (infants, children, youths, pregnant women, adults, and senior citizens).[25,26] In 2015, through a pilot project of Korean Medicine for pregnancy and child care in 10 public health centers, it was confirmed that the Korean Medicine health program had positive results on improving the health knowledge of pregnant women, relieving depression during pregnancy, and raising child-rearing self-efficacy. During 2016–2017, the effectiveness of Korean Medicine health promotion for elderly dementia and depression was verified through pilot projects, and health promotion projects for infants, children, adolescents, the disabled, and menopausal

History, Present and Prospect of Korean Medicine  481

adults were developed. These programs were disseminated to local public health centers.[23,26] As of 2018, 135 public health centers across the country operated 633 health promotion programs in Korean Medicine. The government will continue to develop and disseminate Korean Medicine based health promotion programs that meet the health needs of the local communities.[25]

7.3.4.3  Quality management of Korean Medicine services Clinical Specialist System for Korean Medicine The Republic of Korea uniquely has the specialist system for Korean Medicine doctors. It was first introduced in 2000 to enhance the value of Korean Medicine by developing specialized areas, and to improve the quality of Korean Medicine services. In Western Medicine, specialists are trained in 26 specialist areas, whereas there are eight specialist areas in Korean Medicine. These areas are Korean internal medicine, Korean Medicine gynecology, Korean Medicine pediatrics, Korean Medicine neuropsychiatry, Acupuncture and moxibustion, Korean Medicine Ophthalmology-Otolaryngology- dermatology, Korean Medicine rehabilitation medicine, and Sasang constitutional medicine. This certificate of specialization for certain department of Korean Medicine is given out by the minister of Ministry of Health and Welfare. As of 2019, the total number of Korean Medicine specialist was 3,160, which is about 12.2% of all registered licensed Korean Medicine doctors[20] (Table 7–6). To be a specialist, a Korean Medicine doctor has to go through one year of internship and three years of residency after earning a license of Korean Medicine doctor. After the 4-year course, there is a qualification examination which should be passed for the specialization board. The specialist system is somewhat abnormally developed in the Republic of Korea. Originally, specialists, in contrast to primary care physicians, work at the basic hospital level and manage more complex medical issues with the relevant devices, facilities, and staff. However, the roles of primary care physicians and secondary or acute-care hospitals are not clearly separated in the Republic of Korea and are in competition with one another, while many specialists work at clinic-level institutions. This

482  History, Present and Prospect of World Traditional Medicine

situation is the case because even doctors working in clinics are believed to need specialist licenses to remain competitive. When the implementation of the Korean Medicine specialist system was initially discussed, the Korean Medicine community felt that such issues in the practice of Western Medicine should not be duplicated and that the number of specialists at the hospital should only be as many as required. Hence the training of Korean Medicine specialists was limited to university hospitals, and interim measures to grant conditional license to clinically experienced practitioners over a certain period was approved only for professors at certain university hospitals. Specialized Hospital System In 2006, Ministry of Health and Welfare decided to introduce the “Korean Medicine Specialized hospital system” to enhance the expertise of medical institutions and to satisfy the diverse needs of the people. Seven Korean Medicine hospitals have been designated as pilot institutions for special care for stroke and spinal diseases in 2007. Based on the results of the pilot project, seven hospitals have been designated as specialized hospitals in the first phase (’11.∼’14), and six in the second phase (’15.∼’17) as specialized hospitals in Korean Medicine.[26] Accreditation of Korean Medicine Hospitals In the Republic of Korea, the Korea Institute for Healthcare Accreditation (KOIHA) was established as an institution under the Ministry of Health and Welfare in 2010 and has accredited the quality of care and patient safety of Western Medicine hospitals. As the accreditation system for Western Medicine hospitals was successfully established, the certification system was also introduced for Korean Medicine hospitals. In 2013, the KOIHA studied the criteria for certification of Korean Medicine hospitals, selected four Korean Medicine hospitals for trial application, and finalized the criteria through public hearings and expert discussions. The criteria for certification consists of a total of 241 items, of which 204 are common survey items. When a Korean Medicine hospital that wants to be certified on a voluntary basis applies, the KOIHA evaluates the hospital and notifies the results. The Korean Medicine hospital accreditation system has been in effect since 2014 and 19 Korean Medicine hospitals have been certified as of April 2019.[20,26]

History, Present and Prospect of Korean Medicine  483

Development and Dissemination of Clinical Practice Guideline in Korean Medicine As in the western medical field, evidence on effectiveness and safety became important when the government tried to establish a policy using traditional medicine. Korean Medicine has relied on medical books passed down from ancient times and the experience of clinicians and clinical studies have been accumulated at home and abroad since the 1990s, but the quantity and quality of the evidence is still insufficient. In order to accumulate clinical evidence in the field of Korean Medicine, the Ministry of Health and Welfare of Korea allocated a budget for the development of standard clinical practice guidelines for Korean Medicine from 2016 and established the “Guideline Center for Korean Medicine” under National Institute for Korean Medicine Development (NIKOM) to take charge of the development of the guidelines. Currently, guidelines for Korean Medicine treatment of 30 diseases are being developed and among them, each completed guideline has been reviewed and certified by the relevant academic societies.[20] The evidence for the effectiveness and safety accumulated through the development of clinical practice guidelines contributes to standardizing and improving the quality of Korean Medicine care and is being used to establish health policies such as health insurance coverage. The 30 diseases for which clinical guidelines are being developed or completed includes migraine, Parkinson’s disease, insomnia, stroke, high blood pressure, functional indigestion, allergic rhinitis, menstrual pain, facial nerve paralysis, etc.

7.3.4.4  Korean Medicine-western medicine collaboration Backgrounds From 1951 when dual healthcare system has been maintained in the Republic of Korea, Korean Medicine doctors and Western medical doctors have been coexisting. Especially in the 1970s and 1980s, the Western medical doctors continuously tried to abolish Korean Medicine doctor system. Korean Medicine doctors endured the suppression and in the early 1990s with rapid growth of Korean Medicine service, the need for collaboration policies of Korean Medicine and Western Medicine was suggested.[27] Korean-Western medicine collaboration in the Republic of Korea is generally represented by the term “co-practice between Western Medicine and Traditional Korean Medicine” (abbreviated as co-practice), referring

484  History, Present and Prospect of World Traditional Medicine

to cooperation of Western Medicine and Traditional Korean Medicine under Korea’s special situation of dualized healthcare. Though similar to the notion of “integration of traditional Chinese and Western Medicine” in China, the Republic of Korea’s co-practice is different from that of China where based on single license system, doctors and Chinese Medicine doctors freely integrate and use Western and traditional Chinese clinical knowledge and technique for practice. In the medical law revised in 2010, co-practice means “doctor, traditional Korean doctor, and dentist working and providing health care together in a hospital-level medical institution (general hospital, hospital, traditional Korean hospital, dental hospital, long-term care hospital).” The definition of co-practice is not precisely provided in this statute but it is regarded as healthcare provider with mutually exclusive licenses providing professional medical service within each license to identical patient through “interaction.” Currently the argument is that co-practice would help improve mutual understanding between Western Medicine and Traditional Korean Medicine and achieve complementation and progress, and therefore copractice is a step toward healthcare unification and the argument that emphasizing co-practice would only solidify the dualized healthcare system.[28] Co-practice can be defined as co-management rather than just consultation or referral, and the three concepts can be compared. Therefore, an ideal co-practice lies on the premise that though providing health service within each professional field, the two practitioners share the therapeutic goal and responsibility for its result.[29] Government Policy for KM-WM Collaboration In 1997, government organized “Medical Reform Committee” to address a variety of health issues including KM-WM collaboration. Although no consensus has been reached, it was meaningful in that cooperation was presented in a mid- to long-term direction, rather than absorbing the other. In 2004, the government adopted establishing infrastructure for collaboration as an official policy in a 5-year plan for healthcare progress as part of the reform on healthcare delivery system. In consequent plans such as developing co-practice model and expansion of mutual exchange, institutional support for co-practice vitalization were pushed forward.

History, Present and Prospect of Korean Medicine  485

From 2005, Korean Medicine departments were established in public hospitals, but as a separate institution despite being in a same building with western medical hospital. The revision of medical service act in 2010 is evaluated as a great improvement for promoting the collaboration of Korean and Western medicines. This revision made it legally possible to establish Korean Medicine department in a Western medical hospital and hire Korean Medicine doctors, and also for Korean Medicine hospital to hire Western medical doctors and establish a Western medical department. With the advent of an aging society, the number of long-term care hospitals increased from the late 2000s and most of them claim cooperative treatment of Korean and Western medicines. Therefore, more Korean Medicine doctors are working in such long-term care hospitals. In the same period of time, many medical colleges turned to post graduate school to train multidisciplinary doctors. (However, most of these were returning to medical college.) These medical schools provided exceptional entrance to licensed Korean Medicine doctors. The only school of Korean Medicine also provided exceptional entrance to medical doctors and dental doctors, which made the production of more dual license holders possible. Since 2015, the Ministry of Health and Welfare has launched a pilot project to promote cooperation between Korean Medicine and Western Medicine.[30] In the first stage, basic data for the cooperation were collected and analyzed. Eight public and five private hospitals participated in the project, and the expenses of patients who used these hospitals were reimbursed from National Health Insurance even if they used Korean Medicine and Western Medicine for the same disease in a same day. Unless this pilot project, health insurance covers only the expense of medical institution that is first used if the patient uses both sides with a same disease per day. The status of cooperation of participatory hospitals has been monitored. In the second stage from 2017, standard cooperation models for frequent diseases have been developed, and the clinical effectiveness and economic feasibility of cooperation have been evaluated. The number of participatory hospitals expanded to 45. Current Status on Western-Korean Medicine Co-practice Counting “hospitals that reported to employ doctor and Korean Medicine doctor simultaneously” as collaborative hospitals based on the data on

486  History, Present and Prospect of World Traditional Medicine Table 7–7  Co-Practice rate in Hospital-Level Institutions (by December 2013). Collaborative Hospital

Non-collaborative Hospital

1,133 (33.4%)

2,263 (66.7%)

General Hospital Level or above

17 (5.0%)

324 (95.0%)

Hospital

92 (6.0%)

1,375 (94.0%)

Oriental Hospital

72 (32.4%)

150 (67.6%)

Convalescent Hospital

952 (73.6%)

342 (26.4%)

All Hospitals

convalescent hospitals in December 2013, the proportion of collaborative institutions is calculated as the table below (Table 7–7). It shows that 33.4% of hospital-level institutions as having co-practice service, but ratio by types of hospital differs greatly. Co-practice rate among convalescent hospitals and Korean Medicine hospitals is high, but only 6% of hospitals and 5% of general hospitals offer co-practice. Currently, in 2015, medical school-affiliated hospitals that provide intra-institutional co-practice were only Bundang Cha Hospital and Chaum Hospital of Cha Medical University, and Busan University Hospital Integrative Medicine Center which had installed Korean medicine department. Of the 109 collaborative institutions above hospital level, national public institutions such as veteran hospitals and health centers and county hospitals occupied 31 (28.4%). Co-practice rate among Korean Medicine hospitals is as low as 32.4% in the statistics above because Korean Medicine hospitals that used to copractice with hospitals or clinics under the same foundation or corporation in the form of inter-institutional co-practice adhered to the form, despite the fact that Medical Act amendment enabled intra-institutional co-practice. In the internal data in 2010 from Association of Korean Medicine Hospital, among 167 Korean Medicine hospitals, 116 of them (69.46%) were collaborative hospitals with 55 hospitals (47.4%) co-practicing with hospitals and 61 hospitals (52.6%) co-practicing with clinics.[31] It seems that most Korean Medicine hospitals are doing co-practice in one way or another.

History, Present and Prospect of Korean Medicine  487

Co-practice rate is high in convalescent hospitals primarily because contrary to other types of hospitals they could simultaneously employ doctors and Korean Medicine doctors since 1994. However, though employing both professions is not mandatory, convalescent hospitals show co-practice rate as high as 50 times over ordinary hospitals. This may reflect the senile and chronic patients’ demand and preference for Korean Medicine treatment. Also, institutional factors such as grading convalescent hospitals on number of doctors, and Korean Medicine therapy not being included in flat rate scheme which is the insurance fee system for convalescent hospitals may have played a hand.

7.3.5  Policies and regulations on herbal medicines 7.3.5.1  Policies on herbal medicines Modernization of Manufactured Herbal Medicines In order to enhance the convenience of medication and consumers’ satisfaction, Ministry of Health and Welfare introduced “the project for modernization of manufactured herbal medicines (herbal preparations),” in which medication type of insured herbal medicines was improved and standard manufacturing manuals were disseminated to the pharmaceutical companies. From 2013–2016, 19 herbal preparations with improved medication type such as soft extract and tablet received the product licenses from Ministry of Food and Drug Safety (MFDS) and were registered in the benefits of National Health Insurance. Another nine improved herbal preparations are under the approval process of MFDS.[32] “The project for standardization of herbal medicine efficacy” was introduced by Ministry of Health and Welfare in 2011 and it aimed to investigate the process of drug efficacy expression after oral administration of herbal medicines. In the first stage (2011–2014), standard samples were prepared for 24 items (arrowroot, licorice, peony, angelica, schizandra, etc.) and the pharmacokinetics in animals were investigated. The efficacy standardization for 20 herbs was completed after phase 1 trial. The second phase (2015–2017) targeted insured herbal medicines with improved formulations for convenient use. Pharmacokinetics and drug interaction information were obtained through clinical and animal testing for preparations of nine herbal prescriptions.

488  History, Present and Prospect of World Traditional Medicine

Establishment of Korean Medicine Materials Bank “Korean Medicine Materials Bank Project” consists of “Natural Material Bank Establishment Project” and “Korean Medicine Biomaterial Bank Project.” For quality standardization of herbal medicines with high research demand, in the “Natural Material Bank Establishment Project,” natural substances were separated from herbal medicines, stored in material bank, and supplied to those who demanded. From 2011–2016, a total of 1,197 natural substances were separated and secured in the bank. Among those secured in the bank, 1,346 substances were distributed to 328 organizations including MFDS, government research institutes, universities, and pharmaceutical companies. The “Korean Medicine Bio Material Bank Project” is a project to secure 10,000 species of bio-transitional metabolites over five years (2014–2018) to develop high value-added herbal medicine resources using bio-transformation technology and to support related industries. A total of 4,532 fractions of bio-transitional metabolites were secured and 1,303 species were distributed with fee or for free. Establishment of Infrastructure for Use of Indigenous Herbal Medicines This project aims to promote the registration of genetic resources and set of standards for indigenous herbs in accordance with the Nagoya Protocol. In the first stage of the project (2012–2016), the genetic resources from 96 indigenous herbs were investigated and registered to the National Institute of Biological Resources, and the DNA information of the herbs were registered to the US National Center for Biotechnology Information (NCBI). Index components of 126 indigenous herbs were separated and secured. In the second stage (2017–2021), 50 indigenous herbs which can be grown in mass were selected, the efficacy for four target diseases (gastritis, arthritis, wound, and atopic diseases) was examined by animal testing. For the indigenous herbs that are effective in animal testing, the government plans to support industrial promotion by researching active ingredients, distributing mass cultivation technology, and securing superior cultivar.

7.3.5.2  Regulations on herbal medicines Medicinal Plant Production and GACP In the Republic of Korea, Rural Development Administration has established GACP (Good Agricultural

History, Present and Prospect of Korean Medicine  489

and Collection Practices) and SOP (Standard Operating Procedure) guidelines to set the standard on collection, maintenance, and primary processing process on major medicinal plants. For GAP certification, according to control standards, the soil is analyzed and examined for heavy metal contamination before cultivation, agricultural water and water used for cleansing or post-collection management is examined to see whether they meet criteria and water quality is regularly analyzed. Agricultural water must meet safety standards and is examined for pesticide residue and heavy metal contamination before collection. Agricultural product is processed in GAP management facility approved by the Director of Agricultural Products Quality Control Center, while looking after facility maintenance and hygiene and health of laborers. Agrochemicals, fertilizer, and farming utensils should be stored and maintained against contamination of hazardous substances and environment. Every agricultural and management process should be recorded and preserved with evidence, data, and specified in packing according to agricultural product traceability management standard. Currently, agricultural product quality control standard differs from the control standard of medicinal plants. Therefore, medicinal crops are not certified as standard medicinal plant even if they are produced according to GAP and must be processed according to standards of herbal medicine manufacturers. Medicinal Plant Standard Manufacturing Process Guideline Standard manufacturing process refers to the standardized process from primary processing after collection to minute packaging on 409 items among 546 items listed in official compendium such as The Korean Pharmacopoeia, excluding “Processing” sections. It is applied to the primary manufacturing and processing by herb medicinal material manufacturers. The guideline categorizes medicinal materials by the part used and describes collecting period, part of usage, screening for impurities, and packaging of each item in detail. Korean Food and Drug Administration published the final edition in 2010 after years of research, enabling herbal medicine manufacturers to establish standard manufacturing process of standard product herbal medicine and improve quality under the GMP system.

490  History, Present and Prospect of World Traditional Medicine

7.3.5.3  Herbal medicines manufacturer and herbal Good Manufacturing Practice (hGMP) GMP is short for “Good Manufacturing Practice,” a system in which the government screens and evaluates the manufacturing process of drugs for certification. Quality control is strictly applied to the whole process of drug material purchase, manufacturing and packaging, and supervised by government for enhancement of overall drug quality. WHO general assembly first established GMP standards in 1969 and recommended its compliance. The Republic of Korea established Korean Good Manufacturing Practice (KGMP) in 1977, and GMP was made mandatory on ethical drug and chemicals in 1994. GMP standards on biological was newly established in 2000, extended to general drug in 2008, and introduced to medicinal plants in 2012, the latter referred as hGMP. Herbal GMP (hGMP) is a mandatory certification authorized by Food and Drug Administration on good herb medicinal material for the health and safety of citizens. hGMP was introduced in 2012 and is used as quality assurance for manufacturers of standard herbal product. Herbal Standard Product and Quality Inspection Standard Herbal standard product is herbal medicine manufactured with medicinal materials that passed quality inspection including hazardous substance inspection, and is safe from heavy metal and other hazardous substances. The Republic of Korea abolished self-standardization system under which farmers could simply process, package, and sell their own crops or herbal medicine retailers could process, package, and distribute without quality inspection. From 1 April 2012, only the medicinal plants manufactured by herb manufacturer can be distributed to guarantee the safety of herbal medicine. Therefore herb retailers cannot process, pack, or sell domestic or import herbs without quality inspection, and standard products manufactured by herb manufacturer approved by the Pharmaceutical Law and strictly inspected may be distributed through herbal medicine wholesaler. Also, manufacturer or provider, serial number and manufacture date, use-by date, standard product phase, inspection agency and inspection date are marked in packaging of standard herb product, so that it is

History, Present and Prospect of Korean Medicine  491

distinguished from general agricultural goods. Obligation to use standard herb product is applied to not only Korean Medicine institutions such as Korean Medicine hospital and clinic, but also to Korean Medicine pharmacy and apothecary so that consumers can buy safe herbal medicine. Herbal Preparations and GMP According to Article 2 Subparagraph 5 of “Pharmacy Law,” herbal medicine is raw drug (生藥) that is dried, cut, and prepared from animals, plants or minerals, and Article 2 Subparagraph 6 states that “herbal medicine preparation (韓藥製劑)” refers to medicines mixed and manufactured based on Korean Medicine principles. “Regulation on manufacture and quality control of drug” which oblige GMP regulation on 16 medical products was newly established according to PIC/S GMP regulations in the Republic of Korea after joining “Pharmaceutical Inspection Cooperation/Scheme (PIC/S)” and has been implemented since 1 July 2015. Especially, regulations on manufacturing raw herbal medicine include principle, facility (storage, shed, device), documentation (starting material standard, official compendium), and quality control (specimen collection). Since most raw herbal medicines are complex and diverse, management, storage, and processing of “starting material” in manufacture procedure are stressed. Herbal plants, raw herbal medicines with basic processing (washing, drying, and cutting), or extracted herbal medicines (herbal medicine powder and extracts) may be “starting materials” in herbal medicine manufacturing. Raw herbal medicines must be of appropriate quality, and manufacturers of herbal extractions (herbal powder, extracts) and raw herbal medicines must be provided with evidence data. Also, raw herbal medicines manufacturer must only use starting materials manufactured in accordance with the standards of (material) drug manufacturing and quality control, appraise starting material providers, and let providers prepare necessary papers. Manufacturers must check whether suppliers of herbal plants or raw herbal medicines are complying with good raw herbal medicine manufacture and management guideline or not, or supervise appropriately according to quality risk control (QRM) if necessary. Official Compendium and Quality Control of Herbal Medicine The current Korean Herbal Pharmacopoeia has dealt with herbal medicine in section 2 and section 3 from 2012, and contains more than 200 formulas

492  History, Present and Prospect of World Traditional Medicine

including OTC and reimbursed drugs. Pharmaceutical Codex of each medicine states the following items in relevant articles, and each medicine must satisfy the stated contents according to standard and test method. Furthermore, the Codex separately contains identification test and content test as test methods for crude drugs. Herbal medicine is a multi-component compound; a mixed extraction of diverse medicinal herbs. Thus, for quality control of herbal medicine, more than one extracted component from each of the mixed medicinal must be managed, rather than managing just one index component. Therefore, comparison test of standard decoction made by standard extraction method and herbal medicine and quantitative method using multicomponent profile should be applied to herbal medicine, but such measures are not institutionalized yet. The current Codex is limited to items that may be quantified with major index components of herbal medicines.

7.4  Resources and utilization of Korean Medicine 7.4.1  Human resources In 2019, Korea’s healthcare workforce included 25,592 Korean Medicine doctors, 126,795 Western Medicine doctors, and 31,640 dentists. There were five times as many Western Medicine doctors as there were Korean Medicine doctors. Those working in Korean Medicine related areas were counted to constitute 2,649 herbal pharmacists, 25,180 herbal dispensary pharmacists, 706 herbal medicine apothecaries, 4 acupuncturists, and 2 moxibustionists. Comparing with the past decade, the numbers revealed a steady increase in Korean Medicine doctors and herbal pharmacists, and a decrease in herb dispensary pharmacists, herbal medicine apothecaries, acupuncturists, and moxibustionists.[1,20] Herbal pharmacists are those who graduated from the department of herbal pharmacy and professionally maintain and dispense herbal medicines. Herb dispensary pharmacists are Western pharmacists who obtained an additional license to dispense herbal medicines. Herbal medicine apothecaries are not considered to be a part of healthcare and may only distribute, mix, and sell herbal medicines, but conventionally,

History, Present and Prospect of Korean Medicine  493 Table 7–8    The numbers of Korean Medicine related personnel.

Year

Korean Medicine Doctor

Western Herbal Medicine Phar­ Doctor macist

Herbal Dispensary Pharmacist

Herbal Moxi­ Medicine Acupunc­ bus­ Apothecary turist tionist

2010

19,132

101,443

1,515

26,630

1,367

30

7

2015

23,245

116,045

2,193

25,674

872

22

5

2019

25,592

126,795

2,649

25,180

706

4

2

Source: Ministry of Health and Welfare License Supervision System.

they have prescribed and dispensed herbal medicines like Korean Medicine doctors. There has been no more new herbal medicine apothecary since 1983. Also, acupuncturist and moxibustionist have not been newly licensed after liberation from Japan in 1945 (Table 7–8). One of the unique properties of the Korean Medicine system is the system of the Korean Medicine specialists. The Korean Medicine specialist system was initiated in 2000 to improve and specialize the Korean Medicine service. To obtain a license as a Korean Medicine specialist, with regulations identical to Western Medicine, one must train for one year in an internship course and for three years as a resident in hospitals that are designated for residency training. After residency training, licenses are authorized upon passing the qualification exam. The Association of Korean Medicine governs the qualification exam by delegation from the Ministry of Health and Welfare, and the license is authorized by the Minister of Health and Welfare.[12] There are eight areas for specialization in Korean Medicine, including Internal Medicine, Pediatrics, Gynecology, Psychiatry, Acupuncture & Moxibustion, Eye-ENT & Dermatology, Rehabilitation Medicine, and Sasang Constitutional Medicine. By 2019, there were 3,160 Korean Medicine specialists who qualified. Korean Medicine Internal specialists were the largest in number, with 1,120 specialists, followed by 655 specialists in Acupuncture Medicine.[20] The Korean Medicine specialist system stimulated the professional development of eight specialties and improvements in medical service in Korean Medicine hospitals (Table 7–9).

494  History, Present and Prospect of World Traditional Medicine Table 7–9    The numbers of Korean Medicine specialists.

Year

Gyne­ Internal col­ Medicine ogy

Pedi­ atrics

Neuro­ psy­ chi­atry

Acupunc­ Eye, ENT ture & & Moxi­ Derma­ Reha­bil­i­ bustion tology tation

Sasang Con­sti­ tutional Medicine Total

2010

703

168

66

109

373

109

217

98

1,843

2015

964

216

95

159

533

150

355

139

2,611

2019

1,120

251

116

189

655

186

476

167

3,160

Source: Publication Committee for Korean Medicine Yearbook, 2019 Yearbook of Traditional Korean Medicine, 2021.

7.4.2  Hospitals, clinics, and pharmacies, etc. By 2019, there were 1,842 hospitals, 32,441 WM clinics, 353 Korean Medicine hospitals, and 14,442 Korean Medicine clinics. Over the past 10 years, there was a 50% increase in Korean Medicine hospitals and a 30% increase in Korean Medicine clinics.[1] Under the same regulations as Western hospitals, Korean Medicine hospitals with more than 30 beds are granted permission to be established. Korean Medicine hospitals usually care for both inpatients and outpatients, with the majority of inpatients consisting of musculoskeletal, cerebrovascular, and neurological patients. To manage inpatients, Western medical diagnostic tools and drugs in addition to the Korean Medicine diagnosis and treatment methods are used. For this, most Korean Medicine hospitals have additionally included Western clinics or employed doctors. Due to legal restrictions, Korean Medicine hospitals had previously installed separate Western clinics while actually performing co-practices internally, but as the Medical Act was amended in 2011 to promote Korean-Western medicine co-practices, Korean Medicine hospitals were given authority to directly employ Western medical doctors or internally install Western Medicine clinics. Of course, (Western) hospitals can also directly employ Korean Medicine doctors or install Korean Medicine departments (Table 7–10). There are 701 herbal pharmacies, 706 herbal drug stores (run by apothecaries), and 801 herbal wholesalers in 2019.[20] Herbal pharmacies are operated by herbal pharmacists who sell pre-manufactured

History, Present and Prospect of Korean Medicine  495 Table 7–10    Numbers of Herbal pharmacies, and drugstores, etc. (2019). N Herbal Pharmacies

701

Herbal Drugstores

706

Herbal Medicine Wholesalers

801

Source: Ministry of Health and Welfare, Reference Data for Main Tasks (Juyo Upmoo Chamgojaryo), 2020.

herbal medicines (decoctions, pills, powders, and ointments, etc.). The herbal drug stores are operated by the herbal apothecaries who are only licensed for the mixture of medicinal herbs. Herbal medicine can also be purchased in pharmacies that are operated by herbal dispensary pharmacists. After separating, prescribing, and dispensing in 2000, the function of pharmacy has been specialized into dispensing (prior to the separation, pharmacists acted as pseudo-doctors in Korea). The number of (Western) pharmacies arbitrarily dispensing herbal medicine has greatly diminished, and at present, very few pharmacies dispense herbal medicines.

7.4.3  Usage of Korean Medicine services As of 2019, Korean Medicine services were provided in 353 Korean Medicine hospitals, 1,335 long-term care hospitals, and 14,442 Korean Medicine clinics. There are also 91 public hospitals, 254 public health centers, and 709 public health sub-centers which provided medical services and health promotion programs using Korean Medicine.[20] In a nation-wide survey of 5,000 Koreans over the age of 20, 92% of respondents had experienced Korean Medicine services in their lifetime, 27.1% had used an outpatient service in Korean Medicine hospitals or clinics in the past three months, and 0.8% had been hospitalized in Korean Medicine hospitals in the past year.[2] Usage of Korean

496  History, Present and Prospect of World Traditional Medicine

Medicine hospitals and clinics increased in comparison with the previous year. Outpatient care for Korean Medicine was used by more females than males, with the largest age group represented by those between 50 and 59 years of age. When examining the academic backgrounds of patients, it was found that usage by those whose highest level of education was high school was considerably lower than that by those who had completed up to middle school or college. Usage correlated positively with income. The usage of inpatient hospitalization was similar to that of the outpatient service, with a preference for females, people in their fifties, and people with a higher income. Patients whose education ended at or before middle school are receiving more treatment than those who have completed higher levels of education. Regarding the perception of the effectiveness of Korean Medicine services, 59.7% of the respondents thought the services were somewhat effective, and 8.0% answered that the treatment was very effective, with a total of 67.7% indicating a positive response regarding the effectiveness of Korean Medicine. In contrast, 26.6% said the effect was mediocre, and only 5.6% answered that Korean Medicine was not effective. In response to a similar question regarding the intention for the future usage of Korean Medicine, 68.8% responded positively, while 21.6% responded negatively. When asked about problems experienced in the use of Korean Medicine services, 40.9% of respondents noted that the fees were too expensive, 27.6% expressed worry as to the safety of the medicinal plants used, 15.5% stated that they were uncertain of the effectiveness of treatment, and 9.2% felt the need for areas of specialization. Recently, another nation-wide survey for 1,010 patients who used Korean Medicine in outpatient care in 2018 showed the most frequently used treatment was acupuncture (93.5% of respondents used), followed by moxibustion (48.0%), KM physical therapies (51.1%), cupping (49.3%), pharmacopuncture (22.1%), herbal preparations (16.4%), and Chuna manual therapy (6.2%).[21] When asked whether each treatment was effective, Chuna received the highest score of 3.6 out of 4, 3.5 for acupuncture and herbal acupuncture, and 3.4 for moxibustion and herbal medicines. According to the National Health Insurance Statistics, the number of claims made by Korean Medicine hospitals and clinics per year was about 900,000 in 2009. The number increased to 140 million in 2014, and has

History, Present and Prospect of Korean Medicine  497

maintained since then, exceeding 100 million. This number of claims accounts for about 7.5% of total number of claims by all healthcare institutions and pharmacies.[22,23] Although the use of Korean Medicine is increasing, diseases treated by Korean Medicine have been concentrated in musculoskeletal diseases. The following table shows the 10 most common disability claims for health insurance in Korean Medicine hospitals and clinics. In addition to indigestion, most are musculoskeletal disorders such as sprains and tension in the joints. This is because when the Korean Medicine began to be covered in the National Health Insurance in 1987, the coverage was set around acupuncture and moxibustion, which have strengths in musculoskeletal diseases (Table 7–11).

Table 7–11  Frequency of diseases treated by Korean Medicine in 2019 (outpatients). Rank

KCD Disease Code and Name

No. of Patients

1

M54 Back pain

4,110,362

2

M79 Other soft tissue disorders

2,034,589

3

S33 Dislocation, sprain and strain of joints and ligaments of lumbar spine and pelvis

1,966,265

4

M62 Other disorders of muscle

1,213,108

5

S93 Dislocation, sprain and strain of joints and ligaments at ankle and foot level

944,224

6

M25 Other joint disorders, not elsewhere classified

893,337

7

S13 Dislocation, sprain and strain of joints and ligaments at neck level

809,481

8

K30 Indigestion

746,908

9

M75 Shoulder lesions

701,334

10

S43 Dislocation, sprain and strain of joints and ligaments at wrist and hand level

530,321

Note: KCD: Korea classification of disease and death. Source: Publication committee for Korean Medicine yearbook, 2019 Yearbook of Traditional Korean Medicine, Korea Institute of Oriental Medicine, 2021.

498  History, Present and Prospect of World Traditional Medicine

7.5  Education in Korean Medicine 7.5.1  Overview Modern education in Korean Medicine started at Dongje medical school in 1904, which was sponsored by Emperor Gojong at his own expense, but lasted for only three years, as Emperor Gojong was deposed in 1907. Since that time, Korean Medicine education barely maintained its existence through small institutions until the liberation from Japan. In 1948, Dongyang Medical College was established, and it was given a legal basis with implementation of the National Medical Service Act of 1951, which reinstated Korean Medicine doctors and Korean Medicine education. Dongyang Medical College was a 4-year institution with departments of both Korean Medicine and pharmacology. Although Dongyang Medical College achieved status as a 6-year institution in 1964, it merged with Kyunghee University only a year later. When the popular use of Korean Medicine increased with the introduction of health insurance for Korean Medicine in 1987, interest in Korean Medicine increased and additional Korean Medicine colleges were established. An increased demand for a standardized educational curriculum began following this trend. A common educational goal was set for each subject and was reflected in the national examination, and national standard textbooks were published for various basic and clinical subjects. There are now 11 colleges of Korean Medicine and one school of Korean Medicine. Each college of Korean Medicine is composed of two years of pre-medical and four years of medical course. School of Korean Medicine has two kinds of courses; a 4-year course for those with higher or equal to a bachelor’s degree, and a 7-year course combining bachelor and master’s course. Colleges and school of Korean Medicine are as popular as medical schools and dental schools in Korea, which the top 1% high school students apply for. The annual number of students entering the 11 colleges of Korean Medicine and one school of Korean Medicine is 750. The highest quota was given to Kyunghee University and the Daegu Haany University with 108 students each, followed by 90 students at Wonkwang University, and 72 students each at Daejeon University and Dongguk University. The total

History, Present and Prospect of Korean Medicine  499 Table 7–12    List of colleges and school of Korean Medicine in Korea. Year of Established

Annual Entrance Quota

Year

Kyunghee University College of Korean Medicine

1947

108

6

Seoul

Wonkwang University College of Korean Medicine

1972

90

6

Jeollabuk-do

Dongguk University College of Korean Medicine

1979

72

6

Gyeongsangbuk-do

Daegu Haany University College of Korean Medicine

1980

108

6

Daegu

Daejeon University College of Korean Medicine

1981

72

6

Daejeon

Dongshin University College of Korean Medicine

1987

40

6

Jeollanam-do

Dong-eui University College of Korean Medicine

1987

50

6

Busan

Sangji University College of Korean Medicine

1988

60

6

Gangwon-do

Woosuk University College of Korean Medicine

1988

30

6

Jeollabuk-do

Gachon University College of Korean Medicine

1989

30

6

Gyeonggi-do

Semyung University College of Korean Medicine

1992

40

6

Chungcheongbuk-do

Pusan National University School of Korean Medicine

2008

50 25 25

4 7

Gyeongsangnam-do

Location

number of students attending Korean Medicine colleges and school was 4,598 in 2019[23] (Table 7–12). The herbal pharmacist system was introduced in 1993 for the development of herbal medicine management, distribution, and dispensation. Department of herbal pharmacy with 4-year course was established at three colleges of pharmacy with 120 of total annual quota; Kyunghee University and Wonkwang University in 1996 and Woosuk University in

500  History, Present and Prospect of World Traditional Medicine

1998. Beginning with the qualification of 89 herbal pharmacists in 2000, a total of 2,649 herbal pharmacists were trained until 2019.[23] One of the most important milestones in the modern Korean Medicine education is the establishment of the School of Korean Medicine at Pusan National University, which is the first school for Korean Medicine at a national university since liberation from Japan. The School of Korean Medicine at Pusan National University is the only graduate school of Korean Medicine that is innovating modern education system in Korean Medicine by reorganizing the previous 6-year course into the 4-year medical school system, and adopting an integrated curriculum, research training course, and advanced training modules in basic and clinical medicine, such as PBL (Problem-Based Learning), OSCE (Objective Structured Clinical Examination) and CPX (Clinical Practice Examination). These changes are being extended to other Korean Medicine colleges. The Korean Medicine education system is maintained at the same high-quality level as Western Medicine education, and the license for Korean Medicine doctor is issued by the Minister of Health and Welfare for those who pass the national examination. In the annual OECD Health Data, the number of physicians of Korea includes the number of Korean Medicine doctors.

7.5.2  Education system for Korean Medicine doctor 7.5.2.1  6-year college of Korean Medicine education The 6-year course at the college of Korean Medicine, which is identical to Korean colleges for Western Medicine, is composed of a 2-year preparatory course and a 4-year regular course. The preparatory course educates students in cultural studies, such as the principles of Korean Medicine, Chinese medical classics, and basic Western Medicine. Basic and clinical subjects in Korean Medicine and clinical practice are taught in the regular course. Kyunghee University College of Korean Medicine, the oldest Korean Medicine college, has the curriculum with a total of 244 credits. Classifying the courses by fields of study, the curriculum consists of 20% of cultural, humanities, and social studies subjects, 50.4% of Korean Medicine subjects, and 28.5% of Western Medicine subjects.

History, Present and Prospect of Korean Medicine  501 Table 7–13    Curriculum composition at college of Korean Medicine, Kyunghee university. Cultural Studies, Humanities & Social Studies

Credits Percentage (%)

49 20.1

Basic Korean Medicine

Clinical Korean Medicine

Western Medicine

Total

55 22.5

70.5 28.9

69.5 28.5

244 100.0

This composition ratio is not precise as some subjects are ambiguous in their nature, but this shows the general outline of composition. Western Medicine accounts for approximately 30% of the curriculum, but in actuality, each clinical subject in Korean Medicine contains relevant clinical substance from Western Medicine, so the proportion of Western Medicine taught in Korean Medicine colleges is estimated over 40% (Table 7–13). The subjects taught at Kyunghee University College of Korean Medicine are shown in the Table 7–14.

7.5.2.2  Education of school of Korean Medicine The School of Korean Medicine has been established only at Pusan National University. As of 2019, the curriculum at the Pusan National University School of Korean Medicine consisted of 172 credits. As the school of Korean Medicine does not offer preparatory courses, there are few liberal arts subjects. Additionally, the subjects taught for 2–4 semesters in Korean Medicine colleges are shortened to 1–2 semesters by integrating courses and block lectures. Courses such as Korean Medicine research, Korean-Western Medicine co-practice methodologies, and specialist practice, distinguishes this school from other colleges. Among the fields of study, the courses for basic Korean Medicine and clinical subjects are similar to those from other colleges, but because the school does not offer preparatory courses, there are far fewer liberal arts and Western Medicine courses. Korean Medicine clinical subjects taught at the school of Korean Medicine also contain a significant number of contents of Western Medicine.

502  History, Present and Prospect of World Traditional Medicine Table 7–14    Curriculum of College of Korean Medicine, Kyunghee University. Pre-medicine Required Basic Chinese classics, Subjects Subjects Introduction to Oriental medicine, Medical English, Medical Chinese, Medical history, Physiology and lab, Medial qigong, Herbology, Biochemistry and lab (WM), Embryology (WM)

Clinical Subjects

Electives

Medicine (Requisites) Pathology and lab, Herbology and lab, Chinese classics, Shanghanlun, Famous theories in Oriental medicine, Studies on febrile diseases, Meridianology and lab, Preventive medicine and lab, Prescriptionology and lab, Medical ethics, Public health regulations, Anatomy and lab (WM), Physiology (WM), Pathology (WM), Histology (WM), Pharmacology and lab, Preventive medicine (WM), Microbiology and lab (WM) Sasang constitutional medicine, Internal medicine, Acupuncture and moxibustion, Diagnostics, Gynecology, Dermatology and surgery, Ophthalmology and Otorhinolaryngology, Neuropsychiatry, Pediatrics, Rehabilitation medicine, Manipulation, Diagnostics (WM), Radiology (WM), Laboratory medicine (WM), Emergency medicine (WM), Forensic science (WM)

Classics reading, Clinical psychology, Alternative Psychology, medical medicine, Integrative medicine, management, medical Clinical dietetics, Special informatics, writing, lectures English conversation, Chinese conversation, Molecular biology, Eastern philosophy, Philosophy of science, Medical statistics (electives run differently according to school policy)

History, Present and Prospect of Korean Medicine  503

Another important characteristic of the curriculum at the Pusan National University School of Korean Medicine is that an advanced methodology of medical education is introduced — that is, PBL (ProblemBased Learning), OSCE (Objective Structured Clinical Examination), and CPX (Clinical Performance Examination), which were generalized in Western medical education but not in traditional medicine. To make these methodologies reflect Korean Medicine characteristics, many Korean Medicine specialists, professors, and educational methodology scholars have been working since 2008 to develop PBL, OSCE modules, and standard patient models. Since 2011, those models have been applied to clinical education of School of Korean Medicine. To disseminate these educational methodologies — thereby improving the educational level of all Korean Medicine colleges, Pusan National University has offered open OSCE and CPX courses to professors of other colleges and signed an MOU with other colleges to share and co-develop this educational module. Recently, in 2015, the School of Korean Medicine newly established 7-year course with combining bachelor-master courses. Students of combined course take 3-year preparatory course work and, after that, join the 4-year master course. The following figure summarizes the education system for Korean Medicine doctors. After passing the national licensing examination, Korean Medicine doctors can choose either to open their own clinics or to enter internship course for specialist certificate. Male doctors who did not complete mandatory military service have to work as a public health doctor in rural areas for three years instead of military service. When a Korean Medicine doctor acquires a professional qualification, he can replace the military service duty as a military doctor for three years (Figure 7–2).

7.5.3  Education system for herbal pharmacist A department of herbal pharmacy has been established in the pharmacy colleges at three universities: Kyunghee University, Wonkwang University, and Woosuk University. The curriculum for the Kyunghee University

504  History, Present and Prospect of World Traditional Medicine

Figure 7–2    Summary of Korean Medicine education system.

Department of Herbal Pharmacy comprises 163 credits. Basic science and basic Korean Medicine subjects are mainly covered in the initial years and upper grades curricula are composed of advanced core courses. Specific major courses are evenly distributed throughout the four school years (Table 7–15).

7.5.4  Clinical specialist education The Korean Medicine specialist system was introduced in 2000 to promote the professional development of each branch of Korean Medicine and to improve the quality of medical services. There are eight specialist areas in Korean Medicine: Internal medicine, Gynecology, Pediatrics, Psychiatry, Acupuncture and Moxibustion medicine, Ophthalmology-Otolaryngology-Dermatology, Rehabilitation, and Sasang constitutional medicine.

History, Present and Prospect of Korean Medicine  505 Table 7–15    Curriculum of the department of herbal pharmacy in the college of pharmacy. Requisite Courses

Major Electives

Medicinal Botany, Chinese in Korean General Chemistry, Medial Medicine, Introduction to Herbal Terminology, Bioscience, Korean Medicine, Classics of Herbal Medicine, Medicine Terminology, Natural Herbology and Lab, Pharmaceutical Products, Anatomy, Physical Organic Chemistry, Physiology and Pharmacy, Bioinorganic Chemistry, Lab, Pathology, Pharmaceutical Pharmaceutical Statistics, Analysis, Pharmaceutical Biochemistry Introduction of Meridianology, and Lab, Pharmacognosy, Physiology Instrumental Analysis, (Wm), Natural Product Chemistry and Pharmaceutical Organic Chemistry, Lab, Microbiology, Pharmacopoeia, Pharmaceutical Biochemistry, Herbal Processing and Lab, Advanced Instrumental Analysis, Prescriptionology and Lab, Shanghanlun, Herbal Medicine, Pharmacology, Pharmaceutics and Lab, Medical Microbiology, Industrial Korean Medicine Pharmacology and Property Rights, Bioinformatics, Lab, Clinical Herbology, Immunology, Public Health, Pharmaceutical Jurisprudence, Pharmacotherapy, Sasang Pharmaceutical Distribution and Pharmacology, Health Functional Storage, Identification of Herbal Foods, Clinical Herbal Medicine, Medicine and Lab, Preventive Pharmacy Herbal Pharmacy Management, and Public Health Quality Control

The training program consists of one year of general training (internship) and three years of specialist training (residency). Western Medicine training generally comprises a 1-year internship and a 4-year residency, with the exception of a 3-year residency for family medicine. As of March 2019, there are 213 Korean Medicine interns and 429 residents. The 36 Korean Medicine hospitals provided training for both interns and residents and 15 Korean Medicine hospitals did only for interns. A Korean Medicine hospital must meet the following requirements to train interns and residents. Generally, interns circulate to each department every month for training, similar to internships in Western hospitals. After the internship, the trainees apply to their desired specialist departments. During residency

506  History, Present and Prospect of World Traditional Medicine

training, the residents are responsible for outpatient and inpatient treatment, attendance and presentation at department conferences, writing and publishing papers, and educating undergraduates for three years. After completing a certain amount of outpatient and inpatient treatment and successful publication of papers, the doctor-in-training is eligible for the specialist qualifying examination. The qualifying examination for Korean Medicine specialist is conducted by the Association of Korean Medicine under the mandate of the Ministry of Health and Welfare.

7.5.5  Continuing medical education in Korean Medicine Since the continuing medical education clause was added to the Medical Act in 1965 to improve national healthcare by making healthcare providers obtain the necessary medical knowledge, the Association of Korean Medicine conducts continuing education annually, also known as refresher training, for Korean Medicine doctors. This training is offered in accordance with Article 30 of the Medical Act and Enforcement Decree Article 20, the articles of the association, and refresher education regulations. Currently, the Association of Korean Medicine provides various refresher courses in the form of national and international academic conferences, city and state branch education opportunities, paper publishing, and cyber lectures. The educational term runs from 1 January to 31 December every year, and a total of eight credits must be completed in a term. One credit is given after completing one half-hour to one hour course, depending on the type of course. Continuing Medical Education (CME) has long been part of the practice of Korean Medicine, but many Korean Medicine doctors doubt the actual contribution of CME to maintenance and enhancement of their capacity. The nature of Korean Medicine is such that changes in its study occur at a lower rate than Western Medicine, and CME’s purpose of helping practitioners acquire new medical information is not as effective in this case. Instead, it is commonly believed among the Korean Medicine community that practitioners with more clinical experience have better clinical skills. Thus, many Korean Medicine doctors feel that unofficial CME, such as study group sessions or apprenticeships with experienced

History, Present and Prospect of Korean Medicine  507

local practitioners, is superior to the official refresher courses offered by the Association. Many Korean Medicine doctors with less than a decade of clinical experience actually take “private lessons” from more experienced Korean Medicine doctors who are masters of certain classic or clinical techniques. These small group studies may enhance practical clinical skills, but the quality of these clinical lecturers is inconsistent, and practitioners may be misled regarding the use of clinical procedures or methods with little scientific evidence. Therefore, maintaining and enhancing the skills of Korean Medicine doctors through official CME and the quality improvement of official courses is one of the principal concerns for the Association of Korean Medicine and Korean Medicine doctors.

7.5.6  Accreditation and evaluation of education for Korean Medicine institutions Medical education evaluation was introduced in the 1990s in Korea. Korean Medicine attempted to establish education evaluation in the 2000’s. Initially, this evaluation began with creating a training education evaluation for the designation of clinical training hospitals but soon the evaluations for training hospitals and Korean Medicine colleges became separate. The Institute of Education in Korean Medicine & Evaluation (IKMEE), the first and only institution for the accreditation and evaluation of education in Korean Medicine, was established in 2005 and is probably the first institution in the world to evaluate education of traditional medicine. IKMEE was designated as a non-profit corporation by the Minister of Health and Welfare based on Article 32 of Civil Code for the purposes of research, development, and evaluation of education in Korean Medicine. IKMEE aims to educate, produce, and manage medical professionals for the quality improvement of Korean Medicine healthcare services. The specific goal is to nationally standardize education in Korean Medicine by establishing a quality standard for educational conditions and curricula at Korean Medicine institutions. Starting with the revision of curriculum goals at Korean Medicine colleges, education standardization work, such as the development of a

508  History, Present and Prospect of World Traditional Medicine

residency training clinical handbook and practice guidelines, was done. Specifically, evaluation and accreditation standards and specific guidelines for Korean Medicine institutions were developed to establish a Korean Medicine education evaluation and accreditation system. The guidelines also required the development of internal evaluation reports that can be used as self-assessment evaluation reports for appraised institutions and an evaluation guideline manual for evaluating professionals to maintain reliability and objectivity. IKMEE also conducts an evaluator fostering and education program and a textbook development project. The evaluator training program educates participants in the evaluation and accreditation system and standards and the execution of relevant fieldwork. The program is for novices in evaluation and accreditation (teachers with no experience in the evaluation and accreditation process) and other participants comprise the evaluator staff pool. IKMEE organizes an evaluation and accreditation group to establish an evaluation system and permanent bodies such as an operation committee, a specialist committee, a decision committee and non-permanent bodies such as a visiting evaluation group, and a decision committee. The specialist committee researches and develops evaluation criteria, designs the general evaluation and accreditation plan, and works with the accreditation standard committee, which is in charge of evaluator training. The accreditation system committee is in charge of policy and regulation development, and the accreditation management committee maintains the quality of evaluation, accreditation and ex-post facto management. Additionally, the visiting evaluation committee is composed of those who have completed a basic program for training evaluators and fieldwork education, while the decision committee decides on the accreditation type and follow-up measures for the Korean Medicine educational program and the environment of the Korean Medicine college (school).

7.6  Korean Medicine in health security system 7.6.1  National health insurance and Korean Medicine On December 1984, the Ministry of Health and Social Affairs launched a 2-year pilot project for National Health Insurance coverage of

History, Present and Prospect of Korean Medicine  509

Korean Medicine services for 26 Korean Medicine clinics in Cheongju city and Cheongwon county in Chungcheongbuk-do (province). In this pilot project, the benefit coverage included outpatient visits, acupuncture, moxibustion, cupping, and herbal medication. At that time, 98 crude herbal drugs were covered, and the Korean Medicine doctors were able to prescribe 1 of 26 codified formulas that could be composed of these 98 raw herbal drugs. The fee for the outpatient visit was equal to that for Western Medicine, and the fees for acupuncture, herbal medicine, and other interventions, were calculated based on market prices. The outcomes of the pilot project were largely optimistic; the rate of the treatment of episodes was higher than anticipated, and there was a high demand for expansion of the prescription list. In addition, the users reported a high level of satisfaction with the project. In October 1986, the Ministry of Health and Social Affairs decided to expand the pilot Korean Medicine coverage project to implement a continuous, nationwide program, which went into effect in February 1987. Although other services were maintained in the pilot project, the number of insured herbal medicines in the nationwide program was reduced from 98 to 68. Furthermore, the insured form of herbal medicines in the initial pilot project comprised packages of raw herbal drugs (Chŏpyak) was substituted with herbal powders that were extracted from each raw herbal medicines and mixed with starch or corn powder. Although a major method was excluded, Korean Medicine insurance has since gradually expanded in coverage, and the number of notified formulas increased to 56 in 1990. Korean Medicine test devices, such as Yangdorak (Ryodoraku)a and the pulse detector, were covered in 1994, and three Korean Medicine physical therapies were added for coverage in 2009. With respect to the reimbursement structure, the Resource-Based Relative Value Scale (RBRVS) was introduced for Korean Medicine health insurance in 2002, providing a methodical approach for the estimation of fees and adjustment of balances among Korean Medicine services and procedures. a

 Yangdorak (Ryodoraku) is the device used to detect excessive or deficient conditions of the organs by measuring electrical resistance in the skin.

510  History, Present and Prospect of World Traditional Medicine

7.6.1.1  Current reimbursement scheme and NHI coverage for KM The general procedure for Korean Medicine reimbursement through the NHI are as follows.[33] First, outpatient care is reimbursed using the Fee for Service (FFS) system based on the Resource-Based Relative Value Scale (RBRVS), which was originally developed by Professor Hsiao at Harvard University in the 1980s and modified for the Korean NHI by Korean researchers. The RBRVS system was implemented for Western Medicine and dental procedures in 2000 and for Korean Medicine procedures in 2002. In the RBRVS system, the fee for each procedure is calculated by multiplying the relative value (RV) of each procedure or service by a conversion factor (CF) corresponding to a monetary amount per RV score. The RV scores are adjusted every five years based on the research data, and the CF is determined at the end of each year based on negotiation and contract, in principle, between the NHIS and the Association of Korean Medicine (AKOM). The CF for the year 2020 was 87.3 Korean Won (0.07 USD). Second, an additional fee is reimbursed to each claim depending on the type of medical institution because indirect costs may differ according to the size of each type of institution. For university-affiliated hospitals, the markup rate is 25%; that is, the NHI reimburses 125% of the total amount of the notified fee for a claim. For Korean Medicine hospitals, the markup rate is 20%, whereas the markup rate is 15% for Korean Medicine clinics. Third, for all medical institutions, the total reimbursed amount may be partially decreased depending on the number of outpatients per day. For example, there are no reductions if one doctor treats 75 or fewer outpatient cases; however, if one doctor treats more than 75 cases, 90% of the total benefit amount is reimbursed for claims up to 100 cases, 75% is reimbursed for claims up to 150 cases, and 50% is reimbursed for claims over 150 cases. Fourth, to prevent patients from experiencing a moral hazard, the Korean NHI applies both copayment and coinsurance. The guardians of patients under the age of seven have to pay 21% of the total treatment amount themselves, while for patients aged 7–64 years, the charge is 30% of the treatment fee. The fee structure is more complicated for patients

History, Present and Prospect of Korean Medicine  511

aged 65 years and older: patients pay 1,500 KW (1.3 USD) up to a total treatment amount of 15,000 KW (12.7 USD), and 30% of the total fee if it is more than 15,000 KW (if there is a medication, the reference point is increased to 20,000 KW). Finally, the benefit coverage for Korean Medicine includes outpatient visits, inpatient care, acupuncture, moxibustion, cupping, medication, diagnostic tests, and other treatments. Table 7–16 shows the current benefit coverage for Korean Medicine and RV scores in the NHI. Of these items, the most frequently utilized treatment modalities are acupuncture, moxibustion, and cupping. Acupuncture treatment may be provided alone, but it was usually accompanied by cupping or moxibustion treatment. Since the reimbursement for outpatient care of national health insurance follows the fee-for-service way, Korean Medicine doctors tend to provide as many treatment modalities within the standard as possible. Herbal medicine is also a frequently used strategy along with acupuncture. However, it only accounts for 2.0% of total claims of Korean Medicine service as of 2019.[23] This results from raw herbal decoction (boiled liquid of a number of medicinal herbs according to formulas, the type of herbal medicine preferred by most Koreans) not being covered by the national health insurance, and only herbal preparations being covered, which are very few in number.[9] Recently, in 2020, Ministry of Health and Welfare decided to implement 3-year pilot coverage project for herbal decoctions for the treatment of Bell’s palsy, stroke after effects, and menstrual pain with the annual budget of 42 million USD.[34] Chuna manual therapy (CMT) has been covered since 2019 after a 2-year pilot coverage project examining its clinical effectiveness and financial effect (Table 7–16).[15]

7.6.1.2  Growth of Korean Medicine uses in national health insurance With respect to the number of claims, in 1990 (corresponding to the early stage of Korean Medicine health insurance), Korean Medicine represented

512  History, Present and Prospect of World Traditional Medicine Table 7–16    KM Insurance Benefits and RV Scores (as of 2020). Benefits

RV score

Outpatient visit First visit

152.06

Outpatient visit Repeated patient

95.98

Inpatient care

KM hospital

417.36

Inpatient care

KM clinic

355.29

Dispensing of herbal preparations (1 day) *The costs of 68 single herbal preparations are notified separately

10.22

Acupuncture

General acupuncture

33.94

Acupuncture

Special acupuncture Acupuncture in the intraorbital cavity

40.16

Acupuncture Acupuncture into the intranasal sinus Special acupuncture

36.46

Acupuncture Acupuncture in the intraperitoneal cavity 36.51 Special acupuncture Acupuncture Acupuncture in the intra-articular joints Special acupuncture

39.64

Acupuncture Acupuncture in the intervertebrae spaces 40.67 Special acupuncture

Acupuncture

Acupuncture Penetration acupuncture Special acupuncture

40.81

Laser acupuncture

33.98

Electrical stimulation for acupuncture needle

34.81

Moxibustion

Direct type

102.42

Moxibustion

Indirect type

42.44

Cupping

Cupping only

46.62

Cupping

Cupping with bloodletting

81.95

Pattern identification (Bianjing)

38.54

Diagnostic test Yangdorak (Ryodoraku)

38.70

Diagnostic test Pulse diagnosis

43.42

Diagnostic test Meridian function test

49.83

Diagnostic test Dizziness test

48.51

Diagnostic test Personality test

171.20

Diagnostic test Dementia test

303.47 (Continued)

History, Present and Prospect of Korean Medicine  513 Table 7–16   (Continued) Benefits

RV score

Psycho-therapy Individual psychotherapy

147.56

Psycho-therapy Psychiatric personal history taking

97.92

Psycho-therapy Family psychotherapy

195.05

Physical therapies

Hot pack

20.97

Physical therapies

Ice pack

19.81

Physical therapies

Infra-red irradiation

16.15

Chuna manual Basic therapy Complex Special

219.50 370.60 568.08

Source: Association of Korean Medicine. Korean Medicine fee schedules and coverage criteria in the National Health Insurance (Hanui Geongangboheom Yoyang Geupyeo Biyong mit Geupyeokijun), 2020.

only 1.1% of the total NHI claims, but this percentage has increased to 7.1% by 2019[35] (Figure 7–3 and Figure 7–4). The total expense attributed to Korean Medicine was only 7 million USD in 1988 but had increased to 3,012 million USD in 2019, representing 3.5% of the total expenditure of NHI. If the pharmacy portion was excluded, the total expense of Korean Medicine would represent 4.4% of the total expense resulting from all medical institutions in 2019. Although the annual treatment amount has steadily grown, the proportion of the total expense has decreased since 2000 because of the rapid growth of higherlevel general hospitals and increase in number or long-term care hospitals. The roles of hospitals and clinics have not yet been adequately divided in Korea, and therefore the growth of the use of hospitals highlights the stagnancy or decrease in use of clinics. Most institutions of Korean Medicine are clinics. With 34 years of development, the Korean Medicine insurance system can be regarded as the most advanced model in the world in terms of benefit coverage and the reimbursement scheme for traditional medicine. Korean Medicine was able to increase public use and social influence

514  History, Present and Prospect of World Traditional Medicine

Figure 7–3    Number of KM claims from the NHI. Source: National Health Insurance Service, National Health Insurance Statistical Yearbook, for each year.

Figure 7–4    Total treatment amounts for Korean Medicine in the NHI. Source: National Health Insurance Service, National Health Insurance Statistical Yearbook, for each year.

History, Present and Prospect of Korean Medicine  515

through public insurance programs. However, Korean Medicine is currently facing challenges due to public safety concerns and stagnancy in medical demand.

7.6.2  Other medical guarantees and Korean Medicine 7.6.2.1  Industrial accident compensation insurance Industrial Accident Compensation Insurance in the Republic of Korea has reimbursed the Korean Medicine service for industrial accident patients since 1997. Social attention toward Korean Medicine industrial accident insurance increased when pneumoconiosis patients in coal mine areas demanded industrial accident reimbursement for Korean Medicine treatment in the late 1980s. In Korean Medicine, the subsequent continuous community effort and social recognition of the utility of Korean Medicine for the treatment and rehabilitation of industrial accident patients has increased. Korean Medicine services are reimbursed in cases of patients with an injury who require Korean Medicine care after surgical treatments, musculoskeletal diseases such as lumbago and sprains, or occupational diseases such as cerebrovascular disease or cardiac ailment. Payment for herbal decoctions and decocting fees has been added to the previously reimbursed Korean Medicine services and herbal drug products in 2009. Korean Medicine service for industrial accident compensation insurance accounts for 1.1% of total numbers treatment from industrial accidents and 0.7% of total expense for industrial accidents.[23]

7.6.2.2  Motor insurance and Korean Medicine Medical expenses occurring from car accidents are reimbursed by motor insurance, which began to reimburse Korean Medicine care in 1999. In addition to items that are paid by national health insurance, herbal decoctions, decocting fees, Chuna manual therapy, pharmacopuncture, Digital Infrared Thermal Imaging, and physiotherapies such as hot packs, ice packs, infrared therapy, Transcutaneous Electrical Nerve Stimulation, and

516  History, Present and Prospect of World Traditional Medicine

Interference Current Therapy are currently reimbursed by motor insurance. In the past three years, Korean Medicine expenses for car insurance have increased rapidly. Korean Medicine expenses for car insurance represented 44.6% of the total expense in 2019, while sharing at only 4.4% of total health insurance expenses (except pharmacy expense). A larger proportion of Korean Medicine expenses for car insurance was due to increased popularity of Korean Medicine that primarily treated musculoskeletal patients, as well as reimbursements for herbal decoctions, which are not covered by the National Health Insurance.[23]

7.6.3  Patient classification system in Korean Medicine With the increase in use of Korean Medicine service, the management tool for appropriate Korean Medicine service is also applied to Korean Medicine service. Health Insurance Review & Assessment Agency is monitoring the service provisions of Korean Medicine hospitals and clinics via Costliness Index (CI) and Lengthiness Index (LI). To adjust patient compositions of hospitals and clinics, outpatient classification system (KOPG-KM) and inpatient classification system (KDRG-KM) for Korean Medicine were developed for the first time in the world and are utilized in the health insurance area. The KOPG-KM reorganizes the MDC classification into 25 diseases and classifies outpatients’ claims according to the provision of procedures including acupuncture, moxibustion, and cupping for each disease. Patients who did not receive the procedures belong to the consultation/medication group, those who did not get acupuncture among those who received the procedures were assigned to the non-acupuncture group, and those who used acupuncture alone or in combination with other procedures were assigned to the acupuncture group. There will be separate groups, if there is a difference in medical expenses depending on the age. Finally, outpatient claims are allocated to one of the 247 patient groups[36] (Figure 7–5). KDRG-KM, which classifies inpatients’ claims, is similar to KOPG-KM, but KDRG-KM separates the claims from admission of Korean Medicine hospitals and that of Western Medicine hospitals or long-term care

History, Present and Prospect of Korean Medicine  517

Figure 7–5  Korea Outpatient Groups for Korean Medicine (KOPG-KM).

hospitals. Korean Medicine treatments can also be provided in the Western Medicine hospitals and long-term care hospitals which have a Korean Medicine department or hire Korean Medicine doctors. KDRG-KM classifies Korean Medicine inpatients into 233 groups[37] (Figure 7–6).

7.7  Industry and R&D of Korean Medicine 7.7.1  Overview The Korean Medicine industry can be classified into the primary industry as herbal medicine cultivation, the secondary industry as herbal medicine manufacturing, medical device manufacturing, herbal cosmetics manufacturing, herbal beverage and food manufacturing, and the tertiary industry as Korean Medicine service, herbal medicine distribution, medical tourism, and research. The size of the domestic Korean Medicine and related product and service industry is on the rise from 4.7 billion USD in 2009 to 7.9 billion

518  History, Present and Prospect of World Traditional Medicine

Figure 7–6    Korea Diagnosis-Related Groups for Korean Medicine (KDRG-KM).

USD in 2017. The industry with the largest sales volume is the Korean Medicine service sector, accounting for about 50.5% of the total, followed by the manufacturing sector with 39.2%. R&D investment for Korean Medicine is steadily increasing. In 2018, the government’s investment in Korean Medicine research was about 103.5 million USD, or 0.63% of the government’s total R&D investment.[23] The Korean government enacted the “Act on the Promotion of Korean Medicine and Pharmaceuticals” in 2003 to foster the Korean Medicine industry, and based on the Act, has established a national plan for the development of Korean Medicine every five years since 2005. The plan’s vision was scientification, industrialization, and globalization of Korean Medicine, and to set up objectives including advancing Korean Medicine services, strengthening the quality control system of herbal medicines, expanding R&D support to secure core technologies of Korean Medicine,

History, Present and Prospect of Korean Medicine  519

and globalizing the Korean Medicine industry.[26] Currently, the government is promoting the third (2016–2020) national development plan to strengthen the quality control and distribution system of herbal medicines, support R&D of Korean Medicine products through technological innovation, and strengthen the international competitiveness of Korean Medicine. In order to realize the vision of the Korean Medicine development plan, the government plans to implement policies to enhance the reliability and accessibility of Korean Medicine services and products, and through this, to expand the base of the domestic Korean Medicine industry. In addition, the government intends to expand R&D to accumulate objective evidences for the safety and effectiveness of Korean Medicine, thereby contributing to the health insurance coverage of Korean Medicine and the improvement of nation’s health.

7.7.2  Korean Medicine industry 7.7.2.1  Current Status of Korean Medicine industry According to a survey of Korean Medicine-related companies nationwide in 2018[38], 29,463 companies were involved in the Korean Medicine industry at the end of December 2017, up 0.6% (186 companies) from December 2015. By major category, the number of companies/providers of Korean Medicine services increased by 4.3% (606 companies), and the number of companies manufacturing products decreased by 2.3% (299 companies). The number of employees in the Korean Medicine industry was 108,656 — an increase of 2.1% (2,265) from December 2015. By major category, the number of employees providing Korean Medicine services increased by 4.2% (2,708) and the number of employees in the manufacturing companies decreased by 10.4% (363). The total sales of the Korean Medicine industry were 7.9 billion USD — up 14.9% (1.0 billion USD) from December 2015. By major category, the sales of Korean Medicine service business increased by 17.4% (687.8 million USD) and the sales of the retail business decreased by 7.8% (10.8 million USD).

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The number of providers and employees and the sales of the Korean Medicine clinics were the largest among all business areas. Among the manufacturing industries, the liquefied food for health supplements business had the largest number of companies and employees but ginseng food business was the largest in sales (Table 7–17). Table 7–17    Statistics of Korean Medicine related industry in 2017. Number of Companies/ Providers N

Number of Employees

Percentage (%)

N

Percentage (%)

Sales Amount (million USD)

Total

29,463

—

108,656

—

7,853.3

Sub-total: Manufacturing Business

12,872

100.0

38,609

100.0

3,077.5

Ginseng Food

942

7.3

4,829

12.5

1,085.4

Herbal Beverage

246

1.9

3,350

8.7

404.1

Food Extraction and Processing

140

1.1

2,041

5.3

243.7

11,232

87.2

18,758

48.5

376.8

191

1.5

2,929

7.6

383.1

Finished Drugs Containing Herbs

7

0.1

4,715

12.2

344.3

Medical Device

49

0.4

664

1.7

52.8

Herbal Cosmetics

66

0.5

1,323

3.4

187.4

1,901

100.0

3,125

100.0

138.8

Herbal Pharmacy

928

48.8

1,590

50.9

83.6

Herbal Apothecary

972

51.1

1,535

49.1

44.3

Sub-Total: Medical Service Business

14,690

100.0

66,922

100.0

3,960.1

Korean Medicine Hospital

260

1.8

10,692

16.0

801.8

Korean Medicine Clinics

13,695

93.2

55,196

82.5

3,825.6

735

5.0

1,034

1.5

20.3

Liquefied Food for Health Supplements Herbal Medicines

Sub-Total: Retail Business

Acupuncturist, Moxibutionist, etc.

Note: Processing and packaging raw medicinal herbs, tablet, capsule, syrup, injections, and ointment, etc. Source: Korea Institute of Oriental Medicine, Korean Medicine Industry Survey report, 2018.

History, Present and Prospect of Korean Medicine  521

7.7.2.2  National Institute for Korean Medicine Development (NIKOM) The National Institute for Korean Medicine Development (NIKOM) was established in 2016 on the basis of the “Act on the Promotion of Korean Medicine and Pharmaceuticals,” and its mission is to promote the Korean Medicine related industry and contribute to public health. The budget of NIKOM was 30.99 million USD in 2019 and the number of regular workers was 81 in 2019. NIKOM is a core organization for the development and promotion of the Korean Medicine industry, and a secretariat in developing national plans for Korean Medicine every five years. In cooperation with the Ministry of Health and Welfare, NIKOM monitors and collects national data on Korean Medicine utilization and herbal medicines consumption, dedicates itself to the expansion of health insurance coverage of Korean Medicine, and accredits herbal dispensary facilities. NIKOM operates Good Laboratory Practice (GLP) facility and Good Manufacturing Practice (GMP) facility, National Medicinal Crops Seeds Supply Center for the preservation of medicinal resources, and quality certification center for herbal medicines. NIKOM also conducts basic scientific research on herbal medicines, studying new applications of Korean Medicine to chronic and incurable diseases, improving the dosage forms of herbal medicine products for easier intake and absorption. In addition, NIKOM is developing and distributing Clinical Practices Guidelines (CPG) of Korean Medicine for higher quality Korean Medicine Services through the National Clearinghouse for Korean Medicine (NCKM). Main functions of NIKOM are as follow: – To help promote the scientification and informatization of the technologies of Korean Medicine and Pharmaceutics. – To support the cultivation of good-quality pharmaceutical herbal plants used for Korean Medicine and their production and distribution.

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– To support the inheritance and development of Korean Medicine markets and to preserve and research species of pharmaceutical herbal plants used for Korean Medicine. – To develop policies for promoting Korean Medicine and Pharmaceutics and to support the establishment of comprehensive plans. – To strengthen joint cooperation and international competitiveness related to Korean Medicine and Pharmaceutics at home and abroad. – To support the industrialization of technologies related to Korean Medicine and Pharmaceutics. – To foster specialists and experts of industries related to Korean Medicine and Pharmaceutics.

7.7.3  Research & development of Korean Medicine 7.7.3.1  Current status of R&D investment Research of Korean Medicine has been conducted at universities since the 1970s, but the government started systemic R&D investment for Korean Medicine in 1994 when the Korea Institute of Oriental Medicine was established. It was expanded in 1996, as the Ministry of Health and Welfare first launched the “Research Project on the Development of Korean Medicine.” From 2004, the Korea Institute of Oriental Medicine began to receive large-scale research budgets from the Ministry of Science and ICT, and the investments from the Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety also increased[23] (Table 7–18). The government’s Korean Medicine R&D budget in 2018 was about 103.5 million won, accounting for about 0.63% of the government’s R&D investment budget of 164.8 billion USD, and about 7.8% of the healthcare R&D budget (1.3 billion USD). For five years from 2014–2018, the government-invested research fund for Korean Medicine R&D was 560.34 billion won, with an annual average growth rate of 4.9%. As of 2018, the Ministry of Science and ICT has invested the most with 63.6% of the total government’s Korean Medicine research funding, followed by the Ministry of Health and Welfare (20.0%), the Ministry of Education (6.1%), and the Ministry of Food and Drug Safety (4.2%). The 64.1% of

History, Present and Prospect of Korean Medicine  523 Table 7–18    Annual government R&D investment for Korean Medicine (million USD). 2014

2015

2016

2017

2018

Ministry of Science and ICT

54.7

56.9

56.5

56.5

65.8

Ministry of Health and Welfare

12.0

17.8

20.3

20.0

20.7

Ministry of Education

3.2

3.2

3.8

4.1

6.3

Ministry of Food and Drug Safety

2.4

3.9

5.1

4.6

4.3

Ministry of SMEs and Startups

2.8

2.4

2.8

5.0

3.5

Rural Development Administration

0.2

1.8

1.3

1.3

0.8

Ministry of Trade, Industry and Energy

5.9

5.3

4.9

1.5

0.6

Korea Forest Service

—

0.0

0.1

0.8

0.5

Ministry of Agriculture, Food and Rural Affairs

0.5

0.7

0.7

0.5

0.4

Ministry of Oceans and Fisheries

—

—

—

0.1

0.2

Others Total

—

—

—

—

0.4

81.7

92.0

95.4

94.4

103.5

Source: National Science & Technology Information Service (http://www.ntis.go.kr).

research funding supported by the Ministry of Science and ICT is being provided to the Korea Institute of Oriental Medicine, a governmentfunded research institute. The Ministry of Science and ICT mainly supports basic research and original technology development, and the Ministry of Health and Welfare supports clinical research and cooperative research between Korean Medicine and Western Medicine.[23]

7.7.3.2  Korean Medicine R&D funded by ministry of health and welfare The aim of Korean Medicine R&D funded by Ministry of Health and Welfare is to 1) promote the Korean Medicine industry and advance into the global pharmaceutical market by developing new drugs and new medical devices through non-clinical and clinical trials for empirical traditional treatments, and 2) improve public health and expand health insurance

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coverage by accumulating the scientific evidence of safety and effectiveness of Korean Medicine. – Korean Medicine advanced technology development project. In accordance with Article 5 of the Health and Medical Service Technology Promotion Act and Article 10 of the Act on the Promotion of Korean Medicine and Pharmaceuticals, a national plan for development of Korean Medicine was established in 1996. Based on the plan, the “Research Project on the Development of Korean Medicine” was launched with a government funding of 2.5 million USD in 1996, and it was converted to “Research and Development Project on Korean Medicine Technology (2010 project)” the following year. This project continued until 2009, when “Korean Medicine Advanced Technology Development Project” was launched, based on “Mid- and Long-term Plan for Fostering and Developing Korean Medicine R&D (2008–2017).” A total of KRW 129.1 million USD was invested from 1998–2018. In 2018, a total of 14.3 million USD was invested, focusing on three areas: “supporting the development of herbal preparations,” “establishing an infrastructure of clinical research for Korean Medicine,” and “clinical research for creating evidence for Korean Medicine”.[23] In 2017, as a part of the project, “Guideline center for Korean Medicine” has supported the development of clinical practice guidelines of Korean Medicine for 30 diseases. Most guidelines received the preliminary approvals from related societies, and the Integrated clinical information system to disseminate the guidelines was established. In the herbal medicine research, the effect of inhibiting lung cancer growth of herbal medicine (HAD-B) was confirmed, and the IND (Instructive New Drug) approval for a phase 2 clinical trial from the Ministry of Food and Drug Safety was granted. In the support for the development of Korean Medicine products, there have been many timely product development achievements, such as developing and launching functional materials and products using medicinal herbs and cosmetics that have the effect of improving skin problem caused by fine dusts.[26] In 2018, the project continued to promote the development of new herbal preparations and medical devices, and continued to support the

History, Present and Prospect of Korean Medicine  525

clinical research and development of clinical practice guidelines of Korean Medicine. – Project on Western Medicine-Korean Medicine Convergence Technology Development. From 2014, the “Project on Western Medicine-Korean Medicine Convergence Technology Development” began in order to develop high-tech medical technologies with high added value. To develop core technologies for convergence medicine (fusion new drug, fusion treatment technology, etc.), Western-Korean Convergence preclinical and clinical research have been supported. To receive the research grant, researchers from both Western Medicine and Korean Medicine area must participate in the research jointly.[26] Through the “Project on Western Medicine-Korean Medicine Convergence Technology Development,” new Western-Korean Medicine fusion agent (UI026) that was effective for acute and chronic bronchitis was discovered and approved for phase 3 clinical trial. In the process of investigating the mechanism of Parkinson’s disease, new candidate material for the treatment of Parkinson’s disease was discovered and two patents were registered. With the sunset of the “Project on Western Medicine-Korean Medicine Convergence Technology Development” in 2018, the “Korean Medicine Based Fusion Technology Development Project” began. This project aims to develop knowledge and technology to prevent and treat diseases by fusion of modern science and technology such as IT, BT, and NT with Korean Medicine.[26]

7.7.3.3  R&D of Korean Institute of Oriental Medicine (KIOM) KIOM, established in 1994, is the government supported research institute specializing in R&D of Korean Medicine and affiliated with the Ministry of Science and ICT. Main functions of KIOM are: R&D on Korean Medicine and establishment of infrastructure for Korean Medicine technologies, development of source technologies for diagnosis and treatment based on

526  History, Present and Prospect of World Traditional Medicine

Korean Medicine, development of core technologies for herbal medicine, establishment of infrastructure for knowledge and information on Korean Medicine, implementation of its role as a national stronghold for Korean Medicine, development of policies and strategies on Korean Medicine, research establishment and dissemination of standards for Korean Medicine technologies, and global Promotion of Korean Medicine. The budget of the KIOM increased 11.4% annually from 17 billion won in 2006 to 61.8 billion won in 2018, and the number of regular workers also increased 10.9 % annually from 78 in 2006 to 270 in 2018.[23] Since 2005, as the research expenses and manpower of KIOM increased, quantitative research results of KIOM have also increased sharply. The number of research papers listed in SCI(E) in 2018 increased by about 150% compared to 2009. Patent applications also increased significantly. In 2018, the number of patent applications was 138, including 56 overseas applications, and for patent registration, a total of 78 patents were registered, including 8 overseas patents. In addition to various researches on herbal medicine and acupuncture, KIOM developed advanced diagnosis and treatment devices such as Tongue Image Analysis System, Sasang constitutional Analysis Tool, Pulse Analysis system, and Integrated Constitutional Health Diagnosis and Stimulation System, and established Korea Constitutional Multicenter Bank (KCMB) and Korean Medicine Data Center (KDC). In the age of the 4th industrial revolution, KIOM is focusing on the convergence of Korean Medicine and AI (Artificial intelligence) technologies, and building an AI platform to systematically collect and analyze big data in Korean Medicine and develop ICT convergence technology for diagnosis and prediction.

7.8  Future directions for Korean Medicine Korean Medicine is a successful model of the modernization of traditional medicine and has achieved developments in various aspects. However, in order to further contribute to public health, the following tasks are recommended as top priorities:

History, Present and Prospect of Korean Medicine  527

7.8.1  Improving reliability of Korean Medicine through scientific evidence accumulation Since the procedures of Korean Medicine are based on the theories of pathology and diagnosis that are different from those of modern medicine, and the many individual herbal medicines and much more ingredients are combined in each herbal medicine prescription, it is difficult to fully evaluate the effectiveness and safety of Korean Medicine through modern clinical research and systematic review. Even so, the accumulation of objective evidence for Korean Medicine is very important in a situation where the evidence based on clinical research have become a key technical criterion in the decision-making of modern health and medical policy. As described in the text, over the past 20 years, the Korean government has invested heavily in clinical research in Korean Medicine. Based on the clinical evidence accumulated in these studies and the results of overseas studies, Korean Medicine clinical practice guidelines have recently been developed for 30 diseases. In the future, clinical practice guidelines should be developed systematically for more diseases and existing guidelines should be revised regularly through standard procedures. The 4th National Promotion and Development Plan for Korean Medicine (2021–2025), which is currently being led by the Ministry of Health and Welfare, will also support the clinical research on the effectiveness and safety of Korean Medicine and expand the development of clinical practice guidelines, which will contribute to improving the quality of Korean Medicine services and enhancing public reliability in Korean Medicine.

7.8.2  Innovating Korean Medicine education The establishment of the School of Korean Medicine at Pusan National University in 2008 brought an innovative change in the Korean Medicine education field that has evolved for decades. The introduction of the 4 + 4 academic system, integrated subjects, OSCE (Objective Structured Clinical Examination) and CPX (Clinical Performance Examination) performance, and Problem based learning (PBL), gave a fresh stimulus to existing Korean Medicine colleges.

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However, Korean Medicine education faces challenges that require more innovative changes. The World Federation for Medical Education (WFME) proposed “Basic Medical Education WFME Global Standards for Quality Improvement 2015 Revision (BME)” for the purpose of improving the quality of basic medical education, and the Korean Institute of Medical Education and Evaluation (KIMEE) in Western Medicine field in the Republic of Korea has reorganized the standards for evaluation of medical education in accordance with the BME standards of the WFME. Accordingly, the Institute of Korean Medicine Education & Evaluation (IKMEE) also set as the basic direction to meet the BME standards WFME in June 2018 and to maintain the level of Korean Medicine education higher than that. Considering the situation, the criteria for the evaluation of Korean Medicine education were revised (Korean Medicine Education Accreditation Standards 2021, KAS 2021) and will be implemented from 2021. It aims to maintain the level of international standards or higher for various elements of performance and competency-based education and plans to induce improvement of the curriculum of each college to strengthen the biomedical sciences, Western Medicine, humanities education, and clinical clerkship.

7.8.3  Expanding health insurance coverage for Korean Medicine With the development in the past three decades, Korean Medicine insurance system can be regarded as the most advanced model in the world in the aspects of the benefit coverage and the reimbursement scheme for traditional medicine. However, continuous quantitative and qualitative improvement is needed for the coverage of Korean Medicine health insurance. First, the rate of health insurance coverage to the treatment expense of Korean Medicine hospitals and clinics were 34.9% and 52.7% respectively in 2018, which is low compared to the 63.8% coverage rate of all medical institutions. The main reason why the coverage rate of Korean Medicine institutions is low is that herbal decoctions, which are main treatment method in Korean Medicine, are not being covered by health insurance, and the

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number of prescriptions of insured herbal medicine preparations is only 56. Fortunately, a pilot coverage project on herbal decoctions for three diseases will start from the end of 2020, but the coverage will begin in a very limited boundary that the herbal decoctions provided only at Korean Medicine clinics (not hospitals) are reimbursed and the number of uses of reimbursed herbal decoction by patient is only once a year. In the future, the reimbursement of herbal decoctions should be expanded to cover at least 30 diseases for which Clinical Practice Guidelines have been developed and the number of uses of the covered herbal decoctions should also be expanded. In addition, the number of prescriptions of herbal preparations covered by national health insurance should be expanded from 56 prescriptions to more than 200 prescriptions like other East Asian countries. Herbal acupuncture (pharmacopuncture), which is frequently used by patients, should also be paid sequentially. In terms of payment method, all Korean Medicine procedures are compensated according to Fee for Service (FFS). Considering the characteristics of Korean Medicine treatments where acupuncture, moxibustion, and cupping are usually combined for a patient, a more comprehensive compensation system needs to be introduced to increase the autonomy of Korean Medicine doctor and the efficiency of payment management.

7.8.4  Enhancing the Korean Medicine-Western medicine co-practice To promote proper co-practices, the government needs to improve related regulations to settle adequate co-practice models and interaction and education for practitioners of both medicines are necessary to facilitate communication between each other. The long-term plan needs to establish disease-specialized co-practice centers for quality care and to implement inter-institutional co-practice or intra-institutional co-practice based on each institution’s situation. Co-practice standard manual including process of consultation and co-practice, medical record management, and operation of co-practice

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committee need to be developed and continuously improved during actual execution. Many researchers point out the current reimbursement system as the largest obstacle in activating co-practice. Consultation fee on hospitalized patient is only reimbursed once a month, and subordinated treatment is uninsured if an outpatient receives treatment from both sides on the same date for the same diagnosis code under the current medical fee system. Reimbursement system should be improved so that ideal co-practice can be appropriately insured, while preventing rise in a patient’s cost burden or total medical cost. Creating a favorable environment for co-practice is necessary. Electronic medical record (EMR) created by the recent growth of IT industry helps (general) hospitals and university Korean Medicine hospitals conduct consultation and co-practice in outpatient department, which is an important environmental factor that can promote co-practice. In the future, co-practice related EMR system needs to be standardized so that joint diagnosis and treatment can be implemented, rather than just limited co-practice in simple consultation stage.

7.8.5  Promoting Korean Medicine industry and R&D In the future, it is planned to promote the R&D of Korean Medicine. First, the development of herbal medicine resources are necessary — new herbal medicine preparations, modernization of herbal medicine preparations, standardization of efficacy of herbal preparations, and herbal acupuncture. Second, preclinical and clinical research on Korean Medicine services will be continuously supported. For chronic diseases and intractable diseases, which have not many effective methods to control, the effectiveness and safety of Korean Medicine procedures will be studied. In addition, to provide infrastructure for herbal medicine R&D, a natural substance product data bank and herbal medicine bio material bank plan to be established and native herbal medicine resources will be registered. To foster Korean Medicine industry, R&D for Korean Medicine based equipment, devices, health supplements, and herbal drug quality control also need to be promoted. Based on the national plan for developing

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Korean Medicine, mid- and small-sized companies will be provided with technical support and employee training programs. National standards on Korean Medicine must be accumulated while striving to register global standards such as the ISO. The development of standards on Korean Medicine services and devices based on scientific evidence should be initiated, with domestic and international cooperation.

References   [1] Ministry of Health and Welfare. Health and Welfare Statistical Year Book [R]. Sejong, 2020.  [2] Korea Health Industry Development Institute. A Survey on Korean Medicine Utilization and Herbal Medicines Consumption[R]. 2014.  [3] World Health Organization. Programme on Traditional Medicine. Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review[Z]. 2001.  [4] Shin S. Reestablishement of Korean Medicine History. Hankook Hanuihaksaui Jaejeongrip [Z]. Daejeon: Korea Insitute of Oriental Medicine, 1995.   [5] Kim DJ. History of Korean Medicine[J]. Yongsangu: Tamgudang, 1954.   [6] Na SS. East Asian Medicine in Korea[J]. Harvard Asia Quarterly, 2012, 14(4): 44–56.   [7] Shin D. History of Modern Health Care in Korea[J]. Hanwul Academy, 1997.   [8] Lim B. Contemporary Education in Korean Medicine. Korean Medicine: Current Status and Future Prospects [M]. Busan: Pusan National University School of Korean Medicine, 2015: 113–135.  [9] Lim B. Korean Medicine Coverage in the National Health Insurance in Korea: Present Situation and Critical Issues[J]. Integrative Medicine Research, 2013, 2(3): 81–88. [10] Cho HJ. Traditional Medicine, Professional Monopoly and Structural Interests: A Korean Case[J]. Social Science & Medicine, 2000, 50(1): 123–135. [11] Cho BH. The Politics of Herbal Drugs in Korea[J]. Soc Sci Med, 2000, 51(4): 505–509. [12] Lim B. Policy and Management of Korean Medicine. Korean Medicine: Current Status and Future Prospects[M]. Busan: Pusan National University School of Korean Medicine, 2015: 85–112.

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[13] Kim Y. Therapeutic Technologies in Korean Medicine. Korean Medicine: Current Status and Future Prospects[M]. Busan: Pusan National Universtiy School of Korean Medicine, 2015: 57–83. [14] Park TY. An Introduction to Chuna Manual Medicine in Korea: History, Insurance Coverage, Education, and Clinical Research in Korean literature[J]. Integrative Medicine Research, 2014, 3(2): 49–59. [15] Yu J, Lim B. White Paper of Health Insurance Coverage for Chuna Manual Therapy [Z]. Busan: Pusan National University, 2019. [16] Koh BH. Sasang Constitutinal Medicine and Clinical Application[Z]. Seoul: Jipmoondang, 2019. [17] Kim JY, Pham DD. Sasang Constitutional Medicine as a Holistic Tailored Medicine [Z]. Evid Based Complement Alternat Med, 2009. [18] Yang BM. Health Care Policy in East Asia: A World Scientific Reference (Volume 3): Health Care System Reform and Policy Research in Korea[M]. Singapore: World Scientific Publishing Co, 2019. [19] World Health Organization. Regional Office for the Western Pacific. (2015). Republic of Korea Health System Review. WHO Regional Office for the Western Pacific[EB/OL]. https://apps.who.int/iris/handle/10665/208215. [20] Ministry of Health and Welfare. Reference Data for Main Tasks[Z]. Juyo Upmoo Chamgojaryo, 2020. [21] National Institute for Korean Medicine Development. 2017 A Survey on the Utilization of Korean Medicine[R]. 2018. [22] National Health Insurance Service. 2019 National Health Insurance Statisitcal Yearbook [Z]. 2020. [23] Publication Committee for Korean Medicine Yearbook. 2019 Yearbook of Traditional Korean Medicine[Z]. Daejeon: Korea Institute of Oriental Medicine, 2021. [24] Kim CH. The TOs of Korean Medicine Military Doctors was Filled with Western Medicine Doctors[J]. The Minjok Medicine News, 2015, 9 (5): 115. [25] Korea Health Promotion Institute. 2020 Introduction to Korean Medicine Health Promotion Program [Z]. 2019. [26] Ministry of Health and Welfare. 2017 Ministry of Health and Welfare White Book [Z]. 2018. [27] Yun Y. Korean-Western Co-practice. Korean Medicine: Current Status and Future Prospects[M]. Busan: Pusan National University School of Korean Medicine, 2015: 177–199. [28] Cho JG. Changes in Healthcare Environment and Medical Unification. Health and Welfare Issue & Focus Korea Institute for Health and Social Affairs [Z]. 2010.

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[29] Kim CB. Research on the Development of Korean Medicine-MedicineDentistry Collaborating System[R]. Seoul: Yonsei University, 2010. [30] Ministry of Health & Welfare. Introduction to the 2nd Stage of the Pilot Project for the Cooperation between Western Medicine and Korean Medicine [Z]. 2017. [31] Kwon YK. Preliminary Study on the Diseases for Co-practice Considering Treatment Effectiveness[M]. Busan: Pusan National University, 2012. [32] Kim Y. Quality Control and Regulation of Herbal Medicine. Korean Medicine: Current Status and Future Prospects[M]. Busan: Pusan National University, 2015: 137–157. [33] Association of Korean Medicine. Korean Medicine Fee Schedules and Coverage Criteria in the National Health Insurance (Hanui Geongangboheom Yoyang Geupyeo Biyong mit Geupyeokijun)[R]. 2020. [34] Division of Korean Medicine Policy, Division of Medical Security Management. Implementation of Pilot Project on Health Insurance Coverage for Herbal Decoctions[Z]. 13th Health Insurance Policy Deliberation Committee: Ministry of Health and Welfare, 2020. [35] National Health Insurance Service. National Health Insurance Statistical Yearbook [Z]. 2021. [36] Health Insurance Review & Assessment Service. Guidebook for Patients Classification in Korean Medicine. 2017. [37] Kim D, Ryu J, Lim B, et al. Assessment of Validity of Inpatient Classification System in Korean Medicine [J]. Journal of Korean Medicine, 2016. [38] Korea Institute of Oriental Medicine. Korean Medicine Industry Survey report [R]. 2018.

Appendix Act on the Promotion of Korean Medicine and Pharmaceuticals (Act No. 15910) [First version was enacted on 6 August 2003 and enforced on 7 August 2004] [The Act was partially amended on 17 October 2007, 29 February 2008, 18 January 2010, 14 July 2011, 22 October 2012, 11 December 2018]] [Recent version was enforced on 12 June 2019] Ministry of Health and Welfare (Korean Medicine Policy Division) +82–(0)44–202–2574

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Chapter 1 General Article 1 (Purpose) The purpose of this Act is to set forth the matters required to lay the groundwork and basic directions for the promotion of Korean Medicine and Pharmaceutics technology and to implement R&D related to the field to contribute to the promotion of people’s health and the development of the national economy. [Wholly amended on 22 October 2012.] Article 2 (Definitions) For the purpose of this Act, the following terms specified in this Act shall have the meaning ascribed to them herein: 1) “Korean Medicine and Pharmaceutics” shall mean any medical treatment services based on Korean Medicine as traditionally handed down from the nation’s ancestors, scientifically applied and developed Korean Medicine services, and Korean Medicine pharmaceutical affairs; 2) “Korean Medicine pharmacist” shall mean a person who is engaged in the production (growing), processing, manufacturing, dispensing, importing, selling, appraising and storing of herbal medicines or matters related to traditional Korean pharmacy technology; 3) “Korean Medicine and Pharmaceutics technology” shall mean Korean Medicine practices and pharmaceutical dispensing as well as those technology related to the relevant goods and services, including finished herbal products (which refers to remedies manufactured in accordance with the relevant Korean Medicine the same applies to the term stated (in the following Article 5) and the growing (including the development of good-quality species), manufacturing, distribution and storage of herbal preparations used for Korean Medicine and Pharmaceutics as stipulated by the relevant Presidential decree; 4) Herbal medicines are largely made from botanical extracts, but sometimes also from animal-derived extracts or minerals. They are natural medicines, in unprocessed form, whereby natural ingredients are simply dried and cut, or at times ground into a powder and rolled into a pill; 5) “Herbal preparations” shall mean a raw material that is used to make a herbal medicine or a finished herbal product. [Wholly amended on 22 October 2012.] Article 3 (Duties of Government): 1) The Government shall establish and implement comprehensive policies for the development of Korean Medicine and Pharmaceutics technology. 2) Local administrative units

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shall establish and implement policies for the development of Korean Medicine and Pharmaceutics technology in consideration of the central government’s relevant policies and of the prevailing local situations. [Wholly amended on 22 October 2012.] Article 4 (Development of Korean Medicine and Pharmaceutics Technology through Scientific Operation Based on Information Technology): 1) Both the central Government and local administrative units shall establish and implement policies for the development of Korean Medicine and Pharmaceutics technology through scientific operation based on information technology. 2) Both the central Government and local administrative units shall ensure that a sufficient number of private experts and organizations take part in the process of policy development and implementation in order to enhance the transparency and rationality of the policies related to Korean Medicine and Pharmaceutics technology. [Wholly amended on 22 October 2012] Chapter 2 Establishment of Basic Policy for the Development of Korean Medicine & Pharmaceutics Article 5 (Basic Directions for the Development of Korean Medicine and Pharmaceutics) Both the central Government and local administrative units shall establish, manage and operate policies for the development of Korean Medicine and Pharmaceutics based on the following basic directions: 1) Ensure the protection and development of its unique characteristics; 2) Lay the necessary foundations for its development; 3) Pursue the information-based development of its technology; 4) Implement systematic management and standardization based on international standards; 5) Undertake the necessary groundwork for the stable production of herbal preparations; 6) Reinforce the international competitiveness of the relevant industries and promote international cooperation; 7) Provide support for the herbal medicine market. [Wholly amended on 22 October 2012] Article 6 (Comprehensive Plan to Foster Korean Medicine and Pharmaceutics): 1) The Minister of Health and Welfare shall establish a comprehensive plan for the development of Korean Medicine and Pharmaceutics (“comprehensive plan”) every five years and have it reviewed by the Korean Medicine and Pharmaceutics Development Deliberation Committee in accordance with the following 3. 2) The

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comprehensive plan shall include the following: a) The basic objectives and directions necessary for its development; b) A system for the provision of support related to the formation of the groundwork for relevant research; c) The training of relevant manpower and instructions on how to use them; d) The enhancement of relevant technology and how to provide support for them; e) How to globalize the Korean Medicine and Pharmaceutics; f) The promotion of exchange and cooperation with Democratic People’s Republic of Korea; g) Other items pertaining to its development. 3) The Korean Medicine and Pharmaceutics Development Deliberation Committee shall be established under the control of the Minister of Health and Welfare for the review of the comprehensive plan. Matters concerning its composition and operation shall be fixed in accordance with the relevant Presidential decree. 4) The Committee shall have up to twenty members, including one chairperson and one deputy chairperson. Members who are not government officials shall make up the majority of the Committee members. 5) Other necessary matters concerning the composition and operation of the Committee for the Development of Korean Medicine under Paragraph 3 shall be prescribed by Presidential Decree. 6) The Minister of Health and Welfare shall consult with the head of the relevant central Government office prior to setting up the comprehensive plan, if he/she judges that one or more items stated in the foregoing 2 is/are related to the business of such a central Government office.

[Wholly amended on 22 October 2012.] Article 7 (Establishment and Implementation of Methods of Promotion of Major Policies) Once the comprehensive plan is established, Minister of Health and Welfare and the heads of other related government agencies shall establish and implement a rolling annual plan, drawn up every year, based on the comprehensive plan. [Wholly amended on 22 October 2012.] Article 8 (Establishment and Implementation of Regional Plan of Korean Medicine and Pharmaceutics Development): 1) Once a long-term policy plan is established, heads of local governments shall establish and implement a regional plan of Korean Medicine and Pharmaceutics

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development (hereinafter “regional plan”), in accordance with relevant laws and in consideration of local situations. 2) Heads of local governments may designate relevant institutions or organizations for the implementation of the regional plan. [Wholly amended on 22 October 2012.] Article 9 (Cooperation in Plan Establishment): 1) The Minister of Health and Welfare, the head of the relevant central Government office and the heads of local administrative units may ask for the cooperation of the relevant institutions or organizations when and if required for the establishment and implementation of the comprehensive plan, and the methods required to promote major measures and regional plans. 2) The relevant institutions or organizations stated in the foregoing 1 shall comply with such a request for cooperation, unless there is a special reason for not doing so. [Wholly amended on 22 October 2012.] Chapter 3 Promotion of Projects for the Development of Korean Medicine and Pharmaceutics Technology Article 10 (Promotion of R&D Projects for Korean Medicine and Pharmaceutics): 1) Both the central Government and local administrative units shall do their best to encourage R&D in health & industrial technology, using Korean Medicine services and herbal medicines, and provide support measures designed to commercialize Korean Medicine and Pharmaceutics technology and products and reinforce international competitiveness in the field. 2) To efficiently promote research in Korean Medicine and Pharmaceutics of related technologies, both national and local government agencies must encourage and facilitate joint or collaborative research between the industry and academia. 3) Both the central Government and local administrative units shall establish a system of clinical trials and verification for Korean Medicine services and Korean Medicine products. 4) Both the central Government and local administrative units may designate relevant institutions or organizations for the implementation of R&D, if so required for its efficient promotion as stated in the foregoing 1. 5) Both the central Government and local administrative units may provide financial support to the relevant institutions or organizations that implement R&D as stated in the foregoing 4. [Wholly amended on 22 October 2012]

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Article 11 (Establishment of a Korean Medicine and Pharmaceutics Clinical Center): 1) The Minister of Health and Welfare may establish a Korean Medicine and Pharmaceutics Clinical Center to carry out clinical trials related to Korean Medicine services and Korean Medicine products as stated in Article 10, Paragraph 3. 2) The Minister of Health and Welfare may designate a Korean Medicine service institution or a similar entity as a Korean Medicine and Pharmaceutics Clinical Center, if so required for the efficient operation of such a center as stated in the foregoing 1. [Wholly amended on 22 October 2012.] Chapter 4 Undertaking the Groundwork for Korean Medicine Industry

Article 12 (Formation of a Korean Medicine industrial complex): 1) Both the central Government and local administrative units may implement the necessary measures for the formation of an industrial complex and the provision of the relevant infrastructure for Korean Medicine, or provide administrative and financial support to private businesses intending to form such a complex. 2) Matters related to support for the development of industrial complex of Korean Medicine under Paragraph 1 shall be reviewed by the Committee under Article 6 (3). 3) The formation of an industrial complex related to Korean Medicine under Paragraph 1 shall follow Articles 6, the Article 7, the Article 7–4, the Article 10 to 13, the Article 13–2, the Article 13–3, the Article 16, the Article 16–2, the Article 17, the Article 17–2, the Article 18, the Article 19–2, the Article 20, the Article 20–2, the Article 21, the Article 26, the Article 28, the Article 37, the Article 38, and the Article 38–2 and Chapter 5 in the Act on Industrial Sites and its Developments. 4) Matters pertaining to the support of a Korean Medicine and Pharmaceutics industrial complex and the composition and operation of the Korean Medicine and Pharmaceutics Development Council as stated in the foregoing 1 and 2 shall be fixed in accordance with the relevant Presidential decree. [Wholly amended on 2012.10.22.] Article 13 (National Institute for Korean Medicine Development): 1) The Minister of Health and Welfare may establish the National Institute for Korean Medicine Development (NIKOM) to provide efficient support for the promotion of Korean Medicine technology. 2) NIKOM shall be a corporation and shall be

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established by completing at the main office location. 3) NIKOM’s articles shall include the following: a) Purposes, b) Title, c) City where its main office is located, d) Items concerning its assets, e) Items concerning its officers and employees, f) Operation of its board of directors, g) Scope, contents, and execution of its business, h) Accounting, i) Method of public notice, j) Amendment to its articles, k) Other important items concerning the operation of NIKOM. 4) Any entered matter to NIKOM’s articles shall be approved by the Minister of Health and Welfare. 5) NIKOM shall perform the following duties: a) To help promote the scientification and informatization of the technologies of Korean Medicine and Pharmaceutics as stipulated in Article 4; b) To support the cultivation of good-quality pharmaceutical herbal plants used for Korean Medicine and their production and distribution under Article 14; c) To support the inheritance and development of Korean Medicine markets and to preserve and research species of pharmaceutical herbal plants used for Korean Medicine; d) To develop policies for promoting Korean Medicine and Pharmaceutics and to support the establishment of comprehensive plans under Article 6; e) Projects to strengthen joint cooperation and international competitiveness related to Korean Medicine and Pharmaceutics at home and abroad; f) Promotion of scientification of technologies related to Korean Medicine and Pharmaceutics and projects to develop related digital contents; g) Projects to support the industrialization of technologies related to Korean Medicine and Pharmaceutics; h) Projects for fostering specialists and expert personnel for promoting industries related to Korean Medicine and Pharmaceutics; and i) Services related to the promotion and development of Korean Medicine and Pharmaceutics entrusted by the Minister of Health and Welfare and heads of related central and local government agencies. 6) The government may contribute funds required for the projects and operation of NIKOM within its budget. 7) Unless otherwise provided for NIKOM under this Act, the provisions of the Civil Act governing incorporated foundations shall apply mutatis mutandis to NIKOM. [Wholly amended on 22 October 2012] [Title amended on 11 December 2018]

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Chapter 5 Criteria for Good Quality Herbal Medicines Improvement of the Quality of Herbal Medicines Article 14 (Criteria for Good Quality Herbal Medicines): 1) The Minister of Health and Welfare may establish the criteria for the growing of good-quality of herbal preparations, and the distribution, production and management of herbal medicines (“in accordance with good-quality herbal medicine management criteria”), if such is required for the proper control of their quality. 2) The Minister of Health and Welfare may make it obligatory for pharmacies and Korean Medicine service institutions to use only those herbal preparations and herbal medicines that satisfy the goodquality herbal medicine management criteria stated [Wholly amended on 22 October 2012.] Article 15 (Improvement of the Quality of Herbal Medicines and Adoption of an Advanced Method of Distribution): 1) The Minister of Health and Welfare must design policies to help improve the quality of herbal medicines, touching different stages of their production, from the cultivation of medicinal herb crops to the manufacturing and distribution of herbal medicines, in accordance with related Health and Welfare Ministry decrees. 2) The Minister of Health and Welfare must, furthermore, commission research to assess the current status of the herbal medicine industry and develop policies and programs for improving product quality and the efficiency of warehousing and distribution systems. The scope of research must also include policies for promoting international trade and cooperation in the area. [Wholly amended on 22 October 2012.] Chapter 6 Supplementary Rules Article 16 (Governmental Support for Expenses): 1) The Government may provide the local administrative units with financial aid to cover all or part of the expenses incurred in implementing the regional plans within the limit of its budget. 2) The local administrative units may provide subsidies to agencies and organizations that perform the regional plans as set forth in Paragraph 2, Article 8. [Wholly amended on 22 October 2012.] Article 17 (Entrustment of Rights) The Minister of Health and Welfare may entrust part or all of the rights endowed to him/her under this Act to the head of the relevant institution or organization in accordance

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with the relevant Presidential decree. [Wholly amended on 22 October 2012] Article 18 (Relations with Other Laws) With the exception of those matters stipulated in this Act, matters pertaining to R&D in the field of Korean Medicine and Pharmaceutics technology shall be conducted in accordance with Health and Medical Service Technology Promotion Act. [Wholly amended on 22 October 2012.] Addenda Article 1 (Enforcement Date) This Act shall enter into force six months after the date of its promulgation. Article 2 (Transitional measures for the Committee organization): 1) When the amended provision in the latter part of Paragraph 4, Article 6 is not satisfied at the time the members of the Committee [for Review of Promotion and Development of Korean Medicine and Pharmaceutics] (“the Committee” hereinafter) are appointed or commissioned, members other than government officials shall be commissioned until the requirements in the amended provisions are satisfied. 2) Regarding the composition of the members of the Korean Medicine and Pharmaceutics Development Deliberation Committee, the previous provisions shall apply to the appointment or commission of members of the Deliberation Committee until the amended provision in the latter part of Paragraph 4, Article 6 is satisfied. The Korean Medicine and Pharmaceutics Development Deliberation Committee. Article 3 (Transitional measures for the National Development Institute of Korean Medicine-NIKOM): 1) The National Development Institute of Korean Medicine, founded with the approval of the Minister of Health and Welfare pursuant to Article 32 of the Civil Act (“NIKOM” hereinafter in this Article) may apply for the Minister’s approval to have the new National Development Institute of Korean Medicine, founded pursuant to the amended provisions of Article 13, inherit all its assets, rights, and duties based on a resolution by its board of directors. 2) Upon obtaining approval from the Minister of Health and Welfare pursuant to Paragraph 1, NIKOM shall be deemed to have been dissolved at the time the new Institute under this Act is founded, notwithstanding the provisions of the Civil Act concerning the dissolution or liquidation of corporations, and all the assets, rights, and duties that belonged to NIKOM shall

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inclusively be inherited by the new Institute. In such case, the title of NIKOM as indicated for its assets, rights, and duties on the register or other official records shall be deemed to be under the title of the new Institute. 3) The officers and employees of NIKOM at the time the new Institute is founded shall be deemed to be the officers and employees of the new Institute. 4) The value of the assets inclusively inherited by the new Institute pursuant to Paragraph 2 shall be their book value at the time of inheritance.

© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_0008

Chapter 8

History, Present and Prospect of Traditional Chinese Medicine Yan Shiyun, Chen Liyun, Zhou Min, Xu Shuang, Zhang Huaiqiong, Zhao Zhiping, Su Jinying, Nie Aiguo, Han Chouping

Abstract Traditional Chinese Medicine (TCM) is a treasure of Chinese civilization, embodying the wisdom of the nation and its people. It is also a key component of traditional medicines in the world. This chapter aims to introduce TCM in three aspects: its origin and history of development, its fundamental theories as well as skills and practices in disease diagnosis and treatment, along with current status on national policies, regulation and new progress in education, research, industry, standardization, internationalization, and cultural perspective, and prospect of its further development and promotion. Keywords: Traditional Chinese Medicine, history, current status, future prospect

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Introduction Traditional Chinese Medicine (TCM) is a treasure of Chinese civilization embodying the wisdom of the nation and its people. It is also a key component of traditional medicines in the world. This chapter aims to introduce TCM in five parts: Part I “The Sprouting, Formation and Development” reviewing the origin and development of TCM, Part II “The Fundamentals and Concepts of TCM” expounding the main theories and thoughts of TCM, Part III “TCM Healthcare Skills and Practices” introducing various diagnosis and treatment techniques and health-preserving ideas of TCM, Part IV “Current Status of TCM” introducing the current status of TCM development systematically and comprehensively, and Part V “Future Directions for TCM” analyzing the development and future of TCM in the new era. It is hoped that through the contents of this chapter, the world can understand TCM, and TCM will reach out to the world, benefit the world, and play a greater role in safeguarding human health.

8.1  The sprouting, formation, and development 8.1.1  The origin of Traditional Chinese Medicine 8.1.1.1  Accumulation of medical knowledge To survive and thrive, human beings have never stopped fighting against life-threatening diseases and injuries. They accumulated therapies and experiences over time and these experiences have later become the solid foundation for the birth and development of Traditional Chinese Medicine (TCM). As one of the four great ancient civilizations of the world (together with ancient Egypt, Babylon, and India), China has a long and ancient history. Through archaeological discoveries and written records, remarkable achievements have been made in literature, literature, music, art, astronomy, calendar, history, philosophy, and medicine during the Xia, Shang, and Zhou Dynasties. The early advance in culture and science contributed to the development of TCM, while the TCM development facilitated the further progress in other fields of knowledge.

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The early medical practice can be categorized into three groups. The first is the accumulation of medicinal knowledge. There are countless medicinal animals, plants, and minerals in nature. During the practice of farming and animal husbandry, ancient people gradually gained the knowledge in identifying and knowing more medicinals and categorizing them according to their place of origin, growth period, shape, and flavor. At the same time, people came to realize they should avoid or use certain medicinals from their own experiences of mistakenly ingesting poisonous herbs (Figure 8-1 and Figure 8–2). The second is the development of medical devices. Our ancestors, during the Neolithic age, had learned to make production tools, living utensils, ornaments, weapons, and even more primitive medical tools, including the well-known bian-stones in different shapes (knife/sword, needle, cone, and pyramid) and functions (to incise, massage, hot compression, or pricking).[1]

Figure 8–1    Ivory statue of Huang Di [Qing Dynasty (1644–1911), Shanghai museum of Traditional Chinese Medicine collection].

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Figure 8–2  Picture of Shen Nong [Qing Dynasty (1910), Shanghai museum of Traditional Chinese Medicine collection].

The third is external therapy. Due to the low ability to defend against diseases or natural disasters, early human beings were susceptible to insect/beast bite and traumatic injuries. The demand for immediate treatment of pain, swelling, and traumatic bleeding led to the emergence of external therapies including tui na, pressure or applying smashed medicinal plants to the wounds, which later developed into massage, hemostasis, and bone-setting. In addition, the use of fire helped to acquire better therapeutic effects, especially in pain relief. These achievements are also associated with the later development of moxibustion.

8.1.1.2  The sprouting of TCM theories Originating in the pre-Qin period, the knowledge and philosophy of TCM can be classified into four categories. The first is the understanding about physiology and disease, such as headache, eye diseases, toothache, abdominal pain, etc., shown in inscriptions on bones or tortoise shells; some were based on physiological functions such as muteness

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(unable to speak) and some are based on symptoms such as tinnitus, diarrhea, dental caries, or nasal polyps. Apparently, these descriptions are based on close observation of the physiological functions and structures of the human body. This accumulated knowledge are fundamental to the TCM theoretical system centered on zang-fu organs, meridians, qi, and blood. The second is the understanding of etiological factors. With advanced knowledge in agriculture, astronomy and calendar, people in the Zhou Dynasty had noticed the influence of climate and seasonal changes on human health. They also noticed that emotions, environment, and lifestyles are associated with health. Although these simple observations and understandings were somewhat artistic or idealistic conclusions, and also have a considerable part of the literary color or idealized description, they did open a new door for later generations. The third is the knowledge of Traditional Chinese Medicinals. There were fewer texts on pharmacy in ancient literature, however, they recorded a large number of medicinal plants, animals, and minerals, along with descriptions of their origin, seasons of collection, and medicinal properties as well as internal (eating, drinking) or external (applying to the affected area) use. It is also worth noting the use of alcohol and decoction — the former refers to the series of fermentation processes, whereas the latter refers to decocting medicinals in water, which provided sufficient technical support for compound formulas and processing medicinals.[2] The fourth is disease diagnosis and treatment. Unlike witchcraft, people gradually learned about diagnostic methods through observation, smelling and pulse taking, supplemented by dietary therapy, medication, acupuncture, and moxibustion.

8.1.1.3  Early medicine and witchcraft Objectively speaking, TCM has evolved a long process of interactions among multiple factors. In ancient times, due to limited scientific knowledge, people were full of curiosity, uncertainty, and fear about the natural world. When there were no persuasive scientific explanations, people tended to attribute natural phenomena (including physiology and pathology of the human body) to supernatural forces that dominate the world, and further develop into belief or worship toward that power. This led to

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a series of ritualized organizations and actions, providing a realistic basis and ideological resources for witchcraft or religion. On the other hand, the slow progress and differentiation of knowledge enabled the clergy to possess all types of knowledge — they were both witches and doctors and they were responsible for the written records. Consequently, it was inevitable that the early medicine contained a part of witchcraft. Actually, this happened to many ancient human civilizations, not only to the Chinese nation. Historically, witchcraft did play a role in curing ailments and saving people’s lives (such as psychological comfort). However, it was very different from medical science and gradually separated from medicine thanks to the advanced technologies.[3]

8.1.1.4  Overview of TCM fundamentals Theories of Dao, Essence and Qi Like other early civilizations, the Chinese ancestors used unique Chinese philosophy to explore and understand the origin of the world. The hundred schools of thought during the turbulent Spring and Autumn period (770–476 BC) and Warring States period (475–221 BC) provided diverse resources for traditional medicine. The Daoism traces the origin of the world to the abstract Dao, which has a profound impact on later generations, and this specific concept has gradually become a well-known abstract concept. So is the concept of qi — because of its dispersing and intangible characteristics, Chinese ancestors used this concept to explain many natural phenomena, and over time, summarized its connotation and extension and uplifted it to one of the basic concepts in natural philosophy, developing into a unique cognition of unity between Dao and qi. As a result, the viewpoints of the natural philosophy were easily absorbed by ancient physicians. The theoretical construction of the concept of qi by traditional physicians is, in fact, an academic path to link natural philosophy with medicine. In addition, the natural qi is considered as an etiological factor and later, the theory of pathogenic qi and antipathogenic qi would be developed. Theories of Yin, Yang, and Five Elements In essence, both the yinyang theory and the five-element theory categorize all things in the universe according to their attributes and changing patterns.

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The yin-yang theory can be traced back to Zhou Yi (The Book of Changes). It is mainly used to explain the changing pattern of things with two opposite but interconnected aspects. When this pattern (such as the alternation of the day and night, the waxing and waning of the moon, etc.) has been proven time and again, it has been extended to a broader and even abstract field. Traditional medicine combines the concepts of yin and yang in natural science and philosophy, and creatively transforms them into the understanding of life and applies to clinical practice. The five-element theory comes from another Confucian classic, Shang Shu Hong Fan (the Great Plan, Book of Documents).[4] Chinese ancestors had a special but common understanding of the number “five” and used five common things in the natural world (wood, fire, earth, metal, and water) to categorize all things. Likewise, they explained their mutual-promoting and mutual-restraining interactions with the viewpoints of early natural science and philosophy.

8.1.2  TCM in the pre-Qin and Han Dynasties (221 BC–220 AD) 8.1.2.1  Social background Progress in Science, Technology and Culture The establishment of a unified country paved the way for sustainable cultural growth. The Qin and Han Dynasties witnessed further advances in science and culture, which allowed a rapid development in TCM. For example, broader land developing in agriculture enabled people to better understand the category and medicinal properties of plants; advancement in salt making, metalsmelting, and mining enabled people to make metallic tools such as iron needles and to use some minerals as medicinals such as mirabilite, brimstone and cinnabar. In addition, the pursuit of immortality, to some degree, contributed to medical progress. The knowledge in mathematical astronomy helped with the development of theories on five movements and six qi as well as etiologies. Progress in Medical System An almost complete medical system was established in the unified Qin and Han governments. The Qin government had a minister of imperial medical affairs, imperial physicians

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to serve the royal family, and assistant doctors. During the Han Dynasty, the medical regulation system included the Ministry of Rites and Ceremonies (to be in charge of the state medical affairs), Ministry of Finance (to be in charge of royal medical affairs) on the top, followed by medical officers on medicine and formulas, court physician, female court physician, office of imperial physicians, imperial physicians under the Ministry of Finance, herbalist under the Ministry of Finance, medical officers and formula officers. The Eastern Han government had one imperial physician under the Ministry of Finance to be in charge of the state medical affairs on the top, followed by one medical officer and one formula officer. There were a total of 293 staff including royal medical officer, medicinal officer, medicine-tasting officer, and chief medical officer.[5] The set-up of medical organizations and professional staff provided a basic platform for medical education and practice.

8.1.2.2  Groundbreaking books for theoretical framework of TCM Huang Di Nei Jing (Yellow Emperor’s Internal Classic) Compiled over 2,200 years ago during the Warring States period (475–221 BC), the Huang Di Nei Jing is the earliest and most important written work of Traditional Chinese Medicine. It is composed of two texts — Su Wen (Basic Questions) and Ling Shu (Spiritual Pivot), each of 81 chapters or treatises in a question-and-answer format between the mythical Yellow Emperor and six of his equally legendary ministers. This book covers the theoretical foundation of Chinese Medicine (essence, qi, spirit, yin, yang, five elements, etc.), its diagnostic methods, etiological factors, pathogenesis, pattern identification, treatment strategies, acupuncture therapy, and health preservation.[6] Shang Han Za Bing Lun (Treatise on Cold Damage and Miscellaneous Diseases) Compiled by Zhang Zhongjing (about 150–219) in the late Eastern Han Dynasty, the Shang Han Za Bing Lun was unfortunately lost in history due to war. The part about cold diseases was collected by Wang Shuhe, an imperial doctor in the Western Jin Dynasty, and known as Shang Han Lun (Treatise on Cold Diseases). Since it covers the theory, therapeutic principles, and prescriptions for the treatment of exogenous

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diseases, it was and is still of great importance in medicine. The part about miscellaneous diseases in the original book was later on compiled into another book known as Jin Gui Yao Lue (Synopsis of Golden Cabinet). This book established the principle, therapy, prescription, and ingredients in treating diseases as well as eight major methods — sweating, vomiting, purging, warming, clearing, harmonizing, reinforcing, and draining. In addition, it recorded 269 formulas with high-quality compatibility of ingredients and modifications. Most of these formulas are still popular today and known as classic formulas, and Zhang Zhongjing is honored as the father of Chinese herbal formula.[7] Shen Nong Ben Cao Jing (Shennong’s Classic on Materia Medica) As the oldest surviving Chinese materia medica, the Shen Nong Ben Cao Jing is a compendium of all the herbs that were in use during the Eastern Han Dynasty. This book did not have a single author or represent one person’s perspective or experience but was rather put together by an unknown number of authors over a period of time, and credited to Shen Nong. It recorded 365 medicinals, including 252 medicinal plants, 67 medicinal animals, and 46 medicinal minerals. The 365 medicinals were categorized into three groups according to their properties and functions — superior, average, and inferior. Many scholars state that this tripartite organization represents a theoretical framework that explains how to use herbs in clinical practice. In addition, this book also covered the theories on jun (chief), chen (assistant), zuo (envoy), shi (messenger), seven compatibility methods, four properties, five flavors, and collecting, processing, and quality evaluation of herbs. It is also worth noting that the idea of pursuing immortality and divination combined with mystical Confucianism belief in the book had a negative influence[8] (Figure 8–3). Huang Di Ba Shi Yi Nan Jing (Yellow Emperor’s Classic on EightyOne Difficult Issues) This book, often abbreviated as Nan Jing (Classic on Difficult Issues), is an ancient Chinese medical classic compiled probably during the Western Han Dynasty (202 BC–8 AD). This book discussed 81 issues using a question-and-answer format, including pulse diagnosis, zang-fu organs, yin-yang, five elements, diseases, Ying-nutrients and Weidefense, acupuncture points, acupuncture and moxibustion, Sanjiao, Mingmen (the vital gate), and eight extraordinary meridians, along with detailed explanations on human physiology, anatomy, syndrome, or

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Figure 8–3    Bronze mortar and pestle [Han Dynasty (220–206 BC), shanghai museum of Traditional Chinese Medicine collection].

diagnosis. Above all, one of the most brilliant contributions of this book is the pulse diagnosis from the wrist (Cunkou), which made a foundation for the later theories on meridians, Mingmen (vital gate) and Sanjiao.[9]

8.1.3  TCM in the Wei, Jin, Southern & Northern, Sui, Tang, and five dynasties (220–960) 8.1.3.1  Impact of humanities on TCM After the Wei and Jin Dynasties (220–420), the medical field was widely penetrated by the ideas and concepts of Metaphysics, Daoism, and Buddhism. Due to the growing crisis and social conflicts between the late Eastern Han to the Wei and Jin Dynasties, the Metaphysics characterized by nihilism and negativity started to replace Confucianism among some scholars, including He Yan, Wang Bi, and Seven Sages of the Bamboo Grove (seven literati secluded themselves in a bamboo grove — Ji Kang, Ruan Ji, Shan Tao, Liu Ling, Xiang Xiu, Wang Rong, and Ruan Xian). They had farreaching influences in the conception of value, thought and attitude to life, aesthetic appreciation, and style of literature creation. Originating in ancient India and introduced to China during the Eastern Han Dynasty (25–220), Buddhism developed rapidly since the Wei, Jin, Southern and Northern Dynasties, with monks and temples across China. The spread of Buddhism in China inevitably experienced

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the process of indigenization. The well-structured Buddhist institutions, to a certain extent, shouldered the function of healthcare. In addition to preaching, monks such as Zhi Facun and Zhu Qian also practiced medicine and wrote medical books. Unfortunately, these books were lost. As a localized religion, Daoism flourished in this period because of the strong support from the rulers. The Dan Ding school of Daoism were more concerned with longevity and immortality than with the making of gold and was naturally involved with finding the Elixir of Immortality and with prescriptions for prolonging life. Despite its absurd purpose, the alchemy practice promoted the progress in the processing of herbal medicine. Eminent physicians including Ge Hong and Tao Hongjing are closely associated with Daoism.

8.1.3.2  Overview of TCM achievements There were two types of medical achievements in this period: one is the collation of previous medical classics and the other is the accumulation of clinical experience.

8.1.3.3  Collation of the Huang Di Nei Jing During the Sui and Tang Dynasties, Quan Yuanqi from the Southern Dynasty, Yang Shangshan from the Sui-Tang Dynastie, and Wang Bing from the middle Tang Dynasty collated and annotated the Huang Di Nei Jing. The Huang Di Nei Jing Tai Su (Grand Simplicity of “The Yellow Emperor’s Inner Classic”) compiled by Yang Shangshan, is the earliest annotated version of Huang Di Nei Jing, which reclassified the 81 chapters in Su Wen (Basic Questions) and Ling Shu (Spiritual Pivot) into 19 categories and a number of sub-categories according to their contents. In addition, his annotations were based on ancient classics and of great academic significance. The Bu Zhu Huang Di Nei Jing Su Wen (Supplemented Annotations to Basic Questions, Yellow Emperor’s Internal Classic) was compiled by Wang Bing, who made a major adjustment to the order of the original book through deleting repetitions and merging the similar contents into 81 chapters according to health preservation, yin-yang, zang-fu organs,

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diagnosis, syndromes, meridians, and treatment methods. In addition, he highlighted the idea of prevention and supplemented seven chapters on five movements and six qi.[10]

8.1.3.4  Collation of the Nan Jing The Ba Shi Yi Nan Jing (Classic on Eighty-one Difficult Issues), adapted and annotated by Lǚ Guang, is the earliest annotation on Nan Jing (Classic on Difficult Issues). In addition, Yang Xuancao supplemented some notes in Huang Di Ba Shi Yi Nan Jing Zhu (Annotations to Yellow Emperor’s Eighty-one Difficult Issues). Unfortunately, these two books have been lost and some fragments could be found in Nan Jing Ji Zhu (Collected Annotations to Classic on Difficult Issues) by Wang Jiusi from the Ming Dynasty (1368–1644).

8.1.3.5  Chao Yuanfang and Zhu Bing Yuan Hou Lun Chao Yuanfang (550–630), an eminent physician during the Sui and Tang Dynasties, summarized the achievements of etiology, pathogenesis, and syndromes before the 7th century and completed the 50 volumes of Zhu Bing Yuan Hou Lun (Treatise on the Origins and Manifestations of Various Diseases), which covered 67 categories and 1,739 diseases, including their diagnosis and prognosis as well as a relatively brief treatment. This masterpiece is the first known extant treatise on etiology and syndromes in China. It has been directly or indirectly cited by Qian Jin Fang (Important Formulas Worth a Thousand Gold Pieces), Wai Tai Mi Yao (Arcane Essentials from the Imperial Library), Tai Ping Sheng Hui Fang (Formulas from Benevolent Sages Compiled during the Taiping Era), and Sheng Ji Zong Lu (Comprehensive Recording of Divine Assistance). In the Song Dynasty, the book was listed as a compulsory book for professional doctors and a subject for national medical examination.[11]

8.1.3.6  Sun Simiao and Qian Jin Fang The Bei Ji Qian Jin Yao Fang (Important Formulas Worth a Thousand Gold Pieces for Emergency) and Qian Jin Yi Fang (Supplement to

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“Important Formulas Worth a Thousand Gold Pieces”) were written by Sun Simiao (581–682), a great physician in the Tang Dynasty, whose native place was Jingzhao Huayuan (now Tongchuan City, Shaanxi Province). Printed in 652, the Bei Ji Qian Jin Yao Fang was a comprehensive treatise on the practice of medicine in 30 chapters. The introduction to the book (Chapter 1) describes the characteristics of a great physician and inappropriate conduct, especially the desire for wealth or reputation. Printed in 682, the Qian Jin Yi Fang was a supplement to the Bei Ji Qian Jin Yao Fang, which recorded 30 years of Sun’s own experience with special attention to folk remedies. Sun initiated the study of Shang Han Lun (Treatise on Cold Damage) from the formula, syndrome, and treatment. The Bei Ji Qian Jin Yao Fang recorded over 6,500 medical prescriptions — including past prescriptions, folk prescriptions, ethnic minority prescriptions, and foreign prescriptions. It is also worth noting that Sun Simiao wrote several books on Daoist alchemy, giving advice on regular and moderate lifestyles for health preservation.[12]

8.1.3.7  Wang Tao and Wai Tai Mi Yao Wang Tao (670–755), the author of Wai Tai Mi Yao (Arcane Essentials from the Imperial Library), had worked in the National Library for a long time and therefore had access to previous medical classics. It took him more than 10 years to compile this book. This book consists of 40 chapters and 1,140 conditions involving internal medicine, ENT, sores or ulcers, metallic wounds, and wind, along with animal diseases, patent formulas (pills, powder), and acupuncture. Since all cited documents were marked with the book names and chapter numbers, this book preserved many previous medical literatures.[13]

8.1.3.8  Books on Materia Medica Since the Wei, Jin, and Southern and Northern Dynasties, there was an urgent demand to correct the errors and omissions in the Ben Cao Jing Ji Zhu (Collective Commentaries on the Classic of Materia Medica) compiled by Tao Hongjing (456–536).

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In 657, with the support of the Tang government, Su Jing (599–674), a pharmacist in the Tang Dynasty organized a team of 20 people to compile the Xin Xiu Ben Cao (Newly Revised Materia Medica). The book was completed in 659. This book consists of three parts (main body, medicinal picture, and illustrated descriptions), 54 chapters, and 844 medicinals. It is the first pharmacopoeia published by the Chinese government and is widely considered as the first pharmacopoeia in the world. The information regarding the medicinal property, flavor, origin of production, functions, and indications came from the collection and collation organized by the Tang government. The book even included some foreign medicinals. As a result, this book is of high academic and scientific value. In addition, Li Xun, a descendant of Persian immigrants during the late Tang and Five Dynasties, wrote a book called Hai Yao Ben Cao (Materia Medica from the [Southern] Seaboard Area), which consists of six chapters and 124 medicinals (including those imported from overseas but cultivated in China), such as Olibanum and spikenard (that can be used for medicinal purposes but also for beauty and seasoning).

8.1.4  The Song, Jin, and Yuan dynasties (960–1368) 8.1.4.1  Social background The Northern Song Dynasty paid much more attention to medicine than the previous dynasties. The government established medical institutions (e.g., the Imperial Medical College, the Bureau for Imperial Medical Affairs, the Imperial Pharmacy, the Imperial Medical, the Bureau for Revising Medical Books, and the Bureau of Imperial Pharmacy and Dispensary) to perform medical administrative duties across the country and formulate medical system and regulations. In addition, the government selected a large number of medical personnel to develop medical education, collected medical books and medicinal specimen, and revise medical classics. These measures provided an institutional guarantee for medical development and were thus copied by later dynasties, for example, the Imperial Academy of Medicine established in the Jin Dynasty (1115–1234) had a great impact on medical administrative system in the later Yuan (1271–1368), Ming, and Qing Dynasties (1271–1368).

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At the social level, many scholars chose to study and practice medicine, which uplifted the knowledge structure and clinical treatment of medical professionals. This period witnessed a qualitative leap of medical development. Economically, through a long period of development, the vast areas of southern China became the economic center. The rapid progress in agriculture, handicrafts, industry, commerce, and manufacturing, provided a solid foundation for the development in science, education, and culture. Additionally, the Maritime Silk Road played a tremendous role in importing a large number of medicines from foreign countries, especially spices that are widely used to transform dampness, circulate blood, and resolve stasis. The typography, compass, and gunpowder are well-known examples of rapid progress in science and technology in the Song Dynasty. The progress in printing technique accelerated the publishing of medical books and helped to preserve ancient medical classics. In addition, the Song Dynasty also experienced outstanding achievements in astronomy and calendar, mathematics, physics, biology, agriculture, geology, geography, shipbuilding, meteorology, chemistry, smelting and casting, weaponry, water conservancy, construction, and medicine.

8.1.4.2  TCM achievements The Song, Jin, and Yuan dynasties (960–1127) witnessed a rapid development in medicine and unprecedented academic groups and discussions on fundamental theories. Representative figures included Liu Wansu, Zhang Yuansu, Zhang Congzheng, Li Gao (aka Li Dongyuan), Wang Haogu, Chen Yan, and Zhu Zhenheng (aka Zhu Danxi).

8.1.4.3  Yang Jie and Cun Zhen Tu After observing the internal organs inside the chest and abdomen of executed criminals, Yang Jie and the painter painted the Cun Zhen Tu (Anatomical Atlas of Truth), which showed their front, back, and side views as well as the locations of different systems. This atlas quickly replaced the previous Ouxi Fan Wu Zang Tu (OuXifan’s Anatomical

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Illustrations) and was used until the early Qing Dynasty (1644–1912). In addition, anatomical knowledge on skeletons and internal organs were also recorded in other texts such as the Sheng Ji Zong Lu Gu Kong Xue Fa (Location of Points on the Bones and Joints, Comprehensive Recording of Divine Assistance), Xi Yuan Ji Lu (Records for Vindication), Shi Yi De Xiao Fang (Effective Formulas from Generations of Physicians), and Yuan Shi (History of Yuan Dynasty).

8.1.4.4  In-depth study of classics There were numerous books on the in-depth study of Huang Di Nei Jing (The Yellow Emperor’s Internal Classic) during the Song, Jin, and Yuan Dynasties (960–1127). These books were more than collation and annotation but rather explanations from different perspectives and clinical experience, which greatly uplifted the study quality. Examples included Liu Wansu’s Su Wen Xuan Ji Yuan Bing Shi (Explanation of Mysterious Pathogeneses and Etiologies Based on the “Basic Questions”), Su Wen Bing Ji Qi Yi Bao Ming Ji (Collection of Writings on the Mechanism of Disease, Suitability of Qi, and the Safeguarding of Life as Discussed in the “Basic Questions”), and Huang Di Su Wen Xuan Ming Lun Fang (Formulas from the Discussion Illuminating the Yellow Emperor’s Basic Questions). Hua Shou (aka Hua Boren, 1304–1386) summarized the essential contents of Su Wen (Basic Questions) into 12 categories and compiled the Du Su Wen Chao (Notes from Reading the Basic Questions). Hua Shou also contributed to the promotion of Nan Jing (Classic on Difficult Issues). His Nan Jing Ben Yi (The Original Meaning of the “Classic of Difficult Issues”) collected literatures on Ling Shu (Spiritual Pivot), Su Wen (Basic Questions), and books of Zhang Zhongjing and Wang Shuhe, and is therefore regarded as the most important work on Nan Jing before the Yuan Dynasty (1271–1368). In addition, Li Yuanli, Ji Tianxi, Li Fei, and Zhang Yuansu also wrote books on Nan Jing, however, these documents were lost.[14] After revisions and reprinting, the Shang Han Lun (Treatise on Cold Damage) was listed as a compulsory course for formulas and pulses by the Imperial Medical Bureau. Many doctors conducted systematic study on Shang Han Lun through annotation, collation, supplementation, and

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clinical practice. This led to the formation of Shang Han school with more than 75 books in this area. In addition, Wang Zhu (997–1057), a scholar in the Imperial Academy, obtained three volumes of Jin Gui Yu Han Yao Lue (The Jade Case Essentials from the Golden Cabinet). Later, Lin Yi, Gao Baoheng, and Sun Qi deleted the first volume “identification of cold damage” and compiled the second and third volume into Jin Gui Yao Lue Fang Lun (Formulas and Explanations from “Essentials from the Golden Cabinet”), which greatly benefited the later generations.

8.1.4.5  Innovative development of theories on etiology and pathogenesis Before the Song and Jin Dynasties (960–1234), discussions on etiological factors were basically based on the theories in Zhu Bing Yuan Hou Lun (Treatise on the Origins and Manifestations of Various Diseases). Chen Wuze (1121–1190), a physician in the Southern Song Dynasty, classified etiological factors into three types — externa (six pathogenic factors), internal (seven emotions), and neither external nor internal (improper diet, overexertion, sexual indulgence, and traumatic injuries). He also emphasized the interactions among pathogenic factors as well as their complex changes. The theory of the “three causes” broke the old etiological theory that lasted hundreds of years. In the Song Dynasty (960–1279), the pathogenesis was more about preponderance of yin/yang or ascending and descending of qi activity. Physicians with innovative ideas such as Liu Wansu, Zhang Yuansu, Zhang Congzheng, Li Gao, and Zhu Zhenheng, further developed the theory of pathogenesis. Specifically, Liu Wansu believed wind, cold, dampness, and dryness can all transform into fire and extreme heat can generate internal wind; Zhang Congzheng believed disease or illness is caused by pathogenic factors attacking the upper, middle, and lower parts of the body; Li Gao believed internal damage to the spleen and stomach is associated with almost all diseases; Wang Haogu especially emphasized deficiency of yang qi in dysfunctions of zang-fu organs and developed his yin syndrome theory; Zhu Zhenheng believed that “yang is often in excess whereas yin is often in insufficiency” and developed his ministerial fire theory, believing that phlegm heat can general internal wind.

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8.1.4.6  Emergence of TCM Schools Prominent physicians during Jin and Yuan Dynasties were brave enough to doubt the ancient theories and come up with new theories — fire heat, internal damage to the spleen and stomach, attacking pathogenic factors, pattern identification of zang-fu organs, meridian tropism, yin syndrome, yang often in excess and yin often in insufficiency, ministerial fire, and three causes. The emergence of academic schools greatly promoted the TCM development and prosperity. Representative academic schools included the Hejian School (focusing on external pathogenic fire-heat) represented by Liu Wansu, Yishui School (focusing on zang-fu dysfunctions) represented by Zhang Yuansu, the Earth School (focusing on internal damage to the spleen and stomach) represented by Li Gao, the Attacking and Purging School represented by Zhang Congzheng, the Warming and Reinforcing School represented by Wang Haogu, and Danxi School (focusing on internal fire-heat) represented by Zhu Zhenheng.

8.1.4.7  Liu Wansu (1120–1200): Six Qi transforming into fire Liu Wansu was deeply influenced by the Su Wen (Basic Questions), Shang Han Lun (Treatise on Cold Damage), and theories of five movements and six qi. He placed particular importance on fire and heat and believed all six qi may transform into fire, which broke down the tradition of following Zhang Zhongjing’s doctrine after the Wei-Jin period (220–420). He initiated the academic contending of the Jin-Yuan period and became the predecessor of the Warm-heat theory. As a representative of the Cold and Cooling School, he stressed the importance of pattern identification. Liu Wansu is honored as the head of the four great masters and father of Hejian School.[15]

8.1.4.8  Zhang Yuansu (1151–1234): Pattern identification of zang-fu organs and meridian tropism Zhang Yuansu is younger than Liu Wansu. As the father of Yishui School, he explained the prescriptions from the perspective of five movements and six qi and focused on pattern identification of zang-fu organs. His theory on

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physiology, pathology, symptoms, progression, treatment, and prognosis has become the most important method for internal diseases. In addition, based on the recordings in Huang Di Nei Jing, Zhang Yuansu did an in-depth study on medicinal flavor, yin, yang, and meridian tropism and founded the theories on meridian tropism of medicinals and their ascending, descending, sinking, and floating, which later became the foundation of Chinese herbal medicine.[16]

8.1.4.9  Zhang Congzheng (1150–1228): Attacking pathogenic factors By integrating the essence of ancient and contemporary physicians with theories from Huang Di Nei Jing, Zhang Zhongjing, and Liu Wansu, Zhang Congzheng summarized that diseases are associated with three categories of pathogenic factors — six pathogenic qi of heaven (wind, cold, summer-heat, dampness, dryness, and fire), six pathogenic qi of earth (fog, dew, ice, hail, rain, and mud) and six pathogenic factors of man (sour, bitter, sweet, pungent, salty, bland). He advocated using sweating, vomiting, and purging methods to remove pathogenic factors and became the representative figure of the Attacking and Purging School.[17]

8.1.4.10  Li Gao (1180–1251): Internal injuries of the spleen and stomach Li Gao was a student of Zhang Yuansu. He believed that internal injuries of the spleen and stomach can do great harm to the body. He stated that an inappropriate lifestyle, overexertion, and mental stress could damage the spleen and stomach and result in other systemic diseases. He placed particular importance on mental stress. Strongly opposed to old formulas, he proposed the treatment strategies of supplementing qi, reducing fire, ascending the clear, and descending the turbid, and developed new formulas such as Bu Zhong Yi Qi Tang (Middle Jiao-Supplementing and Qi-Boosting Decoction) and Sheng Yang Tang (Yang-Ascending Decoction). He is honored as the father of Yishui School (reinforcing the spleen and stomach), which deeply influenced the warming and reinforcing theory in the Ming Dynasty.[18]

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8.1.4.11  Wang Haogu (1200–1264) and yin syndrome theory As a student of Zhang Yuansu and Li Gao, Wang Haogu studied yin syndrome from yang qi deficiency of the liver, spleen, and kidney and comprehensively explained the etiology, pathogenesis, diagnosis, and treatment of yin syndrome. His yin syndrome theory supplemented the theory of Zhang Zhongjing. As for treatment, besides the three major formulas of Zhang Zhongjing for damage to three yin — Tong Mai Si Ni Tang (MeridianUnblocking for Frigid Extremities Decoction), Dang Gui Si Ni Tang (Chinese Angelica Frigid Extremities Decoction), and Li Zhong Tang (Middle Jiao-Regulating Decoction), Wang also collected formulas to warm and reinforce the spleen and kidney such as Fan Yin Dan (Yin-Restoring Elixir), Zheng Yang San (Yang-Strengthening Powder), Fu Zi San (Aconite Powder), and Bai Zhu San (Atractylodis Macrocephalae Powder).[19]

8.1.4.12  Zhu Zhenheng (1281–1358): Ministerial fire, yang in excess and yin in insufficiency Zhu Zhenheng first studied Neo-Confucianism under Xu Qian, then studied medicine under Luo Zhiti and Liu Wansu, and also read the books of Zhang Congzheng and Li Gao. By integrating the theories of eminent physicians with his clinical practice, Zhu Zhenheng developed his ministerial fire theory and believed that yang is often in excess while yin is often in insufficiency and qi excess equals fire. Influenced by the Neo-Confucianism and the correspondence between the human and the universe, he believed that there is more movement than stillness because living humans are constantly in movement and it’s difficult to gather yin qi during the process of human birth, growth, development, and senescence; human emotion and limitless desire may stir up reckless movement of ministerial fire to consume yin essence. Zhu Zhenheng emphasized the important role of yin essence in the body and became the representative figure of Nourishing Yin School.[20]

8.1.4.13  Literature and achievements in materia medica The Song-Yuan period, especially the Song Dynasty, witnessed a major development in theories of medicinal property, including the theory on

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properties and flavors, meridian tropism, ascending, descending, sinking and floating, and meridian conduction as well as knowledge on poisonous medicinals. The Song government organized the compilation of five books on materia medica to collate and summarize the literature, folk experience, and new medicinals. A total of 1,883 medicinals were recorded — increased by 1,033 medicinals than the Xin Xiu Ben Cao (Newly Revised Materia Medica) in the Tang Dynasty, including 299 newly discovered medicinals. The publication of Tu Jing Ben Cao (Illustrated Classic of Materia Medica) and Jia You Ben Cao (Materia Medica of the Jiayou Era) is regarded as a milestone development of Chinese materia medica. The Shao Xing Ben Cao (Materia Medica of the Shaoxing Era) and Bao Qing Ben Cao (Materia Medica of the Baoqing Era) focused on the medicinal property, flavor and functions, while the Zuan Lei Ben Cao (Edited Materia Medica) and Ben Cao Ji Yi (Extension of the Materia Medica) re-edited the most valuable medicinals recorded in the Da Guan Ben Cao (Materia Medica of the Daguan Era). The Jing Shi Zheng Lei Bei Ji Ben Cao (Classified Materia Medica from Historical Classics for Emergency) by Tang Shenwei recorded 1,558 medicinals (increased by 476 medicinals than the materia medica of the Jiayou Era) from literature and historical classics before the Song Dynasty of 3,000 formulas and 1,000 formula explanations. Each herb is attached with pictures and formulas. Later, the book was modified into Jing Shi Zheng Lei Da Guan Ben Cao (Classified Materia Medica of the Daguan Era) and used as the national pharmacopeia in 1108. Then, it was remodified into Zheng He Xin Xiu Jing Shi Zheng Lei Bei Yong Ben Cao (Classified Materia Medica of the Zhenghe Era from Historical Classics for Emergency) in 1116 and Shao Xing Jiao Ding Jing Shi Zheng Lei Bei Ji Ben Cao (Classified Materia Medica of the Shaoxing Era from Historical Classics for Emergency) in 1159. In 1249, Zhang Cunhui compiled the Chong Xiu Zheng He Jing Shi Zheng Lei Bei Yong Ben Cao (Newly Revised Classified Materia Medica of the Zhenghe Era from Historical Classics for Emergency) on the basis of Kou Zongshi’s Ben Cao Yan Yi (Extension of the Materia Medica), which recorded a total of 1,748 medicinals and over 240 historical prescriptions. This book was actually an important reference for Li Shizhen’s Ben Cao Gang Mu (Great

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Compendium of Matera Medica). Many valuable books on materia medica were lost, such as Kai Bao Ben Cao (Materia Medica of the Kaibao Era), Ri Huazi Ben Cao (Ri Huazi’s Materia Medica), and Jia You Ben Cao (Materia Medica of the Jiayou Era), the Zheng Lei Ben Cao (Classified Materia Medica from Historical Classics for Emergency) fortunately survived and was of great significance to the study of materia medica. Unlike physicians in the Tang and Song Dynasties, physicians in the Jin-Yuan period made remarkable achievements in medicinal meridian tropism, ascending, descending, sinking, floating, and flavors and established a complete inference pattern based on the shape, color, property, and flavor of medicinals using the theories on qi transformation, five movements, six qi, yin, yang, and five elements. This can be seen in books such as Zhen Zhu Nang (Pearl Capsule) and Zang Fu Biao Ben Yao Shi (Prescription Format for Biao and Ben Problems of Zang-fu Organs) by Zhang Yuansu, Yao Lei Xin Fa (Inference Pattern for Classified Medicinals) and Yon Yao Xin Fa (Experience in Prescriptions) by Li Dongyuan, Tang Ye Ben Cao (Materia Medica for Decoctions) by Wang Haogu, and Ben Cao Yan Yi Bu Yi (Supplement to the “Extension of the Materia Medica”) by Zhu Danxi. These books enriched the essential theories of Chinese herbal medicine. However, the simple mechanical inference also produced negative effects on the study of materia medica.

8.1.5  TCM in the Ming and Qing Dynasties (1368–1912) 8.1.5.1  Social background During the Ming Dynasty, the Imperial Academy of Medicine strictly required that all physicians must pass on their profession to their offspring. This led to the birth of well-known families of physicians, including Chen Sicheng the author of Mei Chuang Mi Lu (Secret Record on Syphilis), Yan Jishi (aka Yang Jizhou) the author of Zhen Jiu Da Cheng (The Great Compendium of Acupuncture and Moxibustion), Wan Quan the author of You Ke Fa Hui (Elaboration on Pediatrics), Xue Ji the author of Xue Shi Yi An (Xue’s Case Records), and Gong Tingxian the author of Shou Shi Bao Yuan (Prolonging Life and Preserving the Origin) and Wan Bing Hui Chun (Restoration of Health from the Myriad Diseases).

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The Ming government appointed special personnel to cast acupuncture bronze figure during the reign of Hongwu (1328–1398) and Zhengtong (1436–1449) and made the stele of Illustrated Classic of Acupoints on the Bronze Figure in imitation of the Song Dynasty. During the reign of Emperor Daoguang of the Qing Dynasty (1821–1850), the emperor issued a decree banning the acupuncture and moxibustion department in the Imperial Academy of Medicine. In addition, the campaign of respecting classics and cultural revivalism allowed many scholars to escape from reality and concentrate on the collation, compilation, and textual criticism of ancient classics. These scholars had the spirit of seeking truth from facts, the critical spirit of doubt and denial, the creative spirit of daring to surpass the predecessors, and the academic norm of opposing plagiarism. A considerable number of comprehensive medical works were closely related to this social fashion, such as the Pu Ji Fang (Formulas for Universal Relief ), Gu Jin Yi Tong Da Quan (The Complete Compendium of Ancient and Modern Medical Works) by Xu Chunfu, Jing Yue Quan Shu (The Complete Works of [Zhang] Jing-yue) by Zhang Jiebin, and Gu Jin Yi Tong Zheng Mai Quan Shu (The Complete Collections of Ancient and Modern Medical Works) by Wang Kentang. Medical literatures organized by the Qing government such as Gu Jin Tu Shu Ji Cheng Yi Bu Quan Lu (Complete Records of Ancient and Modern Medical Works of the Grand Compendium of Books) and Yi Zong Jin Jian (Golden Mirror of the Medical Tradition) well preserved the TCM classics before the Ming and Qing Dynasties.

8.1.5.2  Enrichment and improvement of fundamental TCM theories It was a major loss to the medical field when the Ouxi Fan Wu Zang Tu (OuXifan’s Anatomical Illustrations) and Cun Zhen Tu (Anatomical Atlas of Truth) by Yang Jie were lost after the early Qing Dynasty. Wang Qingren, a Qing Dynasty physician, was strongly against the textual research methods from literature to literature. Instead, he frequently went to the execution site to observe the corpses and compiled the Yi Lin Gai Cuo (Correction of Errors in Medical Works) in 1830, which included the structures and tissues such as the common carotid artery, abdominal aorta,

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renal artery, superior vena cava, pyloric sphincter, common bile duct, pancreas, and diaphragm.

8.1.5.3  Collation and annotations of medical classics Study of Huang Di Nei Jing Thanks to the popular textual research in the Ming and Qing Dynasties, many physicians were devoted to the study of Huang Di Nei Jing (Yellow Emperor’s Internal Classic) and obtained outstanding achievements — the increase in annotations of the whole text, classified texts, and specific elaborations. For example, Zhang Jiebin (aka Zhang Jingyue), in the Ming Dynasty, compiled Lei Jing (The Classified Study of Nei Jing), which basically combines the contents of the Su Wen (Basic Questions) with that of the Ling Shu (Spiritual Pivot), rearranging them into 12 categories and adding lengthy explanations or illustrative descriptions on difficult or controversial passages. In Qing Dynasty, Wang Ang (1615–1695) selected the contents (except for acupuncture and moxibustion) in Su Wen (Basic Questions) and Ling Shu (Spiritual Pivot) and compiled them into Su Ling Lei Zuan Yue Zhu (Classified and Simple Annotations of the Basic Questions and Spiritual Pivot). In his Yi Jing Yuan Zhi (Original Purpose of Medical Classics), Xue Shengbai re-annotated Nei Jing on the basis of Zhang Jiebing’s Lei Jing (The Classified Study of NeiJin). In addition, Huang Yuanyu (1705–1758) compiled Su Wen Xuan Jie (Explanation of Unresolved Issues in Basic Questions) and Ling Shu Xuan Jie (Explanation of Unresolved Issues in Spiritual Pivot). Study of Nan Jing After Ding Deyong in the Ming Dynasty and Hua Shou in the Yuan Dynasty, Zhang Shixian in the Ming Dynasty compiled the Tu Zhu Ba Shi Yi Nan Jing (Illustrated Classic on Eighty-one Difficult Issues). The Nan Jing Ji Zhu (Annotation Collects of Classic on Difficult Issues), by Wang Jiusi (1468–1551), preserved the literature before the Ming Dynasty. More than 40 physicians conducted study on Nan Jing (Classic on Difficult Issues) and influential books including Nan Jing Jing Shi (Annotation on the “Classic of Difficult Issues”) by Xu Dachun, Gu Ben Nan Jing Chan Zhu (Elaborations and Annotations of Ancient Classic on Difficult Issues) by Ding Jin, and Nan Jing Zheng Yi (Orthodox Meaning of Classic on Difficult Issues) by Ye Lin.

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Study of Shang Han Lun The study on Shang Han Lun (Treatise on Cold Damage) flourished in the Ming and Qing Dynasties. There were three groups of scholars who focused on re-editing, preserving the conventional structure, and advocating treatment based on pattern identification respectively. Representative physicians included Fang Youzhi, Yu Chang, Zhang Suichen, Zhang Zhicong, Zhang Xiju, Chen Xiuyuan, Ke Qin, Xu Dachun, You Yi, Qian Huang, and Bao Cheng. Influential books included Shang Han Zhun Sheng (Standards for Treatise on Cold Damage) by Wang Kentang, Zhuan ji Shang Han Shi Yan Jing Fa (Experiential Treatment and Formulas on Cold Damage) by Zhang Wuren, Shang Han Wu Fa (Five Methods on Treatise on Cold Damage) by Chen Changqing, Jing Yue Quan Shu (The Complete Works of [Zhang] Jing-yue) by Zhang Jiebin, and Shang Han Lai Su Ji (Collected Writings on the Renewal of the “Treatise on Cold Damage”) by Ke Qin. Study of Jin Gui Yao Lue The study on Jin Gui Yao Lue (Essentials from the Golden Cabinet) started to gain attention in the Qing Dynasty. Influential works included Jin Gui Yao Lue Lun Zhu (The Annotated “Essentials from the Golden Cabinet”) by Xu Bin, Jin Gui Yao Lue Zhi Jie (Direct Interpretation of the “Essentials from the Golden Cabinet”) by Cheng Lin, Jin Gui Yu Han Jing Er Zhu (Annotations of the Jade Case Classic of the Golden Cabinet) by Zhou Yangjun, Jin Gui Yao Lue Fang Lun Ben Yi (Original Meanings of Medicinal Formulas from the Golden Cabinet) by Wei Litong, and Jin Gui Yao Lue Qian Zhu (Simple Annotations of “Essentials from the Golden Cabinet”) by Chen Xiuyuan. Most characteristic books included Jin Guo Yao Luo Xin Dian (Personal Standards for the “Essentials from the Golden Cabinet”) by You Yi, Jin Gui Xuan Jie (Explanation of Unresolved Issues in the “Essentials from the Golden Cabinet”) by Huang Yuanyu, and JinGui Yao Lue Ji Zhu (Collected Annotations of “Essentials from the Golden Cabinet”) by Wu Qian. Study of Shen Nong Ben Cao Jing The Study on Shen Nong Ben Cao Jing (Shennong’s Classic on Materia Medica) also flourished in the Ming and Qing Dynasties. Some physicians were devoted to the restoration and compilation of the original text, such as the Shen Nong Ben Cao Jing edited by Lu Fu in the late Ming Dynasty and an exceptional one was edited by Sun Xingyan and his student Sun Fengyi. Some physicians were devoted to explaining the mechanism of medicinals, such as the Ben Cao

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Jing Shu (Commentary on Shennong’s Classic of Materia Medica) by Miu Xiyong in the Ming Dynasty and Ben Cao Chong Yuan (Reverence for the Origin of the Materia Medica) by Zhang Zhicong in the Qing Dynasty. In addition, the Shen Nong Ben Cao Jing Bai Zhong Lu (A Hundred Records on “Shen Nong’s Classic of the Materia Medica”) by Xu Dachun and Shen Nong Ben Cao Jing Du (Readings on Shennong’s Classic on Materia Medica) by Chen Xiuyuan are of practical value in clinical use.

8.1.5.4  Formation of the Wenbing theory Epidemic diseases were rampant during the end of the Ming Dynasty. Wu Youxing (aka Wu Youke, 1582–1652) believed that epidemic pathogenic factors enter the body via the mouth and nose and then stay in Moyuan (a body part in TCM: pleuro-diaphragmatic interspace). He obtained excellent results in treating pestilence with Da Yuan Yin (Reaching Moyuan Decoction) and San Xiao Yin (Three Resolving Decoction), and then developed his Treatise on Pestilence. Dai Tianzhang then further enriched the theory by proposing the pattern identification of qi, complexion, tongue, spirit, and pulse as well as five major treatment methods (sweating, purging, clearing, harmonizing, and reinforcing). In the middle Qing Dynasty, Ye Gui (aka Ye Tianshi) diagnosed and treated febrile diseases with the principle of Wei-defense, qi, Yingnutrients, and blood, separating warm-heat diseases from cold damage. In his Wen Re Tiao Bian (Systematic Differentiation of Warm-Heat Diseases), Xue Shengbai explained the etiology, pathogenesis, pathogenic features, transmission pattern, pattern identification, and prescriptions for warmheat diseases. Wu Tang (aka Wu Jutong) emphasized the principle of treating warm-heat, damp-heat, and warm pestilence from the upper, lower, and middle jiao and proposed the treatment strategies of clearing heat in collaterals, clearing heat in Ying-nutrients, clearing heart fire, and nourishing yin with well-known formulas such as Sang Ju Yin (Mulberry Leaf and Chrysanthemum Beverage) and Yin Qiao San (Lonicera and Forsythia Powder). In his Wen Re Jing Wei (Warp and Woof of Warm-Heat Diseases), Wang Shixiong summarized the previous experiences on febrile disease and explained pathogenic summer heat, pathogenic warmth, normal/reversed transmission, and cholera.[21]

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8.1.5.5  Establishment of Wei-defense, qi, Ying-nutrients, and blood as well as pattern identification of sanjiao In the middle Qing Dynasty, Ye Gui developed the principle of pattern identification of Wei-defense, qi, Ying-nutrients, and blood. He analyzed the etiology, pathogenesis, routes of contraction, and affected sites of febrile diseases, classified the whole pathological process into four phases — Wei-defense, qi, Ying-nutrients, and blood and explained their interactions and transmissions. Wu Tang further supplemented Ye’s theory and developed pattern identification of Sanjiao, which perfected and improved the pattern identification system of febrile diseases.

8.1.5.6  Ben Cao Gang Mu and achievements in materia medica The Ben Cao Gang Mu (Compendium of Materia Medica) by Li Shizhen in the late Ming Dynasty is the most complete and comprehensive medical book ever written in the history of Traditional Chinese Medicine. The Compendium in effect epitomizes the pharmaceutical achievements and developments of Chinese Medicine before the Ming Dynasty. On the basis of his predecessors’ achievements in the pharmacological studies, Li contributed further by developing the advanced Medicinal categorization method. The contribution of this Compendium is not limited to pharmacy, but also extended to medicine, botany, zoology, astronomy, phenology, meteorology, and physics[22] (Figure 8–4). In the Qing Dynasty, Zhao Xuemin (1736–1795) compiled the Ben Cao Gang Mu Shi Yi (Supplement to “The Grand Compendium of Materia Medica”), which recorded Ya Dan Zi (Fructus Bruceae), Ji Xue Teng (Caulis Spatholobi), Dong Chong Xia Cao (Cordyceps), Tai Zi Shen (Radix Pseudostellariae), and Pang Da Hai (Radix Pseudostellariae) and proposed using the viewpoint of biological evolution to observe and understand biological changes and development. Other two books on materia medica are Ben Cao Meng Quan (Enlightening Primer of Materia Medica) by Chen Jiamo, which focused on the relationship between medicinals and their origin of production, and Dian Nan Ben Cao (Diannan Materia Medica), a book dedicated to endemic and folk

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Figure 8–4   Compendium of Materia Medica reprinted by Qian Weiqi [Published in Ming Dynasty (1640), Shanghai Museum of Traditional Chinese Medicine Collection].

medicinals in Yunnan province and first recorded Chuan Bei Mu (Bulbus Fritillariae Cirrhosae) and Tu Fu Ling (Rhizoma Smilacis Glabrae).

8.1.6  TCM in modern times China was closed to the West before 1840. However, after 1840, the ancient empire was forced to open its door to the outside world. The spread of Western learning to the East produced a great impact on TCM, which has been seeking the new historical coordinates and starting point.

8.1.6.1  Collision between TCM and Western Medicine and call for their convergence and connection Since modern times, some TCM physicians and people who agree with the integration of Chinese and Western Medicine have gradually realized that modern medicine and traditional medicine have their own advantages. Modern medicine has more strength in anatomy, physiology, bacteriology, pathology, and local lesions. It is therefore essential to upgrade and improve TCM by the means of modern science. Yun Tieqiao advocated using scientific methods to study TCM to avoid extreme outcome of abandoning medicine while preserving medications. Zhu Weiju proposed to improve the specific procedures of

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TCM — first, to absorb the essence in modern physiology, anatomy, and pathology, second, to adopt both ancient and modern pharmaceutical research methods to study medicine, and third to use modern knowledge to improve formulas, diagnosis, and treatment. Lu Yuanlei praised the efficacy of Chinese Medicine and proposed to study traditional medicine with scientific methods, using modern medicine as a reference. Shi Jinmo shared the same idea and believed in applying modern medical device to clinical treatment. Zhang Zanchen and Yu Wuyan also held similar views. Objectively speaking, this large-scale debate on TCM has not completely changed its setback through the collision between Chinese Medicine and Western Medicine. However, it had produced a far-reaching effect on the overall prospect of TCM.[23]

8.1.6.2  Non-governmental TCM societies and education In 1912, the Ministry of Education of Nanjing National Government issued a new education decree, which excluded TCM. The move sparked concern, debate, and large-scale protests across the country. Since then, people from all walks of life had given great support to the founding of TCM schools. According to incomplete statistics, during that period, more than 100 TCM schools were established by TCM supporters. Most of them were closed due to financial difficulties, however, some lasted for a long time. Examples included Shanghai School of Traditional Chinese Medicine (1915), Shanghai China Medical College (1927), Shanghai Shenzhou Medical School (1918), New China Medical College (1935), and Workshop Center Affiliated to China Acupuncture Research Society (1935). Other schools included Shanxi Medical School, Guangdong School of Traditional Chinese Medicine, Zhejiang Lanxi School of Traditional Chinese Medicine, Peking College of Traditional Chinese Medical, Sichuan College of Traditional Chinese Medicine, Tianjin Open College of Traditional Chinese Medicine, and Hunan School of Traditional Chinese Medicine. Professional TCM education or training requires corresponding teaching materials. In July 1927, TCM schools in Southeastern China held a textbook editorial committee meeting in Shanghai, agreeing to teach

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physiology, pathology, internal medicine, pharmacy, surgery, diagnosis, anatomy, Chinese language, gynecology, medical classics, pediatrics, traumatology, ophthalmology, acupuncture, general introduction to medicine, hygiene, foreign language, bacteriology, medical history, military training, tuina, forensics, obstetrics, and medical chemistry. Some TCM schools held another two textbook editing meetings in Shanghai in 1928 and 1929. However, only a few textbooks were published. Medical education and academic study will eventually return to clinical treatment. TCM hospitals established in the Republic of China are as follows: Shanghai Guangyi Hospital of Traditional Chinese Medicine founded by Ding Zezhou and his son Ding Zhongying in 1921, Hualong Hospital of Traditional Chinese Medicine (which kept the earliest document record about the ward round system of TCM graduates) also founded by Ding Zhongying in 1930, the Guangdong Hospital of Traditional Chinese Medicine founded in 1933, which was renamed as Guangdong Provincial TCM Hospital affiliated to Guangzhou College of Traditional Chinese Medicine in 1956 and then the Second Affiliated Hospital of Guangzhou College of Traditional Chinese Medicine in 1991 (which remains largest and most well-equipped TCM hospital with the longest history in China), and clinic affiliated to North China National Medical College in 1932. In addition, local TCM hospitals were also set up in Jiangsu, Guangdong, Jiangxi, Guangxi, Sichuan, and other provinces. In addition to the above-mentioned TCM education and clinical institutions, there were also non-governmental academic societies. According to statistics, between 1913 and 1947, there were more than 240 TCM associations, research societies, medical improvement societies, TCM associations, and trade unions. These institutions have made valuable contributions to TCM academic research, exchange, and development.

8.1.6.3  Publishing of TCM books and newspapers The years between 1911 and 1949 witnessed the publishing of numerous TCM books and newspapers. There were more than 250 TCM journals between 1920 and 1937, and 90 were based in Shanghai. Other journals were based in Zhejiang, Jiangsu, Guangdong, Fujian, Beijing, Hong Kong,

History, Present and Prospect of Traditional Chinese Medicine  573

and Macao. At the same time, TCM journals were also established in Singapore. Influential journals included Shaoxing Medical Journal (founded in 1908, resumed publication in 1915 and renamed as Three Three Medical Journal in 1923 until 1929), Journal of Chinese and Western Medicine founded by Gu Mingsheng in 1910 (suspended in June 1930), Shenzhou Medical Journal founded by Yu Botao and Bao Shisheng in May 1913 (suspended in October 1916, resumed publication in October 1923, suspended again in 1925 and renamed as Shenzhou Journal of Chinese Medicine in January 1932, and suspended in June 1937 because of the anti-Japanese war), Shanxi Medical Journal founded in June 1921 (published a total of 95 issues until its suspension in 1937 because of the anti-Japanese war), and Monthly Journal of Xinglin Medicine founded in January 1929 under the support of Chen Renmei, Head of Guangdong School of Traditional Chinese Medicine. Influential reference books included the Grand Dictionary of Chinese Medicine compiled by Xie Guan in 1921 (selected more than 100,000 entries from over 2,000 TCM books), the Grand Dictionary of Chinese Pharmacy compiled by Chen Cunren in 1935, Collections of Rare Medical Books compiled by Qiu Qingyuan in 1936 (selected 90 TCM classics in 12 categories), the Great Compendium of Chinese Medicine compiled by Cao Bingzhang in 1936 (collected key medical books between Wei, Jin, Ming and Qing Dynasties, along with some books written by Japanese doctors), 22 Yaoan Medical Books compiled by Yun Shujue, 72 Huanghan Medical Books by Chen Cunren, book series of Introduction to Chinese Medicine by Chen Jingqi, and books series of Guidance of Traditional Chinese Medicine and Ten Reference Books on Chinese Medicine by Zhou Yuxi.

8.1.6.4  TCM development after the founding of the People’s Republic of China After the founding of the People’s Republic of China in 1949, China has made continuous progress in TCM development, enabling it to play a unique role in safeguarding and promoting people’s health.

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Changes in TCM Administration and Functional Departments On 1 November 1949, the Ministry of Health was officially founded under the Central People’s Government, including a TCM section under the Department of Medical Affairs. In May 1953, the TCM section was upgraded to TCM Department and then to TCM Bureau in November 1953. In October 1978, the TCM Bureau was restored. In 1995, the Bureau of Drug Administration, Ministry of Health set up six departments — comprehensive regulation, standard registration, Chinese Medicine, biological products, the management of special drugs, and medical equipment management. At the same time, the department of drug administration had been established under the health bureau of all provinces, municipalities, and autonomous regions, along with the department/section of drug administration in all prefectures, cities, and autonomous prefectures. Sections of drug administration and personnel are available even in the county level. TCM Research Institutions Since the middle 1950s, national and local research institutes for TCM, Chinese material medica, acupuncture, traumatology, and integrative medicine have been established to conduct in-depth study on TCM fundamentals, clinical treatment, Chinese medicinal preparations, and new medicines. In December 1955, the Research Academy for Traditional Chinese Medicine was established in Beijing, which was renamed as the Research Academy for Chinese Medicine and Pharmacology in 1985. At the same time, TCM research institutions have also been founded in all provinces, municipalities, and autonomous regions. In July 1992, the State Administration of Traditional Chinese Medicine set up key research offices and the center for Chinese Medicine literature search. Pharmacopoeia of People’s Republic of China In 1950, a total of 72 well-known medical experts were appointed by the Ministry of Health for the Chinese Pharmacopoeia Commission. Then, the Pharmacopoeia of People’s Republic of China was published in 1953, 1963, 1977, 1985, 1990, 1995, and 2000. This Commission was listed as an organization directly under the Ministry of Health and responsible for six editions of the Pharmacopoeia of People’s Republic of China (1953, 1963, 1977, 1985, 1990 and 1995). In 1984, the Law of the People’s Republic of China on Drug Administration was issued and came into effect on 1 July 1985.

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In 1953, the Ministry of Health organized the compilation of the Handbook of Chinese Herbal Medicine. In 1963, the Ministry of Health formulated the review and approval methods for new medicines. In 1979, the Ministry of Health and State Drug Administration co-formulated the Management of New Drugs, which states that all new drugs be reviewed and approved by the Ministry of Health.

8.1.6.5  Academic societies of TCM Since 1950s, academic societies of TCM, acupuncture and integrative TCM and Western Medicine have been founded, including China Association of Traditional Chinese Medicine (CACM), which was known as All China Association of Traditional Chinese Medicine in May 1979. After 1981, many second or third level CACM societies have been founded, including CACM society of Internal Medicine. In 1985, the China Association of Acupuncture and Moxibustion (CAAM) was founded upon the approval of the State Commission for Restructuring Economy. In November 1981, the Chinese Association of the Integration of Traditional and Western Medicine was founded and affiliated to Chinese Academy of Chinese Medical Sciences. In 1990, the association was renamed as Chinese Association of Integrative Medicine upon the approval of China Association for Science and Technology.

8.1.6.6  TCM publishing Since 1949, the People’s Medical Publishing House and Associated Science and Technology Publishing Houses have published numerous TCM classics and books. After 1982, publishing houses dedicated to TCM were founded, including the Publishing House of Ancient Chinese Medical Books, China Press of Traditional Chinese Medicine, and Shanghai University of Traditional Chinese Medicine Press. Important TCM journals include Journal of Traditional Chinese Medicine (founded in January 1955), Journal of Traditional Chinese Medicine (English version, founded in July 1981), Chinese Traditional and Herbal Drugs (founded in January 1980), the Journal of Integrating Chinese with Modern Medicine (Chinese version, founded in July 1981),

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Chinese Acupuncture & Moxibustion (founded in August 1981), Chinese Acupuncture & Moxibustion (English version, founded in January 1994), Education of Chinese Medicine (founded in January 1982), and the Journal of Chinese Medicine Information on Traditional Chinese Medicine (founded in June 1986). In addition, all levels of TCM association, acupuncture and moxibustion association, integrative medicine association, TCM universities, TCM research institutes, and TCM hospitals have established academic journals.

8.1.6.7  TCM education Upon the approval of the State Council, four TCM colleges were established in Beijing, Shanghai, Guangzhou, and Chengdu in 1956. At the same year, Nanjing School of Traditional Chinese Medicine was renamed as Nanjing College of Traditional Chinese Medicine. Then, TCM colleges were established in other provinces, along with TCM departments in some military or medical colleges. Upon the approval of the Ministry of Education, Beijing College of Traditional Chinese Medicine and Shanghai College of Traditional Chinese Medicine were renamed as Beijing University of Chinese Medicine and Shanghai University of Traditional Chinese Medicine in December 1993, followed by the renaming of Guangzhou University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Nanjing University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, and Heilongjiang University of Traditional Chinese Medicine. The postgraduate education in TCM started in 1978. The Master degree programs, doctorate degree programs and post-doctoral research stations have been developed in China Academy of Chinese Medical Science, Beijing University of Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Nanjing University of Traditional Chinese Medicine, Guangzhou University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, etc. To better develop TCM education, the State Administration of Traditional Chinese Medicine has organized the compilation of many high-quality TCM textbooks since 1959.

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8.1.6.8  Policies and measures on TCM development As a great treasure of China, TCM has done significant contribution to the health and prosperity of Chinese nation. In 1958, Chairman Mao said, “Traditional Chinese Medicine is a great treasure house and efforts should be made to explore them and raise them to a higher level.” The Chinese government placed emphasis on uniting Chinese and Western Medicine as one of its four guidelines for health work and enshrined the important role of TCM. After the Third Plenary Session of the 11th CPC Central Committee in 1978, Deng Xiaoping said, “efforts have to be made to support the development of TCM.” Other party and state leaders including Jiang Zemin and Hu Jintao all showed their strong support for polices regarding the promotion of TCM. The recent years have witnessed more supportive policies and action plans for further development of TCM. Since the 18th CPC National Congress, Xi Jinping has made a series of statements regarding TCMrelated work, focused primarily on the contemporary challenge of preserving, innovating, and developing TCM. In these statements, he has fully affirmed the unique strengths and applications of TCM and offered thorough answers to fundamental and forward-looking questions such as how TCM should be understood, developed, and shaped in the new era. He has therefore offered a source of fundamental reference and a guide to action for TCM-related work by setting out a clear direction, a blueprint, and a set of tasks for preserving, innovating, and developing TCM in the new era. On 24 April 2015, the General Office of the State Council issued the Development Plan for TCM Health Service (2015–2020) to boost the use of TCM in health preservation, rehabilitation, elder care, and cultural and healthy tourism. Later, 12 departments including the Ministry of Industry and Information Technology and the State Administration of Traditional Chinese Medicine co-formulated the Protection and Development Plan for Chinese Medicine (2015–2020). After 1949, China has made continued improvement in boosting the overall strength of its public health and medical services and successfully controlled infectious diseases, parasitic diseases, and endemic diseases. In March 2016, the 13th 5-year plan included promoting TCM inheritance and development, facilitating TCM industry innovation, and

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accelerating standardization of TCM pharmaceutical industry. In August 2016, the 13th 5-year plan on medicine and health stated nine priorities including enhancing TCM inheritance and innovation, expanding TCM service and promoting its overseas development.[24] In July 2017, the Law of the People’s Republic of China on Traditional Chinese Medicine came into effect. This Law is developed for purposes of inheriting and carrying forward Traditional Chinese Medicine, guaranteeing, and promoting the development of the Traditional Chinese Medicine undertaking and protecting the health of the people. In 2018, the overall goals for TCM development included paying equal attention to TCM and Western Medicine, carrying forward innovative development of TCM, implementing the strategic outline for TCM development, facilitating, and deepening the TCM reform, promoting the TCM service quality and capacity, and making new contribution to the building of healthy China and a moderately prosperous society in all respects. On 24 July 2019, Xi Jinping, general secretary of the CPC Central Committee, presided over the meeting for deepening overall reform. The meeting reviewed and approved a guideline on promoting the TCM inheritance, innovation, and development and issued the Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine. On 25 October 2019, Xi Jinping said in an instruction that we must follow the patterns underlying the development of TCM, and carry on its essence by preserving effective practices while pursuing innovations. In addition, we should speed up the modernization and industrialization of TCM. Equal importance should be placed on both TCM and Western Medicine to allow them to complement each other and develop in a coordinated manner. Xi also called for the unique role of TCM in disease prevention and treatment to come into full play and allow it to contribute to the building of a healthier nation and achieving the Chinese dream of national rejuvenation. TCM combines profound philosophical wisdom with thousands of years of the Chinese nation’s knowledge and practical experience on health. It is the crown jewel of ancient Chinese science and the key that

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unlocks the vast treasure trove of Chinese culture. In-depth study of TCM is of great significance to enrich the world medicine and advance the study in life science.

8.2  The Fundamentals and Concepts of TCM During its course of development spanning a couple of millennia, TCM has kept drawing and assimilating advanced elements of natural science and humanities. Through many innovations, its theoretical base covered more ground and its remedies against various diseases expanded, displaying unique characteristics. First, setting great store by the holistic view. TCM deems that the relationship between humans and nature is an interactive and inseparable whole, as are the relationships between humans and the society, and between the internal organs of the human body, so it values the impacts of natural and social environment on health and illness. Moreover, it believes that the mind and body are closely connected, emphasizing the coordination of physical and mental factors and their interactions in the conditions of health and illness. Second, setting great store by the principle of harmony. TCM lays particular stress on the importance of harmony on health, holding that a person’s physical health depends on harmony in the functions of the various body organs, the moderate status of the emotional expression, and adaption and compliance to different environments, of which the most vital is the dynamic balance between yin and yang. The fundamental reason for illness is that various internal and external factors disturb the dynamic balance. Therefore, maintaining health actually means conserving the dynamic balance of body functions, and curing diseases means restoring chaotic body functions to a state of coordination and harmony. Third, emphasis on individuality. TCM treats a disease based on full consideration of the individual constitution, climatic and seasonal conditions, and environment. This is embodied in the term “giving treatment on the basis of syndrome differentiation.” Syndrome differentiation means diagnosing an illness as a certain syndrome on the basis of analyzing the specific symptoms and physical signs collected by way of inspection,

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auscultation and olfaction, inquiry, and palpation, while giving treatment means defining the treatment approach in line with the syndrome differentiated. TCM therapies focus on the person who is sick rather than the illness that the patient contracts, i.e., aiming to restore the harmonious state of body functions that is disrupted by pathogenic factors. Fourth, emphasis on preventative treatment. Preventative treatment is a core belief of TCM, which lays great emphasis on prevention before a disease arises, guarding against pathological changes when falling sick, and protecting recovering patients from relapse. TCM believes that lifestyle is closely related to health, so it advocates health should be preserved in daily life. TCM thinks that a person’s health can be improved through emotional adjustment, balanced labor and rest, a sensible diet, and a regular life, or through appropriate intervention in the lifestyle based on people’s specific physical conditions. By these means, people can cultivate vital energy to protect themselves from harm and keep healthy. Fifth, simplicity. TCM doctors diagnose patients through inspection, auscultation and olfaction, inquiry, and palpation. In addition to medication, TCM has many non-pharmacological alternative approaches such as acupuncture and moxibustion, tuina (massage), cupping, and guasha (spooning). There is no need for complex equipment. TCM tools, for example, the small splints used in Chinese osteopathy, the spoons used in guasha, or the cups used in cupping therapy, can draw from materials close at hand, so that such treatments can spread easily.

8.2.1  Yin-Yang theory The original concept of yin-yang theory came from the observation of nature and the environment by ancient Chinese people. This understanding about the world was formed in the Shang Dynasty (1600–1046 BC) (present in the inscriptions on bones or tortoise shells) and matured in the Spring, Autumn, and Warring States period (771–221 BC).

8.2.1.1  Concept of Yin and Yang Philosophically, yin, and yang were used by ancient Chinese people to view the world. Originally, the yang means the sunny side. Gradually, this

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understanding was developed into a system of thought that was applied to all things in the universe, which occurred in pairs and had complementary and opposing characteristics. TCM is an example of one area where the yin and yang theory is used to understand complicated relationships in the human body.[25]

8.2.1.2  Contents of yin-yang theory The contents of yin-yang theory include unity of yin and yang, opposing of yin and yang, dependence between yin and yang, changing and growing of yin and yang, and transformation between yin and yang. The unity of yin and yang means everything has its dual aspect, the yin and the yang. There is always yin within yang and yang within yin. Yin alone cannot exist, neither does yang. The opposing of yin and yang keeps a continuous state of dynamic balance. Take body functions for example, vital activities are maintained by the mutual interaction and restriction of yin and yang. Otherwise, disease may occur as a result of incoordination between yin essence and yang qi. Dependence between yin and yang means yin and yang cannot exist without each other or stand alone. They depend on each other for definition and can only be measured by comparing themselves to each other. Take qi (yang) and blood (yin) for example, qi and blood are inseparable — blood carries qi and qi generates blood. The changing and growing of yin and yang means the balance between yin and yang is neither static nor absolute. At certain times, yin increases while yang decreases. At other times, the opposite is true. Transformation between yin and yang means that when one aspect goes to an extreme, it will undergo a reverse transformation into the opposite character. This sudden transformation usually takes place in a particular situation. This transformation is the source of all changes, which allow both yin and yang to generate each other.

8.2.1.3  The application of yin-yang theory The yin-yang theory has been widely used in many areas including TCM. In TCM, this theory is used to explain the body’s structure (body parts,

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zang-fu organs, qi, blood, body fluids, and meridians), physiological functions, and pathological changes. It is also used to guide clinical diagnosis and treatment.[26] In addition, the yin-yang theory is used to categorize herbal properties and as a basic guideline in herbal application. Herbal properties are often based on the four natures, five flavors, and qualities of ascending and descending. Generally, yang herbs have the floating or ascending quality and act to release the exterior, remove wind, dissipate cold, induce vomiting, and opening orifices, while yin herbs have the sinking or descending quality and act to promote bowel movement, clear heat, induce urination, tranquilize the mind, submerge yang, remove wind, down-regulate qi, and astringe and consolidate.

8.2.2  The five-element theory The five elements refer to movement and changes of five substances — wood, fire, earth, metal, and water. The five-element theory categorizes things or phenomena according to the functions of the five substances and deduces the interactions and change patterns among things or phenomena according to the mutual promotion and constraint among the five elements.

8.2.2.1  Basic contents of the five-element theory Basic contents of the five-element theory include mutual generation, mutual restriction, over-restriction, counter-restriction, and balance between generation and restriction. The cycle of mutual generation means one element promotes, supports, and enhances another element. This relationship is sometimes referred to as a mother-child relationship. The cycle of mutual restriction means one element restricts or controls another element. If there is no generation, there will be no development and growth. If there is no restriction, the unbalanced excitement will be harmful. It is necessary to have restriction within generation and to have generation within restriction to make sure that everything operates continuously in both a complementary

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and opposite manner. The generation and restriction properties of the five elements hold each other in check, maintaining a dynamic balance. In addition, we can further summarize the essential principle of overall coordination of the five elements. Take fire for example, hyperactive fire may over-restrict metal→the weak metal fails to restrict wood→the hyperactive wood restricts earth→the restricted earth loses its power in restricting water→the hyperactive water restricts hyperactive fire and eventually achieves balance. The other way around, a weak fire will be over-restricted by water→the weak fire fails to restrict metal→the hyperactive mental enhances its power in restricting wood→the weak wood fails to restrict earth→the hyperactive earth restricts water and eventually achieves balance again.

8.2.2.2  The application of five-element theory in TCM The five-element theory is used in TCM to explain physiology and pathology of the human body, predict disease prognosis, and guide disease prevention and treatment.

8.2.3  The zang-fu theory The zang-fu theory is also known as zang-xiang theory. The word zang means internal zang-fu organs and tissues, while the word xiang means external physiological functions and pathological manifestations.

8.2.3.1  Zang-xiang and zang-xiang system The zang-xiang system is a general term for five major systems that centered on five-zang organs, namely, the heart system, lung system, spleen system, liver system, and kidney system. The five systems connect with one another, and each system is respectively associated with the six-fu organs, five sense organs, nine orifices, five lusters, five tissues, five liquids, and five emotions. The zang-xiang theory is characterized by a systemic and holistic view centered on the five-zang organs. Based on the location,

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morphology, and physiology, the zang-fu system is categorized into five-zang organs, six-fu organs, and extraordinary fu organs. The fivezang organs are different from the six-fu organs in their physiological functions, dominating mental activities, and morphological structures. The extraordinary fu organs are hollow as the six-fu organs, however, they store yin essence as the five-zang organs. In addition, the five-zang organs store shen-mind/spirit; extraordinary fu organs are not associated with emotions except for the brain and gallbladder. [27]

8.2.3.2  Five-zang organs Five-zang organs are liver, heart, spleen, lung, and kidney. They dominate mental activities and share the common physiological features of transforming, producing, and storing essence and qi. The heart is located slightly to the left of the chest cavity, above the diaphragm, and protected in a membrane called the pericardium. It is related to fire in the five-element theory. Physiologically, the heart dominates blood vessels and mental activities. The lungs are located on either side of the chest cavity and right above the diaphragm. They connect with the outside environment through the airways via the mouth and nose. In five-element theory, the lung is related to metal. Physiologically, the lung dominates breathing and qi of the entire body. The spleen is located in the abdominal cavity and below the diaphragm. In the five-element theory, the spleen is related to earth. Physiologically, the spleen dominates transformation and transportation, governs blood, and controls the ascending of clear qi. The liver is located on the upper right side of the abdominal cavity, under the right ribcage. In TCM theory, it is a resolute organ. In the fiveelement theory, it is related to wood and spring. Physiologically, the liver dominates the free flow of qi and stores blood. The kidneys are located in the middle of the back against the back muscles, with one on either side of the spine. In the five-element theory, it is related to water. Physiologically, the kidney stores essence and dominates the reception of qi.

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8.2.3.3  Six-fu organs Six-fu organs are gallbladder, stomach, large intestine, small intestine, urinary bladder, and Sanjiao. They are filled but not full because their common physiological functions are to decompose, digest food, transform nutritive substances into pure essence, and excrete wastes. The gallbladder is located inferior and posterior to the liver in the upper right quadrant of the abdomen. It is connected to the liver via the biliary tract. It is a hollow organ that stores bile. Physiologically, the gallbladder stores and discharges bile to help with digestion and dominates decision-making to regulate emotions. The stomach is located in the upper-left area of the abdomen. It links the esophagus to the first part of the small intestine. Its main function is to store and break down the foods and liquids that we consume before those contents travel to other organs to be further digested. The spleen and stomach are located in the middle jiao and interior-exteriorly connected via the stomach and spleen meridians. In the five-element theory, the spleen and stomach are both related to earth. The stomach is yang and dislikes dryness, while the spleen is yin and dislike dampness. Physiologically, the stomach receives and decomposes food and liquids and controls descending of qi. The small intestine is located within the central and lower abdominal area. It stretches from the stomach to the large intestine, coiling around several times to fit. Physiologically, the small intestine digests and further absorbs food, separates pure from impure and dominates thin fluids. The large intestine begins on the right side of the abdomen and joins the end of the small intestine at the cecum, via the ileocecal valve. Its lower end leads to anus. In TCM, the large intestine is further categorized into ileum and sigmoid rectum. Physiologically, the large intestine dominates the thick fluids and absorbs water from the remaining indigestible food matter, and then passes the useless waste material from the body. The urinary bladder is a muscular sac in the pelvis, just above and behind the pubic bone. It receives urine produced in the kidneys via the ureters and passes it out into the external environment through the urethra. The urinary bladder is interior-exteriorly connected with the kidney via the bladder and kidney meridians. Physiologically, the urinary bladder stores and passes urine.

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There are controversies as to the location and morphology of Sanjiao. It’s generally believed that Sanjiao can be further categorized into upper jiao (including the heart and lung), middle jiao (including the spleen and stomach), and lower jiao (including the kidney, urinary bladder, and large and small intestines). Physiologically, Sanjiao regulates the passage of qi and fluids.

8.2.3.4  The interactions among the zang-fu organs TCM sees the human body as an organic whole. The zang-fu organs and tissues are physiologically interconnected and pathologically affected with one another through meridians. The interactions among the zang-fu organs mainly manifest in breathing, food digestion and absorption, discharge of residual wastes, the generation and circulation of blood, and water metabolism. In addition, the zang-fu organs are also associated in terms of yin, yang, and five elements. Take five-zang organs for example, according to the five-element theory, the five-zang organs support, coordinate, and constrain one another physiologically, and at the same time, they affect one another pathologically. In terms of yin, yang, interior, and exterior, the zang organs are yin and interior, while the fu organs are yang and exterior. The interactions among the fu organs mainly manifest in the coordination in digestion, absorption and excretion.

8.2.4  Qi, blood, and body fluids Qi, blood, and body fluids are essential substances to constitute the body and maintain vital activities. These substances are both the products and substantial foundation of zang-fu organs and meridians.[28]

8.2.4.1  Qi The ancient Chinese people believed qi is the most fundamental entity making up the world. They thought everything in the universe resulted from the movement and change of qi. As a vital nutritive substance, qi is composed of inborn essential qi, essence transformed from the grains and liquid after birth as well as clear qi of the nature.

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Qi is further classified into yuan-primordial qi, zong-pectoral qi, yingnutritive qi, and wei-defensive qi. The yuan-primordial qi is the most original, essential, and vital type found in the human body. It possesses prenatal and congenital properties (inherited from parents). After conception, the congenital essence (an essential substance inherited from one’s parents) is stored in the kidney. The yuan-primordial qi is further nourished by acquired essence of the spleen and stomach. Then it moves through Sanjiao and circulates through the zang-fu organs and meridians, providing the power source for growth, development, and other life activities. The zong-pectoral qi is stored in the chest. It is formed by combining the fresh air inhaled by the lung, the food essence derived from the spleen and stomach, and the yuan-primordial qi distributed over the chest. As zong-pectoral qi concentrates in the chest, it can penetrate the blood vessels of the heart and lung and move outward during exhalation and inward during inhalation. By flowing through the respiratory tract, the zong-pectoral qi supports the breathing function of the lung and influences how loud and clear the voice can be. Its ability to flow through the blood vessels and the heart is important in regulating the heartbeat and supporting the circulation of other types of qi and blood. The ying-nutritive qi supplies nourishment to the body. It mainly circulates through the blood vessels with the blood. Sometimes this combination of nutritive qi and blood is referred to collectively as “nutritive blood.” The ying-nutritive qi mainly comes from food essence derived by the transformation and transportation of the spleen and stomach. Starting from the Sanjiao, the ying-nutritive qi goes in the lung and enters the main circulation. It has yin properties and can form into materials needed by other parts of the body. The wei-defensive qi moves outside the blood vessels. It comes from the food essence derived by the spleen and stomach. The wei-defensive qi moves between the skin and muscles providing protection against external pathogenic factors. It also regulates the sweat glands and pores and provides nourishment for the zang-fu organs, muscles, skin, and hair. Although the ying-nutritive qi and the wei-defensive qi share the same origin, their compositions, distributions, and functions are very different. The ying-nutritive qi is softer and pertains to yin, while the wei-defensive

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qi is more resolute and pertains to yang. The coordination between nutritive yin and defensive yang guarantees normal physiological functioning. Qi has five major functions: promoting, warming, defending, consolidating, and transforming. More specifically, qi provides the vital energy necessary for the growth and development of the human body and perform the physiological functions of the organs, meridians, and tissues. It promotes the formation and circulation of blood and supports the metabolism of body fluids. Qi warms the body and keeps it at a constant temperature so normal physiological functions can take place. By resisting the entry of external pathogenic factors, qi defends against their attack and maintain healthy physiological functions. Qi consolidates and retains the body’s substances and organs by holding everything in its proper place. Qi also possesses vaporization or transformation functions, which are important for the metabolism of fundamental substances. Actually, the mutual transformation among qi, blood, and body fluids are the nature of life activities.

8.2.4.2  Blood In TCM, blood is the red fluid inside the blood vessels that provide nutrition for the body. It is one of the essential substances that constitute the body and maintain life activities. The blood is governed by the heart, stored in the liver, and controlled by the spleen. Blood mainly originates from food essence derived by the spleen and stomach. Its generation is mainly associated with functions of the spleen, stomach, heart, liver, and kidney. In terms of its physiological functions, blood nourishes and moistens the entire body and provides material foundation for mental activities.

8.2.4.3  Body fluids Body fluids refer to all physiological fluids in the body, including fluids in the organs and tissues, gastric fluids, intestinal fluids, semen, and tears. They are fundamental substances to maintain life activities. Body fluids originate from food and water transformed and transported by the spleen and stomach. Body fluids are made up of two parts — jin (the clear and thin fluids) and ye (the thick and sticky fluids). The

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former flows over the surface of the body, skin, muscles, and pores and enters blood to nourish the body, while the latter permeates over the zangfu organs, bones, joints, brain, and marrow to moisten the organs and tissues. Body fluids also help excrete metabolic waste and toxins.

8.2.4.4  Interactions among qi, blood, and body fluids Despite the differences in the form, function and distribution, qi, blood, and body fluids are all essential substances to constitute the body and maintain vital activities, and they all come from the food essence derived from the spleen and stomach. Physiologically, they support and transform into one another. Pathologically, they affect one another.

8.2.4.5  Essence Essence is the most original substance to constitute the body and maintain the life activities. Physiologically, essence is classified into the essence for reproduction and the essence of zang-fu organs. In term of life source, essence is classified into congenital essence and acquired essence. For individuals, the congenital essence is supplemented and nourished by acquired essence after birth. The mutual support and promotion of congenital essence and acquired essence constitute the essence of the human body. Sealed and stored inside the body, essence has important and powerful physiological functions in the reproduction, growth, and development of the human body as well as normal functioning of zang-fu organs.

8.2.4.6  Shen-mind/spirit The shen-mind/spirit is one of the core concepts of TCM fundamentals. Originated in ancient natural science and philosophy, it refers to the internal mechanism of dominating and controlling the occurrence, development, change and disappearance of things or phenomena. It was used in TCM to generalize the overall life process and phenomena. It synthesizes, organizes, integrates, and coordinates the qi activities and physiological functions of the zang-fu organs.

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We can also say the shen-mind/spirit coordinates physiological functions and mental activities. Loss of or abnormality of shen-mind/spirit’s function may cause separation between body and mind, even leading to death.

8.2.4.7  Body-mind relationship The tangible essence is the origin of life. The intangible qi is the driving force of life. The shen-mind/spirit is the dominator and manifestation of life. As a result, essence, qi, and spirit have long been regarded as three treasures of life. The interactions among the three treasures can be understood as follows: essence can transform into qi, qi can generate essence, essence can transform into spirit, spirit can protect essence, qi can generate spirit and spirit is the commander of qi. Furthermore, the interactions among the three can be summarized as body-mind relationship. Essence and qi are the origin of body and mind. A sound body secures a sound mind. This understanding is of clinical significance in disease prevention and achieving longevity.

8.2.5  Meridians As an important part of TCM theoretical system, the meridian theory studies the concept, composition, pathways, physiological functions, and pathological manifestations of meridians as well as their interactions with zang-fu organs.

8.2.5.1  Basic concept of meridians As a general term for meridians and collaterals, meridians are the pathways for the circulation of qi and blood. They connect the internal zang-fu organs with external tissues, sense organs, and orifices and act as the passages for information conduction. Meridians are known as Jing Luo in Chinese — the word Jing means pathway, referring to the major longitudinal trunk, while the word Luo means network, referring to the branches of meridians. The two are separated but closely connected.

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Like a giant web, the meridian system link internal zang-fu organs with the surface of the body as well as other body parts. Its pathways make up a comprehensive yet complicated body map that supplies vital energy to every part of the body and ensures normal life activities.[29]

8.2.5.2  Clinical use of meridian theory In addition to explaining the physiological functions of the human body, meridians can also expound the pathological changes and guide disease diagnosis and treatment. As for expounding the pathological changes, take liver meridian for example, since the liver meridian winds around the external genitalia, reaches the lower abdomen, distributes over the subcostal areas, ascends to connect the eye system, liver qi stagnation may cause pain in the subcostal areas and lower abdomen; ascending of liver fire may cause red eyes and damp heat in the liver meridian may cause itchy eczema around the external genitalia. In addition, the liver meridian pertains to the liver, curves around the stomach, and passes through the diaphragm to branch out in the subcostal area; liver problems may affect the stomach and liver fire may affect the lung. As a guide to disease diagnosis (according to the pathways of meridians), pain in subcostal areas often indicates liver or gallbladder problems, pain in the supraclavicular fossa often indicates lung problems, and chest pain that radiates towards the left arm and small finger often indicates heart problems. As for guiding the disease treatment, meridians are the theoretical foundation for acupuncture, tuina, and medicine. Common point selection methods include selecting points along the pathways of meridians, point combination of interior-exteriorly connected meridians, point combination of front-Mu and back-Shu points, and point combination of yin meridians and yang meridians. In addition, meridian theory can also guide the use of formulas, for example, the Chinese patent medicine Jiao Tai Wan (Heart-Kidney Coordination Pill, consisting of two ingredients: Huang Lian and Rou Gui) is indicated for disharmony between the heart and kidney since Huang Lian (Rhizoma Coptidis) enters the heart meridian to clear fire and Rou Gui (Cortex Cinnamomi) enters the kidney meridian to warm yang.

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8.2.6  Characteristics and practice of TCM clinical thinking The TCM clinical thinking means to diagnosis and treat diseases through investigating and analyzing the patients’ symptoms, predicting the disease prognosis, and prescribing formulas.

8.2.6.1  Characteristics of TCM clinical thinking TCM is based on theories of qi, yin, yang, and five elements because it is deeply rooted in traditional Chinese culture and closely associated with Chinese history and philosophy. Through the long-term medical practice, TCM has gradually established a people-centered holistic view, including dynamic yin-yang balance and preventative idea.[30]

8.2.6.2  Practice of TCM clinical thinking This means to obtain information through observation, olfaction, inquiry, and palpation, understand the nature of disease, and make appropriate treatment strategies. This process covers a complete diagnosis and treatment system from disease/syndrome differentiation to making treatment principles and prescribing formulas. The key to diagnosis is to investigate and collect information using traditional diagnostic methods and modern examination technologies, followed by differentiation of disease and syndrome. The goal of treatment is to cure disease or improve symptoms, control the severity and frequency of episodes, reduce relapses, improve efficacies, prevent transmission, or improve the patient’s quality of life. The treatment principle should be adapted according to individuality, geographic features, and seasonal changes, along with deficiency, excess, cold, and heat. The eight major treatment methods include sweating (to release the exterior), vomiting, purging, harmonizing, warming, clearing, reinforcing, and eliminating. These methods can be used alone or in combination. Formulas are based on the principles of composing a formula such as compatibility of sour, sweet, bitter, pungent, and salty medicinals, compatibility of medicinals that share similar functions, and compatibility

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of medicinals that have opposite functions, along with proportions of ingredients, formula types (classical formula, formulas after Zhang Zhongjing, experienced formulas, or combination of formulas), and dosage forms (decoction, pills, powder, paste, elixir, tablets, injections, granules, syrup, etc.).

8.2.6.3  Efficacy evaluation and error correction Since treatment is a process to use special measures to change or interfere with an unhealthy state of the human body, it is quite unusual to evaluate its outcome and value. Efficacy evaluation includes evaluating whether a treatment is effective, whether a treatment works for the local or the entire body, whether the efficacy is the short term or the long term, and whether expected outcome is achieved. Wrong diagnosis and treatment are inevitable in medical practice. These errors can be caused by multiple complicated reasons. The identification of errors is also the beginning of correct treatment. There is no short cut to perfect diagnosis and treatment. The only way is to gather clinical experience and never stop learning.

8.3  TCM healthcare skills and practices 8.3.1  Acupuncture therapy 8.3.1.1  The origin of acupuncture A primitive form of acupuncture and moxibustion can be traced back as far as the Chinese Stone Age. There was still no consensus regarding which came first — Meridians or point? Acupuncture or moxibustion? No matter what the answers are, acupuncture and moxibustion had a very long history and may not be limited to China.[31] In the primitive society, when people got wounded or suffered from pain, they simply used hands or objects to knead, press, and pound the painful area to alleviate pain. Alternatively, they also used bian-stone to tap certain areas of the body or to perform bloodletting to remove stagnant blood. That was actually the beginning of acupuncture therapy. The Shan

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Hai Jing (Classic of Mountains and Seas) recorded how ancient people drained pus or incised abscesses using needles made of bian-stones, with the invention of metal-casting techniques, the bian-stone instruments gave way to bronze, iron, gold and silver, and finally to today’s stainless-steel needles. Moxibustion was closely associated with the cold living environment and the use of fire. While using hot stones to warm themselves, ancient people realized that warming could alleviate pain. They first tried tree branches and gradually used herb Artemisia vulgaris (mugwort). The term meridian was first recorded in the Huang Di Nei Jing (Yellow Emperor’s Internal Classic). In TCM Fundamentals, the origin of meridian was described as, “meridian theory is based on ancient people’s long-term medical experience in acupuncture, massage, and qigong as well as their anatomical knowledge.” It seems the discovery of meridians had nothing to do with anatomy and the “anatomical knowledge” was not so important, probably because modern medical technology still cannot identify the meridian system. Some scholars believed points came before meridians and meridians are merely the lines connecting points (Figure 8–5). Modern practice has proven that stimulating the yuan-primary or other points in people with high sensitivity may produce sensations radiating toward the pathways of meridians. It’s of great significance to uncover the secret of meridians by figuring out how ancient people discovered meridians. The bone or bronze needles of the Xia-Shang (2070–256 BC) period unearthed in Ningxia, Gansu, Henan (Majishan, Huaiyang, and Yu county), and Jiangsu (Zhenjiang) were proofs of early acupuncture. Thanks to the social, political, economic, and cultural development in the feudal society during the Qin and Han period (221 BC–220 AD), TCM further developed and acupuncture tools changed from bian-stone and bones to metals. According to the Zuo Zhuan (Zuo’s Commentary), famous doctors during the Warring State period (475–221 BC) Yi Huan and Yi He were both acupuncture experts. According to legend, Bian Que (his real name was Qin Yueren but people gave him the name of the Bian Que due to the extraordinary nature of his healing abilities) brought a “dead” (a coma-like state) prince back to life by needling the Baihui (GV 20) point on the head.

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Figure 8–5    Ming Tang Chart of Bronze Figure [(1665), Shanghai Museum of Traditional Chinese Medicine Collection].

8.3.1.2  Academic development of acupuncture and meridian theory Meridians and collaterals are the pathways for circulation of qi and blood. They connect internal zang-fu organs with the surface of the body. Meridians are composed of regular meridians, divergent meridians, and extraordinary meridians. Collaterals are composed of divergent collaterals, superficial collaterals, and minute collaterals. Internally, meridians and collaterals connect

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with the zang-fu organs. Externally, they connect with muscular and cutaneous regions. The Huang Di Nei Jing (Yellow Emperor’s Internal Classic) explains the theories on yin, yang, qi, blood, five elements, zang-fu organs, and meridians from a holistic view, along with meridians, points, acupuncture, moxibustion and their indications as well as contraindications. The Ling Shu (Miraculous Pivot, also known as Classic of Acupuncture) has a whole section dedicated to the use of acupuncture and moxibustion.

8.3.1.3  Qin and Han dynasties (221 BC–220 AD) TCM developed in this period due to social, economic, cultural, and medical progress. The Nan Jing (Classic of Difficult Issues) supplemented the theories on eight extraordinary meridians, yuan-primordial qi, and eight confluent points. It further explained the five-Shu points according to the five-element theory. During this period, eminent physicians such as Chun Yuyi (215–140 BC) and Zhang Zhongjing [who established pattern identification of six meridians and authored Shang Han Lun (Treatise on Cold Damage)] paid great attention to academic study of acupuncture. The Chapter On Taiyang Diseases, Shang Han Lun, includes 20 items on acupuncture. Hua Tuo, a famous surgeon, was also an acupuncture expert. The extra Jiaji points were named after Hua Tuo Jiaji to honor his contributions in acupuncture.

8.3.1.4  Jin-Tang dynasties (265–906) This period also witnessed a flourishing development in acupuncture. Sun Simiao developed Ashi points (also known as Bu Ding or Tian Ying points), extraordinary points and proportional measurement methods in his Qian Jin Yao Fang (Important Formulas Worth a Thousand Gold Pieces). In addition, Sun Simiao also introduced treating mental problems (depression or mania) by needling the 13 ghost points.

8.3.1.5  Song, Yuan, Ming, and Qing dynasties (960–1644) The Northern Song Dynasty (960–1127) witnessed the compilation of Tong Ren Shu Xue Zhen Jiu Tu Jing (Illustrated Classic of Acupoints on

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the Bronze Figure) by Wang Weiyi (987–1067) and the casting of two lifesize male bronze statues. The Zhen Jiu Zi Sheng Jing (Classic of Nourishing Life with Acupuncture and Moxibustion) by Wang Zhizhong (1140–1207) during the Southern Song Dynasty (1127–1279) summarized previous academic achievements in acupuncture. The Shi Si Jing Fa Hui (Elucidation on Fourteen Meridians) by Hua Boren (1304–1386) during the Yuan Dynasty (1271–1368) used the 14 meridians for the first time by combining the 12 regular meridians with Ren meridian (Conception Vessel) and Du meridian (Governor Vessel). The Qi Jing Bai Mai Kao (Study of the Eight Extraordinary), by Li Shizhen (1518–1593) in the Ming Dynasty (1368–1644), systematically clarified the pathways of eight extraordinary meridians, explained their pathological changes and the close association with the 12 regular meridians, which enriched the meridian theory and attracted widespread attention on the eight extraordinary meridians by physicians of later generations[33] (Figure 8–6).

8.3.1.6  Early Qing — Republic of China (1644–1949) In this period, China went through a major breakdown in social, political, and economic systems. The Ci Jiu Xin Fa Yao Jue (Essential Teachings

Figure 8–6   The Illustrated Manual of Acupoints in the Newly Cast Bronze Figure [Published in Ming Dynasty (1443), Shanghai Museum of Traditional Chinese Medicine Collection].

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on Acupuncture and Moxibustion), Yi Zong Jin Jian (Golden Mirror of the Medical Tradition) written by Wu Qian (1689–1748) in 1742, further developed the essential principles of acupuncture and moxibustion, and the Yi Zong Jin Jian was appointed as a compulsory book for the Imperial Medical Academy. In 1822, the Qing government ordered to permanently abolish the department of acupuncture and moxibustion from the Imperial Medical Academy with a declaration that “acupuncture and moxibustion are not suitable to be applied to the emperor.” However, acupuncture and moxibustion still was widely used among the general public. The Zhen Jiu Feng Yuan (The Source of Acupuncture and Moxibustion), written by Li Xuechuan in 1822, emphasized point selection based on pattern identification and listed all 361 points. To deal with the setbacks and government-led campaign against TCM during the period of Republic of China, many acupuncturists established acupuncture societies and wrote acupuncture books. At the same time, TCM was well preserved in CPC-led areas, for example, the Bethune International Peace Hospital in the city of Yanan had outpatient department of acupuncture.

8.3.2  Tuina 8.3.2.1  The origin of Tuina Tuina, also known as Anmo, Anqiao, or Anwu, is a unique therapy in TCM. It’s called Anmo (massage) because ancient tuina manipulations mainly include An-pressing and Mo-rubbing. Tuina practitioners apply An-pressing, Mo-rubbing, Tui-pushing, Na-grasping, Rou-kneading, and Nie-pinching to certain body areas to unblock meridians, circulate qi and blood, harmonize yin and yang, reinforce the body, and remove pathogenic factors. The origin of tuina is more associated with instinct. In ancient times, when people got wounded or suffered from pain, they found simple pressing or touching can alleviate the pain and discomfort. Initially, there were mainly two manipulations — pressing and rubbing. In fact, about 10 manipulations were recorded in the Huang Di Nei Jing (Yellow Emperor’s Internal Classic).

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8.3.2.2  History and development of Tuina Qin and Han dynasties (221 BC–220 AD) In 1970s, numerous medical texts on silk scrolls and bamboo strips were unearthed at the Han Tomb No. 3, Mawangdui, Changsha, Hunan province, including the Wu Shi Er Bing Fang (Fifty-two Medical Formulas) that contains references to 10 specific Anmo techniques for internal, external, traumatological, dermatological, pediatric, and gynecological conditions. The Huang Di Nei Jing (Yellow Emperor’s Internal Classic) recorded the action mechanism, pattern identification and contraindications of Anmo. In one chapter, Anmo is said to have originated in the central area (Luoyang, Henan province) of China and was associated with the geographical features, climate, and lifestyles. At that time, Anmo was used to treat various disorders, including joint pain, muscle weakness and atony, facial paralysis, and stomach pain. A 10-volume work entitled Huangdi Qibo Anmo was supposedly the earliest Chinese medical text devoted entirely to the practice of tuina. The original is unfortunately lost but quotes from the text can be found in other books. Well-known physicians including Bian Que, Hua Tuo, and Zhang Zhongjing further supplemented and developed the contents of Anmo. The Wei, Jin, Southern and Northern Dynasties (220–589) This period witnessed the widespread use of Anmo. The Zhou Hou Bei Ji Fang (Emergency Formulas to Keep Up One’s Sleeve) by Ge Hong (281–341) recorded massage combined with ointment and multiple methods (such as finger pinching, abdomen grasping, patting, etc.) for emergencies. In addition, it also recorded spine-pinching method that continues today as a common practice. The Sui-Tang Dynasties (581–907) Anmo flourished in the Sui and Tang dynasties. Eminent physicians such as Chao Yuanfang (605–616) and Sun Simiao (581–682) included Anmo into their medical books — not only for disease treatment but also for disease prevention. Other medical texts recorded healthcare massage methods such as rubbing the eyes, nose, and soles. This period also witnessed official education and strict examination system. In the Tang Dynasty, the imperial medical schools included Anmo as a specialized branch of medicine. Practitioners who specialized in Anmo during the Tang Dynasty were divided into three levels: Anmo

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doctorates, Anmo masters, and Anmo technicians. They teach students Anmo and Daoyin. It was also at this time that Chinese Anmo was first brought to Korea, Japan, India, and other Asian countries.[34] The Song, Yuan, Ming, and Qing Dynasties (960–1644) Anmo was not so welcome during the Song Dynasty (960–1279) due to feudal ethical codes, and the Anmo department was abolished by the Imperial Medical Bureau. However, the Tai Ping Sheng Hui Fang (Formulas from Benevolent Sages Compiled during the Taiping Era) compiled by the Song government recorded treating pediatric problems with combined massage and ointment. The Sheng Ji Zong Lu (Comprehensive Recording of Divine Assistance), another book compiled by the Song government also included specific contents on Anmo and described its principal effect was “warming, unblocking and releasing blockages, and stagnation in meridians.” Taiji and Yi Jin Jing were both developed during this period because people believed the combination of Anmo and Daoyin can prevent and treat diseases. In his Ru Men Shi Qin (Confucians’ Duties to Their Parents), Zhang Congzheng (one of the Great Masters in Jin-Yuan period) described how percussing the point Fengfu DU16 (at the base of the occiput) until sweating is induced can release the exterior and thus treat cold and flu. During the Song Dynasty, self-massage was also quite popular. With the increase in indications and manipulations, the word Anmo became insufficient for this therapy, and hence the term Tuina began. The Anmo therapy obtained continued development during the early years of the Qing Dynasty (1644–1912) (Figure 8–7). The Zheng Gu Xin Fa Yao Zhi (Essential Teachings on Bone Setting) recorded Anmo therapy for traumatology as well as a milestone massage device. Today there are two massage devices of the Qianlong Reign (1736–1796) and Guangxu Reign (1875–1908) in the Royal Pharmacy, the Palace Museum — one is made of three honeywaxed court beads and the other is a prismatic gold star stone carving.

8.3.3  Qigong and Daoyin 8.3.3.1  Qigong and Daoyin theories Qigong is an ancient body-mind exercise method to benefit health and wellness. It includes regulation of the breathing, body, and mind. There

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Figure 8–7    Elucidation of Massage for Children [Published in Qing Dynasty (1644– 1911), Shanghai Museum of Traditional Chinese Medicine Collection].

are two types of qigong practice — static qigong and dynamic qigong. Static qigong is when you quietly meditate while doing breathing exercises such as Zhan Zhuang (a standing practice where one stands still, in an upright posture, as if standing like a tree) and Zuo Chan (seated meditation). Dynamic qigong involves intentional, active movement, and breathing, such as Daoyin. Daoyin is a medical exercise method to combine breathing with physical movements. The word Dao means to guide qi to achieve an internal balance and the word Yin means to stretch the body to gain strength and flexibility. Daoyin refers to the fact that physical movements are guided by the strength of the mind and in turn stimulate the internal flow of qi within the body. In ancient times, people were aware that dancing can relax sinews, strengthen the bones, and benefit the body. During the Spring, Autumn, and Warring States period (771–221 BC), Laozi, Zhuangzi, and Zihuazi all emphasized health preservation, for example, Laozi recorded breathing methods of “chui” and “hou” and the Huang Di Nei Jing (Yellow Emperor’s Internal Classic) recorded information on Daoyin, stating that

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people living in the central area of China used Daoyin and Anqiao (massage) to treat joint weakness or pain.

8.3.3.2  Daoyin practices in the Han Dynasty (206 BC–220 AD) A Daoyin Tu (Illustrated Daoyin Exercise) of 100 cm in length and approximately 50 cm in height was unearthed at Han Tomb No 3, Mawangdui, Changsha in 1970s. This drawing contains 44 human figures performing exercises, some with captions. The 44 figures were divided into 11 rows, 11 in each row. Judging from their clothes, there are men and women in different ages. Judging from their movements and postures, some are standing, some are walking, some are sitting, some are using instruments, and some are imitating animal movements such as bear hanging, bird spreading its wings, wolf rotating its head, ape stretching its arms, monkey exhaling, pigeon stretching the back, and crane listening. As shown in the captions, ancient people used Daoyin techniques to treat motor system, ear, nose, throat, and digestive system problems as well as infectious diseases.

8.3.3.3  The (Hua Tuo) Five Animal Frolics The Five Animal Frolics (Wu Qin Xi in Chinese Pinyin) was created by Hua Tuo (140–208 AD) through his long-term medical practice. He believed that practicing these animal frolics can strengthen the body and prevent diseases. According to the Biography of Hua Tuo, San Guo Zhi (Records of the Three Kingdoms), “I have this technique called ‘movements of the five animals’ the first is called the tiger, the second is called the deer, the third is the bear, the fourth is the ape, and the fifth is the bird, useful in preventing illnesses, beneficial to the limbs because they are a form of stretching. If your body experiences some discomfort, simply perform one of the animal exercises. Upon sweating, sprinkle some powder on yourself and your body will feel relaxed, giving you a healthy appetite.” Wu Pu, one of his students, followed these instructions and lived to be more than 90 years of age. His ears and eyes were still sharp as ever, his teeth all held firm and strong. Tao Hongjing (456–536), an eminent physician during the Southern and Northern Dynasties, edited and

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recorded the Wu Qin Xi Jue (Rhymes of Five Animal Frolics) in his Yang Xing Yan Ming Lu (Notes on Cultivating Nature and Extending Life). Ge Hong (283–363) recorded movements of animals including dragon, tiger, bear, bird, ape, and rabbit in his Bao Pu Zi. Chao Yuanfang (605–616), an eminent physician in the Sui Dynasty also included the Daoyin techniques for health preservation in his Zhu Bing Yuan Hou Lun (Treatise on the Origins and Manifestations of Various Diseases) and mentioned qi circulating of animals including dragon, snake, mandarin duck, tortoise, and wild goose. In the Tang Dynasty (618–906), the imperial medical schools included Anmo as a specialized branch of medicine to teach Daoyin techniques. This means therapeutic exercise had been included in medical schools. Sun Simiao (581–682) recorded many health-preservation theories and methods in his Qian Jin Fang (Important Formulas Worth a Thousand Gold Pieces) and advocated moderate physical exercise. He also introduced two complete massage methods (physical exercise) — Laozi massage methods and Tianzhu massage methods. Sun Simiao’s descriptions are very similar to today’s Nei Yang Gong (Inner Nourishing Qigong). Multiple healthcare exercises appeared after the Sui and Tang Dynasties, including Ba Duan Jin, She Er Duan Jin, Yi Jin Jing, and Taijiquan. However, unlike general gymnastics in both technique and theory, medical Daoyin and qigong can strengthen the body, prevent diseases, delay aging, and achieve longevity.

8.3.4  Cupping therapy 8.3.4.1  The origin of cupping therapy Cupping is an age-old external therapy used in ancient China. The Zhou Hou Bei Ji Fang (Emergency Formulas to Keep Up One’s Sleeve) by Ge Hong (281–341) recorded the horn therapy. The Wai Tai Mi Yao (Arcane Essentials from the Imperial Library) written in 755 by Wang Tao recorded using bamboo slips for the treatment of minor illness. The Su Shen Liang Fang (Good Medicinal Formulas by Su Shi and Shen Kuo) during the Song Dynasty (960–1279) recorded using fire cupping for chronic cough. In the Ming Dynasty (1368–1644), the Ji Ji Xian Fang

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(Prescriptions for Emergency from Immortals) by Liu Yuanran recorded using bamboo tubes to remove toxins and the Wai Ke Zheng Zong (Orthodox Lineage of External Medicine) by Chen Shigong recorded specific formulas used in combination with bamboo cupping. In the Qing Dynasty (1644–1911), the Yi Zong Jin Jian (Golden Mirror of the Medical Tradition) recorded the cupping therapy. The advances in human civilization has resulted in innovative development of cupping therapy, along with the improvement in materials of the cup — from animal horn, bamboo, pottery, and glass to plastic vacuum cupping. In addition, the methods have been extended to retaining cupping, moving cupping, flash cupping, wet (blood-letting) cupping, and combined needling, and cupping. Today, cupping therapy is widely used in the treatment of internal, external, gynecological, pediatric, ENT, and dermatological conditions.

8.3.4.2  Classification of cupping therapy Bamboo Cups There are three sizes of bamboo cups: big, small, and medium. The bamboo cups are light, unbreakable, and convenient to use. Pottery Cups Pottery cups vary in size. They have a flat cup mouth and a bulging belly. Despite the strong suction, pottery cups are easy to break. Glass Cups There are three sizes of glass cups: big, small, and medium. Glass cups are a good option for combined needling and cupping because they are transparent and allow doctors to observe the skin and evaluate the effects of treatment. Glass teacups or empty canned bottles can also be used as glass cups in special occasions. Plastic Vacuum Cups There are three sizes of plastic vacuum cups: big, small, and medium. With a piston device at the bottom of the cup, plastic vacuum cups are a good option for children because they do not use fire and are not easy to break.

8.3.5  Chinese herbal medicine Chinese herbal medicine can be traced back to hunting and plant collecting in the primitive human society. The progress in economy, politics, and

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culture allowed ancient people to summarize their experience and knowledge in Chinese herbal medicine. The Shen Nong Ben Cao Jing (Shen Nong’s Classic of the Materia Medica), during the Han Dynasty (202 BC– 220 AD), documented the materia medica before the Han Dynasty. The Ben Cao Jing Ji Zhu (Collective Commentaries on the Classic of Materia Medica), during the Southern and Northern Dynasties (420–589), recorded 730 medicinals, categorized them according to their natural properties, and described the principles in collection, identification, processing, and preparation. The Xin Xiu Ben Cao (Newly Revised Materia Medica) in the Tang Dynasty (618–907) is considered to be the earliest national pharmacopoeia in China. The Ben Cao Gang Mu (The Grand Compendium of Materia Medica), in the Ming Dynasty (1368–1644), represents the highest academic achievement on materia medica.[35] In addition to literature achievements, physicians in the Qin and Han dynasties (221 BC–220 AD) had the knowledge of materia media; the state administration for materia medica was established in the Song Dynasty (960–1279) and numerous TCM schools were founded during the Republic of China (1912–1949). Since the founding of the People’s Republic of China in 1949, the Chinese government has formulated policies to promote TCM development, organized the compilation of Pharmacopoeia of People’s Republic of China, Great Dictionary of Chinese Herbal Medicine and Records of Chinese Medicinals, and established TCM colleges and research institutes.

8.3.5.1  The properties and characteristics Chinese Medicinal properties mainly include four natures, five flavors, meridian tropism, ascending, descending, sinking, floating, and toxicity. The four natures include cold, heat, warm, and cool. The warm and heat are yang in nature, whereas cold and cool are yin in nature. They may vary in degrees, such as extreme heat, extreme cold, mild warm, or mild cold. In addition, some herbs are neutral (neither cold nor heat). The five flavors include pungent, sweet, sour, bitter, and salty. In addition, sour contains puckery and sweet contains bland. The Huang Di Nei Jing (Yellow Emperor’s Internal Classic) classified the actions of the five flavors as — dispersing with pungent, astringing with sour, moderating with sweet,

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clearing with bitter, and softening with salty. The ascending, descending, sinking, and floating are used to describe medicinal tendencies: ascending and floating (dispersing) are yang in nature, whereas sinking (astringing and sealing) and descending are yin in nature. Meridian tropism means that medicinal herbs may often produce their therapeutic effects on certain meridians or zang-fu organs in predominance but it may seem to produce fewer effects on or seem not related to the other organs or meridians. It is based on the theories of zang-fu organs and meridians and the indication of syndromes. Toxicity refers to the harm to the body. Generally, it is essential to avoid toxic medicinals, however, sometimes it might be necessary to use poison to fight poison.

8.3.5.2  The processing and combination The medicinal processing includes general and specific methods, such as preliminary processing, water processing and fire processing and processing with both water and fire. The purposes of medicinal processing are to reduce or eliminate the toxic or side effects of medicinals, safeguard their safety, enhance their potency, improve clinical efficacy, and change medicinal property or potency to better adapt to patients’ conditions. In addition, this also helps with medicinal storage and preparation, achieving better medicinal quality and clinical use. The use of Chinese Medicine was summarized into seven emotions. Except for one single medicine, the six emotions are all associated with compatibility: mutual reinforcement (using two medicines sharing similar properties in combination to reinforce each other’s action), mutual assistance (using two or more medicines sharing common efficacies in combination, one being the principal medicine while the others play a subsidiary role to reinforce the action of the principal one), mutual restraint (when two medicines are used in combination, the toxic or side-effects of one medicine can be reduced or eliminated by the other using), mutual suppression (when two medicines are used in combination, one medicine can reduce or eliminate the toxic or side-effects of the other), mutual aversion (when two medicines are used in combination, the positive effects of one medicine can be reduced or eliminated by the other), and mutual opposition (when two medicines are used in combination, their toxic or

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side-effects can be produced or enhanced), such as 18 incompatibilities and 19 incompatibilities. Chinese herbal formulas are higher forms of medicinal compatibility.

8.3.5.3  The dosage form and clinical use The dosage form refers to the form of a prepared medicine designed for medical treatment or prevention. It is based on the medicinal property, patients’ condition, and routes of medication administration, and aims to maximize the medicinal efficacy and minimize the toxic effect of medicinals. Major TCM dosage forms include decoction, pills, powder, paste, medicated liquor, and elixir. Decoction is a liquid preparation form by soaking and boiling ingredients in water and taken after the sediment is removed. It is the earliest and most extensive dosage form because it meets the need of pattern identification, easy preparation, and fast medicinal efficacy. The ingredients for decoction have changed from coarsely cut herbs, powder to slices. Decoction is an age-old dosage form that has not only been sustained but also progressed into newer forms. A pill is a solid globular mass made of finely powdered medicines with a suitable excipient or binder. It can be further categorized into honeyed pill, water-honeyed pill, watered pill, pasted pill, waxed pill, concentrated pill, and dripping pill. Some forms are still being used today. Some are modified to meet the clinical use, for example, dripping pills are to be absorbed under the tongue to avoid the first-pass (pre-systemic hepatic) metabolism and gastric degradation loss, thus enabling the highlyconcentrated medicine to reach the target organ and take effect rapidly. With the addition of sustained-release preparation, some forms can significantly extend the half-life of medicines. Powder is solid state fine bulk, composed of ground medicinals or mixture of ground medicinals and excipients in dry form. It is one of the oldest dosage forms and can be used both internally (taken with boiled water or liquor, for example, red bean powder, cosmetic powder, etc.) and externally (to be applied to the affected area, for example, longan seed powder). Paste is a greasy or thick semi-solid dosage from and can be used both internally and externally. Externally, it is made from decocted

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medicines with vegetable or animal oil and can be applied to the affected area for an extended period of time to treat skin ulcers or sores. Internally, it is also known as condensed paste (Gaofang) in TCM made of decocted medicine with suitable fatty base. Due to its high medicinal concentration and stability, condensed paste is widely used for internal, external, gynecological, pediatric, traumatological, and ear, nose, and throat (ENT) problems as well as weakened immune system upon recovery of severe diseases. Medicated liquor is a liquid form of herbal extracts prepared with distilled liquor. Some medicinal ingredients do not dissolve in water but dissolve in alcohol — a useful solvent. In addition, alcohol acts to warm and unblock blood vessels and boost the medicinal potency. Medicated liquor for rheumatism remains popular both at home and abroad. Elixir is an age-old dosage form extracted from heated minerals such as mercury or sulfur. Despite its small dose, elixir produces a big effect. Generally, elixirs are used for surgical or dermatological purposes, for example, Hong Sheng Dan (Wound-Healing Elixir), Bai Jiang Dan (Crystal Mixed with Mercury Bichloride and Mercury Subchloride), etc. What is more, elixir is also used for valuable or specific dosage forms, for example, Zhi Bao Dan (Supreme Jewel Elixir, a patent formula to regain consciousness), Zi Xue Dan (Purple Snow Elixir, a patent formula to refresh the mind), etc. Today, elixir is gradually losing its popularity because of its toxicity. Apparently, the dosage forms of TCM medicines have increased from a traditionally limited number of forms into more advanced ones, indicating marked improvement in the technological level of Chinese medicinal drug production and better clinical efficacy (Figure 8–8).

8.3.6  Health preservation TCM relieves the sufferings and pain of patients and cures them from disease and illness. It also helps with health preservation through nourishing the mind, regulating the diet, exercising the body, and adapting to seasonal changes. The term health preservation (yang sheng) first appears in the Inner Chapters of Zhuangzi, meaning to nurture or nourish life — fostering health and well-being by nurturing body, mind, and spirit in

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Figure 8–8  CAO’s Wood Pharmaceutical Stamp [Republic of China (1912–1949), Shanghai Museum of Traditional Chinese Medicine Collection].

harmony with the natural rhythms, and with universal laws.[36] Sometimes this term is also translated as health cultivation or life nourishment. This chapter focuses on three aspects of health preservation: diet, mental/spiritual cultivation, and exercise. A healthy diet provides the body with essential nutrition and helps maintain or improve one’s overall health. Ancient dieticians had long emphasized the importance of food, along with the health cultivation principle of eating appropriate food first before taking any medicines. The Huang Di Nei Jing (Yellow Emperor’s Internal Classic) states, “When the body is deficient, the five grains are used to nourish, the five fruits to assist, the five animals to tonify and the five vegetables to fulfil.”

8.3.6.1  Diet therapy Improper food is the cause of many diseases. According to the Yang Xing Yan Ming Lu (Notes on Cultivating Nature and Extending Life) by an eminent Daoist Tao Hongjing (451–536), improper food causes more damage than sensual pleasures, since people can abstain from the indulgence of sensual pleasure for a year but cannot abstain from food for one day. Food can benefit our health but may also harm our health. Diet therapy is a broad term for the practical application of nutrition as a preventative or corrective treatment of disease. This usually involves the modification of an existing dietary lifestyle to promote optimum health. Sometimes it’s hard to separate food from medicine.

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Diet has long been used to boost the overall health in China. One legend goes that Chinese herbal decoction was invented by a cook named Yi Yin during the Shang Dynasty (16th century–11th century BCE). The Rites of Zhou recorded an organized medical system in which court officials of the emperor had different specialties such as dieticians. The Wei, Jin, and the Southern and Northern Dynasties (220–589) saw many books on food and cooking. The Tang Dynasty (618–907) saw monographs on diet therapy, such as the volume of food therapy in Sun Simiao’s Qian Jin Yao Fang (Important Formulas Worth a Thousand Gold Pieces); Sun’s student Meng Shen authored three volumes of Shi Liao Ben Cao (Materia Medica for Dietary Therapy) and introduced the therapeutic efficacies of more than 300 types of food.

8.3.6.2  Diet, nutrition, and herbal diet Thanks to the exchange between China and foreign countries and between ethnic groups during the Tang Dynasty (618–907), new types of food were introduced to China and recorded in the Shi Liao Ben Cao  (Materia Medica for Dietary Therapy), such as spinach, lettuce, coriander, etc. In addition, animal organs were used at that time to treat organ-related diseases. Lou Juzhong, a pediatrician in the Song Dynasty (960–1279), mentioned in his Shi Zhi Tong Shuo (Common Understanding on Food Therapy) that, “appropriate food intake makes a sound body.” However, herbal diet is different from food therapy because it adds herbs into the food and needs to be taken according to doctor’s advice.

8.3.6.3  Mental/spiritual cultivation Health preservation is also known as nurturing life, including nurturing the mind as well as body. Sun Simiao mentioned in the forward to the chapter of nurturing one’s nature, Qian Jin Yao Fang (Important Formulas Worth a Thousand Gold Pieces), “to be skilled at nurturing one’s nature is to treat disease before it arises.”

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8.3.6.4  Nurturing both body and mind This is based on the theory of body-mind unity. Huan Tan, a Confucian scholar and philosopher during the Eastern Han Dynasty (25–220), believed that there is a soul or spirit in the body that is supported by good deportment and so, will never extinguish. Like the flame of a candle which cannot leave the candle, the spirit cannot leave the body.

8.3.6.5  Nurturing the mind Ancient Chinese health-preservation experts believed in nurturing both body and mind, especially the mind, i.e., one’s nature, character, mental state, or peaceful emotions. Wang Bing, an eminent physician in the Tang Dynasty (618–907) mentioned, “the first and foremost is to nurture the mind, then to nurture the body.” According to Huang Di Nei Jing (Yellow Emperor’s Internal Classic), excessive emotions may consume the essence and harm the mind. Specifically, excessive panic and worries may damage the spirit, extreme feeling of pleasure may disturb the spirit, extreme fear or fright may consume and scatter the spirit. It is therefore important to be positive, optimistic and stay away from negative emotions.

8.3.6.6  Exercise Exercise has long been an important part for health preservation in ancient China. According to Zhuangzi, “exhaling the old and inhaling the new breath, hanging like a bear, and stretching like a bird, these are all methods for longevity.” The Lǚ Shi Chun Qiu (The Annals of LüBuwei), one of the great monuments of Chinese thinking, believed that “running water does not grow stale; the pivot of the door does not get bug-infested. The reason for this is that they move.” The Huang Di Nei Jing (Yellow Emperor’s Internal Classic) believed “extended sitting, lying down, or standing are all harmful to the body and therefore advocates balance between physical exertion and fatigue.” The “five animal frolics” by Hua Tuo was a milestone of traditional health-preservation exercise. Physicians of later generations including Sun Simiao and Zhu Danxi used healthy exercise in disease prevention and treatment.

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8.3.6.7  Sun Simiao and health-preservation exercise Sun Simiao recorded his experience with herb formulas and his knowledge of medicine in his book Qian Jin Yao Fang (Prescriptions Worth a Thousand Gold). The book presented life-saving remedies, hence the title reflecting their great value — a life is worth more than a thousand gold coins. He explained his understandings on health-preservation excise in one chapter.

8.3.6.8  Regulating breathing During the life process, spirit is easy to be consumed but hard to be kept inside. In his book, Sun Simiao introduced the method to regulate breathing — inhale the natural yang clean qi and exhale the turbid qi out of the body to preserve life and achieve longevity.

8.3.6.9  Rest-exercise balance Sun Simiao believed moderate physical exercise harmonizes qi and blood and benefit overall health. Otherwise, qi and blood may become stagnant and result in problems. It’s worth noting that he emphasized “moderate” physical exercise instead of intense, strenuous exercise.

8.3.6.10  Moderation and regularity in lifestyle In volume 27 of his book, Sun Simiao emphasized the need for moderation and regularity in lifestyle and diet, live in harmony with the seasons, and avoid physical overexertion and emotional excess, and follow the man-nature unity recorded in the Huang Di Nei Jing (Yellow Emperor’s Internal Classic).

8.3.6.11  Zhu Danxi and health-preservation exercise Zhu Danxi (1281–1358), an eminent physician during the Jin and Yuan Dynasties believed, “Heaven governs all living things, therefore it is constantly moving; similarly, living humans are also constantly in

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movement.” He also believed there is more movement (yang) than quietness (yin) in nature. It is essential to have natural breathing and a peaceful mind free of distractions during physical exercise. After 1949, health-preservation excise such as daoyin/qigong or martial arts has become more and more popular among the public. The advances in science and technology as well as public demand for improvement of the quality of life have resulted in the documentation of ancient books and literature on health preservation, along with the R&D of healthy products.

8.4  Current status of TCM TCM originated in the Chinese culture. It explains health and diseases from a macro, systemic, and holistic perspective. It shows how China perceives nature. As a unique form of medicine, TCM exercises a profound influence on the life of the Chinese people. It is a major means to help the Chinese people maintain health, cure diseases, and live a long life. The Chinese nation has survived countless natural disasters, wars and pestilences, and continues to prosper. In this process, TCM has made a great contribution and produced a positive impact on global civilization. TCM inheritance, innovation, and development are essential to socialism with Chinese characteristics in the new era and a great event to the great rejuvenation of the Chinese nation. A healthcare system with Chinese Characteristics requires equal importance to and mutual complementation of TCM and Western Medicine. China lays great store by the development of TCM. The Party and the government have granted greater importance to the development of TCM, and made a series of major policy decisions and adopted a number of plans to boost its inheritance and innovation.[37] To achieve this goal, the comprehensive (prevention, treatment, and rehabilitation) TCM service system has been established to provide accessible life circle TCM service, relying on the national TCM center, regional TCM healthcare center, all levels of TCM institutions, TCM departments in medical institutions, and grass-root medical and health institutions. TCM has now become a unique resource in terms of healthcare, an outstanding cultural resource, an economic resource with great potential, and

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a scientific and technological resource with originality advantages. It is therefore essential to intensify the education and training for TCM professionals, promote TCM research, accelerate the development of TCM pharmaceutical industry, and enhance TCM standardization and cultural development as well as international exchange and cooperation.

8.4.1  Policies and measures on TCM development TCM is an important part of Chinese healthcare system. It is stipulated in the Constitution of the People’s Republic of China that the state promotes modern medicine and TCM to protect the people’s health. In 2003, the State Council issued the Regulations of the People’s Republic of China on Traditional Chinese Medicine. In 2016, the State Council issued the Law on Traditional Chinese Medicine — a milestone event for TCM development. According to the Law of the People’s Republic of China on Basic Medical and Health Care and the Promotion of Health, the state vigorously develops TCM, attaches equal importance to both TCM and Western Medicine, combines inheritance and innovation, and maximizes the unique role of TCM in medical, healthcare, and health promotion. China lays great store by the development of TCM. When the People’s Republic of China was founded in 1949, the government placed emphasis on uniting Chinese and Western Medicine as one of its three guidelines for health work and enshrined the important role of TCM. In 1986, the State Council set up a relatively independent administration of TCM. All provinces, autonomous regions, and municipalities directly under the central government have established their respective TCM administrations, which has laid an organizational basis for TCM development. At the Fourth Meeting of the Seventh National People’s Congress, equal emphasis was put on Chinese and Western Medicine, which was made one of the five guidelines in China’s health work in the new period. In 2009, the State Council issued the Opinions on Supporting and Promoting the Development of Traditional Chinese Medicine, gradually forming a relatively complete policy system on TCM. The Party and the government have granted greater importance to the development of TCM and made a series of major policy

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decisions and adopted a number of plans in this regard. At the National Conference on Hygiene and Health, President Xi Jinping emphasized the importance of revitalizing and developing Traditional Chinese Medicine. The CPC’s 18th National Congress and the Fifth Plenary Session of the 18th CPC Central Committee both reiterated the necessity to pay equal attention to the development of TCM and Western Medicine and lend support to the development of TCM and ethnic minority medicine. In 2016, the CPC Central Committee and the State Council issued the Outline of the Healthy China 2030 Plan, a guide to improving the health of the Chinese people in the coming 15 years. It sets out a series of tasks and measures to implement the program and develop TCM. The State Council also issued the Outline of the Strategic Plan on the Development of Traditional Chinese Medicine (2016–2030), [38] which made TCM development a national strategy, with systemic plans for TCM development in the new era. [39] In July 2019, Xi Jinping, general secretary of the CPC Central Committee, presided over the meeting for deepening overall reform. The meeting reviewed and approved a series of official documents including a guideline on promoting the TCM inheritance, innovation, and development. In October 2019, the CPC central committee and State Council issued the Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine. It was stated at the National Conference on Traditional Chinese Medicine that “TCM inheritance, innovation, and development are essential to socialism with Chinese characteristics in the new era and a great event to the great rejuvenation of the Chinese nation” and “TCM should play a role in building healthy China and achieving the Chinese dream of national rejuvenation.” In 2021, the State Council issued a document on Policies and Measures on Accelerating the Characteristic Development of TCM. These decisions and plans have mapped out a grand blueprint that focuses on the full revitalization of TCM, accelerated reform of the medical and healthcare system, the building of a medical and healthcare system with Chinese characteristics, and the advancement of the healthy China plan, thus ushering in a new era of development for TCM.[40]

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8.4.2  Regulations on TCM service After the founding of the People’s Republic of China, the TCM division was set up under the Ministry of Health as a TCM regulatory body. In 1986, the State Council issued the Notice on Establishing the State Administration of Traditional Chinese Medicine (SATCM), stipulating that SATCM is an agency directly under the State Council and administered by the Ministry of Health. In 1988, the section of Chinese Medicines under the State Drug Administration (SDA) was transferred to SATCM. The establishment of SATCM is of milestone significance in the history of TCM development. There are eight components within the SATCM: the Administration Office, the Department of Human Resource and Education, the Department of Planning and Finance, the Department of Policy, Regulations and Supervision, the Department of Medical Administration, the Department of Science and Technology, the Department of International Cooperation, and the Department for Party-related Affairs. The main responsibilities of SATCM are: – To draft strategies, plans, policies, and standards on TCM and ethnic minority medicine, to draft related laws and regulations, to plan, organize, and enforce major TCM projects. – To supervise and regulate TCM medical care, prevention, health prevention, rehabilitation, and clinical medication, to conduct overall planning and to coordinate the structural layout of TCM healthcare and research institutions as well as operation mechanism reform, to formulate management standard and technical protocols for TCM medical and healthcare institutions and guide their implementations. – To supervise and coordinate the integration of TCM and Western Medicine in healthcare and research institutions and formulate management ethics and technical protocols. – To organize the exploring, categorizing, and summarizing of the theory, medical skills and medicines of ethnic minority medicine and draft the management standard and technical protocols for the practice of ethnic minority medicine. – To organize and conduct the survey of Chinese Medicine resource and facilitate its preservation, development, and rational use, to formulate

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the development plan, industry policy and supportive policies for TCM pharmaceutical industry, to participate in the work of developing the National Essential Medicine System (NEMS). To formulate national development programs for TCM personnel and organize related departments to draft accreditation criteria for TCM professionals and supervise the enforcement, to coordinate and organize TCM master-apprentice education, postgraduate education and continuing education as well as advanced training, to guide the education reform and development plan on TCM education. To formulate and organize TCM research and technology development, administer key national TCM research projects and promote the transformation, application, and promotion of TCM Sci-Tech achievements. To lead the protection of endangered TCM diagnostic and therapeutic skills and processing techniques, organize the categorizing of TCM classics as well as TCM inheritance and development, to offer proposals on the protection of intangible TCM cultural heritage and publicize the TCM knowledge on disease prevention and treatment. To organize and conduct global promotion and use of TCM and facilitate international exchange and cooperation in TCM as well as the TCM cooperation with Hong Kong SAR, Macao SAR, and Taiwan Province of China. To undertake other work as designated by the State Council and Ministry of Health.

At the same time, a systemic TCM regulation system has been formed across the nation — all provinces, autonomous regions, and municipalities directly under the central government have established their respective TCM administrations, which has laid an organizational basis for TCM development.

8.4.3  TCM service There were numerous varieties of TCM institutions during the early years of the People’s Republic of China. The Academic Research Committee for TCM was founded in 1955. At the same time, tens of thousands of

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clinics were set up for unorganized TCM workers. The TCM services were provided by the State-owned or collective-owned TCM hospitals or clinics as well as the Department of TCM in general hospitals. Currently, a TCM medical care system covering both urban and rural areas has been established in China. An urban TCM medical care network, mainly comprising hospitals for TCM (including ethnic minority medicine and integrated Chinese and Western Medicine), TCM clinics and general hospitals’ TCM clinical departments, and community health centers, has been formed. A rural TCM medical care network has been established, mainly composed of county-level TCM hospitals, TCM clinical departments of general hospitals (specialized hospitals and maternal & child health centers), TCM departments of township-level health centers, and village health clinics, which provides basic TCM healthcare services. In the 14th 5-year plan period (2021–2025), the Chinese government will continue to perfect the comprehensive TCM service system that is comprised of national TCM centers, regional TCM healthcare centers, all levels of TCM institutions, departments in other medical institutions, and community-level medical and health service institutions, providing preventative care, disease treatment, and rehabilitation service for all citizens throughout their full life cycle.

8.4.3.1  TCM service in TCM institutions TCM institutions make up the backbone of TCM medical care system. These include all levels of general TCM hospitals, TCM specialty hospitals, integrated Chinese and Western Medicine hospitals, TCM clinics, and ethnic minority medicine hospitals. Statistics collected at the end of 2019 show that there were 5,232 TCM hospitals across the country, including 4,221 TCM-oriented hospitals, 699 hospitals of integrated Chinese and Western Medicine, and 312 hospitals of ethnic minority medicine. There were 57,268 TCM clinics and 3,267 TCM outpatient departments. There were 625,000 practitioners and assistant practitioners of TCM (including practitioners of ethnic minority medicine and integrated Chinese and Western Medicine). There were 1.16 billion visits (16.4% of the national total) that year to TCM medical and health service units across the country and 38,589,000

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inpatients (14.6% of the national total) treated. In 2019, out-patient expenses per visit and in-patient expenses per capita at public TCM hospitals were, 11.23% and 24.96% respectively, lower than those at general public hospitals.

8.4.3.2  TCM service in general and specialty hospitals The general and specialty hospitals provide TCM service by setting up TCM clinical departments. As of 2019, TCM clinical departments had been set up in 4,010 (85.01%) public general hospitals at or above secondary level, including 94.54% tertiary public hospitals and 74.90% secondary public hospitals. TCM clinical departments had also been set up in 932 (62.51%) private general hospitals at or above secondary level, including 87.70% tertiary private hospitals and 60.26% secondary private hospitals. The beds in general hospitals’ TCM clinical departments were 115,600 in total. In 2019, there were 111.124 million patients visit (11.6% of the total TCM service) to TCM outpatient and emergency departments and 5.843 million patients discharged (15.3% of the total TCM service).

8.4.3.3  TCM service at the grassroots level Medical and healthcare institutions at grassroots level are essential to TCM service system. As of 2019, there were a total of 53,764 primary care institutions across China, including community health service centers, community health service stations, and township health centers, and 94.87% of these institutions (51,007) provide basic TCM services. There were 131,611 practicing (assistant) TCM doctors and 29,227 TCM pharmacists (assistant pharmacists). There were 408,588 (71.28%) village clinics that provide TCM services, 33,698 (15.78%) practicing (assistant) TCM doctors in village clinics, and 15.81% of village doctors practice TCM, integrated TCM and Western Medicine and ethnic minority medicine.

8.4.3.4  TCM and public health Health for all is a solemn promise to the people by the Chinese government. It is essential to enhance development of TCM disease

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prevention and healthcare services. The system of TCM disease prevention and healthcare services has been expedited by establishing preventative healthcare departments at TCM hospitals at/above the second class and providing TCM preventative medical care services at community-level medical and health service institutions, maternal and child health centers, and rehabilitation centers. Also seen is rapid growth in the number of privately run TCM healthcare institutions. Endeavor has been made to promote the development of TCM health services and carry out TCM health tourism and TCM integrated treatment and convalesce. TCM health management program has been incorporated as a separate category into the national basic public health service program, gradually releasing the potential and strengths of TCM in public health services, thus fostering a shift from treatment of serious diseases to comprehensive health management in the mode of health development. In addition to making contribution to disease prevention and treatment as well as health service, TCM has played an important role in the prevention and treatment of major epidemics and medical relief in public emergencies and natural disasters. The contribution of TCM and integrated Chinese and Western Medicine in treating SARS (severe acute respiratory syndrome), influenza A virus subtype H1N1 and COVID-19, has been affirmed by the World Health Organization (WHO) and international community. Upon the sudden outbreak of COVID-19, approximately 5,000 TCM doctors joined the clinical treatment in the city of Wuhan. The TCM treatment was included in six editions (the 3rd–8th) of national protocols and used in the whole process of COVID-19 diagnosis and treatment in 92% confirmed cases. In addition to its immediate use in pandemic control, TCM has also proved its unique strength in dealing with cluster or sporadic cases in ongoing pandemic prevention and control. Actually, TCM has made distinctive contributions to the prevention and control of epidemics such as HIV/AIDS (Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome), HFMD (Hand, Foot and Mouth Disease), and Influenza A virus subtype H7N9 in humans, as well as to medical relief following the Wenchuan earthquake, the Zhouqu mudslide, and other public emergencies and natural disasters.

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8.4.4  Education and training for TCM professionals After the founding of the People’s Republic of China, the government has attached great importance to education and training for TCM professionals, which is essential for the development of TCM. Thus, great efforts have been made to promote development of education in TCM, basically putting in place a system of training for TCM professionals that features an effective link-up between college education, postgraduate education, and continuing education, as well as master-apprenticeship training.

8.4.4.1  TCM college education Since 1949, great efforts have been made to promote development of education in TCM. In 1956, the State Council approved the founding of four TCM colleges — Beijing College of Chinese Medicine, Shanghai College of Traditional Chinese Medicine, Guangzhou College of Traditional Chinese Medicine, and Chengdu College of Traditional Chinese Medicine. The last 65 years have witnessed the steady improvement of TCM education quality and the gradual formation of training system that covers undergraduate, postgraduate, and postdoctoral education. The last 65 years have also witnessed the training achievements of approximately 2 million TCM professionals in TCM medical and healthcare, research, education, industry, and international exchange and cooperation.

8.4.4.2  TCM postgraduate education In 2010, Shanghai, as a pilot city, implemented the standardized residency training (SRT) program (including TCM) to set quality standards for residency training. This program aims to help residents reach the same professional standards regardless of hospital type to provide high-quality care throughout Shanghai. In 2013, the State Council issued the Guiding Opinions on Establishing Standard Residency Training System and stated that doctor requirements include completing at least undergraduate degree program and three years of residency training before becoming eligible for medical licensing.

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In 2020, the Ministry of Education, the National Health Commission, and the State Administration of Traditional Chinese Medicine issued the Implementation Opinions on Deepening the Collaboration of Medical Education and Further Promoting the Reform and High-quality Development of TCM Education to improve the TCM postgraduate education.

8.4.4.3  TCM continuing education and master-apprenticeship education Continuing education is an essential part of medical education system. The concept of continuing education was introduced into TCM in the late 1980s. In 1992, the State Administration of Traditional Chinese Medicine (SATCM) issued the Opinions on Developing TCM Continuing Education and Interim Measures for Regulations of All-China TCM Training and Education. In 1997, the SATCM issued the Interim Regulations for TM Continuing Education, the Proposed Regulations on Credit Granting in TCM Continuing Education and the Proposed Methods for Application and Approval of National TCM Continuing Education. In the 21st century, further measures have been implemented on TCM continuing education, especially after the CPC’s 18th National Congress. Between 2018 and 2019, a total of 12,113 national TCM continuing education programs were organized and implemented, involving approximately 190,000 TCM professionals, along with provincial/municipal TCM continuing education programs. The masterapprenticeship has long been an important model in TCM education. However, eventually, the general popularity of apprenticeships declined owing to the founding of TCM colleges. In the middle 1950s, the prominent TCM doctors were encouraged to teach apprenticeship programs according to the Instructions on Developing TCM MasterApprenticeship Education and the Short Notice on Inheritance of Prominent TCM Experts’ Academic Experience. After the gradual recovery and exploration between the 1970s and 1980s, masterapprenticeship education further developed as a model of TCM continuing education in 1990s. Since 1990, efforts have been made to conserve and disseminate the academic ideas and practical experience

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of six batches of prominent TCM experts. In 2018, the SATCM issued the Guiding Opinions on Deepening TCM Master-Apprenticeship Education and clearly stated that, in addition to college education, postgraduate education, and continuing education, the masterapprenticeship model, is an essential part of the training system for TCM professionals.

8.4.4.4  Current status of TCM professionals By the end of 2019, there were 767,000 TCM professionals (7.56% of the national medical personnel) across China, including 625,000 practicing (assistant) practitioners (0.45‰). Until now, there are 21 TCM academicians. Since 2009, the title of TCM Master have been awarded to 90 experts practicing TCM and ethnic minority medicine, the first batch of top 100 TCM doctors, 80 TCM outstanding contribution winners, and 60 best teachers in TCM colleges/universities. In the course of implementing the program of training professionals for inheritance and innovation in TCM, efforts have been made to conserve and disseminate the academic ideas and practical experience of prominent TCM experts. So far, a national training center for TCM professionals has been built, along with 30 training bases for high-level TCM professionals, 1,482 studios to carry forward the expertise of prominent TCM experts, and 64 studios for promoting various schools of TCM.[41] Great efforts have been made to build a strong team of TCM leading talents, excellent young and middle-aged TCM scholars and backbone talents at grassroots level. The 13th five-year (2016–2020) period witnessed the selection of 10 chief scientists, 99 scholars, and 100 young scholars of the TCM “Ten Thousand Talents Program,” along with 600 excellent TCM clinicians and 5,500 personnel in TCM clinical practice, TCM pharmacy, TCM nursing, and TCM learners with a medical background. A total of 902 studios have been set up for passing on the expertise of prominent TCM experts at the grassroots level to upgrade the TCM service capacity in rural areas.

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8.4.5  TCM research and innovation The last decades have witnessed rapid progress in TCM scientific research. Since 2000, 117 TCM research achievements have been awarded national Sci-Tech prizes, including 50 National Science and Technology Progress Awards after the CPC’s 18th National Congress. Tu Youyou won the 2011 Lasker Award in clinical medicine, the 2015 Nobel Prize in Physiology or Medicine for discovering qinghaosu (artemisinin), and the 2016 State. Supreme Science and Technology Award of China. Wang Zhenyi and Chen Zhu were awarded the 7th Annual Szent-Gyorgyi Prize for Progress in Cancer Research for combining the Western Medicine ATRA and the TCM compound arsenic trioxide to treat acute promyelocytic leukemia (APL). For the same reason, Chen Zhu also won the 2018 Sjöberg Prize.

8.4.5.1  The TCM research system The key research offices and laboratories on all TCM disciplines have been established, along with national engineering (technology) research centers and engineering labs, forming a comprehensive TCM research and innovation system consisting of independent TCM research institutions, TCM universities, TCM hospitals at or above the provincial level, and involvement of comprehensive universities, general hospitals, and TCM enterprises. By the end of 2019, there were 72 TCM research and development institutions across China (including 10 ministerial-level institutions, 42 provincial/ municipal-level ones, and 20 city-level ones).

8.4.5.2  Major projects on TCM inheritance and innovation Since 2005, a total of 203 projects on TCM theories have been supported by the National Natural Science Foundation of China (NSFC). The Technical Specifications for TCM Knowledge Protection has been formulated and the Database for TCM Knowledge Protection has been built. Enhanced efforts have been made to inherit academic experience of senior TCM doctors and to further explore TCM classics. Approximately 400 book series on ancient Chinese medical classics have been published.

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The 13th Five-Year Plan for TCM Innovative Projects has been formulated and released, followed by the implementation of Major Science and Technology Programs, Major New Drug Development Programs, the National Key Research and Development Program of China, the National High Technology Research and Development Program of China, and the National Key Technology Support Program. Over 1 billion yuan has been invested by the National Key Research and Development Program of China to support 83 key projects on TCM modernization. A clinical research system for TCM prevention and treatment of infectious diseases has been built and studies are being conducted by 41 key research offices of the State Administration of Traditional Chinese Medicine (SATCM). In addition, the SATCM Rehabilitation Research Center and 31 provincial demonstration centers have been established to facilitate the study on TCM for preventative healthcare. A pilot program for Chinese medicinal resources survey has been implemented, forming a dynamic information and technology system with one central platform, 28 provincial-level centers, and 65 monitoring stations. Sixteen seed and seedling bases for Chinese medicinal plants and two germplasm banks have been established. Forty national clinical research bases have been established, along with 145 SATCM key research offices, and four national engineering technology research centers. The platform for research and innovation has been improved, including five national engineering research centers for Traditional Chinese Medicine, two key MoE (Ministry of Education) laboratories, three safety evaluation centers for Chinese Medicine, and four standardized clinical trial centers for Chinese Medicine. Thanks to agricultural mechanization, intensification, and industrialization, the GAP (Good Agriculture Practice) service system of Chinese materia medica has been gradually established. TCM industry has become an important part of national pharmaceutical industries. About a third of the top 100 pharmaceutical enterprises are TCM companies and quite a few of these TCM companies obtained annual revenue of over 10 billion yuan. The TCM Research Ethics Regulations has been formulated to build ethical review system for TCM clinical research (CAP certified) and

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real-world TCM clinical trial model. One chapter on traditional medicine was included in ICD-11 for the first time, including 150 diseases and 196 patterns. Every year, more than 3,000 (35%) SCI papers on TCM are published by Chinese scholars. In addition, remarkable achievements have been made on internationalization of Chinese herbal slices.

8.4.6  TCM pharmaceutical industry TCM has become a unique resource in terms of healthcare, an outstanding cultural resource, an economic resource with great potential, and a scientific and technological resource with originality advantages. In recent years, the national supportive policies enabled a rapid development of Chinese medicinal materials, Chinese herbal slices, and Chinese patent medicine — the three pillars of TCM pharmaceutical industry. A number of laws and regulations have been enacted and implemented on strengthening the protection of TCM wild medicinal resources; a number of national and local nature reserves have been established; research has been conducted on the protection of rare and endangered Chinese medicinal resources and artificial production or wild tending have been carried out for certain scarce and endangered resources. A basic registration management system has been established for TCM pharmaceuticals under the guidance of theories of Traditional Chinese Medicine and pharmacology, highlighting the strengths of TCM, setting great store by clinical practice and encouraging innovation. To date, 60,000 TCM and ethnic minority medical drugs have been approved and 2,088 pharmaceutical enterprises that have been approved by the Good Manufacturing Practice (GMP) of Medical Products are manufacturing Chinese patent medicines. The dosage forms of TCM medicines have increased from a traditionally limited number of forms such as pills, powders, ointments, and pellets into more than 40, including dropping pills, tablets, pods, and capsules, indicating marked improvement in the technological level of Chinese medicinal drug production, and initial establishment of a modern Chinese Medicine industry based on the production of medicinal materials and industrial production and tied together by commerce. The third survey and statistics on Chinese materia medica

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resource showed that there are 12,807 Chinese medicinals, including 11,146 medicinal plants, 1,581 medicinal animals, and 80 medicinal minerals. In 2015, the total output value of the TCM pharmaceutical industry was RMB 786.6 billion, accounting for 28.55% of the total generated by the country’s pharmaceutical industry and becoming a new source of growth in China’s economy. Planting Chinese medicinal herbs has become a key means of adjusting the rural industrial structure, improving the ecoenvironment, and increasing farmers’ incomes. Trade in Chinese medicinal products maintained rapid growth and the export value of Chinese medicines amounted to US$3.72 billion in 2015, signifying the great potential of Chinese medicines in overseas markets. The TCM pharmaceutical industry has gradually developed into an industry with distinctive strengths and broad market prospects, which is of strategic importance to national economic and social development.

8.4.7  Seven TCM standardization and cultural development Positive progress has been made in TCM standardization. The Outline of the Medium- and Long-term Development Plan for the Standardi­ zation of Traditional Chinese Medicine (2011–2020) has been issued and implemented, putting in place initially a system of TCM standards which amount to 649, showing an average annual growth of 29%. Five national technical committees of standardization have been established for, respectively, Chinese Medicine, acupuncture and moxibustion, TCM drugs, integrated Chinese and Western Medicine, and seeds and seedlings of Chinese medicinal plants, with local standardization technical committees of Traditional Chinese Medicine and pharmaceuticals being set up in Guangdong, Shanghai, Gansu, and some other localities. The building of 42 research and application bases for TCM standardization is proceeding smoothly, and the clinical application of guidelines for TCM diagnosis and treatment of commonly seen diseases and guidelines for acupuncture and moxibustion is proving effective.

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Steady progress has also been witnessed in standardization of ethnic minority medicine, so has been orderly advancement in the formulation of guidelines for diagnosis and treatment of commonly seen diseases. In this regard, Uyghur Medicine has taken the lead, with the publishing of 14 guidelines for disease diagnosis and treatment and curative effect evaluation. The first local technical committee for standardization of Tibetan Medicine has been established in the Tibet Autonomous Region. Constant improvement has been observed in the competence and efficiency of institutions and workers in relation to the standardization of ethnic minority medicine and pharmacology. Chinese civilization represented by TCM is a precious treasure of splendid traditional Chinese culture. Health is closely associated with each and every one of us. With its profound cultural and philosophical ideas, TCM not only brings us health but allow us to experience the charm of traditional culture. The Chinese government treasures and protects the cultural value of TCM, and endeavors to build a system for passing on the traditional culture of TCM. In 2011, the Law of the People’s Republic of China on Intangible Cultural Heritage was issued and traditional medicine was included into the scope of intangible cultural heritage. In total, 130 TCM elements have been incorporated into the Representative List of National Intangible Cultural Heritage, with TCM acupuncture and moxibustion being included in the Representative List of the Intangible Cultural Heritage of Humanity by UNESCO, and the Huang Di Nei Jing (Yellow Emperor’s Internal Classic) and Ben Cao Gang Mu (Compendium of Materia Medica) are listed in the Memory of the World Register. Efforts have been reinforced to promote public awareness in TCM healthcare, including events under the campaign of Traditional Chinese Medicine across China. Public talks have been organized through media and TCM education bases popularizing basic knowledge and skills of TCM healthcare and prevention and treatment of illnesses. In this way, public awareness of and ability to practice TCM healthcare has been enhanced, and general public health has improved.

8.4.8  International exchange and cooperation in TCM The globalization of TCM had long been included in the 9th and 10th 5-year plan. Today, TCM has spread to 183 countries and regions around

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the world. The Chinese government has signed 86 TCM cooperation agreements with other countries and international organizations and has supported the building of 10 TCM centers overseas. According to the World Health Organization, 103 member states have given approval to the practice of acupuncture and moxibustion, 29 have enacted special statutes on traditional medicine, and 18 have included acupuncture and moxibustion treatment in their medical insurance provisions. TCM medicines have gradually entered the international system of medicines, and some of them have been registered in Russia, Cuba, Vietnam, Singapore, United Arab Emirates, and other nations. Some 30 countries and territories have opened a couple of hundred TCM schools to train local TCM professionals. The World Federation of AcupunctureMoxibustion Societies, headquartered in China, has 194 member organizations from 53 countries and territories, and the World Federation of Chinese Medicine Societies has 251 member organizations from 67 countries and territories. TCM has become an important area of health and trade cooperation between China and the ASEAN, EU, Africa, and Central and Eastern Europe, a key component in people-to-people exchanges between China and the rest of the world and between Eastern and Western cultures, and an important vehicle for China and other countries to work together in promoting world peace, improving the well-being of humanity, and developing a community of shared future. The Chinese government is dedicated to promoting the development of traditional medicine throughout the world and works closely with the WHO to contribute to progress traditional medicine around the globe. China has summarized its successful TCM practices and offers them to the world. It hosted the first WHO Congress on Traditional Medicine in Beijing in 2008 and played an important role in drafting the Beijing Declaration. In accordance with initiatives of the Chinese government, the 62nd and 67th World Health Assemblies passed two resolutions on traditional medicine and urged its member states to implement the WHO’s Traditional Medicine Strategy (2014–2023). To promote the orderly development of TCM around the globe and ensure its safe, efficient, and targeted application, China has facilitated the founding of the ISO/TC249 Traditional Chinese Medicine in the ISO. With its secretariat in Shanghai, it has now issued 62 ISO standards on

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TCM. By the end of September 2020, the ISO/TC 249 had 45 member bodies. Thanks to China’s efforts, the WHO has included traditional medicine, represented by TCM, in the new version of the International Classification of Diseases (ICD-11). China is working actively to promote international exchange and cooperation in the supervision and management of traditional medicine, in an effort to ensure that it is safe and effective.

8.5  Future directions for TCM President Xi Jinping pointed out in his report at the 19th CPC National Congress that, “The socialism with Chinese characteristics has crossed the threshold into a new era. This is a new historic juncture in China’s development.” TCM has done remarkable contribution to the survival and wellness of Chinese nation. It plays an irreplaceable role in protecting people’s health, promoting socio-economic development, dealing with the challenges of healthcare reform, and meeting people’s need. As a key symbol and carrier of Chinese civilization, the development of TCM has been made a national strategy. Today, the innovative development of TCM is facing the rare historical opportunity presented by big data, artificial intelligence (AI), and internet of things (IoT) and information technology (IT). There’s every reason to believe that TCM will continue to play a more significant role in building a healthier China, maintaining people’s health, and facilitating a harmonious society. The future directions for TCM development include carrying on the essence of TCM while pursuing innovations and speeding up its modernization and industrialization. The government will continue to place equal importance to both TCM and Western Medicine, allowing the two systems to complement each other and develop in a coordinated manner.[42]

8.5.1  Improving TCM service system Efforts should be made to perfect the comprehensive TCM service system that is comprised of national TCM centers, regional TCM healthcare centers, all levels of TCM institutions, departments in other medical institutions and community-level medical and health service institutions,

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providing preventative care, disease treatment, and rehabilitation service for all citizens through their full life cycle. Efforts should also be made to facilitate the training for TCM professionals at grassroots level, perfect the TCM knowledge and skills training for general practitioners and village doctors, upgrade the TCM service capacity, and integrate information technology to TCM service system by building smart hospitals with new service models.

8.5.2  Giving play to the unique role of TCM in maintaining and promoting people’s health In the context of socio-economic and technological advancement, change in spectrum of disease, outbreak of emerging diseases as well as moving from disease-centered to health-centered concept, efforts should be made to strengthen the advantages of TCM in disease prevention, treatment, and rehabilitation, address major diseases and key issues with integrated TCM and Western Medicine, and build an effective mechanism to enable TCM to contribute to the prevention and treatment of emerging infectious diseases and public health emergencies. Efforts should also be made to spread knowledge of TCM, advocate healthy ways of life and work, integrating traditional exercise methods with modern rehabilitation therapies and thus develop rehabilitation medicine with Chinese characteristics.[43]

8.5.3  Promoting TCM quality enhancement and high-quality TCM industry development Efforts should be made to protect Chinese medicinal resources, guarantee their quality, preserve rare and precious TCM wild medicinal resources, and implement the survey and dynamic monitoring for Chinese medicinal resources. Efforts should also be made to standardize plantation of Chinese medicinal plants, work on the directory of genuine medicinal plants, facilitate their elite seed production, promote their sustainable development by using green technologies in agriculture and bioengineering, and thus modernizing the research and development of TCM.

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8.5.4  Strengthening the building of TCM professionals Enhanced efforts should be made to cultivate the TCM way of thinking, implement reform of TCM college education, strengthen the principal status of TCM majors, perfect the standard TCM resident training model, facilitate education on integrated TCM and Western Medicine, and train high-level leading professionals and innovative research team. At the same time, efforts should also be made to establish an incentive mechanism for outstanding TCM professionals and support the participation of TCM professionals in China’s national talent programs and academician selection.

8.5.5  Facilitating the TCM inheritance, openness, and innovative development Efforts should be made to explore the essence of TCM, perfect the academic inheritance, and spread the TCM culture. Efforts should also be made to facilitate TCM research and innovation, develop clinical trials on prevention and treatment of major, difficult, rare, and emerging infectious diseases, speed up the research and development of new Chinese medicines and devices, and protect the intellectual property of TCM industry. At the same time, it’s essential to include TCM into the mission of building a global community with shared destiny and “Belt and Road” internal cooperation.

8.5.6  Reforming and improving the TCM management system and mechanism Efforts should be made to implement prioritized review and approval system based on clinical value of special TCM services, perfect national TCM medical insurance policies, build stable investment mechanism for TCM development and form a TCM-oriented regulation system by coordinating departments among education, drug administration, and service supervision.

References   [1] Zhou Lifeng, Xu Zhi. Traditional Recovery Technology[M]. Zhengzhou: Henan Science And Technology Press, 2014: 2.

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 [2] Zhen Zhiya. Chinese Medical History[M]. Beijing: Chinese Traditional Medical Ancient Archive Press, 1987: 6.   [3] Ma Yani. Chinese Traditional Medical Nourishing and Keeping Health[M]. Xi’an: Shanxi People’s Press, 2008: 2.   [4] Ren Yingqiu. Ten Lessons of Chinese Traditional Medical Basic Theory by Ren Yingqiu[M]. Beijing: China Medial Science Press, 2019: 15.   [5] Li Chengwen. Chinese Traditional Medical History[M]. Beijing: Military Science Publishing House, 2009: 19.   [6] Yang Haitao. Chuan Cheng[M]. Nanchang: Baihuazhou Literature and Art Publishing House, 2018: 226.   [7] Wang Shoukuan, Qu Zhimin. Essence of Chinese Traditional Culture[M]. Lanzhou: Gansu People’s Press, 2018: 409.  [8] Hu Jianpeng. Inventions of Chinese Traditional Medical’s Theory by Generations of Ancient Chinese Doctors[M]. Beijing: University of Science and Technology of China’s Press, 2018: 63.   [9] Xu Jiangyan. Chinese Medical History[M]. Shanghai: Shanghai Scientific & Technical Publishers, 2017: 26. [10] Li Luoli. Tongjian of Chinese History[M]. Beijing: China International Culture Press, 1997: 3996. [11] Xuan Yang, Li Yurong. Chinese Traditional Medical Ethics[M]. Hefei: Anhui University Press, 2018: 56. [12] The Committee of Chinese Traditional Medical Culture. Chinese Traditional Medical History and Stories[M]. Beijing: China Light Industry Press, 2018: 87. [13] The Committee of Benshu. The Brief Introduction of Chinese Academical Masterpieces[M]. Shanghai: Fudan University Press, 2019: 307. [14] Wang Anbang. Biographies of Chinese Ancient Doctors[M]. Zhengzhou: Henan Science and Technology Press, 2019: 92. [15] Yang Yunsong. Different Schools of Chinese Traditional Medical Theory[M]. Wuhan: Hubei Science and Technology Press, 2020: 18. [16] Yang Yunsong. Different Schools of Chinese Traditional Medical Theory[M]. Wuhan: Hubei Science and Technology Press, 2020: 56. [17] Yan Shiyun. Different Schools of Chinese Traditional Medical Theory[M]. Beijing: China Press of Chinese Traditional Medicine, 2017: 127. [18] Yan Shiyun. Different Schools of Chinese Traditional Medical Theory[M]. Beijing: China Press of Chinese Traditional Medicine, 2017: 98. [19] Yan Shiyun. Different Schools of Chinese Traditional Medical Theory[M]. Beijing: China Press of Chinese Traditional Medicine, 2017: 109. [20] Chang Cunku. Chinese Medical History[M]. Beijing: China Press of Chinese Traditional Medicine, 2017: 113.

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[21] Ma Boying. Chinese Medical Culture History[M]. Shanghai: Shanghai People’s Press, 2019: 459. [22] Wang Yusheng, Chen Liyun. Medical History and Stories[M]. Shanghai: Shanghai Scientific and Technological Literature Press, 2019: 74. [23] Shanghai Medical Association. Qihuang History and Stories[M]. Shanghai: Shanghai Scientific & Technical Publishers, 2018: 138. [24] The White Paper. Traditional Chinese Medicine in China[M]. 2016. [25] Zhang Qingxiang. Basic Theory of Traditional Chinese Medicine[M]. Jinan: Shandong Science and Technology Press, 2020: 15. [26] Zhang Qingxiang. Basic Theory of Traditional Chinese Medicine[M]. Jinan: Shandong Science and Technology Press, 2020: 22. [27] Zhang Nong. Chinese Traditional Medicine[M]. Jilin: Jilin University’s Press, 2012: 25. [28] Li Mei, Zhou Bei. Basic Theory of Traditional Chinese Medicine and Pharmacy[M]. Beijing: China Medicine and Pharmacy Science Press, 2016: 69. [29] Gao Xiyan, Zhu Pingsheng. Dictionary of Traditional Chinese Medicine[M]. Xi’an: Shanxi Science and Technology Press, 2017: 772. [30] Jiang Deyou. Practice Methods of Traditional Chinese Medicine Clinic[M]. Beijing: China Press of Traditional Chinese Medicine, 2017: 60. [31] Huang LX. Traditional Chinese Medicine in Pictures — Acupuncture & Moxibustion [M]. Beijing: People’s Medical Publishing House, 2007: 2. [32] Chen LY. The Story of Traditional Chinese Medicine [M]. Shanghai: Shanghai Scientific & Technical Publishers, 2018: 41. [33] Yan SY. Academic Development History of Traditional Chinese Medicine [M]. Shanghai: Shanghai University of Traditional Chinese Medicine Press, 2004: 288. [34] Pan GJ, Fan ZL. Traditional Japanese Medicine (Kampo) [M]. Beijing: China Press of Traditional Chinese, 1994: 126. [35] Ma BY. A History of Medicine in Chinese Culture [M]. Shanghai: Shanghai People’s Publishing House, 2010: 165. [36] Zhang ZB, Zheng JS. Traditional Chinese Medicine in Pictures — Health Cultivation [M]. Beijing: People’s Medical Publishing House, 2007: 86. [37] Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine[R]. 2019. [38] Outline of the Strategic Plan on the Development of Traditional Chinese Medicine (2016–2030) [R]. 2016. [39] Outline of the Healthy China 2030 Plan[R]. 2016.

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[40] The Action Plan on Belt and Road Initiative in Traditional Chinese Medicine (2016–2020) [R]. 2017. [41] Zhang BL, Zhu JP. A Centennial History of Traditional Chinese Medicine (1912–2015) [M]. Shanghai: Shanghai Scientific & Technical Publishers, 2016: 105. [42] Tong XL, He LS, Zhao LH. Traditional Chinese Medicine and the Era of Precision Medicine [J]. Journal of Traditional Chinese Medicine, 2016, 57 (20): 1715. [43] Zhang BL. Facing the Future: The World Needs Traditional Chinese Medicine [J]. Negative, 2016, (1): 2.

Introduction of Appendixes TCM is an important part of Chinese health care system. In order to promote inheritance, innovation and development of TCM, Chinese government has issued a white paper on the development of TCM in 2016. Then, China’s top legislature has adopted a law on TCM to advance its role in building healthy China. Ever since the outbreak of Covid-19, China’s National Health Commission has been advocating the integration of Chinese and Western Medicine. In 2022, the National Health Commission and State Administration of Traditional Chinese Medicine updated the Covid-19 Diagnosis and Treatment Protocol (the 9th edition). The WHO organized Expert Meeting on Evaluation of Traditional Chinese Medicine in the Treatment of COVID-19. We provided aforementioned four important documents as annexes for your reference. Let’s work together on safe and scientific development of traditional medicine and contribute more to public health and wellness.

Appendix I Traditional Chinese Medicine In China The State Council Information Office of the People’s Republic of China December 2016 First Edition 2016

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Preface Humanity has created a colorful global civilization in the long course of its development, and the civilization of China is an important component of the world civilization harboring great diversity. As a representative feature of Chinese civilization, traditional Chinese medicine (TCM) is a medical science that was formed and developed in the daily life of the people and in the process of their fight against diseases over thousands of years. It has made a great contribution to the nation’s procreation and the country’s prosperity, in addition to producing a positive impact on the progress of human civilization. TCM has created unique views on life, on fitness, on diseases and on the prevention and treatment of diseases during its long history of absorption and innovation. It represents a combination of natural sciences and humanities, embracing profound philosophical ideas of the Chinese nation. As ideas on fitness and medical models change and evolve, TCM has come to underline a more and more profound value. Since the founding of the People’s Republic of China in 1949, the Chinese government has set great store by TCM and rendered vigorous support to its development. TCM and Western medicine have their different strengths. They work together in China to protect people from diseases and improve public health. This has turned out to be one of the important features and notable strengths of medicine with Chinese characteristics.

I.  The Historical Development of TCM 1. History of TCM In remote antiquity, the ancestors of the Chinese nation chanced to find that some creatures and plants could serve as remedies for certain ailments and pains and came to gradually master their application. As time went by, people began to actively seek out such remedies and methods for preventing and treating diseases. Sayings like “Shennong (Celestial Farmer) tasting a hundred herbs” and “food and medicine coming from the same source” are characteristic of those years.

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The discovery of alcohol in the Xia Dynasty (c. 2070–1600 BC) and the invention of herbal decoction in the Shang Dynasty (1600–1046 BC) rendered medicines more effective. In the Western Zhou Dynasty (1046–771 BC), doctors began to be classified into four categories — dietician, physician, doctor of decoctions, and veterinarian. During the Spring and Autumn and Warring States period (770–221 BC), Bian Que drew on the experience of his predecessors and put forward the four diagnostic methods — inspection, auscultation & olfaction, inquiry, and palpation, laying the foundation for TCM diagnosis and treatment. The Huang Di Nei Jing (Yellow Emperor’s Inner Canon) compiled during the Qin and Han times (221 BC–AD 220) offered systematic discourses on human physiology, on pathology, on the symptoms of illness, on preventative treatment, and on the principles and methods of treatment. This book defined the framework of TCM, thus serving as a landmark in TCM’s development and symbolizing the transformation from the accumulation of clinical experience to the systematic summation of theories. A theoretical framework for TCM had been in place. The Shang Han Za Bing Lun (Treatise on Febrile Diseases and Miscellaneous Illnesses) collated by Zhang Zhongjing in the Eastern Han Dynasty (25–220) advanced the principles and methods to treat febrile diseases due to exogenous factors (including pestilences). It expounds on the rules and principles of differentiating the patterns of miscellaneous illnesses caused by internal ailments, including their prevention, pathology, symptoms, therapies, and treatment. It establishes the theory and methodology for syndrome pattern diagnosis and treatment differentiation. The Shen Nong Ben Cao Jing (Shennong’s Classic of Materia Medica), another masterpiece of medical literature appeared during this period, outlines the theory of the compatibility of medicinal ingredients. For example, it holds that a prescription should include at the same time the jun (or sovereign), chen (or minister), zuo (or assistant), and shi (or messenger) ingredient drugs, and should give expression to the harmony of the seven emotions as well as the properties of drugs known as “four natures” and “five flavors.” All this provides guidance to the production of TCM prescriptions, safe application of TCM drugs, and enhancement of the therapeutic effects, thus laying the foundation for the formation and

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development of TCM pharmaceutical theory. In the late years of the Eastern Han Dynasty, Hua Tuo (c. 140–208) was recorded to be the first person to use anesthetic (mafeisan) during surgery. The Zhen Jiu Jia Yi Jing (AB Canon of Acupuncture and Moxibustion) by Huangfu Mi during the Western Jin time (265–316) expounded on the concepts of zangfu (internal organs) and jingluo (meridians and collaterals). This was the point when theory of jingluo and acupuncture and moxibustion began to take shape. Sun Simiao, a great doctor of the Tang Dynasty (618–907), proposed that mastership of medicine lies in proficient medical skills and lofty medical ethics, which eventually became the embodiment of a moral value of the Chinese nation, a core value that has been conscientiously upheld by the TCM circles. A herbology and nature masterpiece, the Ben Cao Gang Mu (Compendium of Materia Medica) compiled by Li Shizhen in the Ming Dynasty (1368–1644), was the first book in the world that scientifically categorized medicinal herbs. It was a pioneering work that advanced TCM pharmaceutical theory. The Wen Re Lun (A Treatise on Epidemic Febrile Diseases), by Ye Tianshi during the Qing Dynasty (1644–1911), developed the principles and methods for prevention and treatment of pestilential febrile diseases. It represents the theory and results of the practice of TCM in preventing and treating such diseases. Following the spread of Western medicine in China from the midQing Dynasty, especially during the period of the Republic of China (1912–1949), some TCM experts began to explore ways to absorb the essence of Western medicine for a combination of TCM with Western medicine. 2. Characteristics of TCM During its course of development spanning a couple of millennia, TCM has kept drawing and assimilating advanced elements of natural science and humanities. Through many innovations, its theoretical base covered more ground and its remedies against various diseases expanded, displaying unique characteristics. First, setting great store by the holistic view. TCM deems that the relationship between humans and nature is an interactive and inseparable

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whole, as are the relationships between humans and the society, and between the internal organs of the human body, so it values the impacts of natural and social environment on health and illness. Moreover, it believes that the mind and body are closely connected, emphasizing the coordination of physical and mental factors and their interactions in the conditions of health and illness. Second, setting great store by the principle of harmony. TCM lays particular stress on the importance of harmony on health, holding that a person’s physical health depends on harmony in the functions of the various body organs, the moderate status of the emotional expression, and adaption and compliance to different environments, of which the most vital is the dynamic balance between yin and yang. The fundamental reason for illness is that various internal and external factors disturb the dynamic balance. Therefore, maintaining health actually means conserving the dynamic balance of body functions, and curing diseases means restoring chaotic body functions to a state of coordination and harmony. Third, emphasis on individuality. TCM treats a disease based on full consideration of the individual constitution, climatic and seasonal conditions, and environment. This is embodied in the term “giving treatment on the basis of syndrome differentiation.” Syndrome differentiation means diagnosing an illness as a certain syndrome on the basis of analyzing the specific symptoms and physical signs collected by way of inspection, auscultation and olfaction, inquiry, and palpation, while giving treatment means defining the treatment approach in line with the syndrome differentiated. TCM therapies focus on the person who is sick rather than the illness that the patient contracts, i.e., aiming to restore the harmonious state of body functions that is disrupted by pathogenic factors. Fourth, emphasis on preventative treatment. Preventative treatment is a core belief of TCM, which lays great emphasis on prevention before a disease arises, guarding against pathological changes when falling sick, and protecting recovering patients from relapse. TCM believes that lifestyle is closely related to health, so it advocates health should be preserved in daily life. TCM thinks that a person’s health can be improved through emotional adjustment, balanced labor and rest, a sensible diet, and a regular life, or through appropriate intervention in the lifestyle based on

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people’s specific physical conditions. By these means, people can cultivate vital energy to protect themselves from harm and keep healthy. Fifth, simplicity. TCM doctors diagnose patients through inspection, auscultation and olfaction, inquiry, and palpation. In addition to medication, TCM has many non-pharmacological alternative approaches such as acupuncture and moxibustion, tuina (massage), cupping, and guasha (spooning). There is no need for complex equipment. TCM tools, for example, the small splints used in Chinese osteopathy, the spoons used in guasha, or the cups used in cupping therapy, can draw from materials close at hand, so that such treatments can spread easily. 3. TCM’s Contributions TCM is an important component and a characteristic feature of traditional Chinese culture. Applying such principles as “man should observe the law of the nature and seek for the unity of the heaven and humanity,” “yin and yang should be balanced to obtain the golden mean,” and “practice of medicine should aim to help people,” TCM embodies the core value of Chinese civilization. TCM also advocates “full consideration of the environment, individual constitution, and climatic and seasonal conditions when practicing syndrome differentiation and determining therapies,” “reinforcing the fundamental and cultivating the vital energy, and strengthening tendons and bones,” and “mastership of medicine lying in proficient medical skills and lofty medical ethics,” all concepts that enrich Chinese culture and provide an enlightened base from which to study and transform the world. TCM originated in the Chinese culture. It explains health and diseases from a macro, systemic, and holistic perspective. It shows how China perceives nature. As a unique form of medicine, TCM exercises a profound influence on the life of the Chinese people. It is a major means to help the Chinese people maintain health, cure diseases, and live a long life. The Chinese nation has survived countless natural disasters, wars, and pestilences, and continues to prosper. In this process, TCM has made a great contribution. Born in China, TCM has also absorbed the essence of other civilizations, evolved, and gradually spread throughout the world. As early as the Qin and Han Dynasties (221 BC—AD 220), TCM was popular in many neighboring countries and exerted a major impact on their traditional

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medicines. The TCM smallpox vaccination technique had already spread outside of China during the Ming and Qing Dynasties (1368–1911). The Ben Cao Gang Mu (Compendium of Materia Medica) was translated into various languages and widely read, and Charles Darwin, the British biologist, hailed the book as an “ancient Chinese encyclopedia.” The remarkable effects of acupuncture and moxibustion have won its popularity throughout the world. The discovery of qinghaosu (artemisinin, an antimalaria drug) has saved millions of lives, especially in developing countries. Meanwhile, massive imports of medicinal substances such as frankincense and myrrh have enriched TCM therapies.

II.  Policies and Measures on TCM Development China lays great store by the development of TCM. When the People’s Republic was founded in 1949, the government placed emphasis on uniting Chinese and Western medicine as one of its three guidelines for health work, and enshrined the important role of TCM. In 1978, the Communist Party of China (CPC) Central Committee transmitted throughout the country the Ministry of Health’s “Report on Implementing the Party’s Policies Regarding TCM and Cultivating TCM Practitioners,” and lent great support in areas of human resources, finance, and supplies, vigorously promoting the development of TCM. It is stipulated in the Constitution of the PRC that the state promotes modern medicine and TCM to protect the people’s health. In 1986, the State Council set up a relatively independent administration of TCM. All provinces, autonomous regions, and municipalities directly under the central government have established their respective TCM administrations, which has laid an organizational basis for TCM development. At the Fourth Meeting of the Seventh National People’s Congress, equal emphasis was put on Chinese and Western medicine, which was made one of the five guidelines in China’s health work in the new period. In 2003 and 2009, the State Council issued the “Regulations of the People’s Republic of China on Traditional Chinese Medicine” and the “Opinions on Supporting and Promoting the Development of Traditional Chinese Medicine,” gradually forming a relatively complete policy system on TCM.

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Since the CPC’s 18th National Congress in 2012, the Party and the government have granted greater importance to the development of TCM and made a series of major policy decisions and adopted a number of plans in this regard. At the National Conference on Hygiene and Health held in August 2016, President Xi Jinping emphasized the importance of revitalizing and developing TCM. The CPC’s 18th National Congress and the Fifth Plenary Session of the 18th CPC Central Committee both reiterated the necessity to pay equal attention to the development of TCM and Western medicine and lend support to the development of TCM and ethnic minority medicine. In 2015, the executive meeting of the State Council approved the Law on Traditional Chinese Medicine (draft) and submitted it to the Standing Committee of the National People’s Congress for deliberation and approval, intending to provide a sounder policy environment and legal basis for TCM development. In 2016, the CPC Central Committee and the State Council issued the Outline of the Healthy China 2030 Plan, a guide to improving the health of the Chinese people in the coming 15 years. It sets out a series of tasks and measures to implement the program and develop TCM. The State Council issued the Outline of the Strategic Plan on the Development of Traditional Chinese Medicine (2016–2030), which made TCM development a national strategy, with systemic plans for TCM development in the new era. These decisions and plans have mapped out a grand blueprint that focuses on the full revitalization of TCM, accelerated reform of the medical and healthcare system, the building of a medical and healthcare system with Chinese characteristics, and the advancement of the healthy China plan, thus ushering in a new era of development for TCM. The basic principles and main measures envisioned to develop TCM are: Putting people first and making achievements in TCM development accessible to everyone. TCM roots deep among the public and the philosophies it contains are easy to understand. To meet the people’s demand for healthcare, China endeavors to expand the supply of TCM services, improve community-level TCM health management, advance the integral development of TCM with community service, care of the elderly and tourism, spread knowledge of TCM and advocate healthy ways of life and

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work, enhance welfare for the public, and ensure that the people can enjoy safe, efficient, and convenient TCM services. Equal attention to TCM and Western medicine. Equal status shall be accorded to TCM and Western medicine in terms of ideological understanding, legal status, academic development, and practical application. Efforts shall be made to improve system of administration related to TCM, increase financial input, formulate policies, laws and regulations suited to the unique features of TCM, promote coordinated development of TCM and Western medicine, and make sure that they both serve the maintenance and improvement of the people’s health. Making TCM and Western medicine complementary to each other and letting each play to its strengths. The state encourages exchanges between TCM and Western medicine and creates opportunities for Western medical practitioners to learn from their TCM counterparts. Modern medicine courses are offered at TCM colleges and universities to strengthen the cultivation of doctors who have a good knowledge of both TCM and Western medicine. In addition to the general departments, TCM hospitals have been encouraged to open specialized departments for specific diseases. General hospitals and community-level medical care organizations have been encouraged to set up TCM departments, and TCM has been made available to patients in the basic medical care system and efforts have been made to make it play a more important role in basic medical care. A mechanism has been established for TCM to participate in medical relief of public emergencies and the prevention and control of serious infectious diseases. Upholding the dialectical unity of tradition and innovation, i.e., maintaining TCM’s characteristics while actively applying modern science and technology in TCM development. A system has been established to carry forward the theories and clinical experience of well-known veteran TCM experts, and efforts have been made to rediscover and categorize ancient TCM classics and folk medical experience and practices. A system of technological innovation has been established to advance TCM progress, and efforts have been made to carry out systemic research on the fundamental theories, clinical diagnosis and treatment, and therapeutic evaluation of TCM. Interdisciplinary efforts have been organized in joint research on the treatment and control of major difficult and complicated

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diseases and major infectious diseases, as well as research on the prevention and treatment of common diseases, frequently occurring diseases, and chronic diseases using TCM. Endeavor has been made in the research and development (R&D) of new TCM medicines, and medical devices and equipment. Making overall plans for integrated, coordinated, and sustainable development of TCM. The state makes overall plans for the coordinated development of TCM, integrating such areas as TCM clinical practices, healthcare, R&D, education, industry, and culture. Efforts have been made to improve community-level TCM services and the TCM medical care system. A health promotion project featuring preventative treatment of diseases has been launched to enhance TCM medical care. China has built research bases for TCM clinical studies, developed a system of coordination and innovation for the prevention and treatment of major diseases with TCM, and launched programs for training professionals necessary for TCM inheritance and innovation and improving the quality of the ranks of TCM workers. The state has set out to promote the green development of the entire TCM industrial chain and vigorous efforts have been made in the development of non-pharmacological therapies. Further efforts have been made to upgrade the TCM industry and develop it into an emerging strategic industry. A nationwide program has been conducted to promote the core values of TCM. Promoting TCM development by way of government support and multi-party participation. The government has made TCM an important component of economic and social development and has included it in relevant plans and provided financial support. The state has strengthened the supervision and administration of TCM practices, and initiated a market access system for TCM practitioners, TCM medical institutions, and TCM medicines, and improved the standards for the quality and safety of TCM service. The government has developed preferential policies to let the market play a full and decisive role in allocating resources and is striving to create a market environment characterized by equal participation and fair play, so as to maximize the potential and vitality of TCM. Encouragement has been given to social capital to support the development of TCM and to private investors to establish TCM healthcare institutions.

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III. Carrying Forward the Tradition and Ensuring the Development of TCM Establishment of a TCM medical care system covering both urban and rural areas. An urban TCM medical care network, mainly comprising hospitals for TCM (including ethnic minority medicine and integrated Chinese and Western medicine), TCM clinics and general hospitals’ TCM clinical departments, and community health centers, has been formed. A rural TCM medical care network has been established, mainly composed of county-level TCM hospitals, TCM clinical departments of general hospitals (specialized hospitals and maternal & child health centers), TCM departments of township-level health centers, and village health clinics, which provides basic TCM healthcare services. Statistics collected at the end of 2015 show that there were 3,966 TCM hospitals across the country, including 253 hospitals of ethnic minority medicine and 446 hospitals of integrated Chinese and Western medicine. There were 452,000 practitioners and assistant practitioners of TCM (including practitioners of ethnic minority medicine and integrated Chinese and Western medicine). There were 42,528 TCM clinics, including 550 for ethnic minority medicine and 7,706 for integrated medicine. There were 910 million visits that year to TCM medical and health service units across the country and 26,915,000 inpatients treated. In addition to making contribution to the prevention and treatment of common, endemic, and difficult diseases, TCM has played an important role in the prevention and treatment of major epidemics and medical relief in public emergencies and natural disasters. The contribution of TCM and integrated Chinese and Western medicine in treating SARS (severe acute respiratory syndrome) has been affirmed by the World Health Organization (WHO). TCM treatment of influenza A virus subtype H1N1 has yielded satisfactory results, arousing widespread attention in the international community. In addition, TCM has made distinctive contributions to the prevention and control of epidemics such as HIV/AIDS (Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome), HFMD (Hand, Foot and Mouth Disease), and Influenza A virus subtype H7N9 in humans, as well as to medical relief following the Wenchuan

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earthquake, the Zhouqu mudslide, and other public emergencies and natural disasters. Expedited development of TCM disease prevention and healthcare services. The system of TCM disease prevention and healthcare services has been expedited by establishing preventative healthcare departments at TCM hospitals at/above the second class and providing TCM preventative medical care services at community-level medical and health service institutions, maternal and child health centers, and rehabilitation centers. Also seen is rapid growth in the number of privately run TCM healthcare institutions. Endeavor has been made to promote the development of TCM health services and carry out TCM health tourism and TCM integrated treatment and convalesce. TCM health management program has been incorporated as a separate category into the national basic public health service program, gradually releasing the potential and strengths of TCM in public health services, thus fostering a shift from treatment of serious diseases to comprehensive health management in the mode of health development. Important role played by TCM in the reform of the medical care system. In the course of advancing the reform, TCM’s distinct strengths, such as its clinical effectiveness, its unique role, flexible ways of treatment, and relatively low cost in disease prevention and healthcare, have been fully exploited to augment benefits of reform for the people and enriched the connotation of China’s basic medical care system with distinct characteristics. With relatively low cost, TCM has contributed a rather higher share of services in relation to the resources it is entitled to. The medical care services provided by TCM institutions in the national total increased from 14.3–15.7% in the few years from 2009–2015. In 2015, out-patient expenses per visit and in-patient expenses per capita at public TCM hospitals were, respectively, 11.5% and 24% lower than those at general public hospitals. Building a distinctive system of training for TCM professionals. Training of professionals is essential for the development of TCM. Thus, great efforts have been made to promote development of education in TCM, basically putting in place a system of training for TCM professionals that features an organic link-up between college, graduate, and continuing education, and run through master-apprenticeship training. This,

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together with a mechanism for training of practical TCM professionals geared toward the needs of the urban and rural communities that has also been initially established, forms a multi-dimensional education network covering multiple disciplines at different levels, including TCM, traditional Chinese pharmacology, integrated Chinese and Western medicine, and ethnic minority medicine at secondary and higher vocational schools, colleges, postgraduate and doctoral studies. By the end of 2015, there were 42 institutions of higher learning in TCM (including 25 TCM colleges) throughout the country and more than 200 Western medicine institutions of higher learning or non-medical higher learning institutions offering programs in TCM, enrolling in total as many as 752,000 students. In the course of implementing the program of training professionals for inheritance and innovation in TCM, efforts have been made to conserve and disseminate the academic ideas and practical experience of the fifth batch of prominent TCM experts. By 2015, 1,016 studios had been set up for carrying forward their expertise; 200 studios had been set up for passing on the expertise of prominent TCM experts at the grassroots level; 64 studios had been established for promoting various schools of TCM. TCM training programs targeted at professionals at both grassroots and higher levels have been held, such as training in TCM knowledge and skills for village doctors, training for conserving special traditional pharmacological skills, and advanced training for outstanding TCM clinical practitioners. Together, 124 researchers are finishing postdoctoral studies in TCM inheritance at the Chinese Academy of Chinese Medical Sciences and their work is being evaluated. Exploration has been made in establishing an incentive mechanism for outstanding TCM workers to come to the fore. By 2015, the title of TCM Master had been awarded to a total of 60 experts practicing TCM and ethnic minority medicine. Positive progress made in TCM scientific research. Sixteen national TCM clinical research bases have been built as part of the clinical research system for preventing and treating infectious diseases and chronic noninfectious diseases with TCM. This, together with a number of key research centers and labs covering all disciplines of TCM and national engineering (technology) research centers and labs in this respect, have brought into being a TCM sci-tech innovation system that is based on independent TCM research institutes, TCM universities, and TCM

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hospitals at and above the provincial level, and participated by comprehensive universities, general hospitals, and TCM enterprises. In recent years, 45 TCM research achievements have been awarded national sci-tech prizes, of which five were first-prize winners of the National Science and Technology Progress Award. Tu Youyou won the 2011 Lasker Award in clinical medicine and the 2015 Nobel Prize in Physiology or Medicine for discovering qinghaosu (artemisinin). Wang Zhenyi and Chen Zhu were awarded the 7th Annual Szent-Gyorgyi Prize for Progress in Cancer Research for combining the Western medicine ATRA and the TCM compound arsenic trioxide to treat acute promyelocytic leukemia (APL). A pilot program for Chinese medicinal resources survey has been implemented, forming a dynamic information and technology system with one central platform, 28 provincial-level centers, and 65 monitoring stations. Sixteen seed and seedling bases for Chinese medicinal plants and two germplasm banks have been established. Organizational work has been done for collation of literature and screening of appropriate skills of ethnic minority medicine, involving 150 works on ethnic minority medicine and 140 appropriate skills. The transformation and application of these research results has provided support for enhancing clinical effectiveness, ensuring the quality of Chinese medicine, and fostering the sound development of the TCM pharmaceutical industry. Rapid development of the TCM pharmaceutical industry. A number of laws and regulations have been enacted and implemented on strengthening the protection of TCM wild medicinal resources; a number of national and local nature reserves have been established; research has been conducted on the protection of rare and endangered Chinese medicinal resources; and artificial production or wild tending have been carried out for certain scarce and endangered resources. A registration management system has been basically established for TCM pharmaceuticals under the guidance of theories of TCM and pharmacology, highlighting the strengths of TCM, setting great store by clinical practice and encouraging innovation. To date, 60,000 TCM and ethnic minority medical drugs have been approved, and 2,088 pharmaceutical enterprises that have been approved by the Good Manufacturing Practice (GMP) of Medical Products are manufacturing

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Chinese patent medicines. The dosage forms of TCM medicines have increased from a traditionally limited number of forms such as pills, powders, ointments, and pellets into more than 40, including dropping pills, tablets, pods, and capsules, indicating marked improvement in the technological level of Chinese medicinal drug production, and initial establishment of a modern Chinese medicine industry based on the production of medicinal materials and industrial production and tied together by commerce. In 2015, the total output value of the TCM pharmaceutical industry was RMB786.6 billion, accounting for 28.55% of the total generated by the country’s pharmaceutical industry and becoming a new source of growth in China’s economy. Planting Chinese medicinal herbs has become a key means of adjusting the rural industrial structure, improving the ecoenvironment, and increasing farmers’ incomes. Trade in Chinese medicinal products maintained rapid growth and the export value of Chinese medicines amounted to US$3.72 billion in 2015, signifying the great potential of Chinese medicines in overseas markets. The TCM pharmaceutical industry has gradually developed into an industry with distinctive strengths and broad market prospects, which is of strategic importance to national economic and social development. New progress in TCM culture. The Chinese government treasures and protects the cultural value of TCM and endeavors to build a system for passing on the traditional culture of TCM. In total, 130 TCM elements have been incorporated into the Representative List of National Intangible Cultural Heritage, with TCM acupuncture and moxibustion being included in the Representative List of the Intangible Cultural Heritage of Humanity by UNESCO, and the Huang Di Nei Jing (Yellow Emperor’s Inner Canon) and Ben Cao Gang Mu (Compendium of Materia Medica) are listed in the Memory of the World Register. Efforts have been reinforced to promote public awareness in TCM healthcare, including events under the campaign of Traditional Chinese Medicine Across China. Public talks have been organized through media and TCM education bases popularizing basic knowledge and skills of TCM healthcare and prevention and treatment of illnesses. In this way, public awareness of and ability to practice TCM healthcare has been enhanced, and general public health has improved.

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Positive progress in TCM standardization. The Outline of the Medium- and Long-term Development Plan for the Standardization of Traditional Chinese Medicine (2011–2020) has been issued and implemented, putting in place initially a system of TCM standards which amount to 649, showing an average annual growth of 29%. Five national technical committees of standardization have been established for, respectively, Chinese medicine, acupuncture and moxibustion, TCM drugs, integrated Chinese and Western medicine, and seeds and seedlings of Chinese medicinal plants, with local standardization technical committees of traditional Chinese medicine and pharmaceuticals being set up in Guangdong, Shanghai, Gansu, and some other localities. The building of 42 research and application bases for TCM standardization is proceeding smoothly, and the clinical application of guidelines for TCM diagnosis and treatment of commonly seen diseases and guidelines for acupuncture and moxibustion is proving effective. Steady progress has also been witnessed in standardization of ethnic minority medicine, so has been orderly advancement in the formulation of guidelines for diagnosis and treatment of commonly seen diseases. In this regard, Uyghur medicine has taken the lead, with the publishing of 14 guidelines for disease diagnosis and treatment, and curative effect evaluation. The first local technical committee for standardization of Tibetan medicine has been established in the Tibet Autonomous Region. Constant improvement has been observed in the competence and efficiency of institutions and workers in relation to the standardization of ethnic minority medicine and pharmacology.

IV. International Exchanges and Cooperation in TCM Promoting the globalization of TCM. TCM has been spreading to 183 countries and regions around the world. According to the World Health Organization, 103 member states have given approval to the practice of acupuncture and moxibustion, 29 have enacted special statutes on traditional medicine, and 18 have included acupuncture and moxibustion treatment in their medical insurance provisions. TCM medicines have

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gradually entered the international system of medicines, and some of them have been registered in Russia, Cuba, Vietnam, Singapore, United Arab Emirates, and other nations. Some 30 countries and regions have opened a couple of hundred TCM schools to train native TCM workers. The World Federation of Acupuncture-Moxibustion Societies, headquartered in China, has 194 member organizations from 53 countries and regions, and the World Federation of Chinese Medicine Societies has 251 member organizations from 67 countries and regions. TCM has become an important area of health and trade cooperation between China and the ASEAN, EU, Africa, and Central and Eastern Europe, a key component in people-to-people exchanges between China and the rest of the world and between Eastern and Western cultures, and an important vehicle for China and other countries to work together in promoting world peace, improving the well-being of humanity, and developing a community of shared future. Supporting the global development of traditional medicine. The Chinese government is dedicated to promoting the development of traditional medicine throughout the world and works closely with the WHO to contribute to progress in traditional medicine around the globe. China has summarized its successful TCM practices and offers them to the world. It hosted the first WHO Congress on Traditional Medicine in Beijing in 2008 and played an important role in drafting the Beijing Declaration. In accordance with initiatives of the Chinese government, the 62nd and 67th World Health Assemblies passed two resolutions on traditional medicine and urged its member states to implement the WHO’s Traditional Medicine Strategy 2014–2023. Currently, the Chinese government has signed 86 TCM cooperation agreements with other countries and international organizations and has supported the building of 10 TCM centers overseas. Promoting standard management of TCM internationally. To promote the orderly development of TCM around the globe and ensure its safe, efficient, and targeted application, China has facilitated the founding of the ISO/TC249 Traditional Chinese Medicine in the ISO. With its secretariat in Shanghai, it has now issued a series of ISO standards on TCM. Thanks to China’s efforts, the WHO has included traditional medicine, represented by TCM, in the new version of the International Classification

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of Diseases (ICD-11). China is working actively to promote international exchange and cooperation in the supervision and management of traditional medicine, in an effort to ensure that it is safe and effective. Providing TCM medical aid overseas. While seeking its own development, within its capacity, China has persisted in providing aid and assistance to other developing countries, fulfilling its due international obligations. To date, China has sent medical teams to over 70 countries in Asia, Africa, and Latin America, with TCM professionals in almost every team, accounting for 10% of the total number of staff. A project has been launched to build TCM centers in African countries, and specialized TCM stations have opened in Kuwait, Algeria, Tunisia, Morocco, Malta, and Namibia. The Chinese government has sponsored 10 TCM centers overseas. In recent years, China has strengthened work in the prevention and control of AIDS and malaria in developing countries, and in African countries in particular, sending a total of 400 TCM specialists to more than 40 countries including Tanzania, Comoros, and Indonesia. Chinese medical teams have treated complicated and refractory diseases with TCM, acupuncture and moxibustion, medical massage, and methods combining Chinese and Western medicine, saving many lives, and winning extensive appreciation from governments and people concerned.

Conclusion China’s economic development has entered a new historical period. TCM has come to play an increasingly significant role in the socio-economic development; it has become a unique resource in terms of healthcare, an economic resource with great potential, a scientific and technological resource with originality advantages, an outstanding cultural resource, and an ecological resource of great importance. The time has come for TCM to experience a renaissance. China will learn from the achievements of modern civilization, uphold the principle of making the ancient serve the contemporary, and strive to promote the modernization of TCM by making every effort to carry on the good traditions and practices of Chinese medicine, and promote the innovative development of TCM for health preservation, so that TCM will be

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incorporated into the modern outlook on health to serve the people. By 2020, every Chinese citizen will have access to basic TCM services, and by 2030 TCM services will cover all areas of medical care. Meanwhile, China will also actively introduce TCM to the rest of the world, and promote the integration of TCM and other traditional medicine with modern technology, so as to explore a new model of healthcare to improve the well-being of all people of the world and make a full contribution to global progress and a brighter future for mankind.

Appendix II Law of the People’s Republic of China on Traditional Chinese Medicine Full Text Citation of Sangbinsheng. Law of the People’s Republic of China on Traditional Chinese Medicine (Chinese-English)[M]. Beijing: People’s Medical Publishing House, 2017. Adopted at the 25th Session of the Standing Committee of the Twelfth National People’s Congress of the People’s Republic of China on 25 December 2016.

Chapter I  General Provisions Article 1 The Law is enacted for the purposes of inheriting and carrying forward traditional Chinese medicine, ensuring, and promoting the development of traditional Chinese medicine for the health of the people. Article 2 Traditional Chinese medicine (hereafter referred to as TCM) in this law is a general term for the medicine of all ethnic groups including the Han nationality and ethnic minorities in China. It is a medical and pharmacological science system that reflects Chinese people’s understanding of life, health, and disease, with a long history and unique theories and techniques. Article 3 TCM undertaking is an important part of medicine and healthcare fields in China. The state shall vigorously develop TCM

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undertaking, carrying out the principle of balance between Chinese and Western medicine, establishing an administrative system that conforms to TCM features and giving TCM full play in the medical and healthcare affairs in China. In the development of the TCM undertaking, the core value and laws of TCM development shall be followed, the integration of inheritances and innovation is adhered to, TCM features and advantages preserved and maximized, and modern scientific technologies utilized, so as to promote the development of TCM theories and practice. The state shall encourage Chinese and Western medicine to learn and complement one other, develop with coordination, and maximize their own advantages so as to promote the integration of Chinese and Western medicines. Article 4 The people’s government at or above the county level shall incorporate TCM into their national economic and social development plans, to establish a sound TCM management system, and make overall plans for the promotion and development of TCM. Article 5 The competent TCM administration department under the State Council shall take charge of the nationwide administration for TCM within its administrative region. Other relevant departments under the State Council shall take charge of other affairs related to TCM administration within their respective authority. The competent TCM department under the local people’s governments at or above the county level shall be responsible for the administration of TCM in their respective administrative regions. Other relevant departments of the local people’s governments at or above the county level shall be responsible for the affairs related to TCM administration within the scope of their respective functions. Article 6 The state shall strengthen the construction of TCM service system, rationally plan and allocate TCM service resources, and guarantee available access for citizens to TCM services. China encourages social forces to invest in the TCM undertaking and supports organizations and individuals to make donation and provide fund for TCM undertaking. Article 7 The state shall promote TCM education to establish a TCM education system satisfying the needs during the developmental progress

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of TCM undertaking with proper scale, rational structure, and different forms to cultivate TCM talents. Article 8 The state shall support TCM scientific research and technological development of TCM, encouraging innovation in TCM science and technologies, promote the application of scientific and technological achievements of TCM, protecting TCM intellectual property, and promoting scientific and technological level of TCM. Article 9 The state shall support international exchange and cooperation to promote international transmission and application of TCM. Article 10 Organizations and individuals that have made outstanding contributions to the TCM undertaking shall be commended and rewarded in accordance with relevant provisions of China.

Chapter II  TCM Services Article 11 The people’s governments at or above the county level shall include the launch of TCM medical institutions into the plan on the setup of medical institutions, launching proper scaled TCM medical institutions, and supporting the development of medical institutions with distinct TCM features and advantages. To merge or cancel a TCM medical institution launched by the government or convert it into a TCM institution, opinions shall be solicited from the competent TCM department under the people’s government at the next higher level. Article 12 The comprehensive hospitals and maternal and childcare institutions and qualified specialized hospitals, community health service centers, and township health centers launched by the government should set up TCM departments and clinics. The people’s governments at or above the county level shall take measures to strengthen the capability of community health service stations and village clinics to provide TCM services. Article 13 The state supports non-governmental investment to launch Chinese medical institutions. Chinese medical institutions launched by non-governmental investment shall enjoy the same rights as those organized by the government

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related to permission, practice, basic medical insurance, scientific research and teaching, the evaluation of titles for medical personnel, etc. Article 14 To launch a TCM medical institution, the approval formalities shall be undergone according to the provisions of the state on the administration of medical institutions and the provisions on the administration of medical institutions shall be observed. To launch a TCM clinic, name, address, scope of service, and staffing of the clinic shall be reported to the competent TCM department under the local people’s government at the county level and registered before starting medical practice. The TCM clinic shall publicize its medical treatment scope and the names of TCM practitioners and their practice scope in a visible position of the clinic. The clinic shall not conduct medical activities beyond the registered scope. The specific provisions shall be formulated by the competent TCM department under the State Council and be submitted to the administrative department of public health under the State Council for review and issuance. Article 15 Personnel engaged in medical activities of TCM shall, in accordance with the provisions of the Law of the People’s Republic of China on Practitioners, obtain the qualification as a TCM physician through the TCM medical qualification examination, and conduct practice registration. The content of the qualification examination for TCM physician shall reflect TCM features. A person who has been learning TCM from a teacher the form of apprenticeship or indeed has specialty in medical skills through many years of practice, shall be recommended by at least two TCM physicians and may be qualified as a TCM physician after passing the appraisal and examination for the qualification of a licensed doctor under the auspices of the competent TCM department of the people’s government of the provinces, autonomous regions, or municipalities directly under the Central Government. After conducting practice registration according to the examination content, he or she may be engaged in TCM medical activities in the form of individual business operation or working in medical institutions within the registered scope of practice. The competent TCM department of the State Council shall draft the measures for the categorized examination of the personnel described in this paragraph

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according to the safety risks of TCM techniques and report the measures to the health administration department of the State Council for review and issuance. Article 16 A TCM institution shall be mainly equipped with TCM professionals and technicians, mainly providing TCM services. TCM practitioners who have obtained physician qualification upon examinations may, in accordance with relevant provisions of China, adopt modern scientific and technological methods related to their professions in their medical practice after obtaining training and passing the examination. The modern scientific and technological methods applied in medical activities shall be conductive to preserving and giving full play of TCM features and advantages. The community health service centers, township health centers, community health service stations, and qualified village clinics shall reasonably assign TCM professional technicians and apply and promote appropriate TCM techniques. Article 17 TCM services shall be carried out by taking TCM theories as the guidance and applying TCM techniques and comply with the basic requirements for TCM services formulated by the competent TCM department under the State Council. Article 18 The people’s government at or above the county level shall develop TCM in services of prevention and healthcare and incorporate them into basic public health service items for overall planning and implementation in accordance with the relevant provisions of China. The people’s government at or above the county level shall allow TCM to fully play its role in emergency response to sudden public health events, and strengthen the reserves of TCM emergency response supplies, equipment, facilities, technologies, and talents. Medical and health institutions shall actively apply TCM theories and techniques in disease prevention and control. Article 19 A medical institution that plans to release a TCM medical advertisement shall be subjected to the revision and approval of the competent TCM department of the people’s government of the province, autonomous region, or municipality directly under the Central Government and shall not issue the advertisement without revision and

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approval. The content of the issued TCM medical advertisement shall be consistent with the content approved upon revision and comply with the relevant provisions of the Advertising Law of the People’s Republic of China. Article 20 The competent TCM department under the people’s government at or above the county level shall strengthen the supervision and inspection of TCM services and make the following items as the focus of supervision and inspection: – Whether the TCM medical institution or practitioners conducts medical activities beyond the registered scope; – Whether the TCM services complies with the basic requirements for TCM services formulated by the competent TCM department under the State Council; – Whether the release of medical advertisements related to TCM complies with the provisions of this Law. The competent TCM department shall carry out supervision and inspection according to the laws, and the relevant units and individuals shall cooperate with it and shall not refuse or obstruct it.

Chapter III  TCM Protection and Development of TCM Article 21 The state shall formulate the technical specifications and standards for the cultivation, collection, storage, and initial processing of Chinese materia medica and strengthen the quality supervision and management during the whole process of production and circulation to guarantee the quality safety of Chinese materia medica. Article 22 The state shall encourage the development of standardized cultivation of Chinese material medica, strictly control the use of pesticides, fertilizers, and other agricultural inputs, prohibit the use of highly poisonous or toxic pesticides during the cultivation of Chinese material medica, and support the breeding of fine varieties of Chinese material medica to improve the quality.

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Article 23 The state shall establish the evaluation system of genuine regional materia medica, support the variety breeding of genuine regional materia medica, support the launch of production bases for the genuine regional materia medica, strengthen the ecological environment protection of the production base of genuine regional materia medica, and encourage the protection of genuine regional materia medica by geographical indication and other measures. The genuine regional materia medica in the preceding article refer to those selected by long-term clinical application of TCM, produced in certain areas with better quality and efficacy compared with the same species produced in other regions, and thereby with stable quality and high popularity. Article 24 The department of pharmaceutical supervision and administration under the State Council shall organize and strengthen the quality monitoring of Chinese materia medica and regularly publish the results. The relevant departments under State Council shall cooperate in the accomplishment of the quality monitoring of Chinese materia medica. The collection and storage of Chinese materia medica and their initial processing shall conform to the relevant technical specification, standard, and administrative regulation of China. The state shall encourage the development of a modern distribution system of Chinese materia medica, improve the technological standards for packaging and warehousing of Chinese materia medica, and establish the circulation traceability system for Chinese materia medica. The pharmaceutical manufactures shall establish a system of inspection and record for the purchase of Chinese materia medica. The proprietors of Chinese medicinals shall establish an inspection system for the purchase of goods and registration system of the buying and selling and indicate the geographical origin of the Chinese materia medica. Article 25 The state shall protect the medicinal wildlife resources, carry out dynamic monitoring and regular general-survey on the medicinal wildlife resources, establish a germplasm gene bank for the medicinal wildlife resources, encourage the development of artificial cultivation and breeding, and support the development of the protection, breeding, and relevant research of precious and endangered medicinal wildlife according to the law.

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Article 26 TCM practitioners from village medical institutions and countryside doctors with Chinese materia medica knowledge and identification skills may plant and collect Chinese materia medica for the application in their clinical activities in accordance with relevant provisions of the state. Article 27 China protects the traditional processing techniques for decoction pieces of Chinese crude drugs, supports the application of traditional processing techniques in processing decoction pieces of Chinese crude drugs, and encourages the use of modern science and technology to develop the processing technology of decoction pieces of Chinese crude drugs. Article 28 For the decoction pieces of Chinese crude drugs which are not supplied on the market, a medical institution may process and use them within the medical institution based on corresponding formulas prescribed by physicians of this institution. Medical institution shall abide by relevant provisions on the processing of decoction pieces and take charge of drug quality to ensure safety. The processing of decoction pieces of Chinese crude drugs by medical institutions should be reported to the department of pharmaceutical supervision and administration under the local municipal people’s government for the record. According to the needs of clinical medication, a medical institution may reprocess decoction pieces of Chinese crude drugs based on the formulas prescribed by physicians of the institution. Article 29 China encourages and supports the development and production of new Chinese materia medica. The state shall protect traditional processing techniques and techniques and procedures of Chinese materia medica, support the production of traditional dosage form of Chinese patent medicine, and encourage the application of modern science and technology to study and develop traditional Chinese patent medicine. Article 30 For the production of compound preparation of Chinese materia medica derived from ancient classical formulas meeting the national prescribed condition, it may only provide non-clinical safety research materials when applying for the drug approval number. Specific regulations shall be developed by the department of pharmaceutical

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supervision and administration under the State Council in conjunction with the competent TCM department. The ancient classical formulas in the preceding article refer to prescriptions that are still widely used, with definite efficacy and outstanding characteristics and advantages recorded in the ancient classics of TCM. The specific catalogue shall be formulated by the competent TCM department under the State Council in conjunction with the department of pharmaceutical supervision and administration. Article 31 The state shall encourage medical institutions to prepare and use Chinese medicinal preparation according to their clinical needs, and support the application of traditional techniques in preparing Chinese medicinal preparation and the development of new TCM drugs on the basis of Chinese medicinal preparation. Medical institution shall obtain the Pharmaceutical Preparation Certificate for Medical Institution in accordance with the Pharmaceutical Administration Law of the People’s Republic of China or entrust a pharmaceutical manufacturing enterprise that has obtained the Drug Manufacturing Certificate or other medical institutions that have obtained the Pharmaceutical Preparation Certificate for Medical Institutions to prepare Chinese medicinal preparation. The documents of Chinese medicinal preparation should be submitted to the department of pharmaceutical supervision and administration under the people’s government of the province, autonomous region, or municipality directly under the Central Government where the entrusting party files on record. Medical institutions shall be responsible for the quality of self-made Chinese medicinal preparation. For the entrustment of preparation, the entrusting party and entrusted party shall respectively bear the corresponding responsibilities for the quality of Chinese medicinal preparation. Article 32 Medical institutions shall obtain the preparation approval number according to the law for the self-made Chinese medicinal preparation products. However, the approval number is not required for the Chinese medicinal preparation products prepared simply with traditional techniques and shall be reported to pharmaceutical supervision and administrative department under the local people’s government of the

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province, autonomous region, or municipality directly under the Center Government for record. Medical Institutions shall strengthen monitoring on adverse reactions caused by registered Chinese medicinal preparation products and report the case in accordance with the relevant provisions of China. The pharmaceutical supervision and administrative department shall strengthen the supervision and inspection on the preparation and use of the self-made Chinese medicinal preparation products on record.

Chapter IV  Education and Training of Traditional Chinese Medicine Article 33 The TCM education shall follow the developmental rules of TCM talents, with TCM as the main content, and shall reflect the culture features of TCM and emphasize TCM classical theories and clinical practice, as well as the combination of modern and traditional education methods. Article 34 The state shall improve the education system for TCM universities and vocational schools, and support the development of higher education institutions, secondary vocational schools, and other educational institutions that specialize in the implementation of TCM education. The training objectives, length of schooling, teaching mode, teaching content, teaching evaluation, and academic evaluation standard of TCM schools shall reflect the features of TCM disciplines and conform to the development rules of TCM disciplines. Article 35 The state shall develop TCM master-disciple education and support TCM physicians and technical expertise to impart theories and technical methods to disciples in practice and medical activities to train professional TCM and technical TCM personnel. Article 36 The state shall strengthen the education and training for TCM physicians, professional TCM, and technical TCM personnel of the grass-root level in urban and rural area. The state shall develop education for integrated Chinese and Western medicine to cultivate high-level talents integrating TCM and Western medicine.

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Article 37 The competent TCM departments under the local people’s governments at or above the county level shall organize and develop TCM continuing education plans and strengthen basic TCM knowledge and skills training towards medical personnel, especially those TCM technicians at the grass-root level in urban and rural areas. Professional TCM technician personnel shall participate in further education in accordance with the provisions and local institutions shall create favorable conditions to support them.

Chapter V  TCM Scientific Research of TCM Article 38 The state shall encourage scientific research institutions, higher education schools, medical institutions, and pharmaceutical manufacturers to carry out scientific research on TCM by applying both modern scientific and technological research methods and TCM research techniques, strengthen the study on integration of Chinese and Western medicine, so as to promote the inheritance and innovation of TCM theories and technical methods. Article 39 The state shall take measures to support the collation, study, and use of ancient TCM literature, academic thoughts and diagnostics and treatment experience of famous TCM experts, and folk TCM technical techniques. The state shall encourage organizations and individuals to donate TCM literature, secret or proved formulas, and diagnostic and treatment methods and techniques with great value in scientific research and clinical application. Article 40 The state shall establish and improve the scientific and technological innovation system, evaluation system, and administrative system that conform to TCM features so as to promote TCM scientific and technological progress and innovation. Article 41 The state shall take measures to strengthen the scientific research of basic TCM theories and treatment according to syndrome differentiation methods, prevention, and treatment for common diseases, frequently occurring diseases, chronic diseases, major difficult diseases, and major infectious diseases by means of TCM, and research projects, playing significant roles in the promotion the of theoretical and practical TCM development.

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Chapter VI  Inheritance and Cultural Communication of TCM Article 42 The competent TCM departments under the people’s governments at or above the provincial level should organize the selection of academic heritage projects and successors of TCM within their respective administrative regions to carry forward TCM theories and technical methods with significant academic values and create favorable conditions for inheritance. The inheritors shall carry out heritance activities to cultivate successors, and collect, collate, and properly preserve relevant academic materials. The inheritance activities for representative projects of intangible cultural heritage, the inheritance activities shall be carried out in accordance with the relevant provisions of the Law of the People’s Republic of China on the Protection of Intangible Cultural Heritage. Article 43 The state shall establish the database, list, and system for the protection of traditional knowledge of TCM. Practitioners possessing TCM knowledge shall have the right to inherit and use their own knowledge. They shall have informed consent and shared interest for their TCM knowledge to be obtained and applied by others. The state shall implement special protection for the composition and manufacturing process of China secret prescriptions of traditional TCM identified according to law. Article 44 The state shall encourage the development of TCM healthcare and health preservation services and support non-governmental investments to launch standardized TCM healthcare institutions. The standards and criteria of TCM healthcare service shall be formulated be formulated by the competent TCM department under the State Council. Article 45 The people’s governments at or above the county level should strengthen the Public education of TCM knowledge and culture and encourage organizations and individuals to create TCM culture and popular works. Article 46 The activities for publicity and popularization TCM culture and knowledge should be carried out in compliance with the relevant provisions of the state. No organization or individual shall make any false or

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exaggerated TCM publicity, nor shall they make fraudulent use of TCM to seek illegitimate interests. The radio, television, newspaper, internet, and other media shall employ professional TCM technical personnel when promoting TCM knowledge.

Chapter VII  Safeguard Measures Article 47 The people’s governments at or above the county level shall provide policy support and material support for the TCM development and incorporate the funds for the TCM development in the financial budgets of the governments at corresponding levels. The people’s government at or above the county level and relevant government authorities should invite the competent TCM department in drafting and developing policies for basic medical insurance payment, drug administration and other medical and health issues, so as to fully exploit TCM advantages to encourage practice and application of TCM services. Article 48 The people’s governments at or above the county level and their relevant departments shall rationally set the charge items and standards of TCM services according to the statutory authority for price management and reflect the cost of services and professional and technical values of TCM services. Article 49 In accordance with the provisions of the state, the relevant departments of the local people’s governments at or above the county level shall incorporate qualified TCM institutions of into the medical institutions designated for basic medical insurance with the inclusion of qualified TCM diagnostic and treatment projects, TCM decoction pieces, Chinese patent medicine, and self-made TCM preparation into the scope of basic medical insurance payment. Article 50 The state shall strengthen the construction of the TCM standard system and develop standards for the technical requirements that need to be unified according to the TCM features and revise them in time. The national and industrial TCM standards shall be formulated or revised by the relevant departments under the State Council in accordance

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with their responsibilities and be published on their websites for the freeaccess to the public. The state shall promote the establishment of the TCM international standard system. Article 51 The evaluation, assessment, and appraisal of TCM required by the law and the administrative regulations shall be carried out with the launch of special organizations or the participation of TCM experts. Article 52 The state shall take measures to strengthen support towards ethnic minority medicine in inheritance and innovation, application-oriented development and talent cultivation, and enhance the launch of medical institutions and establishment of physician team, so as to promote and standardize the development of ethnic minority medicine.

Chapter VIII  Legal Liability Article 53 The competent TCM department of the people’s government at or above the county level and other relevant departments that fails to perform their duties as required by this law shall be instructed for rectification by the people’s government at the same level or the relevant department of the people’s government at the next higher levels. If the circumstances are serious, the person directly in charge and other persons directly responsible shall be penalized according to law. Article 54 Any TCM clinic, in violation of the provisions of this Law, that carries out medical activities beyond the registered practice scope shall be instructed to rectify by the competent TCM department under the local people’s government at the county level, and the illegal gains shall be confiscated and impose with a fine of no less than RMB 10,000 yuan but no more than RMB 30,000 yuan. If the circumstances are serious, it shall be instructed to cease the practice. For any TCM clinic instructed to cease the practice, the person directly in charge shall be barred from being engaged in the management of medical institution within five years from the issuance date of the penalty decision is made. For any medical institution that hires the abovementioned persons to engage in the management work, the medical

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practice license shall be revoked by the former license issuance department or the institution, shall be instructed to cease the practice by the former registration department. Article 55 Any TCM physician obtained qualification of a licensed doctor after passing the examination who is engaged in medical activities beyond the registered practice scope, in violation of the provisions of this Law, shall be instructed to suspend the practice activities for no less than six months but not more than one year by the competent TCM departments under the people’s governments at or above the county level and impose a fine of no less than RMB 10,000 yuan but no more than RMB 30,000 yuan. If the circumstances are serious, his/her medical practice license shall be revoked. Article 56 In the case of failure in record keeping or filling with false materials in launching TCM clinic, processing decoction pieces or entrusting other to prepare Chinese medicinal preparation in violation of the provisions of this law, offenders shall be instructed to rectify by the competent TCM department and pharmaceutical supervision and administrative department according to their respective responsibilities. The illegal gains shall be confiscated and impose a fine of not more than RMB 30,000 yuan and the relevant information should be publicized. If offenders refuse to rectify, they shall be instructed to cease the practice or the processing for TCM decoction pieces and the entrusted TCM preparation, and the person directly responsible shall be barred from being engaged in any TCM activities within five years from the date of the issuance of the penalty decision. Any TCM institution fails to record on files when applying traditional process to prepare Chinese medicinal preparation in violation of provisions of this Law or fails to make Chinese medicinal preparation in accordance with the requirements stated clearly in the record files, shall be penalized as producing counterfeit. Article 57 In case of releasing a TCM advertisement not in conformity with the reviewed and approved edition, in violation of the provisions of this Law, the regulatory department responsible for the approval will revoke the approval document for the advertisement and dismiss the application for advertising review submitted by this medical institution within one year.

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In violation of the provisions of this law, other illegal actions when releasing TCM advertisement, offenders shall be penalized in accordance with the provisions of the Advertising Law of the People’s Republic of China. Article 58 In case of using high-toxic pesticides in the process of planting Chinese materia medica, in violation of the provisions of this Law, offenders shall be penalized in accordance with the relevant laws and administrative regulations; If the circumstances are serious, the person directly in charge or other persons directly responsible may be detained by the public security organ for not less than five days but not more than 15 days. Article 59 In the case of causing personal or property damage in violation of the relevant provisions of this Law, the offender shall bear civil liability in accordance with the Law. In case of violations of this Law involving criminal offenses, the offenders shall be prosecuted in accordance with the law.

Chapter IX  Supplementary Provisions Article 60 The administration of TCM that is not specified by this Law shall apply to the provisions of relevant laws and administrative regulations such as the Law of the People’s Republic of China on Medical Practitioners and the Drug Administration Law of the People’s Republic of China. The administration of TCM in the armed force shall be organized and implemented by the miliary health authorities in accordance with this Law and the relevant provisions of the armed forces. Article 61 Autonomous regions of ethnic minorities may formulate measures to promote and standardize the development of local ethnic minority medicine based on their practical situations, in accordance with the Law of the People’s Republic of China on Regional National Autonomy and the relevant provisions of this Law, Article 62 If the blind obtain qualification for braille medical massage personnel in accordance with the relevant provisions of China, medical massage services could be provided in the form of an individual business or within a medical institution. Article 63 This Law shall come into force as of 1 July 2017.

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Appendix III Traditional Chinese Medicine Treatment COVID-19 Diagnosis and Treatment Protocol (the 9th Edition) In traditional Chinese medicine (TCM), COVID-19 falls under the category of “pestilences,” which occur upon exposure to epidemic pathogens. This Protocol represents standard TCM pattern identification and treatment. Modifications can be made to satisfy the patients’ actual conditions, local climate, or individualized body constitutions. Consult with a doctor first before using a higher-than-recommended dosage by the Pharmacopoeia of the People’s Republic of China.

1  Medical Observation Clinical manifestations 1: Fatigue and gastrointestinal discomfort Recommended Chinese patent medicine: Huoxiang Zhengqi Jiaonang/Wan/ Shui/Koufuye (Agastache Qi-Correcting Capsules/Pills/Water/Oral Liquid) Clinical manifestations 2: Fatigue and fever Recommended Chinese patent medicine: Jinhua Qinggan Keli (Honeysuckle Flower Cold-Relieving Granules), Lianhua Qingwen Jiaonang/Keli (Forsythiae and Honeysuckle Flower Pestilence-Clearing Capsules/Granules), Shufeng Jiedu Jiaonang/Keli (Wind-Expelling and Toxin-Removing Capsules/Granules)

2  Clinical Treatment (Confirmed Cases) 2.1  Qingfei Paidu Tang (Lung-Cleansing and ToxinsRemoving Decoction) and Qingfei Paidu Keli (Lung-Cleansing and Toxins-Removing Decoction Granules) Indications Clinical observations have suggested that this formula can be used for mild, moderate, or severe cases; it may also be used for critically ill patients on an as-needed basis.

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Ingredients Ma Huang (Herba Ephedrae) 9 g, Zhi Gan Cao (Radix et Rhizoma Glycyrrhizae Praeparata cum Melle) 6 g, Xing Ren (Almond) 9 g, Shi Gao (Gypsum) 15–30 g, Gui Zhi (Ramulus Cinnamomi) 9 g, Ze Xie (Rhizoma Alismatis) 9 g, Zhu Ling (Polyporus) 9 g, Bai Zhu (Rhizoma Atractylodis Macrocephalae) 9 g, Fu Ling (Poria) 15 g, Chai Hu (Radix Bupleuri) 16 g, Huang Qin (Radix Scutellariae) 6 g, Zi Yuan (Radix et Rhizoma Asteris) 9 g, Dong Hua (Flos Farfarae) 9 g, She Gan (Rhizoma Belamcandae) 9 g, Xi Xin (Radix et Rhizoma Asari) 6 g, Shan Yao (Rhizoma Dioscoreae) 12 g, Zhi Shi (Fructus Aurantii Immaturus) 6 g, Chen Pi (Pericarpium Citri Reticulatae) 6 g, Huo Xiang (Herba Agastachis) 9 g. Note: A smaller dose for patients without a fever and bigger dose for those with a fever/high fever. Method Decoct the above ingredients (prepared slices) with water, one formula a day. Drink the decoction warm in two divided doses, once in the morning and once in the evening. A treatment course consists of three formulas. Continue with the second treatment course if the symptoms are improved but not fully resolved. Modify the formula if patients have emerging or other pre-existing conditions. Discontinue the formula when the symptoms resolved. For Qingfei Paidu Keli (Lung-Cleansing and Toxins-Removing Decoction Granules), take 2 packets with warm water for each dose, 2 doses a day, for 3 ∼  6 days. Tips If conditions allow, drink 1/2 bowl of rice soup after taking the warm decoction; patients with a dry tongue can drink a bowl. Source of the Formula The Notice on Recommending the Use of “Qingfei Paidu Decoction” in Integrated Traditional Chinese & Western Medicine Treatment for COVID-19 issued by the General Office, National Ministry of Health Commission, and the Office, National Administration of Traditional Chinese Medicine (NATCM) (2020 File No 22, Medical Administration Bureau, NATCM).

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2.2  Mild Cases 2.2.1  Cold-Dampness Stagnating in the Lung Signs and Symptoms Fever, fatigue, generalized body aches, cough, expectoration, chest tightness with labored breathing, a poor appetite, nausea, vomiting, and sticky stools with a feeling of incomplete bowel movement. The tongue is pale and swollen with teeth marks and white, thick, and curd-like coating. Alternatively, the tongue may be pale red, and the tongue coating may be white and greasy. The pulse is soft or slippery. Recommended Formula Ma Huang (Herba Ephedrae) 6 g, Shi Gao (Gypsum) 15 g, Xing Ren (Almond) 9 g, Qiang Huo (Rhizoma et Radix Notopterygii) 15 g, Ting Li Zi (Semen Lepidii) 15 g, Guan Zhong (Rhizoma Cyrtomii) 9 g, Di Long (Pheretima) 15 g, Xu Chang Qing (Radix et Rhizoma Cynanchi Paniculati) 15 g, Huo Xiang (Herba Agastachis) 15 g, Pei Lan (Herba Eupatorii) 9 g, Cang Zhu (Rhizoma Atractylodis) 15 g, Yun Ling (Poria) 45 g, Bai Zhu (Rhizoma Atractylodis Macrocephalae) 30 g, Jiao Mai Ya (Fructus Hordei Germinatus Praeparata) 9 g, Jia Shan Zha (Fructus Crataegi Praeparata) 9 g, Jiao Shen Qu (Massa Medicata Fermentata) 9 g, Hou Po (Cortex Magnoliae Officinalis) 15 g, Jiao Bing Lang (Semen Arecae Praeparata) 9 g, Wei Cao Guo (Fructus Tsaoko Praeparata) 9 g, Sheng Jiang (Fresh Ginger) 15 g. Method Decoct with water to get 600 mL, one formula a day. Drink the decoction in three divided doses (morning, noon, and evening) before meals. This formula also applies to moderate cases.

2.2.2  Damp-Heat Accumulating in the Lung Signs and Symptoms Low-grade or no fever, mild aversion to cold, fatigue, a heavy sensation in the head and body, dry coughs with scanty phlegm, sore throat, and a dry mouth with no desire to drink water.

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Alternatively, chest tightness, epigastric fullness, absence of sweating or inhibited sweating, vomiting, a poor appetite, and loose stools or sticky stools with a feeling of incomplete bowel movement may also be present. The tongue is pale red with a white, thick and greasy or thin, yellow coating. The pulse is soft or slippery and rapid. Recommended Formula Bing Lang (Semen Arecae) 10 g, Cao Guo (Fructus Tsaoko) 10 g, Hou Po (Cortex Magnoliae Officinalis) 10 g, Zhi Mu (Rhizoma Anemarrhenae) 10 g, Huang Qin (Radix Scutellariae) 10 g, Chai Hu (Radix Bupleuri) 10 g, Chi Shao (Radix Paeoniae Rubra) 10 g, Lian Qiao (Fructus Forsythiae) 15 g, Qing Hao (Herba Artemisiae Annuae) 10 g (decoct later), Cang Zhu (Rhizoma Atractylodis) 10 g, Da Qing ye (Folium Isatidis) 10 g, Gan Cao (Radix et Rhizoma Glycyrrhizae) 5 g. Method Decoct with water to get 400 mL, one formula a day. Drink the decoction in two divided doses, once in the morning and once in the evening. Recommended Chinese Patent Medicines Jinhua Qinggan Keli (Honeysuckle Flower Cold-Alleviating Granules): 1–2 packets for each dose, 3 doses a day, for 5–7 days. Lianhua Qingwen Keli (Forsythiae and Honeysuckle Flower PestilenceClearing Granules): 1 packet for each dose, 3 doses a day, for 7–10 days. Lianhua Qingwen Jiaonang (Forsythiae and Honeysuckle Flower Pestilence-Clearing Capsules): 4 capsules for each dose, 3 doses a day. Acupuncture Therapy Recommended points: Hegu (LI 4), Houxi (SI 3), Yinlingquan (SP 9), Taixi (KI 3), Feishu (BL 13), and Pishu (BL 20) Method Select three points for each treatment with even reinforcingreducing technique and retain the needles for 30 minutes, one treatment a day.

2.3  Moderate Cases 2.3.1  Damp Toxin Stagnating in the Lung Signs and Symptoms Fever, cough with scanty or yellow phlegm, chest tightness, shortness of breath, abdominal distension, and constipation with

History, Present and Prospect of Traditional Chinese Medicine  673

difficult defecation. The tongue is dark red and enlarged with a yellow, greasy, or dry yellow coating. The pulse is slippery and rapid or wiry and slippery. Recommended Formula Ma Huang (Herba Ephedrae) 6 g, Cao Guo (Fructus Tsaoko) 10 g, Xing Ren (Almond) 15 g, Shi Gao (Gypsum) 30 g, Yi Yi Ren (Semen Coicis) 30 g, Cang Zhu (Rhizoma Atractylodis) 10 g, Huo Xiang (Herba Agastachis) 15 g, Qing Hao (Herba Artemisiae Annuae) 12 g, Hu Zhang (Rhizoma Polygoni Cuspidati) 20 g, Ma Bian Cao (Herba Verbenae) 30 g, Gan Lu Gen (dried Rhizoma Phragmitis) 30 g, Ting Li Zi (Semen Lepidii) 15 g, Ju Hong (Exocarpium Citri Rubrum) 15 g, Gan Cao (Radix et Rhizoma Glycyrrhizae) 10 g. Method Decoct with water to get 400 mL, one formula a day. Drink the decoction in two divided doses, once in the morning and once in the evening. Recommended Chinese Patent Medicine Xuanfei Baidu Keli (LungDispersing and Toxins-Removing Granules): 1 packet for each dose, 2 doses a day, for 7–14 days. Alternatively, follow your doctor’s instructions.

2.3.2  Cold-Dampness Obstructing the Lung Signs and Symptoms Low-grade fever, a feverish sensation without a high temperature, dry coughs with scanty phlegm, lassitude, fatigue, chest tightness, and epigastric fullness. Alternatively, absence of fever, nausea, vomiting, and loose stools may be present. The tongue is pale or pale red with a white or white and greasy coating. The pulse is soft. Recommended Formula Cang Zhu (Rhizoma Atractylodis) 15 g, Chen Pi (Pericarpium Citri Reticulatae) 10 g, Hou Po (Cortex Magnoliae Officinalis) 10 g, Huo Xiang (Herba Agastachis) 10 g, Cao Guo (Fructus Tsaoko) 6 g, Sheng Ma Huang (Herba Ephedrae) 6 g, Qiang Huo (Rhizoma et Radix Notopterygii) 10 g, Sheng Jiang (Fresh Ginger) 10 g, Bing Lang (Semen Arecae) 10 g.

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Method Decoct with water to get 400 mL, one formula a day. Drink the decoction in two divided doses, once in the morning and once in the evening.

2.3.3  Epidemic Toxins Mixed with Dryness Signs and Symptoms Aversion to cold, fever, muscle ache, runny nose, unproductive coughing, a sore and scratchy throat, a dry mouth and throat, and constipation. The tongue is dry and pale with a thin, white or dry coating. The pulse is superficial and tight. Recommended Formula Xuanfei Runzao Jiedu Fang (Lung-Dispersing, Dryness-Moistening and Toxins-Removing Formula). Ma Huang (Herba Ephedrae) 6 g, Xing Ren (Semen Armeniacae Amarum) 10 g, Chai Hu (Radix Bupleuri) 12 g, Sha Shen (Radix Adenophorae seu Glehniae) 15 g, Mai Dong (Radix Ophiopogonis) 15 g, Xuan Shen (Radix Scrophulariae) 15 g, Bai Zhi (Radix Angelicae Dahuricae) 10 g, Qiang Huo (Rhizoma et Radix Notopterygii) 15 g, Sheng Ma (Rhizoma Cimicifugae) 8 g, Sang Ye (Folium Mori) 15 g, Huang Qin (Radix Scutellariae) 10 g, Sang Bai Pi (Cortex Mori) 15 g, Sheng Shi Gao (Gypsum Fibrosum) 20 g. Method Decoct with water to get 400 mL, one formula a day. Drink the decoction in two divided doses, once in the morning and once in the evening. Recommended Chinese Patent Medicines Jinhua Qinggan Keli (Honeysuckle Flower Cold-Alleviating Granules): 1–2 packets for each dose, 3 doses a day, for 5–7 days. Lianhua Qingwen Keli (Forsythiae and Honeysuckle Flower PestilenceClearing Granules): 1 packet for each dose, 3 doses a day, for 5–7 days. Lianhua Qingwen Jiaonang (Forsythiae and Honeysuckle Flower Pestilence-Clearing Capsules): 4 capsules for each dose, 3 doses a day. Acupuncture Therapy Recommended points: Neiguan (PC 6), Kongzui (LU 6), Quchi (LI 11), Qihai (CV 6), Yinlingquan (SP 9) and Zhongwan (CV 12).

History, Present and Prospect of Traditional Chinese Medicine  675

Method Select three points for each treatment with even reinforcingreducing technique and retain the needles for 30 minutes, one treatment a day.

2.4  Severe Cases 2.4.1  Epidemic Toxin Blocking the Lung Signs and Symptoms Fever with a red face, cough with scanty, yellow, and sticky phlegm, chest tightness, shortness of breath, lassitude, fatigue, a dry, bitter, and sticky mouth, nausea, loss of appetite, difficult defecation, and dark, scanty urine. Alternatively, blood-stained phlegm may be present. The tongue is red with a yellow, greasy coating. The pulse is slippery and rapid. Recommended Formula Huashi Baidu (Dampness- Resolving & ToxinRemoving) formula. Ma Huang (Herba Ephedrae) 6 g, Xing Ren (Almond) 9 g, Shi Gao (Gypsum) 15 g, Gan Cao (Radix et Rhizoma Glycyrrhizae) 3 g, Huo Xiang (Herba Agastachis) 10 g (decoct later), Hou Po (Cortex Magnoliae Officinalis) 10 g, Cang Zhu (Rhizoma Atractylodis) 15 g, Cao Guo (Fructus Tsaoko) 10 g, Fa Ban Xia (Rhizoma Pinelliae Praeparatum) 9 g, Fu Ling (Poria) 15 g, Da Huang (Radix et Rhizoma Rhei) 5 g (decoct later), Huang Qi (Radix Astragali) 10 g, Ting Li Zi (Semen Lepidii) 10 g, Chi Shao (Radix Paeoniae Rubra) 10 g. Method Decoct with water to get 100–200 mL, one or two formulas a day. Drink the decoction in two-4 divided doses or feed via a nasal tube. Recommended Chinese Patent Medicine Huashi Baidu Keli (Dampness-Transforming and Toxins-Removing Granules): Take 2 packets with warm water for each dose, 2 doses a day. Alternatively, follow your doctor’s instructions.

2.4.2  Flaring Heat in both Qi and Ying Phases Signs and Symptoms High-grade fever with excessive thirst, chest tightness, shortness of breath, delirium, unconsciousness, and blurred vision.

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Alternatively, skin rashes (in patches), vomiting blood, nosebleed, and convulsions of the four limbs may also be present. The tongue is crimson with scanty or no coating. The pulse is deep, thready, and rapid or floating, big and rapid. Recommended Formula Shi Gao (Gypsum) 30–60 g (decoct first), Zhi Mu (Rhizoma Anemarrhenae) 30 g, Sheng Di (Radix Rehmanniae) 30–60 g, Shui Niu Jiao (Cornu Bubali) 30 g (decoct first), Chi Shao (Radix Paeoniae Rubra) 30 g, Xuan Shen (Radix Scrophulariae) 30 g, Lian Qiao (Fructus Forsythiae) 15 g, Dan Pi (Cortex Moutan) 15 g, Huang Lian (Rhizoma Coptidis) 6 g, Zhu Ye (Herba Lophatheri) 12 g, Ting Li Zi (Semen Lepidii) 15 g, Gan Cao (Radix et Rhizoma Glycyrrhizae) 6 g. Method Decoct Shi Gao (Gypsum) and Shui Niu Jiao (Cornu Bubali) with water first and then add the rest of the ingredients to decoct and get 100–200 mL, one formula a day. Drink the decoction in two-4 divided doses. Recommended Chinese Patent Medicine Table 8–Appendix III-1. Acupuncture Therapy Recommended points: Dazhui (DU 14), Feishu (BL 13), Pishu (BL 20), Taixi (KI 3), Lieque (LU 7), and Taichong (LR 3). Table 8–Appendix III-1 Recommended Chinese patent medicine. Name

Ingredients

Xiyanping injection

sulfonated andrographolide

Xuebijing injection

Hong Hua (Flos Carthami), Chi Shao (Radix Paeoniae Rubra), Chuan Xiong (Rhizoma Chuanxiong), Dan Shen (Radix et Rhizoma Salviae Miltiorrhizae) and Dang Gui (Radix Angelicae Sinensis)

Reduning injection

Qing Hao (Herba Artemisiae Annuae), Jin Yin Hua (Flos Lonicerae Japonicae), and Zhi Zi (Fructus Gardeniae)

Xingnaojing injection

Moschus, borneol, Fructus Gardeniae, etc.

Note: One or two injections can be used together, in combination with traditional Chinese medicine decoction.

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Method Select 3–5 points (back-Shu points combined with points on the limbs) for each treatment with even reinforcing-reducing technique and retain the needles for 30 minutes, one treatment a day.

2.5  Critical Cases Internal Blocking Causing External Collapse Signs and Symptoms Difficulty breathing, panting upon exertions (mechanical ventilation may be required), unconsciousness, restlessness, sweating, and cold limbs. The tongue is dark purple with a thick, greasy, or dry coating. The pulse is floating, big and rootless. Recommended Formula Take Suhexiang Wan (Storax Pill) or Angong Niuhuang Wan (Peaceful Palace Bovine Bezoar Pill) with the decoction of Ren Shen (Radix et Rhizoma Ginseng) 15 g, Hei Fu Zi (Radix Aconiti Lateralis Praeparata) 10 g, and Shan Zhu Yu (Fructus Corni) 15 g. Modifications For abdominal distension, constipation or difficult defecation following mechanical ventilation, use 5–10 g of Da Huang (Radix et Rhizoma Rhei). For patient-ventilator asynchrony (PVA), 5–10 g of Da Huang (Radix et Rhizoma Rhei) and Mang Xiao (Natrii Sulfas) can be used in combination with sedative and muscle relaxants. Recommended Chinese Patent Medicine Table 8–Appendix III-2. Recommended use of Chinese Medicine Injections for Severe and Critically Ill Cases It’s worth noting that traditional Chinese medicine injections should start from a smaller dose and gradually increase. – For viral infection or combined viral and bacterial infection, add 100mg Xiyanping injection (bid) to 250 mL sodium chloride 0.9%; or add 20 mL Reduning injection to 250 mL sodium chloride 0.9%. – For high-grade fever with disturbance of consciousness, add 20 mL (bid) of Xingnaojing injection to 250 mL sodium chloride 0.9%. – For systemic inflammatory response syndrome and/or multiple organ failure (MOF), add 100 mL (bid) Xuebijing injection to 250 mL sodium chloride 0.9%.

678  History, Present and Prospect of World Traditional Medicine Table 8–Appendix III-2 Recommended Chinese patent medicine. Name

Ingredients

Xuebijing injection

Hong Hua (Flos Carthami), Chi Shao (Radix Paeoniae Rubra), Chuan Xiong (Rhizoma Chuanxiong), Dan Shen (Radix et Rhizoma Salviae Miltiorrhizae) and Dang Gui (Radix Angelicae Sinensis)

Reduning injection

Qing Hao (Herba Artemisiae Annuae), Jin Yin Hua (Flos Lonicerae Japonicae), and Zhi Zi (Fructus Gardeniae)

Xingnaojing injection

Moschus, borneol, Fructus Gardeniae, etc.

Shenfu injection

Hong Shen (Radix et Rhizoma Ginseng Rubra) and Hei Fu Zi (Radix Aconiti Lateralis Praeparata Nigrum)

Shengmai injection

Hong Shen (Radix et Rhizoma Ginseng Rubra), Mai Dong (Radix Ophiopogonis) and Wu Wei Zi (Fructus Schisandrae Chinensis)

Shenmai injection

Hong Shen (Radix et Rhizoma Ginseng Rubra) and Mai Dong (Radix Ophiopogonis)

Note: One or two injections can be used together, in combination with traditional Chinese medicine decoction.

– For immunoregulation, add 100 mL Shenmai injection or 20–60 mL (bid) Shengmai injection to 250 mL sodium chloride 0.9%. Acupuncture Therapy Recommended points: Taixi (KI 3), Danzhong (CV 17), Guanyuan (CV 4), Baihui (DU 20), Zusanli (ST 36) and Suliao (DU 25). Method Select 3–5 points for each treatment with even reinforcingreducing technique and retain the needles for 30 minutes, one treatment a day.

2.6 Convalescence 2.6.1  Qi Deficiency of the Lung and Spleen Signs and Symptoms Shortness of breath, lassitude, fatigue, a poor appetite, nausea, vomiting, abdominal fullness, weak bowel movements, and a sense of incomplete evacuation. The tongue is pale and swollen with a white, greasy coating.

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Recommended Formula Fa Ban Xia (Rhizoma Pinelliae Praeparatum) 9 g, Chen Pi (Pericarpium Citri Reticulatae) 10 g, Dang Shen (Radix Codonopsis) 15 g, Zhi Huang Qi (Radix Astragali Praeparata cum Melle) 30 g, Chao Bai Zhu (Rhizoma Atractylodis Macrocephalae Praeparata) 10 g, Fu Ling (Poria) 15 g, Huo Xiang (Herba Agastachis) 10 g, Sha Ren (Fructus Amomi) 6 g (decoct later), Gan Cao (Radix et Rhizoma Glycyrrhizae) 6 g. Method Decoct with water to get 400 mL, one formula a day. Drink the decoction in two divided doses, once in the morning and once in the evening.

2.6.2  Deficiency of Qi and Yin Signs and Symptoms Fatigue, shortness of breath, a dry mouth, thirst, palpitations, profuse sweating, a poor appetite, a low-grade or no fever, and dry coughs with scanty phlegm. The tongue is dry. The pulse is thready or weak. Recommended Formula Nan Sha Shen (Radix Adenophorae) 10 g, Bei Sha Shen (Radix Glehniae) 10 g, Mai Dong (Radix Ophiopogonis) 15 g, Xi Yang Shen (American ginseng) 6 g, Wu Wei Zi (Fructus Schisandrae Chinensis) 6 g, Shi Gao (Gypsum) 15 g, Dan Zhu Ye (Herba Lophatheri) 10 g, Sang Ye (Folium Mori) 10 g, Lu Gen (Rhizoma Phragmitis) 15 g, Dan Shen (Radix et Rhizoma Salviae Miltiorrhizae) 15 g, Gan Cao (Radix et Rhizoma Glycyrrhizae) 6 g. Method Decoct with water to get 400 mL, one formula a day. Drink the decoction in two divided doses, once in the morning and once in the evening. Acupuncture Therapy Recommended points: Zusanli (ST 36) for moxibustion, Baihui (DU 20) and Taixi (KI 3). Method: Needle the recommended points with even reinforcing-reducing technique and retain the needles for 30 minutes, one treatment a day. Recommended points for indirect moxibustion: Dazhui (DU 14), Feishu (BL 13), Pishu (BL 20) and Kongzui (LU 6). Method: Keep the point application for 40 minutes, once a day.

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2.6.3  Chinese Medicine Treatment for Children As children and adults share same pattern identification and essential pathogenesis, the treatment protocol for adults also applies to children. However, it’s necessary to modify the dosages of decoctions or Chinese patent medicines.

Appendix IV WHO Expert Meeting on Evaluation of Traditional Chinese Medicine in the Treatment of COVID-19 (28 February–2 March 2022) (Traditional, Complementary and Integrative Medicine World Health Organization)

Abbreviations & Acronyms AI Artificial intelligence CT Computerized tomography GACP Good agricultural and collection practice GMP Good manufacturing practice HPLC High-performance liquid chromatography ICTRP International Clinical Trials Registry Platform ICU Intensive care unit IRCH International Regulatory Cooperation for Herbal Medicines NATCM  National Administration of Traditional Chinese Medicine PICO Population, Intervention, Comparison, Outcome RCT Randomized controlled trial RTO Retrospective treatment outcome RWD Real-world data SDGs Sustainable Development Goals SOPs Standard operating procedures T&CM Traditional and complementary medicine TCI Traditional, complementary and integrative medicine TCM Traditional Chinese Medicine UHC Universal health coverage

History, Present and Prospect of Traditional Chinese Medicine  681

Background Following a high-level policy dialogue between the Director-General of WHO and China’s National Administration of Traditional Chinese Medicine (NATCM) in Geneva on 17 January 2022, WHO decided to convene a meeting of experts to evaluate the role of Traditional Chinese Medicine (TCM) in the treatment of COVID-19. The subsequent Expert Meeting on Evaluation of Traditional Chinese Medicine in the Treatment of COVID-19 was held virtually from 28 February to 2 March 2022 from 13:00 to 16:00 Central European Time each day. The 21 international experts from the six WHO regions included five members of the WHO Expert Advisory Panel, representatives of eight WHO collaborating centers, three members of the WHO International Regulatory Cooperation for Herbal Medicines (IRCH), and members of the China Academy of Chinese Medical Sciences. Technical staff from WHO headquarters, regional and country offices also attended the meeting. The meeting considered three reports on traditional Chinese medicine and COVID-19-including on clinical service, research and evidence-based evaluation provided by national expert groups in China. The evidencebased evaluation report focused on outcomes from the reports as well from 12 randomized controlled trials (RCTs) which had been registered and published. The objectives of the meeting were: – To understand the methodology applied in producing the reports; – To review and analyze the reports and randomized controlled trials of TCM in various phases of the progression of COVID-19 disease; – To evaluate the contribution of a TCM integrated approach in the treatment of COVID-19; and – To discuss how effectively to enhance the contribution of traditional medicine in global pandemics.

Opening and Welcome By WHO The opening of the meeting was moderated by Dr. Zhang Qi, head of the unit of Traditional, Complementary and Integrative (TCI) Medicine in the

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WHO Department of Integrated Health Services. Dr. Zhang welcomed participants to the meeting and introduced Dr. Rudi Eggers, Director of the Department of Integrated Health Services, who delivered an opening address. Dr. Eggers said that WHO considers traditional and complementary medicine as an essential part of integrated health services. Dr. Eggers noted that there is considerable interest worldwide in traditional medicine, pointing out that traditional and complementary medicine was one of the most downloaded topics from the WHO website during the past year. Chinese medicine is officially supported by the Chinese government and it was hoped that the outcome of the meeting would lead to a better understanding of the role of traditional medicine in the response to future pandemics.

By China Dr. Yu Wenming, Commissioner of China’s NATCM welcomed WHO’s continued support for traditional medicine.a He said that the treatment of SARS with traditional Chinese medicine (TCM) had led to satisfactory outcomes and that the use of TCM in combating COVID-19 disease was an important element in keeping the extent of disease low in China. The Constitution of the People’s Republic of China refers to the need to promote both conventional medicine and traditional Chinese medicine, with the latest law to promote TCM (and the improvement of treatment protocols) coming into force in December 2017. The NATCM, which is a national governmental body of the People’s Republic of China for the TCM, sent TCM specialists to Wuhan to investigate and to treat patients as soon as the COVID-19 pandemic was reported. Three TCM medicines were developed for COVID-19 and these treatments are now optimized to treat new variants. The National Administration will continue to optimize TCM diagnosis and treatment protocols, screening formulas and evaluating efficacy, as well as analyzing a

 For instance, the Beijing Declaration on Traditional Medicine, 2008; the Sixty-second World Health Assembly resolution WHA62.13 on traditional medicine, 2009; the Traditional Medicine Strategy (2014–2023), 2013; and the inclusion of traditional th medicine in the International Classification of Diseases, 11 revision (ICC-11), 2019.

History, Present and Prospect of Traditional Chinese Medicine  683

effective formulas to try to explain efficacy mechanisms scientifically. Dr. Yu added that China was ready to assist other WHO Member States in strengthening the role of traditional medicine in their health systems.

Introduction Dr. Zhang Qi of WHO proposed two members of the group to serve as co-chairs and two as co-rapporteurs. Consequently, Professor Harry Fong of the College of Pharmacy, University of Illinois at Chicago, USA, and Professor Elaine Elisabetsky of the Institute of Health Basic Sciences, Federal University of Rio Grande do Sul, Brazil, were elected as co-chairs of the meeting. The persons elected as co-rapporteurs were Professor Charlie Xue of RMIT University, Victoria, Australia, and Professor Heather Boon of the University of Toronto, Canada. Meeting participants were informed that Dr. Huang Luqi, president of the China Academy of Chinese Medical Sciences, would serve as a temporary advisor for the period of the meeting. Dr. Zhang outlined the purposes of WHO’s current traditional medicine strategy, namely: 1) harnessing the potential contribution of traditional and complementary medicine to health, wellness, people-centered health care and universal health coverage (UHC) and 2) promoting safe and effective use of traditional and complementary medicine through the regulation, research and integration of traditional and complementary medicine products, practices, and practitioners into the health system, as appropriate. As of 2018, some 170 WHO Member States acknowledged the use of traditional and complementary medicine and 55% of countries said they had a national office for policy on, and regulation of, traditional, complementary, and integrative medicine. The mission of WHO’s TCI team was described as promoting and supporting the effective use of, and equitable access to, quality TCI products and health services that are safe, integrated, and people-centered across the life course, the care continuum, and various sectors in order to contribute to UHC and to achievement of the United Nations Sustainable Development Goals (SDGs). WHO’s International Clinical Trials Registration Platform (ICTRP) shows 369 trials on traditional medicine with a further 138 on TCM. In late February 2022, WHO’s COVID-19

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research database contained 3986 articles on traditional medicine and 1441 on TCM. WHO also organized workshops on traditional medicine and COVID-19 to share the knowledge and practices of traditional and complementary medicine with countries and professional organizations. Participants in the Expert Meeting included specialists in research, clinical practice, herbal medicines, epidemiology, and statistics. Participants were informed that the meeting would reach its conclusions by consensus. The conclusions and recommendations were expected to cover six aspects of TCM, namely: 1) the efficacy/effectiveness of TCM in treating COVID-19, 2) the safety of TCM, 3) whether the benefits of TCM are found throughout the care continuum, 4) whether the integrated approach is a good model, 5) suggestions for future research in China or internationally, and 6) recommendations on experiences to be shared with other countries and on proposals for strengthening international cooperation in the treatment and control of COVID-19, the recovery of health systems from the current pandemic and preparation for future pandemics.

Presentation of Reports on Traditional Chinese Medicine and COVID-19 Dr. Huang Luqi, president of the China Academy of Chinese Medical Sciences introduced the three presenters.

Report 1: Clinical use of Traditional Chinese Medicine in Fighting Against COVID-19 in China Dr. Li Guangxi From the first stage of the response to COVID-19 in China (up to 28 April 2020) the treatment model incorporated both TCM and conventional medicine in an integrated approach. TCM was particularly used as an intervention in clusters of infections. In the second stage of response (from 29 April 2020 onwards), TCM was applied in provincial and city hospitals in the early stages of disease, with specialists in both TCM and conventional medicine cooperating closely in ward visiting and consultations and working together to formulate diagnosis and treatment plans.

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The core principles and practices of TCM remain the same, with treatment being adjusted according to different patterns on the basis of the national protocol. Early TCM intervention was important because it helped to reduce progression to serious disease, including in older patients. Significant outcomes have been claimed following treatment, including TCM medicines combined with specific acupuncture, moxibustion, transdermal therapy and Tai Chi exercises, of patients with mild or moderate COVID-19. For patients with severe disease and in a critical condition, TCM intervention was applied as an accompaniment to conventional medicine. It was noted that the proportion of patients progressing to severe disease appeared to be reduced among those receiving TCM. A number of cases of recovery following TCM intervention were provided as examples, noting interventions designed for specific symptoms such as anorexia and fatigue. It was also suggested that TCM could assist in the prevention of COVID-19 illness. During the long lockdown in Wuhan, the public were encouraged not only to maintain a healthy lifestyle and ensure their personal hygiene but also to follow a TCM diet with items such as Chinese yam, Chinese dates, and Goji berries. Members of the TCM team took supplies of TCM herbs to communities and delivered TCM items to patients’ doors. As people recovered from COVID-19 infection, many who were discharged from hospital still had complaints such as tiredness, anorexia, shortness of breath, insomnia, and emotional instability. TCM was therefore also used to ease discomfort and speed recovery. In summary, the speaker pointed out that TCM had a role to play at all stages of viral infection, as follows: Prevention — during lockdown many people voluntarily chose to consume plants and herbs with medicinal value. They were encouraged to do so as such foods can help stimulate the immune system and promote health and wellness. Mild and moderate disease — the RCTs data indicates that TCM was seen to shorten the time to resolution of symptoms, viral clearance and to reduce the proportion of patients progressing to severe disease. Severe and critical disease — patients were treated with conventional medicine along with TCM. It was felt that this combined approach both shortened the length of stay in intensive care and reduced the duration of

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mechanical ventilation. It was claimed that TCM reduced mortality among critically ill patients. Convalescence — TCM serves as the main pillar of care at this stage. TCM interventions were reported to improve clinical symptoms and the quality of life. The speaker indicated that the advantages of TCM in a pandemic situation include the wide availability of the herbal medicine ingredients and the speed with which TCM can be used to intervene at an early stage of illness. The aim was to boost the immune system before the infection develops and, where severe disease does occur, to assist in recovery by reducing sepsis and emotional disturbance. In conclusion, it was stated that the Chinese approach to COVID-19 was based on the integration of TCM and conventional medicine. Thus, TCM played, and continues to play, a key role in reducing the impact of the pandemic.

Report 2: Scientific Research on Prevention and Treatment of COVID-19 with TCM Dr. Shang Hongcai When the COVID-19 pandemic began, the Government of China allocated funding (equivalent to some US$ 50 million) through the NATCM for research into this new infection. A dedicated TCM research team was charged with launching anti-pandemic projects in three areas, namely: 1) screening for effective medicines and formulas, 2) clinical and basic research on prevention, treatment, and rehabilitation, and 3) the development of TCM and natural medicinal products. The overall aim was to promote the optimization of TCM diagnosis and treatment. As of March 2022, the Chinese Clinical Trials Registry, which is part of WHO’s ICTRP, showed 859 clinical studies of COVID-19 in China, with 70% of the projects registered in January–May 2020. Among these Chinese clinical trials, 213 relate to TCM. The trials included a range of studies which together have addressed six target groups associated with different stages of COVID-19 infection, namely: 1) the general community population, 2) close contacts, 3) suspected cases, 4) patients with mild/moderate disease, 5) patients with severe/critical disease, and 6) convalescent patients. A variety of interventions were implemented — all

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derived from clinical practice, with existing evidence of their effectiveness, using standard treatment protocols and with controlled quality. Of the Chinese clinical studies considering mild conditions, 106 looked at TCM’s impact on fever, 103 assessed the impact on cough, and 94 considered TCM and tiredness. An example was provided of a multicenter RCT with 284 patients from 23 hospitals in nine Chinese provinces who were given TCM in capsule form.b It was reported that, overall, patients in the trial who were given this medicine recovered from their symptoms in a shorter time than patients not given the TCM intervention; the researchers therefore judged that the TCM intervention shortened the period to resolution of clinical symptoms of COVID-19. Twenty-one studies suggest that TCM helps shorten the time of positive-to-negative conversion of COVID-19 nucleic acid and a further 43 indicate that this effect reduces the rate at which non- severe COVID-19 worsens. In line with this finding, another unblinded, cluster-randomized trial that enrolled 408 patients with mild COVID-19 and treated them with another TCM granule formulation, reduced the likelihood that COVID-19 would worsen. A number of studies also looked at TCM’s impact on the duration of mechanical ventilation and of stay in an intensive care unit. For instance, a national retrospective registry study of 8939 patients in 15 hospitals found that COVID-19 mortality was 1.2% among patients receiving TCM and 4.8% among those not receiving it, leading the researchers to conclude that TCM was associated with a substantially lower risk of in-hospital mortality.c More studies, including a multicenter, double- blind RCT which enrolled 131 patients during the rehabilitation period of COVID-19 infection at five hospitalsd, showed improvements in exercise tolerance and imaging manifestations on CT. The conclusion of b

 Hu K, Guan WJ, Bi Y, et al. Efficacy and Safety of Lianhuaqingwen Capsules, a Repurposed Chinese Herb, in Patients with Coronavirus Disease 2019: A Multicenter, Prospective, Randomized Controlled Trial[J]. Phytomedicine, 2021, 85:153242. c  Zhang L, Zheng X, Bai X, et al. Association between Use of Qingfei Paidu Tang and Mortality in Hospitalized Patients with COVID-19: A National Retrospective Registry Study[J]. Phytomedicine, 2021, 85:153531. d  Chen Y, Liu C, Wang T, et al. Efficacy and Safety of Bufei Huoxue Capsules in the Management of Convalescent Patients with COVID-19 Infection: A Multicenter, DoubleBlind, and Randomized Controlled Trial[J]. J Ethnopharmacol, 2022, 284:114830.

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the trial was that TCM may exert strong rehabilitative effects on the physiological activity in patients recovering from COVID-19, which may attenuate symptoms of tiredness and improve exercise tolerance. Throughout the research, no TCM-related serious adverse events were observed. The opportunity was taken to find out more about the pharmacology of certain TCM ingredients, focusing on properties relevant to the treatment of COVID-19, such as those with antiviral and anti-inflammatory effects. Some of the products have been registered in other countries and studies are under way.

Report 3: Methodology Applied in Selection of the Randomized Controlled Trials Dr. Sun Xin As of late February 2022, there were no conventional medications for COVID-19. TCM products had played an important role by lowering progression to severe disease, shortening the time to viral clearance, and speeding up recovery. However, there were no efficacy studies of this, so a team was established to carry out an evidence-based investigation. The team reviewed the type of evidence (RCTs), type of TCM (fixed process, national standards), type of publication (peer-reviewed), quality (design, implementation, reporting), registration (ethical approval, registration platform), and outcomes. The PICO eligibility criteria were used and eight databases were searched as well as the COVID-19 repository. Some 150,522 reports were searched and 12 RCTs were selected (see Annex 3). These included 2,066 inpatients in China in 2020. All 12 trials — 11 on non-severe COVID-19 and one on severe disease, were published in peer-reviewed journals. Sample sizes ranged from 40 to over 400 and all trials used diagnoses based on National Health Commission guidelines. Overall, it appeared that TCM shortened the time to symptom resolution of fever, cough, and tiredness. A cohort study of 780 patients showed that TCM shortened several parameters of COVID-19 recovery — such as nucleic acid conversion and time to resolution of symptoms and that it reduced the rate of conversion to severe

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disease.e However, the assessment noted the paucity of evidence of the effect of TCM on severe disease. It was reported that there was sufficient evidence of efficacy on mild and moderate COVID-19 but only preliminary evidence on severe or critical patients. A number of suggestions were made for future research and it was felt that greater international collaboration and multicenter research could lead to better evidence in future.

Questions and Answers (Begun on day 1 and continued on day 2) Members of the Expert Panel thanked the three speakers for their reports and acknowledged the emergency context in which the trials had been conducted. Members of the panel asked a series of questions about the presentations and the accompanying printed reports.

Regulatory challenges: Selection Criteria and Quality Control Members of the Expert Panel raised questions about the selection criteria used in choosing the TCM formulas. It was pointed out that selection should be based on quality, efficacy, and safety but it was unclear what criteria were used in the Chinese studies as these formulas can be made up of numerous plant species and therefore a diversity of chemical ingredients. In response it was stated that there are different prescriptions according to the grading and severity of the patient and there is a quality standard within the Chinese Pharmacopeia for the medicines that were used in the studies. As for the raw materials, the plants and herbs are grown and collected in accordance with Good Agricultural Collection Practices (GACP), processed in accordance with Standard Operating Procedures (SOPs) and produced in accordance with Good Manufacturing e

 Shi N, Liu B, Liang N, et al. Association between Early Treatment with Qingfei Paidu Decoction and Favorable Clinical Outcomes in Patients with COVID-19: A Retrospective Multicenter Cohort Study[J]. Pharmacol Res, 2020, 161:105290.

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Practice (GMP). The Chair reminded participants that WHO has guidelines for the collection and processing of medicinal plants. In response to a subsequent question on quality control and the consistency of the ingredients, it was noted that the amount and profiles of chemical constituents may vary according to geographical and seasonal variations, but that all variations are controlled to ensure that they comply with official standards. With regard to any possible adverse effects from the TCM, it was pointed out that, even when some persons who were living with HIV or had autoimmune disorders were among the patients who received the medicine, no adverse effects were reported.

Efficacy: Preventative Effects of TCM One issue raised was the suggestion that some TCM formulations may inhibit the virus. Meeting participants asked what evidence exists to support this antiviral potential. In response, it was stated that there had been a study which showed antiviral potential.f There was a discussion about how one could determine the possibility of prevention from a few hundred people when the medicine might be given to hundreds of thousands. In particular, owing to limited safety information on pregnant women and children using TCM against COVID-19, what criteria have been taken to conduct a largescale clinical trial? In response, it was stressed that, so far, pregnant women and children have been treated with certain TCM with no serious adverse reactions. It was stated that one study, which was not included among the 12 submitted to the meeting and that had not yet been published, had looked at 202 children who were treated with TCM in six provinces at different times during the past two years and found that no adverse reactions had been reported. It was also pointed out that, as in conventional medicine, TCM has certain contraindications for pregnant women and doses are adjusted according to age and weight. (However, one participant noted that, according to a WHO f

 Zhao C, Li L, Yang W, et al. Chinese Medicine Formula Huashibaidu Granule Early Treatment for Mild COVID-19 Patients: An Unblinded, Cluster-Randomized Clinical Trial[J]. Front Med, 2021, 16 Sept.

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publication on medicinal plants, these substances should not be used in women and children without prior data). It was also noted that pregnant women were excluded from the 12 selected RCTs.

Safety of TCM and Liver Functions A comment had been made about a study which reported problems of liver function in some 20% of patients.g In fact, in the study in question, it was found that both the treated group and the control group had elevated liver enzymes. It was suggested that this might be due to the use of conventional medication to lower the temperature of the patients since some medicines that lower temperature may have an effect on the liver. Nevertheless, it was pointed out that conventional medicine can also be linked to problems of liver function and COVID-19 is not only a disease of the lungs but may have some impact on the liver too.

Blinding of Studies Another question was raised about how TCM interventions were blinded and, in the case of one study in particular, what placebo was used.h It was explained that the TCM (Xuebijing, or XBJ) intervention was delivered by injection diluted with saline and that saline was also used as the placebo in the control group. Both the XBJ-saline and the placebo saline were delivered in brown infusion bags and via brown infusion sets to ensure that they looked the same.

Mechanistic Study: Symptom Differentiation A question was asked about symptom differentiation in the studies. The response was that the pandemic presented common symptoms so it was g

 Hu K, Guan WJ, Bi Y, et al. Efficacy and Safety of Lianhuaqingwen Capsules, a Repurposed Chinese Herb, in Patients with Coronavirus Disease 2019: A Multicenter, Prospective, Randomized Controlled Trial[J]. Phytomedicine, 2021, 85:153242. h  Luo Z, Chen W, Xiang M, et al. The Preventive Effect of Xuebijing Injection against Cytokine Storm for Severe Patients with COVID-19: A Prospective Randomized Controlled Trial[J]. Eur J Integr Med, 2021, 42:101305.

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possible to come up with a standard prescription which could be adjusted, if necessary, for variations such as different patient conditions or regions. There were comments with regard to the need to evolve these ideas in view of the growing interest in customized medicine. A mechanistic study was proposed to investigate the antiviral effects of specific formulas.

Summary At the end of the first day’s discussion, the Chair (Dr. Elisabetsky) reminded participants of the stated purposes of the meeting. Since the experts were presented with a body of data that showed marked heterogeneity of study designs, cohort size, primary and secondary endpoints used to evaluate the effects of diverse patent (branded) TCM, each formulated with different and complex compositions, and because the experts received a large and complex volume of data based on different groups of patients at different times and different places, a deep analysis of the 12 studies would not be a useful approach. Rather, on the basis of what had been presented, the question to answer would be, “How can we improve the study of TCM for the future?” Participants noted the need for ideas on how to optimize analysis of the database and potentially how to promote and cooperate in international trials on these medicines. She asked for an open-minded discussion the following day.

Day 2 At the invitation of the chair, the rapporteur (Dr. Heather Boon) summarized Day 1 proceedings, and reminded the panel participants of the objectives and anticipated outcomes of the meeting, specifically the conclusions and recommendations expected to cover six aspects of TCM, namely: 1) the efficacy of TCM in treating COVID-19, 2) the safety of TCM, 3) whether the benefits of TCM are found throughout the care continuum, 4) whether the integrated approach is a good model, 5) suggestions for future research in China or internationally, and 6) recommendations on

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experiences to be shared with other countries and on proposals for strengthening international cooperation in the treatment and control of COVID-19, the recovery of health systems from the current pandemic, and preparation for future pandemics.

Discussion Members of the Expert Panel acknowledged that the study results showed that TCM resulted in a shorter time for resolution of the illness among the study participants but also asked how long patients were followed up. Panel members proposed that a retrospective study of treatment outcomes should be carried out by looking at the patients in these studies over longer periods to see if TCM might have any effects with respect to Long COVID-19. Members of the panel also asked for a fuller analysis of results, such as: 1) a pooled analysis with either (a) all available RCTs or (b) a focus on subcategories (herbal combinations or single herbs), 2) review of realworld data (RWD) for safety outcomes, particularly when RWD has a longer follow-up period, and/or 3) for symptoms resolution (a) time in days for symptoms resolution (overall and for each study) and (b) rate/ proportion of symptoms resolution in order to provide a meaningful interpretation for clinical practice and research. Trial design would need to evolve to enable rigorous studies of individualized interventions and it would also be helpful to identify any factors that contribute to the heterogeneity of the findings. Members proposed that Artificial Intelligence (AI) could be used for the analysis of pooled data (e.g., safety and clinical outcomes and correlations with laboratory data). Participants were informed that the data from the studies had already been pooled and the researchers also looked at trials with similar approaches. The chair raised the issue of “lack of appetite” which had been mentioned in the reports by the Chinese delegation as part of the impact of TCM on COVID-19. This is often ignored in the West but could be an important issue, especially in the context of Long COVID which can last for months or even a year. There is a growing understanding of the impact of COVID-19 on the brain and it could be of interest to see if the TCMs used have anti-neuroinflammatory properties and/or impact on blood flow

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to the brain. Additionally, if there are interactions between some TCM treatments and conventional medicines, this would also be an important issue to address in international trials where standard treatments may differ from those used in the selected RCTs. The experts were reminded that the national policy of China is to use both TCM and conventional medicine. Dr. Huang informed the meeting that the first TCM team that went to Wuhan tried to reduce the use of conventional medicine alone. The research suggested that combined use of TCM and conventional medicine can work against COVID-19 and can reduce the adverse effects of conventional medicine. It was pointed out that conventional medicine focuses on the standardization of medicines and no components are increased or decreased. TCM products also have fixed standards but when giving treatment, clinicians may vary the dose or adjust the balance of contents to suit a particular patient. However, the meeting was informed that fixed standards were maintained in the RCTs. The meeting noted that experience indicated the inflexibility of conventional medicine and the flexibility of TCM. In order to emphasize the safety and efficacy of TCM in treating patients with COVID-19, Dr. Zhang Weidong outlined the evidence that is readily available. He presented existing pooled data showing the following: – 12 reliable RCTs were selected from a list of 71 for consideration by the Expert Panel and there are reliable examples of real-world evidence among 79 cohort studies. – For evidence on shortening the time to symptom resolution in patients with non-severe disease, there are seven RCTs with over 1,000 patients. – Evidence for slowing the rate of progress from non-severe to severe disease is supported by five RCTs and two real-world evidence studies with a total of 2,179 patients. – The time taken for nucleic acid conversion in patients with non-severe disease is reported in five RCTs with 826 patients. – There are three RCTs and one real-world study with evidence of reduced hospital stays for non-severe patients, and one RCT and five real-world evidence studies (11,676 patients) to support the argument for reduced mortality in patients with severe disease.

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– One RCT with 58 patients showed that a TCM product significantly reduces the rate of conversion of critical cases, the rate of mechanical ventilation, and the length of ICU stay, as well as shortening the time to symptom resolution. – TCM can reduce the use of resources and there is also evidence to suggest that TCM may help to prevent communicating the disease to close contacts. A study conducted in Yangzhou among 5,686 persons in quarantine facilities found that the 3,438 persons in the TCM treatment group had a positive infection rate of 0.29%, while the 2,248 persons in the untreated group had a positive rate of 1.73%. The Chair proposed that these data should be published in an international journal to generate further discussion and analysis. Participants felt that there were sufficient data for the meeting to make a “cautiously optimistic” judgement that TCM could be helpful in the treatment of COVID-19. A meta-analysis of studies had been proposed as being necessary to get the topic into a high-impact journal but publication would be unlikely since herbal studies in such journals are rare. TCM practitioners base their understanding of active compounds on animal data extrapolated to humans. A pharmacology study on this was recommended as it would be important to understand why these treatments work. By learning more about the medicines that work one learns more about the disease. Dr. Huang commented that TCM can teach us more about disease and more about human physiology. As the discussion of Day 2 came to an end, the Chair reminded participants that Day 3 would be focused on finalizing recommendations.

Day 3 The rapporteur summarized the key points of the discussions of the previous day and reiterated again the objectives of the meeting and the five expected outcomes on: efficacy in treating COVID-19, safety, whether there are benefits throughout the care continuum, the value of the integrated model, international research and experiences to be

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shared with other countries, recommendations on experiences and lessons, and strengthened international collaboration and health systems.

Discussion The experts agreed that the studies presented had applied appropriate and rigorous methodology given the context in which they were being conducted. Although the trials involved different settings, the data suggested that TCM was both safe and beneficial when combined with conventional antiviral medicine. It was agreed that there are promising data on the benefits of TCM in reducing the disease exacerbation rate for mild and moderate cases of COVID-19. However, evidence on the benefit of TCM injection for severe cases is limited and further evaluation is critically needed. It was noted that more data are available on this issue but the meeting needs to address only the material as presented. A set of draft findings, suggestions, and recommendations — to WHO and to its Member States were presented by the Chair (Dr. Elisabetsky). These were then the subject of discussion by participants who, while recognizing that the studies suggested the benefits of TCM, called for further investigation into the effectiveness of these products in other populations. It was noted that most of the trials presented had been done with branded TCM that are produced in a consistent manner in accordance with NATCM safety requirements. In this regard, it was agreed to make clear that the consultation’s findings and recommendations are based on the materials presented to the meeting. It was agreed that international cooperation and trials should be promoted, with reports in line with international reporting standards in order to make the results more widely accessible. This could be done together with TCM hospitals outside China and in partnership with WHO TCI collaborating centers — identifying potential partners to replicate the most promising studies and producing a comprehensive analysis. Quality control would have to be assured at all stages and there must be adherence to WHO’s guidelines on good practices. There would need to be a clearer

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focus on the study design, general guidelines would need to be prepared and adequate placebos provided. WHO was asked to consider producing a technical document for this purpose. Expert Meeting participants then adopted the findings, suggestions, and recommendations, as amended.

Key Findings of the Expert Meeting – The experts agreed that the evidence evaluation reports applied appropriate and rigorous methodology to determine the current level of clinical evidence and safety of the studied TCM interventions used in the trials. – The experts acknowledged that the included trials involved heterogeneous settings and various types of patients and outcome measures. – In addition to routine treatment, the results from the studied TCMs suggest that, on the basis of clinically relevant outcome measures, the studied TCMs are beneficial in the treatment of COVID-19, particularly in mild-to-moderate cases. – There are promising data to suggest that TCM is beneficial in reducing the risk of progression from mild-to-moderate cases to severe COVID-19. – The evidence on the benefit of TCM injection for severe cases is limited, and further evaluation is critically needed. – For mild-to-moderate cases, there is encouraging evidence that the studied TCMs, when administered as add-on interventions to conventional treatment, may shorten the time for viral clearance, resolution of clinical symptoms, and length of hospital stay when compared to conventional treatment alone. – The results of the TCM trials do not substantiate the use of any specific plant species outside the general TCM framework in the context of COVID-19. – The studied TCM interventions given in addition to conventional treatment were well tolerated and have a safety profile that is comparable to that of conventional treatment alone.

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– There is encouraging evidence that early application of TCM may result in better clinical outcomes for patients with mild-to-moderate COVID-19. – Despite inherent limitations, the results from the selected RCTs justify further investments in clinical trials to evaluate the potential benefits of selected TCMs in the management of COVID-19.

Suggested Measures To optimize the analysis of the current database: – Conduct pooled analyses based on subcategories (e.g., shared herbal combinations, single herb if available, individual symptom resolution, rate/proportion of symptom resolution, length of stay in hospital, days in intensive care unit, conversion rates, viral clearance). – Conduct retrospective treatment outcome (RTO) studies regarding Long COVID. – Use artificial intelligence (AI) to scrutinize the data for meaningful correlations. – Explore the potential of AI for data/sample/cohort analysis. To facilitate and improve new trials: – Focus from the beginning on the study design, and especially on key details such as the sample size, randomization method, blinding, and follow-up. – Prepare general guidelines for formatting new trials, including statistics and research design. – Provide adequate placebos for enteral TCM to allow for double-blind trials. – Incorporate the TCM theoretical framework in the process of trial design to facilitate translation of findings into practice.

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– Share all raw data from clinical trials in order to ensure openness, transparency, and sharing as a means towards the recognition of TCM worldwide. – Consolidate safety data. – Employ a holistic approach in order to ensure batch-to-batch consistency of trial medications (i.e., products quality control). – Incorporate qualitative measurement in trial design in order to gain insight into the overall benefit of TCM for COVID-19 patients. To promote international trials and cooperation: – Report studies in accordance with international reporting standards for clinical research (CONSORT and/or CONSORT Extension for Chinese Herbal Medicine Formulas) so that quality can be evaluated comprehensively and accurately and to allow for transparency. – Partner with existing TCM hospitals outside China. – Work with WHO collaborating centers for traditional medicine. – Identify potential partners to replicate the most promising studies with specific branded TCMs. – Produce a comprehensive analysis of biological data relevant to COVID-19 for the species that comprise the studied TCM. – Encourage the quantification of potentially toxic compounds (such as ephedrine and others) in the actual TCM dose given to patients.

Recommendations to WHO The Expert Meeting recommended to WHO: – to share the outcomes of this consultation with Member States in a timely manner given the evolving nature of COVID-19 globally; – to encourage Member States to consider the integration of traditional medicine interventions such as TCM in planning for the clinical management of COVID-19 in the context of their healthcare systems and regulatory frameworks;

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– to provide technical support to Member States for the application of TCM in practice and in further research; – to facilitate international clinical trials to further evaluate the potential benefits and safety of TCM for treatment of persons with COVID-19 across the care continuum; – to encourage Member States to consider the integrative care model that has been developed and applied in China.

Recommendations to Member States The Expert Meeting recommended to Member States: – to consider the potential use of TCM for the management of COVID-19 in the context of their healthcare systems and regulatory frameworks; – to share experiences and lessons, particularly those actively acquired through this organized research program in TCM and clinical experience from China; – to collaborate actively in clinical and mechanistic research to further evaluate and elucidate the clinical benefits and safety of TCM in the management of COVID-19; – to collaborate in developing consistent approaches, where practicable, and to improve healthcare systems for the management of the current pandemic and preparedness for future pandemics.

Commendations The participants in the Expert Meeting: – commended the experts from China for sharing research data and clinical experience in using TCM in conjunction with conventional medicine in the management of COVID-19; – expressed their appreciation for the significant investment and effort made by the Chinese government and its researchers to advance knowledge and to develop therapeutics for the management of COVID-19 from the outset of the current pandemic;

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– stated that further research is warranted on TCM for the treatment of COVID-19 since the progress to date lays a strong foundation for international collaboration and cooperation that will potentially benefit human health globally through more effective and appropriate application of TCM for COVID-19; – expressed appreciation to the leadership provided by WHO in the organization and conduct of this consultation.

Closing The co-chairs of the meeting thanked all the participants for their contributions and expressed their deep appreciation to the Chinese group of experts and the interpreters. All involved in the meeting had made very worthwhile contributions. Dr. Huang expressed his appreciation for the opportunity to present to WHO the efforts of TCM practitioners and producers in China. He thanked the experts for their valuable suggestions to improve studies of TCM and stressed that the NATCM of China stands ready to assist other countries in promoting the use of traditional medicine. Dr. Zhang Qi thanked the participants on behalf of WHO, noting that the key findings and recommendations covered a variety of important matters. He informed the experts that the traditional, complementary, and integrative medicine team in WHO also has a project for the development of a WHO international herbal medicines pharmacopoeia, and that the provision of further documentation and guidance is planned. The meeting closed at 16:20 Central European time.

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Chapter 9

History, Present and Prospect of Thai Traditional Medicine Benjama Boonterm, Yenpat Kamdangyodtai, Anchalee Chuthaputti

Abstract Thai Traditional Medicine (TTM) is the traditional medicine system of Thailand that has been developed throughout the country’s history. TTM comprises Thai medicine, Thai pharmacy, Thai midwifery, Nuad Thai (or traditional Thai massage), and Thai indigenous medicine. Though the role of TTM in healthcare declined for a considerable period of time during the 20th century as it was replaced by modern medicine, the promotion of the use of herbal medicines for primary healthcare in the 1970s and GTZfunded Medicinal Plants and Primary Health Care Project which began in 1985, revived the role of TTM knowledge in the healthcare system again. The establishment of the Institute of Thai Traditional Medicine in 1993 followed by the Department for the Development of Thai Traditional and Alternative Medicine under the Ministry of Public Health (MoPH) in October 2002, has led to a rapid and continuous development of the provision of TTM service in the public health service facilities and all other aspects involved. TTM clinics are available in all regional and general hospitals and community hospitals and some of tambon (sub-district) health promotion hospitals throughout the country. The current situations of the 4Ps in traditional medicine, i.e., TTM practice and service, practitioners 703

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of TTM and educational system, traditional and herbal medicine products, and the protection and promotion of TTM knowledge are presented. In addition, the current situations of ongoing agenda-driven projects based on the government policies and the National Strategy, i.e., the establishment of “Medical Cannabis Clinic in Thai Traditional Medicine” and the “Herbs for the economy” project are also covered. The role of TTM service, TTM herbal medicinal products, and TTM practitioners in the public health service system in the healthcare of Thai people, and the country’s economy is expected to significantly increase in the near future. Keywords: Thai Traditional Medicine, Thai Indigenous Medicine, history, current situation

Introduction The Kingdom of Thailand has her own system of traditional medicine called “Thai Traditional Medicine” (or “Kan Paet Pan Thai” in Thai, TTM), one of the most valuable cultural heritages of the country, which is now a part of the service plan and the policy of the Ministry of Public Health (MoPH). The principle of TTM was developed from traditional medicine used in the Buddhist monastery since the time of the Lord Buddha and was passed on along with the spread of Buddhism to the Southeast Asia where Thailand is now located.[1] Such Buddhism-based traditional medicine was later blended with the indigenous medicine of different local ethnic groups of people native to this region, e.g., Kha, Khom, Mon. Later on, during Ayutthaya period (1350–1767 AD), when different groups of foreign people first came to trade and live in Ayutthaya, Thai ancestors learned about traditional medicine of other countries and adopted some herbal materials commonly used in Persian, Chinese, and Indian traditional medicines and integrated such selected materia medica into our traditional medicine formulas.[2] Hence, it can be seen that TTM has been developed throughout the country’s history until it has become a unique system of traditional medicine that is an identity of Thailand cultural heritage, as evidenced by the herbal materials used in TTM formulas and its systems and procedures for the diagnosis and treatment of various diseases. In legal terms, TTM is defined by the “Protection and Promotion of Thai Traditional Medical Knowledge Act B.E. 2542 (1999)” as “the

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medical procedures relating to the examination, diagnosis, therapy, treatment or prevention of diseases, or promotion and rehabilitation of human or animal health, midwifery, Nuad Thai (Thai traditional massage), as well as the preparation and production of Thai Traditional Medicines and the invention of medical devices and instruments. All are based on the knowledge or treatises which were passed on and developed from generation to generation.”[3] The “Thai Traditional Medical Professions Act B.E. 2556 (2013)” also gives similar definition, except narrowing down to only the medical procedures for human health as the Act deals with the practice of Thai Traditional Medicine in humans only.[4]

9.1  The Principles of Thai Traditional Medicine 9.1.1  The four elements (dhatu) of the body and the causes of illnesses According to TTM, the human body is composed of four elements (“dhatu” in written Thai or “tard” in spoken Thai), i.e., earth, water, wind, and fire. The balance or imbalance of the four body dhatus and the external dhatus play a key role in human health. When the four body dhatus are in equilibrium, a person will be healthy. On the contrary, if an imbalance of body dhatus occurs, i.e., if any of the four dhatus is in a deficit, an excess, or a disability condition, a person will become ill or unhealthy. Therefore, the treatment with TTM is aimed at correcting such imbalance.[5,6] In addition to the imbalance of dhatu, according to TTM, human health is also influenced by: – Seasons that cause changes of weather, heat and cold, rain, wind, and humidity make people vulnerable to different illnesses during different seasons. – Age. In TTM, people at different ages are prone to become ill from the effect of different dhatus. – Geography. The geographic location where one lives also affects one’s health due to the influence of the weather and the environment of that region.

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– Time. The continuous movements of the sun, the moon, and the stars astrologically have different influences on human life and health during different times of the day. – Inappropriate Behaviors. According to TTM, improper behaviors, and mental states can contribute to human sickness, e.g., inappropriate eating habits, imbalanced postures, exposure to extreme heat or cold or polluted air, food, water or sleep deprivation, delayed urination or defecation, overwork, over-exercise, or excessive sexual activity, deep sorrow or extreme exhilaration, and extreme anger and lack of equanimity.[5,6]

9.1.2  Examination and diagnostic procedures of TTM The procedures that TTM practitioners used to examine and diagnose patients are as follows: – Patient’s history and chief complaint. Similar to a medical doctor, a TTM doctor will ask about a patient’s history, symptoms, chief complaints and usual behaviors or habits, date, time, month, and year of birth to determine the patient’s dominant dhatu and the imbalanced dhatu that is the cause of the illness. – Physical examinations, e.g., heart rate, pulse, body temperature, visual and manual examination of affected organs or areas of the body, body structure, degree of movement of joints, and the extremities. – Diagnosis. Since each dhatu controls different organs or body systems, TTM doctors can make clinical diagnosis on what goes wrong with a patient’s dhatu based on his or her symptoms, chief complaint, and physical examination. – Astrological examination. For some TTM practitioners who learn and have experience in TTM astrology, they may astrologically examine patients to determine if their illnesses are due to the influence of their bad karma, the stars, or a supernatural power. If so, the patients usually should make merit or a form of rites might be performed for them to boost their morale.[5,6]

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9.1.3  Treatment modalities in TTM As a form of holistic medicine, TTM treatment is aimed at adjusting the balance of the body dhatus, taking into consideration all illness-causing factors and behaviors previously mentioned. Treatments prescribed for patients can be TTM preparations, herbal medicinal products, Nuad Thai (or Thai traditional massage), hot herbal compression, or herbal steam baths. For post-partum care, a combination of TTM treatment modalities can be prescribed for mothers, e.g., herbal medicines and hot salt pot compression to promote lochia discharge and uterine involution, herbal medicines and herbal compression on the breast to promote adequate lactation, Nuad Thai, and herbal steam bath. Moreover, the TTM health promotion approaches, e.g., avoiding and correcting inappropriate behaviors previously mentioned and practicing dhammanamai, should be used to achieve a state of complete physical, mental, and social well-being. Information about common TTM treatment modalities is summarized as follows[5,6]: Herbal Medicines As the taste of an herbal formula will determine the drug attribute and its therapeutic efficacy, a TTM doctor will therefore prescribe herbal medicine(s) having the taste suitable to treat patient’s diseases and symptoms and correct the imbalance of body dhatus. As of January 2022, there are 86 items of traditional medicines (56 items) and herbal medicines (30 items) selected into the National List of Essential Medicines (NLEM)[7–9] (Figure 9–1). Nuad Thai Based on the principle of TTM, there are 72,000 “sen” lines in the body where the wind flows along. Of these, there are 10 principal sen lines called “sen prathan sib” which have several sen pressure

Figure 9–1    Herbal medicines.

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points associated with each sen line. It is believed that if the flow of the wind along these sen lines is obstructed due to the imbalance of body dhatus, some disorders will occur. The basis of Nuad Thai is to massage or press on these lines and the associated sen pressure points which will help correct the wind flow, stimulate blood circulation, and thereby treat the existing diseases or symptoms (Figure 9–2 and Figure 9–3). Hot Herbal Compression by using “Luk Prakob” or hot herbal compress which is usually given after Nuad Thai, or given alone for the treatment, or relief of pain and inflammation in different organs, myofascial pain syndrome, knee osteoarthritis, or for post-partum care to relieve breast engorgement. Key herbs in Luk Prakob are those in the family Zingiberaceae, i.e., plai (Zingiber montanum), turmeric (Curcuma longa), which have volatile oil and several active principles to exert antiinflammatory effect (Figure 9–4). Herbal Steam Bath helps stimulate blood circulation, relieve muscle pain, induce bronchodilatation to facilitate breathing, nourish the skin, and promote lochia discharge after delivery.

Figure 9–2    Sen lines in the body.

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Figure 9–3    Nuad Thai.

Figure 9–4    Hot herbal compression.

Herbal Poultice locally applied on the affected area of the body, helps reduce pain, inflammation, bruises or swelling. It is commonly used in knee osteoarthritis. Hot Salt Pot Compression (Tub Mor Kleur) The heat from the salt pot and the herbs helps promote uterine involution, promote the discharge of lochia, and reduce ache and pain after childbirth (Figure 9–5). In addition to TTM, Thai indigenous medicine (TIM) also plays a role in the healthcare of Thai people in the communities and in the health service system. According to the Thai Traditional Medical Professions Act

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Figure 9–5    Hot salt pot compression (Tub Mor Kleur).

B.E. 2556 (2013), TIM is categorized as one of the five disciplines of TTM practice.[4] It is a part of local health wisdom and community health care, of which knowledge and practices are unique and related to local traditional culture. In some community hospitals, renowned and well-respected folk healers are invited to provide treatment in their areas of expertise, i.e., folk massage, post-partum care, or herbal medicines, under the supervision of medical doctors of the hospitals. Moreover, some items of traditional medicines in the National List of Essential Medicines originated from the herbal formulas of folk healers. With the permission of the folk healers, local community hospitals then adopted such herbal recipes into their hospital formulary, continuously produced and prescribed these medicines for their patients for longer than 10 years, or in more than 1,000 cases with safe and effective clinical benefits before being selected into the NLEM.

9.2  History of Thai Traditional Medicine 9.2.1  History of the development of Thai Traditional Medicine Before the establishment of Sukhothai, the first Kingdom of Thailand around 1220 AD, during the reign of King Jayavarman VII of the Khmer

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Kingdom (1181–1218), 102 hospitals called “arogayasala” were built to treat people’s illnesses throughout that Kingdom which included the northeastern part of today’s Thailand. The stone inscriptions found in the remains of arogayasala in Thailand showed that there were more than 95 staff including healthcare providers working in each arogayasala where several herbs were gathered, stored, and used for the preparation of herbal decoctions for patients.[10] During the Ayutthaya period (1350–1767), there were a number of pharmacies or drug stores for the public and royal dispensary in the royal palace. In the royal court, several departments were established to take care of the health of the Kings and the royal families, e.g., Medical Service Department, Pharmacy Department, Internist Department, Pediatrician Department, Masseur Department, etc. During the reign of King Narai the Great (1656–1688), the first official TTM textbook entitled “Kumpe Thart Phra Narai” was written compiling all medicinal formulas compounded for the King by Thai and foreign doctors who served in the royal court. Most of the materia medica used for the preparation of such medicines were from local sources and some were from the countries that Ayutthaya traded with, e.g., China, India, Persia, etc.[10] After the fall of Ayutthaya in 1767 and the establishment of the new capital in Bangkok where the Rattanakosin period began in 1782, Kings Rama I, II, and III of the Chakri Dynasty played an important role in the revival of TTM. During the reign of King Rama III (1824–1851), more than 1,000 drug recipes and TTM knowledge on the origin of diseases and their treatments were compiled and inscribed on marble tablets and placed on the walls of two temples, namely Wat Pho and Wat Raja Orosaram. The marble tablet inscriptions at Wat Pho also included the principle of Nuad Thai showing sen lines and associated sen pressure points with the explanations of the symptoms or diseases each point could heal. In addition, King Rama III also ordered the building of 80 Reusi Dadton sculptures (traditional stretching exercise) made of a mixture of zinc and tin placed in Wat Pho and a poem was written to describe the health benefit of each posture of Ruesi Dadton. Wat Pho is therefore considered as the first open university in Thailand as people can come to learn about TTM so that they can use TTM knowledge to take care of their health. Moreover, these epigraphic archives of Wat Pho were inscribed in the “Memory of the World Register” by the UNESCO in 2011.[11]

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During the reign of King Rama V (1868–1910), classical TTM textbooks from various places were compiled, reviewed, and revised to conform with the originals by appointed team of senior royal physicians, and the revised textbook was called “Vejasart Chabap Luang” that literally means “Royal Textbook of Medicine,” which served as the origin and reference of several TTM textbooks later developed during this reign.[10] In 1888, Siriraj Hospital, the first western-style hospital, was officially opened to provide medical service in both Western Medicine and TTM. Due to the insufficiency of doctors, the medical school to teach Western Medicine was opened in 1890 and the teaching of Thai Traditional Medicine was also included in the curriculum in 1892. For many years later, several TTM textbooks were therefore developed, namely 1) Tamra Phaetsart Songkroh (3 volumes), 2) Tamra Vejasart Wanna (Textbook of Descriptive Medicine), 3) Tamra Phaetsart Songkroh Chabap Luang (Textbook of Medicine, Royal edition, 2 volumes) covering 10 classical treatises of TTM, and 4) Tamra Vejasueksa (Textbook of Medicine in Brief, 3 volumes) to facilitate the teaching and studying of TTM. Most of these TTM textbooks (Number 1, 3, and 4) are recognized by the Thai Food and Drug Administration (FDA) as official references of TTM knowledge for the registration of TTM products.[12] Unfortunately, the teaching of TTM and the provision of TTM services at Siriraj Hospital were discontinued in 1916, as it was considered by the school administrators that the principles of the two systems of medicine were conflicting and the studying of both systems caused confusion among medical students. The termination of the systematic teaching of TTM in the medical school, followed by the absence of TTM doctors in the health service system as modern medicine became the only mainstream public healthcare, led to a significant decline in TTM acceptance, especially in the urban areas. The role of TTM doctors in the provision of healthcare for the Thai people was therefore more apparent in the rural areas where modern medicines were not easily accessible during that period of time.[10] During the downturn period of TTM, societies of TTM practitioners were formed at several Buddhist temples, such as Traditional Medicine Practitioners Association of Thailand, Traditional Pharmacy and

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Medicine Association of Thailand (Wat Sam Phraya), and Wat Phra Chetuphon Traditional Medicine Association. These societies helped preserve and pass on TTM knowledge by offering the teaching of traditional medicine, traditional pharmacy, and traditional massage for people interested in TTM and wanted to practice TTM as licensed TTM practitioners.[10]

9.2.2  The Revival of Thai Traditional Medicine 9.2.2.1  National plans and policies on TTM About 60 years after the cessation of TTM services and teaching of TTM at Siriraj Hospital, in 1978, the World Health Organization (WHO) issued the Declaration of Alma-Ata, focusing on the primary health care (PHC) as a means to achieve “Health for All by the Year 2020” target as well as recognizing the role of traditional medicine doctors as a part of health personnel providing healthcare for the communities. WHO also urged member states to include medicinal plants and herbal medicines in their PHC programs. Therefore, Thailand’s Ministry of Public Health answered the call of WHO by selecting and promoting the use of medicinal plants in PHC and this policy became a part of the Fourth Health Development Plan (1977–1981). Initially 57 medicinal plants were selected and recommended for PHC in 19 groups of common minor symptoms and diseases.[13,14] In 1994, the list of medicinal plants in PHC was revised to contain 61 medicinal plants for 21 groups of symptoms and diseases.[15] Government policy regarding the promotion of the use of medicinal plants and herbal medicines, and later on the integration of Thai Traditional Medicine in the country’s health care system, has continued until today as stated in the Fifth to the Twelfth (current) National Economic and Social Development Plans (2017–2021). The current plan places emphasis on the policies to develop innovative herbal products from local medicinal plants as well as to increase the role of TTM services and products as a part of the policy to make Thailand an international medical service hub of the world to contribute to people’s health and the country’s economy.[16]

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9.2.2.2  The establishment of applied Thai Traditional Medicine curriculum In addition to the Ministry and the societies of TTM practitioners mentioned above, the “Foundation for the Promotion of Thai Traditional Medicine,” led by Professor Dr. Ouay Ketusingh, a wellrespected medical professor of Siriraj Hospital, also played a role in the revival and development of TTM. The Foundation established Ayurvedh Vidhayalai (Jevaka Komarapaj) College in 1982, offering a diploma (3-year) curriculum in Applied Thai Traditional Medicine (ATTM). In addition to the teaching of TTM, the curriculum included courses on basic medical sciences, e.g., anatomy, physiology, biochemistry, etc., as well as some basic knowledge of modern medicine. This system of teaching TTM to improve the practice of TTM was different from the existing apprenticeship system and it was later recognized by the MoPH.[17] In 1987, the Control of the Practice of the Art of Healing Act B.E. 2530 (1987) was enacted, categorizing the practice of traditional medicine into two types, namely, 1) general traditional practice of which the study was based on the passing on of traditional medicine knowledge from classical textbooks and what had been taught from generation to generation, not on a scientific basis, and 2) applied traditional practice of which the study was on a scientific basis and no medical equipment is used for the diagnosis and treatment (to differentiate from the medical practice — author’s comment). As a result, the Act allowed the graduates of Ayurvedh Vidhayalai (Jevaka Komarapaj) College, who passed the knowledge test, to become licensed applied traditional medicine practitioners. However, they are legally allowed to use some basic medical equipment, e.g., stethoscope, sphygmomanometer, and thermometer, for physical examination of patients in order to better diagnose the patients and determine whether or not patients should be referred to receive modern medicine therapy. However, applied traditional medicine practitioners can prescribe only traditional medicines and use traditional therapies to treat their patients.[18]

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9.2.2.3  GTZ-funded medicinal plants and primary health care project — the first systematic research and development (R&D) of herbal medicine in Thailand In 1985, the German government, through German Agency for Technical Cooperation (GTZ), began funding the “Medicinal Plants and Primary Health Care Project” in Thailand to conduct R&D of herbal medicines from turmeric (Curcuma longa L.), andrographis [Andrographis paniculata (Burm. f.) Wall. ex Nees], and ringworm bush [Senna alata (L.) Roxb.] for Primary Health Care in dyspepsia, pharyngotonsillitis, and constipation, respectively. The project, started from 1985 and lasted until the 6th National Health Development Plan (1987–1991), was the collaboration between GTZ and the Division of Medical Research, Department of Medical Sciences (DMSc), MoPH where comprehensive research on the three herbs regarding the cultivation, phytochemistry and quality control, pharmacokinetics, pharmacology, toxicity study, production of standardized herbal medicines, and multi-center clinical trials in five community hospitals under the Office of the Permanent Secretary, MoPH were conducted. The results of the studies eventually led to the inclusion of these three scientifically-developed herbal medicines into the newly-established List of Herbal Medicinal Products in the National List of Essential Medicines in 1999.[10,19]

9.2.2.4  The establishment of the Institute of Thai Traditional Medicine In 1989, the “Collaborating Center for the Development of Thai Traditional Medicine and Pharmacy” was established under the Office of the Permanent Secretary, MoPH to play an active role in the revival of TTM. In 1993, the Center became the “Institute of Thai Traditional Medicine” (ITTM), a division under the Department of Medical Services. [20] Through the years, ITTM has organized several activities to develop TTM in various aspects. One of the major achievements of ITTM was the promulgation of The Protection and Promotion of Thai Traditional Medicine Knowledge Act

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B.E. 2542 (1999), a sui generis law which came into force since 27 May 2000, aiming to protect, promote, conserve, and develop TTM knowledge for the benefit of the country and the health of the people.[3] The Act also wishes to enhance the awareness of the public, communities, and private organizations on the value of TTM knowledge, medicinal plants, and traditional medicines and to increase their participation in the protection, development, and sustainable use of TTM knowledge. The Act protects national and personal TTM formulas and TTM treatises and promotes their utilization for healthcare. In addition, the Act also protects some selected medicinal plants that are endangered, valuable for research study, or economically valuable as controlled medicinal plants, as well as protects their places of origin which are in natural ecological system or in biological diversity areas, or which may simply be affected by any act of human within the areas established as conservation areas. Under the Act, the “Thai Traditional Medicine Knowledge Fund” was established as a circulating fund to support R&D of TTM knowledge and other activities to promote and protect TTM wisdom. In February 2001, under the effort of the Institute of Thai Traditional Medicine, the Ministry of Public Health issued the Notification on “the Addition of Nuad Thai as a Branch of Thai Traditional Medicine”. This notification allowed a person to become a TTM practitioner who can provide treatment for patients using Nuad Thai therapy if he or she was registered, received training in professional level of Nuad Thai, passed a knowledge test, and obtained a license of a “TTM practitioner in the branch of Nuad Thai.”[21]

9.2.2.5  The amendment of the law on the practice of the art of healing Another law involving TTM profession, also enacted in 1999, was the Practice of the Art of Healing Act B.E. 2542 (1999) which made significant changes favorable to future development of TTM. The law used the term “Thai Traditional Medicine” and “applied Thai Traditional Medicine” instead of “general traditional medicine” and “applied traditional medicine” stated in the 1987 law. More importantly, the part of the definition that was the obstruction of further development of

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TTM in the previous law (i.e., the study that was not on a scientific basis) was removed. Moreover, the definitions of the branches of TTM practice, i.e., Thai Traditional Medicine (traditional medical practice), Thai traditional pharmacy, and Thai midwifery were also prescribed.[22]

9.2.2.6  Thai traditional medicine preparations and scientifically developed herbal medicines were selected in the national list of essential medicines In 1999, in an effort to include herbal medicines in the health service system, the List of Herbal Medicinal Products under the National List of Essential Medicines was first established and eight items of traditional and herbal medicines were selected. Of these, five were single herbal medicines scientifically developed, three were from the GTZ-supported project previously mentioned, namely turmeric for dyspepsia, andrographis for pharyngotonsillitis, and Senna alata for constipation and dermatophytosis. The other two items were topical herbal medicines, namely Clinacanthus nutans for herpes simplex and herpes zoster, itching, insect bites, rash, and urticaria and Zingiber montanum for muscle pain, bruises, and sprains, researched by the National Institute of Health, DMSc and developed by the Thailand Institute of Scientific and Technological Research. The List also included three other Thai traditional preparations with a long history of safe and effective use for fever, cough, and post-partum care to promote lochia discharge and uterine involution.[23] Also, in 1999, the FDA issued the ministerial notification on “Traditional Household Remedies,” naming 27 Thai Traditional Medicinal preparations as traditional household remedies (THR), with detailed formulas, method of preparation, indications, dosages and administration, and content per package. This notification was aimed at providing people with easier access to herbal medicines registered as traditional household remedies, because according to Drug Act B.E. 2510 (1967), traditional household remedies can be sold in any stores other than licensed drug stores, while registered traditional medicines must be sold in licensed drug stores only. Moreover, this notification also gave the list of herbal materials (crude drugs) that can be used as

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ingredients in 25 groups of traditional household remedies for the manufacturers to choose from when formulating their proprietary traditional household remedies.[24] As a result, more herbal medicinal recipes have later been registered and sold as traditional household remedies.

9.2.2.7  The establishment of the Department for the Development of Thai Traditional and Alternative Medicine (DTAM) and the coverage of Thai traditional medicine and alternative medicine service under the National Health Security Act B.E. 2545 In October 2002, as a result of the Bureaucratic Reform Act B.E. 2545, the “Department for the Development of Thai Traditional and Alternative Medicine” (DTAM) (currently Department of Thai Traditional and Alternative Medicine) was established as a new department under MoPH, comprising ITTM, the Division of Alternative Medicine and the Office of the Secretary.[25,26] About a month later in November 2002, the “National Health Security Act B.E. 2545” (2002) was promulgated to launch the Universal Health Coverage (UHC) policy in Thailand. Section 3 of the Act states that “health services” covered under this Act include Thai traditional and alternative medicine pursuant to the Practice of the Art of Healing Act.[27] The establishment of DTAM and the inclusion of TTM and alternative medicine under the UHC showed the commitment of the government to promote TTM as another means of health service for Thai people and significantly contributed to the full revival of TTM and laid the ground for the development of TTM service in the health care system. In the same year, the National Health Security Committee issued a notification on the types of TTM services covered by the Universal Coverage Programme which included treatment and diagnosis with TTM or applied TTM, treatment and rehabilitation with traditional herbal medicine, and traditional recipes comprising medicinal plant materials, therapeutic Thai massage, herbal steam bath, and hot herbal compression.[28]

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9.2.3  Milestone of major events, changes, and achievements in TTM after the establishment of DTAM 2004 — The First National Herbs Expo was initiated and held by the Ministry of Public Health. This annual five-day event has continuously been organized to disseminate traditional and alternative medicine knowledge for public healthcare until present. More importantly, the event has been the venue to launch and drive key strategic plans on TTM as well as to strengthen the collaboration and the potential of TTM networks. Since the 3rd National Herbs Expo, the venue has been at the IMPACT Exhibition and Convention Center to accommodate about 200,000 visitors and exhibitors every year. The yearly activities include short-course training, exhibitions of folk medicine, medicinal plant garden, a one-stop service for the consultation on the development of herbal products, business matching with foreign buyers, showcase of quality herbal products, exhibitions of traditional medicine from foreign countries, and the sale of herbal products. In addition, the Conference on Thai Traditional Medicine, Thai Indigenous Medicine, and Alternative Medicine has also concurrently been held along with the National Herbs Expo as a platform for the sharing and updating technical information on the latest development in TTM and alternative medicine. In 2020 and 2021, even though COVID19 pandemic was and has still been a major health problem in Thailand and the world, the 17th and the 18th National Herbs Expo could still be held under the “new normal” preventive measures. 2006 — Eleven more items of herbal medicines (eight traditional recipes and three single herbal medicines) were added into the List of Herbal Medicinal Products in the NLEM making a total of 19 items.[29] 2007 — The Thai Traditional Medicine Practice Guideline for Health Service Facilities was developed, covering: 1) the practice guideline in nine groups of the diseases based on the organ systems, i.e., musculoskeletal, skin, respiratory, digestive, cardiovascular, nervous, reproductive, urinary systems, and other systems, 2) the practice guidelines of TTM modalities, i.e., herbal medicines, Thai therapeutic massage, herbal compression, herbal steam bath, TTM for postpartum care, and 3) advices on health promotion/consultations.[30]

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Figure 9–6    On-top budget allocation from NHSO to support & improve TTM service.

2007 — The National Health Security Office (NHSO) began allocating “on-top” additional per capita budget for hospitals providing TT&CM services starting from 0.5 baht per capita in 2007 to promote and support the provision of TTM service in public health service facilities. This additional on-top budget gradually increased yearly to 14.80 baht per capita in 2020 for 48.2640 million beneficiaries for a total of 714.3072 million bah, and in 2021 it was increased to 17.90 baht per capita. The “on-top” budget allocated as regional global budget for the 12 health service regions in the country was based on the number of UC beneficiaries, the number of health service facilities providing TTM service, and TTM service performance (fee schedule basis). The additional on-top budget has therefore played a significant role in the continuous development of TT&CM services in the public health service facilities under MoPH (Figure 9–6). 2008 — Government official position of “Thai Traditional Medical doctor” was, for the first time, officially included in the civil service system of the Office of Civil Service Commission and MoPH. 2010 — WHO Benchmarks for Training in Nuad Thai was published as one of the book series entitled “Benchmarks for training in traditional/ complementary and alternative medicine.”[31] 2010 — The development of TTM hospital was initiated and Thai Traditional and Integrated Medicine Hospital (Yot Se) was formally established in 2015. 2011 — The number of traditional and herbal medicines in the NLEM increased from 19 items to 71 items, of which 50 were traditional medicine recipes and 21 were single herbal medicines.[32] Three more items of

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Figure 9–7    List of herbal medicinal products in the NLEHM 2022. Note: Some items are used for disorders of more than one systems.

single herbal medicines were added two years later in 2013.[33] The number of traditional and herbal medicines in NLEM has stayed at 74 items [50 traditional medicine recipes by names (56 items by formulas) and 24 single herbal medicines] since 2013.[7] In March and June 2021, 12 new items of traditional and herbal medicines were added into the new “National List of Essential Herbal Medicines” (NLEHM).[8] As of March 2022, there are 94 items of herbal medicinal products in the NLEHM, of which 62 items are TTM formulas and 32 items are scientifically-developed single herbal medicines[9] as shown in Figure 9–7. 2013 — The Thai Traditional Medical Professions Act B.E. 2556 (2013) was promulgated, as a result the practice of TTM was no longer under the Practice of the Art of Healing Act B.E. 2542. Under this Act, TTM professions are divided into two categories, namely the profession involving the practice of TTM and the profession involving the practice of ATTM. TTM practices are divided into five disciplines, i.e., Thai traditional medical practice, Thai traditional pharmacy, Thai traditional midwifery, Nuad Thai, and Thai indigenous medicine. The Thai Traditional Medical Council (TTMC), the professional council, was later established

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in 2015 to regulate the educational standards of TTM and ATTM schools, the registration and licensing, and the practice and ethical conduct of TTM and ATTM doctors and Thai folk healers.[4] 2014 — Based on DTAM policy, “Parallel TTM clinics” providing TTM services in parallel with modern medicine service in the outpatient department (OPD) began to operate in many public hospitals. 2015 — Thai traditional and alternative medicine was officially included as one of the health service plans of MoPH and TTM service plan for different levels of healthcare was drawn up. 2016 — Based on the policy of DTAM, four diseases, i.e., paralysis and paresis, knee osteoarthritis, migraine, and upper respiratory allergies (allergic rhinitis), that TTM, Traditional Chinese Medicine (TCM), and alternative medicine were shown to give good therapeutic results were selected and special traditional and alternative medicine (T&AM) clinics providing comprehensive T&AM therapies for such health problems began to provide services in many public hospitals in 2016. The “Practice Guideline for Comprehensive Provision of Thai Traditional & Alternative Medicine Services” was therefore developed for health professionals involved to support the integration of TTM, TCM, and AM services for the treatment of the four selected health problems.[34] 2016 — DTAM was tasked by the government to formulate The First Master Plan on the Development of Thai Herbal Products (2017–2021) by collaborating with nine Ministries and related public and private organizations to promote the production, domestic use, and export of innovative value-added Thai herbal products to generate income for the country. The First Master Plan aims at Thailand becoming the leader in exporting quality herbal raw materials and herbal products in ASEAN by the end of the year 2022, and the value of herbal materials and herbal products of the country will at least double, and DTAM would serve as the collaborating agency on the implementation of the master plan.[35] 2017–2018 — Various activities to implement the master plans were carried out. 2019 — Herbal Products Act B.E. 2562 (2019), the new law to regulate herbal products including herbal medicines (TTM, TCM products and future medicines from alternative medicine), herbal health supplements, and cosmeceuticals, was promulgated and was enforced since 29 June 2019.[36]

History, Present and Prospect of Thai Traditional Medicine  723

Thai FDA and DTAM were tasked to draft and issue many secondary laws thereafter, e.g., Ministerial Regulations or Notifications, within two years after the law became effective to fully enforce or implement the law. 2019 — According to the Narcotics Act B.E. 2522 (1979), cannabis (Cannabis sativa L.) and kratom (Mitragyna speciosa Korth.) were classified as schedule 5 narcotics. No person shall produce, sell, import, export, or possess schedule 5 narcotics unless the Minister of Public Health has issued the license, with the approval of the Narcotics Control Committee on a case-by-case basis. In addition, the law also prohibited the consumption of schedule 5 narcotics.[37] As currently, more and more medical evidences clearly show therapeutic benefits of medical cannabis and kratom for the treatment of various diseases, the government therefore issued the Narcotics Act (Number 7) B.E. 2562 (2019) in order to protect the rights of Thai people to have access to medical cannabis for their medical treatments.[38] This amended law gives exemptions for the production, import, or sale of schedule 5 narcotics in necessary circumstances, i.e., for government benefit, medical benefit, benefit of patient treatments, R&D studies, as well as for the agricultural, commercial, scientific, or industrial conducts for medical benefits. A patient is also allowed to have schedule 5 narcotics in possession at the amount that is not higher than that necessary for the treatment of his or her diseases. The law also allows the prescribing of approved medicines containing medical cannabis, based on Thai Traditional Medicine and Thai Indigenous Medicine, by TTM doctors and folk healers trained on the use of medical cannabis.[38] More details on the current situation of the implementation of the government policy on providing access to medical cannabis for Thai people as well as the new laws and ministerial regulations on cannabis and kratom later issued are described below. 2019 — With the collaborative attempts of the Ministry of Culture, DTAM, and Nuad Thai experts, Nuad Thai was inscribed in the UNESCO’s Representative List of the Intangible Cultural Heritage of Humanity in the annual meeting of the Intergovernmental Committee for the Safeguarding of the Intangible Cultural Heritage in Bogota, Colombia in December 2019.[39]

724  History, Present and Prospect of World Traditional Medicine

9.3 Current situations and status of Thai Traditional Medicine (2020–2021) The current situation of TTM in the healthcare system has been the cumulative results of the continuous development of TTM in all related aspects throughout the years, e.g., TTM practice and its role in the health service system, practitioners and the educational system, and TTM products and the regulatory system. In addition, since 2015, the government under the administration of General Prayuth Chan-ocha has given great attention to TTM and Thai herbal products as it is viewed that Thai herbal products, TTM service, and Nuad Thai should not only play a role in the healthcare of Thai people but also contribute to the country’s economy through global natural product market, health tourism, and wellness business market. Therefore, currently, there have been various projects going on based on such government policies and the 20-Year National Strategy (2017– 2036), and the Health Reform Plan. Moreover, another latest and significant change of the TTM service in public hospitals, as a result of the government policy, is the establishment of medical cannabis clinics in some public health service facilities where patients can be examined, diagnosed, and treated with suitable cannabiscontaining medicines, if appropriate, based on the principle of TTM. This policy and the change of the law regulating the use of cannabis is mainly in response to 1) the demand of the public to have legal access to medical cannabis, e.g., for the palliative care of themselves or their loved ones who are suffering from terminal-stage cancers or other diseases that cannabinoids are shown to provide clinical benefits, and 2) the government’s attempt to stop the illegal and unsafe use of the so-called “underground” cannabis products for medical purpose. The current situation of TTM will therefore be divided into two main parts, namely: – The current situations of the “4P of TTM,” that are the key components of TT&CM, as stated in the “WHO Traditional Medicine Strategy (2014–2023)”[40] and the “Core and Reference Indicators for Monitoring Traditional and Complementary Medicine in South-East Asia” of WHO Regional Office for South-East Asia (WHO SEARO),[41]

History, Present and Prospect of Thai Traditional Medicine  725

are namely: 1) Practice and TTM service, 2) Practitioners & Educational system, 3) Products regarding herbal medicines and their regulation, and 4) Protection of traditional medicine knowledge. – The current situation of ongoing agenda-driven projects based on government policies and the National Strategy, i.e., 1) the establishment of “Medical Cannabis Clinic in Thai Traditional Medicine” to provide people access to cannabis-containing medicines for their healthcare, as well as the current status of cannabis-related activities through the value chain of medical cannabis products, and 2) “Herbs for the Economy” project towards the implementation of the First Master Plan on the Development of Thai Herbal Products.

9.3.1  Current situation of the 4P of TTM 9.3.1.1  Current situation of TTM practice and service in the health service system According to the Thai Traditional Medical Professions Act B.E. 2556 (2013), Thai Traditional Medicine Profession is defined as the profession related to the practice of Thai Traditional Medicine and the practice of applied Thai Traditional Medicine. The practice of Thai Traditional Medicine is the practice of Thai traditional medical practice, Thai traditional pharmacy, Thai traditional midwifery, Nuad Thai, Thai indigenous medicine, or other TTM practice notified or prescribed by the Minister of Public Health under the advice of the Thai Traditional Medical Council Committee. While the practice of Applied Thai Traditional Medicine is defined as the practice of TTM based on the scientific and medical knowledge which is studied from educational institutes certified by the TTMC as well as the application of medical device or equipment in accordance with the rules and regulations of TTMC.[4] The types of TTM practice and services for treatment and rehabilitative purposes currently available in the healthcare system are covered by the Universal Coverage Scheme (UCS) and are as follows: – Nuad Thai – Hot herbal compression

726  History, Present and Prospect of World Traditional Medicine

– Nuad Thai and hot herbal compression – Herbal steam bath – Rehabilitative care of mother for postpartum recovery based on clinical practice guideline in TTM, including Nuad Thai, hot herbal compression, herbal steam bath, hot salt pot compression, and advice on self-care and baby care. – The use of traditional medicine preparations and herbal medicines in the National List of Essential Medicines.[42] In addition to the coverage by the UCS, TTM services are also covered by the other two health security schemes of the country, namely, Social Security Scheme (SSS) and Civil Servant Medical Benefit Scheme (CSMBS). However, the degree of coverage by each scheme may vary. In some hospitals, there may also be other treatment modalities provided which are not covered by the health security systems, e.g., herbal poultice mostly for knee osteoarthritis, certain types of folk medicine treatment, and other modalities provided under the discretion of TTM doctors, as well as recommendations on self-healthcare and health promotion for the patients. Moreover, since 2019, some hospitals have established “Medical Cannabis Clinic in Thai Traditional and Alternative Medicine” and started prescribing and dispensing approved traditional medicine preparations containing cannabis for their patients.[43,44] Details of such service will be described under 9.3.2.1. Number of Health Service Facilities Providing TTM Service The number of health service facilities under the Ministry of Public Health and private clinics providing TTM service are shown in Table 9–1. Monitoring System of TTM Service The provision of TTM service at all levels of health service facilities is continuously monitored and evaluated by the “Health Data Center of Thai Traditional Medical Service” or HDC TTM service (http://hs.dtam.moph.go.th/), the management information system of Thai Traditional & Complementary Medicine (TT&CM) service developed by DTAM in the form of Web Application. [45] The data of TT&CM service from all health service facilities in the summary tables from the Ministry of Public Health’s Health Data Center (HDC-MoPH) are processed to be consistent with the standard format of information and reports.[46]

History, Present and Prospect of Thai Traditional Medicine  727 Table 9–1    Numbers of public health facilities providing TTM service (as of June 2020). Type of Health Service Facilities

Number Provided TTM Services 1,2

Public health service facilities under MoPH

1)  Health service facilities under the Office of the Permanent Secretary – Tertiary level: regional and general hospitals – Secondary level: community hospitals – Primary level: tambon health promotion hospitals, health stations, TTM clinics in provincial health office 2)  Hospitals under DTAM

3)  Hospitals under Department of Mental Health3

121 (100%) 779 (100%) 9,750/ 9,764 (99.85%)

1 (With 3 branches in Bangkok and Nonthaburi and 3 branches in Health Service Regions) 10/18 (55.56%)

Private clinics4 1)  TTM clinics

967

2)  ATTM clinics

167

1

Note: Health service stations that have passed TIPhS assessment 2018–2019. 2 Number of health facilities under the Office of the Permanent Secretary via http://203.157.10.8/ hcode_2014/query_02.php?p=3. 3 Information from Department of Mental Health, MoPH. 4 Information from Department of Health Service Support, MoPH.

The data and the reports of HDC TTM Service can be divided into five categories as follows: 1) Diagnosis data with TTM & TCM diagnosis ranking, 2) Prescription data, which shows the top 20 herbal medicines prescribed, value of herbal medicines, usage of herbal medicines by age and gender, and usage of herbal medicines in NLEM, 3) Medical treatments given classified by TTM treatment modalities, 4) Health promotion by TT&CM service, and 5) Provided for OPD patients shown as percentage of OPD visits receiving TTM & TCM service as compared to total OPD visits and proportion of only UC beneficiaries.[45] The reports can be shown in different ways, e.g., classified by fiscal year and quarterly, by the level of health service facilities, OPD or IPD

728  History, Present and Prospect of World Traditional Medicine

visits, and by patient’s health security systems. Hence, the executives and administers at all levels can conveniently search for real-time comparative reports on TTM & TCM services between health service regions or within each region, province, district, and tambon (sub-district) to help make future service plans to improve their TT&CM service performance. The “percentage of OPD visits receiving TT&CM services” from public hospitals under the Office of the Permanent Secretary of MoPH (item #5 above) has been the selected indicator for the improvement of TT&CM service system and the Key Performance Index (KPI) of DTAM for many fiscal years, even before TT&CM service became a part of MoPH service plan in September 2015. This KPI figure has continuously been monitored by HDC TTM service web application. Figure 9–8 shows the “percentage of OPD visits receiving TT&CM services” from fiscal years 2014–2020. It is noticeable that before the year 2017, the figures had always been lower than KPI targets. However, after the official integration of TT&CM services in the MoPH service plan, there has been a significant increase of “%OPD visits receiving TT&CM service” in the following years and exceeding KPI since 2017. Moreover, since the fiscal year 2019, the KPI target had covered the services for the treatment and rehabilitative purposes only, not including service for health promotion as in the previous years (Figure 9–8). The Standards of TTM Service The standards of TTM service in the regional hospitals, general hospitals, community hospitals, and tambon

Figure 9–8    %OPD visits receiving T&CM services (fiscal years 2014–2020).

History, Present and Prospect of Thai Traditional Medicine  729

(sub-district) health promotion hospitals are based on “Thai Traditional Medicine & Integrative Medicine Promotion Hospital Standard” (TIPhS). TIPhS consists of five standards, namely the standards of 1) premises, equipment, environment, 2) quality assurance, 3) personnel, 4) operations, and 5) service provision.[47] In 2017, the “Thai Traditional Medicine Hospital Accreditation Guidelines” (TTM HA Guidelines) was developed under the cooperation between DTAM by the Institute of Thai Traditional Medicine and the Healthcare Accreditation Institute (Public Organization). This guideline is composed of four parts, namely the overview of TTM service administration, key operational systems of TTM service, procedures for patient care, and TTM service performance.[48] In fiscal year 2020, the guideline was implemented in regional hospitals, general hospitals, and community hospitals nationwide. In addition, with the global COVID-19 pandemic which started in the early 2020, the standard of TTM service in public hospitals was revised and updated and the guidelines for TTM clinics to prevent COVID-19 infection was therefore developed for the hospitals and TTM clinics to follow.[49]

9.3.1.2  Current situation of TTM practitioners and the educational system of TTM As previously mentioned, the practice of TTM profession and the educational system of TTM are regulated by TTMC under the Thai Traditional Medical Professions Act B.E. 2556 (2013). The TTMC is responsible for certifying TTM and ATTM curricula and schools, setting up and regulating the standard of TTM practices, the registration and the issuance of license of TTM and ATTM practitioners, and regulating the conduct of TTM and ATTM practitioners to be in accordance with the professional ethics.[4] TTM Educational System There are two educational systems for the production of TTM workforce, namely: – Study from licensed TTM instructors at TTMC-certified institutes and health facilities. This educational system is one of the two systems for the training of future TTM practitioners (not ATTM practitioners). TTM trainees would receive training from TTM institutes

730  History, Present and Prospect of World Traditional Medicine Table 9–2    Curricular structure for the training of TTM by TTMC-certified institutes and health facilities.[51] Minimum Training Hours Branch of TTM

Fundamental Professional Subjects

Professional Professional Subjects Training

Total Hours

Minimum Duration of Study (Years)

Thai medicine

171

529

500

1,200

3

Thai pharmacy

141

259

400

800

2

Thai massage (Nuad Thai)

195 + 25 hours of professional elective subjects

280

300

800

2

75

125

200

400

1

Thai midwifery

or TTM health facilities certified by the TTMC. Any trainer or instructor in such institutes and health facilities also has to be a qualified TTM practitioner licensed by TTMC as a TTM instructor. Certified teaching institutes and health facilities are required to educate TTM students in different branches of TTM in accordance with the standard curricula established by TTMC for not less than specified periods of time, shown in Table 9–2, in order for the students to be qualified to take the knowledge test (commonly called licensing examination). A trainee under this system of education needs to take separate knowledge tests to become a registered and licensed practitioner in each particular branch of TTM. As of 5 November 2019, there are a total of 89 TTMC-certified TTM institutes and licensed TTM health facilities that can teach at least one branch of TTM based on this system of education.[50] – University System. Under this system of education, there are two types of universities, i.e., those offering 4-year Bachelor’s degree program in Thai Traditional Medicine (Bachelor of Thai Traditional Medicine, B.TM.) and those offering 4-year Bachelor’s degree

History, Present and Prospect of Thai Traditional Medicine  731 Table 9–3    Curricular structure of B.TM. and B.ATM. (Minimum credits).[52–53] Course Categories

B.TM.

B.ATM.

1. General education course

30

30

2. Specific requirement/professional course

91

86

40 51# 16 13 7 12 — 3

40 46* 14 14 6 — 14 —

6

6

2.1 Fundamental professional course 2.2 Professional course – Thai medicine – Thai pharmacy – Thai midwifery – Thai massage (Nuad Thai) – Thai manual therapies – Integrative professional experience training 3. Free elective course

*Not less than 15 credits must be for professional experience training in hospital settings #  Not less than 15 credits must be for professional experience training, of which not less than 4, 3, 2, 3, and 3 credits will be for the professional experience training in Thai medicine, Thai pharmacy, Thai midwifery, Nuad Thai, and integrative professional training, respectively.

program in Applied Thai Traditional Medicine (Bachelor of Applied Thai Traditional Medicine, B.ATM.). As of December 2021, the numbers of TTMC-accredited educational institutions offering B.TM. degree and B.ATM. degree are 23 and 13, respectively.[52,53] Table 9–3 shows curricular structures of B.TM. and B.ATM. as stated in the Notification of the Ministry of Education on the Qualifications Framework for Higher Education in Thai Traditional Medicine and Applied Thai Traditional Medicine, respectively.[54,55] A B.TM. graduate needs to pass separate knowledge tests on each branch of TTM to get licenses for the practice of each branch of TTM disciplines, while only one license for the practice of applied Thai Traditional Medicine will be issued to a B.ATM. graduate who has passed the knowledge test organized by the TTMC. In addition to TTM and ATTM practitioners, TTM assistants are another group of TTM personnel in public health service facilities assisting practitioners of TTM to provide Nuad Thai therapy for the treatment of common and minor musculoskeletal problems under the supervision of

732  History, Present and Prospect of World Traditional Medicine

licensed TTM or ATTM practitioners. The Profession Commission in the Branch of Thai Traditional Medicine first developed the curriculum for the training of TTM assistants in 2002, and revised and issued the 330hour curriculum of TTM assistant (First Revision) in 2007.[56] The institutes and health facilities providing training of this curriculum have to be certified by TTMC. As of November 2021, 109 institutes and health facilities have been certified by the TTMC to provide 330-hour training of TTM assistants.[57] In addition, TTMC has recently approved 372-hour curricula for TTM assistants, developed by Institute of Thai Traditional Medicine, DTAM.[58] However, these TTM assistant curricula in Nuad Thai is not yet considered as a professional level of Nuad Thai therapy. Hence, professional license is not issued to TTM assistants. The Issuance of License to Practice TTM in Thai Indigenous Medicine to Certified Folk Healers. In contrast to TTM and ATTM practitioners to whom licenses to practice are issued after passing knowledge tests organized by TTMC, the issuance of license to practice TTM in Thai indigenous medicine to a folk healer is not via taking written examination process but via the nomination by village committee or local administrative organization to a MoPH-designated government office (i.e., DTAM and Provincial Health Office). A folk healer certified by a designated government office will then undergo the assessment or appropriate knowledge test prescribed under the TTMC Regulation before the license can be issued.[4, 59,60] Basic qualifications of a folk healer for certification are 1) is at least 35 years old, 2) resides in the area nominated for no less than 10 years, 3) has knowledge and ability to promote and care for the health of the community people using TTM knowledge and based on the culture of the community for no less than 10 years, and 4) is well-respected by the community. In addition, he or she must not ask for money or other benefits in return for his or her practice that is not in congruent with the community culture.[59] The Number of Licenses to Practice TTM and ATTM Issued and the Number of TTM Personnel in Public Health Service Facilities under MoPH. The cumulative number of the licenses to practice TTM in the different types of TTM disciplines and in Thai

History, Present and Prospect of Thai Traditional Medicine  733 Table 9–4    Cumulative number of licenses to practice TTM and ATTM issued.

Types of Licenses

Cumulative Number of Licenses Issued

Thai Traditional Medicine (TTM) Note: one practitioner may hold more than one license – Thai medicine

26,771

– Thai pharmacy

34,102

– Thai midwifery

14,289

– Thai massage (Nuad Thai)

8,862

– Thai Indigenous Medicine (IM) Applied TTM

165 4,314

Source: Working Group on Manpower Development, Technical and Planning Division, DTAM (Data from Thai Traditional Medicine Council, 24 November 2021).

indigenous medicine and the licenses to practice ATTM previously issued as of 24 November 2021 are shown in Table 9–4. It should be noted that some TTM practitioners hold more than one license and the numbers shown cannot indicate the number of practitioners who still actively practice or how many have passed away. According to the Information Systems on Human Resource of the Office of the Permanent Secretary (HROPS) and of DTAM, as of November 2021, there are a total of 3,598 TTM and ATTM practitioners working in the health service facilities and different departments and offices under MoPH and they are practitioners who graduated from the university system only. Due to the limited number of government official positions for practitioners of TTM in the MoPH, of these number, only 2,061 are government officers, 100 are government employees, 1,021 are MoPH employees, and 416 are temporary employees. Most of TTM & ATTM practitioners work in the health service facilities and offices under the Office of the Permanent Secretary (3,440), the rest work in DTAM (76), Praboromarajchanok Institute (59), Department of Mental Health (16), Department of Health (6), and Department of Medical Services (1).

734  History, Present and Prospect of World Traditional Medicine

9.3.1.3  Current situation of traditional and herbal medicines and other herbal products Before the promulgation of Herbal Products Act B.E. 2562 (2019) which has been effective since 29 June 2019, TTM and herbal medicine products locally produced or imported for commercial purpose had to be registered and the manufacturers, importers, and sellers had to obtain licenses from FDA under the Drugs Act B.E. 2510 (1967) and its amendments.[61,62] Meanwhile, herbal dietary supplements were regulated as food products under the Food Act B.E. 2522 (1979) and related ministerial regulations.[63] Therefore, health claims of dietary supplement products cannot be made or are impossible to be made by local manufacturers as clinical evidence from costly clinical trials in a large number of healthy populations is required to substantiate a product’s health claim. Therefore, both Drugs Act B.E. 2510 and Food Act B.E. 2522 are considered by the industry sector to be no longer suitable for the regulation of such herbal products as the laws do not support the competitiveness of Thailand’s herbal product industry in local and international markets. Therefore, Thai FDA, DTAM, and the Office of the Permanent Secretary collaborated on drafting the Herbal Products Act to specifically regulate herbal products, i.e., herbal medicines, herbal health supplements including natural cosmeceuticals, and FDA and DTAM are responsible for passing many secondary laws to fully enforce the new Act. Under the Herbal Products Act B.E. 2562, herbal products and product registration can be categorized based on the following criteria: – Risk assessment, i.e., high-risk products (for the treatment of serious diseases, categorized as scheduled medicines, or in injection dosage form, or the dosage and administration is not simple, or has the potential to cause serious side effects) and non-high-risk products (basically, self-selected products by consumers for self-treatment of non-serious symptoms, or diseases or for health maintenance, or lower health risk). – Purposes of use, i.e., 1) for the cure, treatment, and relief of human illnesses or for disease prevention and 2) for health maintenance and enhancement, for the support of the structure and the functions of the body, or for the reduction of disease risk factors.

History, Present and Prospect of Thai Traditional Medicine  735

– Types of products, i.e., traditional medicines, developed herbal medicines, herbal health supplements which include natural cosmeceuticals as shown in Figure 9–9. – Origin of product formula, i.e., whether the formula or the formulation of an herbal product is based on 1) TTM or TCM knowledge, or 2) scientific basis. – Indications, therapeutic benefits, health claims, i.e., traditional health use, traditional treatment, scientifically established treatment, general or nutrition claim, functional claim, disease risk reduction claim, or cosmeceutical claim. Product indications, therapeutic benefits, or health claims can be either 1) non-specific or general, e.g., for health maintenance, relief of symptoms not related to particular diseases, or as a source of vitamins or antioxidants or 2) specific if the indication or claim is related to a named condition or disease.

Figure 9–9    Types of products under Herbal Products Act B.E. 2562.

736  History, Present and Prospect of World Traditional Medicine

In contrast to the old laws, the Herbal Products Act has developed three different methods to grant permission for the production or import of herbal products based on product’s risk and risk management, namely listing, notification, and registration (the time it takes for product review, after the documents submitted by the manufacturer or importer are complete and correct, until the permission is granted, is in ascending order) as shown in Table 9–5. Currently, Herbal Products Division, FDA has developed the draft guideline for the manufacturers and importers, for the preparation of documents, and for licensing application to manufacture and import of non-high-risk herbal products. The document has been opened for public hearing for its revision before being enforced. Basically, the level of scientific (non-clinical and clinical) evidence to substantiate the safety, efficacy, health claim or indication of an herbal product has to be stronger for a high-risk product than a non-high-risk product or when making a specific claim than a non-specific claim. Table 9–5    Types of herbal products based on product’s risk and permission system.

Product’s Risk

Herbal Products

Health Claim/ Indication Statement

Low

Product items as stated in FDA Notifications (positive list)

As specified by FDA in the monograph of each listed product

Medium

Products from the modification of original/ traditional formulas or of listed products

For health promotion and lower health risk

High

Herbal medicines developed through R&D

Treatment of diseases/ symptoms

Permission Systems for the Production and Import of Herbal Products Listing

Notification (of the modifications made)

Registration (Review of product’s quality, safety, and efficacy based on the criteria of FDA)

History, Present and Prospect of Thai Traditional Medicine  737

To implement the Act regarding the permission via listing method, DTAM, FDA and DMSc, expert TTM practitioners and academics have collaborated on developing the monographs of listed TTM and listed herbal health supplements. Each monograph contains detailed information of each particular TTM formula or herbal health supplement. The monographs are meant for the industry to be used as reference when filing for the license to manufacture or import listed herbal products and to follow when they manufacture the products to ensure the quality, safety, and efficacy of the products for the consumers. The updates on draft secondary laws, public hearing announcement on drafted secondary laws, newlyissued secondary laws, monographs of new herbal medicines or herbal health supplements in the positive list, information for manufacturers, importers, or sellers of herbal products, are available on the website of the Herbal Products Division, FDA (https://www.fda.moph.go.th/Herbal/ SitePages/index.html). Committees under the Herbal Products Act B.E. 2562 (2019). There are two Committees under the Herbal Products Act B.E. 2563 (2019),[36] namely: – National Herbal Policy Committee chaired by the Prime Minister or designated Deputy Prime Minister, Minister of Public Health and Minister of Agriculture, Cooperatives as the Vice Chairs, and the Director-General of DTAM serves as the secretary. The ex officio committee members are the Permanent Secretaries and top administrators of government offices and professional councils involved in the value chain of herbal products, Chairpersons of the Federation of Thai Industries and Thai Chamber of Commerce. The experts committee members designated by the Minister of Public Health are academics and experts involved in various fields. The duties and responsibilities of the Committee are to formulate policies and strategies on herbal products every five years, monitor and evaluate the implementation of the policies and strategies, and prescribe comprehensive herbal product research and development plans and measures to promote herbal product operators, as well as public and private sector cooperation in herbal product development.

738  History, Present and Prospect of World Traditional Medicine

– Herbal Products Committee chaired by the Permanent Secretary of the Ministry of Public Health and designated Deputy SecretaryGeneral of FDA serves as the secretary. The duties and responsibilities of the Committee are to give recommendations to the Minister regarding the issuance of various notifications involved and to the National Herbal Policy Committee, to give recommendations, opinions, or approvals to the licensing authority regarding the permission to produce, import, or sell herbal products, and regarding the suspension or revocation of a license as well as to prescribe and notify the criteria, procedures, and conditions on various subjects involving the manufacturing, import, and sale of herbal products, and the monitoring, vigilance, evaluation, and reporting of adverse events resulting from the use of herbal products. National Standards of Herbal Materials and Thai Traditional Medicine Preparations are available in the two pharmacopoeias, namely: – Thai Herbal Pharmacopoeia (THP): The Bureau of Drugs and Narcotics, DMSc is the government office responsible for the development of Thai Pharmacopoeia and Thai Herbal Pharmacopoeia. The Subcommittee on the Establishment of Thai Herbal Pharmacopoeia under the Thai Pharmacopoeia Committee was appointed in 1989. As of 2021, there are six subcommittees responsible for developing different parts of THP and the monographs of herbal materials (used for the production of traditional and herbal medicines), herbal drug preparations, and herbal extracts. THP 2021 is the latest edition of THP containing 99 monographs of the 2020 edition and eight new monographs of herbal materials and herbal drug preparations.[64] The monograph of Cannabis (Cannabis Sativae Inflorescentia Femina) is one of those new monographs. Moreover, there are also monographs of Cannabis Extract and Cannabis Sublingual Drops reproduced from the Thai Pharmacopoeia II Volume 1 Part 1 Supplement 2020 for users’ convenience. – Thai Herbal Preparation Pharmacopoeia (THPP): In an attempt to improve the quality of Thai herbal medicine products commonly used in the health service system, DTAM has therefore developed Thai Herbal Preparation Pharmacopoeia with the aim to establish the

History, Present and Prospect of Thai Traditional Medicine  739

standard specifications of TTM preparations in the National List of Essential Medicines (50 TTM preparations in NLEM, as of October 2020). The second edition of THPP (2020) contains 10 monographs of 8 TTM preparations.[65]

9.3.1.4  Protection and promotion of Thai traditional medicine knowledge As previously mentioned, national TTM formulas or national TTM textbooks (treatises) are protected under Article 19 of The Protection and Promotion of Thai Traditional Medicine Knowledge Act B.E. 2542 (1999). [3] An individual or legal person who wishes to register and produce a national TTM formula, conduct research to develop such formula into a new TM preparation for commercial purpose, or conduct research on a national TTM treatise to develop new TTM knowledge for commercial purposes, is required by law to first request for permission to use such national formula or treatise, pay the permission fee, and settle a compensation for its use.[66] According to the information from the Protection and Promotion of Thai Traditional Medicine Knowledge and Thai Indigenous Medicine Division, DTAM, at the end of the year 2021, a total of 574 items of national traditional treatises, 503 items of stone inscriptions, and 33 palm-leaf inscriptions covering 45,134 national traditional formulas, have so far been notified in the Ministerial Notifications published in the Royal Gazette. In order to promote the utilization of TTM formulas from the national TTM textbooks, DTAM has worked with expert TTM practitioners and other health professionals to select the formulas with known experience of clinical efficacy and safety from the national TTM textbooks as well as from the National List of Essential Medicines and the Ministerial Notifications on Traditional Household Remedies into the “National Thai Traditional Medicine Formulary”. So far, 324 TTM formulas have been selected into the national formulary for 15 disease/symptom categories of TTM and published in the latest edition of the National Thai Traditional Medicine Formulary 2021 Edition.[67] In addition, DTAM has also been in the process of developing Thai Traditional Digital Knowledge Library (TTDKL) as the national level TTM and Thai indigenous medicine (TIM) knowledge bank in the form

740  History, Present and Prospect of World Traditional Medicine

of digital library, with the aim to provide efficient and rapid access to TTM & TIM information. Under the collaboration with the Department of Intellectual Property, it is expected that TTDKL will eventually be linked to international agencies on intellectual property and serve as a reference to protect TTM & TIM knowledge, via the principle of knowledge classification and assignment of TTDK classification numbers that are in line with WIPO’s International Patent Classification (IPC).[68]

9.3.2  The current situation of ongoing agenda-driven projects on TTM based on the government policies and the national strategy (2020–2021) 9.3.2.1  The situation of “cannabis in thai traditional medicine” project and the role of DTAM on the provision of medical cannabis access and service for patients in the health service system As previously mentioned, the issuance of the Narcotics Act (Number 7) B.E. 2562 (2019), that has been effective since 19 February 2019, makes it possible for patients with certain diseases or symptoms that can be relieved by cannabinoid compounds [mainly, delta-9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD)] to have access to medical cannabis, as the new law allows the consumption of medical cannabis, even though it is still a schedule 5 narcotic, as long as it is prescribed by trained healthcare professionals or under an approved research project.[38] According to the Ministerial Notifications issued in 2019, 16 TTM formulas were initially selected from classical TTM textbooks under the suggestion of DTAM and the Thai Traditional Medical Council[43] and two formulas of folk healers compounding for individual patients have been allowed to consume for the treatment of diseases and for research.[44] Of the 16 TTM formulas selected, 11 contain cannabis inflorescence as an ingredient in the formulas, while five formulas use cannabis leaf or petiole. Later on, new Ministerial Notification on Specifying Schedule 5 Narcotics B.E. 2563 was issued in December 2020.[69] Under this new law, parts of cannabis other than the inflorescence and the seed, extract of CBD, or residue from cannabis extraction that contain no more than 0.2% THC by weight,

History, Present and Prospect of Thai Traditional Medicine  741

are exempt from being schedule 5 narcotics. As a result, any TTM formula that does not contain cannabis inflorescence or extract of inflorescence are no longer schedule 5 narcotics.[69] According to the Ministerial Notifications issued in 2019[43–44] (which were later repealed in 2021) and the Ministerial Notifications issued in 2021,[70] schedule 5 narcotic medicinal preparations or formulas having cannabis as an ingredient that are allowed to be consumed for the treatment of diseases or for research, prior to 9 June 2022, can be classified as follows: – Both modern medicine and TTM formulas approved by the FDA for such purposes, – TTM formulas with cannabis as an ingredient from classical TTM treatises under the suggestion of DTAM and the Thai Traditional Medical Council (List 1), – Cannabis-containing medicinal formulas allowed to be produced in the country under Special Access Scheme (SAS) (List 2), – Cannabis-containing medicinal formulas allowed to be used under research projects approved by FDA, and – Traditional medicine formulas compounded by the practitioners of TTM or folk healers based on TTM knowledge and certified by DTAM (List 3).[70] As of December 2021, according to the four Ministerial Regulations issued in the year 2021, there are 19 traditional medicine formulas from TTM treatises classified as schedule 5 narcotics in List 1. List 2 comprises 24 items of both modern medicine formulas standardized the contents of CBD and/or THC (for trained medical doctors to prescribe) as well as traditional medicines formulas (from trained TTM & ATTM practitioners to prescribe) made from different authorized manufacturers. List 3 is composed of 20 DTAM-certified formulas of traditional medicines that are prepared by licensed TTM or ATTM practitioners or folk healers.[71–73] DTAM has been the key government agency to implement the government policy to help establish “Medical Cannabis Clinics in Thai Traditional and Integrative Medicine” at different levels of participating public hospitals nationwide. In doing so, DTAM has collaborated with

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FDA, Narcotics Control Committee and other committees involved, Department of Medical Services, hospitals under MoPH, researchers, universities, community enterprises, etc. The collaborative activities to put the policy into action are as follows: – Facilitate the cultivation of cannabis and the production and distribution of FDA-approved traditional medicine formulas to make cannabis-containing TTM preparations available in the health service system, – Consider and assess the request of TTM or ATTM practitioners, or folk healers for DTAM to certify their cannabis-containing traditional medicine formulas for the treatment of their patients (to be added into List 3 above), – Set up the system to enable TTM & ATTM practitioners and folk healers to prepare FDA- or DTAM-approved cannabis-containing traditional medicine formulas for each individual patient, – Conduct pre-clinical and clinical research projects on traditional medicine formulas, – Collect data from collaborating hospitals on the safety and efficacy of selected traditional medicine formulas for the review by Subcommittee on the Development of National List of Essential Herbal Medicines, formulate and distribute guideline on the use of medical cannabis for palliative care, and set up training system for health professionals on the use of cannabis and the service standards of medical cannabis clinics of TTM in health service facilities, etc. At the end of the year 2021, the situation of the “Cannabis in Thai Traditional Medicine” project, the establishment of “Medical Cannabis Clinic in Thai Traditional and Alternative Medicine,” and some of the above-mentioned activities, are summarized as follows: – The cultivation of cannabis plants. DTAM has developed the model of collaboration between community people in the form of community enterprise and Tambon health promotion hospital (THPH) in the community, in order to promote community involvement in the cultivation of cannabis for medicinal use in TTM. The Provincial Health

History, Present and Prospect of Thai Traditional Medicine  743

Officers or the authorized directors of THPHs will be the applicants for the license from FDA to cultivate cannabis and the THPH will be the controller to oversee the cultivation by collaborating community enterprises. The exact amount of cannabis seeds for cultivation will be provided by DTAM for the growing of 50 cannabis plants. THPH is required to send specified amount of dried cannabis inflorescence back to the FDA-approved receiver units which are authorized manufacturers of cannabis-containing traditional medicines, e.g., Herb and Thai Traditional Medicine Development Division of DTAM, hospitals with WHO GMP production facilities, hospitals and THPH for compounding cannabis traditional medicine preparations for individual patients, or local licensed manufacturers. As of December 2021, there have been 992 applicants from 75 provinces, and licenses to grow cannabis plants have been issued to 214 THPH and their collaborated community enterprises. For the larger scale cannabis growers, as of December 2021, DTAM has collaborated with 23 plantation sites operated by community enterprises, Tambon health promotion hospitals, and universities, and it is expected that they will be able to produce about 4.5 tons of dried cannabis inflorescence for DTAM in the year 2022 for the production of cannabiscontaining traditional medicine preparations. – The production of traditional medicine formulas containing cannabis. As of December 2021, there are five FDA-certified GMP production sites (of DTAM and four hospitals) currently producing some cannabis-containing traditional medicine formulas in List 1 and different formulas of cannabis extract in coconut oil in List 2. Three more hospitals are preparing their production sites and expected to start their production line in 2022. – The development of handbooks and guidelines to improve the provision of TTM services in medical cannabis clinics. In 2020, the “Handbook for the Establishment of a Medical Cannabis Clinic of Thai Traditional Medicine in a Health Service Facility,” which includes the practice guideline on the use of 16 cannabis-containing traditional medicine preparations in health service facilities, was

744  History, Present and Prospect of World Traditional Medicine

published.[74] In 2021, several meetings were organized as a platform for extensive discussion to receive inputs and suggestions from stakeholders for the preparation of the following guidelines and handbook: Guideline on the Provision of Integrative Medical Cannabis Clinic developed by DTAM in cooperation with the Department of Medical Services and the Department of Mental Health,[75] Handbook on Extemporaneous Compounding of Traditional Medicine Preparations Containing Non-Narcotic Parts of Cannabis for Health Service Facilities,[76] and Guideline on the Use of Cannabis-containing Thai Traditional Medicine Preparations for Patients in Need of Palliative Care (in preparation). – The provision of service in the Medical Cannabis Clinics in Thai Traditional Medicine. According to the information from the Office for the Management of Cannabis and Kratom in Thai Traditional Medicine, DTAM, at the end of fiscal year 2021, there are 928 health service facilities throughout the country (923 under MoPH and 5 under universities) that prescribe and dispense cannabis-containing traditional medicines for patients. Currently, there are five TTM formulas and three items of oils of cannabis extract in the National List of Essential Herbal Medicines (NLEHM).[8,9] Of those items in the NLEHM, Ganja Oil (Deja Formula) is the most frequently used traditional formula, being prescribed under research project in 30 hospitals and under SAS in 378 health service facilities. Other top three commonly used TTM formulas containing cannabis in NLEHM are Ya Tamlai Prasumain, Ya Suk Saiyat, and Ya Kae Lom Kae Sen. – The training of the practitioners of Thai Traditional Medicine and folk healers on the use of cannabis-containing TTM formulas. As the use of cannabis as medicine was prohibited by law for a long period of time, before the use of cannabis for medical purposes resumed in 2019, the practitioners of TTM and folk healers who will be the prescribers and dispensers of cannabis-containing medications must be trained on the proper use of such medications for the safety and clinical benefits for the patients. They also need to clearly understand and abide by the related laws and regulations. DTAM has therefore developed and updated the training curriculum. At the end of fiscal year 2021, the cumulative number of TTM practitioners and folk healers

History, Present and Prospect of Thai Traditional Medicine  745

who passed the training on the use of cannabis in TTM are 7,320, while 1,022 passed the training on the use of oils of cannabis extract under SAS, and 4,406 passed the training for the extension of the validity of their licenses to prescribe cannabis-containing traditional medicine preparations. – Pre-clinical and clinical research on cannabis. Various research projects have been conducted by DTAM and other department and hospitals on cannabis-containing traditional medicine formulas to determine their efficacy and safety, e.g., clinical trials and safety monitoring of some selected formulas, acute toxicity testing, and aflatoxin contamination, etc. Regarding the clinical trial on DTAM Ganja Oil (Deja Formula) entitled “Thai Cannabis Practice Pattern and Quality of Life Study (Thai Cannabis PQ Study),” which is the collaborative project between DTAM and the Faculty of Medicine, Chulalongkorn University, it was found that regarding practice pattern of TTM practitioners, the diseases and symptoms that the medication was prescribed for (in a descending order) were insomnia, pain, cancers, migraine, anorexia, allergy, Parkinson, and epilepsy, and 87.8% were prescribed to be used once daily at bedtime. During the threemonth period of the treatment, the medication gradually increased the quality of life of both cancer and non-cancer patients (more than 18,000 cases), as determined by both Edmonton Symptom Assessment System (ESAS) and EQ-5D-5L. The results of this research led to the proposal to FDA for permission to prescribe this medication under SAS for insomnia, anorexia, migraine, chronic pain, and Parkinson. It should be noted that, before 9 June 2022, as cannabis inflorescence and medicines containing cannabis inflorescence were schedule 5 narcotics, any activities related to cannabis and medicines classified as schedule 5 narcotics, i.e., cultivation, production (extraction, processing, manufacturing of cannabinoid-containing products, and quality control), preclinical and clinical research, prescribing cannabis medicines, or export were therefore tightly regulated. This means that cannabis growers, manufacturers of cannabis extracts or medicinal products, cannabis clinics, quality control, or research laboratories had to obtain related licenses from FDA prior to starting any activities involving cannabis. Moreover, every

746  History, Present and Prospect of World Traditional Medicine

measure notified and prescribed by laws for the licenses to conduct, document, and report to FDA had to be followed.[38] In addition, Narcotic Act (No. 7)[38] stated that during the first five years of enforcement, the license to produce, import, or export cannabis for medical benefits or for the treatment of patients will be issued only to government offices responsible for R&D, teaching, or providing services in medicine, pharmacy, science, or agriculture, or government agencies responsible for the regulation and control of narcotics or The Thai Red Cross Society. For health professionals (trained medical doctors, pharmacists, dentists, veterinarians, practitioners of Thai Traditional Medicine, or folk healers under the laws on Thai Traditional Medicine profession) and private sector, e.g., private universities teaching medicine or pharmacy, community enterprises of agriculturists, social enterprises, and agricultural cooperatives, they need to collaborate with and be under the supervision of aforementioned government offices in order to obtain the licenses to produce, import or export of cannabis.[38]

9.3.2.2  Pushing the “herbs for the economy” policy forward through the implementation of the first master plan on the development of Thai herbal products. As previously mentioned, the government, under the administration of General Prayuth Chan-ocha, has stated in the National Strategy to increase the country’s competitiveness on the production of innovative Thai herbal products from our traditional knowledge through R&D for domestic and international markets to generate income for the country. In addition, local traditional knowledge of healthcare, e.g., folk medicine, folk massage, and local indigenous herbs, as well as TTM service, and Nuad Thai should also contribute to the country’s economy through health tourism and wellness service. DTAM was therefore tasked by the government to serve as the secretariat office of the National Herbal Policy Committee, under the Herbal Products Act B.E. 2562,[36] to collaborate with other government agencies, herbal products industry, and private sector involved in the value chain of herbal products and health tourism to implement the policy and the First Master Plan on the Development of Thai Herbal Products (2017–2021)[35]

History, Present and Prospect of Thai Traditional Medicine  747

and the First National Work Plan on Medicinal Plants (2019–2022). Five subcommittees were appointed under the National Herbal Policy Committee to make an integrative effort to drive the herbal product development policies, i.e., Subcommittees on 1) National Herbal Strategy, 2) Herbal Research and Innovation, 3) Herbal Raw Materials, 4) Promotion of Herbal Products Industry and Entrepreneurs, and 5) Image Promotion and Herbal Market. In addition, the Division of Herbs for Economy was therefore established in DTAM to collaborate with and serve as the secretariat office of the Committee and the Subcommittees as well as cooperate with the herbal products industry and all stakeholders to carry out, monitor, and evaluate the implementation of key activities under the National Work Plan. Some of the activities that DTAM and collaborating government agencies have carried out to support and promote herbal product manufacturers and business operators are as follows: – Provide technical consultation for manufacturers on herbal product development, and on R&D of innovative products, – Provide training to enhance the potential of herbal product manufacturers and business operators, – Organize annual competition of different categories of commercial herbal products for “Prime Minister Herbal Awards (PMHA)” to be further promoted for export, – Certify and award quality herbal products as “Premium Herbal Products” or “Quality Thai Herbal Products (QTHP),” – Collaborate with public and private network partners to organize proactive marketing and establish “online” and “offline” domestic and international markets for Thai herbal products, – Establish new channel of distribution of awarded Thai herbal products under the brand “Karaboon,” – Organize events to showcase awarded Thai herbal products to the consumers in appropriate markets, e.g., famous shopping complex, King Power Duty Free. In addition, to implement the First Master plan on the Development of Thai Herbal Products at the provincial level, certain provinces in

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different regions of the country have been selected as “Herbal Cities” for further comprehensive systematic development of herbal products industry from the upstream to the downstream. The development of each herbal city relies on the collaboration between the local governments, private sectors, and NGOs for the cultivation of selected herbs of each province, processing, R&D, and production of herbal products for distribution and sale to generate sustainable development of local communities and their economy. As of the year 2021, there are 14 herbal cities which can be divided into three clusters, namely: – Agricultural cluster comprises of five provinces, i.e., Amnat Charoen, Surin, Maha Sarakham, Uthai Thani, and Sakon Nakhon, which have strength in the production of quality herbal raw materials. – Industrial cluster comprises of Nakhon Pathom, Saraburi, Prachinburi, and Chanthaburi provinces. – Health, beauty, and TTM Tourism cluster is composed of Chiang Rai, Phitsanulok, Udon Thani, Surat Thani, and Songkhla provinces where health, traditional, and folk medicine tourism routes have been developed with more than 24 GI (geographical indications) herbal products available to satisfy the demand of local and foreign tourists. Some of the achievements of the implementation of the First Master Plan on the Development of Thai Herbal Products and the First National Work Plan on Medicinal Plants (2019–2022) are as follows: – Ministry of Agriculture and Cooperatives (MOAC) has supported 363,353 agriculturists to grow medicinal plants in the area of about 455,130 acres. – Different departments and offices under MOAC provided assistance to 92 groups of agriculturists in post-harvest herbal processing at or near the cultivation sites, or the production sites of herbal products in their communities. – There have been 7,295 community enterprises established all over the country for the production of herbal products.

History, Present and Prospect of Thai Traditional Medicine  749

– National Bureau of Agricultural Commodity and Food Standards, MOAC has developed five series of documents on the standards of GAP products and herbal materials based on parts used of the plants. – Country maps of “land suitability” for the cultivation of 24 medicinal plants have been developed by the Land Development Department, MOAC. – Various databases of different departments and offices under MOAC related to medicinal plants, herbal agriculturists, and herbal production areas and outputs have been created and linked. – Central market system for domestically-grown herbs and spices was established under the MOU between DTAM, Department of Agricultural Extension, Talaad Thai, and Thai Agro Exchange Co., Ltd. – E-market called “DGT Farm” for the trading of GAP- or organiccertified herbal products was developed by the National Bureau of Agricultural Commodity and Food Standards. – Department of Medical Sciences, MoPH recently published “Thai Herbal Pharmacopoeia 2021 Edition,” which comprises 109 monographs of standard specifications of herbal materials, herbal extracts, and herbal drug preparations.[64] – In 2021, 57 research projects for the development of medicinal plants and herbal materials and related technology were conducted by Agricultural Research Development Agency (Public Organization), Department of Agriculture, National Science and Technology Development Agency, and Department of Livestock Development. – The Achievements of different clusters of “Herbal Cities” in 14 provinces in the fiscal year 2021 were as follows: Agricultural cluster — More than 3,000 herbal agriculturists were trained on GAP/organic standards, over 3,750 acres of land for cultivation of medicinal plants were GAP or organic certified, and over 95 items of herbal materials produced passed the analyzes of quality standards and certificates of analysis (COA) were issued. Industrial cluster — There are more than 900 GMP-certified production facilities of herbal products, more than 200 herbal product

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entrepreneurs were trained or given consultations, and more than 26 quality herbal products are developed. Health, beauty and TTM tourism cluster — Twelve health tourism routes and more than 27 local herbal products have been developed. Herbal agriculturists and herbal product entrepreneurs under the “Herbal Cities” earned more than US$1.35 million by participating in related expositions organized by different government offices. – The drafting and public hearing of “the Second National Work Plan on Medicinal Plants (2023–2027)” is underway under the theme “Drive for Impact” and five operating strategies, i.e., Strategy 1 — Promotion of the production and processing of quality herbal materials. Strategy 2 — Strengthening the potential of herbal product entrepreneurs and manufacturers throughout the value chain. Strategy 3 — Promotion of herbal product market. Strategy 4 — Promotion of appropriate consumption of herbal products. Strategy 5 — Improvement of ecosystem involved towards effective and sustainable development of Thai herbal products. According to information from the Euromonitor International, among ASEAN+6 countries (10 ASEAN Member States, China, Japan, Korea, Australia, New Zealand, and India), the top five countries regarding domestic consumption values of herbs and herbal products in 2021 are China, Japan, Korea, Thailand, and India. The domestic consumption values of herbs and herbal products of Thailand during 2017, 2018, and 2019 were worth US$1,423, US$1,572, and US$1,720 million, respectively. In addition, the information from the Euromonitor International shows that herbal product market of Thailand has grown over the years at a higher average %year-on-year growth rates (%Y-O-Y) during the years 2017– 2019 than China, Japan, and the Republic of Korea with the average %Y-O-Y of 10.3% vs 5.06%, 0.85%, and 5.43%, respectively. However, %Y-O-Y of herbal products market of Thailand shows a decline in the growth rates from 12.7% in 2015 to 9.4% in 2019. Moreover, as a result

History, Present and Prospect of Thai Traditional Medicine  751

of COVID-19 pandemic, there was a significant decline of %Y-O-Y — to over 10% in the year 2020. However, Euromonitor International expects that the herbal products market in Thailand will grow again from 2021 onward to about US$1,817 million in 2025.

9.4 Future development of Thai traditional medicine With the government policies and the new laws related to TTM becoming effective, it is expected that there will be further development in all aspects of TTM.

9.4.1  TTM practice and provision of TTM service • Selected TTM preparations will be used more for the treatment of mild COVID-19 and long COVID-19. • More herbal medicinal products, both TTM preparations and scientifically developed herbal medicines based on R&D, including cannabis-containing medicines, will be added into the National List of Essential Herbal Medicines. This will give TTM practitioners greater varieties of medicinal items that will be covered by the health security systems to prescribe patients for the treatment of more diseases and symptoms in the public health service system. • More TTM therapies and treatment modalities will also be added into Thai Traditional and Alternative Medicine benefit package of the UHC scheme. • More Thai traditional and herbal medicines will be selected and prescribed, based on clinical evidence of safety and efficacy, as substitutes of some modern medicines have the potential to cause serious side effects in certain groups of patients, e.g., to replace NSAID in patients with chronic kidney disease or in the elderly. • More Thai Traditional and Integrative Medicine hospitals and hospitals under DTAM will be established in selected provinces of the country. • Excellence Center in Thai Traditional Medicine Research and Service established as a new unit under DTAM will conduct R&D on TTM

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medicinal products and treatment modalities to support evidencebased TTM practice and innovations. • Practitioners of TTM will be a part of Primary Care Cluster (PCC) team of health professionals and the roles of TTM to provide primary care for community people in PCC and in the health service system in general will receive more and better recognition by patients, other health professionals, and the Ministry of Public Health.

9.4.2  TTM practitioners and TTM educational system More government official and government employee positions will be available for TTM practitioners in the health service system, especially at the subdistrict level in the tambon health promotion hospitals, where currently less than half have TTM practitioners as healthcare staffs. As a result, Thai people in rural communities will be able to have better access to TTM service. The curriculum of Bachelor’s Degree in TTM will be expanded more than four years to improve clinical skill and competency of the graduates and TTM practitioners in the health service system in the future.

9.4.3  TTM products and herbal products for economy More monographs of TTM preparations, Thai herbal medicines, and Thai herbal health supplements with appropriate health claims will be developed and added into the respective positive lists to facilitate the registration of herbal products by the listing system. As a result, more herbal products, including TTM products, TCM products and herbal health supplements, and natural cosmeceuticals, will be registered with FDA and enter the herbal product market. Therefore, more Thai herbal products will be exported in the future.

9.4.4  Protection and promotion of TTM knowledge With the selection of more than 340 traditional medicine formulas into the National Thai Traditional Formulary, it is expected that such traditional medicine formulas will be chosen and produced by TTM manufacturers for

History, Present and Prospect of Thai Traditional Medicine  753

commercial purpose and the practitioners of TTM and Thai people will have more TTM medicines to choose from for their practice and for healthcare.

9.4.5  Medical cannabis service More cannabis clinics will be opened in a larger number of public hospitals so that patients will have better access to medical cannabis service from public health service system and from licensed private clinics in the future. An increasing number of cannabis-containing traditional medicines will be selected into the National List of Essential Herbal Medicines and covered by national health security systems. Besides, more cannabis-containing traditional medicine preparations will be notified and prescribed for practitioners of TTM to use for the treatment of their patients and for use under special access scheme (SAS). There will also be additional tambon health promotion hospitals (THPH) and community enterprises that will participate in the production of medical cannabis raw materials for DTAM and other licensed cannabis medicine manufacturing facilities, and more THPH will be able to produce some cannabis-containing traditional medicines for their own patients, as needed.

Acknowledgements The authors wish to thank Mrs. Mala Soisamrong and Miss Ornphapa Chanhom of the Office for the Management of Cannabis and Kratom in TTM, DTAM for their contribution of the information on the progress of the “Cannabis in Thai Traditional Medicine” project as well as Dr. Monthaka Teerachaisakul and Miss Pitchayarat Wanvuttikul of the Division of Herbs for Economy, and DTAM for providing update on the implementation of the “Herbs for Economy” policy.

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  [2] Picheansoonthon C, Chavalit M, Jirawongse V. An Explanation of King Narai’s Formulary: A Special Edition to Commemorate the 60th Birthday Anniversary of His Majesty the King, 5 December B.E. 2542[R]. Amarin Publishing and the Wisdom Foundation.  [3] Protection and Promotion of Thai Traditional Medicine Knowledge Act B.E. 2542 (1999, 19 November)[R]. Government Gazette, 2020.   [4] Thai Traditional Medical Professions Act B.E. 2556 (2013, 9 January)[R]. Government Gazette, 2013.   [5] Subcharoen P. Thai Traditional Medicine: Holistic Medicine[M]. ed 2nd. Bangkok: E.T.O. Printing, 2001: 7–104.  [6] Sittitanyakit K, Termwiset P. People’s Manual on the Use of Thai Traditional Medicine for Health Care[M]. Bangkok: War Veterans Administration Printing, 2004: 1–82, 104–150.   [7] Notification of the Committee on the Development of National Medicine System on the National List of Essential Medicines B.E. 2563 (2020, 28 September)[R]. Government Gazette, 2020: 270–330.  [8] Notification of the Committee on the Development of National Medicine System on the National List of Essential Herbal Medicines B.E. 2564 (2021, 31 March)[R]. Government Gazette, 2021:60, 3 pages of attachment list; (2021, 2 June)[R]. Government Gazette, 2021: 46–47, 2 pages of attachment list.   [9] Notification of the Committee on the Development of National Medicine System on the National List of Essential Herbal Medicines B.E. 2564 (2021, 25 November)[R]. Government Gazette, 2022: 47–48, 11 pages of attachment list. [10] Sobhanasiri S. History of the Development of Thai Traditional Medicine, Indigenous Medicine and Alternative Medicine[J]. Thai Traditional and Alternative Health Profile: Thai Traditional Medicine, Indigenous Medicine, and Alternative Medicine, 2009, 10: 1–64. [11] UNESCO. Memory of the World Epigraphic Archives of Wat Pho (2020–12–03) [EB/OL]. [2022–03–06]. http://www.unesco.org/new/en/ communication-and-information/flagship-project-activities/memoryof-the-world/register/full-list-of-registered-heritage/registeredheritage-page-3/epigraphic-archives-of-wat-pho/. [12] Notification of the Ministry of Public Health on Specifying Pharmacopoeias and Formularies B.E. 2561 (2018, 6 December) [R]. Government Gazette, 2019. [13] Medicinal Plant and Primary Health Care Project (Under the support of UNICEF), Office of the Permanent Secretary, Ministry of Public Health. Medicinal Plants Manual, Volume 1[M]. Bangkok: H.N. Printing, 1984.

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[14] Medicinal Plant and Primary Health Care Project (Under the support of UNICEF), Office of the National Economic and Social Development Council. Medicinal Plants Manual, Volume 2[M]. Bangkok: War Veterans Administration Printing, 1985. [15] Wamanont M, Subcharoen P. Medicinal Plants for Primary Health Care[M]. Bangkok: War Veterans Administration Printing, 1994. [16] Office of the National Economic and Social Development Council. The Twelfth National Economic and Social Development Plan (2017–2021) [EB/OL]. [2022–03–06]. https://www.nesdc.go.th/nesdb_en/ewt_dl_link. php?nid=4345. [17] Thaiwibulwong L. The History of the Foundation for the Promotion of Thai Traditional Medicine[J]. Ayurvedh Year Book BE, 1990, 2532: 39–41. [18] Ketusingh O. Ayurvedh Doctors-Modern Traditional Doctors[J]. Ayurvedh Year Book BE, 1990, 2532: 60–65. [19] Vichai Chokevivat MD, Chuthaputti A. The Role of Thai Traditional Medicine in Health Promotion: The 6th Global Conference on Health Promotion[C]. Bangkok, Thailand, 2005. [20] Department of Medical Services. The Establishment of the Institute of Thai Traditional Medicine and Pharmacy, No. 112/2536[R]. Department of Medical Services, 1993. [21] Notification of the Ministry of Public Health B.E. 2544 on the Addition of Thai Massage as a Branch of Thai Traditional Medicine (2001, 1 February) [R]. Government Gazette, 2001. [22] Practice of the Art of Healing Act B.E. 2542 (1999, 10 May) [R]. Government Gazette, 1999. [23] National Essential Drug List Committee, National Drug Committee. The National List of Essential Drugs B.E. 2542 (List of Herbal Medicinal Products)[M]. Bangkok: War Veterans Administration Printing, 2000. [24] Notification of the Ministry of Public Health on Traditional Household Remedies (1999, 26 June)[R]. Government Gazette, 1999. [25] Bureaucratic Reform Act B.E. 2545 (2002, 2 October)[R]. Government Gazette, 2002. [26] Ministerial Regulation on the Organization of the Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health B.E. 2545 (2002, 9 October)[R]. Government Gazette, 2002. [27] National Health Security Act B.E. 2545 (2002, 11 November)[R]. Government Gazette, 2002. [28] National Health Security Committee Notification on Thai Traditional Medicine Services[R]. 2002.

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[29] National Drug Committee. List of Herbal Medicinal Products A.D. [M]. Bangkok: Ministry of Public Health, 2006. [30] Committee on the Development of Thai Traditional Medicine Practice Guideline for Public Health Service Facilities. Thai Traditional Medicine Practice Guideline for Public Health Service Facilities[M]. Bangkok: Institute of Thai Traditional Medicine, 2007. [31] World Health Organization. Benchmarks for Training in Traditional/ Complementary and Alternative Medicine: Benchmarks for training in Nuad Thai[M]. Switzerland: WHO Press, 2010. [32] Notification of the Committee on the Development of National Medicine System on the National List of Essential Medicine (Number 4) B.E. 2554 (2011, 25 May)[R]. Government Gazette, 2011. [33] Notification of the Committee on the Development of National Medicine System on the National List of Essential Medicine B.E. 2556 (2013, 7 August)[R]. Government Gazette, 2013. [34] Technical Working Group on Thai Traditional Medicine and Midwifery. Practice Guideline for Comprehensive Provision of Thai Traditional & Alternative Medicine Services[M]. Bangkok: Institute of Thai Traditional Medicine, 2016. [35] Ministry of Public Health and Public and Private Organizations. The First Master Plan on the Development of Thai Herbal Products (2017–2021)[M]. Bangkok: Department of Thai Traditional and Alternative Medicine, 2016. [36] Herbal Products Act B.E. 2562 (2019, 26 April)[R]. Government Gazette, 2019. [37] Narcotics Act B.E. 2522 (1979, 22 April)[R]. Government Gazette, 1979. [38] Narcotics Act (Number 7) B.E. 2562 (2019, 17 February) [R]. Government Gazette, 2019. [39] UNESCO. Nuad Thai, Traditional Thai Massage-Inscribed in 2019 (14. COM) on the Representative List of the Intangible Cultural Heritage of Humanity (2020–12–06) [EB/OL]. [2022–03–06]. https://ich.unesco.org/ en/RLnuad-thai-traditional-thai-massage-01384. [40] World Health Organization. WHO Traditional Medicine Strategy: 2014– 2023[M]. Geneva: WHO Press, 2013. [41] World Health Organization. Core and Reference Indicators for Monitoring Traditional and Complementary Medicine in South-East Asia[M]. New Delhi, India: WHO Regional Office for South-East Asia, 2017. [42] National Health Security Office (2019)[R]. Management Handbook of the National Health Security Fund: Fiscal Year B.E. 2563: 73–74.

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[43] Notification of the Ministry of Public Health on Prescribing Schedule 5 Narcotic Medicines Containing Cannabis as an Ingredient that can be Consumed for the Treatment of Diseases or for Research B.E. 2562 (2019, 29 March)[R]. Government Gazette, 2019. [44] Notification of the Ministry of Public Health on Prescribing Schedule 5 narco.tic Medicines Containing Cannabis as an Ingredient that can be Consumed for the Treatment of Diseases or for Research (Number 3) B.E. 2562 (2019, 21 August)[R]. Government Gazette, 2019. [45] Technical and Planning Division, Department of Thai Traditional Medicine. HDC TTM service[EB/OL]. [2022–03–06]. http://hs.dtam.moph.go.th/. [46] Health Data Center Service. Standard Report Groups — Access to Thai Traditional Medicine Service[EB/OL]. [2022–03–06]. https://hdcservice. moph.go.th/hdc/reports/page.php?cat_id=30bc6364fc06a33a7802e16bc59 6ac3b. [47] Stienrut P, Angsusingh K, Chayachavalit S, et al. Thai Traditional Medicine & Integrative Medicine Promoting Hospital Standard (TIPhS)[M]. Bangkok: Institute of Thai Traditional Medicine, 2013. [48] Visithanon K, Nimnuan S, Rinthawong P, et al. Thai Traditional Medicine Hospital Accreditation Guidelines[M]. Bangkok: Institute of Thai Traditional Medicine, 2018. [49] Department of Thai Traditional Medicine. Notification of Department of Thai Traditional and Alternative Medicine on Guidelines on the Provision of Thai Traditional Medicine Service in Public Health Service Facilities in order to Prevent and Control COVID-19 Infection (or Coronavirus Disease 2019) B.E. 2563 (2020–03–26) [EB/ OL]. [2022–03–06]. https://www. dtam.moph.go.th/index.php?option=com_content&view=article&id=5770 :pr0985& catid=8&lang=th&Itemid=114. [50] Thai Traditional Medical Council. List of Certified Institutes or Health Facilities Allowed to Pass on Knowledge for the Training in Thai Traditional Medical Profession According to the Thai Traditional Medical Professions Act B.E. 2556 (2020–11–05) [EB/OL]. [2022–03–06]. https:// thaimed.or.th/download/สถาบันผ่านการรับรอง/?wpdmdl=6610&refresh=5fcf407 6cfecb1607417974. [51] Thai Traditional Medical Council. Curricula of Thai Traditional Medicine Professions [EB/OL]. [2022–03–06]. https://thaimed.or.th/หลักสูตรวิชาชีพการ แพทย/. [52] Thai Traditional Medical Council. List of Higher Educational Institutions Providing Bachelor’s Degree or Degree-Equivalent Certificate Level of

758  History, Present and Prospect of World Traditional Medicine

Education in Thai Traditional Medicine Certified by Thai Traditional Medical Council according to the Thai Traditional Medical Professions Act B.E. 2556 (2021–04–03) [EB/OL]. [2022–03–06]. https://thaimed.or.th/ download/สถาบั น ผ่ า นการรั บ รอง-ข/?wpdmdl=6632&refresh=61e14365 e8f301642152805. [53] Thai Traditional Medical Council. List of Higher Educational Institutions Providing Bachelor’s Degree or Degree-Equivalent Certificate Level of Education in Applied Thai Traditional Medicine Certified by Thai Traditional Medical Council according to the Thai Traditional Medical Professions Act B.E. 2556 (2021–11–23) [EB/OL]. [2022–03–06]. https:// thaimed.or.th/download/สถาบันผ่านการรับรอง-ประ/?wpdmdl=6639&refresh=61e1 3e6f2c69e1642151535. [54] Notification of the Ministry of Education on the Qualifications Framework for Higher Education in Thai Traditional Medicine B.E. 2560 (2017, 18 September)[R]. Government Gazette, 2017. [55] Notification of the Ministry of Education on the Qualifications Framework for Higher Education in Applied Thai Traditional Medicine (2011, 30 December)[R]. Government Gazette, 2012. [56] Profession Commission in the Branch of Thai Traditional Medicine. Thai Traditional Medicine Assistant Curriculum B.E. 2550 (First Revision) [R]. 2007. [57] Thai Traditional Medical Council. List of Institutes and Health Facilities Certified to Provide Training of 330-hour Thai Traditional Medicine Assistant Curriculum [EB/OL]. [2022–03–06]. https://thaimed.or.th/download/รายชือ่ สถาบันหรือสถานพ/?wpdmdl=11181&refresh=61e123b9df8161642144697. [58] Thai Traditional Medical Council. Thai Traditional Medicine Assistant Curriculum (2020–07–30) [EB/OL]. [2022–03–06]. https://thaimed.or.th/ ผู้ช่วยแพทย์แผนไทย/. [59] Regulation of the Ministry of Public Health on the Certification of Folk Healers B.E. 2562 (2019, 16 May) [R]. Government Gazette, 2019. [60] Notification of the Department of Thai Traditional and Alternative Medicine on Prescribing Forms according to the Regulation of the Ministry of Public Health on for the Certification of Folk Healers B.E. 2562 (2019, 19 July)[R]. Government Gazette, 2019. [61] Drugs Act B.E. 2510 (1967, 15 October) [R]. Government Gazette, 1967. [62] Drugs Act (Number 6) B.E. 2562 (2019, 15 April) [R]. Government Gazette, 2019. [63] Food Act B.E. 2522. (1979, 8 May) [R]. Government Gazette, 1979.

History, Present and Prospect of Thai Traditional Medicine  759

[64] Subcommittee on the Establishment of the Thai Herbal Pharmacopoeia. Thai Herbal Pharmacopoeia 2021. Department of Medical Sciences[EB/ OL]. [2022–03–06]. https://bdn.go.th/thp/member/register. [65] Thai Herbal Preparation Pharmacopoeia Committee. Thai Herbal Preparation Pharmacopoeia Committee[EB/OL]. [2022–03–06]. https://www.dtam. moph.go.th/E-Book/THPP/THPP_2020/e-book_THPP_2020.pdf. [66] Ministerial Regulation on Request for Permission and Permission, Limitation of the Right, and Compensation for the Use of National Thai Traditional Medicine Formulas or National Thai Traditional Medicine Treatises B.E. 2558 (2015, 13 February)[R]. Government Gazette, 2015. [67] Subcommittee on the Preparation of National Thai Traditional Medicine Formulary, Committee on the Protection and Promotion of Thai Traditional Medicine Knowledge. Division of the Protection and Promotion of Thai Traditional Medicine and Thai Indigenous Medicine Knowledge. Department of Thai Traditional and Alternative Medicine[EB/OL]. [2022–03–06]. https://fund.dtam.moph.go.th/images/FundDtam2564/1.N-Funddtam01/ dl0120-ThaiMed_August2021.pdf. [68] Chotchanadechawong N, Chantraket R. Situation of Thai Traditional Medicine Knowledge Protection in Thailand[M]// Wongkongkathep S, Prasertsiripong N, Stienrut P, et al. Thai Traditional and Alternative Medicine Health Profile: Thai Traditional Medicine, Indigenous Medicine and Alternative Medicine 2014–2016[M]. Bangkok: Department of Thai Traditional and Alternative Medicine, 2018: 207–272. [69] Notification of the Ministry of Public Health on Specifying Schedule 5 Narcotics B.E. 2563 (2020, 8 December)[R]. Government Gazette, 2020. [70] Notification of the Ministry of Public Health on Prescribing Schedule 5 Narcotic Medicines Containing Cannabis as an Ingredient that can be Consumed for the Treatment of Diseases or for Research B.E. 2564 (2021, 4 February)[R]. Government Gazette, 2021. [71] Notification of the Ministry of Public Health on Prescribing Schedule 5 Narcotic Medicines Containing Cannabis as an Ingredient that can be Consumed for the Treatment of Diseases or for Research (Number 2) B.E. 2564 (2021, 30 July)[R]. Government Gazette, 2021. [72] Notification of the Ministry of Public Health on Prescribing Schedule 5 Narcotic Medicines Containing Cannabis as an Ingredient that can be Consumed for the Treatment of Diseases or for Research (Number 3) B.E. 2564 (2021, 7 December)[R]. Government Gazette, 2021.

760  History, Present and Prospect of World Traditional Medicine

[73] Notification of the Ministry of Public Health on Prescribing Schedule 5 Narcotic Medicines Containing Cannabis as an Ingredient that can be Consumed for the Treatment of Diseases or for Research (Number 4) B.E. 2564 (2021, 7 December)[R]. Government Gazette, 2021. [74] Department of Thai Traditional and Alternative Medicine. Handbook for the Establishment of a Medical Cannabis Clinic of Thai Traditional Medicine in a Health Service Facility (2020–07–01) [EB/OL]. [2022–03–06]. http:// utoapp.moph.go.th/e_doc/views/uploads/5f0587a677ab9-05403ac4706ce867b6229e4188993a61-989.pdf. [75] Bureau of Mental Health Service Administration. Guideline on the Provision of Integrative Medical Cannabis Clinic (2021–01–29) [EB/OL]. [2022–03–06]. http://www.mhso.dmh.go.th/page/subject_details.php? subject_id=325. [76] Office for the Management of Cannabis and Kratom in Thai Traditional Medicine, Department of Thai Traditional and Alternative Medicine. Handbook on Extemporaneous Compounding of Traditional Medicine Preparations Containing Non-Narcotic Parts of Cannabis for Health Service Facilities[EB/OL]. [2022–03–05]. https://drive.google.com/drive/ folders/1RcMaKdvL7-mLjeg0mn6UUKzgjudAhdY-?usp=sharing.

© 2024 World Scientific Publishing Company https://doi.org/10.1142/9789811282171_bmatter

Index

AB Canon, 452 Abulcasis, 250 Accreditation, 113 Act on Korean Medicine and Pharmaceutics Promotion, 460 Act on the Promotion of Korean Medicine and Pharmaceuticals, 474 acupuncture, 397, 448, 460 acupuncture points, 418 acupuncture points revision, 418 adipogenesis, 271 Agni (transinformatory energy), 36 Ahara (food), 42 Alchemilla vulgaris, 286 Alhacen, 248 Al-Kindi, 240 Alkindus, 240, 250 Al-Tibb al-Nabawi, 238 Ama (undigested metabolities), 37 American Medical Association (AMA), 75 Ammi visnaga, 268 Amoenitates Exoticarum, 407

Anmo, 598 anthocyanins, 278 anti-inflammatory, 279 anti-inflammatory mediators, 285 antioxidant, 279 Anzai Yasukane, 413 Arab-Islamic civilization, 235 Asada Sohaku, 409 Asafoetida asafoetida, 268 Asahina Yasuhiko, 411 Association of Korean Medicine, 457 Atriplex halimus, 268 ATTM Issued, 732 Avenzoar, 241, 251 Avicenna, 237 AYUSH, 47 Babylon, 544 back-Shu, 591 Baihui, 594 Bai Jiang Dan, 608 Bai Zhu San, 562 Bao Cheng, 567 Bao Pu Zi, 603 761

762  History, Present and Prospect of World Traditional Medicine

Bao Qing Ben Cao, 563 Ba Shi Yi Nan Jing, 554 B.ATM, 731 Beijing College of Chinese Medicine, 621 Beiji Qianjin Yaofang, 399 Bei Ji Qian Jin Yao Fang, 554 Ben Cao Chong Yuan, 568 Ben Cao Gang Mu, 563, 605 Ben Cao Gang Mu Shi Yi, 569 Ben Cao Jing Ji Zhu, 555, 605 Ben Cao Jing Shu, 567 Ben Cao Ji Yi, 563 Ben Cao Meng Quan, 569 Ben Cao Yan Yi, 563 Ben Cao Yan Yi Bu Yi, 564 Bian Que, 594 Bianzhen Lunzhi, 400 BJ Palmer, 82 Black seeds, 240 blood, 547, 596 blood pressure, 274 BMI, 272 Bramacharya (positive lifestyle), 45 B.TM, 730 Buddhism, 552 Buddhist literature, 14 Bu Zhong Yi Qi Tang, 561 Bu Zhu Huang Di Nei Jing Su Wen, 553 Canon of Difficult Questions, 452 Canon of Medicine, 242 Capparis spinosa, 268 cardiovascular diseases, 269 Carl Peter Thunberg, 407 Central Council of Indian Medicine (CCIM), 50

Central Council of Research in Ayurvedic Sciences, 54 Chao Yuanfang, 554, 599, 603 Chen Changqing, 567 Chen Cunren, 573 Chengdu College of Traditional Chinese Medicine, 621 Cheng Lin, 567 Chen Jiamo, 569 Chen Jingqi, 573 Chen Sicheng, 564 Chen Wuze, 559 Chen Xiuyuan, 567, 568 Chen Yan, 557 China, 544 chiropractic college, 80 Cholevel, 272 Chong Xiu Zheng He Jing Shi Zheng Lei Bei Yong Ben Cao, 563 chronic diseases, 269 Chuna Manual therapy, 448, 460, 467 Chun Yuyi, 596 Cichorium intybus, 268 Ci Jiu Xin Fa Yao Jue, 597 Classified Collection of Medical Formulas, 453 Classified Materia Medica, 452 Clinical Practice Guideline, 483 Cold and Cooling School, 560 Cold Damage Diseases, 466 Collections of Prescriptions for Cattle and Horse-New Edition, 455 Collections of Rare Medical Books, 573 Compendium of Formulas Using Homeland Herbs, 453 Competition, 120

Index  763

Compilation of Formulas and Medicinals, 466 Confucian, 549 Conium maculatum, 268 Council on Chiropractic Education (CCE), 80 COVID-19, 620 Crawford F. Sams, 414 crude drugs, 396 Cumin, 285 Cuminum cyminum, 268, 272 Cunkou, 552 Cun Zhen Tu, 557 cupping, 448, 460 Curcumin, 283 Cyperus rotundus, 268 Da Guan Ben Cao, 563 Daikenchuto, 443 Dai Tianzhang, 568 Dang Gui Si Ni Tang, 562 Daniel David Palmer, 77 Danxi School, 560 Daoism, 552 Daoyin, 601 Dashin, 401 data analytics, 109 Da Yuan Yin, 568 De Acupunctura, 407 Dejima island, 407 Deng Xiaoping, 577 Department of Defense (DoD), 89 Department of Thai Traditional and Alternative Medicine, 718 Dhatus (tissues), 31 diabetes, 269 Diagnostic imaging, 92

Dian Nan Ben Cao, 569 Dinacharya, 45 Ding Fubao, 410 Ding Jin, 566 Direction of cure, 316, 317, 345 Dongje Medical School, 456 Donguibogam, 453 Dongui Suse Bowon, 468 Doshas (biologicial energies), 25 Du Su Wen Chao, 558 Earth School, 560 Eastern Doctor’s Experience Prescription, 452 Edo Igakukan, 398 Effective Prescriptions for Relieving Public, 452 Egypt, 544 electronic medical records, 105 ellagic acid, 278 Elucidation of Massage for Children, 601 Employer-sponsored on-site clinics, 100 Engelbert Kaempfer, 407 Ephedra herba, 396 Eriobotrya japonica, 272 Eruca sativa, 268 Essential Prescriptions Collected by Royal Physician-New Edition, 452 ethnopharmacological surveys, 288 Experiential Prescriptions Acupuncture, 454 Fang Youzhi, 567 Fan Yin Dan, 562 First Master Plan on the Development of Thai Herbal Products, 746

764  History, Present and Prospect of World Traditional Medicine

five elements, 548, 596 five-element theory, 582 five movements, 554 five-zang organs, 583 Flora Japonica, 408 Foeniculum vulgare, 268 French envoy Léon Roches, 409 front-Mu, 591 Fujita Kenzo, 413 Fukushin, 401 Fu Zi San, 562 GACP, 488 Gao Baoheng, 559 Ge Hong, 553, 599 Ginseng, 396 Glucolevel, 272, 273 Gojoseon, 451 Gong Tingxian, 564 Good Manufacturing Practice, 417 Goryeo dynasty, 452 Grand Dictionary of Chinese Medicine, 573 Grand Dictionary of Chinese Pharmacy, 573 Great Compendium of Chinese Medicine, 573 Greco-Arab and Islamic Medicine, 235 Guang, 554 Guangzhou College of Traditional Chinese Medicine, 621 Gu Ben Nan Jing Chan Zhu, 566 Guidance of Traditional Chinese Medicine and Ten Reference Books, 573 Gu Jin Tu Shu Ji Cheng, 565

Gu Jin Yi Tong Da Quan, 565 Gu Jin Yi Tong Zheng Mai Quan Shu, 565 72 Huanghan Medical Books, 573 H7N9, 620 Hadith, 238 Hai Yao Ben Cao, 556 Hara Shimetaro, 414 Harikikigaki, 400 Hashida Kunihiko, 411 HDC TTM service, 726 HDL, 278 Health Data Center of Thai Traditional Medical Service, 726 Hejian School, 560 Heo Im, 454 Heo Jun, 453 herbal acupuncture, 448 Herbal Cities, 748 herbal medicine dispute, 458 herbal medicines, 259, 460 Herbal pharmacists, 492 Herbal Products Act, 722 Herbal Products Committee, 738 herbs for the economy policy, 746 Herman Buschof, 402 He Yan, 552 HFMD, 620 Hidenten, 424 Higuchi Etsunosuke, 413 HIV/AIDS, 620 Homeopathy, 301 Hong Sheng Dan, 608 Hosono Shiro, 416 Hua Boren, 597 Huang Di Ba Shi Yi Nan Jing, 551

Index  765

Huang Di Ba Shi Yi Nan Jing Zhu, 554 Huang Di Nei Jing, 550, 594 Huangdi Neijing Taisu, 398 Huangdi Qibo Anmo, 599 Huang Di Su Wen Xuan Ming Lun Fang, 558 Huang Lian, 591 Huang Yuanyu, 567 Hua Shou, 417, 558 Hua Tuo, 596 Hu Jintao, 577 Hyangyak, 453 Hyodo Masayoshi, 424 Hypericum triquetrifolium, 268 Ibaraki Gengyo, 400 Ibn al-Nafis, 248 Ifa Dachenglun, 421 Ikai No Tettsui, 409, 410 immune mediators, 237 immune system, 237 India, 544 Inoue Keiri, 420 Institute of Clinical Medicine of East Asia, 411, 416 Institute of Education in Korean Medicine & Evaluation, 507 Institute of Natural Medicine, University of Toyama, 436 integration, 98, 119 internet of medical things (IOMT), 109 Introduction to Chinese Medicine, 573 Inula viscose, 268 Iryakusho, 407 Ishihara Yasuhide, 411

Ishikawa Hidetsurumaru, 412 Ishikawa Tachio, 424 Ishinpo, 398 Ishituryo, 397 Isshuudo series, 407 Itakura Takeshi, 411 itchy eczema, 591 Ivan Pavlov, 412 Izawa Ranken, 406 Japan Acupoint Committee, 418 Japan Acupuncture and Moxibustion Society, 416 Japanese Industrial Standards Committee, 442 Japanese Medicine Institute, 419 Japanese Pharmacopoeia, 409 Japanese Society for the History of Medicine, 437 Japanese Society of Pharmacognosy, 434 Japan Kampo Medicines Manufacture Association, 417, 429 Japan Medical Association, 417 Japan Society of Acupuncture and Moxibustion, 416 Japan Society of Medical Acupuncture, 415 Japan Society of Medical and Pharmaceutical Sciences for Traditional Medicine, 433 Japan Traditional AcupunctureMoxibustion Society, 421 Jiang Zemin, 577 Jian Zhen, 397 Jiao Tai Wan, 591 Jiayi Jing, 397

766  History, Present and Prospect of World Traditional Medicine

Jia You Ben Cao, 563, 564 Ji Ji Xian Fang, 603 Ji Kang, 552 Jing Luo, 590 Jing Shi Zheng Lei Bei Ji Ben Cao, 563 Jin Gui Xuan Jie, 567 Jin Gui Yao Lue, 551 Jin Gui Yao Lue Fang Lun, 559 Jin Gui Yao Lue Fang Lun Ben Yi, 567 JinGui Yao Lue Ji Zhu, 567 Jin Gui Yao Lue Lun Zhu, 567 Jin Gui Yao Lue Qian Zhu, 567 Jin Gui Yao Lue Zhi Jie, 567 Jin Gui Yu Han Jing Er Zhu, 567 Jin Gui Yu Han Yao Lue, 559 Jin Guo Yao Luo Xin Dian, 567 Jing Yue Quan Shu, 565, 567 JLOM, 439 Joseon Dynasty, 453 Journal of Chinese and Western Medicine, 573 Kai Bao Ben Cao, 564 Kaiko Gakuen, 411 Kaitaishinsho, 405 Kampo Medicine, 395 Keiketsu Sanyo, 407 Keiketsushuusei, 418 Keitekian, 399 Keitekishu, 400 Ke Qin, 567 Kimura Chokyu, 410 Kinoshita Haruto, 422 Kitasato University Oriental Medicine Research Center, 434 Kojima Hoso, 406

Kokan Igaku, 410 Komai Kazuo, 412 Korea Institute of Oriental Medicine, 522 Korean Medicine doctor, 457 Korean Medicine hospitals, 494 Korean Medicine Materials Bank, 488 Korean Medicine public health doctors, 478 Korean Medicine specialist, 481 Korean Pharmacopoeia, 489 Kotenshinkyu kenkyukai, 421 Kou Zongshi, 563 Kumazawa Takao, 424 Kurosawa Mieko, 439 Kyung Hee University, 457 Laozi, 601 Law of Similars, 303–305, 307, 345, 351, 353, 354, 371 Laws governing, 85 LDL, 278 Lee Jema, 455 Lei Jing, 566 licorice, 396 Li Gao, 557 Ling Shu, 596 Lin Yi, 559 Li Shizhen, 563, 597 Liu Ling, 552 Liu Wansu, 557 Liu Yuanran, 604 Li Xuechuan, 598 Li Xun, 556 Li Zhong Tang, 562 Longevity & Life Preservation In Eastern Medicine, 468 low back pain, 91

Index  767

Lǚ Guang, 554 Luo Zhiti, 562 Lǚ Shi Chun Qiu, 611 Lu Yuanlei, 571 Maeno Ryotaku, 404 Malas (waste products), 35 Manaka Yoshio, 422 Manase Dosan, 399 Manas (mind), 39 Maritime Silk Road, 557 Materia Medica, 303, 304, 306, 312, 339, 354, 356, 357, 363–365 median annual wage, 94 medical cannabis, 723 medical cannabis clinics, 743 Medieval period and colonial rule, 21 mediterranean diet, 276 Mei Chuang Mi Lu, 564 Meiji University of Acupuncture and Moxibustion, 428 Meiji University of Integrative Medicine, 428 Melissa officinalis, 268 meridian points, 418 meridians, 547 meridian theory, 590 Meridian Therapy, 420 Metaphyics, 552 Mie College of Medicine, 412 Mingmen, 551 Ming Tang, 397 Ming Tang Chart of Bronze Figure, 595 Ministry of Finance, 550 Ministry of Rites and Ceremonies, 550

Misono Isai, 401 Miu Xiyong, 568 Miyairi Keinosuke, 414 Mori Tatsuyuki, 406 Motoki Ryoui, 404 Moxa, 402 Moxafrica, 415 moxibustion, 448, 460, 546 Moxibuston, 402 Mushi, 400 Nagai Nagayoshi, 411 Naizo Taiheki Hansha, 424 Nakajima Hiroshi, 418 Nakatani Yoshio, 424 Nangyo Sosho, 407 Nanjing, 420 Nan Jing, 551 Nan Jing Ben Yi, 558 Nan Jing Jing Shi, 566 Nan Jing Ji Zhu, 554 Nan Jing Zheng Yi, 566 National Board of Chiropractic Examiners (NBCE), 87 National Health Insurance, 471 National Health Security Act, 718 National Herbal Policy Committee, 737 National Institute for Korean Medicine Development, 483 National List of Essential Herbal Medicines, 721 National List of Essential Medicines, 707 National Thai Traditional Medicine Formulary, 739 neck, 91 neuroplastic changes, 121

768  History, Present and Prospect of World Traditional Medicine

NHMRC, 373, 384 Nidra (sleep), 44 Nigella sativa, 268 Nihon Daikei Igakukai, 421 Nihonkoku Kenzaisho Mokuroku, 398 Nihonshinkyu kenkyukai, 421 Ninnaji Temple, 425 Nuad Thai, 707 obesity, 269 Ohkubo Tekisai, 412 Ojas (essence of dhatu), 34 Okabe Sodo, 420 Olea europaea, 268 olive oil, 276 olive tree, 270 on-site corporate clinic, 99 Oranda Zenku Naigai Bungouzu, 404 Origanum majorana, 268 osteopathy, 77 Otsuka Yoshinori, 410 Ouxi Fan Wu Zang Tu, 557 4P of TTM, 724 Panchamahabhutas (five elements), 23 Patient classification system, 516 pattern identification, 461 Peganum harmala, 265 percentage of OPD visits receiving TT&CM services, 728 pharmacopuncture, 448, 460 Philipp Franz von Siebold, 407 phytochemicals, 284 polyphenol, 275 pomegranate, 278

Portulaca oleracea, 268 potentization, 304, 305, 309, 361, 368, 379 practice, 85 Prakriti (constitution), 29 probiotic, 280 pro-inflammatory cytokines, 285 Prophet’s Medicine, 238 Protection and Promotion of Thai Traditional Medicine Knowledge Act, 715 Public perception, 85, 101 Pu Ji Fang, 565 Punica granatum, 268, 276 Punicalagin, 278 Purana literature, 13 Pusan National University, 500 qi, 547, 596 Qian Huang, 567 Qian Jin Fang, 554, 603 Qian Jin Yao Fang, 596 Qian Jin Yi Fang, 554 Qi Jing Bai Mai Kao, 597 Qin Yueren, 594 Quan Yuanqi, 553 Ratricharya, 46 Record of No Chagrin-New Annotation, 455 Reimbursement, 96 repertorization, 354 Repertorization, 356 repertory, 355 Repertory, 354, 356 Resa uti Europa, Africa, Asia, förrätled åren, 408 Residencies, 113

Index  769

Residency, 92 Resource-Based Relative Value Scale, 510 Rhazes, 237 Rhei rhisoma, 396 Ricinus communis, 265 Ri Huazi Ben Cao, 564 Rikkunshito, 443 Ritucharya, 46 Rou Gui, 591 Ruan Ji, 552 Ruan Xian, 552 Ruijuho, 405 Ru Men Shi Qin, 600 Ruscus aculeatus, 268 Ruta chalepensis, 268 Ryodo points, 424 Sa-am, 461 Sa-am acupuncture, 454, 461 Sakaguchi Hiroshi, 422 Salvia fruticosa, 268 Samhita period, 15 Sang Ju Yin, 568 San Guo Zhi, 602 Sanjiao, 551 San Xiao Yin, 568 Sasagawa Kyugo, 432 Sasang constitutional medicine, 455, 456, 460, 468 Sato Akio, 424 Satsusho Benchi, 400 school of Korean Medicine, 498 Second National Work Plan on Medicinal Plants, 750 sen, 707 sen prathan sib, 707 sen pressure points, 707

Serizawa Katsusuke, 413 Seven Sages of the Bamboo Grove, 552 Shanghai College of Traditional Chinese Medicine, 621 Shanghai museum of Traditional Chinese Medicine, 545 Shang Han Lai Su Ji, 567 Shang Han Lun, 550, 596 Shang Han Wu Fa, 567 Shang Han Za Bing Lun, 550 Shang Han Zhun Sheng, 567 Shang Shu Hong Fan, 549 Shan Hai Jing, 593 Shan Tao, 552 Shao Xing Ben Cao, 563 Shao Xing Jiao Ding Jing Shi Zheng Lei Bei Ji Ben Cao, 563 Shaoxing Medical Journal, 573 Sheng Ji Zong Lu, 554, 600 Sheng Ji Zong Lu Gu Kong Xue Fa, 558 Sheng Yang Tang, 561 Shen Nong Ben Cao Jing, 551, 605 Shen Nong Ben Cao Jing Bai Zhong Lu, 568 Shen Nong Ben Cao Jing Du, 568 Shennung’s Bencaojing, 396 Shenzhou Medical Journal, 573 Shibue Chusai, 406 Shi Jinmo, 571 Shi Liao Ben Cao, 610 Shimaura Wadaichi, 403 Shimizu Tohtaro, 411 Shinchi Saiyou Ikensho, 409 Shinchi Shinsho, 412 Shirota Bunshi, 413

770  History, Present and Prospect of World Traditional Medicine

Shisijing Fahui, 417 Shi Si Jing Fa Hui, 597 Shi Yi De Xiao Fang, 558 Shi Zhi Tong Shuo, 610 Shohogenzou, 413 Shokanron Shugi, 407 Shosoin, 397 Shou Shi Bao Yuan, 564 SIA, 422 Silk Road, 398 Silybum marianum, 268 Sir Hans Sloane, 408 six-fu organs, 584 six qi, 554 Société Internationale d’Acupuncture, 422 Soeum-in, 463 Somonshi, 407 Soyang-in, 463 specialist system, 481 specialties, 81 spinal adjustment, 78 spinal manipulative therapy (SMT), 78 sports chiropractor, 93 Srotas (circulatory channels), 38 standardization, 123 Standard Meridian Points, 418 subluxations, 91 Sugita Genpaku, 404 Sugiyama Waichi, 403 Sugi Yasusaburo, 413 Su Jing, 556 Su Ling Lei Zuan Yue Zhu, 566 Sun Fengyi, 567 Sun Qi, 559 Sun Simiao, 555, 599 Sun Xingyan, 567

suppression, 318, 319 susceptibility, 315, 316, 318, 319 Su Shen Liang Fang, 603 Su Wen, 397, 550 Su Wen Bing Ji Qi Yi Bao Ming Ji, 558 Su Wen Xuan Jie, 566 Su Wen Xuan Ji Yuan Bing Shi, 558 Swasthavrtta (healthy lifestyle practice), 45 Synopsis of Prescriptions of the Golden Chamber, 466 Taeguk acupuncture, 461 Taeum-in, 463 Taeyang-in, 463 Tao Hongjing, 609 Tai Ping Sheng Hui Fang, 554, 600 Takagi Kentaro, 423 Takemi Taro, 417 Taki Mototane, 406 Taki Motoyasu, 406 Tamba Yasuyori, 398 Tamba Yorimoto, 398 Tang Ye Ben Cao, 564 Tao Hongjing, 553, 555 Tatsuno Kazuo, 416 TCM, 613 Thai Herbal Pharmacopoeia, 738 Thai Herbal Preparation Pharmacopoeia, 738 Thai indigenous medicine, 709 Thai Traditional Digital Knowledge Library, 739 Thai Traditional Medical Professions Act, 721 Thai Traditional Medicine, 703

Index  771

The Impact of Somatosensory Input on Autonomic Functions, 425 The Japan Society for Oriental Medicine, 431 The Japan Society of Acupuncture and Moxibustion, 432 The Japan Traditional AcupunctureMoxibustion, 434 The National Commission for Indian Systems of Medicine (NCISM), 50 the Society of Japanese Medicine, 413 Three Three Medical Journal, 573 Thymoquinone, 282 Tohokai, 421 Tokugawa Yohimune, 403 Tong Mai Si Ni Tang, 562 Tong Ren Shu Xue Zhen Jiu Tu Jing, 596 Toyohari Igakukai, 421 Toyoigaku Zenpon-sosho, 425 Traditional Knowledge Digital Library (TKDL), 55 Traya upastamaba (three supportive pillars), 42 Treasured Mirror of Eastern Medicine, 453 Trigonella foenum-graecum, 268 TTM assistants, 731 tuberculosis, 414 tui na, 546 Tuina, 598 Tu Jing Ben Cao, 563 Turmeric, 283 Tu Zhu Ba Shi Yi Nan Jing, 566 Ui-Nyeo, 455 Upanishadic literature, 12 Urtica dioica, 268

Vedic period, 5 Veterans Administration (VA) clinics, 89 vitalism, 77 Wada Keijuro, 409 Wada Tokaku, 406 Wai Ke Zheng Zong, 604 Waitai Miyao, 399 Wai Tai Mi Yao, 554 Wakan-yaku symposium, 433 Wanbinghuichun, 400 Wan Bing Hui Chun, 564 Wang Ang, 566 Wang Bi, 552 Wang Haogu, 557, 564 Wang Jiusi, 554, 566 Wang Kentang, 567 Wang Qingren, 565 Wang Rong, 552 Wang Shixiong, 568 Wang Shuhe, 550 Wang Tao, 555 Wang Weiyi, 597 Wang Zhizhong, 597 Wang Zhu, 559 Wan Quan, 564 Warm-heat theory, 560 Wat Pho, 711 Weighlevel, 286 Wei Litong, 567 Wen Re Jing Wei, 568 Wen Re Tiao Bian, 568 Western Medicine, 613 WHO Western Pacific Regional Office, 418 Willem ten Rhijne, 407 World Congress of Acupuncture, 422

772  History, Present and Prospect of World Traditional Medicine

World Federation of AcupunctureMoxibustion Societies, 423 World Health Organization (WHO), 103 Wu Jutong, 568 Wu Pu, 602 Wu Qian, 567, 598 Wu Qin Xi Jue, 603 Wu Shi Er Bing Fang, 599 Wu Tang, 568 Wu Youxing, 568 Xiang Xiu, 552 Xiaopinfang, 397 Xi Jinping, 577, 615 Xin Xiu Ben Cao, 556, 605 Xi Yuan Ji Lu, 558 Xu Bin, 567 Xu Chunfu, 565 Xu Dachun, 566, 567, 568 Xue Ji, 564 Xue Shengbai, 566 Xue Shi Yi An, 564 Xu Qian, 562

Ye Gui, 568 Ye Lin, 566 Yellow Emperor, 550 Yellow Emperor’s Inner Canon, 452 Yi He, 594 Yi Huan, 594 Yi Jing Yuan Zhi, 566 Yi Lin Gai Cuo, 565 yin, 596 Yin Qiao San, 568 Yin, Yang, 548 Yishui School, 560 Yi Zong Jin Jian, 565, 598, 604 Yokukansan, 443 Yon Yao Xin Fa, 564 Yoshimasu Nangai, 405 Yoshimasu Todo, 405 You Ke Fa Hui, 564 You Yi, 567 Yuan Shi, 558 Yu Chang, 567 Yun Shujue, 573 Yun Tieqiao, 570 Yu Wuyan, 571

22 Yaoan Medical Books, 573 Yakazu Domei, 410 Yakazu Yudo, 410 Yakucho, 405 Yamawaki Toyo, 404 Yanagiya Sorei, 411 yang, 596 Yang Jie, 557 Yang Shangshan, 553 Yang Shoujing, 406 Yang Xing Yan Ming Lu, 603, 609 Yang Xuancao, 554 Yao Lei Xin Fa, 564

zang-fu, 596 Zang Fu Biao Ben Yao Shi, 564 zang-fu organs, 547 zang-fu theory, 583 zang-xiang theory, 583 Zenkisei, 413 Zhang Congzheng, 557, 599, 600 Zhang Jiebin, 565, 567 Zhang Jingyue, 566 Zhang Shixian, 566 Zhang Suichen, 567 Zhang Wuren, 567 Zhang Xiju, 567

Index  773

Zhang Yuansu, 557 Zhang Zanchen, 571 Zhang Zhicong, 567, 568 Zhang Zhongjing, 400, 596 Zhao Xuemin, 569 Zheng Gu Xin Fa Yao Zhi, 600 Zheng He Xin Xiu Jing Shi Zheng Lei Bei Yong Ben Cao, 563 Zheng Yang San, 562 Zhen Jiu Da Cheng, 564 Zhen Jiu Feng Yuan, 598 Zhen Jiu Zi Sheng Jing, 597 Zhen Zhu Nang, 564 Zhi Bao Dan, 608 Zhi Facun, 553 Zhou Hou Bei Ji Fang, 599 Zhou Yangjun, 567

Zhou Yi, 549 Zhou Yuxi, 573 Zhuangzi, 601 Zhuan ji Shang Han Shi Yan Jing Fa, 567 Zhubingyuanhoulun, 401 Zhu Bing Yuan Hou Lun, 554, 603 Zhu Danxi, 400, 557, 611 Zhu Qian, 553 Zhu Weiju, 570 Zhu Zhenheng, 557, 559 Zihuazi, 601 Zi Xue Dan, 608 Zoshi, 404 Zuan Lei Ben Cao, 563 Zuo Zhuan, 594