Model Validity and Risk of Bias in Randomised, Placebo-Controlled, Trials of Non-individualised Homeopathic Treatment: Impact on Meta-Analysis Findings

Background: Randomised controlled trials (RCTs) of non-individualised homeopathic treatment (NIHT) apply a pre-selected medicine to typical symptoms of a medical condition. Meta-analysis of such RCTs revealed a small, statistically significant, effect greater than placebo. We have also assessed these RCTs for the risk of bias (RoB; extent of reliable evidence) and for model validity (MV; evidence of best therapeutic practice). Three RCTs were identified 'reliable evidence', based on RoB. When meta-analysis was restricted to these three RCTs, statistical significance was not maintained (pooled odds ratio [OR]: 1.39; 95% confidence interval [CI]: 0.84–2.33; p = 0.20), consistent with a conclusion that NIHT is not distinguishable from placebo. Nine trials were rated as having 'acceptable MV'.