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Randomised controlled trials of homeopathy: examining the evidence

What is this project about?

This large programme of work, funded significantly by the Manchester Homeopathic Clinic, aims to clarify the research evidence in homeopathy that is available from published randomised controlled trials (RCTs). Using the robust methods of systematic review and meta-analysis, the programme aims to identify the study quality and the magnitude of the treatment effect that has been reported in peer-reviewed RCTs.

Importantly, the review work reflects the key differences between: placebo-controlled and other-than-placebo controlled trials; individualised and non-individualised homeopathy; treatment and prevention.

The review programme’s findings

Phase 1: Placebo-controlled RCTs of individualised homeopathic treatment (study protocol). These studies focus on ‘classical’ homeopathy, which involves in-depth consultation and an individualised prescription per patient: 32 RCTs were eligible for the review. The article reporting the findings was published in the journal Systematic Reviews in December 2014. Its statistical analysis identified an effect of individually prescribed homeopathic medicines that was greater than that of placebos and was statistically significant.

Phase 2: Placebo-controlled RCTs of non-individualised homeopathic treatment (study protocol). Each of these examined a homeopathic medicine pre-selected for its match with the typical symptoms of a given clinical condition: 75 RCTs were eligible for this review. The article reporting those findings was published in Systematic Reviews in March 2017.

The original literature search for the review programme included all RCT papers published up to and including 2011. Each new systematic review necessarily requires an updated search. The relevant flowchart for Phase 2 of included and excluded RCT papers updates the original search up to the end of 2014. There are associated detailed lists of RCT papers that are potentially eligible for systematic review and RCT papers that have been rejected from further analysis.

Phase 3: Other-than-placebo-controlled RCTs of individualised homeopathic treatment (study protocol). This work is ongoing. The relevant flowchart for Phase 3 of included and excluded RCT papers updates the original search to the end of 2015. There are associated detailed lists of potentially eligible RCT papers and rejected RCT papers.

Researcher

Dr Robert Mathie attained BSc, then PhD, in Physiology at the University of Glasgow. During 25 years in the university sector, he published around 100 peer-reviewed journal articles and book chapters, mostly on the topic of blood flow regulation. He then held the post of Research Development Adviser at the British Homeopathic Association for 15 years during which he led clinical data collection projects with the Faculty of Homeopathy’s doctors, dentists and veterinarians. Latterly, in a key initiative to identify robust evidence in homeopathy, Robert has extended his work in reviewing and clarifying the research literature by means of a major programme of systematic reviews of randomised controlled trials. His research publications in homeopathy currently total more than 30. Robert became an independent research consultant in March 2016.

Why is this project important?

Effects of individualised homeopathic medicines may be difficult to observe readily in any one particular placebo-controlled trial, in which both groups of participants have had exactly the same type of consultation followed by the homeopathic prescription or the placebo. Our findings suggest, however, that individually prescribed homeopathic medicines have a small specific effect, at least across the medical conditions included in the meta-analysis.

In general, the quality of the RCT evidence was low or unclear: only 3 of the trials in the systematic review were judged to comprise ‘reliable evidence’ (Bell et al. 2004; Jacobs et al. 1994; Jacobs et al. 2001). Nevertheless, those 3 best-quality trials collectively displayed a significant treatment effect as well as high ‘model validity’ (i.e. they involved the use of good-quality homeopathy).

The limited extent of highest-quality data indicates the need for caution in interpreting the review’s findings, and an obvious requirement for new and better-quality RCT research.

Publications related to this project

Randomised controlled trials of homeopathy in humans: characterising the research journal literature for systematic review.
Mathie RT, Hacke D, Clausen J, Nicolai T, Riley DS, Fisher P.
Homeopathy 2013; 102: 3-24 [Abstract]

Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis.
Mathie RT, Lloyd SM, Legg LA, Clausen J, Davidson JRT, Moss S, Ford I. Systematic Reviews 2014; 3: 142 [Full text]

Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis.
Mathie RT, Ramparsad N, Legg LA, Clausen J, Moss S, Davidson JRT, Messow C-M, McConnachie A.
Systematic Reviews 2017; 6: 63 [Full text]

Author publicationsLess

Mathie RT, Roniger H, Van Wassenhoven M, Frye J, Jacobs J, Oberbaum M, Bordet M-F, Nayak C, Chaufferin G, Ives JA, Dantas F, Fisher P. Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study. BMC Med Res Methodol 2012; 12: 49 [Full text]

Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Roniger H, Frye J, Manchanda RK, Terzan L, Chaufferin G, Dantas F, Fisher P.
Model validity of randomised placebo-controlled trials of individualised homeopathic treatment. Homeopathy 2015; 104: 164-169. [Abstract]

Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Frye J, Manchanda RK, Roniger H, Dantas F, Legg LA, Clausen J, Moss S, Davidson JRT, Lloyd SM, Ford I, Fisher P. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med 2016; 25: 120-125. [Abstract]

ReferencesLess

Bell I, Lewis D, Brooks A, Schwartz G, Lewis S, Walsh B, Baldwin C. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology 2004; 43: 577-582. [Abstract]

Jacobs J, Jimenez LM, Gloyds SS, Gale JL, Crothers D. Treatment of acute childhood diarrhea with homeopathic medicine; a randomized clinical trial in Nicaragua. Pediatrics 1994; 93: 719-725. [Abstract]

Jacobs J, Springer DA, Crothers D. Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J 2001; 20: 177-183. [Abstract]