Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis

Abstract

Background: A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos.

Methods: The review's methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial's risk of bias to be designated as low, unclear or high. A trial was judged to comprise 'reliable evidence' if its risk of bias was low or was unclear in one specified domain. 'Effect size' was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

Results: Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed 'uncertain risk of bias', three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed 'high risk of bias'. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

Conclusions: Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous 'global' systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

Figure 1

Forest plot showing odds ratio (OR) and 95% confidence interval (CI) for each of 22 RCTs of individualised homeopathy, with pooled OR (random-effects [RE] model) for trials with continuous outcomes, dichotomous outcomes, and for all 22 RCTs.

Figure 2

Funnel plot: 22 RCTs of individualised homeopathy.

Figure 3

Forest plots showing odds ratio (OR) and 95%cconfidence interval (CI) for each of (a) 22 RCTs of individualised homeopathy, with pooled OR (random-effects [RE] model) for trials with unclear risk of bias (RoB), high RoB, and for all 22 RCTs; (b) 12 ‘B’-rated RCTs of individualised homeopathy, with pooled OR (RE model) for trials with non-reliable evidence, reliable evidence, and for all 12 RCTs.

Figure 4

Sensitivity analysis, showing progressive effect on pooled odds ratio (OR) of removing data by trials’ risk-of-bias rating.

Figure 5

Interactions between sub-groups for (a) all N  = 22 trials with analysable data and (b) N  = 12 ‘B’- rated trials.