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Systematic Review of ‘Pragmatic’ Randomised Controlled Trials of Individualised Homeopathic Treatment
05 February 2018 (online)
Introduction: This ongoing study focuses on randomised controlled trials (RCTs) of individualised homeopathic treatment (IHT) in which the control (comparator) group was other than placebo (OTP).
Objectives: To assess the risk of bias (RoB) and determine whether its study attitude was relatively ‘pragmatic’ or ‘explanatory’. To determine the comparative effectiveness of IHT on health-related outcomes, including for any clinical condition that has been the subject of at least one OTP-controlled trial.
Methods: Systematic review. For each eligible trial, published in the peer-reviewed literature up to the end of 2015, we assessed its RoB using the seven-domain Cochrane tool and its relative pragmatic or explanatory attitude using the 10-domain PRECIS tool. We sub-grouped RCTs by whether they examined IHT as alternative treatment (study design ‘a’), adjunctively with another intervention (design ‘b’), or compared with no intervention (design ‘c’). We identified a single ‘main outcome measure’ per RCT to use in meta-analysis.
Results: Eleven RCTs, representing 11 different medical conditions, were eligible for this study: 7 design ‘a’ and 4 design ‘b’ trials. Five of the 11 RCTs had relatively pragmatic study attitude, 2 were relatively explanatory, and 4 were equally pragmatic and explanatory. Nine trials were rated ‘high RoB’ overall. Only one trial, which was equally pragmatic and explanatory, did not have high RoB in at least one domain; another, relatively pragmatic, trial had high RoB solely in regard to participant non-blinding. Data extraction for comparative effectiveness analysis is a work in progress.
Conclusion: Two trials with least RoB contribute most importantly to comparative effectiveness research in IHT. The modest proportion of relatively pragmatic trials is noteworthy. Absence of replicated research for any given medical condition will focus our data analysis on single trials and on sub-groups of trials by study design and by RoB.
Keywords: Comparative effectiveness, explanatory trial, individualised homeopathic treatment, pragmatic trial, randomised controlled trial, risk of bias, systematic review