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ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report Evidence profile for the efficacy of homeopathy – A new paradigm for medical sciences: "The Body Information Theory".
First question addressed: The activity of very highly diluted preparations.
Homeopathic practitioners will argue that the use of preparations that are diluted beyondAvogadro's number (i.e. potencies greater than C10) happens in only 25% of the prescribedhomeopathic medications. Nevertheless, for some people this question is the most importantobstacle to the acceptance of homeopathy.
A/ The experimental model that is cheapest, most reproducible and also the most easilyresearched is probably the "acetylcholine-induced contraction of the rat ileum". It is a well-recognized scientific model (Chang FY, Lee SD, et al. Rat gastrointestinal motor responsesmediated 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). Signalsand Images. Kluwer Academic Publishers 1997: 161-170).
Professor Wolfgang Süß, Institute of Pharmacy at the University of Leipzig, has used thismodel to test the transfer of the activity of a homeopathic remedy (in this case Atropinumsulphuricum D60) from the original liquid form to the homeopathic tablet. As usual, severalcontrols were performed. Alpha-lactose monohydrate tablets impregnated with the highlydiluted Atropinum had systematically efficacy, on the contrary with anhydrous alpha-lactosetablets no effect can be ascertained. Thus, the quality of homeopathic tablets can be testedbefore daily use in pharmacy (constant reproducibility). This very simple model therefore hasthe potential to remove doubts about the activity of very highly diluted homeopathic remedies(Schmidt F, Süß WG, Nieber K. In-vitro Testung von homöopathischen Verdünnungen. 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 internationalcooperation, that the results have finally been accepted in a high-standard peer-reviewedjournal, Inflammation Research. This model is different from the Benveniste model; he usedthe same control but not the same activator.
Professors Marcel Roberfroid and Jean Cumps of the Institute of Pharmacy at the Universityof Louvain, who respectively coordinated the European multi-centre (4 centres) trial andperformed the statistical analysis, explained the protocols and discussed the results. The workdemonstrates a significant inhibition of human basophil degranulation, as measured by alcianblue staining, by high dilutions of histamine (10-30 – 10-38 M). This multi-centre research hassubsequently been confirmed in three laboratories by applying flow cytometry analysis and inone laboratory by measuring histamine release. Even if, at present, the molecular theorycannot explain these findings, the facts remain indisputable as recognized by the editor ofInflammation 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.) ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report C/ Research on high dilutions has existed since the 1950s, but the number and quality ofpublications has increased in the last decade. Reviews and meta-analyses have even beenperformed but often ignored or even denied (see COST B4 supplement report EUR 19110ISBN 92-828-7434-6). This research is not encouraged and even deemed inadvisable byacademic 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.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report Second question addressed: The content of very highly diluted homeopathic
preparations.
Professor Jean Cambar introduced the theme by asking what are the contributions of thedifferent spectroscopies (Raman, Ultraviolet, X-ray or Magnetic Nuclear Resonance) inrevealing the structure of water and solvents in high dilutions? What is the real relevance ofAvogadro's number in evaluating the precise pattern of molecules? Can a dilution workwithout any molecule? One of the most innovative perspectives in this last decade was thedemonstration that high dilutions have as much activity and effectiveness in an organizedstructured solvent without any solute molecule as they do when molecules are present (evenonly some molecules).
Professor Louis Rey, Doctor of Sciences, Lausanne, a specialist in low temperaturethermoluminescence, 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 theexperiments he carried out together with Dr. Philippe Belon on the thermoluminescence ofultra-high dilutions of lithium chloride and sodium chloride. Ultra-high dilutions of lithiumchloride 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, theirthermoluminescence was studied and it was found that, despite their dilution beyond theAvogadro number, the emitted light was specific of the original salts dissolved initially. Muchto the authors' surprise, the experimental results showed, without ambiguity, the specificity ofthe contained information. The findings proved to be reproducible in the course of manydifferent identical experiments. As a working hypothesis, the researchers propose that thisphenomenon results from a marked structural change in the hydrogen bond network initiatedat the onset by the presence of the dissolved ions and maintained in the course of the dilutionprocess, 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. Shewas able to demonstrate the biological effect of two ultra-low dose compounds. (Publicationin 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.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report 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; seewww.giriweb.com), Professor Madeleine Bastide (University of Montpellier) and AgnèsLagache (Professor of Philosophy, Paris) have been working on this topic for 16 years. A newparadigm for medical science is needed to explain these facts and to allow more preciseresearch models in the future. A working group of 7 members applied this new paradigm tothe analysis of experimental results.
"When the observed fact does not correspond to a famous theory, the fact
has to be accepted and the theory rejected"; "A theory must be modified to
be adapted to nature and not nature to adapt itself to the theory". Claude
Bernard (Introduction à la Médecine Expérimentale).
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 theself-treated organism without showing the illness symptoms (Charles Nicolle, Nobel Prize1929, Life and Death of Illness). Symptoms and biological modifications are not the same andconcern different levels in the body. The symptom may be an expression of the body when itcannot find any answer whatever the situation (infection, stress, strong emotion…).
Example: Rubella in a normal subject: no apparent sickness. Rubella in immuno-deficientsubject: 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 tothe patient. They are the personal expression of the sickness by the patient. They are used tochoose 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 learningprocess; it communicates at every level with its environment. It is able to receive and treatsemantic and corporeal information; it is not an inert object.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report 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 similiaand whole person principles, and the use of very high dilutions. The effects of high dilutionscannot be explained by a simple molecule-receptor interaction (mechanistic paradigm), the"well established theory" of modern science. Prof. Bastide & Lagache propose anepistemological approach to homeopathy based on body information processes received andinterpreted by the living organism; this follows the rules of information exchange. Exchangeof objects between a giver and a receiver is very simple: one loses, the other gains, and thesum 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 footitself. For him, this footprint means ‘there is another man on this island'. Friday's foot is theoriginator (matrix) of the information; the footprint is information but is not an object; thesand is the carrier of the information (the mediator). When the carrier disappears, theinformation disappears too. The information is understood only by the receiver and theunderstanding of the information depends on its context – he knows that he is alone on theisland. Prof. Bastide & Lagache therefore suggest that in homeopathy, the originator of theinformation is the starting material of the remedy; succussed dilutions of the starting materialin a solvent are mediators. High dilutions contain only information from that material and nomolecules remain. This mediation results from the succussed solvent being in a specific state,implying perhaps electro-magnetic processes. The receiver (the whole living body) receivesand 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 systematicexperimental 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.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report The final question addressed: The clinical effects of homeopathic preparations.
An experimental design is only relevant if it takes into account the observed phenomenonwithin its specific framework and if the subject addressed can be isolated of all externalinfluences. Considering human medicine, the psychological factors are responsible for non-specific effects and the medication effects are called specific effects. Whatever the researchmodel, taking into account the homeopathic approach, the idiosyncratic symptoms (specific tothe 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, onlyhomeopathic treatments are authorized for biological farming. The use of homeopathy isaimed at avoiding chemical residues in the food chain. More institutional support is certainlyneeded.
In recent studies, the use of homeopathic complexes has been tested with very good resultsusing parallel placebo groups, blinded design, homogeneity of samples with sufficientanimals, 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 duringtransportation by about 30%.
Riaucourt A. L´Exemple de la Filière Porcine. Annals of the "Entretiens Internationaux deMonaco 2002", 5-6 October, 2002. http://www.giriweb.com. The use of a complex (with endogenous and exogenous substances) to improve oestrus manifestation in female pigsinduced a reduction of the repetitions of inseminations and semen loss.
Veterinary studies are also useful for questioning homeopathic study design. Using the modelof psychogenic dermatosis in dogs and cats (Torro, et al. In press), six months of treatmentwith the simillimum shows 70% success. One year after finishing the treatment there was norecurrence. The entire study duration is six years. The very long efficacy of the homeopathictreatment is a reason for questioning cross-over design.
Because veterinary pathogenetic studies are very rare, veterinarians often need to doextrapolations from human pathogenesis and their Materia medica is based on classicalstudies performed in humans.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report 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 criteriafor the choice of the best homeopathic dilution. The general rule is to use high potencies forchronic / mental disturbances and low potencies for acute / organic disturbances. The anti-depressive effect of Hypericum perforatum in rats was better in 200CH than in 30CH: testedby the Porsolt forced swimming method (Goulart et al. Avaliação dos efeitos de Hypericumperforatum (Hp) dinamizado homeopaticamente em comportamento de ratos. Anais do VIIISINAPIH, 20-22 May 2004: p.14. http//climed.epm.br/sinapih/index); this was a blinded, welldesigned 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.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report 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 particularlyconsidered 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 doingRandomized 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. "ClinicalUse Testing" (CUT), starting with case reports, epidemiological outcomes and cost-benefitstudies, is only interesting for public health authorities and patients but it is never sufficient toreach EBM. No real bridge exists between these two approaches.
Evidence Based Homeopathy (EBH) starts and ends with the individualized patient. It can berepresented as the arch of homeopathy: at one side there is the examination of the patient, andat the other side the therapeutic instrument. In order to understand the patient, we mustconsider his totality in time and space to be able to understand his basic vulnerability, latent ormanifest. This totality must be qualitatively modalized with chronological assessment to getthe Minimal Syndrome of Maximal Value. The therapeutic instrument can be self-healing (nosyndrome, no medication), or management of life-style or nutrition in order to avoid obstaclesto cure. A homeopathic remedy can be considered after study of its physico-chemicalcharacteristics, 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 healthyvolunteers; third is the confirmation by further "provings"; fourth is the corroboration byphysio-pathological study; and last is the clinical verification in daily practice. For theremedies we must have the same qualitative assessment as for the patients. But the keystoneof the whole homeopathic process, without which the arch will crumble, is the Law ofSimilars. Research in homeopathy must be concentrated on qualitative "proving" on healthyvolunteers and clinical verification in daily practice. Therefore after many years of studies,our first priority must be systematic clinical files collection (CLIFICOL project). TheBayesian statistic, a statistical approach (likelihood ratio), can help establishing a scientificbase for our symptoms' repertories. This approach was presented by Dr Lex Rutten from TheNetherlands.
Can one get over the gap that exists between EBM and EBH? ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report B.2) Dr Harald Walach, University of Freiburg, presented an overview of the alreadypublished papers.
Homeopathy is certainly popular (used by 50% of the population in France) and is historicallysuccessful, both individually (by Fieldmarshall Radetzky, Paganini, etc.) and generally (incholera and other epidemics all over Europe). Homeopathy remained effective in the face ofadversaries 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 abetter improvement in work-days lost compared with conventional practice. For specificdiagnoses such as bronchial asthma (89% improvement; even better after 2 years), cancerpatients in palliative care (improvement of quality of life, fatigue and anxiety but not pain),hyperactive children (after 3 months, 75% improvement versus 65% for conventionaltreatment), URTI (67.3% improvement with homeopathy, 56% with conventional treatment;side effects 7.8% homeopathy versus 22% conventional), homeopathy is at least as effectiveas 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 ofevidence, for conventional medicine the RCT is of the highest value – the best rigour andinternal validity – but it has a low applicability score, a low external validity and itsconclusions are generalized with great difficulty. On the contrary the applicability of caseseries is great, showing a high external validity and its conclusions generalized easily. RCTimplicitly tests the placebo hypothesis; the question is only: "Is the homeopathic therapydifferent from placebo?" It presupposes a local-causal model of homeopathy, that the physicalpresence and "information" of a remedy is decisive (without considering the "receiver" healthstatus), and that a "true" effect would be detectable through replication. It is apparent thatdiscrepancies exist regarding homeopathy in daily practice and the RCT approach.
Nevertheless RCTs have been performed and meta-analyses of these studies have concludedthat there is clear evidence of efficacy in favour of homeopathic treatments that cannot beattributed 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 beenreached: rheumatoid arthritis (6 studies); childhood diarrhoea (3 studies); postoperative ileus(8 studies); hayfever, asthma (4 studies). For migraine, results of RCTs are disappointing. Inchildren, 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 backpain, 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 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.
B.3) Future projects were discussed.
Surveys on homeopathic practice have already been published. Dr Galen Ives (Priority Research, Sheffield) made some recommendations for future projects. Questionnairedesign should be driven by requirements for data analysis, and professional advice soughtbefore starting, in particular thinking carefully about measurement scales (subjective data notexpressed in numbers but crossing a box), and assuming all respondents lack prior experiencein such recording. The question of timescales is a sensitive one therefore it would be better toinclude only new patients. If the aim is to look at the daily practice, a large demographic datais needed. The question about why the patients chosen homeopathy must be addressed. Acomparison group is not a common requirement in such studies, but to avoid editorialcomments on this question, it would be explained in the discussion part. The aims of the studymust be kept clearly in mind. Example: analysis of effectiveness versus conventionalmedicine (CM); cost-effectiveness versus CM. It would be recommended to use inclusioncriteria (such as state of health) and sub-groups (as example acute cases). The study ofpatient's satisfaction is not the same as looking at treatment efficiency. Efficiency can best bechecked through Quality of Life studies, in this case at least 2 successive questionnaires areneeded with a greater risk of drop out.
Dr Kivellos Spiros (Athens) introduced a severity scale that aims to embody the laws of classical homeopathy in clinical study protocols. He proposed a classification of"level of health", starting on level 1 (healthy) down to level 12 (irreversible internal injuries).
The homeopathic prognosis can be estimated using such a scale and group classification hasbeen elaborated.
ECH GENERAL ASSEMBLY – XVIII Symposium of GIRI 12 to 14th of November 2004 Scientific Report Conclusions from this colloquium:
• There is evidence that highly dilute homeopathic dilutions have biological activity.
• The presence of a "footprint" of the original substance can be detected in the high diluted • Explaining the observed phenomenon a new paradigm for medical sciences exists.
• Veterinary studies confirm the clinical efficacy of homeopathy.
• Human studies reveal clinically significant improvement in 70% of patients (more in children); the homeopathic effects cannot be attributed only to a placebo effect and forsome indications the efficacy of homeopathy has reached a high level of statisticalsignificance.
• Future studies are needed that investigate the preventive effects of homeopathy in children and chronic diseases. Funding of research into homeopathy must be considered as vital.
Finally, the participants wrote the following press release:
At the invitation of the European Committee for Homeopathy, which
represents 33 homeopathic doctors' associations in 24 European countries,
joining the XVIII symposium of GIRI, ten internationally renowned university
professors in the field of research met in Brussels for a 3 day meeting starting
on Friday November 12th 2004.
The results of the research discussed by these university professors are all in
accord with one another – namely, that there is clear evidence for the
effectiveness of homeopathic medications. There is sufficient reason for
further research.
The professors expressed their amazement at the lack of response from the
health authorities to these convincing results.
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Omeopatia, la ricerca continua
La relazione scientifica del XVIII simposio del GIRI svoltosi a Bruxelles all'interno dell'Assemblea
generale dell'ECH (European Committee for Homeopathy) novembre 2004
Le prove di efficacia
Nel corso dell'incontro è stata affrontata innanzitutto la questione riguardante l'attività dei preparati ad
altissima diluizione. Gli omeopati affermano che solo il 25% dei medicinali omeopatici prescritti sia diluito
oltre il numero di Avogadro (potenze superiori alla 10 C). Ciò nonostante, alcuni lo considerano l'ostacolo
maggiore all'accettazione dell'omeopatia.
Il modello di ricerca più facile da utilizzare, economico e riproducibile è forse "la contrazione dell'ileo di
ratto indotta da acetilcolina". Si tratta di un modello scientifico riconosciuto (Chang FY, Lee SD, et al. Rat
gastrointestinal motor responses mediated via activation of neurokinin receptors. J.Gastroenterol Hepatol
1999; 14: 39-45) disegnato dal ricercatore rumeno A. Cristea con lo scopo di valutare l'attività di diluizioni
molto elevate di Belladonna. I risultati di questo studio sono stati pubblicati (Bastide M (ed). Signals and
Images. Kluwer Academic Publishers 1997: 161-170).
Il professor Wolfang Süß, dell'Istituto di Farmacia dell'Università di Lipsia, ha utilizzato questo modello
per verificare il trasferimento di attività di un medicinale omeopatico (Atropinum sulphuricum D 60) dalla
forma liquida originale al globulo omeopatico. Come di prassi, sono stati eseguiti diversi controlli. I globuli
di alfa lattosio monoidrato impregnati con Atropinum ad alta diluizione sono stati efficaci in modo
sistematico, ma non si è riuscito ad accertare nessun effetto con i globuli di alfa lattosio anidro. In questo
modo è possibile testare la qualità dei globuli omeopatici prima del loro uso quotidiano in farmacia
(riproducibilità costante). Con questo semplicissimo modello è possibile pertanto fugare i dubbi sull'attività
dei rimedi omeopatici ad altissima diluizione (Schmidt F, Süß WG, Nieber K. In-vitro Testung von
homöopathischen Verdünnungen. Biol. Med./Heft 1/February 2004;32-37).
C'è voluto molto più tempo perché la comunità scientifica accogliesse un altro modello. La sua prima
pubblicazione risale al 1991, ma soltanto nel 2004, dopo uno studio internazionale, i risultati sono stati
finalmente accettati da una rivista peer reviewed di alto livello come Inflammatory Research. È un modello
diverso da quello di J. Benveniste, che utilizzava lo stesso controllo, ma non lo stesso attivatore. I professori
Marcel Roberfroid e Jean Cumps, dell'Istituto di Farmacia dell'Università di Lovanio, che hanno realizzato
rispettivamente lo studio europeo multicentrico (condotto in 4 centri) e l'analisi statistica, hanno spiegato i
protocolli di ricerca e illustrato i risultati. Dal lavoro si evince una significativa inibizione della
degranulazione dei basofili umani con alte diluizioni di istamina (10-30 – 10-38M). Questa ricerca
multicentrica è stata confermata da 3 laboratori applicando la citometria a flusso e da un altro attraverso la
misurazione del rilascio di istamina. Anche se, allo stato attuale, la teoria molecolare non è in grado di
spiegare questi risultati, i fatti sono incontrovertibili, come ha riconosciuto il direttore della rivista
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).
La ricerca sulle alte diluizioni esiste dagli anni Cinquanta, ma qualità e quantità degli studi sono cresciutenell'ultimo decennio. Sono state condotte rassegne sistematiche e metanalisi, spesso ignorate o addiritturanegate (si veda COST B4 supplement report EUR 19110 ISBN 92-828-7434-6). Queste ricerche non solonon vengono incoraggiate, ma sono giudicate inopportune dalle autorità accademiche.
Il professor Jean Cambar, preside della Facoltà di Farmacia dell'Università di Bordeaux, ha descritto iprincipali modelli di ricerche già pubblicate su riviste internazionali e che confermano l'effetto di preparatiomeopatici ad alte diluizioni. Lavori che dimostrano l'efficacia di diluizioni omeopatiche molto elevate dimolecole naturali animali o umane (chiamate anche molecole endogene) sono stati pubblicati più volte suriviste prestigiose. Questi alcuni degli esempi: 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 Toxicol1995; 37(3): 259-260 (Thyroxine, Endler PC); Int J Immunopathol Pharmacol 1996; 9: 43-51 (Bursin,Youbicier-Simo BL).
Nel corso dell'incontro Dimitris Zienkiewicz, immunologo dell'Università scozzese di Edimburgo, hapresentato i risultati preliminari di uno studio che ha valutato con immunosorbenza (citometria di affinità) ecitometria a flusso l'alterazione nell'attivazione e funzione di cellule dendritiche a seguito del lorotrattamento con diluizioni omeopatiche di un batterio. Le cellule dendritiche svolgono un utile ruolonell'attivazione e regolazione del sistema immunitario. Cambiamenti sistematici del profilo delle citochineIL-10, IL-11 e IL-12 non sono spiegabili con la teoria molecolare.
Studi sull'efficacia di diluizioni omeopatiche molto elevate con modelli farmacologici sono stati pubblicatianche su riviste peer-reviewed. Questi alcuni dei riferimenti: Thrombosis. Res. 1994; 76: 225-229(Acetylsalicylic acid in a vessel model. Doutremepuich C); Haemostasis 1990; 20: 99-105 (Acetylsalicylicacid in healthy volunteers. Doutremepuich C); Thrombosis. Res. 1987; 48: 501-504 (Acetylsalicylic acid inhealthy volunteers, Doutremepuich C). Il modello utilizzato più a lungo, negli studi internazionali, è quello tossicologico (Arsenicum, Cadmium,Cisplatino, Cuprum sulphatum ecc.), applicabile a materiale vegetale, animale, a colture di laboratorio eanche a studi clinici. Questo modello è ancora utilizzato ed è al centro della collaborazione fra l'Università di Berna e quella diBologna, mirata a testare gli effetti biologici di trattamenti con triossido di arsenico omeopatico su modellivegetali. Questo gruppo di lavoro (Dr Lucietta Betti. DISTA-, Università di Bologna) ha recentementepubblicato almeno 6 lavori che sono stati eseguiti con rigore, in condizioni controllate, con un numerosufficiente di piante, animali o cellule e con un'analisi statistica corretta. I fatti sono indiscutibili,statisticamente significativi e riproducibili, ma non sono spiegabili con la teoria molecolare.
Il contenuto di preparati omeopatici ad alta diluizione
Questo tema è stato introdotto da Jean Cambar, il quale si è chiesto quali siano i contributi dei vari tipi di
spettroscopia (Raman, ultravioletti, risonanza magnetica o raggi X) nel rivelare la struttura di acqua e
solventi in alte diluizioni. Qual è la vera rilevanza del numero di Avogadro quando si tratta di valutare il
preciso modello molecolare? Una diluizione può funzionare in assenza di molecole? Una delle prospettive
più nuove dell'ultimo decennio è stata la dimostrazione che le alte diluizioni hanno la stessa attività ed
efficacia sia in un solvente strutturato senza nessuna molecola di soluto sia in presenza di molecole (anche
solo alcune molecole).
Il professor Louis Rey, di Losanna, specialista in termoluminescenza a bassa temperatura, ha pubblicato
lavori su questo tema sulle riviste internazionali Nature (1988; 391: 418) e C.R.Physique (2000; 1: 107-
110). Rey ha presentato i risultati più recenti delle ricerche condotte con Philippe Belon sulla
termoluminescenza di diluizioni ultramolecolari di cloruro di litio e di sodio. Diluizioni ultramolecolari di
cloruro di sodio e di litio (10-30 g-cm-3) sono state irradiate con raggi X e gamma a 77 K, indi sono state
progressivamente riscaldate a temperatura ambiente. Durante quella fase si è studiata la loro
termoluminescenza e si è visto che, nonostante le sostanze fossero diluite oltre il numero di Avogadro, la
luce emessa era specifica dei sali originali dissolti all'inizio.
Con grande sorpresa degli autori, i risultati sperimentali hanno dimostrato, senza margini di dubbio, la
specificità dell'informazione contenuta nella diluizione. Questi risultati si sono mostrati riproducibili in
molti altri identici esperimenti. L'ipotesi di lavoro proposta dai ricercatori è che il fenomeno derivi da un
marcato cambiamento strutturale nella rete dei legami di idrogeno avviato, all'inizio, dagli ioni dissolti,
conservata nel processo di diluizione e imputabile, probabilmente, a successivi e vigorosi scuotimenti
meccanici (Physica 2003; A323: 67-74).
La professoressa Guadalupe Ruiz-Vega, dell'Università messicana di San Nicolas de Hidalgo, ha presentato
le sue ultime pubblicazioni in termodinamica che hanno dimostrato l'effetto biologico di due composti a
dosi ultramolecolari (in corso di pubblicazione)
Il ricorso alle tecniche moderne da parte di specialisti è dunque il metodo migliore per mostrare agli scettici
che i fatti empirici sono solidamente fondati e confermati da esperimenti riproducibili. Anche in diluizioni
ultramolecolari, l'informazione specifica della sostanza primaria rimane nel preparato e si può scoprire
sperimentalmente.
Un nuovo paradigma teorico
È stata affrontata anche la questione dell'impianto teorico che consente di spiegare gli effetti delle diluizioni
omeopatiche.
Due membri del GIRI (Gruppo internazionale di ricerca sull'infinitesimale, www.giriweb.com), Madeleine
Bastide (Università di Montpellier) e Agnes Lagache (Cattedra di Filosofia, Parigi) studiano questo tema da
16 anni. Un nuovo paradigma della scienza medica è necessario per spiegare certi fatti e per formulare, in
futuro, modelli di ricerca più precisi.
Un gruppo di lavoro di 7 membri ha applicato questo nuovo paradigma all'analisi dei risultati
sperimentali."Quando il fatto osservato non corrisponde a una teoria nota, bisogna accettare il fatto e
rifiutare la teoria" (Claude Bernard, Introduction à la médicine expérimentale).
Madeleine Bastide ha spiegato che l'omeopatia e i modelli di ricerca si basano sull'osservazione dei
"sintomi". Esistono patologie asintomatiche che provocano "cicatrici biologiche" come prova che
l'organismo si è autocurato senza mostrare i sintomi della malattia (Charles Nicolle, Premio Nobel 1929,Life and death of illness). Sintomi e modificazioni biologiche non sono equivalenti e competono a livelli diversi del corpo. Il sintomopuò essere un'espressione del corpo quando questo non riesce a trovare una risposta, quale che sia lasituazione (infezione, stress, forti emozioni). Si consideri il seguente esempio: rosolia in soggetto normale,nessuna malattia manifesta; rosolia in soggetto immunodeficiente, malattia manifesta.
Per l'approccio sperimentale allopatico, i sintomi sono patognomonici, specifici della malattia, e vengonoutilizzati per diagnosticare una patologia. Una volta formulata la diagnosi, la terapia convenzionale siindirizzerà contro i sintomi. Per l'approccio sperimentale omeopatico, i sintomi sono idiosincrasici, vale a dire specifici del paziente.
Essi sono l'espressione, assolutamente personale, della malattia di quel paziente e servono per selezionareun rimedio specifico sulla base della similitudine con i sintomi osservati, nel proving, in un soggetto sano.
Il corpo vivente è in un processo costante e irreversibile di apprendimento; comunica con l'ambiente a ognilivello. Esso è in grado di ricevere e trattare informazioni, semantiche e materiali, e non è un oggetto inerte(The paradigm of corporeal signifiers. Bastide M., Lagache A. Revue Intern. Systémique 1995; 9: 237-249and Altern Ther Health Med. 1997; 3: 35-9).
La storia di Robison Crusoe
Sono 3 i principi che definiscono l'omeopatia basata sull'analisi clinica e sperimentale: il principio della
similitudine, quello della persona nella sua globalità e l'utilizzo di alte diluizioni. Gli effetti delle alte
diluizioni non si possono spiegare con la semplice interazione molecola-recettore, come fa il paradigma
meccanicista alla base della scienza moderna.
Bastide e Lagache propongono un approccio epistemologico all'omeopatia che si fonda sui processi delle
informazioni ricevute e interpretate dall'organismo vivente; questo approccio segue le regole dello scambio
di informazioni. Lo scambio di oggetti fra un donatore e un ricevente è molto semplice: uno perde e l'altro
guadagna, la somma è costante. D'altro canto l'informazione non è un oggetto, ma la traccia di un oggetto –
la mediazione fra oggetto e chi lo riceve è necessaria perché sia trasmesso un segnale.
Si prenda come esempio la storia di Robinson Crusoe: Crusoe scorge l'orma di Venerdì sulla sabbia, ma non
vede il piede. Per lui l'orma significa che c'è un altro uomo sull'isola. Il piede di Venerdì è dunque la
matrice dell'informazione, mentre la sabbia è il carrier, il vettore. Quando il vettore scompare, scompare
anche l'informazione.
L'informazione è compresa solo dal ricevente e la comprensione dipende dal contesto (R. Crusoe sa di
essere solo sull'isola). Lagache e Bastide suggeriscono perciò che in omeopatia la matrice dell'informazione
sia la sostanza di partenza del rimedio, mentre le diluizioni e succussioni del materiale originario in un
solvente sono i mediatori. Le alte diluizioni contengono solo informazioni di quel materiale, ma non restano
molecole. Questa mediazione scaturisce dal fatto che il solvente succusso si trova in uno stato specifico che
implica, forse, processi elettromagnetici.
Il ricevente (l'intero corpo vivente) riceve e processa l'informazione contenuta nel rimedio in conformità
con il suo stato, se è sano si avrà un proving, se è malato una terapia. Le basi di questo paradigma sono
confermate da risultati sperimentali sistematici ottenuti come descritto nella prima parte della conferenza. Il
nuovo paradigma è necessario per spiegare i fatti empirici e capire il fallimento dei modelli di ricerca non
conformi ad esso.
L'effetto clinico dei preparati omeopatici
Un disegno sperimentale è pertinente solo se prende in considerazione il fenomeno osservato nella sua rete
specifica e se il soggetto preso in esame può essere isolato dalle influenze esterne. Nella medicina umana, i
fattori psicologici sono responsabili di effetti non specifici, mentre gli effetti del farmaco si definiscono
specifici. Quale che sia il modello sperimentale, nell'approccio omeopatico si devono considerare i sintomi
idiosincratici (specifici del paziente) ed escludere quelli patognomonici.
Il professor Leoni Bonamin, dell'Università Paulista di San Paolo in Brasile, presidente del GIRI, ha passato
in rassegna gli studi di veterinaria omeopatica. Sono studi importanti per l'omeopatia: in veterinaria, infatti,
è più facile isolare l'azione del trattamento essendo l'effetto placebo quasi inesistente e le considerazioni
etiche minori. Inoltre, gli studi condotti su greggi ben definiti permettono di includere campioni molto
omogenei di un ampio numero di animali. Nondimeno, le regole per condurre studi ben disegnati devono
considerare le peculiarità della ricerca omeopatica riguardo al principio dei Simili (esaminando i sintomi
idiosincratici).
Gli studi in veterinaria rivestono grande importanza anche per la normativa riguardante gli allevamentibiologici. In Europa in questi allevamenti è ammesso l'uso solo di medicinali omeopatici; l'omeopatiarisponde allo scopo di eliminare i residui chimici dalla catena alimentare.
Studi recenti hanno valutato l'impiego di complessi omeopatici utilizzando gruppi placebo paralleli, disegnosperimentale in cieco, campioni omogenei con un numero sufficiente di animali e un protocollo di facilegestione in un allevamento; i risultati sono stati molto buoni. (Filliat C. Particularité de l´utilisation de l´homéopathie en production avicole. Annals of the "Entretiens Internationaux de Monaco 2002", 5-6October 2002. http://www.giriweb.com.). Nei tacchini la somministrazione di complessi omeopatici haridotto l'incidenza di ematomi durante il trasporto di circa il 30%. L'utilizzo di un complesso omeopatico (con sostanze endogene ed esogene) per migliorare la comparsadell'estro nelle scrofe ha consentito di ridurre le inseminazioni ripetute, e dunque la perdita di seme(Riaucourt A. L´Exemple de la Filière Porcine. Annals of the "Entretiens Internationaux de Monaco 2002",5-6 October, 2002. http://www.giriweb.com).
Gli studi in veterinaria minimizzano l'effetto placebo e confermano l'efficacia dei trattamenti omeopatici.
Sono utili anche per analizzare il disegno sperimentale in omeopatia. Applicando un modello di dermatosipsicogena su cani e gatti (Torro et al, in corso di pubblicazione) il trattamento con il simillimum per 6 mesiha ottenuto il 70% di successo. Un anno dopo la fine del trattamento non ci sono state recidive, lo studio èdurato nel complesso 6 anni. La lunghissima efficacia del trattamento omeopatico è una delle ragioni checonsentono di studiare a fondo il disegno sperimentale in cross over. Poiché gli studi patogenetici sonomolto rari in veterinaria, spesso i veterinari sono costretti a estrapolare i dati dalla patogenesi umana; la loroMateria Medica si basa dunque sui classici studi condotti sull'uomo.
Gli studi clinici sull'uomo
Un secondo gruppo di lavoro si è occupato di ricerca clinica affrontando in particolare i temi
dell'individualità e della complessità.
La medicina basata sulle prove di efficacia (EBM) dà la precedenza assoluta alla valutazione dell'effetto
terapeutico (TET, therapeutic effects testing), a partire dalla ricerca di base, fino alla ricerca clinica, agli
studi randomizzati e controllati (RCT), alle revisioni e metanalisi di più RCT.
Il livello di TET raggiunto stabilisce il livello di evidenza di un dato farmaco. La valutazione dell'uso
clinico (CUT, clinical use testing) - singoli casi, ricerche epidemiologiche, studi costi-benefici - interessa
solo le autorità sanitarie pubbliche e i pazienti, ma non è sufficiente ai fini della medicina basata
sull'evidenza. Fra questi due approcci non c'è di fatto nessun contatto.
L'omeopatia basata sulle prove di efficacia (EBH) inizia e finisce con il paziente individualizzato. Essa si
può raffigurare come un arco: da una parte c'è l'esame del paziente, dall'altra lo strumento terapeutico. Per
capire il paziente, coglierne la vulnerabilità di base, latente o manifesta, dobbiamo considerarne la totalità
nel tempo e nello spazio. Questa totalità deve essere modalizzata qualitativamente con una valutazione
temporale per ottenere la sindrome minima di valore massimo. Lo strumento terapeutico può essere
l'autoguarigione (nessuna sindrome, nessun rimedio) o l'applicazione di un modello di vita o di un regime
dietetico atto a eliminare gli ostacoli alla cura.
Si può prendere in considerazione un rimedio omeopatico dopo averne studiato le caratteristiche chimico-
fisiche, la tossicologia, l' impiego terapeutico consueto: è il primo passo, l'ipotesi.
Il secondo gradino concerne la probabilità, attraverso un primo proving (protocollo in cieco) su volontari
sani, il terzo è la conferma con altri proving, il quarto la conferma con uno studio fisio-patologico e l'ultimo
la verifica nella pratica clinica quotidiana.
Per i rimedi dobbiamo avere la stessa valutazione qualitativa che abbiamo per i pazienti, ma la chiave di
volta del processo omeopatico (senza la quale quell'arco crollerebbe) è la Legge dei Simili. La ricerca
omeopatica deve concentrarsi su proving di qualità eseguiti su volontari sani e sulla verifica clinica nella
pratica quotidiana. Dopo molti anni di studio, perciò si deve dare la massima precedenza alla raccolta
sistematica di casi clinici (progetto CLIFICOL). Il metodo statistico Bayesiano, un approccio particolare che
adatta i risultati a seconda dei dati in ingresso, può aiutare a definire la base scientifica dei repertori
omeopatici.
Questo approccio è stato illustrato dall'olandese Lex Rutten. È possibile colmare il gap che c'è fra medicina
basata sull'evidenza e omeopatia basata sull'evidenza?
Harld Walach, dell'Università di Friburgo, ha presentato una rassegna dei lavori già pubblicati. L'omeopatia
è una medicina popolare (in Francia è utilizzata da circa il 50% della popolazione) e storicamente di
successo sia sul piano di singoli individui (Paganini, Radetzky ecc.) sia su quello generale (efficacia nel
colera e altre epidemie che hanno funestato l'Europa). L'omeopatia resta efficace nonostante le critiche chele vengono rivolte e cresce nonostante (o a causa di?) la moderna tecnologia medica. Le pubblicazioni più recenti, utilizzando questionari validati sulla qualità della vita, hanno mostrato, per glianni 2000-2004, un significativo miglioramento clinico in 6915 pazienti (circa il 70%, percentuali più altenei bambini). Si è visto che l'omeopatia ha costi minori rispetto alla medicina convenzionale e consente diridurre le giornate di congedo per ragioni di salute. In patologie come l'asma bronchiale (89% di miglioramento, percentuale più alta dopo 2 anni di terapia), lapalliazione dei pazienti oncologici (miglioramento della qualità della vita, riduzione di ansia eaffaticamento, non del dolore), iperattività infantile (dopo 3 mesi miglioramento del 75% contro il 65%ottenuto con terapie convenzionali), infezioni del tratto respiratorio superiore (miglioramento del 67.3% conl'omeopatia, 56% con il trattamento convenzionale; effetti collaterali: 7.8% con l'omeopatia, 22% con laterapia convenzionale); l'omeopatia è efficace almeno quanto la medicina convenzionale, ma ha costiinferiori e un profilo di sicurezza maggiore. Si deve riconoscere però un "paradosso dell'efficacia". Secondo la gerarchia dell'evidenza, in medicinaconvenzionale lo studio randomizzato e controllato rappresenta il valore più alto, il massimo di rigore evalidità interna. Questo tipo di studi però ha un punteggio di applicabilità basso, una bassa validità esterna ele conclusioni si generalizzano con grande difficoltà. Le serie di casi, invece, mostrano una grande applicabilità, un'elevata validità esterna e conclusionifacilmente generalizzabili. Lo studio randomizzato e controllato valuta implicitamente la questione delplacebo, si chiede solo: "La terapia omeopatica è diversa dal placebo?". Presuppone dunque un modello diomeopatia locale e causale, che la presenza materiale e la "informazione" di un rimedio siano decisive(senza considerare lo stato di salute del "ricevente") e che un effetto "vero" si possa scoprire attraverso lareplicazione. Appare perciò evidente che ci sono delle discrepanze tra l'omeopatia nella pratica clinica quotidiana el'approccio dello studio randomizzato e controllato. Nondimeno degli studi randomizzati e controllati sonostati eseguiti e le metanalisi di questi studi hanno concluso che esiste una chiara evidenza dell'efficacia deltrattamento omeopatico. Evidenza che non si può attribuire solo all'effetto placebo (Linde K, Clausius N,Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Lancet 1997; 350: 834-43 and Dean M.E. HansWalz Preisschrift, Essen:KVC Verlag, 2004.). Per alcune patologie è stato raggiunto lo stesso livello di evidenza della medicina convenzionale: artritereumatoide (6 studi), diarrea infantile (3 studi), ileo post operatorio (8 studi), raffreddore da fieno, asma (4studi). Per l'emicrania i risultati degli studi randomizzati e controllati sono invece deludenti. In pediatria siottengono risultati significativi nelle infezioni ricorrenti, nell'agitazione post-operatoria, problemi diadenoidi, otite media, stomatite in pazienti oncologici (complicanza della terapia convenzionale). Ci sonostudi pilota promettenti su lombosciatalgia, sindrome premestruale e affaticamento cronico.
I problemi degli studi randomizzati e controllati sono i seguenti: sono difficili da replicare (ciò vale anche per il trattamento convenzionale); sono invasivi e costosi, provocano un calo d'interesse dovuto alla mancanza di fondi; quelli in cieco rispondono solo alla questione del placebo; fanno ipotesi infondate.
Esistono chiare prove dell'efficacia clinica dell'omeopatia, come si evince dalla pratica quotidiana e daglistudi controllati. Ci sono dunque indicazioni sufficienti che il "placebo" non basta a spiegare l'azione dellamedicina omeopatica.
L'omeopatia può essere simile o superiore alla terapia convenzionale e, quando è stata studiata, si è mostratameno costosa a lungo termine. Bisognerebbe dare la precedenza a molti interrogativi che finora non si sonoposti, per esempio qual è il potenziale terapeutico dell'omeopatia per evitare trattamenti invasivi in pediatriaoppure, nell'attenzione primaria, la sua azione a lungo termine per prevenire le cronicità.
Idee per il futuro
Nell'incontro si sono discussi anche i progetti per il futuro. Il dottor Galen Ives (Priority Research,
Sheffield) ha condiviso alcune raccomandazioni. Il disegno dei questionari dovrebbe essere orientato dai
requisiti per l'analisi dei dati e il parere professionale richiesto prima di iniziare, pensando con attenzione
alle scale di misurazione (dati soggettivi non espressi in cifre) e presumendo che tutti i responder non
abbiano avuto esperienze precedenti in questo campo. La questione delle scale di tempo è significativa e perquesta ragione è preferibile includere solo nuovi pazienti. Se lo scopo della ricerca è osservare la pratica clinica quotidiana, sono necessari dati demografici ampi.
Bisogna chiedere perché i pazienti hanno scelto l'omeopatia e tenere bene a mente l'obiettivo dello studio.
Per esempio, l'analisi dell'efficacia dell'omeopatia contro la medicina convenzionale, il rapporto costi-efficacia contro la medicina convenzionale. Si consiglia di utilizzare i criteri di inclusione (per es. lo stato disalute) e i sottogruppi (per es. i casi acuti).
Realizzare uno studio sul livello di soddisfazione di un paziente non è la stessa cosa che condurre uno studiosull'efficienza del trattamento. L'efficienza si può valutare al meglio attraverso gli studi sulla qualità dellavita; in questo caso, per il maggior rischio di abbandoni (dropout), sono necessari almeno due questionarisuccessivi.
Il dottor Kivellos Spiros di Atene ha introdotto una scala di gravità che mira a inglobare le leggidell'omeopatia classica nei protocolli di ricerca clinica. Ha proposto una classificazione di "livello di salute"a partire da un livello 1 (soggetto sano) fino al livello 12 (lesioni interne irreversibili). Questo tipo di scalaconsente di valutare la prognosi omeopatica; è stata elaborata la classificazione dei gruppi.
Alla fine dell'incontro sono state tratte le seguenti conclusioni: • Ci sono prove che le alte diluizioni omeopatiche esplicano un'attività biologica.
• Nei preparati omeopatici ad alte diluizioni si può rilevare l'impronta della sostanza di partenza.
• Per la spiegazione dei fenomeni osservati esiste un nuovo paradigma della scienza medica.
• Gli studi in veterinaria confermano l'efficacia clinica dell'omeopatia.
• Gli studi sull'uomo mostrano un miglioramento significativo nel 70% dei pazienti (percentuali più alte in pediatria); l'effetto dell'omeopatia non si può attribuire solo all'effetto placebo; per alcuneindicazioni l'omeopatia ha raggiunto un alto livello di significatività statistica.
• Sono necessari nuovi studi per indagare l'azione preventiva dell'omeopatia in pediatria e nelle malattie croniche. Il finanziamento della ricerca in omeopatia è una questione di vitale importanza. Infine, i partecipanti al simposio hanno diramato questo comunicato stampa:"Su invito dell'ECH, che rappresenta 33 associazioni mediche di 24 Paesi europei, partecipando al XVIIIsimposio del GIRI, 10 docenti universitari di fama internazionale nel campo della ricerca si sono incontrati aBruxelles dal 12 al 15 novembre 2004. Hanno concordato sul fatto che esistono prove chiare dell'efficaciadei medicinali omeopatici e che ciò è una base sufficiente e razionale per sviluppare la ricerca in questosettore. I docenti si sono detti meravigliati per l'assenza di reazione e interesse delle autorità sanitarie aquesti risultati convincenti".
(traduzione e adattamento a cura di Mariella Di Stefano)

Source: http://www.homeovet.cl/Libros/ECH___XVIII_GIRI_Symposium_Nov._2004___Evidence_profile_for_the_efficacy_of_Homeopathy_Tra.pdf