Homeopathy and evidence-based medicine
In order to carry out scientific research, and keep up with the standards of evidence-based medicine, homeopathy has had to use a scientific model designed for conventional medicine, despite the fundamental differences between these systems.
When discussing homeopathic scientific research, we must first consider the role of evidence-based medicine, as this has become the “gold standard” for therapeutics, since the late 20th century.1Evidence-based medicine uses current evidence, from scientific research, to assist in the process of making decisions in medical care. This concept leads us to consider an important question we want to leave you with: what were decisions in medical care based on, prior to the late 20th century?
The methodologies most commonly used in evidence-based medicine comprise those based on studies that have already been published, such as systematic reviews and meta-analyses, and those used to carry out the studies, such as double-blind randomized controlled trials (RCTs). Here, the focus will be placed on RCTs because this is the experimentation methodology used in evidence-based medicine, and we want to discuss it in the context of its utilization in homeopathy. In brief, double blind RCTs are experiments to test medicines and placebo (plain sugar pills) in a blinded fashion, using a randomized group of study subjects with a similar ailment (neither study subjects, researchers nor result evaluators know who is taking placebo, and who is taking the medicine being tested). If the effect of the medicine on eliminating symptoms is significantly higher than that of the placebo, the medicine is deemed effective for the ailment.
The problem with RCTs for homeopathy
The methodology of RCTs, developed according to models that apply to conventional medicine, has several aspects that conflict with the principles of homeopathy.
Individualization: Homeopathic methodology regards each person as a unique individual with unique characteristics. Homeopathic medicine selection that takes this individuality into consideration gives excellent results. However, in order to conform to the conditions of group treatment, for a specific ailment used in an RCT, this individualization cannot exist – despite the reality that this is one of homeopathy’s strengths.
Totality: Conventional medicine treats symptoms—“the parts”—while homeopathy treats the whole individual—“the totality”. The “totality” includes not only physical, mental and emotional symptoms, but also the interactions of the individual with their environment. RCTs measure quantitative parameters, making the model subject to errors when used in homeopathy.
However, this situation is changing in favor of homeopathy, and the medical modalities that consider the totality of each person and their individuality. There is a trend in evidence-based medicine towards the use of qualitative methods alone, or with quantitative methods.2,3 This is because the benefits of qualitative methods have been demonstrated in studies such as early diagnosis in dementia,4recovery,5 and the efficiency of RCTs.6 Methods such as comparative trials have been proposed to measure the real practice of homeopathy, where the specificity of homeopathic medicine, the non-specificity of homeopathic consultation, and the interaction of the two are taken into account. 7
Efficacy trials and treatment trials: Efficacy trials and treatment trials are carried out in the same way in conventional medicine, but not in homeopathy. Treatment trials used in conventional medicine can be adapted to homeopathy to some extent, because both aim to determine whether a medicine is more effective than placebo, in improving a condition.
Efficacy trials in conventional medicine fundamentally differ with efficacy trials, or provings, in homeopathy. In conventional medicine, the purpose of these trials is to suppress symptoms, while in homeopathy; the purpose of these trials is to produce symptoms.8
For a homeopathic drug proving trial, a medicinal substance with unknown, or few known, medical applications is tested in a randomized group of healthy subjects. Changes in the condition of the healthy subjects are evaluated individually, and in the group. The resulting number of common and significant symptoms is referred to as the symptom picture of the medicinal substance. This substance can be used to treat those experiencing the same symptoms. If significant improvement is obtained, the substance is included in the repertory, or materia medica, for the symptoms. Clinical results will differentiate between presence and absence of resolution of symptoms.
The criticism of this system is subjectivity, because it relies on observations and reporting from the subject and the homeopaths involved in the experimentation. However, a recent study has shown how most of the mentioned difficulties can be overcome. A group of investigators from Germany demonstrated that a traditional homeopathic proving methodology can be adapted to a placebo-controlled phase 1 trial, using the present requirements for research under current drug regulations in Europe. In brief, the study was a randomized, double-blind placebo-controlled phase 1 trial, with 30 healthy participants. The homeopathic drug proving (HDP) study involved a base-line observation of 7 days, an intervention period of 5 days and a follow-up period of 16 days. Subjects were either doctors or students of homeopathy, and the drug identity was hidden; unlike conventional trials where participants are informed about the identity of the drug and the possible risks involved. Globules of a homeopathic medicine, in the potency of c12, and sucrose globules, which acted as placebo, were used. Subjects took 5 globules, 5 times a day, for 5 consecutive days. Participants stopped taking globules when they experienced proving symptoms. Subjects documented these symptoms in a diary. Adverse events and proving symptoms were documented together. The primary outcome for the HDP was individualistic and peculiar symptoms, in order to respect homeopathic criteria according to the Hahnemann’s organon. The secondary outcome parameters were qualitative differences in profile of characteristic and proving symptoms. Proving symptoms were analyzed using content analysis according to Mayring (adaptation to homeopathic qualitative analysis method).9
Blinding: The blinding component of RCTs also presents difficulties when applied to homeopathy. At a homeopathic first consultation, the homeopath gets information from the subject about mental, physical and emotional symptoms, constitution, lifestyle, childhood, family history and all of the traits that make the patient different and unique, through a thorough questioning. The study of this information allows the homeopath to find the most appropriate homeopathic medicine that will stimulate the body to heal.
But, by RCT protocol, the prescriber should not know about the medicine the study subject is taking, so as to avoid biased interpretations during follow-ups. To get around this obstacle, the homeopath is allowed to select the medicine, but the subjects may receive either placebo or the medicine without the homeopath knowing which.
Evaluation difficulties also arise when the potency is not appropriate, or the subject doesn’t respond for some other reason. Because of the blinding factor, the homeopath can’t get the feedback needed to make changes that will ensure treatment success.
Placebo Effect: One of the arguments used by homeopathy’s detractors is that responses to homeopathic remedies are due to the placebo effect. In efficacy trials, questionnaires are designed to limit the number of symptoms being considered because the amount of symptoms experienced by the study subjects can be overwhelming. It is certain that during RCTs, interaction of study subjects with these questionnaires, with limited symptoms, may result in an increased placebo effect, but carefully designed studies ease these interactions. It has been demonstrated that placebo effect resulting from homeopathic trials is not higher than that obtained from conventional drug trials. 10
Good evidence that the action of homeopathic medicines is real, and not a result of placebo effect, is the improvement of ailments suffered by babies and animals (who can’t verbally express what they feel and are not affected by psychosomatic influences) due to homeopathic treatment.
The argument that the pseudoskeptics make to this is that the babies & animals are affected by their caretakers’ or owners’ belief… a sort of placebo-effect-by-proxy. To counteract this argument we would like to pose some questions supported by clinical evidence and research studies in the area.
Would the beliefs of a mother influence the drop of a high fever in a baby, after the use of a homeopathic medicine like belladonna? Could the rapid healing of a common infectious skin disease in a baby, after the use of a homeopathic medicine like sulphur, possibly be the result of a placebo-effect-by proxy?
Would farm animals healing from infections, when homeopathic medicines are added to their food or water, be the result of any influence by their owner’s beliefs? What about when the role of homeopathic medicine is in prevention? Homeopathic medicines have shown to be effective in the prevention of mastitis during the dry period of dairy cows. 11 On the other hand, double blinded RCTs in animals have shown superior effect of homeopathic medicines compared to placebo controls.12
Would researchers have the power to influence in-vitro study results? There is growing evidence from in-vitro studies of the biological effect of homeopathic remedies against viruses13-15; the inhibitory effect of Nux vomica and Calendula officinalis homeopathic preparations on the gene expression ofhelicobacter pylori16; changes in the growth-rate of plants by homeopathic medicines17; and the in-vitro activation of bone marrow cells by homeopathic preparations.18
Why is there so much controversy and criticism concerning homeopathy and homeopathic scientific research?
Accepting that homeopathic medicines have a biological effect, even in potencies where dilution goes beyond Avogadro’s number—the point at which not a single molecule of the original substance is likely to remain in the solution—is not easy. It is hard for people steeped in long-established precepts of chemistry to accept that their knowledge might be wrong, or at least incomplete.
Scientists exploring the mechanisms of how homeopathy works are very cautious about their comments, or prefer to remain silent, for good reason. Throughout history (see Homeopathy: A History of Opposition) experiments suggesting theories that could support the effectiveness of homeopathy, such as “the memory of water”, proposed in 198819, have been sabotaged, attacked and ignored.
Jacques Benveniste, the main investigator of this theory, lost his laboratory, his funding and his reputation. More recently, Nobel laureate Luc Montagnier, the co-discoverer of the HIV virus, has been strongly attacked, and denied funding, to continue with his research – forcing him to move to China to pursue his work on the electromagnetic waves produced by highly-diluted DNA of some microorganisms.20
The situation of Montagnier brings us to another important factor delaying progress in high quality research in homeopathy: lack of funding. Pharmaceutical companies fund a high percentage of the research studies on conventional medicines because the business for them is there. However, homeopathic medicines are extremely cost-effective, so homeopathic pharmacies do not have that kind of financial clout.
As far as publication in prestigious scientific journals goes, research relating to homeopathy is often denied publication for no good reason. For instance, Dr. Gustavo Bracho’s team, who did a 2.3-million-population clinical trial on homeopathic prevention of leptospirosis in Cuba, had spectacular results, yet his paper was rejected by several prominent medical journals (personal communication, 2009) before it was published in the main, international peer-reviewed journal in homeopathy.21
To add to the controversy, the media is easily confused about evidence for the effectiveness of homeopathy, because there are plenty of apparently-respectable scientists or doctors decrying any study in the area as non-definitive. Why? Who could be interested in attacking homeopathy now, when its popularity is rapidly growing due to the increasing evidence of its effectiveness, the discovery of many unknowns about its mechanism of action, and the technological advancements in material science, quantum science etc. that define the present era?
Who, lacking real interest in seeing chronic diseases cured and cost-effective improvement of health for wealthy and poor alike, would feel menaced by homeopathy? Who would have the money and power to fund pseudo skeptics (individuals without any knowledge of homeopathy, who dare to criticize a science without an understanding of science, or the application of a ‘scientific method’ to prove/disprove their denigrating arguments against the science of homeopathy)? Who, for obvious reasons, would not be interested in reviewing any clinical evidence or “scientific” proof of homeopathy? Who could be using their power over the media to counteract the popularity of homeopathy? To help answer these questions, read the complete story about the pseudoskeptics and their funding (see Media Skeptics: A Popcorn Gallery.)
Despite all of these obstacles, more and more evidence in the area of ultra-high dilutions has been published recently (see High Dilution Studies and Extraordinary Evidence: Homeopathy’s Best Research). Some particularly interesting publications are: a review that show preliminary evidence supporting the biologic effects of ultra-high dilutions22; a study demonstrating that different high-potency homeopathic medicines, and different potencies of high-potency homeopathic medicines, can be distinguished from one another using spectroscopy23; and a report on the presence of the starting substance in ultra-high dilutions of homeopathic medicines, in the form of nanoparticles (microscopic-size particles).24
The fact that studies have shown positive results for homeopathy, despite numerous obstacles and continual accommodations to fit the standard medical science model, is a testament to the validity of homeopathy—a system of medicine with a 200-year record of successful clinical results. Homeopathy serves humanity by curing acute and chronic conditions, including those considered untreatable by conventional medicine, safely, gently and permanently.
Glossary of some terms in the context of homeopathic scientific research:
- Avogadro’s number. 6.022137 X 10 23 mol-1. Refers to the number of atoms or molecules present in a unit mole of a substance.
- High dilutions. In homeopathy, the term refers to dilution levels beyond Avogadro’s number.
- Clinical trial. A research study that aims to evaluate the effectiveness of a therapeutic intervention.
- Homeopathic Material Medica. A book that contains a compilation of the knowledge about curative properties of homeopathic medicines.
- Homeopathic repertory. A book that contains an index of symptoms with corresponding homeopathic medicines (from the material medica) with the medicinal effect for each symptom.
- Meta-analysis: Involves rigorous statistical analysis that integrates results obtained from a large collection of studies; all of which attempt to address the same research question.
- Objective. Refers to what can be seen, touched, or described, because it is factual.
- Phase 1 trial. Tests that aim to explore the safety and pharmacological properties of a new medicine/treatment in a small group of study subjects.
- Placebo effect. A physiological improvement that may be observed, measured, or felt as a result of personal beliefs and preconceptions of the mind, rather than the treatment.
- Potency. The strength of a homeopathic medicine. The potency is shown after the medicine name, by a number that indicates the repetition of dilution and succussion and a Roman numeral. X refers to the decimal dilution, C to the centesimal dilution, M to the millesimal dilution.
- Provings / Homeopathic drug proving trials (HDP) / homeopathic pathogenic trials.These trials find clinical indications according to the laws of homeopathy.
- Qualitative methods. In these methods, the reasoning goes from the specific to the general, and is subjective. The questions are open-ended, and the analyses use narrative descriptions and comparisons.
- Quantitative methods. In these methods, the reasoning goes from the general to the specific, and is objective. The questions are specific and the analyses use numbers and statistics.
- Systematic review: An examination of scientific literature that aims to identify, select and summarize high quality publications, in order to answer a specific research question.
- Scientific method. A method that involves observation of phenomena, enunciation of hypotheses about the phenomena, experimentation to test the hypotheses, analyses of the results and formulation of conclusions that accept or deny the hypotheses.
- Subject. A person who participates in a scientific experiment as one being experimented upon (taking a medicine/placebo pill, undergoing a procedure, etc.)
- Subjective. Refers to the unique experience of an individual.
References
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16. Hofbauer R, Pasching E, Moser D, Frass M. Heparin-binding epidermal growth factor expression in KATO-III cells after Helicobacter pylori stimulation under the influence of strychnos Nux vomica and Calendula officinalis. Homeopathy. Jul 2010;99(3):177-182.
17. Scherr C, Simon M, Spranger J, Baumgartner S. Effects of potentised substances on growth rate of the water plant Lemna gibba L. Complement Ther Med. Apr 2009;17(2):63-70.
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21. Bracho G, Varela E, Fernandez R, et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy. Jul 2010;99(3):156-166.
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Author: Clara Amaya, PhD, earned her M.Sc. degree in microbiology at the University of “Los Andes” in her home country, Colombia, in 1986. She then worked as an investigator at an industrial research laboratory, went to France and Germany to get trained in biotechnology, and, as an assistant professor, taught biotechnology and microbiology at the university level.
Upon her arrival in Canada in 1991, she worked as a technician, in microbiology research at the Botany Department of the University of Toronto, then went to the University of Guelph to pursue a Ph.D. in biochemistry. Postdoctoral work in enzymology and DNA microarrays at the Food Science Department of the University of Guelph was followed by research on the immunopathology of paediatric multiple sclerosis as a research assistant for the Departments of Biochemistry and Neurology. She then worked as clinic coordinator for the multiple sclerosis clinic at the Hospital for Sick Children.
Presently, with an honours D.H.M.H.S. from the Ontario College of Homeopathic Medicine, she proudly practices homeopathy, along with nutrition and Bowen Therapy, in Mississauga, Canada.
Fuente: Extraordinary Medicine
Fuente: Extraordinary Medicine
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