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01.12.2017 | Research | Ausgabe 1/2017 Open Access

Systematic Reviews 1/2017

Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis

Zeitschrift:
Systematic Reviews > Ausgabe 1/2017
Autoren:
Robert T. Mathie, Nitish Ramparsad, Lynn A. Legg, Jürgen Clausen, Sian Moss, Jonathan R. T. Davidson, Claudia-Martina Messow, Alex McConnachie
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13643-017-0445-3) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: Checklist. PRISMA 2009 Checklist. (DOC 66 kb)
13643_2017_445_MOESM1_ESM.doc
Additional file 2: Details of records of non-individualised homeopathy included in, and excluded from, systematic review and meta-analysis. SD, standard deviation. In comparison to the protocol [ 3], A110 Ramelet has been excluded from this systematic review due to its updated identification as a prophylaxis trial. (DOCX 76 kb)
Additional file: 3 Risk-of-bias bar-graph for 75 RCTs of non-individualised homeopathy. (DOCX 170 kb)
13643_2017_445_MOESM3_ESM.docx
Additional file 4: Forest plots, showing (a) standardised mean difference (SMD) and (b) odds ratio (OR), with 95% confidence interval (CI) for original data (continuous or dichotomous) extracted per trial of non-individualised homeopathy. Pooled effects estimate shown for fixed-effect and random-effects model. W, weighting. To ensure consistent direction of measurement with disease severity, sign inversion was applied to the mean value of five trials in (a). [Reflecting the fact that OR > 1 favours homeopathy, the direction of change toward homeopathy in plot (b) is to the right, thus differing from all other plots]. (ZIP 15 kb)
13643_2017_445_MOESM4_ESM.zip
Literatur
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