Homeopathy 9788132329824, 9781283490955, 1283490951, 8132329821

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First Edition, 2012

ISBN 978-81-323-2982-4

© All rights reserved. Published by: Orange Apple 4735/22 Prakashdeep Bldg, Ansari Road, Darya Ganj, Delhi - 110002 Email: [email protected] 

Table of Contents Chapter 1 - Homeopathy Chapter 2 - Homeopathic Dilutions Chapter 3 - Electrohomeopathy Chapter 4 - Substances used in Homeopathy Chapter 5 - Regulation and Prevalence of Homeopathy Chapter 6 - Homeopathic Remedies Chapter 7 - Anthroposophical Medicine Chapter 8 - Water Memory Chapter 9 - Placebo

Chapter 1

Homeopathy

Homeopathy (also spelled homoeopathy or homœopathy) is a form of alternative medicine in which practitioners treat patients using highly diluted preparations that are believed to cause healthy people to exhibit symptoms that are similar to those exhibited by the patient. The collective weight of scientific evidence has found homeopathy to be no more effective than a placebo. The basic principle of homeopathy, known as the law of similars, is "let like be cured by like". It was first stated by German physician Samuel Hahnemann in 1796. Principles of homeopathy are taken on his word and are not based on the scientific method. Homeopathic “remedies” are prepared by serial dilution with shaking by forceful striking on an elastic body, which homeopaths term succussion. Each dilution followed by succussion is assumed to increase the effectiveness. Homeopaths call this process potentization. Dilution often continues until none of the original substance remains. Apart from the symptoms, homeopaths examine aspects of the patient's physical and psychological state, then homeopathic reference books known as repertories are consulted, and a “remedy” is selected based on the totality of symptoms. While some individual studies have positive results, systematic reviews of published trials fail to demonstrate efficacy. Furthermore, higher quality trials tend to report results that are less positive, and most positive studies have not been replicated or show methodological problems that prevent them from being considered unambiguous evidence of homeopathy's efficacy. Depending on the dilution, homeopathic “remedies” may not contain any pharmacologically active molecules, and for such “remedies” to have pharmacological effect would violate fundamental principles of science. Modern homeopaths have proposed that water has a memory that allows homeopathic preparations to work without any of the original substance; however, there are no verified observations nor scientifically plausible physical mechanisms for such a phenomenon. The lack of convincing scientific evidence to support homeopathy's efficacy and its use of “remedies” lacking active ingredients have caused homeopathy to be described as pseudoscience, quackery, and a "cruel deception". Homeopathic “remedies” are safe at high dilutions

recommended by Hahnemann, since they likely contain no molecules of the original substance, but they may not be safe at lower dilutions. Homeopathy has been criticized for putting patients at risk due to advice against conventional medicine such as vaccinations, anti-malarial drugs, and antibiotics. The regulation and prevalence of homeopathy is highly variable from country to country. There are no specific legal regulations concerning its use in some countries, while in others, licenses or degrees in conventional medicine from accredited universities are required. In several countries, homeopathy is covered by the national insurance to different extents, while in some it is fully integrated into the national health care system. In many countries, the laws that govern the regulation and testing of conventional drugs do not apply to homeopathic “remedies”.

Philosophy

A homeopathic “remedy” prepared from marsh Labrador tea. The "15C" dilution shown here contains no molecules of the original herb. Homeopathy is a vitalist philosophy which interprets diseases and sickness as caused by disturbances in a hypothetical vital force or life force. It sees these disturbances as manifesting themselves as unique symptoms. Homeopathy maintains that the vital force has the ability to react and adapt to internal and external causes, which homeopaths refer to as the law of susceptibility. The law of susceptibility implies that a negative state of mind can attract hypothetical disease entities called miasms to invade the body and produce symptoms of diseases. However, Hahnemann rejected the notion of a disease as a separate thing or invading entity and insisted that it was always part of the "living whole". Hahnemann proposed homeopathy in reaction to the state of traditional western medicine at that time, which often was brutal and more harmful than helpful. Hahnemann coined the expression "allopathic medicine" to pejoratively refer to traditional western medicine.

Hahnemann's "Law of similars" Hahnemann observed from his experiments with cinchona bark, used as a treatment for malaria, that the effects he experienced from ingesting the bark were similar to the symptoms of malaria. He therefore decided that cure proceeds through similarity, and that treatments must be able to produce symptoms in healthy individuals similar to those of the disease being treated. Through further experiments with other substances, Hahnemann conceived of the law of similars, otherwise known as "let like be cured by

like" (Latin: similia similibus curentur) as a fundamental healing principle. He believed that by using drugs to induce symptoms, the artificial symptoms would stimulate the vital force, causing it to neutralise and expel the original disease and that this artificial disturbance would naturally subside when the dosing ceased. It is based on the belief that a substance that in large doses will produce symptoms of a specific disease will, in extremely small doses, cure it. Hahnemann's law of similars is an "ipse dixit" "axiom", in other words an unproven assertion made by Hahnemann, and not a true law of nature.

Miasms and disease In 1828, Hahnemann introduced the concept of miasms; underlying causes for many known diseases. A miasm is often defined by homeopaths as an imputed "peculiar morbid derangement of [the] vital force". Hahnemann associated each miasm with specific diseases, with each miasm seen as the root cause of several diseases. According to Hahnemann, initial exposure to miasms causes local symptoms, such as skin or venereal diseases, but if these symptoms are suppressed by medication, the cause goes deeper and begins to manifest itself as diseases of the internal organs. Homeopathy maintains that treating diseases by directly opposing their symptoms, as is sometimes done in conventional medicine, is ineffective because all "disease can generally be traced to some latent, deep-seated, underlying chronic, or inherited tendency". The underlying imputed miasm still remains, and deep-seated ailments can only be corrected by removing the deeper disturbance of the vital force. Hahnemann's miasm theory remains disputed and controversial within homeopathy even in modern times. In 1978, Anthony Campbell, then a consultant physician at The Royal London Homeopathic Hospital, criticised statements by George Vithoulkas claiming that syphilis, when treated with antibiotics, would develop into secondary and tertiary syphilis with involvement of the central nervous system. This conflicts with scientific studies, which indicate that penicillin treatment produces a complete cure of syphilis in more than 90% of cases. Campbell described this as "a thoroughly irresponsible statement which could mislead an unfortunate layman into refusing orthodox treatment". Originally Hahnemann presented only three miasms, of which the most important was "psora" (Greek for itch), described as being related to any itching diseases of the skin, supposed to be derived from suppressed scabies, and claimed to be the foundation of many further disease conditions. Hahnemann believed psora to be the cause of such diseases as epilepsy, cancer, jaundice, deafness, and cataracts. Since Hahnemann's time, other miasms have been proposed, some replacing one or more of psora's proposed functions, including tubercular miasms and cancer miasms. The theory of miasms has been criticized as an explanation developed by Hahnemann to preserve the system of homeopathy in the face of treatment failures, and for being inadequate to cover the many hundreds of sorts of diseases, as well as for failing to

explain disease predispositions as well as genetics, environmental factors and the unique disease history of each patient.

Diet, exercise, and hygiene Hahnemann stressed the importance of diet, exercise, and cleanliness. Hahnemann could only recommend diets based on what was available in Germany at that time, which has been considerably broadened in modern times. The state of European medicine at that time was terrible. It was governed by occult principles that required bleeding patients. European hospitals were frequently filthy. By introducing hygiene to his hospitals, and doing nothing but give remedies that contained only water or alcohol, this made a patient much less likely to die, resulting in a popularization of homeopathy in Europe.

Remedies

Homeopathic “remedy” Rhus toxicodendron, derived from poison ivy. “Remedy” is a technical term in homeopathy that refers to a substance prepared with a particular procedure and intended for treating patients; it is not to be confused with the generally accepted use of the word, which means "a medicine or therapy that cures disease or relieves pain". Homeopathic practitioners rely on two types of reference when prescribing “remedies”: Materia medica and repertories. A homeopathic Materia medica is a collection of "drug pictures", organised alphabetically by “remedy”, that describes the symptom patterns associated with individual “remedies”. A homeopathic repertory is an index of disease symptoms that lists “remedies” associated with specific symptoms.

Homeopathy uses many animal, plant, mineral, and synthetic substances in its “remedies”. Examples include Arsenicum album (arsenic oxide), Natrum muriaticum (sodium chloride or table salt), Lachesis muta (the venom of the bushmaster snake), Opium, and Thyroidinum (thyroid hormone). Homeopaths also use treatments called nosodes (from the Greek nosos, disease) made from diseased or pathological products such as fecal, urinary, and respiratory discharges, blood, and tissue. Homeopathic “remedies” prepared from healthy specimens are called sarcodes. Some modern homeopaths have considered more esoteric bases for “remedies”, known as imponderables because they do not originate from a material but from electromagnetic energy presumed to have been "captured" by alcohol or lactose. Examples include X-rays and sunlight. Recent ventures by homeopaths into even more esoteric substances include thunderstorms (prepared from collected rainwater). Today there are about 3,000 different “remedies” commonly used in homeopathy. Some homeopaths also use techniques that are regarded by other practitioners as controversial. These include paper "remedies", where the substance and dilution are written on a piece of paper and either pinned to the patient's clothing, put in their pocket, or placed under a glass of water that is then given to the patient, as well as the use of radionics to prepare “remedies”. Such practices have been strongly criticised by classical homeopaths as unfounded, speculative, and verging upon magic and superstition.

Preparation

Mortar and pestle used for grinding insoluble solids, including quartz and oyster shells, into homeopathic “remedies”.

In producing “remedies” for diseases, homeopaths use a process called dynamisation or potentisation whereby a substance is diluted with alcohol or distilled water and then vigorously shaken by ten hard strikes against an elastic body in a process called succussion. Hahnemann advocated using substances which produce symptoms like those of the disease being treated, but found that material doses intensified the symptoms and exacerbated the condition, sometimes causing dangerous toxic reactions. He therefore specified that the substances be diluted. Hahnemann believed that the succussion activated the vital energy of the diluted substance and made it stronger. To facilitate succussion, Hahnemann had a saddle-maker construct a special wooden striking board covered in leather on one side and stuffed with horsehair. Insoluble solids, such as quartz and oyster shell, are diluted by grinding them with lactose (trituration).

Dilutions Three logarithmic potency scales are in regular use in homeopathy. Hahnemann created the centesimal or C scale, diluting a substance by a factor of 100 at each stage. The centesimal scale was favored by Hahnemann for most of his life. A 2C dilution requires a substance to be diluted to one part in one hundred, and then some of that diluted solution diluted by a further factor of one hundred. This works out to one part of the original substance in 10,000 parts of the solution. A 6C dilution repeats this process six times, ending up with the original material diluted by a factor of 100−6=10−12 (one part in one trillion or 1/1,000,000,000,000). Higher dilutions follow the same pattern. In homeopathy, a solution that is more dilute is described as having a higher potency, and more dilute substances are considered by homeopaths to be stronger and deeper-acting "remedies". The end product is often so diluted that it is indistinguishable from the dilutant (pure water, sugar or alcohol). Hahnemann advocated 30C dilutions for most purposes (that is, dilution by a factor of 1060). In Hahnemann's time it was reasonable to assume that “remedies” could be diluted indefinitely, as the concept of the atom or molecule as the smallest possible unit of a chemical substance was just beginning to be recognized. The greatest dilution that is reasonably likely to contain one molecule of the original substance is 12C.

This bottle contains arnica montana (wolf's bane) D6, i.e. the nominal dilution is one part in a million (10-6). Some homeopaths developed a decimal scale (D or X), diluting the substance to ten times its original volume each stage. The D or X scale dilution is therefore half that of the same value of the C scale; for example, "12X" is the same level of dilution as "6C". Hahnemann never used this scale but it was very popular throughout the 19th century and still is in Europe. This potency scale appears to have been introduced in the 1830s by the American homeopath, Constantine Hering. In the last ten years of his life, Hahnemann also developed a quintamillesimal (Q) or LM scale diluting the drug 1 part in 50,000 parts of diluent. A given dilution on the Q scale is roughly 2.35 times its designation on the C scale. For example a “remedy” described as "20Q" has about the same concentration as a "47C" “remedy”.

X Scale, D Scale Ø 1X, D1 2X, D2 6X, D6 8X, D8 12X, D12 24X, D24

Ø — 1C 3C 4C

1:1 1:10 1:100 10−6 10−8

6C

10−12

60X, D60

30C 10−60

C Ratio Scale

12C 10−24

Note mother tincture (undiluted) described as low potency called higher potency than 1X by homeopaths allowable concentration of arsenic in U.S. drinking water

Has a 60% probability of containing one molecule of original material if one mole of the original substance was used. Dilution advocated by Hahnemann for most purposes; patient would need to consume 1041 pills (a billion times the mass of the Earth), or 1034 gallons of liquid “remedy” (10 billion times the volume of the Earth) to consume a single molecule of the original substance Moreover, since even in a 15C solution there would very likely be no molecules of the original substance left, the 30C solution would probably contain no molecules of water that had come into contact with the original substance.

400X, 200C 10−400 Dilution of popular homeopathic flu “remedy” Oscillococcinum D400 Critics and advocates of homeopathy alike commonly attempt to illustrate the dilutions involved in homeopathy with analogies. Hahnemann is reported to have joked that a suitable procedure to deal with an epidemic would be to empty a bottle of poison into Lake Geneva, if it could be succussed 60 times. Another example given by a critic of homeopathy states that a 12C solution is equivalent to a "pinch of salt in both the North and South Atlantic Oceans", which is approximately correct. One third of a drop of some original substance diluted into all the water on earth would produce a “remedy” with a concentration of about 13C. A popular homeopathic treatment for the flu is a 200C dilution of duck liver, marketed under the name Oscillococcinum. As there are only about 1080 atoms in the entire observable universe, a dilution of one molecule in the observable universe would be about 40C. Oscillococcinum would thus require 10320 more universes to simply have one molecule in the final substance. The high dilutions characteristically used are often considered to be the most controversial and implausible aspect of homeopathy. Dilution debate Not all homeopaths advocate extremely high dilutions. Many of the early homeopaths were originally doctors and generally used lower dilutions such as "3X" or "6X", rarely going beyond "12X". The split between lower and higher dilutions followed ideological

lines. Those favoring low dilutions stressed pathology and a strong link to conventional medicine, while those favoring high dilutions emphasised vital force, miasms and a spiritual interpretation of disease. Some products with such relatively lower dilutions continue to be sold, but like their counterparts, they have not been conclusively demonstrated to have any effect beyond that of a placebo.

Provings Hahnemann experimented on himself and others for several years before using “remedies” on patients. His experiments did not initially consist of giving “remedies” to the sick, because he thought that the most similar “remedy”, by virtue of its ability to induce symptoms similar to the disease itself, would make it impossible to determine which symptoms came from the “remedy” and which from the disease itself. Therefore, sick people were excluded from these experiments. The method used for determining which “remedies” were suitable for specific diseases was called proving, after the original German word Prüfung, meaning "test". A homeopathic proving is the method by which the profile of a homeopathic “remedy” is determined. At first Hahnemann used material doses for provings, but he later advocated proving with “remedies” at a 30C dilution, and most modern provings are carried out using ultradilute “remedies” in which it is highly unlikely that any of the original molecules remain. During the proving process, Hahnemann administered “remedies” to healthy volunteers, and the resulting symptoms were compiled by observers into a drug picture. The volunteers were observed for months at a time and made to keep extensive journals detailing all of their symptoms at specific times throughout the day. They were forbidden from consuming coffee, tea, spices, or wine for the duration of the experiment; playing chess was also prohibited because Hahnemann considered it to be "too exciting", though they were allowed to drink beer and encouraged to exercise in moderation. After the experiments were over, Hahnemann made the volunteers take an oath swearing that what they reported in their journals was the truth, at which time he would interrogate them extensively concerning their symptoms. Provings have been described as important in the development of the clinical trial, due to their early use of simple control groups, systematic and quantitative procedures, and some of the first application of statistics in medicine. The lengthy records of selfexperimentation by homeopaths have occasionally proven useful in the development of modern drugs: For example, evidence that nitroglycerin might be useful as a treatment for angina was discovered by looking through homeopathic provings, though homeopaths themselves never used it for that purpose at that time. The first recorded provings were published by Hahnemann in his 1796 Essay on a New Principle. His Fragmenta de Viribus (1805) contained the results of 27 provings, and his 1810 Materia Medica Pura contained 65. For James Tyler Kent's 1905 Lectures on Homoeopathic Materia Medica, 217 “remedies” underwent provings and newer substances are continually added to contemporary versions.

Physical, mental, and emotional state examination; Repertories

Homeopathic repertory by James Tyler Kent. Homeopaths generally begin with detailed examinations of their patients' histories, including questions regarding their physical, mental and emotional states, their life circumstances and any physical or emotional illnesses. Examination of psychological state may include an inquiry into the content of dreams. The homeopath then attempts to translate this information into a complex formula of mental and physical symptoms, including likes, dislikes, innate predispositions and even body type. From these symptoms, the homeopath chooses how to treat the patient. A compilation of reports of many homeopathic provings, supplemented with clinical data, is known as a homeopathic materia medica. But because a practitioner first needs to explore the

“remedies” for a particular symptom rather than looking up the symptoms for a particular “remedy”, the homeopathic repertory, which is an index of symptoms, lists after each symptom those “remedies” that are associated with it. Repertories are often very extensive and may include data extracted from multiple sources of materia medica. There is often lively debate among compilers of repertories and practitioners over the veracity of a particular inclusion. The first symptomatic index of the homeopathic materia medica was arranged by Hahnemann. Soon after, one of his students Clemens von Bönninghausen, created the Therapeutic Pocket Book, another homeopathic repertory. The first such homeopathic repertory was Georg Jahr's Symptomenkodex, published in German (1835), which was then first translated to English (1838) by Constantine Hering as the Repertory to the more Characteristic Symptoms of Materia Medica. This version was less focused on disease categories and would be the forerunner to Kent's later works. It consisted of three large volumes. Such repertories increased in size and detail as time progressed. Some diversity in approaches to treatments exists among homeopaths. Classical homeopathy generally involves detailed examinations of a patient's history and infrequent doses of a single “remedy” as the patient is monitored for improvements in symptoms, while clinical homeopathy involves combinations of “remedies” to address the various symptoms of an illness.

Homeopathic pills

Homeopathic pills, homeopathic “remedy” Oscillococcinum Homeopathic pills are made from an inert substance (often sugars, typically lactose), upon which a drop of liquid “remedy” is placed. Depending on the dilution, when the drops have evaporated from the pills, there may be no "remedy" left.

"Active" ingredients The list of ingredients seen on “remedies” may confuse consumers into believing that the product actually contains those ingredients. According to normal homeopathic practice, “remedies” are prepared starting with active ingredients which are often serially diluted to the point where the finished product no longer contains any biologically "active ingredients" as that term is normally defined. The list of ingredients normally refers to the ingredients originally used in their preparation. Following is a demonstrative example:

Zicam Cold Remedy is marketed as an "unapproved homeopathic" product. It contains a number of highly diluted ingredients which are listed as "inactive ingredients" on the label. Some of the homeopathic ingredients used in the preparation of Zicam are galphimia glauca, histamine dihydrochloride (homeopathic name, histaminum hydrochloricum), luffa operculata, and sulfur. Although the product is marked "homeopathic", it does contain two ingredients that are only slightly diluted, zinc acetate (2X = 1/100th dilution) and zinc gluconate (1X = 1/10th dilution), which means that both are present in a concentration that contains biologically active ingredients. In fact, they are strong enough to have caused some people to lose their sense of smell, a condition termed anosmia. This illustrates why taking a product marked "homeopathic", especially an overdose, can still be dangerous because it may contain biologically active ingredients. Although some marketers of “remedies” state that one "cannot overdose on homeopathic medicines", scientific skeptics who wish to demonstrate the ineffectiveness of homeopathic products by taking large overdoses, as was done by the 10:23 campaign groups at 10:23 A.M., 30 January 2010, must ensure that all of the original ingredients have been highly diluted so there are no longer any "active" ingredients. None of the hundreds of demonstrators in the UK, Australia, New Zealand, Canada and the USA were injured and "no one was cured of anything either".

Related practices Isopathy Isopathy is a therapy derived from homeopathy and was invented by Johann Joseph Wilhelm Lux in the 1830s. Isopathy differs from homeopathy in general in that the “remedies”, known as "nosodes", are made up either from things that cause the disease, or from products of the disease, such as pus. Many so-called "homeopathic vaccines" are a form of isopathy.

Flower “remedies” Flower “remedies” can be produced by placing flowers in water and exposing them to sunlight. The most famous of these are the Bach flower “remedies”, which were developed by the physician and homeopath Edward Bach. Although the proponents of these “remedies” share homeopathy's vitalist world-view and the “remedies” are claimed to act through the same hypothetical "vital force" as homeopathy, the method of preparation is different. Bach flower “remedies” are prepared in "gentler" ways such as placing flowers in bowls of sunlit water, and the “remedies” are not succussed. There is no convincing scientific or clinical evidence for flower “remedies” being effective.

Veterinary use The idea of using homeopathy as a treatment for other animals, termed veterinary homeopathy, dates back to the inception of homeopathy; Hahnemann himself wrote and spoke of the use of homeopathy in animals other than humans. The FDA has not

approved homeopathic products as veterinary medicine in the U.S. In the UK, veterinary surgeons who use homeopathy belong to the Faculty of Homeopathy and/or to the British Association of Homeopathic Veterinary Surgeons. Animals may only be treated by qualified veterinary surgeons in the UK and some other countries. Internationally, the body that supports and represents homeopathic veterinarians is the International Association for Veterinary Homeopathy. The use of homeopathy in veterinary medicine is controversial, as there has been little scientific investigation and current research in the field is not of a high enough standard to provide reliable data. Other studies have also found that giving animals placebos can play active roles in influencing pet owners to believe in the effectiveness of the treatment when none exists.

Electrohomeopathy Electrohomeopathy was a 19th century practice combining homeopathy with electric treatment.

Evidence Homeopathy's efficacy is unsupported by the collective weight of modern scientific research. The extreme dilutions used in homeopathic preparations usually leave none of the original material in the final product. The modern mechanism proposed by homeopaths, water memory, is considered implausible in that short-range order in water only persists for about 1 picosecond. Pharmacological effect without active ingredients is inconsistent with the observed dose-response relationships of conventional drugs, leaving only non-specific placebo effects or various novel explanations. The proposed rationale for these extreme dilutions – that the water contains the "memory" or "vibration" from the diluted ingredient – is counter to the laws of chemistry and physics, such as the law of mass action. The lack of convincing scientific evidence supporting its efficacy and its use of “remedies” without active ingredients have led to characterizations as pseudoscience and quackery, or, in the words of a 1998 medical review, "placebo therapy at best and quackery at worst." Use of homeopathy may delay or replace effective medical treatment, worsening outcomes or exposing the patients to increased risk. Referring specifically to homeopathy, the British House of Commons Science and Technology Committee has stated: In the Committee’s view, homeopathy is a placebo treatment and the Government should have a policy on prescribing placebos. The Government is reluctant to address the appropriateness and ethics of prescribing placebos to patients, which usually relies on some degree of patient deception. Prescribing of placebos is not consistent with informed patient choice-which the Government claims is very important-as it means patients do not have all the information needed to make choice meaningful. Beyond ethical issues and the integrity of the doctor-patient relationship, prescribing pure placebos is bad medicine. Their effect is unreliable and unpredictable and cannot form the sole basis of any treatment on the NHS.

The National Center for Complementary and Alternative Medicine of the United States' National Institutes of Health states: Homeopathy is a controversial area of CAM because a number of its key concepts are not consistent with established laws of science (particularly chemistry and physics). Critics think it is implausible that a “remedy” containing a miniscule amount of an active ingredient (sometimes not a single molecule of the original compound) can have any biological effect—beneficial or otherwise. For these reasons, critics argue that continuing the scientific study of homeopathy is not worthwhile. Others point to observational and anecdotal evidence that homeopathy does work and argue that it should not be rejected just because science has not been able to explain it.

High dilutions The extremely high dilutions in homeopathy have been a main point of criticism. Homeopathic “remedies” are usually diluted to the point where there are no molecules from the original solution left in a dose of the final “remedy”. Homeopaths believe that the methodical dilution of a substance, beginning with a 10% or lower solution and working downwards, with shaking after each dilution, produces a therapeutically active “remedy”, in contrast to therapeutically inert water. Since even the longest-lived noncovalent structures in liquid water at room temperature are only stable for a few picoseconds, critics have concluded that any effect that might have been present from the original substance can no longer exist. No evidence of stable clusters of water molecules was found when homeopathic “remedies” were studied using NMR. Furthermore, since water will have been in contact with millions of different substances throughout its history, critics point out that water is therefore an extreme dilution of almost any conceivable substance. By drinking water one would, according to this interpretation, receive treatment for every imaginable condition. Practitioners of homeopathy contend that higher dilutions produce stronger medicinal effects. This idea is inconsistent with the observed dose-response relationships of conventional drugs, where the effects are dependent on the concentration of the active ingredient in the body. This dose-response relationship has been confirmed in multitudinous experiments on organisms as diverse as nematodes, rats, and humans. Physicist Robert L. Park, former executive director of the American Physical Society, has noted that “

since the least amount of a substance in a solution is one molecule, a 30C solution would have to have at least one molecule of the original substance dissolved in a minimum of 1,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000 molecules of water. This would require a container more than 30,000,000,000 times the size of the Earth.

”

Park has also noted that "to expect to get even one molecule of the 'medicinal' substance allegedly present in 30X pills, it would be necessary to take some two billion of them, which would total about a thousand tons of lactose plus whatever impurities the lactose contained". The laws of chemistry state that there is a limit to the dilution that can be made without losing the original substance altogether. This limit, which is related to Avogadro's number, is roughly equal to homeopathic potencies of 12C or 24X (1 part in 1024). Scientific tests run by both the BBC's Horizon and ABC's 20/20 programs were unable to differentiate homeopathic dilutions from water, even when using tests suggested by homeopaths themselves.

Effectiveness

Old bottle of Hepar sulph made from calcium sulfide The effectiveness of homeopathy has been in dispute since its inception. One of the earliest double blind studies concerning homeopathy was sponsored by the British government during World War II in which volunteers tested the effectiveness of homeopathic “remedies” against diluted mustard gas burns. The methodological quality of the research base is generally low, with such problems as weaknesses in design or reporting, small sample size, and selection bias. No individual preparation has been

unambiguously demonstrated to be different from a placebo. Further, as the quality of the trials become better, the evidence for homeopathy preparations being effective diminishes, and the highest-quality trials show that the “remedies” themselves have no effect. Abstract concepts within theoretical physics have been invoked to suggest explanations of how or why “remedies” might work, including quantum entanglement, the theory of relativity and chaos theory. However, the explanations are offered by nonspecialists within the field, and often include speculations which are incorrect in their application of the concepts and not supported by actual experiments. A 2010 inquiry into the evidence base for homeopathy conducted by the United Kingdom's House of Commons Science and Technology Committee concluded that homeopathy is no more effective than placebo.

Meta-analyses Meta-analyses, in which large groups of studies are analysed and conclusions drawn based on the results as a whole, have been used to evaluate the effectiveness of homeopathy. Early meta-analyses investigating homeopathic “remedies” showed slightly positive results among the studies examined, but such studies have warned that it was impossible to draw firm conclusions due to low methodological quality and difficulty in controlling for publication bias in the studies reviewed. One of the positive metaanalyses, by Linde, et al., was later qualified by the authors, who wrote: The evidence of bias [in homeopathic trials] weakens the findings of our original metaanalysis. Since we completed our literature search in 1995, a considerable number of new homeopathy trials have been published. The fact that a number of the new high-quality trials...have negative results, and a recent update of our review for the most "original" subtype of homeopathy (classical or individualized homeopathy), seem to confirm the finding that more rigorous trials have less-promising results. It seems, therefore, likely that our meta-analysis at least overestimated the effects of homeopathic treatments. In 2001, a meta-analysis of clinical trials on the effectiveness of homeopathy concluded that earlier clinical trials showed signs of major weakness in methodology and reporting, and that homeopathy trials were less randomized and reported less on dropouts than other types of trials. In 2002, a review of systematic reviews found that higher-quality trials tended to have less positive results, to the point that those results were clinically irrelevant. Also, when taking collectively all the systematic reviews, there was no convincing evidence that any homeopathic “remedy” had better effects than placebo, and current evidence did not allow to recommend its usage in clinical treatment. In 2005, a systematic review of the representation of homeopathy in the medical literature suggested that mainstream journals had a publication bias against clinical trials of homeopathy that showed positive results, and the opposite was the case for complementary and alternative medicine journals. The authors suggested that this could be due to an involuntary bias, or otherwise a submission bias, in which positive trials tend

to be sent to CAM journals and negatives ones to mainstream journals. Reviews in all journals approached the subject in an apparently impartial manner, though most of the reviews published in CAM journals made no mention of the plausibility of homeopathy, whereas 9 out of 10 reviews in mainstream journals mentioned a lack of plausibility of homeopathy in the introduction. In 2005, The Lancet medical journal published a meta-analysis of 110 placebo-controlled homeopathy trials and 110 matched medical trials based upon the Swiss government's Program for Evaluating Complementary Medicine, or PEK. The study concluded that its findings were compatible with the notion that the clinical effects of homeopathy are nothing more than placebo effects. A 2006 meta-analysis of six trials evaluating homeopathic treatments to reduce cancer therapy side effects following radiotherapy and chemotherapy found "encouraging but not convincing" evidence in support of homeopathic treatment. Their analysis concluded that there was "insufficient evidence to support clinical efficacy of homeopathic therapy in cancer care". A 2007 systematic review of homeopathy for children and adolescents found that the evidence for attention-deficit hyperactivity disorder and childhood diarrhea was mixed. No difference from placebo was found for adenoid vegetation, asthma, or upper respiratory tract infection. Evidence was not sufficient to recommend any therapeutic or preventative intervention. The Cochrane Library found insufficient clinical evidence to evaluate the efficacy of homeopathic treatments for asthma dementia, or for the use of homeopathy in induction of labor. Other researchers found no evidence that homeopathy is beneficial for osteoarthritis, migraines or delayed-onset muscle soreness. Health organisations such as the UK's National Health Service, the American Medical Association, and the FASEB have issued statements of their conclusion that there is no convincing scientific evidence to support the use of homeopathic treatments in medicine. Clinical studies of the medical efficacy of homeopathy have been criticised by some homeopaths as being irrelevant because they do not test "classical homeopathy". There have, however, been a number of clinical trials that have tested individualized homeopathy. A 1998 review found 32 trials that met their inclusion criteria, 19 of which were placebo-controlled and provided enough data for meta-analysis. These 19 studies showed a pooled odds ratio of 1.17 to 2.23 in favor of individualized homeopathy over the placebo, but no difference was seen when the analysis was restricted to the methodologically best trials. The authors concluded "that the results of the available randomized trials suggest that individualized homeopathy has an effect over placebo. The evidence, however, is not convincing because of methodological shortcomings and inconsistencies." Jay Shelton, author of a book on homeopathy, has stated that the claim assumes without evidence that classical, individualized homeopathy works better than nonclassical variations.

Jack Killen, acting deputy director of the National Center for Complementary and Alternative Medicine, says homeopathy "goes beyond current understanding of chemistry and physics." He adds: "There is, to my knowledge, no condition for which homeopathy has been proven to be an effective treatment." Explanations of effects Mainstream science offers a variety of explanations for how homeopathy, if the preparations themselves are ineffective, may appear to cure diseases or alleviate symptoms: • • •

•

•

•

•

•

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Unassisted natural healing — time and the body's ability to heal without assistance can eliminate many diseases of their own accord Unrecognized treatments — an unrelated food, exercise, environmental agent or treatment for a different ailment, may have occurred Regression toward the mean — since many diseases or conditions are cyclical, symptoms vary over time and patients tend to seek care when discomfort is greatest, they may feel better anyway but because the timing of the visit to the homeopath they attribute improvement to the “remedy” taken Non-homeopathic treatment — patients may also receive non-homeopathic care simultaneous with homeopathic treatment, and this is responsible for improvement though a portion or all of the improvement may be attributed to the “remedy” Cessation of unpleasant treatment — often homeopaths recommend patients stop getting conventional treatment such as surgery or drugs, which can cause unpleasant side effects; improvements are attributed to homeopathy when the actual cause is the cessation of the treatment causing side effects in the first place Lifestyle changes — homeopaths often recommend diet and exercise, as well as limitations in alcohol or coffee consumption and stress reduction, all of which can increase health and decrease symptoms The placebo effect — the intensive consultation process and expectations for the homeopathic preparations can result in the release of endorphins or other bodyeffecting chemicals which alleviate pain or other symptoms, or otherwise affect an individual's biology Psychological healing — the care, concern and reassurance provided by a homeopath as part of the consultation can assure the patient the symptoms are minor and easily treated, or alleviate tension that could exacerbate a preexisting condition. This caring engagement can prove particularly effective when conventional physicians have limited time with the patient or cannot provide a diagnosis or treatment. Publishing standards, p-value - Even if something is not effective, the way publishing works means that you must still expect about 1 in 20 tests to show that it is effective. The standard to publish a “positive effect” is as follows - If something is assumed to be false, and then the outcome of the experiment has only about a 1 in 20 chance of happening, then you can publish that it is effective.

This means that about 1 in 20 tests will show homeopathy works, even if it is in fact false. •

•

Publication bias - If a believer in something conducts a test of homeopathy and the test says that something is wrong, they might not publish that there will be no effect, because that would mean they are wrong in their belief. But they would be expected to publish when there is a positive effect, because this means their belief is not wrong. So many of the “disproving” tests of that something may not get published. Even though something is false, since we already expect about 1 in 20 tests to erroneously show it is true, we get even more than about 1 in 20 publications showing that homeopathy is not false. This is called publication bias. A meta-analysis combines the results of several studies. A systematic review is a literature review focused on a research question that tries to identify, appraise, select and synthesize all high quality research evidence relevant to that question.

Effects in other biological systems

Old homeopathic belladonna “remedy”. While some articles have suggested that homeopathic solutions of high dilution can have statistically significant effects on organic processes including the growth of grain, histamine release by leukocytes, and enzyme reactions, such evidence is disputed since attempts to replicate them have failed. In 1987, French immunologist Jacques Benveniste submitted a paper to the journal Nature while working at INSERM. The paper purported to have discovered that basophils, a type of white blood cell, released histamine when exposed to a homeopathic dilution of anti-immunoglobulin E antibody. The journal editors, sceptical of the results, requested that the study be replicated in a separate laboratory. Upon replication in four separate laboratories the study was published. Still sceptical of the findings, Nature

assembled an independent investigative team to determine the accuracy of the research, consisting of Nature editor and physicist Sir John Maddox, American scientific fraud investigator and chemist Walter Stewart, and sceptic and magician James Randi. After investigating the findings and methodology of the experiment, the team found that the experiments were "statistically ill-controlled", "interpretation has been clouded by the exclusion of measurements in conflict with the claim", and concluded, "We believe that experimental data have been uncritically assessed and their imperfections inadequately reported." James Randi stated that he doubted that there had been any conscious fraud, but that the researchers had allowed "wishful thinking" to influence their interpretation of the data.

Methodological and publication issues Ben Goldacre published an article on homeopathy in The Lancet, stating the research on homeopathy is problematic for a variety of reasons. These included the high publication biases of alternative therapy journals, with very few articles reporting null results; ignoring meta-analytic studies in favour of cherry picked positive results; and the promotion of an observational study (that Goldacre described as "little more than a customer-satisfaction survey") as if it were more informative than a series of randomized trials. Goldacre also states that homeopaths who misrepresent scientific evidence to a scientifically illiterate public, have "...walled themselves off from academic medicine, and critique has been all too often met with avoidance rather than argument."

Ethics and safety As homeopathic “remedies” usually contain only water and/or alcohol, they are thought to be generally safe. Only in rare cases are the original ingredients present at detectable levels. This may be due to improper preparation or intentional low dilution. Instances of arsenic poisoning have occurred after use of arsenic-containing homeopathic preparations. Zicam Cold “remedy” Nasal Gel, which contains 2X (1:100) zinc gluconate, reportedly caused a small percentage of users to lose their sense of smell; 340 cases were settled out of court in 2006 for 12 million U.S. dollars. In 2009, the FDA advised consumers to stop using three discontinued cold “remedy” products manufactured by Zicam because it could cause permanent damage to users' sense of smell. Zicam was launched without a New Drug Application (NDA) under a provision in the FDA’s Compliance Policy Guide called "Conditions Under Which Homeopathic Drugs May be Marketed" (CPG 7132.15), but the FDA warned Zicam via a Warning Letter that this policy does not apply when there is a health risk to consumers. Critics of homeopathy have cited other concerns over homeopathic medicine, most seriously cases of patients of homeopathy failing to receive proper treatment for diseases that could have been easily diagnosed and managed with conventional medicine and who have died as a result and the "marketing practice" of criticizing and downplaying the effectiveness of mainstream medicine. Homeopaths claim that use of conventional medicines will "push the disease deeper" and cause more serious conditions, a process referred to as "suppression". Some homeopaths (particularly those who are non-

physicians) advise their patients against immunisation. Some homeopaths suggest that vaccines be replaced with homeopathic "nosodes", created from biological material such as pus, diseased tissue, bacilli from sputum or (in the case of "bowel nosodes") feces. While Hahnemann was opposed to such preparations, modern homeopaths often use them although there is no evidence to indicate they have any beneficial effects. Cases of homeopaths advising against the use of anti-malarial drugs have been identified. This puts visitors to the tropics who take this advice in severe danger, since homeopathic “remedies” are completely ineffective against the malaria parasite. Also, in one case in 2004, a homeopath instructed one of her patients to stop taking conventional medication for a heart condition, advising her on 22 June 2004 to "Stop ALL medications including homeopathic", advising her on or around 20 August that she no longer needed to take her heart medication, and adding on 23 August, "She just cannot take ANY drugs – I have suggested some homeopathic remedies ... I feel confident that if she follows the advice she will regain her health." The patient was admitted to hospital the next day, and died eight days later, the final diagnosis being "acute heart failure due to treatment discontinuation". In 1978, Anthony Campbell, then a consultant physician at The Royal London Homeopathic Hospital, criticised statements made by George Vithoulkas to promote his homeopathic treatments. Vithoulkas stated that syphilis, when treated with antibiotics, would develop into secondary and tertiary syphilis with involvement of the central nervous system. Campbell described this as a thoroughly irresponsible statement which could mislead an unfortunate layman into refusing conventional medical treatment. This claim echoes the idea that treating a disease with external medication used to treat the symptoms would only drive it deeper into the body and conflicts with scientific studies, which indicate that penicillin treatment produces a complete cure of syphilis in more than 90% of cases. A 2006 review by W. Steven Pray of the College of Pharmacy at Southwestern Oklahoma State University recommends that pharmacy colleges include a required course in unproven medications and therapies, that ethical dilemmas inherent in recommending products lacking proven safety and efficacy data be discussed, and that students should be taught where unproven systems such as homeopathy depart from evidence-based medicine. Edzard Ernst, the first Professor of Complementary Medicine in the United Kingdom and a former homeopathic practitioner, has expressed his concerns about pharmacists who violate their ethical code by failing to provide customers with "necessary and relevant information" about the true nature of the homeopathic products they advertise and sell: "My plea is simply for honesty. Let people buy what they want, but tell them the truth about what they are buying. These treatments are biologically implausible and the clinical tests have shown they don't do anything at all in human beings. The argument that this information is not relevant or important for customers is quite simply ridiculous."

Michael Baum, Professor Emeritus of Surgery and visiting Professor of Medical Humanities at University College London (UCL), has described homoeopathy as a “cruel deception”. In an article entitled "Should We Maintain an Open Mind about Homeopathy?" published in the American Journal of Medicine, Michael Baum and Edzard Ernst—writing to other physicians—wrote that "Homeopathy is among the worst examples of faith-based medicine... These axioms [of homeopathy] are not only out of line with scientific facts but also directly opposed to them. If homeopathy is correct, much of physics, chemistry, and pharmacology must be incorrect...".

Regulation and prevalence

Hampton House, the former site of Bristol Homeopathic Hospital, one of two homeopathic hospitals run by the NHS.

Homeopathy is fairly common in some countries while being uncommon in others; is highly regulated in some countries and mostly unregulated in others. It is practised worldwide and professional qualifications and licences are needed in most countries. Regulations vary in Europe depending on the country. In some countries, there are no specific legal regulations concerning the use of homeopathy, while in others, licences or degrees in conventional medicine from accredited universities are required. In Germany, no specific regulations exist, while France, Austria and Denmark mandate licences to diagnose any illness or dispense of any product whose purpose is to treat any illness. Some homeopathic treatment is covered by the public health service of several European countries, including France, the United Kingdom, Denmark, and Luxembourg. In other countries, such as Belgium, homeopathy is not covered. In Austria, the public health service requires scientific proof of effectiveness in order to reimburse medical treatments and homeopathy is listed as not reimbursable but exceptions can be made; private health insurance policies sometimes include homeopathic treatment. The Swiss government, after a 5-year trial, withdrew homeopathy and four other complementary treatments in 2005, stating that they did not meet efficacy and cost-effectiveness criteria, but following a referendum in 2009 the five therapies are to be reinstated for a further 6-year trial period from 2012. The Indian government recognises homeopathy as one of its national systems of medicine, and a minimum of a recognised diploma in homeopathy and registration on a state register or the Central Register of Homoeopathy is required to practice homeopathy in India. In the United Kingdom, MPs inquired into homeopathy to assess the Government's policy on the issue, including funding of homeopathy under the National Health Service and government policy for licensing homeopathic products. The decision by the House of Commons Science and Technology Committee follows a written explanation from the Government in which it told the select committee that the licensing regime was not formulated on the basis of scientific evidence. "The three elements of the licensing regime (for homeopathic products) probably lie outside the scope of the ... select committee inquiry, because government consideration of scientific evidence was not the basis for their establishment," the Committee said. The inquiry sought written evidence and submissions from concerned parties. In February 2010 the House of Commons Science and Technology Committee concluded that: ... the NHS should cease funding homeopathy. It also concludes that the Medicines and Healthcare products Regulatory Agency (MHRA) should not allow homeopathic product labels to make medical claims without evidence of efficacy. As they are not medicines, homeopathic products should no longer be licensed by the MHRA. The Committee concurred with the Government that the evidence base shows that homeopathy is not efficacious (that is, it does not work beyond the placebo effect) and that explanations for why homeopathy would work are scientifically implausible.

The Committee concluded - given that the existing scientific literature showed no good evidence of efficacy - that further clinical trials of homeopathy could not be justified. In the Committee’s view, homeopathy is a placebo treatment and the Government should have a policy on prescribing placebos. The Government is reluctant to address the appropriateness and ethics of prescribing placebos to patients, which usually relies on some degree of patient deception. Prescribing of placebos is not consistent with informed patient choice-which the Government claims is very important-as it means patients do not have all the information needed to make choice meaningful. Beyond ethical issues and the integrity of the doctor-patient relationship, prescribing pure placebos is bad medicine. Their effect is unreliable and unpredictable and cannot form the sole basis of any treatment on the NHS. The Committee also stated:

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We conclude that placebos should not be routinely prescribed on the NHS. The funding of homeopathic hospitals — hospitals that specialise in the administration of placebos — should not continue, and NHS doctors should not refer patients to homeopaths.

”

In July 2010 the newly elected UK Secretary of State for Health deferred to local NHS on funding homeopathy. A nineteen page document details the Government´s response, and it states that "our continued position on the use of homeopathy within the NHS is that the local NHS and clinicians, rather than Whitehall, are best placed to make decisions on what treatment is appropriate for their patients - including complementary or alternative treatments such as homeopathy - and provide accordingly for those treatments." The response also stated that "the overriding reason for NHS provision is that homeopathy is available to provide patient choice".

History

1857 painting by Alexander Beydeman showing historical figures and personifications of homeopathy observing the perceived brutality of medicine of the 19th century

Historical context An early assertion that like cures like was made by Hippocrates about 400 BC, when he prescribed mandrake root, which produced mania, to treat mania, by prescribing a dose smaller than what would produce mania. In the 16th century the pioneer of pharmacology Paracelsus declared that small doses of “what makes a man ill also cures him", anticipating homeopathy, but it was Hahnemann who gave it a name and laid out its principles in the late 18th century. At that time, mainstream medicine employed such measures as bloodletting and purging, used laxatives and enemas, and administered complex mixtures, such as Venice treacle, which was made from 64 substances including opium, myrrh, and viper's flesh. Such measures often worsened symptoms and sometimes proved fatal. While the virtues of these treatments had been extolled for centuries, Hahnemann rejected such methods as irrational and inadvisable. Instead, he favored the use of single drugs at lower doses and promoted an immaterial, vitalistic view of how living organisms function, believing that diseases have spiritual, as well as physical

causes. (At the time, vitalism was part of mainstream science; it wasn't completely discarded until the 20th century, with the development of microbiology, the germ theory of disease, and advances in chemistry.) Hahnemann also advocated various lifestyle improvements to his patients, including exercise, diet, and cleanliness.

Hahnemann's concept

Samuel Hahnemann, considered to be the father of homeopathy Hahnemann conceived of homeopathy while translating a medical treatise by Scottish physician and chemist William Cullen into German. Being skeptical of Cullen's theory concerning cinchona's action in malaria, Hahnemann ingested some of the bark specifically to see if it cured fever "by virtue of its effect of strengthening the stomach". Upon ingesting the bark, he noticed few stomach symptoms, but did experience fever, shivering and joint pain, symptoms similar to some of the early symptoms of malaria, the

disease that the bark was ordinarily used to treat. From this, Hahnemann came to believe that all effective drugs produce symptoms in healthy individuals similar to those of the diseases that they treat. This later became known as the "law of similars", the most important concept of homeopathy. The term "homeopathy" was coined by Hahnemann and first appeared in print in 1807, although he began outlining his theories of "medical similars" or the "doctrine of specifics" in a series of articles and monographs in 1796. Hahnemann began to test what effects substances produced in humans, a procedure which would later become known as "homeopathic proving". These time-consuming tests required subjects to clearly record all of their symptoms as well as the ancillary conditions under which they appeared. Hahnemann saw these data as a way of identifying substances suitable for the treatment of particular diseases. The first collection of provings was published in 1805 and a second collection of 65 “remedies” appeared in his book, Materia Medica Pura, in 1810. Hahnemann believed that large doses of drugs that caused similar symptoms would only aggravate illness, so he advocated extreme dilutions of the substances; he devised a technique for making dilutions that he believed would preserve a substance's therapeutic properties while removing its harmful effects, proposing that this process aroused and enhanced "spirit-like medicinal powers held within a drug". He gathered and published a complete overview of his new medical system in his 1810 book, The Organon of the Healing Art, whose 6th edition, published in 1921, is still used by homeopaths today.

19th century: rise to popularity and early criticism Homeopathy achieved its greatest popularity in the 19th century. Dr. John Franklin Gray (1804–1882) was the first practitioner of Homeopathy in the United States, beginning in 1828 in New York City. The first homeopathic schools opened in 1830, and throughout the 19th century dozens of homeopathic institutions appeared in Europe and the United States. By 1900, there were 22 homeopathic colleges and 15,000 practitioners in the United States. Because medical practice of the time relied on ineffective and often dangerous treatments, patients of homeopaths often had better outcomes than those of the doctors of the time. Homeopathic “remedies”, even if ineffective, would almost surely cause no harm, making the users of homeopathic “remedies” less likely to be killed by the treatment that was supposed to be helping them. The relative success of homeopathy in the 19th century may have led to the abandonment of the ineffective and harmful treatments of bloodletting and purging and to have begun the move towards more effective, science based medicine. One reason for the growing popularity of homeopathy was its apparent success in treating people suffering from infectious disease epidemics. During 19th century epidemics of diseases such as cholera, death rates in homeopathic hospitals were often lower than in conventional hospitals, where the treatments used at the time were often harmful and did little or nothing to combat the diseases. From its inception, however, homeopathy was criticized by mainstream science. Sir John Forbes, physician to Queen Victoria, said in 1843 that the extremely small doses of homeopathy were regularly derided as useless, "an outrage to human reason". James Young Simpson said in 1853 of the highly diluted drugs: "No poison, however strong or

powerful, the billionth or decillionth of which would in the least degree affect a man or harm a fly." 19th century American physician and author Oliver Wendell Holmes, Sr. was also a vocal critic of homeopathy and published an essay in 1842 entitled Homœopathy, and its kindred delusions. The members of the French Homeopathic Society observed in 1867 that some of the leading homeopathists of Europe were not only abandoning the practice of administering infinitesimal doses, but were also no longer defending it. The last school in the U.S. exclusively teaching homeopathy closed in 1920.

Revival in the late 20th century The Food, Drug, and Cosmetic Act of 1938 (sponsored by New York Senator and Homeopathic Physician Royal Copeland) recognized homeopathic “remedies” as drugs. By the 1950s there were only 75 pure homeopaths practicing in the U.S. However, in the mid to late 1970s, homeopathy made a significant comeback and sales of some homeopathic companies increased tenfold. Greek homeopath George Vithoulkas performed a "great deal of research to update the scenarios and refine the theories and practice of homeopathy" beginning in the 1970s, and it was revived worldwide; in Brazil during the 1970s and in Germany during the 1980s. The medical profession started to integrate such ideas in the 1990s and mainstream pharmacy chains recognized the business potential of selling homeopathic “remedies”.

Chapter 2

Homeopathic Dilutions

Homeopathy often involves a process called "dynamisation" or "potentisation" whereby a substance is diluted with alcohol or distilled water and then vigorously shaken in a process called "succussion". The founder of homeopathy, Samuel Hahnemann, believed that the process of succussion activated the vital energy of the diluted substance. Insoluble solids, such as quartz and oyster shell, are diluted by grinding them with lactose (trituration). Considering the understanding of modern biochemistry, it is paradoxical that a process of dilution would arrive at a higher potency than a lower dilution, and in some highly diluted preparations there is very low probability for even a single molecule of the original substance being present.

Potency scales Several potency scales are in use in homeopathy. Hahnemann created the centesimal or "C scale", diluting a substance by a factor of 100 at each stage. The centesimal scale was favored by Hahnemann for most of his life. A 2C dilution requires a substance to be diluted to one part in one hundred, and then some of that diluted solution diluted by a further factor of one hundred. This works out to one part of the original substance in 10,000 parts of the solution. A 6C dilution repeats this process six times, ending up with the original material diluted by a factor of 100−6=10−12. Higher dilutions follow the same pattern. In homeopathy, a solution that is more dilute is described as having a higher potency, and more dilute substances are considered by homeopaths to be stronger and deeper-acting remedies. The end product is often so diluted that it is indistinguishable from the dilutant (pure water, sugar or alcohol). Hahnemann advocated 30C dilutions for most purposes (that is, dilution by a factor of 1060). In Hahnemann's time it was reasonable to assume that remedies could be diluted indefinitely, as the concept of the atom or molecule as the smallest possible unit of a chemical substance was just beginning to be recognized. We now know that the greatest dilution that is reasonably likely to contain one molecule of the original substance is 12C.

This bottle contains arnica montana (wolf's bane) D6, i.e. the nominal dilution is one part in a million (106). Some homeopaths developed a decimal scale (D or X), diluting the substance to ten times its original volume each stage. The D or X scale dilution is therefore half that of the same value of the C scale; for example, "12X" is the same level of dilution as "6C". Hahnemann never used this scale but it was very popular throughout the 19th century and still is in Europe. This potency scale appears to have been introduced in the 1830s by the American homeopath, Constantine Hering. In the last ten years of his life, Hahnemann also developed a quintamillesimal (Q) or LM scale diluting the drug 1 part in 50,000 parts of diluent. A given dilution on the Q scale is roughly 2.35 times its designation on the C scale. For example a remedy described as "20Q" has about the same concentration as a "47C" remedy.

In addition, some homeopathic products on the market today, also use the "millesimal" (M) scale. A potency of 1M means a dilution of 1 part in 1000. The following table is a synopsis comparing the X and C dilution scales and equating them by equivalent dilution. It must be noted, however, that the homeopathic understanding of its principles is not explained by dilution but by "potentisation", hence one can not assume that the different potencies can be equated based on equivalence of dilution factors. X Scale 1X 2X 6X 8X 12X

C Scale — 1C 3C 4C 6C

Ratio

Note

1:10 described as low potency 1:100 called higher potency than 1X by homeopaths 10−6 10−8 allowable concentration of arsenic in U.S. drinking water 10−12 Has a 60% probability of containing one molecule of 24X 12C 10−24 original material if one mole of the original substance was used. If pure water was used as the diluent, no molecules of the 26X 13C 10−26 original solution remain in the water. Dilution advocated by Hahnemann for most purposes: on average, this would require giving two billion doses per 60X 30C 10−60 second to six billion people for 4 billion years to deliver a single molecule of the original material to any patient. Dilution of popular homeopathic flu remedy 400X 200C 10−400 Oscillococcinum Note: the "X scale" is also called "D scale". 1X = 1D, 2X = 2D, etc.

The paradox of homeopathic dilution Serial dilution of a solution results, after each dilution step, in fewer molecules of the original substance per litre of solution. Eventually, a solution will be diluted beyond any likelihood of finding a single molecule of the original substance in a litre of the total dilution product.

The molar limit If one begins with a solution of 1 mol/L of a substance, the 10-fold dilution required to reduce the number of molecules to less than one per litre is 1 part in 1×1024 (24X or 12C) since: 6.02×1023/1×1024 = 0.6 molecules per litre

Homeopathic dilutions beyond this limit are unlikely to contain a single molecule of the original substance. Assuming pure water has been used as a diluent, then dilutions beyond 14C are unlikely to contain any molecules of water used to make the original solution.

Analogies Critics and advocates of homeopathy alike commonly attempt to illustrate the dilutions involved in homeopathy with analogies. The high dilutions characteristically used are often considered to be the most controversial and implausible aspect of homeopathy. Hahnemann's joke: 1 bottle of poison in Lake Geneva Hahnemann is reported to have joked that a suitable procedure to deal with an epidemic would be to empty a bottle of poison into Lake Geneva, if it could be succussed 60 times. 1 Pinch of salt in the Atlantic Ocean Another example given by a critic of homeopathy states that a 12C solution is equivalent to a "pinch of salt in both the North and South Atlantic Oceans", which is approximately correct. 1/3 of a drop in all the waters of the Earth One third of a drop of some original substance diluted into all the water on earth would produce a remedy with a concentration of about 13C. Duck liver 200C in the entire observable Universe A popular homeopathic treatment for the flu is a 200C dilution of duck liver, marketed under the name Oscillococcinum. As there are only about 1080 atoms in the entire observable universe, a dilution of one molecule in the observable universe would be about 40C. Oscillococcinum would thus require 10320 more universes to simply have one molecule in the final substance. Swimming pool Another illustration of dilutions used in common homeopathic remedies involves comparing a homeopathic dilution to dissolving the therapeutic substance in a swimming pool. One example, inspired by a problem found in a set of popular algebra textbooks, states that there are on the order of 1032 molecules of water in an Olympic-size swimming pool and if such a pool were filled with a 15C homeopathic remedy, to have a 63% chance of consuming at least one molecule of the original substance, one would need to swallow 1% of the volume of such a pool, or roughly 25 metric tons of water.

30C: 1 ml in 1,191,016 cubic light years Yet another illustration: 1 ml of a solution which has gone through a 30C dilution is mathematically equivalent to 1 ml diluted into 1054 m3 - a cube of water measuring 1,000,000,000,000,000,000 (1018) metres per side, which is about 106 light years. When spherical, then it would be a ball of 131,1 light years in diameter. Thus, homeopathic remedies of standard potencies contain, almost certainly, only water (or alcohol, as well as sugar and other nontherapeutic ingredients).

Proposed explanations Homeopaths maintain that this water retains some "essential property" of the original material, because the preparation has been shaken after each dilution. Hahnemann believed that the dynamisation or shaking of the solution caused a "spirit-like" healing force to be released from within the substance. Even though the homeopathic remedies are often extremely diluted, homeopaths maintain that a healing force is retained by these homeopathic preparations.

Dilution debate Not all homeopaths advocate extremely high dilutions. Many of the early homeopaths were originally doctors and generally used lower dilutions such as "3X" or "6X", rarely going beyond "12X". The split between lower and higher dilutions followed ideological lines. Those favoring low dilutions stressed pathology and a strong link to conventional medicine, while those favoring high dilutions emphasised vital force, miasms and a spiritual interpretation of disease. Some products with both low and high dilutions continue to be sold, but like their counterparts, they have not been conclusively demonstrated to have any effect beyond the placebo effect.

Chapter 3

Electrohomeopathy

Electrohomoeopathy is a derivative of homeopathy that had its origins in the 19th century with the claims of Count Cesare Mattei. The name is derived from a combination of electro (referring to an electric bio-energy content supposedly extracted from plants and of therapeutic value, rather than electricity in its conventional sense) and homeopathy (referring to an alternative medicinal philosophy developed by Samuel Hahnemann in the 18th century). Electrohomeopathy has been defined as the combination of electrical devices and homeopathy, however some contend that it is the therapeutic use of homeopathic preparations of certain "electric bio-energy" herbs that is intended by the term. It is regarded as distinct from traditional homeopathy, which relies on serially diluted remedies of substances that cause similar symptoms to those as it is attempting to cure as its primary form of treatment, electrohomeopathy, however, does not directly follow the "law of similars". Like traditional homeopathy, modern day applications of electrohomeopathy are generally regarded by the medical and scientific communities as pseudoscience or quackery.

History and criticism The discipline was developed initially by Cesare Mattei (1809–1896) in the latter part of the 19th Century. Mattei, a nobleman living in a castle in the vicinity of Bologna studied natural science, anatomy, physiology, pathology, chemistry and botany. He ultimately focussed on the supposed therapeutic power of 'electricity' in botanical extracts. Massei made bold, unsupported, claims for the efficacy of his treatments including the claim that his treatments offered a non-surgical alternative to cancer. His treatment regimens were met with scepticism by medical orthodoxy: The electrohomeopathic system is an invention of Count Mattei who prates of "red," "blue," and "green" electricity, a theory that, in spite of its utter idiocy, has attracted a considerable following and earned a large fortune for its chief promoter. Notwithstanding criticisms, including a challenge by the British medical establishment to the claimed success of his cancer treatments, electrohomeopathy (or Matteism, as it was sometimes known at the time) was embraced and by the beginning of the 20th century had

adherents in Germany, France, the USA and the UK; it had been the subject of approximately 100 publications and there were three journals dedicated to it. After Mattei's death, his work was built upon by Theodore Krauss (1864–1924) who amplified the number of available treatments, including the introduction of injectable forms of treatment, and modernised production processes.

Philosophy Remedies are derived from what are said to be the active micro nutrients or mineral salts of certain plants. One contemporary account of the process of producing electrohomeopathic remedies was as follows: As to the nature of his remedies we learn...that...they are manufactured from certain herbs, and that the directions for the preparation of the necessary dilutions are given in the ordinary jargon of homeopathy. The globules and liquids, however, are " instinct with a potent, vital, electrical force, which enables them to work wonders." This process of "fixing the electrical principle" is carried on in the secret central chamber of a NeoMoorish castle which Count Mattei has built for himself in the Bolognese Apennines...The "red electricity" and "white electricity" supposed to be "fixed" in these "vegetable compounds" are in their very nomenclature and suggestion poor and miserable fictions. According to Mattei's own ideas however, every disease originates in the change of blood or of the lymphatic system or both, and remedies can therefore be mainly divided into two broad categories groups to be used in response to the dominant affected system. Mattei wrote that having obtained plant extracts, he was "able to determine in the liquid vegetable electricity". Allied to his theories and therapies were elements of Chinese medicine, of medical humours, of apparent Brownianism, as well as modified versions of Samuel Hahnemann's homeopathic principles. Electrohomeopathy has some associations with Spagyric medicine, a holistic medical philosophy claimed to be the practical application of alchemy in medical treatment, so that the principle of modern electrohomeopathy is that disease is typically multi-organic in cause or effect and therefore requires holistic treatment that is at once both complex and natural. 114 plants are used in the preparation of electrohomeopathic medicines. The medicines are prepared by following the three major steps of spagyrism: purification, separation and "cohobation"(also known as cold fermentation). Electrohomeopathic remedies include: • • • • •

Scrofoloso remedies - act on scrofulous disorders and the metabolism. Linfatico remedies - act on both blood and lymphatic systemss. Angioiticos remedies - act on blood vessels and the circulatory system. Canceroso remedies - act on cellular construction and the chronic degeneration of lymph. Febrifugo remedies - act on fevers and all types of intermittent diseases, as well as disorders of the spleen and liver.

• • •

Vermifugo remedies - act on the intestines, but also on the other parts of our organism; also for worms. Pettorale remedies - act on the respiratory system and bronchial tubes. Venereo remedies - general constitutional effect and for venereal infections.

As well as the categories of remedy, practitioners recognise five (and sometimes more) "electric fluids" or electricities: red (a stimulant); white (sedative); blue (antihaemorrhagic); green (analgesic); yellow (intestinal remedy).

Modern usage Although there have been few or no published controlled trials of the efficacy of electrohomeopathy, it continues to be practised. A symposium took place in Bologna in 2008 to mark the 200th anniversary of the birth of Cesare Mattei, with faculty from India, Pakistan, Germany UK,and the USA. The discipline is practised predominantly in India and Pakistan (although it is not a recognised healthcare discipline in India), but there are also a number of electrohomeopathy organisations and institutions worldwide.

Chapter 4

Substances used in Homeopathy

Alfalfa Alfalfa

Medicago sativa

Kingdom: (unranked): (unranked): (unranked): Order: Family: Genus:

Scientific classification Plantae Angiosperms Eudicots Rosids Fabales Fabaceae Medicago

Species:

M. sativa Binomial name Medicago sativa L.

Subspecies Medicago sativa subsp. ambigua (Trautv.) Tutin Medicago sativa subsp. microcarpa Urban Medicago sativa subsp. sativa L. Medicago sativa subsp. varia (T. Martyn) Arcang. Alfalfa (Medicago sativa) is a flowering plant in the pea family Fabaceae cultivated as an important forage crop. In the UK, Australia, South Africa and New Zealand, it is also known as lucerne, and as lucerne grass in south Asia. It resembles clover, with clusters of small purple flowers.

Ecology Alfalfa is a spring or fall season perennial legume which can live more than twenty years, depending on variety and climate. The plant grows to a height of up to 1 metre (3 ft), and has a deep root system, sometimes stretching more than 15 metres (49 ft). This makes it very resilient, especially to droughts. It has a tetraploid genome. This plant exhibits autotoxicity, which means it is difficult for alfalfa seed to grow in existing stands of alfalfa. Therefore, it is recommended that alfalfa fields be rotated with other species (for example, corn or wheat) before reseeding.

Culture Alfalfa is widely grown throughout the world as forage for cattle, and is most often harvested as hay, but can also be made into silage, grazed, or fed as greenchop. Alfalfa has the highest feeding value of all common hay crops, being used less frequently as pasture. When grown on soils where it is well-adapted, alfalfa is the highest yielding forage plant. Its primary use is as feed for dairy cattle—because of its high protein content and highly digestible fiber—and secondarily for beef cattle, horses, sheep, and goats. Humans also eat alfalfa sprouts in salads and sandwiches. Dehydrated alfalfa leaf is commercially available as a dietary supplement in several forms, such as tablets, powders and tea. Alfalfa is believed by some to be a galactagogue, a substance that induces lactation. Like other legumes, its root nodules contain bacteria, Sinorhizobium meliloti, with the ability to fix nitrogen, producing a high-protein feed regardless of available nitrogen in the soil. Its nitrogen-fixing abilities (which increases soil nitrogen) and its use as an animal feed greatly improved agricultural efficiency.

Alfalfa can be sown in spring or fall, and does best on well-drained soils with a neutral pH of 6.8 – 7.5. Alfalfa requires sustained levels of potassium and phosphorus to grow well. It is moderately sensitive to salt levels in both the soil and in irrigation water, although it continues to be grown in the arid southwestern United States, where salinity is an emerging issue. Soils low in fertility should be fertilized with manure or a chemical fertilizer, but correction of pH is particularly important. Usually a seeding rate of 13 – 20 kg/hectare (12 – 25 lb/acre) is recommended, with differences based upon region, soil type, and seeding method. A nurse crop is sometimes used, particularly for spring plantings, to reduce weed problems and soil erosion, but can lead to competition for light, water and nutrients. In most climates, alfalfa is cut three to four times a year, but it can be harvested up to 12 times per year in Arizona and southern California. Total yields are typically around 8 tonnes per hectare (4 short tons per acre) but yields have been recorded up to 20 t/ha (16 short tons per acre). Yields vary with region, weather, and the crop's stage of maturity when cut. Later cuttings improve yield, but with reduced nutritional content.

Alfalfa leafcutter bee, Megachile rotundata, a pollinator on alfalfa flower Alfalfa is considered an insectary due to the large number of insects it attracts. Some pests, such as alfalfa weevil, aphids, armyworms, and the potato leafhopper, can reduce alfalfa yields dramatically, particularly with the second cutting when weather is warmest. Chemical controls are sometimes used to prevent this. Alfalfa is also susceptible to root rots, including Phytophthora, Rhizoctonia, and Texas root rot.

Harvesting

Cylindrical bales of alfalfa When alfalfa is to be used as hay, it is usually cut and baled. Loose haystacks are still used in some areas, but bales are easier for use in transportation, storage and feed. Ideally, the first cutting should be taken at the bud stage, and the subsequent cuttings just as the field is beginning to flower, or one tenth bloom for the reason that carbohydrates are at their highest. When using farm equipment rather than hand-harvesting, a swather cuts the alfalfa and arranges it in windrows. In areas where the alfalfa does not immediately dry out on its own, a machine known as a mower-conditioner is used to cut the hay. The mower-conditioner has a set of rollers or flails that crimp and break the stems as they pass through the mower, making the alfalfa dry faster. After the alfalfa has dried, a tractor pulling a baler collects the hay into bales. There are several types of bales commonly used for alfalfa. For small animals and individual horses, the alfalfa is baled into small two-string bales, commonly named by the strands of string used to wrap it. Other bale sizes are three-string, and so on up to half-ton (six-string) "square" bales — actually rectangular, and typically about 40 x 45 x 100 cm (14 in x 18 in x 38 in). Small square bales weigh from 25 – 30 kg (50 – 70 pounds) depending on moisture, and can be easily hand separated into "flakes". Cattle ranches use large round bales, typically 1.4 to 1.8 m (4 to 6 feet) in diameter and weighing from 500 to 1,000 kg, (1000 to 2000 lbs). These bales can be placed in stable stacks or in large feeders for herds of horses, or unrolled on the ground for large herds of cattle. The bales can be loaded and stacked with a tractor using a spike, known as a bale

spear, that pierces the center of the bale, or they can be handled with a grapple (claw) on the tractor's front-end loader. A more recent innovation is large "square" bales, roughly the same proportions as the small squares, but much larger. The bale size was set so stacks would fit perfectly on a large flatbed truck. These are more common in the western United States. When used as feed for dairy cattle, alfalfa is often made into haylage by a process known as ensiling. Rather than drying it to make dry hay, the alfalfa is chopped finely and fermented in silos, trenches, or bags, anywhere the oxygen supply can be limited to promote fermentation. The anaerobic fermentation of alfalfa allows it to retain high nutrient levels similar to those of fresh forage, and is also more palatable to dairy cattle than dry hay. In many cases, alfalfa silage is inoculated with different strains of microorganisms to improve the fermentation quality and aerobic stability of the silage.

Worldwide production

Worldwide alfalfa production Alfalfa is the most cultivated legume in the world. Worldwide production was around 436 million tons in 2006. Canada is the largest alfalfa producer in the world, but considerable production is found in Argentina (primarily grazed), Australia, South Africa, and the Middle East. Within the United States, the leading alfalfa growing states are California, South Dakota, and Wisconsin. The upper Midwestern states account for about 50% of US production, the Northeastern states 10%, the Western states 40%, and the Southeastern states almost none. Alfalfa has a wide range of adaptation, and can be grown from very cold northern

plains to high mountain valleys, from rich temperate agricultural regions to Mediterranean climates and searing hot deserts.

Alfalfa and bees Alfalfa seed production requires the presence of pollinators when the fields of alfalfa are in bloom. Alfalfa pollination is somewhat problematic, however, because western honey bees, the most commonly used pollinator, are not suitable for this purpose; the pollencarrying keel of the alfalfa flower trips and strikes pollinating bees on the head, which helps transfer the pollen to the foraging bee. Western honey bees, however, do not like being struck in the head repeatedly and learn to defeat this action by drawing nectar from the side of the flower. The bees thus collect the nectar, but carry no pollen and so do not pollinate the next flower they visit. Because older, experienced bees do not pollinate alfalfa well, most pollination is accomplished by young bees that have not yet learned the trick of robbing the flower without tripping the head-knocking keel. When western honey bees are used to pollinate alfalfa, the beekeeper stocks the field at a very high rate to maximize the number of young bees. Western Honey bee colonies may suffer protein stress when working alfalfa only, due to shortage one of the amino-acids comprising the pollen protein, iso-leucine. Today, the alfalfa leafcutter bee is increasingly used to circumvent these problems. As a solitary but gregarious bee species, it does not build colonies or store honey, but is a very efficient pollinator of alfalfa flowers. Nesting is in individual tunnels in wooden or plastic material, supplied by the alfalfa seed growers. The leafcutter bees are used in the Pacific Northwest, while western honeybees dominate in California alfalfa seed production. A smaller amount of alfalfa produced for seed is pollinated by the alkali bee, mostly in the northwestern United States. It is cultured in special beds near the fields. These bees also have their own problems. They are not portable like honey bees, and when fields are planted in new areas, the bees take several seasons to build up. Honey bees are still trucked to many of the fields at bloom time.

Varieties

Small square bales of alfalfa Considerable research and development has been done with this important plant. Older cultivars such as 'Vernal' have been the standard for years, but many better public and private varieties better adapted to particular climates are available. Private companies release many new varieties each year in the US. Most varieties go dormant in the fall, with reduced growth in response to low temperatures and shorter days. 'Nondormant' varieties that grow through the winter are planted in long-seasoned environments such as Mexico, Arizona, and Southern California, whereas 'dormant' varieties are planted in the Upper Midwest, Canada, and the Northeast. 'Nondormant' varieties can be higher yielding, but they are susceptible to winter-kill in cold climates and have poorer persistence. Most alfalfa cultivars contain genetic material from sickle medick (M. falcata), a wild variety of alfalfa that naturally hybridizes with M. sativa to produce sand lucerne (M. sativa ssp. varia). This species may bear either the purple flowers of alfalfa or the yellow of sickle medick, and is so called for its ready growth in sandy soil.

Watering an alfalfa field Most of the improvements in alfalfa over the last decades have consisted of better disease resistance on poorly drained soils in wet years, better ability to overwinter in cold climates, and the production of more leaves. Multileaf alfalfa varieties have more than three leaflets per leaf, giving them greater nutritional content by weight because there is more leafy matter for the same amount of stem. The California Alfalfa Workgroup (UC Davis) has an up-to-date listing of alfalfa variety trial data by location as well as Agronomy Progress Reports for each year.

Genetically modified alfalfa Roundup Ready alfalfa, a genetically modified variety patented by Monsanto Company, is resistant to Monsanto's glyphosate. Although most broadleaf plants, including ordinary alfalfa, are sensitive to Roundup, growers can spray fields of Roundup Ready alfalfa with Roundup, and so kill the weeds without harming the alfalfa crop. Legal issues in the US Roundup Ready alfalfa was sold in the United States from 2005–2007 and more than 300,000 acres (1,200 km2) were planted with it, out of 21,000,000 acres (85,000 km2).

However, in 2006, organic farmers, concerned about the impact of GM alfalfa on their crops, sued Monsanto (Monsanto Company v. Geertson Seed Farms). In response, in May 2007, the California Northern District Court issued an injunction order prohibiting farmers from planting Roundup Ready alfalfa until the US Department of Agriculture (USDA) completed a study on the genetically engineered crop's likely environmental impact. As a result, the USDA put a hold on any further planting of Roundup Ready alfalfa. The key issues of the lawsuit were the possibility that Roundup resistance could be transmitted to other plants, including both other crops and weeds, making major pest species resistant to an important herbicide; also of concern was the contamination of organic alfalfa crops. On 21 June 2010, the US Supreme Court issued a ruling on this matter. The impact of this ruling is somewhat unclear, with both sides appearing to claim victory. According to Barry Estabrook, at 'The Atlantic' website, Even though Monsanto technically won, the most important parts of the lower court's decision were upheld, meaning there are still many regulatory hurdles GM alfalfa has to clear before it can be legally planted on a commercial scale. And in a decision that may have wide-reaching effects on future GM cases, the justices agreed that GM crops could cause environmental harm through cross-pollination.

Phytoestrogens in alfalfa Alfalfa, like other leguminous crops, is a known source of phytoestrogens. Grazing on alfalfa has been suspected as a cause of reduced fertility in sheep.

Medical uses Alfalfa has been used as an herbal medicine for over 1,500 years. Alfalfa is high in protein, calcium, plus other minerals, vitamins in the B group, vitamin C, vitamin E, and vitamin K.

Traditional uses In early Chinese medicines, physicians used young alfalfa leaves to treat disorders related to the digestive tract and the kidneys. In Ayurvedic medicine, physicians used the leaves for treating poor digestion. They made a cooling poultice from the seeds for boils. At the time, alfalfa was also believed to be beneficial to people suffering from arthritis and water retention.

Gallery

Medicago sativa

Medicago sativa

Medicago sativa

Medicago sativa

Flowers

Yellow flowers

Light violet flowers

Seeds

Lucerne field

Bee on alfalfa flower

Atropa belladonna Deadly nightshade

Illustration from Köhler's Medicinal Plants 1887

Kingdom: (unranked): (unranked): (unranked): Order:

Scientific classification Plantae Angiosperms Eudicots Asterids Solanales

Family: Genus: Species:

Solanaceae Atropa A. belladonna Binomial name Atropa belladonna L.

Atropa belladonna or Atropa bella-donna, commonly known as belladonna or deadly nightshade, is a perennial herbaceous plant in the family Solanaceae, native to Europe, North Africa, and Western Asia. The foliage and berries are extremely toxic, containing tropane alkaloids. These toxins include scopolamine and hyoscyamine which cause a bizarre delirium and hallucinations, and are also used as pharmaceutical anticholinergics. The drug atropine is derived from the plant. It has a long history of use as a medicine, cosmetic, and poison. Before the Middle Ages, it was used as an anesthetic for surgery, the ancient Romans used it as a poison (the wife of Emperor Augustus and the wife of Claudius both used it to murder contemporaries) and predating this it was used to make poison tipped arrows. The genus name "atropa" comes from Atropos, one of the three Fates in Greek mythology, and the name "bella donna" is derived from Italian and means "beautiful woman".

Description

Atropa belladonna

Atropa belladonna is a branching herbaceous perennial, often growing as a subshrub, from a fleshy rootstock. Plants grow to 1.5 metres (4.9 ft) tall with 18 centimetres (7.1 in) long ovate leaves. The bell-shaped flowers are tyrian purple with green tinges and faintly scented. The fruits are berries, which are green ripening to a shiny black, and approximately 1 centimetre (0.39 in) in diameter. The berries are sweet and are consumed by animals that disperse the seeds in their droppings, even though the seeds contain toxic alkaloids. There is a pale yellow flowering form called Atropa belladonna var. lutea with pale yellow fruit. Atropa belladona is rarely used in gardens, but when grown it is usually for its large upright habit and showy berries. It is naturalized in parts of North America, where it is often found in shady, moist locations with limestone-rich soils. It is considered a weed species in parts of the world, where it colonizes areas with disturbed soils. Germination of the small seeds is often difficult, due to hard seed coats that cause seed dormancy. Germination takes several weeks under alternating temperature conditions but can be sped up with the use of gibberellic acid. The seedlings need sterile soil to prevent damping off and resent root disturbance during transplanting.

Naming and taxonomy The first botanical description was by Linnaeus in Species Plantarum in 1753. It is in the nightshade family (Solanaceae), which it shares with potatoes, tomatoes, eggplants, jimsonweed, tobacco, wolfberry, and chili peppers. The common names for this species include belladonna, deadly nightshade, divale, dwale, banewort, devil's cherries, naughty man's cherries, black cherry, devil's herb, great morel, and dwayberry. The name Atropa is thought to be derived from that of the Greek goddess Atropos, one of the three Greek fates or destinies who would determine the course of a man's life by the weaving of threads that symbolized their birth, the events in their life and finally their death; with Atropos cutting these threads to mark the latter. The name "belladonna" comes from the Italian language, meaning "beautiful lady"; originating either from its usage as cosmetic for the face, or, more probably, from its usage to increase the pupil size in ladies.

Toxicity

Flowers of belladonna Belladonna is one of the most toxic plants found in the Western hemisphere. All parts of the plant contain tropane alkaloids. The berries pose the greatest danger to children because they look attractive and have a somewhat sweet taste. The consumption of two to five berries by children and ten to twenty berries by adults can be lethal. The root of the plant is generally the most toxic part, though this can vary from one specimen to another. Ingestion of a single leaf of the plant can be fatal to an adult. The active agents in Belladonna, atropine, hyoscine (scopolamine), and hyoscyamine, have anticholinergic properties. The symptoms of belladonna poisoning include dilated pupils, sensitivity to light, blurred vision, tachycardia, loss of balance, staggering, headache, rash, flushing, dry mouth and throat, slurred speech, urinary retention, constipation, confusion, hallucinations, delirium, and convulsions. In 2009, atropa belladonna that was mistaken for blueberries with six berries ingested by an adult woman was documented to result in severe anticholinergic syndrome. The plant's deadly symptoms are caused by atropine's disruption of the parasympathetic nervous system's ability to regulate involuntary activities such as sweating, breathing, and heart rate. The antidote for belladonna poisoning is physostigmine or pilocarpine, the same as for atropine.

Atropa belladonna is also toxic to many domestic animals, causing narcosis and paralysis. However, cattle and rabbits eat the plant seemingly without suffering harmful effects. In humans its anticholinergic properties will cause the disruption of cognitive capacities like memory and learning.

Uses Cosmetics The common name belladonna originates from its historic use by women - Bella Donna is Italian for beautiful lady. Drops prepared from the belladonna plant were used to dilate women's pupils, an effect considered attractive. Belladonna drops act as an antimuscarinic, blocking receptors in the muscles of the eye that constrict pupil size. Belladonna is currently rarely used cosmetically, as it carries the adverse effects of causing minor visual distortions, inability to focus on near objects, and increased heart rate. Prolonged usage was reputed to cause blindness.

Medicine Belladonna tinctures, decoctions, and powders as well as alkaloid salt mixtures are produced for pharmaceutical use and these are often standardised at 1037 parts hyoscyamine to 194 parts atropine and 65 parts scopolamine. The alkaloids are compounded with phenobarbital and/or kaolin and pectin for use in various functional gastrointestinal disorders. The tincture, used for identical purposes, remains in most pharmacopoeias, with a similar tincture of Datura stramonium having been in the US Pharmacopoeia at least until the late 1930s. The combination of belladonna and opium, in powder, tincture, or alkaloid form, is particularly useful by mouth or as a suppository for diarrhoea and some forms of visceral pain and can be made by a compounding pharmacist and may be available as a manufactured fixed combination product in some countries (see, e.g., B&O Supprettes). A banana-flavoured liquid (most common trade name: Donnagel PG) was available until 31 December 1992 in the United States. Scopolamine is used as the hydrobromide salt for GI complaints, motion sickness, and to potentiate the analgesic and anxiolytic effects of opioid analgesics. Atropine is used as the sulphate as a mydriatic and cycloplegic for eye examinations. It is also used as an antidote to organophosphate and carbamate poisoning and is loaded in an autoinjector for use in case of a nerve gas attack. Atropinisation (administration of a sufficient dose to block nerve gas effects) results in 100 per cent blockade of the muscarinic acetylcholine receptors and atropine sulphate is the benchmark for measuring the power of anticholinergic drugs. Hyoscyamine is used as the sulphate or hydrobromide for GI problems and Parkinson's Disease. Its side effect profile is intermediate betwixt that of atropine and scopolamine, and can also be used to combat the toxic effects of organophosphates.

There is currently insufficient scientific evidence to recommend the use of A. belladonna in its natural form for any condition, although some of its components, in particular latropine which was purified from belladona in the 1830s, have accepted medical uses. Donnatal is a prescription pharmaceutical, approved in the United States by the FDA, that combines natural belladonna alkaloids in a specific, fixed ratio with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation. According to its labeling, it is possibly effective for use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Traditional and alternative medicine

Berries of belladonna A. belladonna has been used in traditional treatments for centuries for an assortment of conditions including headache, menstrual symptoms, peptic ulcer disease, histaminic reaction, inflammation, and motion sickness, with at least one 19th century eclectic medicine journal explaining how to prepare a Belladona tincture for direct administration to patients. Homeopathic belladonna preparations have been sold as treatments for various conditions, although there is no scientific evidence to support their efficacy. Clinically and in research trials, the most common preparation is diluted to the 30C level in

homeopathic notation. This level of dilution does not contain any of the original plant, although preparations with lesser dilutions which statistically contain trace amounts of the plant are advertised for sale.

Recreational drug Atropa belladonna, along with related plants such as jimson weed (Datura stramonium), have occasionally been used as a recreational drug because of the vivid hallucinations and delirium that it produces. These hallucinations are most commonly described as very unpleasant, however, and recreational use is considered extremely dangerous because of the high risk of unintentional fatal overdose. In addition, the central nervous system effects of atropine include memory disruption, which may lead to severe confusion.

Poison The tropane alkaloids of A. belladonna were used as poisons and early humans made poisonous arrows from the plant. In Ancient Rome it was used as a poison by Agrippina the Younger, wife of Emperor Claudius, and Livia, who is rumored to have used it to kill her husband Emperor Augustus. Macbeth of Scotland, when he was still one of the lieutenants of King Duncan I of Scotland, used it during a truce to poison the troops of the invading Harold Harefoot, King of England, to the point that the English troops were unable to stand their ground and had to retreat to their ships.

Folklore

Leaves of belladonna In the past, it was believed that witches used a mixture of belladonna, opium poppy, and other plants, typically poisonous (such as monkshood and poison hemlock) in flying ointment they applied to help them fly to gatherings with other witches. Carlo Ginzburg and others have argued that flying ointments were preparations meant to encourage hallucinatory dreaming; a possible explanation for the inclusion of belladonna and opium poppy in flying ointments concerns the known antagonism between tropane alkaloids of belladonna (specifically scopolamine) and opiate alkaloids in the opium poppy, Papaver somniferum (specifically morphine), which produces a dream-like waking state. This antagonism was known in folk medicine, discussed in eclectic (botanical) medicine formularies, and posited as the explanation of how flying ointments might have actually worked in contemporary writing on witchcraft. The antagonism between opiates and tropanes is the original basis of the Twilight Sleep that was provided to Queen Victoria to deaden pain as well as consciousness during childbirth, and which was later modified so that isolated alkaloids were used instead of plant materials. The belladonna herb was also notable for its unpredictable effects from toxicity.

Pasque flower Pasque flower

Pulsatilla vulgaris

Kingdom: Phylum: Class: Order: Family: Genus:

Scientific classification Plantae Magnoliophyta Magnoliopsida Ranunculales Ranunculaceae Pulsatilla Mill.

A pasque flower or pasqueflower (genus Pulsatilla) is one of about 33 species of herbaceous perennials native to meadows and prairies of North America, Europe, and Asia, valued for their finely-dissected leaves, solitary bell-shaped flowers, and plumed seed heads. The pasqueflower is also commonly known as the prairie crocus, wind flower, Easter Flower, and meadow anemone. Anthers are bright yellow and the bell consists of sepals.

Genus The genus Pulsatilla is sometimes considered a subgenus under the genus Anemone.

It also grows in limestone pastures in central and northern Europe and parts of Russia. It is found rarely and locally in southern England from where the Pasque / Parsk / Pask family takes its name - Barnsley Warren SSSI contains one of the Cotswolds largest populations. Different varieties of the Pasque flower are the floral emblems of various territories. Pulsatilla vulgaris is the County flower for both Hertfordshire and Cambridgeshire. Pulsatilla hirsutissima is the state flower of South Dakota and the provincial flower of Manitoba. Pasque refers to Easter (Passover), since the flower blooms early in spring.

Use and toxicity Pasque flower is highly toxic, and produces cardiogenic toxins and oxytoxins which slow the heart in humans. Excess use can lead to diarrhoea, vomiting and convulsions, hypotension and coma. It has been used as a medicine by Native Americans for centuries. Blackfoot Indians used Pasque Flower to induce abortions and childbirth. Pulsatilla should not be taken during pregnancy nor during lactation. Extracts of Pulsatilla have been used in an effort to treat reproductive problems such as premenstrual syndrome and epididymitis. Additional applications of plant extracts include uses as a sedative and for treating coughs. It is used as an initial ingredient in homeopathic remedies, which don't have toxic effects of other remedies because the ingredients are diluted with water until no molecules of the initial substance can be found in a typical quantity.

Pulsatilla vulgaris fruit

Pulsatilla slavica after blooming

Species There are about 33 species, including: • • • • • • •

Pulsatilla alpina Pulsatilla chinensis Pulsatilla grandis Pulsatilla halleri Pulsatilla koreana Pulsatilla montana Pulsatilla nigricans

• • • • • •

Pulsatilla patens Pulsatilla pratensis Pulsatilla vernalis Pulsatilla vulgaris Pulsatilla subslavica Pulsatilla cernua

Chapter 5

Regulation and Prevalence of Homeopathy

Woman looking at homeopathic remedies Homeopathy is fairly common in some countries while being uncommon in others. Regulations vary in Europe depending on the country. In some countries, there are no specific legal regulations concerning the use of homeopathy, while in others, licenses or degrees in conventional medicine from accredited universities are required. In Austria and Germany, no specific regulations exist, while France and Denmark mandate licenses

to diagnose any illness or dispense of any product whose purpose is to treat any illness. Some homeopathic treatment is covered by the national insurance of several European countries, including France, the United Kingdom, Denmark, and Luxembourg. In other countries, such as Belgium and the Czech Republic, homeopathy is not covered. In Austria, public insurance requires scientific proof of effectiveness in order to reimburse medical treatments, but exceptions are made for homeopathy. Two countries which formerly offered homeopathy under their public health insurance schemes have withdrawn this privilege. At the start of 2004, homeopathic treatments, with some exceptions, were no longer covered by German public health insurance, and in June 2005, the Swiss Government, after a 5-year trial, withdrew insurance coverage for homeopathy and four other complementary treatments, stating that they did not meet efficacy and cost-effectiveness criteria, though additional insurance can be bought to cover such treatments provided by a medical doctor.

The homeopathic remedy arsenicum album is derived from arsenic.

Europe European Union In 1992, the Council of the European Communities stated in the preamble to a directive that homeopathy was officially recognized in certain member states but only tolerated in

others. In any case it was prescribed and used in all member states. To harmonize the market of homeopathic products, the council, by Directive 92/73/EEC directed the member states to implement certain changes in their national legislation. Directive 92/73/EEC was replaced by Directive 2001/83/EC on the Community code relating to medicinal products for human use Member states are required to ensure that homeopathic products (for oral or external use) can be registered without proof of therapeutic efficacy, provided that there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the product may not contain either more than one part per 10,000 of the mother tincture or more than 1/100th of the smallest dose used in mainstream medicine, with regard to active principles whose presence in a medicinal product results in the obligation to submit a doctor's prescription. In other words, the dilution must be at least D4/4X/C2, and even higher in special cases. Other homeopathic products can still be registered under the normal rules, and products such as Arnica D1 are legally available. The labels of homeopathic products registered without proof of efficacy must include the words "homeopathic medicinal product without approved therapeutic indications" as well as "a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product". In spite of the harmonization efforts, the availability of certain specific homeopathic products varies significantly between member states. According to the European Committee for Homeopathy, homeopathic industrial manufacturers register only those products that are economically feasible, e.g. in the case of the Netherlands 600 out of a total of 3,000. The strict safety requirements even for very high dilutions of biological substances also impede registration for certain homeopathic products such as nosodes. As a result, several homeopathic products have disappeared from the market. This situation is caused in part by the fact that registration must occur separately in each member state, and that there are essentially no exemptions for medicines produced in low quantities. United Kingdom In Britain homeopathy was first established by Dr. Frederick Quin around 1827, although two Italian homeopathic doctors (Drs Romani and Roberta) had been employed two years previously by the Earl of Shrewsbury based at Alton Towers in North Staffordshire. Homeopathy in Britain quickly became the preferred medical treatment of the upper classes as well as the aristocracy; it retained an elite clientele, including members of the British royal family. At its peak in the 1870s, Britain had numerous homeopathic dispensaries and small hospitals as well as large busy hospitals in Liverpool, Birmingham, Glasgow, London and Bristol. The legislation concerning homeopathic remedies is as described above under European Union.

Although homeopathy is not regulated by law in the United Kingdom, the National Health Service (NHS) currently operates three homeopathic hospitals, and the Lutonbased Faculty of Homeopathy, membership of which is open to statutorily registered healthcare professionals, has over 1,400 members and was incorporated by an Act of Parliament in 1950. There are also a number of organisations for non-medically qualified homeopaths, the largest of which, the Society of Homeopaths, was founded in 1978 and has over 1,500 members. There is some overlap between the memberships of these organisations. According to a 2006 study, forty nine percent of Scottish medical practices prescribed homeopathic remedies. During the study period, 0.22% of patients were prescribed at least one homeopathic remedy; of these, 16 percent were children. The study concluded that critical review of homeopathy's role in the Scottish branch of the national health care system was needed.

Waning utilization and closing of university courses In England, the number of homeopathic remedies prescribed by GPs dropped by over 40% between 2005 and 2007, with homeopathy accounting for only 0.006% of the total prescribing budget. The Tunbridge Wells Homeopathic Hospital, then one of four homeopathic hospitals operated by the NHS, was closed in 2009 following a drop in referrals and a review by the West Kent Primary Care Trust of funding of homeopathy. In September 2010 another of the four, the Royal London Homoeopathic Hospital, was renamed as the Royal London Hospital for Integrated Medicine to more accurately to reflect the nature of its work. A fifth homeopathic hospital run by the NHS, the Hahnemann Hospital in Liverpool, had been closed in 1976. Around 2009, a few UK universities have started closing, reviewing or strengthening the "science base" of their courses on homeopathy and complementary medicine, after accusations that they were teaching "pseudo science". These courses had been attracting bad publicity and criticism for the universities teaching them. In May 2010 it was announced that junior doctors' training would no longer include placements at the Glasgow Homeopathic Hospital.

Recommendations to cease public funding In February 2010 the House of Commons Science and Technology Committee concluded that: "the NHS should cease funding homeopathy. It also concludes that the Medicines and Healthcare products Regulatory Agency (MHRA) should not allow homeopathic product labels to make medical claims without evidence of efficacy. As they are not medicines, homeopathic products should no longer be licensed by the MHRA." Part of the conclusions state that "When the NHS funds homeopathy, it endorses it. Since the NHS Constitution explicitly gives people the right to expect that decisions on the funding of drugs and treatments are made “following a proper consideration of the evidence”, patients may reasonably form the [misleading] view [inferred from the fact of any NHS

financial support] that homeopathy is an evidence-based treatment." Since no evidence of benefit was found - other than the placebo effect - the report's recommendation was that "The Government should stop allowing the funding of homeopathy on the NHS." The government has taken no measures to act upon any of these recommendations, nor have they announced any plans to do so in future. Belgium In Belgium, 81% of consultations in the area of complementary and alternative medicine involve homeopathy (not necessarily exclusively). Belgium has three homeopathic organizations for allopathic physicians and pharmacists and two for patients. Germany In Germany, the legislation for homeopathic remedies is as described above under European Union. Homeopathic remedies are subject to registration, but they need not be tested. (However, homeopathic remedies that are less diluted than D4, or for which a danger of adverse effects exists, cannot be registered under this rule.) They can be sold over-the-counter in pharmacies. Germany is the only member state of the European Union in which homeopathic remedies based on minerals or plants, and produced only in very low quantities, do not need to be registered. In other member states only remedies individually prepared in a pharmacy are exempt. In 2006, homeopathic remedies accounted for 3.16% of sold units (1.08% of business volume) in the pharmaceutical sector. 0.48% of prescriptions covered by public health insurance were for homeopathical remedies. A telephone survey of German adults found that 11.5% had used homeopathy. Homeopathy accounts for 27.4% of patient contacts in the area of complementary/alternative medicine. The title "Homeopathic Physician" is legally protected; it is bestowed by the Federal Medical Chamber after a three-year training programme. Elements of complementary/alternative medicine are part of the standard curriculum for all physicians, and three-fourths of physicians in Germany use complementary/alternative medicine. Homeopathy is taught officially at the medical faculties of universities in Berlin, Düsseldorf, Hannover, Heidelberg and Freiburg.

Switzerland The rules for the registration of homeopathic remedies without a concrete field of application are more liberal in Switzerland than they are in member countries of the European Union. For the majority of homeopathic medicines (those based on well-known low-risk substances), Swissmedic, the regulatory authority, offers very cheap registration by means of a simplified electronic registration procedure.

Australia According to one study, approximately 4.4% of Australian adults have used homeopathic remedies at least once in their lives, including 1.2% that sought treatment exclusively from homeopathic practitioners.

North America Canada In Canada, a study detailing the use of alternative medicines by children in Quebec found that 11% of the sampled 1,911 children used alternative medicines, and 25% of those who did use alternative medicines used homeopathy. The study also pointed out that homeopathy is more commonly used in children in Canada than in adults, of whom only 19% of alternative medicine users used homeopathy. Physicians who choose to use alternative medicines such as homeopathy must follow guidelines set by their province's College of Physicians and Surgeons. Provincial health care generally does not cover homeopathy. In Canada, the practice of homeopathic medicine is regulated by provincial jurisdiction, while homeopathic medicines are governed by federal jurisdiction. In June 2007, the province of Ontario passed the Homeopathy Act to regulate the practice of homeopathy. This was a welcomed event given that homeopathic medicines have been regulated under the Natural Health Products Regulations which came into force on January 1, 2004. The regulations are administered by the Natural Health Products Directorate (Health Canada) located mainly in Ottawa.

United States The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 recognized homeopathic preparations as drugs, but with significant exceptions. A principle sponsor of the Act was New York Senator and homeopathic physician Royal Copeland, who ensured that homeopathy's own Homœopathic Pharmacopœia of the United States (HPUS) be included, as it expressed the "self-professed quality standards" of the homeopathic profession. The finished Act thus created loopholes for the regulation of homeopathic drugs, and they are thus exempted from many of the rules regulating other drugs. The inclusion of HPUS in the Act has since been questioned by "lawyers, doctors, homeopaths, historians, and Food and Drug Administration (FDA) officials." Homeopathic "remedies" are regulated by the Food and Drug Administration (FDA), which regulates manufacturing and other standards that are appropriate for homeopathic drugs, mainly through The Homœopathic Pharmacopœia of the United States (HPUS) as administered by the Homœopathic Pharmacopœia Convention of the United States and section 400.400 of the FDA Compliance Policy Guidance Manual. Homeopathic drugs must be tested for scope of effect, manufactured, and labeled according to the Federal FD&C Act and the HPUS before they are considered official homeopathic drugs. Official

homeopathic drugs can be marketed according to their classification in the HPUS. They are not regulated under the Dietary Supplement Health and Education Act of 1994. Many homeopathic drugs can be sold "over-the-counter"; however, some are classified as prescription only under all circumstances, and some are classified as prescription only in various low potencies. As with all drugs, the labeling requirements are important, as that is one of the primary ways the FDA can regulate drugs. One of the difficulties of regulating homeopathic pharmacy is that homeopathy is alternative and unproven medicine, and the regulatory apparatus that is appropriate for drugs is not a good fit for homeopathic drugs. Homeopathic pharmaceutical techniques are not technologically complicated, and the drugs are generally considered to be biologically safe because they are so diluted to the point where there are no molecules from the original solution left in a dose of the final remedy. The FDA makes significant exemptions for homeopathic remedies as compared to other drugs. Here are a few: 1. They are not required to submit new drug applications to the FDA. 2. They are "exempt from good manufacturing practice requirements related to expiration dating". 3. They are exempt from "finished product testing for identity and strength". 4. They may "contain much higher amounts" of alcohol than other drugs, which may contain "no more than 10 percent...and...even less for children's medications". By 2007, in the United States, $3.1 billion were spent on homeopathic medicine and 2.3% of the persons age 18 or over had consulted a practitioner that year. Homeopathy was first established in the United States by Dr. Hans Burch Gram in 1825 and rapidly gained popularity, partly because conventional medicine of the time was inherently risky. The height of its influence was the end of the 19th century where hardly any city with over 50,000 people was without a homeopathic hospital. In 1890, there were 93 regular schools, 14 of them were fully homeopathic and 8 of them were eclectic. In 1900, there were 121 regular schools, with 22 of them being homeopathic and 10 eclectic. According to one study, in 1990, 0.7% of individuals used homeopathy in the year prior to being questioned; in 1997, 3.4% had used homeopathy at least once in the previous year. According to the same study, of those who used homeopathy, 31.7% had seen a homeopathic practitioner in the past year in 1990 and the number dropped to 16.5% by 1997.

Mexico In Mexico, homeopathy is currently integrated into the national health care system. In 1985, a presidential decree established the first homeopathic school as well as regulations specifying training requirements for homeopathic doctors. Of those individuals who use complementary alternative medicines, over 26% use homeopathy.

South America Some countries in South America, such as Argentina or Colombia, allow only professional doctors who are qualified and have graduated from a recognised medical school to practice homeopathy. Homeopathy has been regulated in other South American countries, such as Colombia, since the beginning of the 20th century. In Brazil, homeopathy is included in the national health system, and since 1991, physicians who want to practice homeopathy must complete 2,300 hours of education prior to receiving the proper licenses.

Middle East and Asia In Asia, the use of homeopathic treatments is increasing, especially in India. Homeopathy arrived in India with Dr Johann Martin Honigberger in Lahore, in 1829–1830. India has the largest homeopathic infrastructure in the world, with low estimates at about 64,000, but going as high as 300,000 practising homeopaths. In addition, there are 180 colleges teaching courses, and 7500 government clinics and 307 hospitals which dispense homeopathic remedies. In China, homeopathy appears to be almost unknown; Traditional Chinese medicine still plays an important role in the healthcare system, is used by over half the population and in most hospitals and has an official medical degree. In Japan homeopathy has not a big presence, and the traditional medicines are classified into Kampo medicine and traditional medicine indigenous to Japan. 72% of registered physicians currently use kampo medicines in their clinical services. In Laos there is a diversity of traditional medical systems, one of them being homeopathy, and homeopathy will be introduced as a discipline at the newly established Faculty of Biomedicine. Asiatic countries many times were exposed to both homeopathic and non-homeopathic ideas about medicine through invading armies that had ties to Europe. In Malaysia, homeopathy was introduced during World War II by Indian military personnel that formed bulk of the British army in Asia. The French army brought early modern medicine to Laos during their 1893 invasion. In China, Shangai had one homeopathic hospital in 1911, and had four later in 1934. In this region, the European models of medicine complemented, but did not replace, the local traditional medicines.

Middle East Homeopathy is becoming popular in the United Arab Emirates (UAE) and in Iran. The UAE Ministry of Health (MOH) recognizes and regulates the practice of homeopathy in a systematic way. Both medical doctors and lay practitioners can practise homeopathy but they all should pass MOH exams which cover both medical science and homeopathy. The Ministry of Health of Iran recognizes homeopathy as a legal alternative treatment. The Iranian Homeopathic Association, formed with the permission of the Ministry of the Interior and the Ministry of Health, is the reference association for providing standards of homeopathy. In Iran only medical doctors can practice homeopathy.

Hong Kong Homeopathy is practised in Hong Kong as an alternative medicine.

India Homoeopathy came to India in early 1810, with travelers, missionaries and military personnels from the West. The first official patronage was given to Dr. John Martin Honigberger, a homeopath called to the Court of Maharaja Ranjeet Singh in 1839 for his treatment. Thereafter, he settled in Calcutta, thereby establishing first base for Homeopathy in India, from where it gradually spread across India Homeopathy research and education is looked after by the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), which is part of the Ministry of Health & Family Welfare, which also takes care of educational standards in the Indian Systems of Medicines and Homoeopathy colleges and promotes research in respective fields. Central Council for Research in Homoeopathy (CCRH), was established as an autonomous organization, at New Delhi in 1978 by Govt. of India. Homeopathic education is regulated by Central Council of Homoeopathy (CCH), a statutory body under the Ministry of Health & Family Welfare, formed in 1973 through Act of Parliament is one of Professional Councils of University Grants Commission (UGC), which monitor all higher education across India.

Israel Homeopathy is widely practised in Israel. It was relatively unknown in the Mandate of Palestine but after the state of Israel was founded in 1948 it widely became popular. Dr Jarus is credited with bringing homeopathy to Israel. In 1993 the Israeli Institute for Homeopathy was founded in order to regulate homeopathic practices within Israel. Approximately 50% of all Israelis are said to have used some form of complementary or alternative medicine at some point in their lives, many of them including homeopathy.

Singapore Although the Singapore health system does not use alternative medicine, the Government of Singapore recognizes several forms of alternative medicine, homeopathy among them. However, there is no legal regulation of alternative medicine, and anyone operating outside of their area of practice would be contravening Singapore's Medical Registration Act. Homeopathy is sometimes practised in some parts of the country. There are no homeopathic colleges or journals, although magazines sometimes carry articles about it. Almost no practitioners are qualified.

Russia / Soviet Union Homeopathy was introduced to Russia in 1824, with the first Russian homeopaths claimed by some sources to be Dr Steghman and Dr. Bhizel. The practice of homeopathy in Russia has been growing over the past two years. The Russian government held a meeting of its Health Care Ministry in January 1998 to discuss the creation of a Doctor of Homeopathy. Homeopathic conferences are also common in parts of Russia such as St. Petersburg, Moscow, and other regions. Homeopathy has also been accepted in other parts of the ex-Soviet Union, including Georgia. A key benefit that Russian homeopaths enjoyed during the Soviet era was that their patients paid out of pocket, which meant that the physicians earned slightly more than a conventional doctor, because conventional doctors were paid lower salaries by the state. Reportedly, a popular and successful homeopathic hospital in Russia is Krasnodar homeopathic Hospital. Though an official US report in 1868 states that the Russian Empire of the Tsars prohibited the practice of homeopathy by means of an administrative ukase (imperial decree), another, possibly less-accurate states that Tsar Nicholas I encouraged the use of homeopathy within Tsarist Russia. However it is clear that the Soviet Union objected to the practise of homeopathy very much, to the point where it was constantly under threat of closure, ban and persecutions even extending into the early 1990s.

Taiwan In Taiwan the Government has not approved homeopathy and so its distribution is purely through word of mouth. It is classified by the official regulatory bodies of Taiwan as an alternative medicine. However, homeopathy is popular in some areas.

Africa South Africa In South Africa, homeopathy is currently regulated by the Allied Health Professions Act, 1982 (Act 63 of 1982) together with the Regulations to the said Act which was set up to provide for the establishment of a statutory body, the Allied Health Professions Council of South Africa (AHPCSA) to regulate the homeopathic profession, amongst ten others. The AHPCSA is one of five Statutory Health Professional Councils regulating health professions in South Africa. Any person wishing to practice Homeopathy in any way whatsover within the boarders of South Africa must be registered with the AHPCSA. Registration is a legal requirement and under South African Law it is a criminal offense to practice homeopathy without registration. Homoeopathic registration in South Africa enjoys a standing, rights and privileges similar to that of conventional medical practitioners. This means that the legal scope of practice of a homeopathic practitioner is very similar to that of a conventional medical practitioner. The scope of practice includes also what would generally be applicable to Naturopathic practitioners in countries like the USA.

A Homeopathic Practitioner may diagnose, in fact being a diagnostic primary health care profession, a Homeopathic Practitioner is legally compelled to make a diagnosis and provide the appropriate ICD-10 diagnostic codes. Homeopathic Practitioners also have to be licensed to compound Homeopathic medicine and to dispense any medicine falling within their scope of practice. Both conventional pharmacology and Homoeopharmaceutics are a legal training requirement. Training therefore is based upon the medical curriculum with Homoeopathy as the primary therapeutic focus. From this perspective it is understandable that (as for Medical Practitioners where the requirement for registration is a MBChB or equivalent) in the case of Homeopathy the requirement for registration is a Masters Degree in Homeopathy MTech(Hom) or equivalent. Homoeopathic practitioners are trained diagnosticians, recognised as primary contact practitioners. It should be noted that, whereas the vast majority of international Homoeopathic schools offer skills-oriented Homoeopathic training, South Africa offers professional training at a level required for the practising of Homoeopathy as a primary contact health profession in accordance with the scope of practice of such a profession. All private Homeopathic colleges were closed during the late 1970s by the South African Department of Health (read the History and Development of Homeopathic Education in South Africa). Existing practitioners were put into a closed register and in terms of the new legislation, and medical doctors were allowed to keep practicing homeopathy regardless of their knowledge of the subject. Nowadays, the only training recognised by the AHPCSA is a five year full-time Masters degree in Homoeopathy offered at the University of Johannesburg and Durban University of Technology. The M.Tech(Hom) consists of a five year full-time medico-scientific course based on the medical curriculum with the core focus on classical, clinical, modern and conventional Homoeopathy, Homoeopharmaceutics and ending with a masters research dissertation. Graduates are registered as Homoeopathic practitioners only after having completed their post-graduate internship. The practice of Homeopathy in South Africa requires medical training as prerequisite. Two routes thus exist for entrance into Homeopathy, either via the medically based homeopathic Masters Degree course (MTech-Hom) or once a medical practitioner is registered for independent practice, by way of the Post Graduate Diploma in Homeopathy offered by the South African Faculty of Homoeopathy (SAFH). Medical practitioners may register as Homoeopathic practitioners only after successful completion of the post graduate diploma. Once registered, homeopathic practitioners may do the prescribed Compounding and Dispensing course through the University of Pretoria and thereafter apply for a License to Compound and Dispense Homeopathic Medicine from the National Department of Health. 22C. Licensing (1) Subject to the provisions of this section- (a) the Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, dentist, practitioner, nurse or other person registered under the

Health Professions Act, 1974, a licence to compound and dispense medicines, on the prescribed conditions; (5) No person shall compound or dispense a medicine unless he or she is authorised thereto in terms of the Pharmacy Act, 1974, is a veterinarian or is the holder of a licence as contemplated in subsection(1)(a). The Medicines Control Council was set up in 1965, and it put all types of medicine under the same standards. It was replaced in 1998 by the South African Medicines and Medical Devices Regulatory Authority, which placed separate procedures for registering regular and alternative medicines, in order to regulate them better.

Nigeria Both medically qualified practitioners and lay persons can practice homeopathy, with the Congress of Homoeopathic Medicine Practitioners having 30 medical doctors on its register in 2005. The All-Nigeria Homeopathic Medical Organization was founded in 1961, and the first homeopathic practitioner, I. Okogeri, began practice the following year. The Nigerian College of Homoeopathic Medicine, founded in 1972, is recognised by the government of the East Central State. The Nigerian Institute of Homeopathy has special consultative status with the United Nations Department of Economic and Social Affairs.

Chapter 6

Homeopathic Remedies

Arsenicum album Arsenicum album (Arsen. alb.) is a frequently-used homeopathic substance derived from the metallic element arsenic. It is used by homeopaths to treat a range of symptoms that include digestive disorders (especially food poisoning), insomnia, allergies, anxiety, depression, and obsessive-compulsive disorder, and it has been studied as a possible treatment for arsenic poisoning. The arsenic oxide in a homeopathic preparation is highly diluted, and so is considered generally safe, although rare reports of arsenic poisoning from poorly-prepared homeopathic treatments sold in India have been reported. When properly prepared, however, the extreme dilutions, typically to at least 1 in 1024, or 12C in homeopathic notation, mean that it is extremely statistically unlikely that any pill contains even a molecule of the original arsenic used. While some small, unblinded studies have claimed an effect on reducing arsenic toxicity, they do not recommend its large-scale use, and studies of homeopathic remedies have been shown to generally have problems that prevent them from being considered unambiguous evidence. There is no known mechanism for how arsenicum album could remove arsenic from a body, and there is insufficient evidence for it to be considered effective medicine (for any condition) by the scientific community.

Use in homeopathy According to a popular homeopathy guide, arsenicum album is one of the fifteen most important remedies in homeopathy. In classical homeopathy, people are grouped by "constitutional type" named after the homeopathic remedy applied, on the argument that people with similar "body shapes and personalities" suffer from the same type of diseases. "Arsen. alb." types are "tense, restless ambitious individuals" with a tendency toward hypochondriasis, pessimism, need for reassurance, and a meticulous attention to neatness and detail. For homeopathic use, arsenicum album is prepared by separating arsenic from iron (as in arsenopyrite), cobalt, or nickel by baking at high temperatures. The powder is then

ground and diluted with lactose. In the final dilution, there are normally no atoms of arsenic left. The final product is sold as tinctures (liquid), tablets, pellets, or powder. Key homeopathic uses include treating anxiety and "fear caused by insecurity", digestive disorders and mucosal inflammation, and ailments characterized symptomatically by burning pain. It was also used once for treatment of syphilis.

Research studies Several studies have been done into Arsenicum album, however, homeopathic studies are known to have problems, such as evidence of bias, lack of rigour, and failure to blind the experimenters or subjects to which group is being analysed that prevent them from being considered definitive evidence for any effect. In addition, the ideas behind homeopathy are scientifically implausible and directly opposed to fundamental principles of natural science and modern medicine, which means that poorly-conducted, small, or unblinded studies are not considered scientific proof of efficacy. The authors of one unblinded study of mice poisoned with arsenic and then given Arsenicum album claimed statistically significant reductions were reported in biochemical markers of liver damage. "However, other scientists remain sceptical", and Andreas Gescher, a biochemical toxicologist interviewed by New Scientist, said "This kind of study uses a dilution so high there is hardly anything there... Is it really possible?" and went on to say that he was "extremely skeptical".

HeadOn HeadOn is the brand name of a topical product claimed to relieve headaches. It is sold as a homeopathic preparation, purportedly developed at the Herpolscheimer clinic in Graz, Austria. It was originally distributed by Miralus Healthcare and was known for its television ads featuring the slogan "HeadOn, apply directly to the forehead" stated three times. On September 26, 2008, ownership of the HeadOn brand and its manufacture were transferred to Sirvision, inc. of North America. Sirvision re-introduced HeadOn with a new formulation, claiming it now contains "a clinically proven active ingredient for topical headache relief." There were no peer reviewed studies showing that the original HeadOn formula worked and the scientific consensus is that homeopathic preparations do not help beyond the placebo effect. The new formulation has not yet been investigated.

Commercial HeadOn's notoriety came in part due to its advertisements on cable and daytime programming on broadcast television which consisted of using only the tagline "HeadOn. Apply directly to the forehead", stated three times in succession, accompanied by a video of a model using the product without ever directly stating the product's purpose.

Manufacturer Miralus Healthcare decided not to include any factual claims about the product in the spots after the National Advertising Division of the Better Business Bureaus objected to the claim that HeadOn provided "fast, safe, effective" headache relief made in an earlier spot. A previous campaign included the phrase "Should I know about HeadOn?" Miralus Healthcare used focus groups to try a number of potential commercials, with one focused solely on repetition; the focus groups recalled the ads much more than with any other method, although many people considered the ads annoying. Dan Charron, vice president of sales and marketing at Miralus, told the Los Angeles Times that nobody in the focus groups had told him that the ads were annoying. Sirvision Inc, which bought the product line, have stated that they intend to refocus the advertisements in a "scientific direction".

Reception The commercial has led to a number of parodies now appearing on Web sites such as YouTube, USA Today reports, and it has since become an internet meme. The technophile magazine Make describes how to turn it into a ring tone. The commercial is parodied in the 2008 spoof film, Disaster Movie.

Other products Three related products are currently produced by former manufacturer of HeadOn Miralus Healthcare: •

• •

ActivOn - described on the company's website as a topical analgesic for arthritislike joint pains, in multiple formulations. Additionally, the product originally named FirstOn, a topical anti-itch product, is now called ActivOn Maximum Strength Anti-Itch. PreferOn - A topical product containing Vitamin E, claimed to improve the appearance of scars. RenewIn - A pill claimed to improve joint comfort, flexibility and mobility, in multiple formulations.

A homeopathic hemorrhoid cream, FREEdHem, was withdrawn from the market. Like HeadOn, FREEdHem featured repetition in its ads, which said "Freedom from hemorrhoids, FREEdHem hemorrhoid cream" or "FREEdHem, the only one-application hemorrhoidal cream" three times.

Ingredients As of September 2008, there are two versions of HeadOn available in stores: "Extra Strength" and "Migraine". Chemical analysis of the Migraine formulation has shown that the product consists almost entirely of wax. The three "active ingredients" are iris

versicolor 12× (a flower), white bryony 12× (a type of vine), and potassium dichromate 6× (a known carcinogen). The "×" notation indicates that the three chemicals have been diluted to 1 part per trillion, 1 part per trillion, and 1 part per million respectively. This amount of dilution is so great that the product has been described as a placebo; with skeptic James Randi calling it a "major medical swindle". The formula for the Extra Strength version of the product is the same as the Migraine except that it excludes the iris versicolor. Seymour Diamond, director of the Diamond Headache Clinic in Chicago and the inpatient headache unit at St. Joseph Hospital, was quoted as saying "I see nothing in this product that has any validity whatsoever." Consumer Reports states that no clinical-trial data involving HeadOn have been presented, and that "any apparent efficacy may be the result of the placebo effect." Correspondence was published with a statement from HeadOn Customer Service that "It works through the nerves."

Licefreee! Licefreee! is the name of a topical non-toxic homeopathic preparation claimed to be of benefit for infestation by ectoparasites, specifically lice, in humans. The product uses sodium chloride diluted to homeopathic levels in a gel. The product was developed by and is manufactured by Tec Labs in Albany, Oregon. Licefreee! gel was first marketed in 1999 as an alternative to delousing treatments that used the insecticides pyrethrum and permethrin. However, claims of any homeopathic preparation's efficacy beyond the placebo effect are unsupported by the collective weight of scientific and clinical evidence.

Sponsorship In 2006 Licefreee! sponsored The United States PTA's “Keeping Kids Lice Free” program to help schools comply with the American Academy of Pediatrics’ guidelines for head lice prevention and control. The manufacturer supplied schools and medical professionals with educational videos on how to conduct a head lice check program as well as how to identify and treat infestations.

Bach flower remedies Bach flower remedies are dilutions of flower material developed by Edward Bach, an English physician and homeopath, in the 1930s. The remedies are intended primarily for emotional and spiritual conditions, including but not limited to depression, anxiety, insomnia and stress. The remedies contain a very small amount of flower material in a 7:8 solution of water and brandy. Because the remedies are extremely diluted they do not have a characteristic scent or taste of the plant. Vendors claim that the remedies contain "energetic" nature of the flower and that this can be transmitted to the user. Although Bach flower remedies often are associated with homeopathy, the remedies do not follow homeopathic precepts such as the law of similars or the assumption that curative powers are enhanced by diluting and shaking ("succussion"). Two systematic reviews of clinical trials of Bach flower remedies found no support for effects beyond a placebo.

Use Each remedy is used alone or in conjunction with other remedies, and each flower is believed by advocates to impart specific qualities to the remedy. Bach flower remedies are also used on pets and domestic animals. Remedies are usually taken orally. Remedies may be recommended by a naturopath or by a trained Bach flower practitioner after an interview. An individual may also choose the combination they feel best suits their situation. Some vendors recommend dowsing to select a remedy. The best known flower remedy is the Rescue Remedy combination, which contains an equal amount each of Rock rose, Impatiens, Clematis, Star of Bethlehem and Cherry Plum remedies. The product is aimed at treating stress, anxiety, and panic attacks, especially in emergencies. Rescue Remedy is a trade mark and other companies produce the same formula under other names, such as Five Flower Remedy. Rescue Cream contains the same remedies in a cream form, with the addition of Crab Apple, the only one of Bach's remedies meant to work directly on the physical body as well as with the emotions. It is applied externally in response to minor skin problems such as itches, cuts, stings, pimples and burns. Research on the effects of a particular remedy is done by case reporting with consensus review by other users. Results found in this manner are susceptible to confirmation bias, a tendency to search for or interpret new information in a way that confirms preconceptions and avoid information and interpretations which contradict prior beliefs.

Philosophy Bach thought of illness as the result of "a contradiction between the purposes of the soul and the personality's point of view." This internal war, according to Bach, leads to negative moods and energy blocking, which causes a lack of "harmony," thus leading to physical diseases. Rather than being based on research using the scientific method, Bach's flower remedies were intuitively derived and based on his perceived psychic connections to the plants.p. 185 If Bach felt a negative emotion, he would hold his hand over different plants, and if one alleviated the emotion, he would ascribe the power to heal that emotional problem to that plant. He believed that early morning sunlight passing through dew-drops on flower petals transferred the healing power of the flower onto the water, so he would collect the dew drops from the plants and preserve the dew with an equal amount of brandy to produce a mother tincture which would be further diluted before use. Later, he found that the amount of dew he could collect was not sufficient, so he would suspend flowers in spring water and allow the sun's rays to pass through them. Bach advertised his remedies in two daily newspapers, but since his practices did not follow any scientific protocol, and his methods and claims were unproven, the General Medical Council disapproved of his advertising. For example, in his treatise Heal Thyself he wrote: Disease will never be cured or eradicated by present materialistic methods, for the simple reason that disease in its origin is not material . . . Disease is in essence the result of conflict between the Soul and Mind and will never be eradicated except by spiritual and mental effort.

Production Edward Bach thought that dew collected from the flowers of plants contains some of the properties of the plant, and that it was more potent on flowers grown in the sun. As it was impractical to collect dew in quantity, he decided to pick flowers and steep them in a bowl of water under sunlight. If this was impractical due to lack of sunlight or other reasons, he decided the flowers may be boiled. The result of this process Bach termed the "mother tincture", which is then further diluted before sale or use. Bach was satisfied with the method, because of its simplicity, and because it involved a process of combination of the four elements: The earth to nurture the plant, the air from which it feeds, the sun or fire to enable it to impart its power, and water to collect and be enriched with its beneficent magnetic healing.

Bach flower remedies are not dependent on the theory of successive dilutions, and are not based on the Law of Similars of Homeopathy. The Bach remedies, unlike homeopathic remedies, are all derived from non-toxic substances, with the idea that a "positive energy" can redirect or neutralize "negative energy."

Manufacturer information Bach flower remedies are produced by several companies around the world. The British Association of Flower Essence Producers (BAFEP) list at least six companies located on the United Kingdom. It also lists several other essence producers. Nelsons is a major producer of Bach flower remedies and manufactures and holds the trademark to Rescue Remedy, which is the best known example of Bach Flower Remedies. They are licensed by the Bach Centre, whose bottling and distribution business was acquired in 1993 by Nelsons. The Bach Centre today is an independent foundation that produces flower tinctures for Nelsons. Nelsons distribute both Rescue Remedy and Bach Original Flower Remedies to more than 60 countries around the world. Another producer in the UK is Healing Herbs Ltd. In the late 1990s, Nelsons and Healing Herbs' Julian Barnard faced a legal dispute concerning the 'Bach flower remedies' and 'Bach' trademarks. In 1998, the High Court in London decided that 'Bach' and 'Bach flower remedies' are generics and cannot be used in the UK as registered trademarks. This decision was upheld in 1999 by the Court of Appeals, in 2000 in the House of Lords and in Europe by the Office for Harmonization in the Internal Market in 2008. However, they remain registered trademarks in other European territories.

Effectiveness A 2002 database review of randomized trials concluded: The hypothesis that flower remedies are associated with effects beyond a placebo response is not supported by data from rigorous clinical trials. All randomized double-blind studies, whether finding for or against the remedies, have suffered from small cohort sizes but the studies using the best methodology were the ones that found no effect over placebo. The most likely means of action for flower remedies is as placebos, enhanced by introspection on the patient's emotional state, or simply being listened to by the practitioner. The act of selecting and taking a remedy may act as a calming ritual. A systematic review in 2009 concluded: Most of the available evidence regarding the efficacy and safety of BFRs has a high risk of bias. We conclude that, based on the reported adverse events in these six trials, BFRs are probably safe. Few controlled prospective trials of BFRs for psychological problems and pain exist. Our analysis of the four controlled trials of BFRs for examination anxiety

and ADHD indicates that there is no evidence of benefit compared with a placebo intervention.

Chapter 7

Anthroposophical Medicine

Rudolf Steiner founded anthroposophical medicine in the 1920s Anthroposophical medicine is an alternative medicine combining anthroposophical philosophy, homeopathy, the doctrine of signatures, and some elements of science based medicine. Anthroposophical philosophy in medicine claims that human illness is related to the spirit world and reincarnation. An example of the practice of homeopathy is to take a substance that causes healthy people to have symtoms similar to those of an illness, then dilute that substance with water until none of the substance remains, leaving pure water, which is then claimed to cure a patient with the illness. An example of medical practice using the doctrine of signatures is that if a willow plant growing on a watercourse is a strong and supple, and other plants are soft and wilt easily, it is believed

that preparations made from willow will treat a person with arthritis so as to be more like a willow. Anthrosophical medicine does not focus on the theory of germs, nor on using the scientific method to examine measurable physical quantities, as does science based medicine. Anthroposophical medicine uses a holistic approach and focuses on factors that support human health, rather than on factors that cause disease (called "salutogenesis"), and also focusing on strengthening both the patient's body and individuality. The selfdetermination, autonomy and dignity of patients is a central theme; therapies are believed to enhance a patient's capacities to heal. The anthrosophical medical system was founded in the 1920s by Rudolf Steiner in conjunction with Ita Wegman as an extension to conventional medicine based on the spiritual philosophy of Anthroposophy. Conventional medical treatments, including surgery and medications, are employed as necessary and anthroposophical physicians must have a conventional medical education, including a degree from an established and certified medical school, as well as extensive post-graduate study. There are currently anthroposophical medical practices in 80 countries worldwide.

Basic idea As stated by altMD Anthroposophical medicine is based on Steiner's concept that spiritual awareness is the foundation of individual health and of the health of society. Steiner believed that many of the oldest systems of healing, such as traditional Chinese medicine, Ayurvedic medicine, and Tibetan medicine, were based on a spiritual perception of the world that modern science has lost. Steiner wanted medicine to get back in touch with spirituality, and at the same time keep and use wisely the gains that science and technology have made. Thus, conventional medicine needed to be extended beyond physical science to include a holistic spiritual science. However, Steiner often dismissed scientific findings and established science. He adopted the pseudoscientific beliefs of homeopathy about chemistry. And he adopted the herbalist doctrine of signatures, that a metaphoric relationships between plant properties and the human body was real, and that the shapes of plants were related to the human body, in order to make his medicines.

Theory Anthroposophical medicine is based upon the anthroposophical view of the human being which considers the patient's: •

Physical constitution (what would be called a physical examination in science based medicine);

• •

•

•

The aura (called the "etheric body") that is believed to be a kind of supernatural "energy field" just around a person's body; The force of "life" (believed to be a mystical vital force differentiating the living from the nonliving), which is seen as the organizing principle directing growth and regeneration. The astral body (the immaterial body as in an out of body experience), understood as the bearer of both the emotional or psychological state (affect), and of consciousness; And the 'ego', which is above the unself aware mind, and is seen as accounting for self-reflection and free will.

AltMD desribes this as "Human beings are made up of four levels ("fourfoldness") of being. The first level is the physical body. The second level is the life or etheric body, which corresponds to the Chinese idea of chi and the Ayurvedic idea of prana. The third level is the soul, or astral body, and the fourth level is the spirit. AM doctors believe that all levels of being influence a patient's health."

Doctrine of signatures An example of anthroposophical medicine is decribed by the Physicians Association of Anthroposophical Medince. "... plants that grow near water are usually heavy, with big, dark green leaves that wilt and break easily. An exception is... the white willow, a tree that always grows near water and loves fight. However, unlike other "watery" plants, the willow has fine, almost dry leaves and looks very light... Its branches are unbelievably tough. They are elastic and cannot be broken. They bend easily and form "joints" rather than break. These few signatures can give us the clue to what salix can be used for therapeutically: arthritis, deformation of joints, swollen joints... " Critics would point out that the joints and qualities of a plant do not have anyting to do with quality of joints of a human body.

Circulatory system Steiner suggested that "the blood was propelled with its own biological momentum, as can be seen in the embryo, and boosts itself with induced momenta from the heart", which has been refuted by more recent understanding of cell biology and human physiology.

Spending time with patients Anthroposophical medicine practitioners believe that spending time with a patient is important, and that patients are typically rushed through science based medical treatment,

so many important factors about the patient are overlooked, and aspects of the patients well being are not helped by the rush. Science based psychology has found that stress impacts the immune system, and science based doctors are critical of their own field for rushing patients.1.

Minimizing over-prescription of antibiotics and drugs Anthroposophical medicine doctors try to minimize the use of antibiotics, drugs, and vaccinations. Overuse of antibiotics and overpresectipion of drugs driven by pharmaceutical industry profit making has been widely criticized by scientists and science based medicine doctors. Anthroposophical doctors generally restrict the use of antibiotics, antipyretics, and have a differentiated individual approach to vaccinations. Some children treated by anthroposophic doctors are vaccinated only against tetanus and polio, and some vaccinations are given later than recommended by health authorities.

Studies of efficacy As with other forms of alternative medicine, for many treatments used in anthroposophical medicine proofs of efficacy have not been made through strictly controlled medical testing.

Mistletoe treatment for cancer The use of mistletoe extracts in the treatment of cancer was first proposed by Rudolf Steiner and developed by anthroposophical researchers; it is now probably the bestknown anthroposophic therapy. Various forms of the medication are widely available in Central Europe, where the treatment regimens of up to two-thirds of all oncology patients includes mistletoe. The extracts are generally no longer used to reduce or inhibit tumor growth, but to improve the patients' quality of life and to reduce tumor-induced symptoms and the side-effects of chemotherapy and radiotherapy; a wide array of clinical studies support the efficacy of the treatment regimen for the latter purposes. There are also phytotherapeutic preparations using non-homeopathic doses of mistletoe; these should not be confused with the anthroposophical preparations. In the United States, mistletoe "holds interest as a potential anticancer agent because extracts derived from it have been shown to kill cancer cells in vitro" but no forms of the extract have been approved by the FDA for any indications. Mistletoe extracts may not be distributed in or imported into the US except for the purpose of clinical research. Although preclinical (animal) studies suggested a potential role for mistletoe extracts in cancer therapies, no such effects have been convincingly reported. Evidence for the efficacy of mistletoe as an anticancer drug from human studies is weak. Though numerous cohort studies and case series have reported tumor remission and regression, double blinded studies have tended not to support this effect, and the cohort and case

studies have been criticized as biased due to their small size and lack of double-blinding. Mistletoe extracts are also frequently used to treat cancer patients in Holland, and in Great Britain. The treatment has been approved as palliative therapy for malignant tumors in Germany. In the United States it is approved for clinical trial only, and numerous clinical trials have evaluated its effectiveness. Approximately 30 types of mistletoe extracts are used clinically; the most commonly used is known as Iscador. Though no serious side effects are normally found from mistletoe treatments, in one case a patient allergic to mistletoe went into anaphylactic shock. Minor side-effects of injections reported include redness, pain or, in a few cases, subcutaneous inflammation. The National Cancer Institute (US) position on mistletoe is: "Extracts of mistletoe have been shown to kill cancer cells in the laboratory and to boost the immune system (the complex group of organs and cells that defends the body against infection or disease). For this reason, mistletoe has been classified as a type of biological response modifier (a substance that stimulates the body's response to infection and disease). Extracts of mistletoe have also been shown in the laboratory to prevent the growth of new blood vessels needed for tumors to grow....At this time, there is not enough evidence to recommend the use of mistletoe as a treatment for cancer except in carefully designed clinical trials. These trials will give more information about whether mistletoe can be useful in treating certain types of cancer." Reviews •

•

•

One review concluded: "Although there is laboratory evidence of biological activity that may be beneficial to cancer patients, the evidence of clinical benefit from human studies remains weak and inconclusive. Because of the absence of serious side effects and the limited evidence that mistletoe products may offer some therapeutic advantages, further research is warranted." The National Cancer Institute has concluded that mistletoe extract has been shown to kill cancer cells in the laboratory and to boost the immune system in animals, and that there is evidence that mistletoe can boost the immune system in human beings. The Institute's review suggests that many studies done on human beings have major weaknesses that raise doubts about the reliability of their findings; in some studies without such weaknesses no significant effect was found, while in others "Iscador proved safe and effective and also showed a significant survival advantage over untreated controls." According to the American Cancer Society, "A number of laboratory experiments suggest mistletoe may have the potential to treat cancer, but these results have not yet been reflected in clinical trials. Available evidence from well-designed clinical trials that have studied mistletoe did not support claims that mistletoe could improve length or quality of life. Review of evidence from carefully conducted controlled human clinical studies indicates that mistletoe does not have any significant anti-tumor activity. Most of the studies that have found positive results from mistletoe extract in the treatment or prevention of cancer are not considered scientifically dependable....Researchers are working to identify the most important components, which are thought to be the lectins (proteins).

•

Laboratory experiments also hint that mistletoe increases the activity of lymphocytes, which are cells that attack invading organisms. " Edzard Ernst, Professor of Complementary Medicine, suggested that there is a danger that some patients might choose to abandon other cancer treatments.

History

Ita Wegman, co-founder of the medical approach, before 1900 in Berlin. The first steps towards an anthroposophical approach to medicine were made before 1920, when homeopathic physicians and pharmacists began working with Rudolf Steiner, who recommended new medicinal substances as well as specific methods for preparing these. In 1921, Dr Ita Wegman opened the first anthroposophic medical clinic, now known as the Ita Wegman Clinic, in Arlesheim, Switzerland. Wegman was soon joined by a number of other doctors. They began to train the first anthroposophic nurses for the clinic.

At Wegman's request, Steiner regularly visited the clinic and suggested treatment regimes for particular patients. Between 1921 and 1925, he also gave several series of lectures on medicine. In 1925, Wegman and Steiner wrote the first book on the anthroposophic approach to medicine, Fundamentals of Therapy. The clinic expanded and soon opened a branch in Ascona. Wegman lectured widely, visiting Holland and England particularly frequently, and an increasing number of doctors began to include the anthroposophic approach in their practices. A cancer clinic, the Lukas Clinic, opened in Arlesheim in 1963.

Modern history and prevalence of practice There are about 28 anthroposophic hospitals, departments of hospitals, rehabilitation centers and sanatoria located in Germany, Switzerland, Sweden, the Netherlands, Great Britain, Italy, the USA and Brazil, as well as over 140 outpatient clinics worldwide. Four of the German and Swiss anthroposophic hospitals are state-sponsored; three are academic teaching hospitals under the aegis of nearby universities. Three European universities (Bern, Hamburg and Witten/Herdecke) have professorships in anthroposophic medicine and other universities offer courses on the field. Anthroposophic medicine is recognized in Germany as a "Special Therapy System", along with homeopathy and herbal medicine , under the Medicines Act and has its own committee at the Federal Institute for Drugs and Medical Devices. Anthroposophical medical treatment has been a recognized specialty within Swiss governmental health policy since 1999. The International Federation of Anthroposophical Medical Associations estimates that there are currently approximately 2,000 Anthroposophical doctors worldwide. Based on the number of prescriptions it has been estimated that anthroposophic medicinal products are prescribed by more than 30,000 physicians.

Chapter 8

Water Memory

Water memory is a conjecture that water is capable of retaining a "memory" of substances once dissolved in it to arbitrary dilution. Shaking the water at each stage of a serial dilution is claimed to be necessary for an effect to occur. The concept was proposed by Jacques Benveniste to explain the purported therapeutic powers of homeopathic remedies, which are prepared by diluting solutions to such a high degree that not even a single molecule of the original substance remains in most final preparations. Benveniste sought to prove this basic tenet of homeopathy by conducting an experiment to be published "independently of homeopathic interests" in a major journal. While some studies, including Benveniste's, have reported such an effect, double-blind replications of the experiments involved have failed to reproduce the results, and the concept is not accepted by the scientific community. Liquid water does not maintain ordered networks of molecules longer than a small fraction of a nanosecond.

The Nature controversy The most prominent advocate of this idea was the French immunologist Jacques Benveniste. His team at the French National Institute of Health and Medical Research (INSERM) diluted a solution of human antibodies to such a degree that there was virtually no possibility that a single molecule remained. Nonetheless, 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. Benveniste stated: "It's like agitating a car key in the river, going miles downstream, extracting a few drops of water, and then starting one's car with the water." At the time, Benveniste offered no theoretical explanation for the effect. Benveniste submitted the research to the prominent science journal Nature for publication. There was concern on the part of Nature's editorial oversight board that the material, if published, would lend credibility to homeopathic practitioners even if the effects were not replicable. There was equal concern that the research was simply wrong, given the changes that it would demand of the known laws of physics and chemistry. The

editor of Nature, John Maddox, stated that, "Our minds were not so much closed as unready to change our whole view of how science is constructed." Rejecting the paper on any objective grounds was deemed unsupportable, as there were no methodological flaws apparent at the time. In the end, a compromise was reached. The paper was published in Nature Vol. 333 on 30 June 1988, but it was accompanied with an editorial by Maddox that noted "There are good and particular reasons why prudent people should, for the time being, suspend judgment" and described some of the fundamental laws of chemistry and physics which it would violate, if shown to be true. Additionally, Maddox demanded that the experiments be re-run under the supervision of a hand-picked group of what became known as "ghostbusters", including Maddox, famed magician-cum-paranormal researcher James Randi, and Walter Stewart, a physicist and freelance debunker at the U.S. National Institutes of Health. In the first series of supervised experiments, the original experimental procedure was followed as it had been when the paper was first submitted for publication. The experiments were successful, matching the published data quite closely. However, Maddox noted that during the procedure the experimenters were aware of which test tubes originally contained the antibodies and which did not. A second experimental series was started with Maddox and his team in charge of the double-blinding; notebooks were photographed, the lab videotaped, and vials juggled and secretly coded. Randi went so far as to wrap the labels in tinfoil, seal them in an envelope, and then stick them on the ceiling so Benveniste and his colleagues could not read them. No memory effect was observed in the blinded experiments. Nature published a follow-up report in the next issue: "We conclude that there is no substantial basis for the claim that antiIgE at high dilution (by factors as great as 10120) retains its biological effectiveness, and that the hypothesis that water can be imprinted with the memory of past solutes is as unnecessary as it is fanciful." Nevertheless, there was no suggestion of fraud; Maddox and his team initially speculated that someone in the lab "was playing a trick on Benveniste," but later concluded, "We believe the laboratory has fostered and then cherished a delusion about the interpretation of its data." Maddox also pointed out that two of Benveniste's researchers were being paid for by the French homeopathic company Boiron. In a response letter published in the same issue of the journal, Benveniste lashed out at Maddox and complained about the "ordeal" he endured at the hands of the Nature team, comparing it to "Salem witchhunts or McCarthy-like prosecutions." In both the Nature response and a following Quirks and Quarks episode, Benveniste especially complained about Stewart, who he stated acted as if they were all frauds and treated them with disdain, complaining about his "typical know-it-all attitude". In his Nature letter, Benveniste also implied that Randi was attempting to hoodwink the experimental run by doing magic tricks, "distracting the technician in charge of its supervision!" He was more apologetic on Quirks and Quarks, re-phrasing his mention of Randi to imply that he had kept the team amused with his tricks and that his presence was generally welcomed. He

also pointed out that although it was true two of his team-members were being paid for by a homeopathic company, the same company had paid for Maddox's team's hotel bill. Maddox was unapologetic, stating "I'm sorry we didn't find something more interesting." On the same Quirks and Quarks show he dismissed Benveniste's complaints, stating that the possibility that the results would be unduly promoted by the homeopathy community demanded an immediate re-test. In failing, the tests demonstrated that the initial results were likely due to the experimenter effect. He also pointed out that the entire test procedure that Benveniste later complained about was one that had been agreed upon in advance by all parties. It was only when the test then failed that Benveniste disputed its appropriateness. The debate continued in the letters section of Nature for several issues before being ended by the editorial board. It continued in the French press for some time. For all of the arguing over the retests, it has done nothing to stop what Maddox worried about; even in the light of their failure they are still used to claim that the experiments "prove" that homeopathy works. One of Benveniste's co-authors on the Nature paper, Francis Beauvais, later stated that while unblinded experimental trials usually yielded "correct" results (i.e. ultradiluted samples were biologically active, controls were not), "the results of blinded samples were almost always at random and did not fit the expected results: some 'controls' were active and some 'active' samples were without effect on the biological system."

Subsequent research After the Nature controversy, Benveniste gained the public support of Brian Josephson, a Nobel laureate physicist with a reputation for openness to paranormal claims. Experiments continued along the same basic lines, culminating with a 1997 paper claiming the effect could be transmitted over phone lines. This was followed by two additional papers in 1999 and another on remote-transmission in 2000 by which time it was claimed that it could also be sent over the Internet. Time magazine reported in 1999 that, in response to skepticism from physicist Robert Park, Josephson had challenged the American Physical Society (APS) to oversee a replication by Benveniste. This challenge was to be "a randomized double-blind test", of his claimed ability to transfer the characteristics of homeopathically diluted water over the Internet. The APS accepted the challenge and offered to cover the costs of the test. When he heard of this, Randi also offered to throw in the long-standing $1 million prize for any positive demonstration of the paranormal, to which Benveniste replied: "Fine to us." in his DigiBio NewsLetter. However, Randi later noted that Benveniste and Josephson did not follow up on their challenge, mocking their silence on the topic as if they were missing persons. An independent test of the 2000 remote-transmission experiment was carried out in the USA by a team funded by the United States Department of Defense. Using the same experimental devices and setup as the Benveniste team, they failed to find any effect

when running the experiment. Several "positive" results were noted, however, but only when a particular one of Benveniste's researchers was running the equipment. "We did not observe systematic influences such as pipetting differences, contamination, or violations in blinding or randomization that would explain these effects from the Benveniste investigator. However, our observations do not exclude these possibilities." Benveniste admitted to having noticed this himself. "He stated that certain individuals consistently get digital effects and other individuals get no effects or block those effects." The experiment is notable for the way it attempted to avoid the confrontational nature of the earlier Maddox test. Third-party attempts at replication of the Benveniste experiment have failed to produce positive results that could be independently replicated. In 1993, Nature published a paper describing a number of follow-up experiments that failed to find a similar effect, and an independent study published in Experientia in 1992 showed no effect. An international team led by Professor Madeleine Ennis of Queen's University of Belfast claimed in 1999 to have replicated the Benveniste results. Randi then forwarded the $1 million challenge to the BBC Horizon program to prove the "water memory" theory following Ennis' experimental procedure. In response, experiments were conducted with the VicePresident of the Royal Society, Professor John Enderby, overseeing the proceedings. The challenge ended with no memory effect observed by the Horizon team. For a piece on homeopathy, the ABC program 20/20 also attempted, unsuccessfully, to reproduce Ennis's results. Research published in 2005 on hydrogen bond network dynamics in water showed that "liquid water essentially loses the memory of persistent correlations in its structure" within fifty millionths of a nanosecond.

Chapter 9

Placebo

The placebo effect can be produced by inert tablets, by sham surgery, and by false information, such as when electrical stimulation is turned "off" in those with Parkinson's disease implanted brain electrodes. A placebo is a sham or simulated medical intervention. Sometimes patients given a placebo treatment will have a perceived or actual improvement in a medical condition, a phenomenon commonly called the placebo effect. In medical research, placebos are given as control treatments and depend on the use of measured deception. Common placebos are inert tablets, sham surgery, and other procedures based on false information. However, placebos can also have a surprisingly positive effect on a patient who knows that the given treatment is without any active drug, as compared with a control group who knowingly did not get a placebo. In one common placebo procedure, however, a patient is given an inert pill, told that it may improve his/her condition, but not told that it is in fact inert. Such an intervention may cause the patient to believe the treatment will change his/her condition; and this belief may produce a subjective perception of a therapeutic effect, causing the patient to feel their condition has improved. This phenomenon is known as the placebo effect. Placebos are widely used in medical research and medicine, and the placebo effect is a pervasive phenomenon; in fact, it is part of the response to any active medical intervention. The placebo effect points to the importance of perception and the brain's role in physical health. However, when used as treatment in clinical medicine (as opposed to laboratory research), the deception involved in the use of placebos creates tension between the Hippocratic Oath and the honesty of the doctor-patient relationship. The United Kingdom Parliamentary Committee on Science and Technology has stated that: "...prescribing placebos... usually relies on some degree of patient deception" and "prescribing pure placebos is bad medicine. Their effect is unreliable and unpredictable and cannot form the sole basis of any treatment on the NHS." Since the publication of Henry K. Beecher's The Powerful Placebo in 1955 the phenomenon has been considered to have clinically important effects. This view was notably challenged when in 2001 a systematic review of clinical trials concluded that there was no evidence of clinically important effects, except perhaps in the treatment of pain and continuous subjective outcomes. The article received a flurry of criticism, but the authors later published a Cochrane review with similar conclusions (updated as of 2010). Most studies have attributed the difference from baseline till the end of the trial to a placebo effect, but the reviewers examined studies which had both placebo and untreated groups in order to distinguish the placebo effect from the natural progression of the disease. However these conclusions have been criticized because of the great variety of diseases - more than 40 - in this metastudy. The effect of placebo is very different in different diseases. By pooling quite different diseases the results can be levelled out.

Definitions, effects, and ethics A placebo has been defined as "a substance or procedure… that is objectively without specific activity for the condition being treated". Under this definition, a wide variety of things can be placebos and exhibit a placebo effect. Pharmacological substances administered through any means can act as placebos, including pills, creams, inhalants, and injections. Medical devices such as ultrasound can act as placebos. Sham surgery, sham electrodes implanted in the brain, and sham acupuncture, either with sham needles or on fake acupuncture points, have all exhibited placebo effects. Bedding not treated to reduce allergies has been used as a placebo to control for treated bedding. The physician has even been called a placebo a study found that patient recovery can be increased by words that suggest the patient “would be better in a few days”, and if the patient is given treatment, that “the treatment would certainly make him better” rather than negative words such as “I am not sure that the treatment I am going to give you will have an effect”. The placebo effect may be a component of pharmacological therapies: Pain killing and anxiety reducing drugs that are infused secretly without an individual’s knowledge are less effective than when a patient knows they are receiving them. Likewise, the effects of stimulation from implanted electrodes in the brains of those with advanced Parkinson's disease are greater when they are aware they are receiving this stimulation. Sometimes administering or prescribing a placebo merges into fake medicine. The placebo effect has sometimes been defined as a physiological effect caused by the placebo, but Moerman and Jonas have pointed out that this seems illogical, as a placebo is an inert substance which does not directly cause anything. Instead they introduced the word "meaning response" for the meaning the brain associates with the placebo, which causes a physiological placebo effect. They propose that the placebo, which may be unethical, could be avoided entirely if doctors comfort and encourage their patients' health. Ernst and Resch also attempted to distinguish between the "true" and "perceived" placebo effect, as they argued that some of the effects attributed to the placebo effect could be due to other factors. The placebo effect has been controversial throughout history. Notable medical organizations have endorsed it, but in 1903 Richard Cabot concluded that it should be avoided because it is deceptive. Newman points out the "placebo paradox", – it may be unethical to use a placebo, but also unethical "not to use something that heals". He suggests to solve this dilemma by appropriating the meaning response in medicine, that is make use of the placebo effect, as long as the "one administering… is honest, open, and believes in its potential healing power". Another possible resolution of the ethical dilemma might come from the "honest placebo" effect found in a 2010 study. at Harvard Medical School, where patients with irritable bowel syndrome experienced a significant beneficial effect even though they were told the pills they were taking were placebos, as compared to a control group who received no pills.

History The word 'placebo', Latin for "I will please", dates back to a Latin translation of the Bible by Jerome. It was first used in a medicinal context in the 18th century. In 1785 it was defined as a "commonplace method or medicine" and in 1811 it was defined as "any medicine adapted more to please than to benefit the patient", sometimes with a derogatory implication but not with the implication of no effect. Placebos were widespread in medicine until the 20th century, and they were sometimes endorsed as necessary deceptions. In 1903 Richard Cabot said that he was brought up to use placebos, but he ultimately concluded by saying that "I have not yet found any case in which a lie does not do more harm than good". In 1961 Henry K. Beecher found that surgeons he categorized as enthusiasts relieved their patients' chest pain and heart problems more than skeptic surgeons. In 1961 Walter Kennedy introduced the word nocebo.

Mechanism of the effect The phenomenon of an inert substance resulting in a patient's medical improvement is called the placebo effect. The phenomenon is related to the perception and expectation which the patient has; if the substance is viewed as helpful, it can heal, but if it is viewed as harmful, it can cause negative effects, which is known as the nocebo effect. The basic mechanisms of placebo effects have been investigated since 1978, when it was found that the opioid antagonist naloxone could block placebo painkillers, suggesting that endogenous opioids are involved.

Expectancy and conditioning Placebos exert an "expectancy" effect whereby an inert substance which is believed to be a drug has effects similar to the actual drug. Placebos can act similarly through classical conditioning, where a placebo and an actual stimulus are used simultaneously until the placebo is associated with the effect from the actual stimulus. Both conditioning and expectations play a role in placebo effect, and make different kinds of contribution. Conditioning has a longer lasting effect, and can affect earlier stages of information processing. The expectancy effect can be enhanced through factors such as the enthusiasm of the doctor, differences in size and color of placebo pills, or the use of other inventions such as injections. In one study, the response to a placebo increased from 44% to 62% when the doctor treated them with "warmth, attention, and confidence". Expectancy effects have been found to occur with a range of substances. Those who think a treatment will work display a stronger placebo effect than those who do not, as evidenced by a study of acupuncture. Because the placebo effect is based upon expectations and conditioning, the effect disappears if the patient is told that their expectations are unrealistic, or that the placebo intervention is ineffective. A conditioned pain reduction can be totally removed when its existence is explained. It has also been reported of subjects given placebos in a trial of anti-depressants, that "Once the trial was over and the patients who had been given placebos were told as much, they quickly deteriorated."

A placebo described as a muscle relaxant will cause muscle relaxation and if described as the opposite, muscle tension. A placebo presented as a stimulant will have this effect on heart rhythm, and blood pressure, but when administered as a depressant, the opposite effect. The consumption of caffeine has been reported to cause similar effects even when decaffeinated coffee is consumed, although a 2003 study found only limited support for this. Alcohol placebos can cause intoxication and sensorimotor impairment. Perceived ergogenic aids can increase endurance, speed and weight-lifting ability, leading to the question of whether placebos should be allowed in sport competition. Placebos can help smokers quit. Perceived allergens which are not truly allergenic can cause allergies. Inventions such as psychotherapy can have placebo effects. The effect has been observed in the transplantation of human embryonic neurons into the brains of those with advanced Parkinson's disease. Because placebos are dependent upon perception and expectation, various factors which change the perception can increase the magnitude of the placebo response. For example, studies have found that the color and size of the placebo pill makes a difference, with "hot-colored" pills working better as stimulants while "cool" colored pills work better as depressants. Capsules rather than tablets seem to be more effective, and size can make a difference. One researcher has found that big pills increase the effect while another has argued that the effect is dependent upon cultural background. More pills, branding, past experience, and high price increase the effect of placebo pills. Injection and acupuncture have larger effect than pills. Proper adherence to placebos is associated with decreased mortality. Motivation may contribute to the placebo effect. The active goals of an individual changes their somatic experience by altering the detection and interpretation of expectation-congruent symptoms, and by changing the behavioral strategies a person pursues. Motivation may link to the meaning through which people experience illness and treatment. Such meaning is derived from the culture in which they live and which informs them about the nature of illness and how it responds to treatment. Research upon the placebo treatment of gastric and duodenal ulcers shows that this varies widely with society: those in Germany having a high rate placebo effect while those in Brazil a low one. Placebo effects in treating gastric ulcers is low in Brazil, higher in northern Europe (Denmark, Netherlands) and extremely high in Germany. But the placebo effect for hypertension is lower in Germany than elsewhere Social observation can induce a placebo effect such when a person sees another having reduced pain following what they believe is a pain reducing procedure. The placebo effect can work selectively. If an analgesic placebo cream is applied on one hand, it will reduce pain only in that hand and not elsewhere on the body If a person is given a placebo under one name, and they respond, they will respond in the same way on a later occasion to that placebo under that name but not if under another.

Placebo effect and the brain Functional imaging upon placebo analgesia shows that it links to the activation, and increased functional correlation between this activation, in the anterior cingulate, prefrontal, orbitofrontal and insular cortices, nucleus accumbens, amygdala, the brainstem periaqueductal gray matter, and the spinal cord. These changes can act upon the brain’s early stages of information processing: research using evoked brain potentials upon painful laser pulses, for example, finds placebo effects upon the N2–P2, a biphasic negative–positive complex response, the N2 peak of which is at about 230 ms, and the P2 one at about 380 ms. They occur not only during placebo analgesia but after receiving the analgesic placebo (the areas are different here, and involve the medial prefrontal cortex, posterior parietal cortex and inferior parietal lobule). Different areas in the higher brain have different functions. The prefrontal involvement could be related to recalling the placebo and maintaining its cognitive presence in a "selfreinforcing feedback loop" (during pain an individual recalls having taken the placebo and reduced pain reinforces its status as an analgesic). The rostral anterior cingulate cortex (rACC) and its subcortical connectivity could be related to the expectation of potential pain stimuli The higher brain works by regulating subcortical processes. High placebo responses link with enhanced dopamine and mu-opioid activity in the circuitry for reward responses and motivated behavior of the nucleus accumbens, and conversely, anti-analgesic nocebos responses were associated with deactivation in this part of the brain of dopamine and opioid release. (It has been known that placebo analgesia depends upon the release in the brain of endogenous opioids since 1978.) Such analgesic placebos activation changes processing lower down in the brain by enhancing the descending inhibition through the periaqueductal gray on spinal nociceptive reflexes, while the expectations of antianalgesic nocebos acts in the opposite way to block this. The brain is also involved in less studied ways upon nonanalgesic placebo effects: • • • • •

Parkinson's disease: placebo relief is associated with the release of dopamine in the brain. Depression: Placebos reducing depression affect many of the same areas that are activated by antidepressants with the addition of the prefrontal cortex Caffeine: placebo caffeinated coffee causes an increase in bilateral dopamine release in the thalamus. Glucose: the expectation of an intravenous injection of glucose increases the release of dopamine in the basal ganglia of men (but not women). Methylphenidate: the expectation of intravenous injection of this drug in inexperienced drug users increased the release of dopamine in the ventral cingulate gyrus and nucleus accumbens, with this effect being largest in those with no prior experience of the drug.

Present functional imaging upon placebo analgesia has been summarized as showing that the placebo response is "mediated by "top-down" processes dependent on frontal cortical areas that generate and maintain cognitive expectancies. Dopaminergic reward pathways may underlie these expectancies". "Diseases lacking major 'top-down' or cortically based regulation may be less prone to placebo-related improvement".

Brain and body The brain has control over the body processes affected by placebos. Pain, motor fatigue and fever are directly organized by the brain. Other processes usually regulated by the body such as the immune system are also controlled indirectly through the sympathetic and parasympathetic nervous system. Research upon conditioning in animals shows the brain can learn control over them. In conditioning, a neutral stimulus saccharin is paired in a drink with an agent that produces an unconditioned response. For example, that agent might be cyclophosphamide that causes immunosuppression. After learning this pairing, the taste of saccharin by itself through neural top down control created immunosuppression, as a new conditioned response. Such conditioning has been found to affect a diverse variety of basic physiological processes not just in the immune system but ones such as serum iron levels, oxidative DNA damage levels, and insulin secretion. This work was originally done on rats, however, the same conditioning of basic physiological processes can also occur in humans. Recent reviews have argued the placebo effect is due to top down control by the brain for immunity and pain. Pacheco-López and colleagues have raised the possibility of "neocortical-sympathetic-immune axis providing neuroanatomical substrates that might explain the link between placebo/conditioned and placebo/expectation responses." A recent fMRI study has shown that a placebo can reduce pain-related neural activity in the spinal cord, indicating that placebo effects can extend beyond the brain.

Evolved health regulation Evolutionary medicine identifies many symptoms such as fever, pain, and sickness behavior as evolved responses to protect or enhance the recovery from infection and injury. Fever, for example, is an evolved self-treatment that removes bacteria or viruses through raised body temperature. These evolved responses, however, also have a cost that depending upon circumstances can outweigh their benefit (due to this, for example, there is a reduction in fever during malnutrition or late pregnancy). According to the health management system theory proposed by Nicholas Humphrey, the brain has been selected to ensure that evolved responses are deployed only when the cost benefit is biologically advantageous. To do this, the brain factors in a variety of information sources, including the likelihood derived from beliefs that the body will get well without deploying its costly evolved responses. One such source of information is the knowledge the body is receiving care and treatment. The placebo effect in this perspective arises when false information about medications misleads the health management system about the likelihood of getting well so that it selects not to deploy an evolved self-treatment.

Clinical utility Duration Placebo effects can last for a long time: over 8 weeks for panic disorder, 6 months for angina pectoris, and two and half years for rheumatoid arthritis. Placebo effects after verbal suggestion for mild pain can be robust and still exist after being repeated 10 times even if they have no actual pharmacological pain killing action

Clinical significance Hróbjartsson and Peter Gøtzsche published a study in 2001 and a follow-up study in 2004 questioning the nature of the placebo effect. The studies were performed as two metaanalyses. They found that in studies with a binary outcome, meaning patients were classified as improved or not improved, the placebo group had no statistically significant improvement over the no-treatment group. Similarly, there was no significant placebo effect in studies in which objective outcomes (such as blood pressure) were measured by an independent observer. The placebo effect could only be documented in studies in which the outcomes (improvement or failure to improve) were reported by the subjects themselves. The authors concluded that the placebo effect does not have "powerful clinical effects," (objective effects) and that patient-reported improvements (subjective effects) in pain were small and could not be clearly distinguished from reporting bias. Other researchers (Wampold et al) re-analysed the same data from the 2001 metaanalysis and concluded that the placebo effects for objective symptom measures are comparable to placebo effects for subjective ones and that the placebo effect can exceed the effect of the active treatment by 20% for disorders amenable to the placebo effect, a conclusion which Hróbjartsson & Gøtzsche described as "powerful spin". Another group of researchers noted the dramatically different conclusions between these two sets of authors despite nearly identical meta-analytic results, and suggested that placebo effects are indeed significant but small in magnitude. Hróbjartsson and Gøtzsche's conclusion has been criticised on several grounds. Their meta-analysis covered studies into a highly mixed group of conditions: the placebo effect does occur with peripheral disease processes (such as Hypertension, asthma, prostatic hyperplasia, anal fissure, bronchitis) though not for processes reflecting physical disease (such as venous leg ulcers, Crohn’s disease, urinary tract infection, and chronic heart failure). Placebos also do not work as strongly in clinical trials because the subjects do not know whether they might be getting a real treatment or a sham one. Where studies are made of placebos in which people think they are receiving actual treatment (rather than merely its possibility) the placebo effect has been observed. Other writers have argued that the placebo effect can be reliably demonstrated under appropriate conditions. In another update by Hróbjartsson & Gøtzsche, published as a 2010 Cochrane systematic review which confirms and modifies their previous work, over 200 trials investigating 60 clinical conditions were included. Placebo interventions were again not found to have important clinical effects in general but may influence patient-reported outcomes in some

situations, especially pain and nausea, although it was "difficult to distinguish patientreported effects of placebo from response bias". Effects were also found for phobia and asthma but were uncertain due to high risk of bias. In other conditions involving three or more trials, there was no statistically significant effect for smoking, dementia, depression, obesity, hypertension, insomnia and anxiety, although confidence intervals were wide. Several clinical (physical placebos, patient-involved outcomes, falsely informing patients there was no placebo) and methodological (small sample size, explicit aim of studying the placebo effect) factors were associated with higher effects of placebo. Despite low effects in general and the risk of bias, the authors acknowledged that large effects of placebo interventions may occur in certain situations.

Negative effects Similar to the placebo effect, inert substances have the potential to cause negative effects via the "nocebo effect" (Latin nocebo = "I will harm"). In this effect, giving an inert substance has negative consequences. Another negative consequence is that placebos can cause side-effects associated with real treatment. One example of this is with those that have already taken an opiate, can then show respiratory depression when given it again in the form of a placebo. Withdrawal symptoms can also occur after placebo treatment. This was found, for example, after the discontinuation of the Women's Health Initiative study of hormone replacement therapy for menopause. Women had been on placebo for an average of 5.7 years. Moderate or severe withdrawal symptoms were reported by 40.5% of those on placebo compared to 63.3% of those on hormone replacement.

Doctor-patient relationship A study of Danish general practitioners found that 48% had prescribed a placebo at least 10 times in the past year. The most frequently prescribed placebos were antibiotics for viral infections, and vitamins for fatigue. Specialists and hospital-based physicians reported much lower rates of placebo use. A 2004 study in the British Medical Journal of physicians in Israel found that 60% used placebos in their medical practice, most commonly to "fend off" requests for unjustified medications or to calm a patient. The accompanying editorial concluded, "We cannot afford to dispense with any treatment that works, even if we are not certain how it does." Other researches have argued that open provision of placebos for treating ADHD in children can be effective in maintaining ADHD children on lower stimulant doses in the short term. Critics of the practice responded that it is unethical to prescribe treatments that don't work, and that telling a patient that a placebo is a real medication is deceptive and harms the doctor-patient relationship in the long run. Critics also argued that using placebos can delay the proper diagnosis and treatment of serious medical conditions. The following impracticalities exist with placebos.

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Roughly only 30% of the population seems susceptible to placebo effects, and it is not possible to determine ahead of time whether a placebo will work or not. (However the placebo effect is zero in studies of blood poisoning and up to 80% in studies of wound on the duodenum). Patients rightfully want immediate relief or improvement from their illness or symptoms. A non-placebo can often provide that, while a placebo might not. Legitimate doctors and pharmacists could open themselves up to charges of fraud since sugar pills would cost pennies or cents for a bottle, but the price for a "real" medication would have to be charged to avoid making the patient suspicious.

About 25% of physicians in both the Danish and Israeli studies used placebos as a diagnostic tool to determine if a patient's symptoms were real, or if the patient was malingering. Both the critics and defenders of the medical use of placebos agreed that this was unethical. The British Medical Journal editorial said, "That a patient gets pain relief from a placebo does not imply that the pain is not real or organic in origin...the use of the placebo for 'diagnosis' of whether or not pain is real is misguided." The placebo administration may prove to be a useful treatment in some specific cases where recommended drugs cannot be used. For example, burn patients who are experiencing respiratory problems cannot often be prescribed opioid (morphine) or opioid derivatives (pethidine), as these can cause further respiratory depression. In such cases placebo injections (normal saline, etc.) are of use in providing real pain relief to burn patients if those not in delirium are told they are being given a powerful dose of painkiller. Referring specifically to homeopathy, the House of Commons of the United Kingdom Science and Technology Committee has stated: In the Committee’s view, homeopathy is a placebo treatment and the Government should have a policy on prescribing placebos. The Government is reluctant to address the appropriateness and ethics of prescribing placebos to patients, which usually relies on some degree of patient deception. Prescribing of placebos is not consistent with informed patient choice-which the Government claims is very important-as it means patients do not have all the information needed to make choice meaningful. Beyond ethical issues and the integrity of the doctor-patient relationship, prescribing pure placebos is bad medicine. Their effect is unreliable and unpredictable and cannot form the sole basis of any treatment on the NHS. A survey in the United States of more than 10,000 physicians came to the result that 24% of physicians would ever prescribe a treatment that's a placebo, simply because the patient wanted treatment. 58% would not, and for the remaining 18%, it would depend on circumstances.

The individual Who is affected Placebos do not work upon everyone. Henry K. Beecher, in a paper in 1955 suggested placebo effects occurred in about 35% of people. However, the response rate is wide, ranging from 0% up to nearly everyone. In a dental postoperative pain model, placebo analgesia occurred in 39%. In research upon ischemic arm pain, placebo analgesia was found in 27%. The placebo analgesia rate for cutaneous healing of left hand skin was 56%. Though not everyone responds to a placebo, neither does everyone respond to an active drug. The percentage of patients who reported relief following placebo (39%) is similar to the percentage following 4 mg (36%) and 6 mg (50%) of hidden morphine.

Individual differences In the 1950s, there was considerable research to find whether there was a specific personality to those that responded to placebos. The findings could not be replicated and it is now thought to have no effect. The desire for relief from pain, "goal motivation", and how far pain is expected to be relieved increases placebo analgesia. Another factor increasing the effectiveness of placebos is the degree to which a person attends to their symptoms, "somatic focus". Individual variation in response to analgesic placebos has been linked to regional neurochemical differences in the internal affective state of the individuals experiencing pain. Those with Alzheimer’s disease lose the capacity to be influenced by placebos, and this is attributed to the loss of their prefrontal cortex dependent capacity to have expectations. Children seem to have greater response than adults to placebos.

Genes In social anxiety disorder (SAD) an inherited variant of the gene for tryptophan hydroxylase 2 (enzyme that synthesizes the neurotransmitter serotonin) is linked to reduced amygdala activity and greater susceptibility to the placebo effect. The authors note "additional work is necessary to elucidate the generalizability of the findings".

Symptoms and conditions The placebo effect occurs more strongly in some conditions than others. One study found placebo effects are most likely to be found with the peripheral aspects of disease processes, rather than processes that reflect physical disease. Dylan Evans has suggested as another factor, that placebos work most strongly upon conditions such as pain,

swelling, stomach ulcers, depression, and anxiety that have been linked with activation of the acute-phase response.

Pain Placebo analgesia is more likely to work the more severe the pain It can be effective: one study found for postoperative pain following the extraction of the third molar, that a saline injected while telling the patient it was a powerful painkiller was as potent as a 6– 8 mg dose of morphine. Most research reports average reduction for a group of people, but this can be lower (some people do not respond). In one study using injection of capsaicin below the skin found that this reduced group average pain compared to no placebo by ~46% to ~57%. Another measure is the ability to endure pain. In one study, placebos increased this on average by about 3.5 minutes in the context of just under 14 minutes without it. The average strength of placebos upon pain on a visual analog scale is 2 out of 10 units Individuals that respond to placebos show greater effects and can be 5 out of 10 units.

Depression A meta-analysis in 1998 found that half of the effectiveness of anti-depressant medication is due to the placebo effect rather than the treatment itself. A meta-analysis in 2008 found that 79% of depressed patients receiving placebo remained well compared to 93% of those receiving antidepressants for the effect of placebos (for 12 weeks after an initial 6– 8 weeks of successful therapy). Another meta-analysis in 2002 found a 30% reduction in suicide and attempted suicide in the placebo groups compared to a 40% reduction in the treated groups. A 2002 article in The Washington Post titled "Against Depression, a Sugar Pill Is Hard to Beat" summarized research as follows: "In the majority of trials conducted by drug companies in recent decades, sugar pills have done as well as -- or better than -antidepressants. Companies have had to conduct numerous trials to get two that show a positive result, which is the Food and Drug Administration's minimum for approval. The makers of Prozac had to run five trials to obtain two that were positive, and the makers of Paxil and Zoloft had to run even more”.

Gastric and duodenal ulcers A meta-study of 31 placebo-controlled trials of the gastric acid secretion inhibitor drug cimetidine in the treatment of gastric or duodenal ulcers found that placebo treatments, in many cases, were as effective as active drugs: of the 1692 patients treated in the 31 trials, 76% of the 916 treated with the drug were "healed", and 48% of the 776 treated with placebo were "healed". These results were confirmed by the direct post-treatment endoscopy. It was also found that German placebos were "stronger" than others; and that, overall, different physicians evoked quite different placebo responses in the same clinical trial (p. 15). Moreover, in many of these trials the gap between the active drugs and the

placebo controls was "not because [the trials' constituents] had high drug effectiveness, but because they had low placebo effectiveness" (p. 13). In some trials, placebos were effective in 90% of the cases, whilst in others the placebos were only effective in 10% of the cases. It was argued that "what is demonstrated in [these] studies is not enhanced healing in drug groups, but reduced healing in placebo groups" (p. 14). It was also noted the results of two studies (one conducted in Germany, the other in Denmark), which examined "ulcer relapse in healed patients" showed that the rate of relapse amongst those "healed" by the active drug treatment was five times that of those "healed" by the placebo treatment (pp. 14–15).

Chronic fatigue syndrome It was previously assumed that placebo response rates in patients with chronic fatigue syndrome (CFS) are unusually high, "at least 30% to 50%", because of the subjective reporting of symptoms and the fluctuating nature of the condition. According to a metaanalysis and contrary to conventional wisdom, the pooled response rate in the placebo group was 19.6%, even lower than in some other medical conditions. The authors offer possible explanations for this result: CFS is widely understood to be difficult to treat, which could reduce expectations of improvement. In context of evidence showing placebos do not have powerful clinical effects when compared to no treatment, a low rate of spontaneous remission in CFS could contribute to reduced improvement rates in the placebo group. Intervention type also contributed to the heterogeneity of the response, low patient and provider expectations regarding psychological treatment may explain particularly low placebo responses to psychiatric treatments.

List of medical conditions The effect of placebo treatments (an inert pill unless otherwise noted) has been studied for the following medical conditions: • •

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ADHD: adult, child Amalgam fillings: attributed symptoms (inert "chelation" therapy) Anxiety disorders Asthma (water aerosol inhalant) Asthma Autism: language and behavior problems Benign prostatic enlargement Binge eating disorder Bipolar mania Cough

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Crohn's disease Depression (light treatment; low red light placebo) Depression Dyspepsia and gastric motility Epilepsy Erectile dysfunction Food allergy: ability to eat ill-making foods p. 54 Gastric and duodenal ulcers Headache Heart failure, congestive Herpes simplex

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Hypertension: mild and moderate Irritable bowel syndrome Migraine prophylaxis Multiple sclerosis Nausea: gastric activity Nausea: chemotherapy Nausea and vomiting: postoperative (sham acupuncture) Pain Panic disorders Parkinson's disease Pathological gambling

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Premenstrual dysphoric disorder. Psoriatic arthritis Reflux esophagitis Restless leg syndrome Rheumatic diseases Sexual dysfunction: women Social phobia Third molar extraction swelling (sham ultrasound) Ulcerative colitis Vulvar vestibulitis

Effects on research Placebo-controlled studies The placebo effect makes it more difficult to evaluate new treatments. Apparent benefits of a new treatment (usually a drug but not necessarily so) may not derive from the treatment but from the placebo effect. This is particularly likely given that new therapies seem to have greater placebo effects. Clinical trials control for this effect by including a group of subjects that receives a sham treatment. The subjects in such trials are blinded as to whether they receive the treatment or a placebo. Often clinical trials are double blinded so that the researchers also do not know which subjects are receiving the active or placebo treatment. The placebo effect in such clinical trials is weaker than in normal therapy since the subjects are not sure whether the treatment they are receiving is active. Knowingly giving a person a placebo when there is an effective treatment available is a bioethically complex issue. While placebo controlled trials might provide information about the effectiveness of a treatment, it denies some patients what could be the best available (if unproven) treatment. Usually informed consent is required for a study to be considered ethical, including the disclosure that some patients will receive placebo treatments. The ethics of placebo-controlled studies have been debated in the revision process of the Declaration of Helsinki. Of particular concern has been the difference between trials comparing inert placebos with experimental treatments, versus comparing the best available treatment with an experimental treatment; and differences between trials in the sponsor's developed countries versus the trial's targeted developing countries. A further issue of concern to pharmaceutical companies is that the effectiveness of placebos has increased over time, thus making it more difficult to demonstrate the effectiveness of new drugs. The reason for the increased effectiveness in disputed.

Nocebo In the opposite effect, a patient who disbelieves in a treatment may experience a worsening of symptoms. This effect, now called by analogy nocebo (Latin nocebo = "I shall harm") can be measured in the same way as the placebo effect, e.g., when members of a control group receiving an inert substance report a worsening of symptoms. The recipients of the inert substance may nullify the placebo effect intended by simply having a negative attitude towards the effectiveness of the substance prescribed, which often leads to a nocebo effect, which is not caused by the substance, but due to other factors, such as the patient's mentality towards his or her ability to get well, or even purely coincidental worsening of symptoms.

Placebo ingredients Placebos used in clinical trials have sometimes had unintended consequences. A report in the Annals of Internal Medicine that looked at details from 150 clinical trials, found that certain placebos used in the trials affected the results. For example, one study on cholesterol-lowering drugs used olive oil and corn oil in the placebo pills. However, according to the report, this "may lead to an understatement of drug benefit: The monounsaturated and polyunsaturated fatty acids of these 'placebos,' and their antioxidant and anti-inflammatory effects, can reduce lipid levels and heart disease." Another example researchers reported in the study was a clinical trial of a new therapy for cancer patients suffering from anorexia. The placebo that was used included lactose. However, since cancer patients typically face a higher risk of lactose intolerance, the placebo pill might actually have caused unintended side effects that made the experimental drug look better in comparison.