Homeopathy always triggers strong feelings. This type of treatment is repeatedly attacked – but in most cases unobjectively – in the trade and lay press, and sometimes in television programs. The opponents bring up a lot of different arguments. The most frequently cited “counterargument” often is the issue of dilution: According to this argument, in homeopathy agents are often used whose dilution was so great that mathematically not a single molecule of the active ingredient could be left. In addition, the similarity principle that homeopathy is based on has been critically scrutinized.
In theoretical models and experimental approaches the mechanism of action, i.e., the principles behind the effect of homeopathic remedies, has been examined for years. A number of positive results were obtained without the general public knowing about them – which also may certainly be due to the lack of response by the media that is generally critical of homeopathy. In the next few years, it will be the task of homeopathy research to make these and other experimental findings that make the case for its efficacy more comprehensible using appropriate theories.
In addition to the experiments on the mechanism of action, for years numerous studies have also been conducted on the efficacy of homeopathic medicines. Critics often claim that there are no positive clinical trials on homeopathy, but this is just not true: There are now approximately 300 clinical trials, many of which were positive and provided evidence about the efficacy of the examined homeopathic remedies.
Below we will provide an overview of the most important theoretical models being discussed in homeopathy research, as well as of promising experimental research results and results from clinical research.
1. Explanatory models and theories on homeopathy’s mechanism of action
1.1 Biophoton theory
One explanation for homeopathy’s mechanism of action was offered by the biochemist and naturopath Dr. Karin Lenger, based on research on biophotons by Fritz-Albert Popp. His research is based on the assumption that weak, coherent (synchronous) photoradiation is given off by living cell systems. With homeopathic dilutions Lenger assumes that the effect is also based on the release of biophotons from the parent drug, whose strength increases with increasing dilution. According to Lenger, in the case of successful drug administration, this leads to a resonance phenomenon (vibration amplification phenomenon) between the biophoton frequency of the drug and the frequency in the body made out of balance by an illness. For measuring the drug frequency and the biophoton radiation from homeopathic remedies she has submitted three publications with experimental results in recent years.
1.2 Imprint theory, clustering and water memory
Simply put, memory of water (or of the homeopathic dilution medium such as a water alcohol mixture or lactose) is to be explained. The basis for this was created especially by the imprint theory suggested in 1967 by Barnard and Stephenson. The theory is based on the assumption that – despite increasing dilution – long polymer chains (chain-like chemical compounds), which come from the starting sub-stance, form in a specific manner in the dissolution medium depending on the particular parent drug. Under the umbrella of imprint theory, other storage mechanisms have also been discussed that are based on other effects, such as certain ordered states of the dipoles of the water.
Likewise, water cluster formation (lump formation) has also been discussed. It is assumed that water molecules form larger subunits – so-called clusters – due to their hydrogen bonding, and these subunits may be responsible for storage of information.
Also models have been suggested that combine the imprint theory with cluster formation. However, the extent to which water or water-alcohol mixtures form ordered structures at all, that are stable enough and exist for more than a split second, and thus may be responsible for the storage of homeopathic drug information, is again being increasingly called into question by new research results.
1.3 Quantum phenomena
With regard to homeopathy’s mechanism of action, there is repeated discussion of phenomena that are based on quantum effects or scientific ideas that were developed using quantum theory, a theory that goes beyond the conventional ideas of classical physics. For this purpose mathematical formalisms (formula systems) were developed by the theoretical physicists Dr. Harald Atmanspacher and Prof. Dr. Hartmann Römer and the psychologist and homeopathy researcher Prof. Dr. Dr. Harald Walach, but whose experimental implementation with regard to homeopathy continues to fail.
1.4 Nano research
In particular in the past few years there has been renewed in-depth discussion about whether, despite the many dilution steps for homeopathic high potencies, one can assume that there is actually a re-maining concentration of the starting material. It is claimed that studies using methods that have been developed in the context of nano-research have proven that above a certain dilution step a relatively constant concentration of the starting material in the form of nanoparticles (particles in the range of about 1 to 100 x 10-9 m) is established, which would support a material mechanism of action.
It is also being investigated whether it is possible that homeopathic-specific succussion after each dilution step is responsible for increasing the surface area of the diluting medium many times, for ex-ample, through the formation of nanobubbles so that the pharmaceutically active molecules can attach to the interfaces. Thus, significantly higher concentrations may be present in homeopathic remedies than previously assumed.
2. Experimental research on homeopathy’s mechanism of action
2.1 Experimental research on the similarity principle
The best known work currently on scientific evidence of the similarity principle stems from the two basic researchers Roeland van Wijk and Fred A. C. Wiegant. They examined the recovery process of cell cultures that were previously exposed to different cell toxins (arsenic and cadmium) or damaging heat. Primarily, the concentrations of stress proteins produced by cells as a response to damage were measured. Researchers were able to show that previously damaged cell systems recover faster when they are again confronted with the harmful substance in an attenuated form, either slightly reheated or treated with dilute arsenic or cadmium. These experiments provide the first indications of how the simi-larity principle can be preclinically (on the cell model) investigated and physiologically (regarding the biological processes) understood.
2.2 Experimental research on potentized remedies
Physical experimental methods
In recent decades, numerous experiments have been conducted to decode homeopathy’s physical mechanism of action. High-potency medicines were compared with placebo mainly using standard spectroscopic methods, to draw conclusions about physical differences. Significant results that were obtained with Raman and NMR spectroscopy (methods that examine the molecular structure with stimulation using laser light or magnetism), were successfully reproduced. The meta-study by Witt (2006) provides a detailed overview of the different experimental physical studies.
Research on living organisms
Likewise, statistically significant results with regard to the effect of high potency remedies were obtained with test systems that work with plant, animal and cell systems. In this case, the focus is less on how the drug works and more on whether it is possible to prove significant effects. The research teams led by Dr. Peter Christian Endler and PD Dr. Stephan Baumgartner have presented especially promising results.
Endler’s research primarily focuses on tadpoles, which are randomized (assigned randomly) to different groups and then treated differently in a blinded approach (the investigator does not know which group is receiving the drug and which the placebo). This amphibian model is based on the influence of the development of the tadpole into a frog by treatment with the thyroid hormone thyroxine, which accelerates the rate of transformation. Endler has conducted numerous trials, including trials with potentized thyroxine compared to placebo to impact the speed of metamorphosis (transformation). In another series of tests all the tadpoles were pretreated first with slightly diluted thyroxine and subsequently further treated with either placebo or potentized thyroxine. The aim of the research was to determine whether the administration of homeopathically prepared thyroxine cancels the accelerated transformation through material thyroxine. Endler et al. were able to show that the tadpoles treated with a homeopathic high potency actually developed more slowly than those treated with placebo.
The research group led by the physicist Baumgartner also expended great efforts on experimental research. Their focus is on ultra-high dilutions: on the one hand in physical studies, on the other, their effects on in-vivo test systems. Very plausible results that support the impact of highly potentized ho-meopathic preparations were obtained with a test system consisting of duckweed cultures, a standard system in ecotoxicology (research on environmental toxins). Since then, several experiments have been carried out with this test system, such as the measurement of the influence of potentized plant hormones (gibberellins) on the growth of duckweed. Likewise, an attempt was made to treat deficient duckweed (calcium, iron or magnesium deficiency) with potentized remedies. In the case of calcium deficiency clear effects of homeopathic potencies on plant growth are observed.
The results published in 2009 by Bellavite also support the impact of homeopathic high potencies. This involved an experiment in which the activity of the mice was tested. Mice that were treated with gel-semium, showed significantly more active behavior towards placebo-treated mice.
3. Clinical research on the efficacy of homeopathy
As was already mentioned at the beginning, in recent years around 300 clinical trials have been con-ducted with homeopathic remedies. Nevertheless, the study design, the homeopathic treatment ap-proach and also the remedies used differed greatly among them. In evidence-based medicine it is common to evaluate multiple trials investigating one treatment approach in overview articles, referred to as reviews, in the form of a meta-analysis. This means that the number of patients or individual results from each study are summarized and evaluated, based on specified statistical criteria in their entirety. This has also been done in the past for clinical trials of homeopathic medicines. The approaches thus taken and the problems associated with them, is shown in the following.
To research clinical studies with homeopathic remedies and further literature, consult the CAM-Quest database by the Karl and Veronica Carstens foundation: www.cam-quest.org
3.1 Different treatment methods make comparisons difficult
A general problem of clinical homeopathy research is that positive study results are regularly disqualified because the study quality would not meet accepted standards; with negative results, however, the efficacy of the entire treatment direction is called into question in general, although “homeopathy” is not a uniform method of treatment. In "traditional" or "classical homeopathy,” in which the accurate history (medical history and symptoms) of the patient is an essential part of treatment, the medicines are, for example, individually selected: Consequently, the examination of the method according to current standards of clinical research becomes a challenge, since a particular disease is not treated in a large patient group with the same medicine. In addition, there are many other homeopathic treatment methods, such as complex homeopathy, which are more accessible to the standards of clinical research. Correspondingly, the current study situation is just as complex.
3.2 Review articles on the status of clinical research
In overview articles, referred to as reviews, on the status of clinical homeopathy research, the question being discussed in the past was mostly based on whether homeopathic remedies work at all, regardless of the type of drug, the treatment method or the particular indication (disease). Thus, a wide variety of clinical studies with homeopathic remedies were considered together, without making any distinctions. Just as controversial are the major reviews that were done on homeopathy and were widely published.
For example, K. Linde et al. published a meta-analysis in 1997, in which 89 placebo-controlled studies (testing a medicine compared to placebo) were evaluated in the internationally known medical journal “The Lancet.” The result of the meta-analysis was that homeopathy was statistically proven superior to placebo. R. Mathie, who analyzed 79 studies in 2003, and M. Dean (2004), who included 205 home-opathy studies in his analysis had likewise positive results establishing the efficacy of homeopathy.
A furor was caused by the 2005 overview study by Shang et al., also published in the “The Lancet,” that compared 110 placebo-controlled homeopathy studies with 110 comparable studies of conventional treatment. Even if ultimately only 8 homeopathy studies and 6 conventional treatment studies were considered good enough to be evaluated by the authors, the negative result of the analysis for homeopathy was pronounced the “end of homeopathy” in the media, because, according to them, the lack of efficacy for homeopathy had finally been scientifically proven. The methodology of Shang et al. and the approach of the study was then heavily criticized by many sources. There is further heated debate about which methods from evidence-based medicine can be used for homeopathy and the extent to which these do justice to homeopathy.
3.3 New approaches
Now the trend in assessing clinical studies is to no longer test “homeopathy“ as a whole, but rather to perform smaller meta-analyses on specific indications, as makes sense, because this will provide clearer results. And there are some positive meta-analyses on the efficacy of homeopathy for specific medical conditions. For example, the meta-analysis by Taylor et al. and the one by Lüdtke and Wiesenauer support the efficacy of homeopathic treatments for hay fever. In addition to these meta-analyses there are several other positive analyses, such as for the homeopathic treatment of fibromyalgia or life-threatening diarrhea in children.
Building on the knowledge that the individualized treatment especially in the field of classical homeopathy can only be reproduced with difficulty using the usual standards of evidence-based medicine, attempts are increasingly being made to demonstrate the efficacy of homeopathy using health services research methods. The long-term treatment success of homeopathically treated patients is investigated in what are referred to as outcome studies. The largest outcome study that included about 4,000 patients was published in 2005 by Witt et al. Generally such studies demonstrate that the health of patients can be significantly improved with homeopathic treatments, and often in the case of chronic diseases the use of conventional drugs can be reduced or even completely avoided. Critics of homeopathy however attribute these successes exclusively to placebo effects.
4. Outlook for clinical research
In general, it is clear that the current state of research on the efficacy of homeopathic remedies or therapies is significantly better than is often alleged by critics. There is abundant scientific literature that supports the efficacy of homeopathy. Although the number of several hundred studies at first glance seems like a lot, it is still minuscule compared to the number of published clinical studies for conventional treatments. In this case it is important to address the positive results already obtained; to verify and expand on them. To do this, though, clinical homeopathy research is in need of more financial support.
The main problem is that clinical homeopathy research has thus far been almost exclusively financed through funds from complementary medicine foundations or by homeopathic medicine manufacturers. In other words, there has been no systematic research of the clinical efficacy of homeopathic remedies supported by public research money. Accordingly, many homeopathy studies are accused of lacking quality, since they are often not carried out in the same dimensions (e.g., number of participating pa-tients and clinics) as the conventional pharmaceutical research studies. However, because in the field of complementary medicine remedies the profit margin is significantly smaller than with many conventional medicine products, for which a package of a patented drug regularly costs several hundred euros, and, additionally, no patents may be submitted for homeopathic remedies, only limited resources for clinical research are provided by pharmaceutical manufacturers. There are relatively few resources, especially in the field of basic research on the mechanism of action of potentized remedies. High-quality and large-scale studies, as demanded by critics, however, depend on a large budget of > EUR 5,000,000. In addition, allegations that the so-called “homeopathy lobby” are influencing the study results may be difficult to refute, as long as the sponsors of homeopathy research consist exclusively of complementary medicine-oriented foundations and homeopathic pharmaceutical manufacturers.
But because the acceptance of homeopathy in the population is very high, as several surveys have shown, and studies of health services research in homeopathy attest to positive effects, it should also be in the public interest to support this research increasingly using public research funds.
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