Attacco di Lancet all'omeopatia: un anno dopo posted on 09-08-2006
Società Svizzera dei medici omeopati (SVHA):
A distanza di una anno, la critica metodica della SVHA è di stringente attualità: il lavoro di Egger non è un corretto studio scientifico e le sue conclusioni sono del tutto inconsistenti.
Link alla versione italiana di Lancet (Abstract)
Ecco la versione inglese integrale della presa di posizione della SVHA:
(il grassetto e le note sono del curatore, Andrea Valeri)
Swiss Association of Homoeopathic Physicians SAHOP SVHA/SSMH/SSMO/SAHOP
Statement of the Swiss Association of Homoeopathic Physicians on the homoeopathic study of the Institute of Social and Preventive Medicine (ISPM) in Bern (“Egger study”)
From a homoeopathic point of view, the ISPM homoeopathic study demonstrates considerable shortcomings and is not tenable for the following reasons.
1. Breach of agreements: ISPM designed the study as part of the Complementary Medicine Evaluation Programme (PEK). With the preview presentation of the study in Basle at the end of August 2003 and the distribution of presentation documents to the media, ISPM breached several PEK agreements. ISPM a) did not submit the study for PEK internal discussion beforehand, b) did not meet the obligation of enlisting specialists, c) did not allow specialists to examine it after the media reports and therefore also disregarded usual scientific practices, d) did not meet the PEK obligation to maintain secrecy and e) did not comply with the Institute’s own publication guidelines. Whether the contract with PEK management was also breached is beyond our knowledge, since the wording of the contract is as unclear to us as the actual purpose of the work. The PEK executive committee and programme management have apologised to homoeopaths for certain errors made in assigning the ISPM study.
2. Untenable proceedings in the media: The ISPM study was the linchpin for the biased report in the SonntagsZeitung of 31.8.2003 [a] . Since then, Profe[ssor Egger and ISPM have repeatedly let it be reported in print and on the radio, that the effects of homoeopathy can be explained by the placebo effect. This damages the reputation of homoeopathy and unfairly condemns it as being simple and generating a lot of media attention, while being rash and wrong (cf. criticism of content). Both the scientific position and practice of Prof. Egger are untenable. The quiet counterstatements of PEK management and the Federal Social Insurance Office (BSV) in September 2003 received no publicity. The homoeopathic side has met the obligation to maintain secrecy within the framework of PEK, even though one of the co-authors of the ISPM study again referred to the negative result at a phytotherapy conference in November 2004 .
[a] Egger article publication date on Lancet is 27/08/2005
3. No examination of the study: Contrary to the agreements, ISPM has long resisted an examination of the content of its study within the framework of PEK. After refusing for a long time, ISPM finally allowed homoeopaths to examine the study at a private crisis talk on 3.6.2004 - 10 months(!) after it had been distributed to the media. And only 1½ years later, from the middle of January 2005, were homoeopathic specialists really able to see the study, which had been submitted for publication in August 2004.
4. No use of specialist knowledge: As the sole PEK contractor, ISPM did not enlist homoeopathic specialists. To avoid criticism about a lack of specialist knowledge, ISPM subsequently included a former homoeopath, now employed by ISPM, in the list of authors, who had not been named as a co-author until 3.6.2004.
5. Odd acknowledgements: ISPM included – without prior request and unknown to them – homoeopathic physicians, who took part in the crisis talks, in the acknowledgements list of its publication. This is a peculiar and odd action, which is seen by homoeopaths as an attempt by the authors to avoid criticism about the non-participation of experts and lack of specialist knowledge. In the meanwhile, all the homoeopaths named in the acknowledgements have prohibited ISPM from naming them in the article.
6. Summary: The approach of Prof. Egger and ISPM with regard to PEK and in the media is in breach of agreements, is unfair, does not conform to scientific practice and is untenable.
7. False message: The simple message of the ISPM study, “Homoeopathy equals placebo”, admittedly generates a lot of media attention, but is untenable. The study claims that it measures homoeopathy but in fact the study is unable to assess homoeopathy at all using its methodology. This is because firstly, the homoeopathic studies examined have almost nothing to do with homoeopathy as it is really practiced, secondly, almost all other large surveys and meta-analyses of homoeopathic studies have a positive result, and thirdly, the study demonstrates a series of further shortcomings.
8. Distorted homoeopathy for study purposes: Most homoeopathy effectiveness studies do not comply with basic homoeopathic rules, in no way correspond to real treatment practice and are – unlike studies of conventional medicine – irrelevant to practice. These studies are only carried out as external justification for homoeopathy. In real practice the selection of homoeopathic remedies is carried out completely on an individual basis. The remedy does not have a universal effect; rather it proves to be effective for the individual. In contrast, for study purposes, homoeopathic practices are usually distorted and standardised and forced into irrelevant research schemes. The result of this is a considerable risk of obtaining falsely negative results. The homoeopathic attitude to such studies is conflicting.
16. Problematic analysis: The assessment is solely carried out using the funnel plot method, a graphical statistical analysis. According to the authors, 21 homoeopathic studies and 9 conventional studies demonstrate higher quality. So the main emphasis is on a very small number of large studies. The result from only 8 “good” homoeopathic studies with a large number of participants is less positive than that from only 6 “good” large conventional studies. With the funnel plot method, the authors draw a straight line from the small and medium-sized studies in the direction of the few large, but less effective ones. The continuation of this straight line moves more in the direction of the placebo line for homoeopathy than for allopathy. Therefore, from the overwhelming number of positive studies (a 3:1 ratio insofar as visible on the graph), a negative result emerges for the authors. The result is suspicious. How can a negative result be produced from so many positive studies? The negative result for homoeopathy is entirely the outcome of a statistical extrapolation from a few large studies. (Here is a comparative example: If the method is used to answer the question of whether there are red apples and in order to do this 10 apple trees with red apples and 3 trees each with a slightly larger number of green apples are examined, the funnel plot method produces the result that - there are no red apples.)
17. Overemphasis of the size of the study and unsuitable study method: The funnel plot method with its biased high evaluation of the number of study participants may be justified as graphical statistical analysis for the examination of homogenous standardised interventions of conventional pharmacotherapy, however, it is not appropriate for homoeopathic studies with their heterogeneity and complex study problems. If for example one takes a range of studies concerning beta-blockers for a certain indication, the size of the study may be important and the ISPM method may contribute to clarification of the effect. With homoeopathic studies this is not the case for the following reasons: 1. The studies include different study models and different distorted homoeopathic methods, which cannot all be regarded in the same way. Otherwise it is like comparing apples to pears. 2. The ISPM method would only be correct for examining the same type of study models or homogenous interventions and methods. 3. As a rule the larger the study, the smaller the chance that adequate homoeopathy has been examined and the less valid it is to real practice (low external validity). 4. The homoeopathic studies hide the risk of falsely negative results because of their low validity to real practice. In the context of this distorted homoeopathy for study purposes there exist trials with both, positive and negative results. A negative result just means that the model is not suitable for proving effectiveness. When counting results, positive and negative ones cannot be set off against each other (HTA Homoeopathy Chap. 12). Proof of effectiveness with distorted homoeopathy for study purposes can only ever be exemplary.
18. Correct application? The technical quality and correct application of the complex statistical graphical analysis method cannot be assessed by us; this must be done by other analysts.
19. Intransparent analysis: In their study the authors do not make it clear which point in their graphical statistical analysis corresponds to which study and ought to be critically analysed, which is clearly a shortcoming. They do not demonstrate in their study, which large studies lead to a negative result. Why this intransparency in making it possible to comprehend the results? Information on the individual studies is missing so that the ISPM study can only be checked by laboriously sifting through the list of references and assessing the individual studies oneself! Only then does it become clear on which studies the negative result of the ISPM study is based.
Conclusion1: Nowhere do the authors acknowledge the homoeopathic quality and the lack of practical relevance of the studies examined (low external validity). They claim to be measuring something which they are unable to assess on the strength of their study. In summary, the ISPM study of Egger and colleagues demonstrates, in addition to questionable procedures, considerable shortcomings with regard to content. The study’s assumption that homoeopathic effect is due to placebo therapy is scientifically untenable on the basis of the facts.
Conclusion 2: Despite a breach of basic homoeopathic rules, numerous studies have succeeded in producing fundamental and exemplary evidence for the experimental effect and clinical effectiveness of homoeopathy. Recent large observational studies (outcome studies), e.g. in Germany on up to 4,000 patients also show evidence of effectiveness under real practice conditions and with higher external validity (HTA Homoeopathy Chap. 3.2.).
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