The History of Homeopathy

Homeopathy (also spelled homœopathy or homoeopathy) from the Greek words όμοιος, hómoios (similar) and πάθος, páthos (suffering), is a controversial system of alternative medicine. The term "homeopathy" was coined by the Saxon physician Samuel Hahnemann (1755–1843) and first published in 1796.

Homeopathy calls for treating 'like with like', a doctrine referred to as the 'Law of Similars'. The practitioner considers the totality of symptoms of a particular case, then chooses as a remedy a substance that has been reported in a homeopathic proving to produce similar symptoms in healthy subjects. The remedial substance is usually given in extremely low concentrations. Dilutions are performed by a procedure known as potentization.

With few exceptions, homeopathy is not accepted by medical doctors or scientists in the relevant fields.

Theory of disease

Hahnemann did not accept the conventional theory of disease of his day, which was based on the four humours. Mainstream medicine focused on restoring the balance in the humours, either by attempting to remove an excess of a humour (by such methods as bloodletting and purging, laxatives, enemas and nauseous substances that made patients vomit) or by suppressing symptoms associated with the humours causing trouble, such as giving feverish (and so hot and wet) patients substances associated with cold and dry.

Hahnemann rejected this in favour of a view of 'spiritual factors' as the root cause of all disease. Some later homeopaths, in particular James Tyler Kent, put even more emphasis on spiritual factors.[2]

"...for it goes to the very primitive wrong of the human race, the very first sickness of the human race that is the spiritual sickness... which in turn laid the foundation for other diseases."

Vitalism was a part of mainstream science in the 18th century. Modern medicine sees bacteria and viruses as the causes of many diseases, but Kent, and some modern homeopaths regard them as effects, not causes, of disease. Others have adapted to the

views of modern medicine by referring to disturbances in, and stimulation of, the immune system, rather than the vital force.

In the twentieth century, medicine discarded vitalism in favour of the germ theory of disease, following the work of Louis Pasteur, Alexander Fleming, Joseph Lister and many others. It also rejected the possibility of highly diluted preparations having any medicinal action, but attributes claimed effects to the Placebo Effect and/or the Forer effect.

The 'Law of Similars'

Homeopathy is founded on the 'Law of Similars', first expressed by Hahnemann in the exhortation similia similibus curentur or 'let likes cure likes'. The relation of similarity is determined by 'provings', in which healthy volunteers, given a substance in homeopathic form, record physical, mental and spiritual changes. This information is compiled in a Materia Medica. Subsequent versions of the Materia Medica incorporate symptoms observed to have been cured by the remedy. A homeopathic repertory is an index of the Materia Medica (a list of symptoms), followed by claimed remedies.

At first, Hahnemann proved substances known as poisons or as remedies. and recorded his findings in his Materia Medica Pura. Kent's Lectures on Homoeopathic Materia Medica (1905) lists 217 remedies, and new chemicals are being added continually to contemporary versions. Homeopathy uses many animal, plant, mineral, and chemical substances of natural or synthetic origin. Examples include Natrum muriaticum (sodium chloride or table salt), lachesis muta (the venom of the bushmaster snake), Opium, and Thyroidinum (thyroid hormone). Other homeopathic remedies, ('isopathic' remedies) involve dilutions of the agent or the product of the disease. Rabies nosode, for example, is made by potentizing the saliva of a rabid dog. Some homeopaths use more esoteric substances, known as imponderables because they do not originate from a material substance but from electromagnetic or electrical energy presumed to have been captured by direct exposure (X-ray, Sol (sunlight), Positronium, and Electricitas (electricity)) or through the use of a telescope (Polaris). Recent ventures by homeopaths into esoteric substances include Tempesta (thunderstorm), and Berlin wall.

Today, about 3000 remedies are used in homeopathy; about 300 are based on comprehensive Materia Medica information, about 1500 on relatively fragmentary knowledge, and the rest are used experimentally in difficult clinical situations based on

the law of similars, either without knowledge of their homeopathic properties or through knowledge independent of the law of similars. Examples include: the use of an isopathic (disease causing) agent as a first prescription in a 'stuck' case, when the beginning of disease coincides with a specific event such as vaccination; the use of a chemically related substance when a remedy fails yet seems well-indicated; and more recently, the use of substances based on their natural classification (the periodic table or biological taxonomy). This last approach is considered to be promising by some in the homeopathic community, because it allows for grouping remedies and classifying the ever-burgeoning Materia Medica, but is rejected by many purists because it involves speculation about remedy action without proper provings.

There are many methods for determining the most-similar remedy (the simillimum), and homeopaths often disagree about the diagnosis. This is due in part to the complexity of the idea of 'totality of symptoms'; homeopaths do not use 'all' symptoms, but decide which are the most characteristic; this evaluation is the aspect of diagnosis requiring the most knowledge and experience. Finally, the remedy picture in the Materia Medica is always more comprehensive than the symptomatology that one individual ever exhibits. These factors mean that a homeopathic diagnosis remains presumptive until it is verified by testing the effect of the remedy on the patient.

The law of similars is not a 'scientific' law in the sense that it is not built on a hypothesis that can be falsified scientifically; a failure to cure homeopathically can always be attributed to incorrect selection of a remedy.

'''Materia Medica Pura''' is a compilation of [[homeopathic]] proving reports, published in six volumes during the 1820s (vol. VI in [[1827]].) by [[Samuel Hahnemann]]. Revised editions of volumes I and II were published in [[1830]] and [[1833]], respectively.

The reports contain details of the symptoms caused by each of 67 homeopathic remedies.

== List of remedies ==*[[aconite|Aconitum napellus]]*[[Ambra grisea]]*[[Angustura]]

*[[Argentum]]*[[Arnica]]*[[Arsenic]]um*[[Wild ginger|Asarum]]*[[Aurum]]*[[Belladonna]]*[[Bismuth]]um*[[Bryonia]]*Calcarea acetica*[[Camphor]]a*[[Cannabis]] *[[Capsicum]] annuum*Carbo animalis ([[ox]] [[leather]] charcoal)*Carbo vegetabilis ([[beech]] [[wood]] [[charcoal]])*[[chamomile|Chamomilla]]*Chelidonium*[[quinine|China]]*Cicuta virosa*Cina*[[Cocculus]]*Colocynthis*[[Conium]]*[[Cyclamen]] europaeum*[[Digitalis]]*Drosera rotundifolia*[[Dulcamara]]*[[Euphrasia]] officinalis*[[Iron|Ferrum]]*[[Guaiacum]]*Helleborus niger*Hepar sulphuris calcareum*[[Hyoscyamus]]*[[Ignatia]]*[[Ledum]]*Magnes*Magnetis polus arcticus

*Magnetis polus australis*Menyanthes trifoliata*[[Mercury (element)|Mercurius]]*[[Musk|Moschus]]*Muriaticum acidum*[[Nux vomica]]*[[Oleander]]*[[Opium]]*[[phosphoric acid|Phosphoricum acidum]]*[[Pulsatilla]]*Rheum*[[Rhus toxicodendron]]*Ruta*Sambucus*Sarsaparilla*[[Scilla]]*Spigelia*[[sponge|Spongia]]*[[tin|Stannum]]*Staphisagria*[[Stramonium]]*[[Sulfur|Sulphur]]*[[Dandelion|Taraxacum]]*[[Thuja]]*[[Veratrum album]]*[[Verbascum]]

== External links ==*[http://www.hpathy.com/materiamedica/hahnemann-materia-pura/ Materia Medica Pura by Samuel Hahnemann] - Full text available online at Hpathy.com

=== The 'Theory of Infinitesimals' ===The most characteristic—and controversial—principle of homeopathy is that the potency of a remedy can be enhanced (and the side-effects diminished) by dilution, in a procedure known as ''dynamization'' or ''potentization''. Liquids are successively diluted (with water, or alcohol for water-insoluble materials) and shaken by

ten hard strikes against an elastic body (''succussion''). Insoluble solids are diluted by grinding them with [[lactose]] (''[[trituration]]''). Higher dilutions are considered to be stronger 'deep-acting' remedies.

The dilution factor at each stage is traditionally 1:10 ('D' or 'X' potencies) or 1:100 ('C' potencies). Hahnemann advocated 30C dilutions for most purposes, i.e. dilution by a factor of 100³⁰ = 10⁶⁰. As [[Avogadro's number]] is only 6.022 × 10²³ particles/mole, the chance of any molecule of the original substance being present in a 15C solution is small, and it is extremely unlikely that one molecule would be present in a 30C solution. For perspective on these numbers, there are under 10⁵¹ atoms in the Earth, and on the order of 10³² molecules of water in an [[Olympic size swimming pool]]; to expect to get one molecule of a 15C solution, one would need to take 1% of the volume of such a pool, or roughly 25 metric tons of water, comparable to the weight of a fully-loaded 18-wheeler. <!-- As per orders of magnitude (volume) article, there's over 2.5 Gg of water in a pool, or about 1.4E8 moles at 18 to the gram, or somewhat over 1E32 molecules -- Pakaran --> Thus homeopathic remedies that have a high "potency" essentially contain just water, but this water is believed by practitioners of homeopathy to retain some 'essential property' of the substance once present.

A key criticism is that any water will, at some time in its history, have been in contact with many different substances. Thus, any drink may be considered to be an extreme dilution of almost any agent you care to mention. Thus, critics argue that almost everyone is almost always receiving homeopathic treatment for almost every condition. Proponents of homeopathy respond that the methodical dilution of a particular substance, beginning with a 10% solution and working downward, is different; exactly why this is different is not clear.

Later homeopaths advocated very high potencies, which could not be made by traditional methods, but required succussion without dilution (Jenichen), higher dilution factors (LM potencies are diluted by a factor of 50,000), or machines which integrate dilution and succussion into a continuous process (Korsakoff). The practitioner's choice of what potency is appropriate is subjective; it involves his or her opinion of how "deep-seated" the disease is; whether it is primarily physical or more mental/emotional; the patient's sensitivity based on the practitioner's intuitive assessment or previous reactions to remedies; and the desired dosing regimen (e.g. low potency repeated often, vs high

potency repeated seldom). Generally, French and German homeopaths use lower potencies than their American counterparts. Most homeopaths believe that the choice of potency is secondary to the choice of remedy: i.e. that a well-chosen remedy will act in a variety of potencies, but an approximately matched remedy might act only in certain potencies.===Miasms===

By 1816, Hahnemann was concerned at the failure of his homeopathic remedies to produce lasting cures for chronic diseases. He found that ''"...the non-venereal chronic diseases, after being time and again removed homoeopathically … always returned in a more or less varied form and with new symptoms."'' To explain this, Hahnemann introduced the miasmatic theory, that three fundamental "miasms" are behind all the chronic diseases of mankind: syphilis, sycosis, and psora. The miasm of psora, he concluded, was behind most of the chronic diseases known to medicine. Miasma, from the Greek for 'stain', was an old medical concept, used for "pestiferous exhalations". The sense of this is indicated by Hahnemann's Note 2 to §11 of the Organon: ''"...a child with small-pox or measles communicates to a near, untouched healthy child in an invisible manner (dynamically) the small-pox or measles, … in the same way as the magnet communicated to the near needle the magnetic property..."''

According to Hahneman, miasmatic infection causes local symptoms, usually in the skin. If these are suppressed by external medication, the disease goes deeper, and manifests itself as organ pathologies. In §80 of the ''Organon'' he asserted psora to be the cause of such diseases as epilepsy, cyphosis, cancer, jaundice, deafness, and cataract.

Even in his own time, many followers of Hahneman, including Hering, made almost no reference to Hahnemann’s concept of chronic diseases. Today, some homeopathic practitioners [http://www.homeopathy.ca/articles/interview-2001-2.html] accept that Hahnemann’s theory does not hold up in light of current knowledge in immunology, genetics, microbiology and pathology, and recognise that Hahnemann neglected to identify genetic, congenital, metabolic, nutritional, and degenerative diseases, and failed to differentiate the multitude of different infectious diseases. However, they believe that some elements of his theory are valid. For instance, they believe that the fundamental cause of disease is constitutional (i.e. the susceptibility to becoming ill), and that it is contrary to good health to suppress symptoms, especially skin eruptions and discharges. They also accept Hahneman's concept of ''latent psora'', the early signs of an organism’s

imbalance that indicate that treatment is needed to prevent the development of more advanced disease.== History ==Hahnemann developed homeopathy after coming upon the idea that 'like cures like' while translating a work on malaria. On reading that Cinchona bark (which contains [[quinine]]) was effective because it was bitter, Hahnemann felt this implausible because other substances were as bitter but had no therapeutic value. To understand the effects of Cinchona bark, he decided to take it himself, and saw that his reactions were similar to the symptoms of the disease it was used to treat. At least one writer has suggested that Hahnemann was hypersensitive to quinine, and that he may have had an allergic reaction. [http://www.angelfire.com/mb2/quinine/allergy.html].

For Hahnemann, the whole body and spirit was the focus of therapy, not just the localised disease. Hahnemann spent a lot of time with his patients, asking them not only about their symptoms or illness, but also about their daily lives. This gentle approach contrasted with the violent forms of [[heroic medicine]] common at the time, which included techniques such as bleeding as a matter of course.

Homeopathy came to the USA in 1825 and rapidly gained popularity, partly because the excesses of conventional medicine were extreme there, and partly due to the efforts of Constantine Hering. Homeopathy reached a peak of popularity in 1865&ndash;1885 and thereafter declined due to a combination of the recognition by the establishment of the dangers of large doses of drugs and bleeding, and dissent between different schools of homeopathy.

Nearly as important as Hahnemann to the development of homeopathy was [[James Tyler Kent]] ([[1849]] &ndash; [[1921]]). Kent's influence in the USA was limited, but in the UK, his ideas became the homeopathic orthodoxy by the end of the [[First World War]].<ref>A. Campbell, [http://www.accampbell.uklinux.net/homeopathy/homeopathy-html/chapter08.html ''Kentian Homeopathy''], Chapter 8 of ''Homeopathy in Perspective''</ref> His most important contribution may be his repertory, which is still used today. Kent's approach was authoritarian, emphasizing the metaphysical and clinical aspects of Hahnemann's teachings, in particular

* insistence on the doctrines of miasm and vitalism;* emphasis on psychological symptoms (as opposed to physical pathology) in prescribing; and* regular use of very high potencies.

Today, the ease with which large [[database]]s can be manipulated has profoundly changed the way homeopathy is practised. Today, many homeopaths use computers to sift through thousands of provings and case studies. Because information about lesser-known remedies is more accessible, it is now more common for homeopaths to prescribe them, which has led to an increase in the number of new provings.

''See also:'' [[List of important homeopaths]]

=== Homeopathy around the world ===There are estimated<ref>[http://www.dw-world.de/dw/article/0,1564,1575855,00.html Homeopathy Seeks More Acknowledgement] from Deutsche Welle</ref> to be more than 100,000 physicians practising homeopathy worldwide, with an estimated 500 million people receiving treatment. More than 12,000 medical doctors and licensed health care practitioners administer homeopathic treatment in the UK, [[France]], and [[Germany]]. Since 2001, homeopathy is regulated in the [[European Union]] by Directive 2001/83/EC; the latest amendments make it compulsory for member states to implement a registration procedure for homeopathic remedies.

<!--English speaking countries-->In the UK, homeopathic remedies may be sold over the counter. The UK has five homeopathic hospitals where treatment, funded by the [[National Health Service]], is available and many regional clinics. Homeopathy is not practised by most of the medical profession, but there is a core of public support, including from the English royal family.

In India, homeopathy has been practised since the middle of the [[19th century]], and is officially recognized. India has the largest homeopathic infrastructure in the world, with 300,000 qualified homeopaths, 180 colleges, 7500 government clinics, and 307 hospitals.<ref>Dr. Raj Kumar Manchanda & Dr. Mukul Kulashreshtha, ''[http://www.delhihomeo.com/paperberlin.html Cost Effectiveness and Efficacy of Homeopathy in Primary Health Care Units of Government of Delhi- A study]''</ref>

Also in India, Ayurveda, another form of medicine that could be likened to homeopathy, was used before 5000 B.C. <ref>[http://indianmedicine.nic.in/html/ayurveda/ayurveda.htm]</ref>

In the USA, homeopathic remedies are, like all healthcare products, regulated by the [[Food and Drug Administration]]. However, the FDA treats homeopathic remedies very differently to conventional medicines. Homeopathic products do not have to be approved by the FDA before sale, they do not have to be proved to be either safe or effective, they do not have to be labeled with an expiration date, and they do not have to undergo finished product testing to verify contents and strength. Unlike conventional drugs, homeopathic remedies do not have to identify their active ingredients on the grounds that they have few or no active ingredients. In the USA, only homeopathic medicines that claim to treat self-limiting conditions may be sold over the counter; homeopathic medicines that claim to treat a serious disease can be sold only by prescription.

<!--deutschsprachiger Raum-->In Germany, about 6,000 physicians specialize in homeopathy. In [[1978]] homeopathy, [[Anthroposophy|anthroposophically extended medicine]] and [[herbalism]], were recognized as "special forms of therapy", meaning that their medications are freed from the usual requirement of proving efficacy. Since [[January 1]], [[2004]] homeopathic medications, with some exceptions, are no longer covered by the country's public health insurance<ref>[http://www.dhu.de/wc_800/archiv/GMG.shtml Gesundheitssystem: Was bringt das neue Gesetz?] (in German)</ref>. Most private health insurers continue to cover homeopathy.

In [[Switzerland]] homeopathic medications were formerly covered by the basic health insurance system, if prescribed by a physician. This ended in June 2005<ref>[http://www.kaufmann-net.ch/ Bundesratsentscheid über die Leistungen für Alternativmedizin: Information about Homeopathy in Switzerland by Vera Kaufmann, BHSc.Hom.] (in German)</ref>. The Swiss Government, after a 5-year trial, withdrew insurance coverage for homoeopathy and four other complementary treatments because they did not meet efficacy and cost-effectiveness criteria. This applies only to compulsory insurance; homeopathy and other complementary medicine is covered by additional insurance, if the treatment is provided by a medical doctor.

=== Classical versus non-classical homeopathy ===Hahnemann's formulation of homeopathy is often referred to as ''classical homeopathy''. Classical homeopaths use one remedy at a time, and base their prescription also on incidental or constitutional symptoms. However, homeopathic remedies are often used both by professionals and by the public based on formulations marketed for specific medical conditions. Occasionally single remedies are used in this way, but more often, mixtures of several remedies are used in a practice known as ''complex homeopathy''. Some formulations use a 'shotgun' approach of the most commonly indicated single remedies in mixture form, while others, such as those by ''Heel'' and ''Reckeweg'', are proprietary mixtures marketed for specific diagnostic critera based on various diagostic systems. Many members of the public are not familiar with classical homeopathy, and equate these practices with homeopathy; others are familiar with the classical approach but regard these as legitimate variants; while others consider it a misuse of the term. Use of non-classical approaches probably exceeds that of classical homeopathy, at least in places where over-the-counter preparations are popular and where many doctors use natural medicines in a conventional clinical setting.==The scientific validity of homeopathy==One of the key problems with homeopathy from a scientific point of view is its lack of a plausible mechanism.

Homeopaths believe that the production of a homeopathic remedy involves a conditioning of the liquid that gives it some active properties, but most [[scientific skepticism|scientists]] prefer alternative explanations. Their preferred explanation is the [[placebo effect]]. If a patient believes that a treatment will be effective, it is often likely to be effective: the brain controls the responses of the body to injury and [[infection]], and our 'state of mind' influences these mechanisms. The placebo effect is often large, so conventional drugs are tested in large, multi-centre, randomised, placebo-controlled [[double-blind]] [[clinical trials]], the object of which is to test whether the drug has an objectively-demonstrable effect that is significantly better than the effect of a placebo.

Most clinical trials of homeopathy have been of very low quality. In 1997, the following statement was adopted as policy of the [[American Medical Association]] (AMA) after a report on a number of alternative therapies including homeopathy:[http://www.ama-assn.org/ama/pub/category/13638.html]

''<blockquote>"There is little evidence to confirm the safety or efficacy of most

alternative therapies. Much of the information currently known about these therapies makes it clear that many have not been shown to be efficacious. Well-designed, stringently controlled research should be done to evaluate the efficacy of alternative therapies."</blockquote>''

In August 2005, The [[Lancet]] published a [[meta-analysis]] of trials of homeopathy, the largest and most rigorous analysis so far conducted, involving 110 placebo-controlled homoeopathy trials and 110 matched conventional-medicine trials. <ref>Shang et al. [http://www.thelancet.com/journals/lancet/article/PIIS0140673605671772/fulltext "Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy"]. ''Lancet'' 2005, '''366''': 726-732 ([http://www.thelancet.com/journals/lancet/article/PIIS0140673605671772/abstract abstract]) (both require registration, but abstract is free).</ref>.The outcome of this meta-analysis suggested that the clinical effects of homoeopathy are indeed likely to be placebo effects. For reactions to this study from homeopaths, see [http://www.hpathy.com/research/bhatia-lancet-homeopathy.asp][http://thorax.bmjjournals.com/cgi/content/abstract/58/4/317][http://www.vithoulkas.com/library_EN/important_issues/imp_issue03.html]== Misconceptions about homeopathy ===== Composition of homeopathic remedies ===It is a common misconception that homeopathic remedies use only natural herbal components (akin to [[herbology]]). Herbs are used, but homeopathy also uses non-biological substances (such as [[salt]]s) and components of animal origin, such as [[duck]] [[liver]] in the remedy [[oscillococcinum]]. Homeopathy also uses substances of human origin, called ''[[nosode]]s''. Some people have the opposite misconception, that homeopathic remedies are only based on [[toxicity|toxic]] substances like [[snake venom]] or [[mercury (element)|mercury]].

In herbology, measurable amounts of herbs are used, while in homeopathy the active ingredient is diluted to the point where it is no longer measurable.

As the term homeopathy is well known and has good marketing value, the public can be confused by people who have adopted the term for other forms of therapy. For example, some companies combine homeopathic with non-homeopathic substances such as herbs or vitamins, and some preparations marketed as homeopathic contain no homeopathic

preparations at all. Classical homeopaths argue that only remedies prepared and prescribed in accordance with the principles of Hahnemann can be called homeopathic. Many producers of homeopathic remedies also produce other types of alternative remedies under the same brand name, which can create confusion for the public.

===Homeopathy and vaccination===To some, homeopathy, particularly the use of nosodes, resembles [[vaccination]], in that vaccines contain a small dose of the "disease" against which they are to protect. Hahnemann interpreted the introduction of vaccination by [[Edward Jenner]] in [[1798]] as a confirmation of the law of similars, but the two practices are fundamentally different. A vaccine is usually a [[bacterium]] or [[virus]] whose ability to produce symptoms has been deliberately weakened, while still providing enough information to the [[immune system]] to afford protection. By preparing the immune system of a healthy organism to meet a future attack by the [[pathogen]], vaccination hopes to prevent disease, in contrast to homeopathy's hope, which is to cure it.

Another important difference between homeopathic preparations and vaccine, is that vaccine contains measurable amounts of the "disease," whereas homeopathic remedies have been so diluted as to contain no traces at all.

== Safety of homeopathic treatment == The FDA considers that there is no real concern over the safety of homeopathic products "because they have little or no pharmacologically active ingredients". There have been a few reports of illness associated with the use of homeopathic products, which may be because some homeopathic remedies are prepared by serial dilution of [[toxicity|toxic]] substances, presenting a risk that by accident they might contain undiluted toxic substances. The medical literature contains several case reports of poisoning by heavy metals such as [[Arsenic|arsenic]]<ref>Chakraborti D, Mukherjee SC, Saha KC, Chowdhury UK, Rahman MM, Sengupta MK: Arsenic toxicity from homeopathic treatment. J Toxicol Clin Toxicol 2003;41(7):963-7.</ref> and [[mercury (element)|mercury]]<ref>Montoya-Cabrera MA, Rubio-Rodriguez S, Velazquez-Gonzalez E, Avila Montoya S: Mercury poisoning caused by a homeopathic drug. Gac Med Mex 1991, 127(3):267-70. Article in Spanish.</ref><ref>Audicana M, Bernedo N, Gonzalez I, Munoz D, Fernandez E, Gastaminza G: An unusual case of baboon syndrome due to mercury present in a homeopathic medicine. Contact Dermatitis 2001, 45(3):185.</ref><ref>Wiesmuller GA, Weishoff-Houben M, Brolsch O, Dott W,

Schulze-Robbecke R: Environmental agents as cause of health disorders in children presented at an outpatient unit of environmental medicine. Int J Hyg Environ Health 2002, 205(5):329-35</ref> found in homeopathic remedies. However, in cases that they reviewed, the FDA discounted the homeopathic product involved as the cause of the adverse reactions. In one case, arsenic was implicated, although FDA analysis revealed that the concentration of arsenic was too low to cause concern. Perhaps the main concern about the safety of homeopathy arises not from the products themselves, but from the possible withholding of more efficacious treatment, or from misdiagnosis of dangerous conditions by a non-medically qualified homeopath.[http://www.publications.parliament.uk/pa/ld199900/ldselect/ldsctech/123/12301.htm]

Homeopathy:Real Medicine or Empty Promises?

by Isadora Stehlin (Isadora Stehlin is a member of FDA's public affairs staff)

FDA Consumer magazine (December 1996)

Some of the medicines of homeopathy evoke positive images--chamomile, marigold, daisy, onion. But even some of Mother Nature's cruelest creations--poison ivy, mercury, arsenic, pit viper venom, hemlock--are part of homeopathic care.

Homeopathy is a medical theory and practice that developed in reaction to the bloodletting, blistering, purging, and other harsh procedures of conventional medicine as it was practiced more than 200 years ago. Remedies made from many sources--including plants, minerals or animals--are prescribed based on both a person's symptoms and personality. Patients receiving homeopathic care frequently feel worse before they get better because homeopathic medicines often stimulate, rather than suppress, symptoms. This seeming reversal of logic is a relevant part of homeopathy because symptoms are viewed as the body's effort to restore health.

The Food and Drug Administration regulates homeopathic remedies under provisions of the Food, Drug, and Cosmetic Act.

Kinder, Gentler Medicine

In the late 1700s, the most popular therapy for most ailments was bloodletting. Some doctors had so much faith in bleeding that they were willing to remove up to four-fifths of the patient's blood. Other therapies of choice included blistering--placing caustic or hot substances on the skin to draw out infections--and administering dangerous chemicals to induce vomiting or purge the bowels. Massive doses of a mercury-containing drug called calomel cleansed the bowels, but at the same time caused teeth to loosen, hair to fall out, and other symptoms of acute mercury poisoning.

Samuel Hahnemann, a German physician disenchanted with these methods, began to develop a theory based on three principles: the law of similars, the minimum dose, and the single remedy.

The word homeopathy is derived from the Greek words for like (homoios) and suffering (pathos). With the law of similars, Hahnemann theorized that if a large amount of a substance causes certain symptoms in a healthy person, smaller amounts of the same substance can treat those symptoms in someone who is ill. The basis of his theory took shape after a strong dose of the malaria treatment quinine caused his healthy body to develop symptoms similar to ones caused by the disease. He continued to test his theory on himself as well as family and friends with different herbs, minerals and other substances. He called these experiments "provings."

But, as might be expected, the intensity of the symptoms caused by the original proving was harrowing. So Hahnemann began decreasing the doses to see how little of a substance could still produce signs of healing.

With the minimum dose, or law of infinitesimals, Hahnemann believed that a substance's strength and effectiveness increased the more it was diluted. Minuscule doses were prepared by repeatedly diluting the active ingredient by factors of 10. A "6X" preparation (the X is the Roman numeral for 10) is a 1-to-10 dilution repeated six times, leaving the active ingredient as one part per million. Essential to the process of increasing potency while decreasing the actual amount of the active ingredient is vigorous shaking after each dilution.

Some homeopathic remedies are so dilute, no molecules of the healing substance remain. Even with sophisticated technology now available, analytical chemists may find it difficult or impossible to identify any active ingredient. But the homeopathic belief is that the substance has left its imprint or a spirit-like essence that stimulates the body to heal itself.

Finally, a homeopathic physician generally prescribes only a single remedy to cover all symptoms--mental as well as physical--the patient is experiencing. However, the use of multi-ingredient remedies is recognized as part of homeopathic practice.

FDA Regulation

In 1938, Sen. Royal Copeland of New York, the chief sponsor of the Food, Drug, and Cosmetic Act and a homeopathic physician, wrote into the law a recognition of any product listed in the Homeopathic Pharmacopeia of the United States. The Homeopathic Pharmacopeia includes a compilation of standards for source, composition and preparation of homeopathic drugs.

FDA regulates homeopathic drugs in several significantly different ways from other drugs. Manufacturers of homeopathic drugs are deferred from submitting new drug applications to FDA. Their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength. Homeopathic drugs in solid oral dosage form must have an imprint that identifies the manufacturer and indicates that the drug is homeopathic. The imprint on conventional products, unless specifically exempt, must identify the active ingredient and dosage strength as well as the manufacturer.

"The reasoning behind [the difference] is that homeopathic products contain little or no active ingredients," explains Edward Miracco, a consumer safety officer with FDA's Center for Drug Evaluation and Research. "From a toxicity, poison-control standpoint, [the active ingredient and strength] was deemed to be unnecessary."

Another difference involves alcohol. Conventional drugs for adults can contain no more than 10 percent alcohol, and the amount is even less for children's medications. But some homeopathic products contain much higher amounts because the agency has temporarily exempted these products from the alcohol limit rules.

"Alcohol is an integral part of many homeopathic products," says Miracco. For this reason, the agency has decided to delay its decision concerning alcohol in homeopathic products while it reviews the necessity of high levels of alcohol.

"Overall, the disparate treatment has been primarily based on the uniqueness of homeopathic products, the lack of any real concern over their safety because they have little or no pharmacologically active ingredients, and because of agency resources and priorities," explains Miracco.

However, homeopathic products are not exempt from all FDA regulations. If a homeopathic drug claims to treat a serious disease such as cancer it can be sold by prescription only. Only products sold for so-called self-limiting conditions--colds, headaches, and other minor health problems that eventually go away on their own--can be sold without a prescription (over-the-counter).

Requirements for nonprescription labeling include:

an ingredients list instructions for safe use at least one major indication dilution (for example 2X for one part per hundred, 3X for one part per

thousand).

Over the past several years, the agency has issued about 12 warning letters to homeopathic marketers. The most common infraction was the sale of prescription homeopathic drugs over-the-counter. "It's illegal, it's in violation, and we're going to focus on it," says Miracco.

Other problems include:

products promoted as homeopathic that contain nonhomeopathic active ingredients, such as vitamins or plants not listed in homeopathic references

lack of tamper-resistant packaging lack of proper labeling vague indications for use that could encompass serious disease conditions. For

example, a phrase like "treats gastrointestinal disorders" is too general, explains Miracco. "This phrase can encompass a wide variety of conditions, from

stomachache or simple diarrhea to colon cancer," he says. "Claims need to be specific so the consumer knows what the product is intended to treat and the indication does not encompass serious disease conditions that would require prescription dispensing and labeling."

In addition to enforcement, the agency is also focusing on preventing problems by educating the homeopathic industry about FDA regulations. "Agency representatives continue to meet with homeopathic trade groups to tell them about problems we've had, difficulties we've seen, and trends we've noticed," says Miracco.

FDA is aware of a few reports of illness associated with the use of homeopathic products. However, agency review of those reported to FDA discounted the homeopathic product involved as the cause of the adverse reaction. In one instance, arsenic, which is a recognized homeopathic ingredient, was implicated. But, as would be expected, FDA analysis revealed the concentration of arsenic was so minute there wasn't enough to cause concern, explains Miracco. "It's been diluted out."

Homeopathic Treatment

Homeopathy consists of highly individualized treatments based on a person's genetic history, personal health history, body type, and present status of all physical, emotional and mental symptoms.

Jennifer Jacobs, M.D., who has a family practice and is licensed to practice homeopathy in Washington state, spends at least an hour and a half with each new patient. "What I do is review the lifetime history of the patient's health," she explains. "Also I ask a lot of questions about certain general symptoms such as food preferences and sleep patterns that usually aren't seen as important in conventional medicine. In looking to make the match between the person and the remedy, I need to have all of this sort of information."

Why does someone trained in conventional medicine turn to homeopathy? "With chronic illnesses such as arthritis and allergies, conventional medicine has solutions that help control the symptoms but you don't really see the patients getting better," says Jacobs. "What I have seen in my homeopathic work is that it really does seem to help people get better. I'm not saying I can cure everyone but I do see where people's overall health is improved over the course of treatment."

Jacobs' hasn't abandoned conventional medicine completely. "My daughter is 17 and she's never taken antibiotics, but I would have no hesitation to use antibiotics if she had pneumonia, or meningitis, or a kidney infection," says Jacobs.

About a third of Jacobs' practice is children, and ear infections are one of the most common problems she treats. "Ear infections are something that seems to respond well to homeopathy," she says. "Of course, if a child is not better within two or three days, or if the child develops a high fever, or if I feel that there's a serious complication setting in, then of course I will use antibiotics. But I find that in the majority of cases, ear infections do resolve without antibiotics."

In addition to treating patients, Jacobs has conducted a clinical trial the results of which suggest that homeopathic treatment might be useful in the treatment of acute childhood diarrhea. The results were published in the May 1994 issue of Pediatrics. In the article, Jacobs concluded that further studies should be conducted to determine whether her findings were accurate. A subsequent article appearing in the November 1995 issue of Pediatrics indicated that Jacobs' study was flawed in several ways.

Although Pediatrics is published by the American Academy of Pediatrics, Jacobs' study and several others published in such journals as The Lancet and the British Medical Journal are considered "scanty at best" by the academy. "Given the plethora of studies that are published [on other topics] in scientific journals, I wouldn't say there are a lot of articles coming out," says Joe M. Sanders Jr., M.D., the executive director of the academy. "Just because an article appears in a scientific journal does not mean that it's absolute fact and should be immediately incorporated into therapeutic regimens. It just means that the study is [published] for critique and review and hopefully people will use that as a stepping stone for further research."

More studies are under way. For example, the Office of Alternative Medicine at the National Institutes of Health has awarded a grant for a clinical trial of the effects of homeopathic treatment on mild traumatic brain injury.

Even with the dearth of clinical research, homeopathy's popularity in the United States is growing. The 1995 retail sales of homeopathic medicines in the United States were estimated at $201 million and growing at a rate of 20 percent a year, according to the American Homeopathic Pharmaceutical Association. The number of homeopathic

practitioners in the United States has increased from fewer than 200 in the 1970s to approximately 3,000 in 1996.

When looking for a homeopathic practitioner, it's important to find someone who is licensed, according to the National Center for Homeopathy. Each state has its own licensing requirements. "Whether that person is a medical doctor or a physician's assistant or a naturopathic physician, I feel that anyone who's treating people who are sick needs to have medical training," says Jacobs.

Real Medicine or Wishful Thinking?

Many who don't believe in homeopathy's effectiveness say any successful treatments are due to the placebo effect, or, in other words, positive thinking.

But homeopathy's supporters counter that their medicine works in groups like infants and even animals that can't be influenced by a pep talk. Jacobs adds that sometimes she mistakenly gives a patient the wrong remedy and he or she doesn't get better. "Then I give the right remedy, and the person does get better," she says. "So it's not like everybody gets better because it's all in their head. I think it's only because we don't understand the mechanism of action of homeopathy that so many people have trouble accepting it."

The American Medical Association does not accept homeopathy, but it doesn't reject it either. "The AMA encourages doctors to become aware of alternative therapies and use them when and where appropriate," says AMA spokesman Jim Fox.

Similarly, the American Academy of Pediatrics has no specific policy on homeopathy. If an adult asked the academy's Sanders about homeopathy, he would tell that person to "do your own investigation. I don't personally prescribe homeopathic remedies, but I would be open-minded."

That open-mindedness applies only to adults, however. "I would have problems with somebody imposing other than conventional medicine onto a child who's incapable of making that decision," he says.

Even professionals who practice homeopathy warn that nothing in medicine--either conventional or alternative--is absolute. "I'm not saying we can cure everyone [with homeopathy]," says Jacobs.

Isadora Stehlin is a member of FDA's public affairs staff.

Homeopathy: The Ultimate Fake

Stephen Barrett, M.D.

Homeopathic "remedies" enjoy a unique status in the health marketplace: They are the only category of quack products legally marketable as drugs. This situation is the result of two circumstances. First, the 1938 Federal Food, Drug, and Cosmetic Act, which was shepherded through Congress by a homeopathic physician who was a senator, recognizes as drugs all substances included in the Homeopathic Pharmacopeia of the United States. Second, the FDA has not held homeopathic products to the same standards as other drugs. Today they are marketed in health-food stores, in pharmacies, in practitioner offices, by multilevel distributors [A], through the mail, and on the Internet.

Basic Misbeliefs

Samuel Hahnemann (1755-1843), a German physician, began formulating homeopathy's basic principles in the late 1700s. Hahnemann was justifiably distressed about bloodletting, leeching, purging, and other medical procedures of his day that did far more harm than good. Thinking that these treatments were intended to "balance the body's 'humors' by opposite effects," he developed his "law of similars" -- a notion that symptoms of disease can be cured by extremely small amounts of substances that produce similar symptoms in healthy people when administered in large amounts. The word "homeopathy" is derived from the Greek words homoios (similar) and pathos (suffering or disease).

Hahnemann and his early followers conducted "provings" in which they administered herbs, minerals, and other substances to healthy people, including themselves, and kept detailed records of what they observed. Later these records were compiled into lengthy reference books called materia medica, which are used to match a patient's symptoms with a "corresponding" drug.

Hahnemann declared that diseases represent a disturbance in the body's ability to heal itself and that only a small stimulus is needed to begin the healing process. He also claimed that chronic diseases were manifestations of a suppressed itch (psora), a kind of miasma or evil spirit. At first he used small doses of accepted medications. But later he used enormous dilutions and theorized that the smaller the dose, the more powerful the effect -- a notion commonly referred to as the "law of infinitesimals." That, of course, is just the opposite of the dose-response relationship that pharmacologists have demonstrated.

The basis for inclusion in the Homeopathic Pharmacopeia is not modern scientific testing, but homeopathic "provings" conducted during the 1800s and early 1900s. The current (ninth) edition describes how more than a thousand substances are prepared for homeopathic use. It does not identify the symptoms or diseases for which homeopathic products should be used; that is decided by the practitioner (or manufacturer). The fact that substances listed in the Homeopathic Pharmacopeia are legally recognized as "drugs" does not mean that either the law or the FDA recognizes them as effective.

Because homeopathic remedies were actually less dangerous than those of nineteenth-century medical orthodoxy, many medical practitioners began using them. At the turn of the twentieth century, homeopathy had about 14,000 practitioners and 22 schools in the United States. But as medical science and medical education advanced, homeopathy declined sharply in America, where its schools either closed or converted to modern methods. The last pure homeopathic school in this country closed during the 1920s [1].

Many homeopaths maintain that certain people have a special affinity to a particular remedy (their "constitutional remedy") and will respond to it for a variety of ailments. Such remedies can be prescribed according to the person's "constitutional type" -- named after the corresponding remedy in a manner resembling astrologic typing. The "Ignatia Type," for example, is said to be nervous and often tearful, and to dislike tobacco smoke. The typical "Pulsatilla" is a young woman, with blond or light-brown

hair, blue eyes, and a delicate complexion, who is gentle, fearful, romantic, emotional, and friendly but shy. The "Nux Vomica Type" is said to be aggressive, bellicose, ambitious, and hyperactive. The "Sulfur Type" likes to be independent. And so on. Does this sound to you like a rational basis for diagnosis and treatment?

The "Remedies" Are Placebos

Homeopathic products are made from minerals, botanical substances, and several other sources. If the original substance is soluble, one part is diluted with either nine or ninety-nine parts of distilled water and/or alcohol and shaken vigorously (succussed); if insoluble, it is finely ground and pulverized in similar proportions with powdered lactose (milk sugar). One part of the diluted medicine is then further diluted, and the process is repeated until the desired concentration is reached. Dilutions of 1 to 10 are designated by the Roman numeral X (1X = 1/10, 3X = 1/1,000, 6X = 1/1,000,000). Similarly, dilutions of 1 to 100 are designated by the Roman numeral C (1C = 1/100, 3C = 1/1,000,000, and so on). Most remedies today range from 6X to 30X, but products of 30C or more are marketed.

A 30X dilution means that the original substance has been diluted 1,000,000,000,000,000,000,000,000,000,000 times. Assuming that a cubic centimeter of water contains 15 drops, this number is greater than the number of drops of water that would fill a container more than 50 times the size of the Earth. Imagine placing a drop of red dye into such a container so that it disperses evenly. Homeopathy's "law of infinitesimals" is the equivalent of saying that any drop of water subsequently removed from that container will possess an essence of redness. Robert L. Park, Ph.D., a prominent physicist who is 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.

Oscillococcinum, a 200C product "for the relief of colds and flu-like symptoms," involves "dilutions" that are even more far-fetched. Its "active ingredient" is prepared by incubating small amounts of a freshly killed duck's liver and heart for 40 days. The

resultant solution is then filtered, freeze-dried, rehydrated, repeatedly diluted, and impregnated into sugar granules. If a single molecule of the duck's heart or liver were to survive the dilution, its concentration would be 1 in 100200. This huge number, which has 400 zeroes, is vastly greater than the estimated number of molecules in the universe (about one googol, which is a 1 followed by 100 zeroes). In its February 17, 1997, issue, U.S. News & World Report noted that only one duck per year is needed to manufacture the product, which had total sales of $20 million in 1996. The magazine dubbed that unlucky bird "the $20-million duck."

Actually, 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, corresponds to homeopathic potencies of 12C or 24X (1 part in 1024). Hahnemann himself realized that there is virtually no chance that even one molecule of original substance would remain after extreme dilutions. But he believed that the vigorous shaking or pulverizing with each step of dilution leaves behind a "spirit-like" essence -- "no longer perceptible to the senses" -- which cures by reviving the body's "vital force." Modern proponents assert that even when the last molecule is gone, a "memory" of the substance is retained. This notion is unsubstantiated. Moreover, if it were true, every substance encountered by a molecule of water might imprint an "essence" that could exert powerful (and unpredictable) medicinal effects when ingested by a person.

Many proponents claim that homeopathic products resemble vaccines because both provide a small stimulus that triggers an immune response. This comparison is not valid. The amounts of active ingredients in vaccines are much greater and can be measured. Moreover, immunizations produce antibodies whose concentration in the blood can be measured, but high-dilution homeopathic products produce no measurable response. In addition, vaccines are used preventively, not for curing symptoms.

Stan Polanski, a physician assistant working in public health near Asheville, North Carolina, has provided additional insights:

Imagine how many compounds must be present, in quantities of a molecule or more, in every dose of a homeopathic drug. Even under the most scrupulously clean conditions, airborne dust in the manufacturing facility must carry thousands of different

molecules of biological origin derived from local sources (bacteria, viruses, fungi, respiratory droplets, sloughed skin cells, insect feces) as well as distant ones (pollens, soil particles, products of combustion), along with mineral particles of terrestrial and even extraterrestrial origin (meteor dust). Similarly, the "inert" diluents used in the process must have their own library of microcontaminants.

The dilution/potentiation process in homeopathy involves a stepwise dilution carried to fantastic extremes, with "succussion" between each dilution. Succussion involves shaking or rapping the container a certain way. During the step-by-step dilution process, how is the emerging drug preparation supposed to know which of the countless substances in the container is the One that means business? How is it that thousands (millions?) of chemical compounds know that they are required to lay low, to just stand around while the Potent One is anointed to the status of Healer? That this scenario could lead to distinct products uniquely suited to treat particular illnesses is beyond implausible.

Thus, until homeopathy's apologists can supply a plausible (nonmagical) mechanism for the "potentiation"-through-dilution of precisely one of the many substances in each of their products, it is impossible to accept that they have correctly identified the active ingredients in their products. Any study claiming to demonstrate effectiveness of a homeopathic medication should be rejected out-of-hand unless it includes a list of all the substances present in concentrations equal to or greater than the purported active ingredient at every stage of the dilution process, along with a rationale for rejecting each of them as a suspect.

The process of "proving" through which homeopaths decided which medicine matches which symptom is no more sensible. Provings involved taking various substances recording every twitch, sneeze, ache or itch that occurred afterward -- often for several days. Homeopathy's followers take for granted that every sensation reported was caused by whatever substance was administered, and that extremely dilute doses of that substance would then be just the right thing to treat anyone with those

specific symptoms.

Dr. Park has 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.

Cell Salts

Some homeopathic manufacturers market twelve highly diluted mineral products called "cell salts" or "tissue salts." These are claimed to be effective against a wide variety of diseases, including appendicitis (ruptured or not), baldness, deafness, insomnia, and worms. Their use is based on the notion that mineral deficiency is the basic cause of disease. However, many are so diluted that they could not correct a mineral deficiency even if one were present. Development of this approach is attributed to a nineteenth-century physician named W.H. Schuessler.

"Electrodiagnosis"

Some physicians, dentists, and chiropractors use "electrodiagnostic" devices to help select the homeopathic remedies they prescribe. These practitioners claim they can determine the cause of any disease by detecting the "energy imbalance" causing the problem. Some also claim that the devices can detect whether someone is allergic or sensitive to foods, vitamins, and/or other substances. The procedure, called electroacupuncture according to Voll (EAV), electrodiagnosis, or electrodermal screening, was begun during the late 1950s by Reinhold Voll, M.D., a West German physician who developed the original device. Subsequent models include the Vega, Dermatron, Accupath 1000, and Interro.

Proponents claim these devices measure disturbances in the flow of "electro-magnetic energy" along the body's "acupuncture meridians." Actually, they are fancy galvanometers that measure electrical resistance of the patient's skin when touched by a probe. Each device contains a low-voltage source. One wire from the device goes to a brass cylinder covered by moist gauze, which the patient holds in one hand. A second wire is connected to a probe, which the operator touches to "acupuncture points" on the patient's foot or other hand. This completes a circuit, and the device registers the flow of current. The information is then relayed to a gauge that provides a numerical readout.

The size of the number depends on how hard the probe is pressed against the patient's skin. Recent versions, such as the Interro make sounds and provide the readout on a computer screen. The treatment selected depends on the scope of the practitioner's practice and may include acupuncture, dietary change, and/or vitamin supplements, as well as homeopathic products. Regulatory agencies have seized several types of electroacupuncture devices but have not made a systematic effort to drive them from the marketplace.

For more information about these devices and pictures of some of them, click here. If you encounter such a device, please read this article and report the device to the practitioner's state licensing board, the state attorney general, the Federal Trade Commission, the FBI, the National Fraud Information Center, and any insurance company to which the practitioner submits claims that involve use of the device. For the addresses of these agencies, click here.

Unimpressive "Research"

Since many homeopathic remedies contain no detectable amount of active ingredient, it is impossible to test whether they contain what their label says. Unlike most potent drugs, they have not been proven effective against disease by double-blind clinical testing. In fact, the vast majority of homeopathic products have never even been tested.

In 1990, an article in Review of Epidemiology analyzed 40 randomized trials that had compared homeopathic treatment with standard treatment, a placebo, or no treatment. The authors concluded that all but three of the trials had major flaws in their design and that only one of those three had reported a positive result. The authors concluded that there is no evidence that homeopathic treatment has any more value than a placebo [2].

In 1994, the journal Pediatrics published an article claiming that homeopathic treatment had been demonstrated to be effective against mild cases of diarrhea among Nicaraguan children [3]. The claim was based on findings that, on certain days, the "treated" group had fewer loose stools than the placebo group. However, Sampson and London noted: (1) the study used an unreliable and unproved diagnostic and therapeutic scheme, (2) there was no safeguard against product adulteration, (3) treatment selection was arbitrary, (4) the data were oddly grouped and contained errors and inconsistencies, (5) the results had questionable clinical significance, and (6) there was no public health

significance because the only remedy needed for mild childhood diarrhea is adequate fluid intake to prevent or correct dehydration [4].

In 1995, Prescrire International, a French journal that evaluates pharmaceutical products, published a literature review that concluded:

As homeopathic treatments are generally used in conditions with variable outcome or showing spontaneous recovery (hence their placebo-responsiveness), these treatments are widely considered to have an effect in some patients. However, despite the large number of comparative trials carried out to date there is no evidence that homeopathy is any more effective than placebo therapy given in identical conditions.

In December 1996, a lengthy report was published by the Homoeopathic Medicine Research Group (HMRG), an expert panel convened by the Commission of the European Communities. The HMRG included homeopathic physician-researchers and experts in clinical research, clinical pharmacology, biostatistics, and clinical epidemiology. Its aim was to evaluate published and unpublished reports of controlled trials of homeopathic treatment. After examining 184 reports, the panelists concluded: (1) only 17 were designed and reported well enough to be worth considering; (2) in some of these trials, homeopathic approaches may have exerted a greater effect than a placebo or no treatment; and (3) the number of participants in these 17 trials was too small to draw any conclusions about the effectiveness of homeopathic treatment for any specific condition [5]. Simply put: Most homeopathic research is worthless, and no homeopathic product has been proven effective for any therapeutic purpose. The National Council Against Health Fraud has warned that "the sectarian nature of homeopathy raises serious questions about the trustworthiness of homeopathic researchers." [6]

In 1997, a London health authority decided to stop paying for homeopathic treatment after concluding that there was not enough evidence to support its use. The Lambeth, Southwark, and Lewisham Health Authority had been referring more than 500 patients per year to the Royal Homoeopathic Hospital in London. Public health doctors at the authority reviewed the published scientific literature as part of a general move toward purchasing only evidence-based treatments. The group concluded that many of the studies were methodologically flawed and that recent research produced by the Royal

Homoeopathic Hospital contained no convincing evidence that homeopathy offered clinical benefit [7].

Proponents trumpet the few "positive" studies as proof that "homeopathy works." Even if their results can be consistently reproduced (which seems unlikely), the most that the study of a single remedy for a single disease could prove is that the remedy is effective against that disease. It would not validate homeopathy's basic theories or prove that homeopathic treatment is useful for other diseases.

Placebo effects can be powerful, of course, but the potential benefit of relieving symptoms with placebos should be weighed against the harm that can result from relying upon -- and wasting money on -- ineffective products. Spontaneous remission is also a factor in homeopathy's popularity. I believe that most people who credit a homeopathic product for their recovery would have fared equally well without it.

Homeopaths are working hard to have their services covered under national health insurance. They claim to provide care that is safer, gentler, "natural," and less expensive than conventional care -- and more concerned with prevention. However, homeopathic treatments prevent nothing, and many homeopathic leaders preach against immunization. Equally bad, a report on the National Center for Homeopathy's 1997 Conference described how a homeopathic physician had suggested using homeopathic products to help prevent and treat coronary artery disease. According to the article, the speaker recommended various 30C and 200C products as alternatives to aspirin or cholesterol-lowering drugs, both of which are proven to reduce the incidence of heart attacks and strokes [8].

Illegal Marketing

In a survey conducted in 1982, the FDA found some over-the-counter products being marketed for serious illnesses, including heart disease, kidney disorders, and cancer. An extract of tarantula was being purveyed for multiple sclerosis; an extract of cobra venom for cancer.

During 1988, the FDA took action against companies marketing "diet patches" with false claims that they could suppress appetite. The largest such company, Meditrend International, of San Diego, instructed users to place 1 or 2 drops of a "homeopathic

appetite control solution" on a patch and wear it all day affixed to an "acupuncture point" on the wrist to "bioelectrically" suppress the appetite control center of the brain.

America's most blatant homeopathic marketer appears to be Biological Homeopathic Industries (BHI) of Albuquerque, New Mexico, which, in 1983, sent a 123-page catalog to 200,000 physicians nationwide. Its products included BHI Anticancer Stimulating, BHI Antivirus, BHI Stroke, and 50 other types of tablets claimed to be effective against serious diseases. In 1984, the FDA forced BHI to stop distributing several of the products and to tone down its claims for others. However, BHI has continued to make illegal claims. Its 1991 Physicians' Reference ("for use only by health care professionals") inappropriately recommended products for heart failure, syphilis, kidney failure, blurred vision, and many other serious conditions. The company's publishing arm issues the quarterly Biological Therapy: Journal of Natural Medicine, which regularly contains articles whose authors make questionable claims. An article in the April 1992 issue, for example, listed "indications" for using BHI and Heel products (distributed by BHI) for more than fifty conditions-including cancer, angina pectoris, and paralysis. And the October 1993 issue, devoted to the homeopathic treatment of children, includes an article recommending products for acute bacterial infections of the ear and tonsils. The article is described as selections from Heel seminars given in several cities by a Nevada homeopath who also served as medical editor of Biological Therapy. In 1993, Heel published a 500-page hardcover book describing how to use its products to treat about 450 conditions [9]. Twelve pages of the book cover "Neoplasia and neoplastic phases of disease." (Neoplasm is a medical term for tumor.) In March 1998, during an osteopathic convention in Las Vegas, Nevada, a Heel exhibitor distributed copies of the book when asked for detailed information on how to use Heel products. A 2000 edition is larger but does not have the neoplasia section [10].

Between October 1993 and September 1994, the FDA issued warning letters to four homeopathic manufacturers:

BHI was ordered to stop making claims that BHI Cold, which contained sulfur and pulsatilla, were effective against mumps, whooping cough, chronic respiratory diseases, herpes zoster, all viral infections, and measles. In addition, when combined with other BHI remedies, it had been illegally claimed to be effective against otitis, pleurisy, bronchitis or pneumonia, conjunctivitis, and tracheitis.

Botanical Laboratories, Inc., which distributed Natra-Bio products, was ordered to stop claiming that BioAllers was a homeopathic remedy for reliving symptoms of allergy due to pollen, animal hair, dander, mold, yeast, and dust. The products were promoted as homeopathic even though some ingredients were not in the Homeopathic Pharmacopeia.

L.B.L.-Bot.Bio.Hom.Corp, of Roosevelt, New York, was ordered to stop making false claims that products could prevent AIDS, reduce cholesterol, cure diabetes and other pancreas disorders, and cancerous blood disorders.

Nutrition Express, of Houston, Texas, was warned that products it was marketing for the temporary relief of infection, minor liver disorders, lymphatic disorders, and menstrual discomforts were misbranded because their labels or labeling included statements that represented that the products were intended to be used for curing or preventing disease.

Greater Regulation Is Needed

As far as I can tell, the FDA has never recognized any homeopathic remedy as safe and effecative for any medical purpose. In 1995, I filed a Freedom of Information Act request that stated:

I am interested in learning whether the FDA has: (1) received evidence that any homeopathic remedy, now marketed in this country, is effective against any disease or health problem; (2) concluded that any homeopathic product now marketed in the United States is effective against any health problem or condition; (3) concluded that homeopathic remedies are generally effective; or (4) concluded that homeopathic remedies are generally not effective. Please send me copies of all documents in your possession that pertain to these questions [10].

An official from the FDA Center for Drug Evaluation and Research replied that several dozen homeopathic products were approved many years ago, but these approvals were withdrawn by 1970 [12]. In other words, after 1970, no homeopathic remedy had FDA as "safe and effective" for its intended purpose. As far as I can tell, that statement is still true today.

If the FDA required homeopathic remedies to be proven effective in order to remain marketable -- the standard it applies to other categories of drugs -- homeopathy would

face extinction in the United States [13]. However, there is no indication that the agency is considering this. FDA officials regard homeopathy as relatively benign (compared, for example, to unsubstantiated products marketed for cancer and AIDS) and believe that other problems should get enforcement priority. If the FDA attacks homeopathy too vigorously, its proponents might even persuade a lobby-susceptible Congress to rescue them. Regardless of this risk, the FDA should not permit worthless products to be marketed with claims that they are effective. Nor should it continue to tolerate the presence of quack "electrodiagnostic" devices in the marketplace.

In 1994, forty-two prominent critics of quackery and pseudoscience asked the agency to curb the sale of homeopathic products. The petition urges the FDA to initiate a rulemaking procedure to require that all over-the-counter (OTC) homeopathic drugs meet the same standards of safety and effectiveness as nonhomeopathic OTC drugs. It also asks for a public warning that although the FDA has permitted homeopathic remedies to be sold, it does not recognize them as effective. The FDA has not yet responded to the petition. However, on March 3, 1998, at a symposium sponsored by Good Housekeeping magazine, former FDA Commissioner David A. Kessler, M.D., J.D., acknowledged that homeopathic remedies do not work but that he did not attempt to ban them because he felt that Congress would not support a ban [14].

Note: We are interested in filing consumer-protection suits against homeopathic sellers. If you have purchased a homeopathic product within the past year and concluded that the product did not work as represented on packaging or in any advertisement, please contact us.

References

1. Kaufman M. Homeopathy in America. Baltimore, 1971, The Johns Hopkins University Press.

2. Hill C, Doyon F. Review of randomized trials of homeopathy. Review of Epidemiology 38:139-142, 1990.

3. Jacob J and others. Treatment of childhood diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua. Pediatrics 93:719-725, 1994.

4. Sampson W, London W. Analysis of homeopathic treatment of childhood diarrhea. Pediatrics 96:961-964, 1995.

5. Homoeopathic Medicine Research Group. Report. Commission of the European

Communities, December 1996. 6. NCAHF Position Paper on Homeopathy . Loma Linda, CA.: National Council

Against Health Fraud, 1994. 7. Wise, J. Health authority stops buying homoeopathy. British Medical Journal

314:1574, 1997. 8. Hauck KG. Homeopathy and coronary artery disease. Homeopathy Today

17(8):3, 1997. 9. Biotherapeutic Index. Baden-Baden, Germany: Biologishe Heilmittel Heel

GmbH, 1993. 10. Biotherapeutic Index , 5th revised English edition. Baden-Baden, Germany:

Biologische Heilmittel GmbH, 2000. 11. Barrett S. Letter to FDA Office of Freedom of Information, Feb 7, 1995. 12. Davis H. Letter to Stephen Barrett, M.D., April 24, 1995. 13. Pinco RG. Status of homeopathy in the United States: Important ominous

developments. Memo to Williard Eldredge, president, American Association of Homeopathic Pharmacists, Jan 17, 1985.

14. Kessler DA. Panel discussion on herbal dietary supplements. Consumer Safety Symposium on Dietary Supplements and Herbs, New York City, March 3, 1998.

Related Topics

Quack "Electrodiagnostic" Devices Used for Selecting Remedies FDA Compliance Policy Guide 7132.15 for Homeopathic Products Homoeopathy and Its Kindred Delusions (Essay by Oliver Wendell Holmes,

1842) Homeopathy and Science: A Closer Look Petition to Ban the Marketing of Homeopathic Products Why Extraordinary Claims Require Extraordinary Proof Alternative Medicine and the Laws of Physics Samuel Hahnemann's Book: Organon of Medicine The Scientific Evaluation of Homeopathy (includes research summary) Hahnemann's Homeopathy (Five articles debunking homeopathic theory and

practice) Homeopathy: All the Idiocy That Fits (Satire by Peter Bowditch)