BackgroundA method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice.MethodsUsing an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic.ResultsThe six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one.ConclusionFuture systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.

Homeopathy may be a cost-effective alternative to antibiotics in the treatment of recurrent infantile rhinopharyngitis.

Little is known about the practice of homeopathic general practitioners (GPs) in France. We report a descriptive, cross-sectional study on this subject. The aim was to acquire a clearer idea of (1) the type of patients who consult homeopathic GPs and (2) the type of treatment provided by such GPs, in terms of diagnoses, prescriptions and costs. The survey was carried out on a representative sample of the French homeopathic GP population and covered three seasons of the year. The data was collected by means of a questionnaire which GPs completed for each consulting patient. It emerged that the type of patients who consult homeopathic GPs are chiefly women, between the ages of 20 and 54, living in an urban environment, not in employment, covered by National Health Insurance for Salaried Workers, and belonging to a Mutual Benefit Association. The most common reasons for consultation were ENT disorders, stress and anxiety. The homeopathic GPs mainly used homeopathy to treat these disorders. On average, four medicinal products per patient were prescribed per 2-month course of treatment, for an average reimbursed cost of 3.78 Euros.

These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with 'uncertain' or 'inadequate' MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.

Purpose : A new programme of systematic reviews of randomised controlled trials (RCTs) of homeopathy distinguishes several key attributes of study design and quality: placebo controlled cf. other-than-placebo controlled; individualised cf. non-individualised homeopathy; treatment cf. prophylaxis; internal validity cf. model validity. The present phase of the review programme focuses on assessing the model validity (MV) of peer-reviewed, placebo-controlled, RCTs of individualised homeopathic treatment. Methods : A systematic literature search and subsequent reappraisal of retrieved records identified 31 RCTs that satisfied the inclusion criteria for the present study. MV of the eligible RCTs was appraised using a novel criterion-based method. Assessment domains address: (i) the rationale for the choice of the particular homeopathic intervention; (ii) the homeopathic principles reflected in the intervention; (iii) the extent of homeopathic practitioner input; (iv) the relevance of the main outcome measure; (v) the capability of the main outcome measure to detect change; (vi) the length of follow-up to the endpoint of the study. These six MV domains per RCT were categorised by each of three independent assessors as ?acceptable?, ?unclear? or ?unacceptable?, disparities of opinion being resolved by consensus discussion. Results : Domain-specific and overall ratings of MV per RCT await the outcome of ongoing consensus discussions. A full set of findings will be presented at conference. Conclusions : MV data contribute importantly to the appraisal of RCT quality in systematic reviews of homeopathy.