[Omeo33] Art 0704 - Homeopathy, 2007, 96 (1), 4-16

Gino Santini g.santini a ismo.it
Mer 4 Mar 2009 08:36:40 CET


A systematic review of the quality of homeopathic pathogenetic trials  
published from 1945 to 1995
F. Dantas, P. Fisher, H. Walach, F. Wieland, D.P. Rastogi, H.  
Teixeira, D. Koster, J.P. Jansen, J. Eizayaga, M.E.P. Alvarez, M.  
Marim, P. Belon and L.L.M. Weckx

Background - The quality of information gathered from homeopathic  
pathogenetic trials (HPTs), also known as ‘provings’, is fundamental  
to homeopathy. We systematically reviewed HPTs published in six  
languages (English, German, Spanish, French, Portuguese and Dutch)  
from 1945 to 1995, to assess their quality in terms of the validity of  
the information they provide.
Methods - The literature was comprehensively searched, only published  
reports of HPTs were included. Information was extracted by two  
reviewers per trial using a form with 87 items. Information on:  
medicines, volunteers, ethical aspects, blinding, randomization, use  
of placebo, adverse effects, assessments, presentation of data and  
number of claimed findings were recorded. Methodological quality was  
assessed by an index including indicators of internal and external  
validity, personal judgement and comments of reviewers for each study.
Results - 156 HPTs on 143 medicines, involving 2815 volunteers,  
produced 20,538 pathogenetic effects (median 6.5 per volunteer). There  
was wide variation in methods and results. Sample size (median 15,  
range 1–103) and trial duration (mean 34 days) were very variable.  
Most studies had design flaws, particularly absence of proper  
randomization, blinding, placebo control and criteria for analysis of  
outcomes. Mean methodological score was 5.6 (range 4–16). More  
symptoms were reported from HPTs of poor quality than from better  
ones. In 56% of trials volunteers took placebo. Pathogenetic effects  
were claimed in 98% of publications. On average about 84% of  
volunteers receiving active treatment developed symptoms. The quality  
of reports was in general poor, and much important information was not  
available.
Conclusions - The HPTs were generally of low methodological quality.  
There is a high incidence of pathogenetic effects in publications and  
volunteers but this could be attributable to design flaws. Homeopathic  
medicines, tested in HPTs, appear safe. The central question of  
whether homeopathic medicines in high dilutions can provoke effects in  
healthy volunteers has not yet been definitively answered, because of  
methodological weaknesses of the reports. Improvement of the method  
and reporting of results of HPTs are required.

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