[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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