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  • #16
    Yes Hans, we are the homeopaths around here afterall. I suspect however that you just like to play at it though, extremely badly!!

    Surely, this then makes most scientific trials fundamentally flawed in some kind of way, drug trials included? Think about that one for a moment hey!!
    Sarah-I. RN, Homeopath, Craniosacral Therapist, Therapeutic Massage Therapist, Reiki Master Teacher.

    Comment


    • #17
      Originally posted by Sarah-I
      *snip*
      Surely, this then makes most scientific trials fundamentally flawed in some kind of way, drug trials included? Think about that one for a moment hey!!
      No, the trials in question were individually flawed. You can actually find formal faults in the protocols. Faults that would compromise the conclusions no matter what was investigated.

      You cannot infer that all scientific trials are flawed.

      Hans
      You have a right to your own opinion, but not to your own facts.

      Comment


      • #18
        Qoute
        The strange thing was that about the time Benveniste was being outed for heresy in 1989, theoretical work by Italian physicists actually predicted the molecular mechanism of just such a water-memory effect using an approach based on quantum theory.

        I must say that this water memory is quite rubbish. As far as we can understanbd the properties of water, it is rather ridiculous to assign it with memory. Much more rational and scientific is to see it as a storage medium, much like a CD. Why this is more rational, is obvious from the fact that when distilled, its supposed memory is wiped. Hence this so-called memory is very labile and thus no memory at all. Otherwise, it would retain it for ever.
        Our own memory does not suffer any diminishing when we go to the sauna and subject it to heat. Yet water loses all. A CD can be wiped of its information and so can water, hence it is nothing more, nor less than a storage medium.
        I think this distinction is quite important to the arguments put forward here.
        Do not accept or reject anything before you have investigated it and that on its own merits.

        Comment


        • #19
          quote (hans): "As for the many theories of how homeopathic remedies might act physically, there is still none that do not require some as yet unvalidated mechanism to exist."

          It is not theoretical when we state that the remedy neutralises the disease and the disease neutralises the remedy. The body in between these two forces is not attracted to either and thus in the healthy state.
          It is like two magnets, whereby the energy of the one neutralises the energy of the other, provided of course that the identical poles are opposite each other. The piece of iron in between will not be attracted to either and thus in the neutral state.
          Do not accept or reject anything before you have investigated it and that on its own merits.

          Comment


          • #20
            Very High Dilutions Beyond Avogadro


            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.

            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:

            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 toxicological 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 contributions 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 temperature. 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 information of the prime dissolved substance still remains in the preparation and can be detected experimentally.
            Do not accept or reject anything before you have investigated it and that on its own merits.

            Comment


            • #21
              The Theoretical Framework


              • Third question addressed: The theoretical framework in which the effects of
              homeopathic diluted preparations can be explained.
              Two members of G.I.R.I. (Groupe International de Recherche sur l’Infinitésimal; see
              www.giriweb.com), Professor Madeleine Bastide (University of Montpellier) and Agnès Lagache (Professor of Philosophy, Paris) have been working on this topic for 16 years. A new paradigm for medical science is needed to explain these facts and to allow more precise research models in the future. A working group of 7 members applied this new paradigm to the analysis of experimental results.
              Prof. Bastide explained that homeopathy and research models are based on the observation of “symptoms”. Asymptomatic pathologies exist that provoke “biological scars” as a proof of the self-treated organism without showing the illness symptoms (Charles Nicolle, Nobel Prize 1929, Life and Death of Illness). Symptoms and biological modifications are not the same and concern different levels in the body. The symptom may be an expression of the body when it cannot find any answer whatever the situation (infection, stress, strong emotion…).
              Example: Rubella in a normal subject: no apparent sickness. Rubella in immuno-deficient subject: symptoms, apparent sickness.
              For the allopathic research approach, the symptoms are pathognomonic, specific to the illness; they are used to diagnose the pathology. When the diagnosis of the pathology is performed, the treatment is chosen accordingly; classical therapy may be also targeted against symptoms.
              For the homeopathic research approach, considered symptoms are idiosyncratic; specific to the patient. They are the personal expression of the sickness by the patient. They are used to choose the specific remedy according to the similarity of the symptoms observed by “proving” in a healthy subject. The living body is in a lasting and irreversible learning process; it communicates at every level with its environment. It is able to receive and treat semantic and corporeal information; it is not an inert object.
              The paradigm of corporeal signifiers (Bastide M., Lagache A. Revue Intern. Systémique 1995; 9: 237-249 and Altern Ther Health Med. 1997; 3: 35-9).
              Three principles define homeopathy, based on clinical and experimental analysis: the similia and whole person principles, and the use of very high dilutions. The effects of high dilutions cannot be explained by a simple molecule-receptor interaction (mechanistic paradigm), the “well established theory” of modern science. Prof. Bastide & Lagache propose an epistemological approach to homeopathy based on body information processes received and interpreted by the living organism; this follows the rules of information exchange. Exchange of objects between a giver and a receiver is very simple: one loses, the other gains, and the sum is constant. On the other hand, information is not an object but the trace of an object – mediation between object and receiver is required for a signal to be transmitted. For example, take the story of Robinson Crusoe: Crusoe sees Friday’s footprint in the sand but not the foot itself. For him, this footprint means ‘there is another man on this island’. Friday’s foot is the originator (matrix) of the information; the footprint is information but is not an object; the sand is the carrier of the information (the mediator). When the carrier disappears, the information disappears too. The information is understood only by the receiver and the understanding of the information depends on its context – he knows that he is alone on the island. Prof. Bastide & Lagache therefore suggest that in homeopathy, the originator of the information is the starting material of the remedy; succussed dilutions of the starting material in a solvent are mediators. High dilutions contain only information from that material and no molecules remain. This mediation results from the succussed solvent being in a specific state, implying perhaps electro-magnetic processes. The receiver (the whole living body) receives and processes the information in the remedy according to its state, whether healthy (“proving”) or sick (therapy). The bases of this paradigm are verified by the systematic experimental results obtained as described in the first parts of the conference.
              This new paradigm is needed to explain the experimental facts and to understand the failure of research models that do not fit it.

              The Clinical Effects


              • 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. Groupe International de Recherche sur l'Infinitésimal__________-. The use of a complex (with endogenous and exogenous substances) to improve oestrus manifestation 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 perforatum (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.






              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). 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.
              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 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 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.

              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 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.
              Do not accept or reject anything before you have investigated it and that on its own merits.

              Comment


              • #22
                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 approaches.
                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.

                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 conventional 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 therapies, 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.

                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, postoperative 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.

                Conclusions


                Conclusions: Clear indications exist about clinical effectiveness of homeopathy; homeopathy is effective in uncontrolled practice or versus comparison groups; enough indications exist that “placebo” is an insufficient explanation for the effects of homeopathy. Homeopathy can be similar or better in effectiveness than conventional treatment and, where it has been studied, it is cheaper in the long run. Many interesting questions not even asked should be prioritized, such as the potential of homeopathy to avoid invasive procedures in children and, in primary care settings, the long-term effect of homeopathy in preventing chronic complications.’

                We may add that there are some more voices that have declared the objections to miss any grounds. We also have contributed to the debate by presenting our views on the matter. We may point out that in nearly all clinical trials homoeopathy fares better and that our placebos are acting better than the allopathic placebos.
                Do not accept or reject anything before you have investigated it and that on its own merits.

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