Words: Dr Clara LOPEZ-AMAYA
Homeopathy’s detractors, whether they are scientists, or not, always find arguments to deny the effectiveness of homeopathy, while arguing that homeopathic studies are flawed, trials in homeopathy do not comply with the scientific method, and homeopathic research studies are not good enough to always be published in prestigious scientific journals.
This article addresses such arguments by defining and discussing concepts and principles as conceived by homeopathy, or contrasted by conventional medicine. With the support of high quality published research, readers will be provided with real facts surrounding the topic.
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 the two 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. Evidence-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 the 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 randomised controlled trials [RCTs].
Here, the focus will be placed on RCTs, because this is the experimentation methodology used in evidence-based medicine, and also because we want to discuss it in the context of its utilisation in homeopathy.
Put simply, double-blind RCTs are experiments to test medicines and placebo [dummy, or plain sugar pills] in a blinded fashion, using a randomised 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.
Individualisation. 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 individualisation 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 favour of homeopathy, aside from 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. This is because the benefits of qualitative methods have been demonstrated in studies, such as early diagnosis in dementia, recovery, and the efficiency of RCTs. 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.
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.
For a homeopathic drug proving trial, a medicinal substance with unknown, or few known, medical applications are tested in a randomised 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 [an exhaustive index of homeopathic medicines and their symptoms], or Materia Medica, which details symptom-pictures of homeopathic remedies.
Clinical results will differentiate between the 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; on healthy volunteers] trial, using the present requirements for research under current drug regulations in Europe.
In brief, the study was a randomised, double-blind placebo-controlled Phase-1 trial, with 30 healthy participants. The homeopathic drug proving [HDP] study involved a base-line observation of seven days, an intervention period of five 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 12C, and sucrose globules, which acted as placebo, were used. Subjects took five globules, five times a day, for five 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 homeopathy’s founder Dr Samuel Hahnemann’s Organon, the landmark book on homeopathic philosophy. The secondary outcome parameters were qualitative differences in the profile of characteristic and proving symptoms. Proving symptoms were analysed using content analysis according to Mayring [or, adaptation to the homeopathic qualitative analysis method].
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 the placebo effect resulting from homeopathic trials is not higher than that obtained from conventional drug trials.
Good Evidence
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 pseudo-sceptics make to this is that the babies and 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 the role of homeopathic medicine in prevention? Homeopathic medicines have shown to be effective in the prevention of mastitis during the dry period of dairy cows. On the other hand, double-blinded RCTs in animals have shown superior effect of homeopathic medicines compared to placebo controls.
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 viruses; the inhibitory effect of homeopathic Nux vomica and Calendula officinalis on the gene expression of Helicobacter pylori; changes in the growth-rate of plants by homeopathic medicines; and, the in vitro activation of bone marrow cells by homeopathic preparations.
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 the 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.
More Evidence
Scientists exploring the mechanisms of how homeopathy works are extremely cautious about their comments, or prefer to remain silent, for good reason. Throughout history experiments suggesting theories that could support the effectiveness of homeopathy, such as ‘the memory of water,’ proposed in 1988, have been sabotaged, attacked and ignored.
Dr Jacques Benveniste, MD, the main investigator of this theory, lost his laboratory, his funding and his reputation. The Nobel laureate Dr Luc Montagnier, PhD, the co-discoverer of the HIV virus, was 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.
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 huge.
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 before it was published in the international peer-reviewed journal, Homeopathy.
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-sceptics [individuals without any knowledge of homeopathy, who dare to criticise 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?
Despite all of these obstacles, more and more evidence in the area of ultra-high dilutions has been published recently. Some particularly interesting publications are: a review that show preliminary evidence supporting the biologic effects of ultra-high dilutions; a study demonstrating that different high-potency homeopathic medicines, and different potencies of high-potency homeopathic medicines, can be distinguished from one another using spectroscopy; 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].
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-plus-year record of successful clinical results.
The inference is simple, also profound. Homeopathy serves humanity by curing acute and chronic conditions, including those considered untreatable by conventional medicine — safely, gently and permanently.
