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Review
. 2017 Mar 24;6(1):63.
doi: 10.1186/s13643-017-0445-3.

Randomised, Double-Blind, Placebo-Controlled Trials of Non-Individualised Homeopathic Treatment: Systematic Review and Meta-Analysis

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Free PMC article
Review

Randomised, Double-Blind, Placebo-Controlled Trials of Non-Individualised Homeopathic Treatment: Systematic Review and Meta-Analysis

Robert T Mathie et al. Syst Rev. .
Free PMC article

Abstract

Background: A rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment.

Methods: Literature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised 'reliable evidence' if its risk of bias was low or it was unclear in one specified domain of assessment. 'Effect size' was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy.

Results: Forty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as 'high risk of bias' and 23 as 'uncertain risk of bias'; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was -0.33 (95% confidence interval (CI) -0.44, -0.21), which was attenuated to -0.16 (95% CI -0.31, -0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: -0.18 (95% CI -0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence.

Conclusions: The quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.

Keywords: Meta-analysis; Non-individualised homeopathy; Randomised controlled trials; Sensitivity analysis; Systematic review.

Figures

Fig. 1
Fig. 1
Updated PRISMA flowchart for all records published up to and including 2014
Fig. 2
Fig. 2
Forest plot for 54 analysable RCTs of non-individualised homeopathy. Shows SMD (Treatment Effect, TE) and 95% confidence interval (CI). Pooled effects estimate shown for fixed-effect and random-effects model. W weighting
Fig. 3
Fig. 3
a Funnel plot for 54 RCTs of non-individualised homeopathy. Central vertical line is pooled effect estimate: SMD = –0.33. Heterogeneity statistic (I 2) = 65%. b Funnel plot for 54 RCTs of non-individualised homeopathy after ‘trim and fill’. Central vertical line is pooled effect estimate: SMD = –0.16. Heterogeneity statistic (I 2 ) = 79%
Fig. 4
Fig. 4
Forest plots showing SMD (Treatment Effect, TE) and 95% confidence interval (CI) for RCTs of non-individualised homeopathy, with pooled SMD (random-effects model) for trials assessed as minimal or low risk of bias (reliable evidence; N = 3); uncertain risk of bias (non-reliable evidence; N = 23); high risk of bias (non-reliable evidence; N = 28)
Fig. 5
Fig. 5
Sensitivity analysis, showing progressive effect on pooled SMD (treatment effect TE) of removing data by trials’ risk-of-bias rating
Fig. 6
Fig. 6
Interactions between sub-groups for: a all N = 54 trials with analysable data; b N = 26 ‘A’- and ‘B’-rated trials
Fig. 7
Fig. 7
Meta-analysis by clinical condition for: a all N = 54 trials with analysable data; b N = 26 ‘A’- and ‘B’-rated trials. p values for pooled effect estimates: a Allergic asthma: p = 0.307; arsenic toxicity: p = 0.219; female infertility (amenorrhoea): p = 0.407; influenza: p = 0.025; irritable bowel syndrome: p = 0.009; muscle soreness: p = 0.762; post-operative pain: p = 0.143; seasonal allergic rhinitis: p = 0.001. b Allergic asthma: p = 0.307; influenza: p = 0.025; muscle soreness: p = 0.762; post-operative pain: p = 0.859; seasonal allergic rhinitis: p = 0.147
Fig. 8
Fig. 8
Meta-analysis by category of clinical condition for: a all N = 54 trials with analysable data; b N = 26 ‘A’- and ‘B’-rated trials. p values for pooled effect estimates: a Allergy and asthma: p = 0.001; Cardiovascular: p = 0.046; Dermatology: p = 0.047; Ear, nose and throat: p = 0.014; Gastroenterology: p = 0.009; Mental disorder: p = 0.865; Musculoskeletal: p = 0.488; Obstetrics and gynaecology: p = 0.088; Respiratory infection: p = 0.092; Surgery and anaesthesiology: p = 0.448; Toxicology: p = 0.406. b Allergy and asthma: p = 0.041; Dermatology: p = 0.047; Ear, nose and throat: p < 0.001; Mental disorder: p = 0.165; Musculoskeletal: p = 0.762; Obstetrics and gynaecology: p = 0.486; Respiratory infection: p = 0.092; Surgery and anaesthesiology: p = 0.576; Toxicology: p = 0.896

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