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First a reply to some of the subjects discussed before.

John and Lionel, here is something that may answer the conundrum of Aristotelian views as opposed to Bacon´s.

THE POWERFUL PLACEBO

Van Wijk and Wiegant (1997) examined the validity of the similia principle. With their research they showed that ‘if low doses of harmful conditions are administered according to the similia principle the capacity for survival (expressed in terms of development of tolerance) is stimulated at cellular level and protector proteins are also stimulated.’ The research gives an important indication of a regulatory mechanism on which the similia principle is founded. Eskinazi (1999) expounded on the scientific state of affairs with regard to the theoretical objections to homeopathy. With modern insights there is little left of the theoretical objections. First the objection to the theory that pathogenic substances can also cure. The author gives and extensive list of examples in which this principle also applies in conventional medicine. This principle has also now been recognised in cellular biology and is known as hormesis. The most surprising thing is that it was a conventional scientist who removed the objection to high dilutions.
Recent articles by two research groups have raised doubts about the scale and even about the existence of the placebo effect. Kienle (1995) carried out a critical analysis of Beecher’s fundamental research, which produced the initial concept of the ‘Powerful Placebo’. She describes a multitude of weaknesses in these studies and demonstrates that all Beecher’s so-called proofs of the placebo effect could have other explanations. From an entirely different point of view, Danish researchers Hrobjartsson and Gotzsche (2001) reviewed 130 clinical trials in which a placebo was compared with an experimental treatment.
They concluded on this basis that is was unlikely that the so-called placebo effect could lead to significant changes in the parameters of physical diseases, but that it can lead to significant changes in psychological disturbances, such as anxiety. Given the notion that a placebo is in essence a psychological phenomenon (for example, the thought and feeling that you are receiving something which will probably help), the researchers’ conclusion that placebos only have a significant psychological and not a physical effect, is understandable.

Ontological Reductionism

Based on the arguments raised above, it is clear that the theory of ontological reductionism fails on internal and external conceptual grounds, as well as empirical grounds. It is also demonstrated that there is evidence of a working mechanism underlying the similia law. Finally it is clear that the alternative explanation – i.e. the placebo effect – for a subsequent effect in studies on the effect of a homeopathic treatment, is unlikely.
This disposes of the theoretical obstacle to the acceptance of homeopathy, namely that a homeopathic treatment cannot be effective because the working mechanism is not compatible with recognised scientific, in this case, biological, chemical and pharmacological, theories and insights.
Furthermore there is the discovery that many scientific facts argue in favour of the theory of ontological holism. This raises the question of why it is not more widely embraced as a theory in science. In my view this is due to the deep-seated belief that effects in nature can only be attributed to material phenomena. Many people are unaware that this belief was not held throughout the majority of human history.
From Plato (427 - 347 BC) and Aristotle (384 - 322 BC) to the Middle Ages however the notion has existed in scientific history that there is a world of ideas, which, as causal principles, give shape to things in nature. These ideas or universals were seen as complex, differentiated systems of forces which gave an organism such as a plant or a human being its shape and enabled it to keep it. Both Plato and Aristotle maintained that such causal principles existed, and that they could be known and understood: according to Plato, by looking in thought into a spiritual world of ideas and according to Aristotle by turning one’s sights on the world of the individual things (Hartmann, 1941; Kienle, 1998).
In the medieval debate on universals, this world of ideas was not denied, but Realists and Nominalists argued about whether man could know these causal principles. The debate was eventually won by the Nominalists and the question was answered in the negative.

Francis Bacon´s ‘Novum Origanum’

The next historical milestone was the work of Francis Bacon in the 17th century. Bacon argued in his ‘Novum Origanum’ that the task of the scientist should not be the broad sweep of ideas, but careful observation and experimentation. A final phase in this historical development came in the second half of the 19th century and the start of the 20th century. In this period, following on from the previous historical views that man could not know the causal principles of forms (universals debate) and that it was not the task of the scientist to know these principles (Bacon), the existence of this body of causal principles was denied. Rudolf Virchow (1907) summarised the biological and medical view of his time as follows:

‘Modern medicine has defined its view as mechanical, its aim as establishing a physics of organisms. This has shown that life is merely an expression of a sum of phenomena each of which proceeds sepa-rately according to the normal physical and chemical (that is to say mechanical) laws. It denies the existence of an independent life force and natural curative power.’
(Virchow R. ‘Cellular Pathology.’)

HISTORICAL DENIAL

This summary conclusion illustrates the historical steps, which led to the gradual denial of the existence of causal principles and the reduction of the cause of natural phenomena to the functioning of material particles. Causal-mechanistic or ontological reductionist thinking is an expression of this development. We have demonstrated above that this theory is not tenable on a number of grounds. To arrive at a reasonable alternative we have to look more closely at the question of causality.

The Perfect Shot

If an experienced tennis player hits a perfect shot at Wimbledon there is, at the physiological level, a sequence of biochemical reactions in time. In this case there must be a transfer of information, which causes all the biochemical steps in time to be attuned to each other so that ultimately the entire process of preparation and execution lead to the ball hitting exactly the right place at exactly the right time. We could call this a ‘time Gestalt’.
In a general sense all this applies afresh to a subsequent but different perfect shot in another place. However, since this is another type of shot there is a different ‘time Gestalt’. In this ‘Gestalt’ we can distinguish two causal layers: a vertical and a horizontal layer. In the horizontal layer there seems at first sight to be a cause-effect chain because, for example, increasing the hormone level leads to an increase in the glucose level in the blood. Each preceding ‘cause’ in time leads to a subsequent ‘effect’ in time.
However, on further consideration there is a problem here, which was previously identified by Bertrand Russel. That is that an effect which precedes something in time, no longer exists when the effect occurs. The cause has already disappeared. How can a cause, which no longer exists, bring about an effect? (Kiene, unpublished).
To solve this problem the scientific literature turns to the concept of ‘information’. The information is supposedly transferred from one stage to the following stage. This brings us to the second, vertical, layer of causality. In the case of the perfect shot, but also in other self-regulatory skills, and the self-organising physiological processes which can only be understood in terms of the species, there is a hierarchically higher-ranked principle that provides the coherence between, say, biochemical stages in time, but which also provides the context for the object of all the processes as a whole, namely performing this specific tennis shot at this moment or creating this specific tissue structure. The principle also provides an explanation for the transfer of information between the various stages in time in the horizontal causality layer. This higher-ranked principle is not immediately perceptible to the senses, but is manifest in bringing coherence in time and space.
Homeopathy and also anthroposophic medicine assume this sort of higher-ranked and forming principle in nature. The pharmaceutical processes used in these forms of complementary medicine, are aimed at releasing these forming or in-form-ing principles from matter, which is set in time and space. In this way these matterless forming forces can be used as medication. From this point of view it is also conceivable that there are medications in which no material molecules remain.

Views: 320

Replies to This Discussion

B/ Last, but not least, the human studies were considered.

B.1) A second G.I.R.I. working group was dedicated to clinical research, and particularly considered the issues of individuality and complexity.
Evidence Based Medicine (EBM) gives first priority to “Therapeutic Effects Testing” (TET), starting from the work of basic scientists in laboratories up to clinical researchers doing Randomized Clinical Trials (RCTs), and finally reviews or meta-analyses of several RCTs.
The achieved level of TET determines the level of EBM for a medicinal product. “Clinical Use Testing” (CUT), starting with case reports, epidemiological outcomes and cost-benefit studies, is only interesting for public health authorities and patients but it is never sufficient to reach EBM. No real bridge exists between these two ap-proaches.
Evidence Based Homeopathy (EBH) starts and ends with the individualized patient. It can be represented as the arch of homeopathy: at one side there is the examination of the patient, and at the other side the therapeutic instrument. In order to understand the patient, we must consider his totality in time and space to be able to understand his basic vulnerability, latent or manifest. This totality must be qualitatively modalized with chronological assessment to get the Minimal Syndrome of Maximal Value. The therapeutic instrument can be self-healing (no syndrome, no medication), or management of life-style or nutrition in order to avoid obstacles to cure. A homeopathic remedy can be considered after study of its physico-chemical characteristics, its toxicology, its usual therapeutic use: this is the first step, the hypothesis.
The second step is the probability by a first “proving” (blinded protocol) on healthy volunteers; third is the confirmation by further “provings”; fourth is the corroboration by physio-pathological study; and last is the clinical verification in daily practice. For the remedies we must have the same qualitative assessment as for the patients. But the keystone of the whole homeopathic process, without which the arch will crumble, is the Law of Similars. Research in homeopathy must be concentrated on qualitative “proving” on healthy volunteers and clinical verification in daily practice. Therefore after many years of studies, our first priority must be systematic clinical files collection (CLIFICOL project). The Bayesian statistic, a statistical approach (likelihood ratio), can help establishing a scientific base for our symptoms’ repertories. This approach was presented by Dr Lex Rutten from The Netherlands.
Can one get over the gap that exists between EBM and EBH?
B.2) Dr Harald Walach, University of Freiburg, presented an overview of the already published papers.
Homeopathy is certainly popular (used by 50% of the population in France) and is historically successful, both individually (by Fieldmarshall Radetzky, Paganini, etc.) and generally (in cholera and other epidemics all over Europe). Homeopathy remained effective in the face of adversaries and is growing despite (or because of?) modern medical technology.

The Latest Publications

Looking only at the latest publications and using validated Quality of Life questionnaires (between 2000 and 2004), 6915 patients presented clinically significant improvement (approximately 70% of cases; more in children). Homeopathy reduced costs and allowed a better improvement in work-days lost compared with conven-tional practice. For specific diagnoses such as bronchial asthma (89% improvement; even better after 2 years), cancer patients in palliative care (improvement of quality of life, fatigue and anxiety but not pain), hyperactive children (after 3 months, 75% improvement versus 65% for conventional treatment), URTI (67.3% improvement with homeopathy, 56% with conventional treatment; side effects 7.8% homeopathy versus 22% conventional), homeopathy is at least as effective as conventional thera-pies, but costs are lower and the safety of homeopathy is greater.

The Efficacy Paradox

On the other hand, an “efficacy paradox” can be acknowledged. Using the hierarchy of evidence, for conventional medicine the RCT is of the highest value – the best rigour and internal validity – but it has a low applicability score, a low external validity and its conclusions are generalized with great difficulty. On the contrary the applicability of case series is great, showing a high external validity and its conclusions generalized easily. RCT implicitly tests the placebo hypothesis; the question is only: “Is the homeopathic therapy different from placebo?” It presupposes a local-causal model of homeopathy, that the physical presence and “information” of a remedy is decisive (without considering the “receiver” health status), and that a “true” effect would be detectable through replication. It is apparent that discrepancies exist regarding homeopathy in daily practice and the RCT approach.

Nevertheless RCTs have been performed and meta-analyses of these studies have concluded that there is clear evidence of efficacy in favour of homeopathic treatments that cannot be attributed only to a placebo effect (Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Lancet 1997; 350: 834-43 and Dean M.E. Hans Walz Preisschrift, Essen:KVC Verlag, 2004.) For some specific diagnoses, the same level of evidence has been reached: rheumatoid arthritis (6 studies); childhood diarrhoea (3 studies); postoperative ileus (8 studies); hayfever, asthma (4 studies). For migraine, results of RCTs are disappointing. In children, using comparison groups, significant results are obtained for recurrent infections, post-operative agitation, adenoids, otitis media, and stomatitis in patients with cancer (complication of the conventional treatment). There are promising pilots studies on low back pain, premenstrual syndrome and chronic fatigue.

The problems with RCTs are:

• they are difficult to replicate (true also for conventional treatment: only 48% of all
SSRI studies are significant);
• they are invasive and expensive, inducing lack of interest due to a lack of funding;
• blinded RCTs answer only the placebo question;
• they make unwarranted presuppositions.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004. Scientific Report.

The Activity Of Very High Dilutions

First question addressed: The activity of very highly diluted preparations.
Homeopathic practitioners will argue that the use of preparations that are diluted beyond Avogadro’s number (i.e. potencies greater than C10) happens in only 25% of the prescribed homeopathic medications. Nevertheless, for some people this question is the most important obstacle to the acceptance of homeopathy.
A/ The experimental model that is cheapest, most reproducible and also the most easily researched is probably the “acetylcholine-induced contraction of the rat ileum”. It is a wellrecognized scientific model (Chang FY, Lee SD, et al. Rat gastrointestinal motor responses mediated via activation of neurokinin receptors. J.Gastroenterol Hepatol 1999; 14: 39-45).
This model has been devised for the verification of very high dilutions of Belladonna by A. Cristea, a Romanian researcher; results have already been published (Bastide M (ed). Signals and Images. Kluwer Academic Publishers 1997: 161-170).
Professor Wolfgang Suess, Institute of Pharmacy at the University of Leipzig, has used this model to test the transfer of the activity of a homeopathic remedy (in this case Atropinum sulphuricum D60) from the original liquid form to the homeopathic tablet. As usual, several controls were performed. Alpha-lactose monohydrate tablets impregnated with the highly diluted Atropinum had systematically efficacy, on the contrary with anhydrous alpha-lactose tablets no effect can be ascertained. Thus, the quality of homeopathic tablets can be tested before daily use in pharmacy (constant reproducibility). This very simple model therefore has the potential to remove doubts about the activity of very highly diluted homeopathic remedies (Schmidt F, Suess WG, Nieber K. In-vitro Testung von homöopathischen Verduennungen. Biol.Med./Heft 1/February 2004;32-37).

B/ It has taken much more time for another model to be accepted by the scientific community. The first publications appeared in 1991 but it is only in 2004, after an international cooperation, that the results have finally been accepted in a high-standard peer-reviewed journal, Inflammation Research. This model is different from the Benveniste model; he used the same control but not the same activator.

Protocols and Results

Professors Marcel Roberfroid and Jean Cumps of the Institute of Pharmacy at the University of Louvain, who respectively coordinated the European multi-centre (4 centres) trial and performed the statistical analysis, explained the protocols and discussed the results. The work demonstrates a significant inhibition of human basophil degranulation, as measured by alcian blue staining, by high dilutions of histamine (10-30 – 10-38 M). This multi-centre research has subsequently been confirmed in three laboratories by applying flow cytometry analysis and in one laboratory by measuring histamine release. Even if, at present, the molecular theory cannot explain these findings, the facts remain indisputable as recognized by the editor of Inflammation Research. (Belon P, Cumps J, Ennis M, Mannaioni PF, Roberfroid M, Sainte-Laudy J, Wiegant FAC. Histamine dilutions modulate basophil activation. Inflamm. Res. 2004; 53: 181-188.)

C/ Research on high dilutions has existed since the 1950s, but the number and quality of publications has increased in the last decade. Reviews and meta-analyses have even been performed but often ignored or even denied (see COST B4 supplement report EUR 19110 ISBN 92-828-7434-6). This research is not encouraged and even deemed inadvisable by academic authorities.
Professor Jean Cambar, Dean of the Faculty of Pharmacy at the University of Bordeaux, described the most important models that have been published previously in international journals, confirming the effects of very highly diluted homeopathic preparations.
The efficacy of very high homeopathic dilutions of human or animal natural molecules (also called endogen molecules) has been published several times in prestigious journals. Examples include the following:

International Journal Publications

Int J Immunotherapy 1987; 3: 191-200 (Thymulin in mice. Bastide M);
Int J Immunopharm 1990; 6: 211-214 (alpha/beta interferon, Carriere V);
J Vet Human Toxicol 1995; 37(3): 259-260 (Thyroxine, Endler PC);
Int J Immunopathol Pharmacol 1996; 9: 43-51 (Bursin, Youbicier-Simo BL).
During this meeting Dimitris Zienkiewicz, immunologist at the University of Edinburgh, presented preliminary findings assessing, by immunosorbent assay and flow cytometry, the alteration in activation and function of dendritic cells that comes about as a result of their treatment with homeopathic dilutions of a bacterium. Dendritic cells play an instrumental role in both activation and regulation of the immune system. Systematic changes in the profile of cytokines IL-10, IL-11 and IL-12 cannot be explained by the molecular theory.
Efficacy of very high homeopathic dilutions using pharmacological models has also been published in peer-reviewed journals. Examples include the following:
Thrombosis. Res. 1994;76: 225-229 (Acetylsalicylic acid in a vessel model. Doutremepuich C);
Haemostasis 1990;20: 99-105 (Acetylsalicylic acid in healthy volunteers. Doutremepuich C);
Thrombosis. Res.
1987; 48: 501-504 (Acetylsalicylic acid in healthy volunteers, Doutremepuich C).
The longest-used model, published frequently all over the world, is the toxico-logical model (Arsenic, Phosphorus, Mercury, Cadmium, Cisplatina, Glutamate, Cuprum sulphate, etc). It can be applied to vegetable, animal, cell culture material or even clinical studies. This model is still used and indeed is the theme for a collaboration between the Universities of Bern and Bologna, testing homeopathic arsenic trioxide treatments by plant-based bioassays. The working variables are the germinated seeds or the stem length on the seventh day. At least 6 recent experiments by this team are published (Dr Lucietta Betti. DISTA-Department of Agro environmental Science and Technology, University of Bologna.).
Experiments are well conducted, in controlled conditions, with a sufficient number of plants, animals or cells, and with a fair statistical treatment. The facts are indisputable, statistically significant and reproducible, even if they cannot be explained using the molecular paradigm.

The Content Of Very High Dilutions

• Second question addressed: The content of very highly diluted homeopathic preparations.
Professor Jean Cambar introduced the theme by asking what are the contribu-tions of the different spectroscopies (Raman, Ultraviolet, X-ray or Magnetic Nuclear Resonance) in revealing the structure of water and solvents in high dilutions? What is the real relevance of Avogadro’s number in evaluating the precise pattern of molecules? Can a dilution work without any molecule? One of the most innovative perspectives in this last decade was the demonstration that high dilutions have as much activity and effectiveness in an organized structured solvent without any solute molecule as they do when molecules are present (even only some molecules).

Professor Louis Rey, Doctor of Sciences, Lausanne, a specialist in low temperature thermoluminescence, has published on this topic in the international journals Nature (1988; 391: 418) and C.R.Physique (2000; 1: 107-110). He presented the latest results of the experiments he carried out together with Dr. Philippe Belon on the thermoluminescence of ultra-high dilutions of lithium chloride and sodium chloride. Ultra-high dilutions of lithium chloride and sodium chloride (10-30 g cm-3) were irradiated by X- and gamma-rays at 77K, then progressively re-warmed to room tem-perature. During that phase, their thermoluminescence was studied and it was found that, despite their dilution beyond the Avogadro number, the emitted light was specific of the original salts dissolved initially. Much to the authors’ surprise, the experimental results showed, without ambiguity, the specificity of the contained information. The findings proved to be reproducible in the course of many different identical experiments. As a working hypothesis, the researchers propose that this phenomenon results from a marked structural change in the hydrogen bond network initiated at the onset by the presence of the dissolved ions and maintained in the course of the dilution process, and probably due to the successive vigorous mechanical stirrings. (Physica 2003; A323: 67-74).
Professor Guadalupe Ruiz-Vega, Universidad Michoacana de San Nicolás de Hidalgo, Morelia, Mexico, presented her most recent publications in the field of thermodynamics. She was able to demonstrate the biological effect of two ultra-low dose compounds. (Publication in process.)
The use of modern techniques in the hands of specialists is the best way to show sceptics that the experimental facts are well grounded and confirmed by reproducible experiments. Even in ultra-molecular homeopathic dilutions, specific informa-tion of the prime dissolved substance still remains in the preparation and can be detected experimentally.
Very informative..our physiological system has 70% wt just because of water molecules. This hydration plays very active role in maintaining the active structure of all the biomolecules in a precise manner. This concept holds to be true even for homeopathic medicines as chemical ligands inside the body. When any molecule comes in contact with water then there must be structural change in both the molecules, that is water network and participating ligand molecule. Homeopathic medicines differ in dilution highlights another important, that is concentration..lower potencies are more concentrated than the higher potencies of lower concentration. During molecular interaction..it is quite possible that higher concentration or lower potencies being highly concentrated contain the drug molecules in multimer form while on successive dilution or lower concentration or higher potencies contain the same drug as monomer. If structurally both multimer or monomeric states of any compound being compared then there must be the lots of differences in all properties whether chemical, biological, biophysical etc..that may be the possible reason of different effect of the same drug.
• The final question addressed:

The Clinical Effects of Homeopathic Preparations.

An experimental design is only relevant if it takes into account the observed phenomenon within its specific framework and if the subject addressed can be isolated of all external influences. Considering human medicine, the psychological factors are responsible for non-specific effects and the medication effects are called specific effects. Whatever the research model, taking into account the homeopathic approach, the idiosyncratic symptoms (specific to the patient) must be considered excluding pathognomonic symptoms.
A/ Professor Leoni Bonamin, Paulista University (São Paulo) and president of G.I.R.I., reviewed studies in veterinary homeopathy. Such studies are relevant for homeopathy because it is easier to isolate the effects of the treatment: the placebo effect is almost nil and there are fewer ethical considerations. Moreover, studies in well-defined herds and features can include a very homogeneous sample from a large number of animals. Nevertheless, the rules for well-designed studies must still consider the particularities of homeopathic research as regards the Similia principle (considering idiosyncratic symptoms).
Veterinary studies are very important for organic farming regulation. In Europe, only homeopathic treatments are authorized for biological farming. The use of homeopathy is aimed at avoiding chemical residues in the food chain. More institutional support is certainly needed.
In recent studies, the use of homeopathic complexes has been tested with very good results using parallel placebo groups, blinded design, homogeneity of samples with sufficient animals, and a protocol that is easy to manage in the farming context.
Filliat C. Particularité de l´utilisation de l´homéopathie en production avicole. Annals of the “Entretiens Internationaux de Monaco 2002”, 5-6 October 2002. http://www.giriweb.com.

The use of homeopathic complex reduced the incidence of haematomas in turkeys during transportation by about 30%.
Riaucourt A. L´Exemple de la Filière Porcine. Annals of the “Entretiens Internationaux de Monaco 2002”, 5-6 October, 2002. http://www.giriweb.com. The use of a complex (with endogenous and exogenous substances) to improve oestrus manifes-tation in female pigs induced a reduction of the repetitions of inseminations and semen loss.
Veterinary studies are also useful for questioning homeopathic study design. Using the model of psychogenic dermatosis in dogs and cats (Torro, et al. In press), six months of treatment with the simillimum shows 70% success. One year after finishing the treatment there was no recurrence. The entire study duration is six years. The very long efficacy of the homeopathic treatment is a reason for questioning cross-over design.
Because veterinary pathogenetic studies are very rare, veterinarians often need to do extrapolations from human pathogenesis and their Materia medica is based on classical studies performed in humans.

Research Protocols in Experimental Animals.

For example, the effects of nosode (isopathic homeopathic remedy) versus allopathy and similar homeopathic remedy using as model the experimental urinary infection of rats (Gonçalves et al. O uso da homeopatia no tratamento da infecção urinária em ratas. Anais do VIII SINAPIH; 20-22 May, 2004: p.25-26. http//climed.epm.br/sinapih/index). This study compares nosode from individual or collective samples. It is a blinded study; the presence of E. coli in gall bladder of rats is evaluated after 12-16 days of treatment: Untreated control, 100% of bacteria colonies (no spontaneous healing), second control is the vehicle (alcohol 5%) 94%, comparison group treated with Antibiotic (levokinolone) 33%*, treated group with nosode from a pool of urines (30D) 73%*, treated group with a self-nosode (30D) 39%*, and treated with a similar homeopathic remedy Phosphorus 30CH (the incorporation of rats in this group happens observing their individual behavior) 22%* (* Fisher test, p=0.05). With such studies it is possible to evaluate some homeopathic parameters such as the criteria for the choice of the best homeopathic dilution. The general rule is to use high potencies for chronic/mental disturbances and low potencies for acute/organic disturbances. The antidepressive effect of Hypericum perforatum in rats was better in 200CH than in 30CH: tested by the Porsolt forced swimming method (Goulart et al. Avaliação dos efeitos de Hypericum perfora-tum (Hp) dinamizado homeopaticamente em comportamento de ratos. Anais do VIII SINAPIH, 20-22 May 2004: p.14. http//climed.epm.br/sinapih/index); this was a blinded, well designed study.
Experimental animal studies have limited application to veterinary or to human homeopathy. Veterinary studies minimize placebo effects and confirm the efficacy of homeopathic treatments. Experiments in laboratory animals help improving research design in homeopathy.
Human Studies

B/ Last, but not least, the human studies were considered.
B.1) A second G.I.R.I. working group was dedicated to clinical research, and particularly considered the issues of individuality and complexity.
Evidence Based Medicine (EBM) gives first priority to “Therapeutic Effects Testing” (TET), starting from the work of basic scientists in laboratories up to clinical researchers doing Randomized Clinical Trials (RCTs), and finally reviews or meta-analyses of several RCTs.
The achieved level of TET determines the level of EBM for a medicinal product. “Clinical Use Testing” (CUT), starting with case reports, epidemiological outcomes and cost-benefit studies, is only interesting for public health authorities and patients but it is never sufficient to reach EBM. No real bridge exists between these two ap-proaches.
Evidence Based Homeopathy (EBH) starts and ends with the individualized patient. It can be represented as the arch of homeopathy: at one side there is the examination of the patient, and at the other side the therapeutic instrument. In order to understand the patient, we must consider his totality in time and space to be able to understand his basic vulnerability, latent or manifest. This totality must be qualitatively modalized with chronological assessment to get the Minimal Syndrome of Maximal Value. The therapeutic instrument can be self-healing (no syndrome, no medication), or management of life-style or nutrition in order to avoid obstacles to cure. A homeopathic remedy can be considered after study of its physico-chemical characteristics, its toxicology, its usual therapeutic use: this is the first step, the hypothesis.

Double Blind Protocol

The second step is the probability by a first “proving” (blinded protocol) on healthy volunteers; third is the confirmation by further “provings”; fourth is the corroboration by physio-pathological study; and last is the clinical verification in daily practice. For the remedies we must have the same qualitative assessment as for the patients. But the keystone of the whole homeopathic process, without which the arch will crumble, is the Law of Similars. Research in homeopathy must be concentrated on qualitative “proving” on healthy volunteers and clinical verification in daily practice. Therefore after many years of studies, our first priority must be systematic clinical files collection (CLIFICOL project). The Bayesian statistic, a statistical approach (likelihood ratio), can help establishing a scientific base for our symptoms’ repertories. This approach was presented by Dr Lex Rutten from The Netherlands.
Can one get over the gap that exists between EBM and EBH?
B.2) Dr Harald Walach, University of Freiburg, presented an overview of the already published papers.
Homeopathy is certainly popular (used by 50% of the population in France) and is historically successful, both individually (by Fieldmarshall Radetzky, Paganini, etc.) and generally (in cholera and other epidemics all over Europe). Homeopathy remained effective in the face of adversaries and is growing despite (or because of?) modern medical technology.

The Latest Publications

Looking only at the latest publications and using validated Quality of Life questionnaires (between 2000 and 2004), 6915 patients presented clinically significant improvement (approximately 70% of cases; more in children). Homeopathy reduced costs and allowed a better improvement in work-days lost compared with conven-tional practice. For specific diagnoses such as bronchial asthma (89% improvement; even better after 2 years), cancer patients in palliative care (improvement of quality of life, fatigue and anxiety but not pain), hyperactive children (after 3 months, 75% improvement versus 65% for conventional treatment), URTI (67.3% improvement with homeopathy, 56% with conventional treatment; side effects 7.8% homeopathy versus 22% conventional), homeopathy is at least as effective as conventional thera-pies, but costs are lower and the safety of homeopathy is greater.

On the other hand, an “efficacy paradox” can be acknowledged. Using the hierarchy of evidence, for conventional medicine the RCT is of the highest value – the best rigour and internal validity – but it has a low applicability score, a low external validity and its conclusions are generalized with great difficulty. On the contrary the applicability of case series is great, showing a high external validity and its conclusions generalized easily. RCT implicitly tests the placebo hypothesis; the question is only: “Is the homeopathic therapy different from placebo?” It presupposes a local-causal model of homeopathy, that the physical presence and “information” of a remedy is decisive (without considering the “receiver” health status), and that a “true” effect would be detectable through replication. It is apparent that discrepancies exist regarding homeopathy in daily practice and the RCT approach.

Meta Analyses

Nevertheless RCTs have been performed and meta-analyses of these studies have concluded that there is clear evidence of efficacy in favour of homeopathic treatments that cannot be attributed only to a placebo effect (Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Lancet 1997; 350: 834-43 and Dean M.E. Hans Walz Preisschrift, Essen:KVC Verlag, 2004.) For some specific diagnoses, the same level of evidence has been reached: rheumatoid arthritis (6 studies); childhood diarrhoea (3 studies); postoperative ileus (8 studies); hayfever, asthma (4 studies). For migraine, results of RCTs are disappointing. In children, using comparison groups, significant results are obtained for recurrent infections, post-operative agitation, adenoids, otitis media, and stomatitis in patients with cancer (complication of the conventional treatment). There are promising pilots studies on low back pain, premenstrual syndrome and chronic fatigue.

The problems with RCTs are:

• they are difficult to replicate (true also for conventional treatment: only 48% of all
SSRI studies are significant);
• they are invasive and expensive, inducing lack of interest due to a lack of funding;
• blinded RCTs answer only the placebo question;
• they make unwarranted presuppositions.
Sorry people, the last post of these GIRI reports appeared first
Homeopathy: Overview Of Human Clinical Trials

Historical review of the main publications
A number of large-scale studies designed to evaluate the huge amount of homeopathic literature have been conducted, especially in the last 10 years.
Organisations and institutes of great international prestige and importance have dealt with the issue of homeopathy. All of them have concluded that homeopathy possesses therapeutic efficacy. The characteristics of these studies are briefly summarised below.
In 1991, J. Kleijnen et al. in the Netherlands evaluated 107 homeopathic clinical trials on the basis of a number of evaluation criteria also used in allopathic clinical trials (Kleijnen J. et al. – Clinical trials in homeopathy. British Medical Journal, 1991; 302:316-323). They selected 22 of these trials, which they judged to be of good quality (large number of patients recruited, type of randomisation, description of patients and methods, double blinding, and stated parameters for evaluation of results). In 15 of these 22 trials, in which patients treated with the homeopathic drug were compared with patients who were untreated or treated with a placebo, demonstrated the therapeutic efficacy of the homeopathic drug.
Kleijnen’s meta-analysis was therefore mainly formulated on the basis of observational studies. Globally, 81 of the 107 studies reviewed by Kleijnen et al. (76%) gave favourable results.
In 1992, in view of the increasingly widespread use of non-conventional medicine (among which homeopathy stands out for the quantity and quality of the basic research and controlled clinical trials) and increased interest by the public and the media, the US Congress instituted the Office of Complementary Alternative Medicine, which later became NICAM (the National Institute of Complementary Alternative Medicine) within the National Institute of Health. NICAM has an annual budget of US$ 100 million, and is responsible for laying down guidelines for research into the validation of complementary medicines, formulating trial protocols and allocating funds for quality research.
In May 1997, a report entitled “Overview of data from homeopathic medicine trials” was published by experts (clinical physicians, university pharmacologists and researchers in the homeopathic field) forming the Homeopathic Medicine Research Group, Advisory Group 1, set up by the European Community.
These experts identified 377 clinical trials, short-listed 220, and reviewed 184. Detailed research lasting several months was conducted on the best trials, to evaluate their scientific value. The conclusions researched by the Advisory Group are unequivocal: the number of significant results cannot be attributed to chance. The analysis provided a random hypothesis value of p < 0.001.

Rejection of the Null-Hypothesis

The Advisory Group remained very cautious, but expressly stated: “The null hypothesis that homeopathy has no effect can be rejected with certainty; in other words, in at least one of the studies examined the patients treated with the homeopathic remedy received benefits compared with the control patients who received the placebo”.
In 1997, K. Linde et al. (Munich University) published the results of a meta-analysis of no less than 135 clinical trials which compared homeopathic drugs with a placebo in Lancet (Linde K. et Al. – Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350:834-843). The authors concluded that “…The results of this meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo”.
Linde had already published the favourable results of basic research studies conducted with homeopathic drugs in 1994 (Linde K. et al. – Critical review and metaanalysis of serially agitated dilutions in experimental toxicology – Human Exp.Toxicol., 1994, 13:481-492).
In 1998, E. Ernst and E.G. Hahn described the state of the art in homeopathy, drawing conclusions similar to those reached by Linde in his 1997 meta-analysis (Ernst E., Hahn E.G. – Homeopathy: a clinical appraisal. Oxford – Butterworth. Heinman, 1998).
In 1998, P. Bellavite, Associate Professor of General Pathology at Verona University, published a detailed review which collected, classified and analysed much of the available scientific literature that documents the effects of homeopathic remedies in clinical trials, together with studies conducted in the field of basic research. As regards clinical research, Bellavite reported on the most significant and methodologically reliable studies, drawing the conclusion that “the common opinion that scientific proof of the clinical efficacy of homeopathy does not exist must therefore be refuted”.
Basic research is also actively developing, and some high-quality in vitro and in vivo studies that demonstrate the efficacy of homeopathy have been published in internationally recognised journals.

Another Meta-analysis

Another meta-analysis conducted in 2000 on 24 studies relating to controlled, randomised clinical trials concluded that “There is some evidence that homeopathic treatments are more effective than placebo” (M. Cucherat et al. – Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. Eur. J. Clin. Pharmacol., 2000; 56:27-33).
Oddly enough, this body of trials and studies, some of which are of great institutional importance (such as the work of the Advisory Group set up by the European Community and the research conducted by NICAM in the US) has not been given sufficient prominence, either within the scientific community or by media.
This book is designed to fill the communication gap by systematically classifying the available studies, and in particular by reporting on the latest controlled clinica trials, which have become increasingly numerous in the past 2-3 years. The chapters which follow are devoted to classification and analysis of the best publications in the clinical field.

APPROXIMATELY 400 PUBLICATIONS

Approximately 400 publications obtainable from international data bases (Medline, Embase, Biosis, the British Library, Stock Alert Service, SIGLE, Amed, etc.) which relate to controlled clinical trials of nosographically defined disorders (accounting for approx. 80% of the homeopathy studies conducted up to December 2001) demonstrate the therapeutic efficacy of the homeopathic drug tested.
No less than 98 studies (25%) were indexed in Medline between 1998 and 2001 alone, clearly indicating researchers’ increasing interest in homeopathy.
We have excluded from our review studies which fail to comply with validated operational protocols; we relied in particular on the “Guidelines on planning, conduct and evaluation of multicentric studies” published in the German Official Federal Gazette No. 299, Vol. 4, 12, 1998.

The Exclusion Criteria

The exclusion criteria were consequently as follows:
1) open studies (only the global efficacy of homeopathy can be considered with
this method, not the effect of each individual drug)
2) retrospective studies (which do not involve comparison with homogeneous
groups)
3) studies in which a number of therapeutic techniques were associated
4) lack of homogeneity of the disorder among groups and within the same group
5) small number of patients recruited
6) defects in methodological procedure.
When these exclusion criteria were applied, the number of publications was reduced to approximately 200. We therefore examined only placebo-controlled trials and trials which compared a homeopathic medicine with the corresponding allopathic reference drug, some of which have been published in major international non-homeopathic journals such as the Lancet, Cancer, the British Medical Journal, the British Journal of Clinical Pharmacology, etc. (Table 2).
Table 1
Total number of scientific publications
reporting significant results:
Homeopathic medicine superior to placebo: Homeopathic medicine not inferior to corresponding allopathic reference drug: studies relating to controlled human clinical trials which provide valid, unequivocal information about the therapeutic effect of the drug in question have consequently been selected.
A) HOMEOPATHIC DRUG Of these VS. PLACEBO =
B) HOMEOPATHIC DRUG VS. THE CORRESPONDING ALLOPATHIC REFERENCE DRUG =
127 77 21 106 83,4% 16,6%

_ Of the 106 studies (A) 77 (72,6%) demonstrated (conducted between 1944 and 2000) that the homeopathic medicine was SUPERIOR to the placebo.
_ Of the 21 studies (B) 21 (100%) demonstrated (conducted between 1991 and 2001) that the homeopathic medicine was NOT THERAPEUTICALLY INFERIOR* to the corresponding allopathic reference drug.
_ 1991 to 1999 = 8
_ 2000 to 2001 = 13.
The table on the next page shows the salient data and references of the 98 publications which demonstrated that a homeopathic medicine was superior to the placebo or not inferior to the corresponding allopathic reference drug.
The term “NOT INFERIOR” means EQUAL or SUPERIOR TO.

LIST OF INTERNATIONAL & NATIONAL MEDICAL JOURNALS

List of international and national non-homeopathic medical journals cited in this book which have published the results of methodologically reliable controlled clinical trials that prove the efficacy of homeopathic medicines.
Experimental Model:
Homeopathic Medicine Vs Placebo
International Scientific Journal:
• Lancet
• British Medical Journal
• Rheumatology
• Phlebology
• Pediatrics
• Pédiatrie
• Allergologie
• British Journal Of Clinical Pharmacology
• Pediatric Infective Diseases Journal
• American Revue Of Respiratory Diseases
• Archives Of Medical Emergency
• Journal Of Head Trauma Rehabilitation
• Canadian Medical Association Journal National Scientific Journal
• Orthopädische Praxis
• Therapiewoche
• Kinderarzt
• Forschungsmedizin
• Revue Française De Gynécologie Et Obstétricie

Experimental Model:
Homeopathic Medicine Vs Corresponding Allopathic Reference Drug
International Scientific Journal:
• Cancer
• Thrombosis Research
• Journal Of Clinical Pharmacology
• Archives Of Otolaringology/Head And Neck Surgery
• Arzneimittel Forschung/Drug Research

THE SUBJECT OF “PUBLICATION BIAS”

The subject of “publication bias” was tackled in the meta-analysis conducted by Kleijnen (1991). However, this problem obviously does not relate to medical/scientific publications only.
Many homeopathic studies with doubtful or negative results are rarely (if not exceptionally) published in homeopathy journals; they are more likely to be published and commented on with negative emphasis in official journals, even when certain subjects are not in line with their editorial strategy.
Conversely, many favourable results obtained with homeopathic medicines as a result of methodologically correct studies are published in homeopathic journals and merely ignored, censored, minimised or hyper-criticised by official allopathic journals, perhaps for fear of taking a favourable approach to a subject that is still controversial.
Despite the problem of publication bias, many prestigious national and international journals have published and given the right degree of emphasis to well-conducted homeopathic clinical trials simply because “the findings speak for themselves”, and science must take an impartial view.

Table 2
Allergies 11 9 2
Arthromyo-fascial apparatus 12 8 4
Gastrointestinal apparatus 9 8 1
Respiratory apparatus, common Cold/influenza syndrome and ent 20 15 5
Surgery, prophylaxis, and post-operative and post-radiation complications9 6 3
Dermatology 6 6 0
Coagulation and circulatory Disorders 6 5 1
Gynaecology and obstetrics 9 7 2
Metabolism 5 5 0
Neurology 9 7 2
Sundry 2 1 1
Total 98 77 21
The Scientific Status of Homeopathy

Author: Gudrun Bornhöft
Contributor: Robbert van Haselen
ECHAMP European Coalition on Homeopathic and Anthroposophic Medicinal Products E.E.I.G.
Rue Gray 100 – 1040 Brussels – Belgium - Tel: +32-2-649.94.40 - Fax: +32-2-649.41.77
office@echamp.eu – www.echamp.eu – VAT BE 0467 826 644 RPR Brussels

CONTENTS
1. The Status of Homeopathy...................................................................... 2
1.1 Definition........................................................................................... 2
1.2 Scientific tradition............................................................................. 2
Annex 1: Two Case Reports....................................................................... 6
1.3 A worldwide medical method.......................................................... 3
2. Evidence Base........................................................................................ 3
2.1 Research methodology................................................................... 3
2.2 Quality of studies............................................................................. 4
2.3 Evidence of effectiveness.............................................................. 4
3. The Working Model (Potentisation)........................................................ 5
References.................................................................................................. 8
Annex 2: Table1 Comparison of the results of the best quality studies of homeopathy currently available and selected studies of conventional medicine............................................................................ 7

1. The Status of Homeopathy
1.1 Definition
1.2 Scientific tradition

This paper gives a brief overview of the scientific status of homeopathy. It demonstrates that there is pre-clinical and clinical evidence for the effectiveness of
homeopathy and that with professional and adequate application, it can be seen as
safe.
Homeopathy is often confused with the more general category of complementary and
alternative medicine (CAM). CAM is an umbrella term that includes all therapeutic and diagnostic procedures which are not taught in conventional medical schools [1]. There is no generally accepted definition of CAM, and the term is used differently in different studies.
It also changes with time. In a workshop held by the office of alternative medicine of the US National Institute of Health in 1995, the participants agreed on the following definition:
‘A broad domain of healing resources that encompass all health systems, modalities and practices, and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. It includes all such products and ideas self defined by their users as preventing or treating illness or promoting health and wellbeing.
Boundaries within complementary and alternative medicine and between
complementary and alternative medicine and the domain of the dominant system are not always sharp or fixed.’ [2].
Thus it is that the Atkins diet, Chinese medicine, homeopathy, iris diagnosis, and
phytotherapy all come under the umbrella of CAM despite the huge differences in their theoretical background, empirical observation and continuity of tradition and experience.
Many patients consider the term homeopathy as an umbrella term for all kinds of alternative treatment – for example they may say ‘I am going to my homeopath’ when in fact they are visiting a herbalist.
To clarify this confusing use of terms: homeopathy was developed by Samuel
Hahnemann in 1796 and is a medical therapy that intends to cure by stimulating the
organism’s own ability to re-establish health.
Symptoms are carefully evaluated and remedies used. These are micro dose stimuli
which would produce symptoms in healthy persons similar to those of the sick person.
This is known as the ‘simile principle’ (let like be cured by like) and is described in
Hahnemann’s ‘Organon’ [3]. Most of these homeopathic therapies use so-called
potencies, specially prepared dilutions, the extent of which may go beyond Avogadro’s number (as yet unknown in Hahnemann’s time) to enhance the homeopathic effect.
Homeopathy has a scientific tradition which dates back over 200 years. It has been based from the beginning on scientific thinking and accurate documentation. This has been maintained since both in classical homeopathy and in the majority of the different schools that have developed, such as complex homeopathy, clinical homeopathy, homotoxicology, anthroposophic medicine and isopathy.
Hahnemann was a leading contemporary scientist. He studied both medicine and chemistry. He turned his back on the medicine of his time because with its profusion of bloodlettings and enemas he thought it too crude and barbaric and actually more harmful to than beneficial for its patients. He was wellread and got impetus for his work from translating medical and chemistry books into German. The search for better understanding as to why quinine was effective in the treatment of malaria, inspired him to take quinine himself to establish its effect in healthy subjects. During this experiment on himself, he noted that he developed many symptoms,
such as intermittent fever, similar to those of malaria. He described his empirical findings that medication which leads to special symptoms in healthy people could be helpful in treating patients with similar symptoms

1.3 A worldwide medical method
2. Evidence Base


(‘similia similibus curentur’ – let like be cured by like).
He was too cautious and scientifically accurate to devise a theoretical working
model, and simply stated that he could see the simile association although he was unable to explain it. He made many trials on himself, his family and colleagues to substantiate his simile hypothesis and carefully documented the many treatment successes with his patients. Subsequently he further refined his method by developing a special dilution method (involving successive dilution and
succussion), called ‘potentisation’.
As early as the nineteenth century, followers of Hahnemann pioneered the use of placebo controls in homeopathic pathogenetic trials (often referred to as ‘drug provings’, wrongly translated from the German ‘Arzneimittelprüfung’) [4,5]. This was long before the widespread use of placebo studies in allopathic medicine which did not take place until after the Second World War.
Homeopathy is now established worldwide as a medical method [6]. In many countries it is considered on equal terms as conventional medicine. Chile (end of the 19th century), Nigeria (1961), India (1973), Brazil (1979) and Cuba (1992) integrated
homeopathy into their public health system [6,7]. In these countries the debate about “the end of homeopathy” in The Lancet [8] was noted with amazement. The state secretary for ayurveda, homeopathy and yoga in India commented on the debate: “How could a single study dismiss an entire system?”
In some European Countries, such as France, Germany, Austria, Switzerland and Latvia, homeopathy is acknowledged by the medical associations as an official specialisation for physicians. It is also acknowledged as a treatment option in many other countries such as Italy, Spain, and Greece. In the UK it is partly integrated into the public health system (National Health Service). Those homeopathic
doctors who make treatment decisions are familiar with both homeopathic and
conventional treatment options, and very often decide in favour of homeopathy.

2.1 Research methodology

Homeopathy provides over 200 years of successful clinical experience (See Annex 1:
Two Case Reports). However today’s ‘gold standard’ of evidence based medicine, the
randomised controlled clinical trial (RCT), usually with double blinding, is not well suited to the specific nature in particular of highly individualised types of homeopathic treatment [9].
A precondition for RCTs in all kinds of studies on homeopathy as well as in conventional medicine is an equipoise regarding the therapies in question (test intervention and control) by patients and physicians. That means that neither patients nor physicians should favour one of the treatment alternatives (even in normal clinical studies this is almost impossible). There is nearly an ‘equipoise’
situation in phase III clinical trials, from which the RCT design originally derived, because of the balance between the hope for a better treatment and the risk of unknown adverse effects or even fatal outcome. But this is not the case in a homeopathic treatment: in visiting a homeopath, the patient is making an active choice and expects proper homeopathic treatment, and the homeopath takes into
account the patient’s unique situation when choosing the remedy. In other words, strong preferences exist, which greatly decrease the likelihood of patients being prepared to enter a clinical trial in which they have a 50% chance of receiving a placebo. It may also be that ‘nonspecific’ treatment effects are enhanced by the
fact that the homeopathic practitioner takes an interest in the individual situation, health conditions and particular symptoms of the patient [10]. Consequently RCTs are less suitable for investigation of the efficacy of highly individualised homeopathic approaches.
This is less of an issue in more ‘clinical’ homeopathic approaches where homeopathic
medicines are prescribed for particular indications. These methodological concerns
are confirmed by the available trial data which indicate that the percentage of positive trials of ‘clinical’ homeopathic approaches is higher than the percentage of positive results in ‘classical’ homeopathic studies [11].

Despite these methodological issues, there are a considerable number of homeopathic clinical trials which fulfil the strictest criteria of evidence based medicine. Shang et al. [12] assessed 110 homeopathic RCT studies
regarding their study quality and compared them with 110 (more or less) matched studies of conventional medicine. Only 6 of the 110 conventional studies and 8 of the homeopathic ones fulfilled all quality criteria (they chose only criteria of so called internal validity: sufficient number of cases, sufficient allocation concealment
and others). From this result and the overall quality of the studies, the authors
concluded that homeopathic studies were of better quality than conventional ones.
The most extensive and carefully collected review of homeopathic clinical trials to date has been done by Kleijnen et al. [16]. They systematically searched a total of 107 studies for three years and assessed them according to a panel of criteria predominantly of internal validity. 81 studies showed a result in favour of
homeopathy (compared with placebo), 24 did not. Of the qualitatively highest rated
studies 15 showed significant results in favour of homeopathy and only 7 did not. The authors stated: “The amount of positive evidence even among the best studies came as a surprise to us. Based on this evidence we would be ready to accept that homeopathy can be efficacious, if only the mechanism of action were more
plausible.”
The most recent comprehensive work about homeopathy consists in the results of a five year Health Technology Assessment, which was initiated by the Swiss authorities involving many independent and well-reputed international university researchers in order to evaluate the benefits of complementary medicine within the national health system. All available reviews as well as systematically searched studies in upper respiratory tract infection were evaluated. In addition to the usual criteria of internal validity the authors also considered external validity - that is whether study design and performance were in concordance with everyday homeopathic practice. Furthermore pre-clinical studies were reported as well as studies about economy,
usage, and safety. The authors concluded: “effectiveness of homeopathy can be
supported by clinical evidence and with professional and adequate application be seen as safe” [17-18].
Further, concise compilations of homeopathic research have been published [19-25]. In more recent homeopathic trials [26-27] as well as in methodological articles on homeopathic and CAM research in general [28-30], new and more appropriate approaches to research design are being successfully pursued in order to overcome some of the methodological problems mentioned above.
The totality of research into homeopathy demonstrates that the majority of clinical trials in homeopathy are positive, including the majority of the more rigorous studies.
This statement might contradict the results of Shang et al [12], who calculated and
compared so-called combined effect values of the best quality studies of homeopathy and allopathic medicine (see above), and found in favour of allopathic medicine. Calculating a combined value of studies from selective data containing such heterogeneous subjects as stroke and influenza or diarrhoea and warts is
not an adequate approach even for evidence based medicine: “It’s important to remember that whatever statistical model you choose, you have to be confident that clinical and methodological diversity is not so great that we should not be combining studies at all.”[13].
When comparing the selected studies one by one, the results for conventional and
homeopathic trials are quite comparable (see Annex 2 Table 1). Moreover, as Lüdtke
demonstrated, results of meta-analyses are highly sensitive to the way the type and
number of trials have been selected [14].
There is clear evidence to suggest that the Shang meta-analysis was disproportionately affected by the results of one single negative
trial [15].

3. The Working Model (Potentisation)

The plausibility of the working model of homeopathy remains the greatest obstacle to its more widespread acceptance. The high dilutions used in some homeopathic medicines (approximately 25% of those sold) mean that in some cases the homeopathic medicines used no longer contain molecules of the starting
material.
When testing drugs for their effects on healthy people, Hahnemann wanted to avoid adverse and toxic effects. Therefore he started to dilute the test substances. He developed a method to sequentially dilute the original substance (in 1:10 or 1:100 steps), shaking the solution vigorously in each dilution step, a process called potentisation. This stepwise vigorous shaking, also known as succussion, is different
from dilution by stirring. When administering these potentised substances to healthy
subjects and patients, he noticed that the treatment effect was enhanced whereas the toxic or adverse effects were diminished. This favourable safety profile of homeopathic medicines still applies and there are very few published reports of adverse events.
Hahnemann called this procedure ‘potentisation’ because it enhanced (potentised)
the desired effect. He stated that he could not explain the working mechanism, but just observed the therapeutic effect.
Two hundred years later, the situation remains more or less the same. There are a number of hypotheses to explain the effect of potentisation. The more recent ones, with nuclear magnetic resonance and ultra-violet spectroscopy as well as with electrochemical and thermodynamic measurements, show differences between homeopathic potencies and controls [31-33] that are significant.
However we are still far from understanding what happens during the potentisation
procedure. What can be stated with some certainty is that there is an interactive effect between potentised high dilutions and a living organism. For instance, in recent studies, Scherr et al. [34] observed highly significant reactions of yeast cells to homeopathic potencies, which were modified by as yet unknown influencing factors.

Annex 1: Two Case Reports

Gypser (1990) [35]:
A fifty-six year old woman with severe and hindering pain in both legs lasting a week described spontaneously, “as if deep in the legs, beginning at the feet, the tendons were being pulled up and out”. According to the corresponding description by Ward [36] and Hering [37] Crotalus horridus was applied and the pains vanished completely within one hour. They returned the next day in a milder form but had never returned since. The patient was under observation for 8 months.
Wegener (1990) [38]:
A forty-one year old woman reported the following complaints:
For 3 years Nightly cramping in the stomach, annually recurring gastritis and depressed mood.
11 years ago Hepatitis from which she hasn’t actually recovered yet 21 years ago Cholecystectomy (gall stones) – at age 21
Since childhood Frequent diarrhoea from excitement. According to the patient’s central symptom “melancholy during gastritis” podophyllum was applied. After an aggravation on the second day, the complaints gradually disappeared within two weeks. They now return sometimes in a considerably milder form.

1This study shows an experimental design and can be interpreted as homeopathic remedy proving in which homeopaths could expect more symptoms in the verum group.
2The interpretation of this study is also somewhat ambiguous because some effects could be due to a homeopathic “treatment” of the fasting condition in which one also would expect results in favour of the control intervention.
Abbreviations: n.s. nonsignificant, sign.: significant

Indication
Conventional Medicine
Study Result
Homeopathy
Study Result
Bacterial vaginosis post abortion
Crowley et al. 2001 [39]: prophylactic treatment with antibiotics n.s.

Stroke
Horn et al. 2001 [40]:
therapeutic treatment with nimodipine n.s.

Seasonal allergic conjunctivitis
Möller et al. 1994 [41]: therapeutic treatment with nedocromil (children); significance in favour of nedocromil in 2 of 3 investigated outcome parameters; high
placebo effect sign.

Influenza
De Flora et al. 1997 [42]:
preventive long-term treatment with N-acetylcysteine; significant reduction of disease symptoms but no prevention of A/H1N1 virus

influenza infection sign.
Nicholson 2000 [43]: therapeutic treatment with oseltamivir sign.
Papp et al. 1998 [44]: therapeutic treatment with Oscillococcinum
Rottey et al. 1995 [45]: therapeutic treatment with microorganisms® sign.
sign.
Kaplan et al. 1999 [46]: therapeutic treatment with loperamide; significantly more total adverse events in loperamide group

Acute diarrhea sign. (children)
Jacobs et al. 2000 [47]: therapeutic homeopathic treatment (children in Nepal);
low incidence of adverse events
sign.

Chronic sinusitis
Weiser & Clasen 1994 [48]: therapeutic treatment with Euphorbium comp.
sign.

Chronic Headache
Walach et al. 1997 [49]: classical homeopathic treatment n.s.

Plantar warts
Labrecque et al. 1992 [50]: therapeutic homeopathic treatment outcome: complete
disappearance of warts n.s.

Muscle soreness after long-distance running
Vickers et al. 1998 [51]: preventive treatment (after long-distance running) with
Amica 30X n.s. (trend in favour of placebo)1

Fasting
Schmidt & Ostermayr 2002 [52]: promotion of body weight reduction in fasting patients by Thyroidinum 30cH n.s. (trend in favour of placebo; without adjustments:significance)²

Annex 2: Table1.

Comparison of the results of the best quality studies of homeopathy currently available and selected studies of conventional medicine

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Great quote from Virchow and a nice summary of the problem from a historical perspective. The higher order onotology determines lower order forms. What i would add to your narrative is an explicit reference to the idea of life itself (which i think you allude to with the word "nature"). Aristotle described living things and their organization in three main works: De Anima, Ethics and Politics. In De Anima he observes life as such, and relates it to a cluster of principles: logos, entelechy, formal/final cause, substance, form, etc. In the late middle ages this cluster of concepts became associated with the idea of essence. The trend to reject essence, beginning as you note with nominalism, extends through Bacon's rejection of formal causation, almost reaches fullness in Hume's rejection of metaphysics altogether, and does reach completion in Darwin. His theory of evolution was heralded and has become the religion of the life-sciences because it provides a theoretical basis for getting rid of Aristotelian essentialism completely, establishing nominalism for living things as well as non-living things. What i think you are pointing at, and what Lionel is pointing at, is that living things have an essence, that this essence is life, or an immediate effect of life, and that it organizes matter in such a way that life can inform it. This is consistent with Hahenmann's naive vitalism. I have a little trouble with the use of the concepts of information, because the word itself is dehumanizing, it is not a word one applies to life essence or principle because information is a dead thing.
my two cents!
thanks
john
i have to correct myself. I have been doing a lot of work in the history part, but have not been thinking about homeopathic theory for some time, and realized that what i had concluded, and still agree with, is something like the information theory, but in a slightly different context. I think the abstract life force, consciousness, is the first thing, the most superior aspect of the living thing; and it is some kind of patterning having something to do with desire that cascades through various kinds of matter until the patterning energy informs the physical matter (as well). That is, to put it in old fashioned language: consciousness (atman) informs the causal body, which informs the astral (and energetic) body, which informs the physical body. I think homeopathic remedies function above the energetic level at the more subtle design/causal level. But, they have no meaning apart from the life-form ... all of these concepts exists in the context of the life-force, consciousness - i just wanted to clarify that i agree with the word information but not as a "scientific" concept because science has no theory of life, science does not see life - chaos, systems and information theory per se do not recognize life to the extent they align themselves with the Darwinian dominant theory of "life", so just wanted to distinguish that.

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