RAS declared homeopathy a pseudoscience
Memorandum of the RAS Commission on Combating Pseudoscience
and falsification of scientific research
ABOUT THE PSEUDOSCIENCE OF HOMEOPATHY
This memorandum of the Commission on Combating Pseudoscience and Falsification of Scientific Research at the Presidium of the Russian Academy of Sciences (hereinafter referred to as the Commission) is dedicated to homeopathy. The Commission states that the treatment of ultra-low doses of various substances used in homeopathy has no scientific basis. This conclusion is based on a thorough analysis of publications in scientific journals, reports on clinical trials, their generalizations and systematic reviews. The Commission confirms that the principles of homeopathy and theoretical explanations of the mechanisms of its intended action contradict known chemical, physical and biological laws, and there are no convincing experimental confirmations of its effectiveness. Homeopathic methods of diagnosis and treatment should be qualified as pseudoscientific.
Homeopathy as a type of alternative medicine has been around for more than 200 years. During this time, attempts have been made repeatedly to bring a scientific basis for homeopathy. All of them were ultimately unsuccessful:
- numerous clinical trials conducted in different countries at different times have failed to experimentally demonstrate the effectiveness of homeopathic remedies and treatment methods;
- numerous proposed theoretical explanations of the possible mechanisms of action of homeopathy are in contradiction with firmly established scientific ideas about the structure of matter, the structure of living organisms and the functioning of medicines;
- a priori postulated "principles of homeopathy" are by their nature speculative dogmatic statements dating back to the protoscientific stage of the development of physiology and medicine.
Homeopathy is not harmless: patients spend significant amounts of money on inactive drugs and neglect treatments with proven effectiveness. This can lead to adverse outcomes, including the death of patients.
This memorandum states that in the scientific community, homeopathy is currently regarded as a pseudoscience. Its use in medicine contradicts the main goals of domestic healthcare and should meet organized state opposition. With this in mind, the Commission formulated recommendations to various individuals and organizations aimed at correcting the current situation when ineffective homeopathic treatment occupies a significant place in the domestic healthcare system.
The Memorandum is based on an Expert Opinion drawn up by an interdisciplinary working group on behalf of the Commission. It includes specialists in the field of evidence-based, experimental and clinical medicine, psychotherapy, psychology, physics, chemistry, biochemistry, immunology, molecular biology, pharmacology, biotechnology, pharmacy and biostatistics.
Recommendations
To the Ministry of Health of the Russian Federation. To review, in the light of current scientific data, the decisions taken more than 20 years ago without sufficient grounds on the introduction of homeopathy into the Russian healthcare system. Remove homeopathic medicines from medical use in state and municipal medical institutions. Do not include homeopathy in new and updated standards of medical care, clinical recommendations (treatment protocols).
Supplement the requirement for mandatory labeling "Homeopathic" on the secondary packaging of homeopathic medicines (Clause 6 of Article 46 of the Federal Law "On Circulation of Medicines") with the requirement of mandatory explicit indication of the absence of proven clinical efficacy and indications for use. Oblige manufacturers to include this indication in the instructions for the drug and its general characteristics, as well as to indicate in the instructions the actual composition of homeopathic remedies. For preparations with a dilution of 12C or more, that is, not containing active substances, indicate only the auxiliary components actually contained in the preparation (water, lactose, and so on). Require to indicate the intended active substance in a separate list "used in preparation". In any dilution, indicate the intended active substance used in the preparation in Russian.
When receiving information from the Federal Service for Supervision in the Field of Healthcare about the inconsistency of data on the effectiveness of homeopathic medicines with the data contained in the instructions, in accordance with Article 65 of the Federal Law "On the Circulation of Medicines", consider suspending the use of registered homeopathic remedies.
Federal Service for Supervision in the Field of Healthcare. Monitor and stop attempts to sell drugs containing a significant amount of the active substance under the guise of homeopathic. Monitor the sending to the authorized body by medical organizations of notices of side effects, adverse reactions or the absence of the expected therapeutic effect of homeopathic remedies with the use, in case of concealment, of appropriate sanctions. If you receive information about the inconsistency of the data on the effectiveness of homeopathic medicines with the data contained in the instructions, send it to the Ministry of Health of the Russian Federation.
To the Council of the Eurasian Economic Commission. To make the following additions and amendments to Decision No. 76 "On Approval of Requirements for Labeling of medicines for Medical use and veterinary medicines" and Decision No. 78 "On Rules for Registration and Examination of Medicines for Medical Use", adopted on November 3, 2016:
- to introduce mandatory labeling of homeopathic medicines, indicating the absence of indications for use and evidence of effectiveness;
- require to indicate in the instructions for the drug and its general characteristics that the drug is homeopathic, has no proven efficacy and indications for use;
- require to indicate in the instructions the actual composition of homeopathic remedies, that is, for preparations with a dilution of more than C12 that do not contain active substances, indicate only the auxiliary components actually contained in the preparation (water, lactose, and so on);
- require at the same time to indicate the intended active substance in a separate list "used in preparation";
- indicate the intended active substance used in the preparation in Russian.
Federal Antimonopoly Service. To ensure the protection of citizens from false advertising of homeopathy, claiming that homeopathic medicines have medicinal properties. Such advertising misleads consumers and pushes them to use ineffective treatment, which can harm their health.
Organizations that implement educational programs in the field of healthcare. Curtail professional development programs in homeopathy and other courses that include homeopathy. To acquaint future physicians and doctors undergoing postgraduate training with the content and criticism of common pseudoscientific ideas in the field of medicine, including homeopathic ones.
Insurance companies. Adhere to standard practices that do not provide insurance coverage for homeopathic services. Consider the possibility of excluding homeopathic treatment and medicines from "extended" insurance contracts by analogy with how the services of folk healers and "psychics" are excluded from them.
Pharmacies. To abandon the joint sale of medicinal and homeopathic medicines and, if possible, to switch to the sale of homeopathic medicines behind a separate counter with the display of these drugs in a separate showcase.
Pharmacists and pharmacists. Do not recommend homeopathic medicines to patients. Inform patients who purchase homeopathic medicines that homeopathy has no indications and scientific evidence of clinical efficacy.
Doctors. To inform patients about the ineffectiveness and pseudoscience of homeopathy, to avoid cooperation with organizations promoting and distributing homeopathy, to abandon the unethical practice of prescribing homeopathic drugs to achieve a placebo effect and to promote the rejection of the use of homeopathy in their medical organization.
Remember the need to adhere to treatment standards, which for the most part do not provide for the use of homeopathy and the obligation to convene a consultation to prescribe treatment not specified in the standards.
Remember the obligation to inform Roszdravnadzor about detected cases of inefficiency of drugs, including homeopathic ones. Notifications are submitted through the automated system "Pharmacovigilance".
Homeopaths. Get acquainted with modern scientific data on the effectiveness of homeopathy. Be critical of the unconfirmed claims of manufacturers of homeopathic remedies about their effectiveness.
Do not use homeopathic medicines as the only therapy for patients in need of medical care. Recommend patients to visit a non-homoeopathic doctor to obtain scientifically based recommendations. In case of conditions threatening serious consequences, abandon attempts to treat the patient with homeopathic medicines and refer him to the system of official non-homeopathic medicine.
Representatives of the media. Do not present homeopathy as an effective or supposedly useful medical practice. To position homeopathy as a pseudoscience in the field of medicine, on a par with magic, healing and "extrasensory". To prevent the promotion and advertising of homeopathy.
Teachers of educational institutions. To educate students about the methodology of scientific experiments and the basic principles of evidence-based medicine.
To patients and all responsible citizens. Refuse to purchase and use homeopathic medicines, inform doctors about their position, as well as disseminate reliable information about homeopathy and support efforts to separate it organizationally and administratively from the state and municipal health care system.
Chairman of the Commission on Combating Pseudoscience
and falsification of scientific research
at the Presidium of the Russian Academy of Sciences,
academician Evgeny Borisovich Alexandrov
06.02.2017
The memorandum was prepared with the support of the Educational Fund "Evolution".
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Expert opinion on the pseudoscience of homeopathy
1. Homeopathy is an alternative medical practice consisting in the use of ultra–small doses of substances that in large doses cause signs of this disease in a healthy person.
The principles of homeopathy and the means and methods of diagnosis and treatment based on them contradict the principles of evidence-based medicine, which are based on the achievements of natural and medical sciences: chemistry, physics, biology and physiology and their sections, such as biochemistry, biophysics, immunology, molecular biology, pathological physiology and pharmacology. Homeopathic methods of diagnosis and treatment are pseudoscientific and do not work. The conviction of individual doctors and patients in the effectiveness of homeopathy "from personal experience" has other explanations that do not contradict what has been said (see Appendix No. 1 "Answers to frequently asked questions and arguments in favor of homeopathy", section I).
2. Homeopathy is based on the following basic principles:
a) "The principle of similarity". According to the founder of homeopathy, Samuel Hahnemann (1755-1843), one should choose "in every case of a disease a medicine that itself can cause suffering similar to that which should be cured." The "principle of similarity" goes back to the practice of sympathetic magic, a form of witchcraft that is based on the idea that objects similar to each other are in a supernatural magical connection.
b) "The principle of drug testing (proving) on healthy people." Testing of homeopathic remedies is carried out on healthy people. The symptoms that occur when they take the drug are analyzed, and it is believed that it will suit patients with similar symptoms.
c) "The principle of a small dose". It is believed that the strength of the effect of homeopathic medicine does not decrease, but increases as its dilution increases.
d) "The principle of potentiation". It is believed that the effect of a homeopathic remedy is enhanced when it is subjected to "potentiation" (or "dynamization") by prolonged and vigorous shaking (or rubbing for insoluble substances).
e) "The principle of individual treatment". Some homeopaths insist that a homeopathic remedy must be selected for the patient "individually", taking into account the totality of the "symptoms" and personal characteristics declared by him. Not all homeopaths share this point of view: many popular homeopathic medicines are over-the-counter and are sold en masse in pharmacies. Comments on this principle are given in Appendix No. 1, section II.
3. Homeopathy originated in an era when the most important concepts of chemistry and biology about the properties of molecules and the existence of microbes were not yet generally accepted. Some scientists then believed that matter was infinitely divisible, and therefore it made sense for them to talk about dilution of solutions to any degree.
Dilutions in homeopathy represent a consistent decrease in the concentration of the active substance, often up to its complete absence in the manufactured "solution". A prerequisite is considered to be potentiation (shaking) at all stages of sequential dilution. Research in the field of physics and chemistry of the XVII–XIX centuries, which discovered the atomic-molecular structure of matter, showed that the possibilities of dilution are limited.
One mole of any substance contains ≈6.02·10 23 molecules (Avogadro number). If a single-polar solution (1 mol / l) of a homeopathic remedy is subjected to successive multiple dilution, then in a liter of solution with a dilution index of 12C =
100-12 = 10-24 one molecule of this drug will be contained with a probability of 60%. In a typical dose of a homeopathic remedy, millionths of a liter of solution are used, so single molecules of the remedy with a dilution index of 12C will occur only in a few of the millions of doses. Recommended by Hahnemann himself and still popular among homeopaths, the degree of dilution of 30C (10-60) is completely devoid of physical meaning, since the whole Earth contains no more than 10-50 molecules.
In an attempt to circumvent this limit and give meaning to high dilutions, homeopaths put forward numerous speculative concepts that do not stand up to scientific criticism, such as, for example, the idea of "water memory", allegedly transmitting the properties of a homeopathic substance in the absence of its molecules (see Appendix No. 4 "On water memory" and Appendix No. 1).
4. Although some homeopathic medicines are prepared from herbs, homeopathic treatment should not be confused with phytotherapy, which uses formulations with a high (measurable) content of active substances obtained from plant raw materials. Everything said in the Memorandum concerns preparations in which active substances are believed to be contained in homeopathic (ultra-low) concentrations, regardless of whether the manufacturer calls its products homeopathic (see Appendix No. 1, section XVI).
5. With the exception of the placebo effect (see Appendix No. 2 "Placebo effect" and Appendix No. 1, Section IV), the manifestation of the therapeutic effect of the drug is impossible without its chemical or physico-chemical interaction with biological substrates that are its targets in the organs, tissues and cells of the patient's body or the causative agent of the disease.
Intermolecular interactions determine the further action of drugs at all levels (from the cellular response to the reaction of the whole organism). There are no plausible and even more confirmed mechanisms of the effect of homeopathic remedies on individual molecular targets or the human body as a whole.
6. In the interests of patients, modern medicine uses an evidence-based approach in which decisions on the use of preventive, diagnostic and therapeutic interventions are made based on the available objective and reliable scientific evidence of their effectiveness and safety. This approach excludes the use of non-evidence-based interventions. Compliance with speculative principles, such as the "similarity principle", says nothing about the therapeutic value of the drug.
In scientific medicine, the efficacy and safety of the drug are established by comparing experimental and control groups of patients. In the simplest case, subjects from the first group receive the studied drug (treatment), and from the second – a placebo (imitation, externally indistinguishable from the studied drug). In order to create the most similar groups and the same management of these groups, patients are distributed between the experimental and control groups based on a draw (randomization). At the same time, neither the patients themselves nor the research doctors should know who is receiving treatment and who is receiving a placebo (double-blind study).
In general, clinical trials are conducted in parallel in many medical centers in different countries on a wide socio-demographic sample of patients, and the comparison is conducted not only with placebo, but also with the best available methods of treatment. At the same time, only the strictest adherence to the experimental protocol allows us to obtain scientifically reliable conclusions about the effectiveness of a particular treatment method.
The generalized results (meta-analyses) of clinical studies indicate the absence of clinical efficacy of homeopathic remedies. Researchers have come to such conclusions repeatedly. One of the most convincing and large-scale generalizations of clinical studies was conducted by the Medical Research Council of Australia in 2015. The Council analyzed 1800 publications [1] and came to the following conclusion:
"No reliable evidence has been found in human studies that homeopathy is effective in treating the diseases considered [61 diseases]: no qualitative study with a sufficient sample size has confirmed that homeopathy causes greater health changes than placebo..." [2]
13 additional documents are also presented on the website of this Council [3].
Earlier, in 2010, a similar conclusion was reached by the Committee on Science and Technology of the British Parliament [4], which decided: "There is no plausible evidence that homeopathy is effective...". The same conclusions were obtained in a number of reviews published in peer-reviewed scientific journals [5-7]. For example, a 2005 article in the Lancet showed that in studies of the highest quality, the effectiveness of homeopathic remedies, unlike conventional drugs, is indistinguishable from the effectiveness of placebo. Modern reviews, in which the most popular homeopathic remedies were studied, also indicate a lack of proven effectiveness [8]. Single studies allegedly confirming the effectiveness of some homeopathic remedies were either conducted in violation of scientific methodology, or relate to drugs mistakenly called homeopathic (not conforming to its principles), or their result was not reproduced by independent researchers (see Appendix No. 5. "Some studies of homeopathy containing errors").
Experimental studies of the effectiveness of homeopathy were conducted in the USSR in 1937, as well as in 1974-1975. There was no evidence of its effectiveness (see Appendix No. 3. "History of the introduction of homeopathy into the domestic healthcare system").
In 2016, the US Federal Trade Commission (FTC) concluded that:
"Statements about the effectiveness of traditional over-the-counter homeopathic medicines are supported exclusively by homeopathic theories and proofs that are not recognized by modern experts in the field of medicine and are not reliable scientific evidence of effectiveness" [9].
On this basis, the FTC proposed limiting the advertising of homeopathic remedies to the following measures: in the absence of proper clinical studies confirming the effectiveness of homeopathic remedies, the consumer should be informed that the drug has no proven therapeutic value.
Similar requirements for labeling of homeopathic medicines are formulated in the recent decision of the Council of the Eurasian Economic Commission No. 76 dated 03.11.2016 "On approval of requirements for labeling of medicines for medical use and veterinary medicines":
"In the labeling of a homeopathic medicinal product registered under the simplified registration procedure, only the following (and no other) information should be indicated:
<…>
l) entry: "Homeopathic medicinal product without an approved indication for use";
m) a warning about the need to consult a doctor if the symptoms of the disease persist."
7. The danger of homeopathy lies in the fact that its proponents often neglect treatments with proven effectiveness. This can lead to adverse outcomes, including the death of patients [10, 11]. In 2016, the FDA (US Food and Drug Administration) warned consumers against using homeopathic dental tablets and gels, which may be dangerous to the health of children [12].
Another danger is that the procedures for the production of homeopathic remedies, as a rule, are not controlled as strictly as the production of medicines. Contrary to the manufacturers' claims, such preparations may contain toxic substances in dangerous concentrations (see Appendix No. 1, section VII).
8. Thus, homeopathy is based on theoretical propositions that do not correspond to or directly contradict the fundamental scientific principles and laws of physics, chemistry, biology and medicine. Empirical data obtained in independent clinical studies of a high level of evidence do not confirm the clinical effectiveness of homeopathic remedies.
Science is aimed at building the most plausible and consistent picture of the world that best corresponds to the facts. The totality of facts relating to different fields of knowledge – from the results of clinical studies to modern scientific ideas about the structure of matter, the chemical foundations of intermolecular interactions and human physiology, allows us to conclude that the theoretical provisions of homeopathy have no scientific meaning, and homeopathic methods of diagnosis and treatment do not work.
In an effort to gain the trust of patients, homeopathy, as a rule, presents its principles and methods with a claim to some alternative scientific value. The absence of reliable scientific evidence of its effectiveness for two centuries has traditionally been explained by the fact that classical scientific approaches are allegedly inapplicable to the study of this area.
The combination of the external science of homeopathy with its opposition to the general system of scientific knowledge allows us to speak of it as a pseudoscientific discipline.
More detailed information on a number of the above issues is provided in the appendices.
List of applications
Answers to frequently asked questions about homeopathy and arguments in its favor.
The history of the introduction of homeopathy into the domestic healthcare system.
Some studies of homeopathy containing errors.
For the list of references and signatures of experts, see the original The memorandum.
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