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Systematic Reviews
Published in: Systematic Reviews 1/2017

Open Access 01-12-2017 | Research

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

Authors: Robert T. Mathie, Nitish Ramparsad, Lynn A. Legg, Jürgen Clausen, Sian Moss, Jonathan R. T. Davidson, Claudia-Martina Messow, Alex McConnachie

Published in: Systematic Reviews | Issue 1/2017

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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.
Appendix
Available only for authorised users
Footnotes
1
In practice, data were not derivable from the three relevant trials with continuous data: due to the original authors’ use of either medians or ‘change’ data only.
 
2
This nomenclature is not intended to be definitive, but a basis for more refined analysis at a later date.
 
4
Additional file 2 represents an update of the flowchart included in the original study protocol [3].
 
5
Mathie RT, Van Wassenhoven M, Rutten ALB, Klein-Laansma CT, Eizayaga J, Pla i Castellsagué A, Jong MC, Manchanda RK, Dantas F, Oberbaum M, Frye J, Roniger H, Baumgartner S, van Haselen R, Nicolai T, Fisher P. Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment. Submitted for publication.
 
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Metadata
Title
Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis
Authors
Robert T. Mathie
Nitish Ramparsad
Lynn A. Legg
Jürgen Clausen
Sian Moss
Jonathan R. T. Davidson
Claudia-Martina Messow
Alex McConnachie
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2017
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-017-0445-3

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