Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study

Abstract

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.

Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment

“…We previously applied the appraisal methods for RoB and for model validity of homeopathic treatment (MVHT), as described, 1,[3][4][5] to peer-reviewed papers that reported randomised placebo-controlled trials of individualised homeopathy, published up to the end of 2013. Through formal literature search methods, and after application of defined exclusion criteria, 31 papers (reporting a total of 32 RCTs) were found to be eligible for systematic review.…”

“…For each trial, the domains for MVHT assessment are summarised as follows 3,5 : Domain I (Rationale): Would a significant body of accredited homeopaths support the rationale for the intervention used in the study? Domain II (Principles): Is the specific intervention used consistent with homeopathic principles?…”

“…9 It is unknown to what extent model validity might impact on the interpretation of RCT findings in other branches of Complementary/Alternative Medicine (CAM); our MVHT method seems adaptable to addressing that question, as previously proposed. 5 It is also currently unknown if other potential flaws, connected with deficiencies of external validity for example, 10 might impinge on overall quality ratings of the trials we examined.…”

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“…According to the philosophy of Homeopathy, treatment of any illness is based on the totality of symptoms and selection of medicines through reportorial approach based on individualization 7 .…”

An Open-Label Pilot Study of Homeopathic Treatment of Attention Deficit Hyperactivity Disorder in Children and Youth

“…Recommended study design features in this field include allowing choice and change of the homeopathic remedy intervention throughout the course of the treatment period; performing pilot analyses to obtain accurate estimates of effect size achievable by specific practitioners; and testing long treatment periods to enable observation of remedy changes over the course of treatment [10,11,12,13,14]. …”