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Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Non-Individualised Homeopathic TreatmentFunding The systematic review programme has been supported by a grant from the Manchester Homeopathic Clinic.
01 August 2018
09 November 2018
30 January 2019 (online)
Introduction This study focuses on randomised controlled trials (RCTs) of non-individualised homeopathic treatment (NIHT) in which the control (comparator) group was other than placebo (OTP).
Objectives To determine the comparative effectiveness of NIHT on health-related outcomes in adults and children for any given condition that has been the subject of at least one OTP-controlled trial. For each study, to assess its risk of bias and to determine whether its study attitude was predominantly ‘pragmatic’ or ‘explanatory’.
Methods Systematic review. For each eligible trial, published in the peer-reviewed literature up to the end of 2016, we assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. We grouped RCTs by whether these examined IHT as alternative treatment (study design 1a), adjunctively with another intervention (design 1b), or compared with no intervention (design 2). RCTs were sub-categorised as superiority trials or equivalence/non-inferiority trials. For each RCT, we designated a single ‘main outcome measure’ to use in meta-analysis: ‘effect size’ was reported as odds ratio (OR; values > 1 favouring homeopathy) or standardised mean difference (SMD; values < 0 favouring homeopathy).
Results Seventeen RCTs, representing 15 different medical conditions, were eligible for study. Three of the trials were more pragmatic than explanatory, two were more explanatory than pragmatic, and 12 were equally pragmatic and explanatory. Fourteen trials were rated ‘high risk of bias’ overall; the other three trials were rated ‘uncertain risk of bias’ overall. Ten trials had data that were extractable for analysis. Significant heterogeneity undermined the planned meta-analyses or their meaningful interpretation. For the three equivalence or non-inferiority trials with extractable data, the small, non-significant, pooled effect size (SMD = 0.08; p = 0.46) was consistent with a conclusion that NIHT did not differ from treatment by a comparator (Ginkgo biloba or betahistine) for vertigo or (cromolyn sodium) for seasonal allergic rhinitis.
Conclusions The current data preclude a decisive conclusion about the comparative effectiveness of NIHT. Generalisability of findings is restricted by the limited external validity identified overall. The highest intrinsic quality was observed in the equivalence and non-inferiority trials of NIHT.
Keywordscomparative effectiveness - explanatory trial - non-individualised homeopathic treatment - meta-analysis - pragmatic trial - randomised controlled trial - risk of bias - systematic review
• This systematic review focuses on randomised controlled trials (RCTs) of non-individualised homeopathic treatment (NIHT) in which the control (comparator) group was other than placebo.
• For each eligible trial, risk of bias was assessed using Cochrane methods, and its relative pragmatic or explanatory attitude was approximated using the PRECIS tool.
• Seventeen RCTs, representing 15 different medical conditions, were eligible for inclusion.
• Fourteen RCTs were rated ‘high risk of bias’; the other three trials were rated ‘uncertain risk of bias’.
• Only three RCTs were judged to have clearly pragmatic study attitude.
• Quantitative data extraction did not yield a decisive conclusion about the comparative effectiveness of NIHT.
RTM devised and led the study, developed the study protocol and contributed to all facets of the work. YYYF helped to develop the study protocol, co-assessed trials for risk of bias, co-assessed trials for pragmatic/explanatory study attitude, contributed to data interpretation and edited the manuscript. PV helped to develop the study protocol, co-assessed trials for pragmatic/explanatory study attitude, contributed to data interpretation and edited the manuscript. AKLT co-assessed trials for risk of bias and contributed to data interpretation. JRTD helped to develop the study protocol, contributed to data interpretation and edited the manuscript. All authors have approved the final manuscript.
Authors RTM, YYYF, PV and AKLT are (or were) associated with a homeopathy organisation whose significant aim is to clarify and extend an evidence base in homeopathy. RTM holds an independent research consultancy contract with the Deutsche Homöopathie-Union, Karlsruhe, Germany. YYYF and AKLT belong to Living Homeopathy Ltd., which has contributed funding to some (but not this current) HRI project work. RTM and PV have no other relationships or activities that could appear to have influenced the submitted work. JRTD had no support from any organisation for the submitted work; in the last 3 years, and for activities outside the submitted study, he received personal fees, royalties or out-of-pocket expenses for advisory work, invitational lectures, use of rating scales, published book chapters or committee membership; he receives royalties from Springer Publishing Company for his book, A Century of Homeopaths: Their Influence on Medicine and Health. JTRD has no other relationships or activities that could appear to have influenced the submitted study.
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