Homeopathy 2017; 106(04): 194-202
DOI: 10.1016/j.homp.2017.07.003
Original Paper
Copyright © The Faculty of Homeopathy 2017

Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment

Robert T. Mathie
1   Homeopathy Research Institute, 142 Cromwell Road, London SW7 4EF, UK
,
Michel Van Wassenhoven
2   Belgian Homeopathic Medicines Registration Committee, FAMHP (Federal Agency for Medicines and Health Products), Belgium
,
A.L.B. Lex Rutten
3   Independent Researcher
,
Christien T. Klein-Laansma
4   Department Nutrition & Health, Louis Bolk Institute, Driebergen, The Netherlands
,
José Eizayaga
5   Department of Homeopathy, Maimonides University, Buenos Aires, Argentina
,
Anna Pla i Castellsagué
6   Research Sub-committee, European Committee for Homeopathy, Belgium
,
Miek C. Jong
4   Department Nutrition & Health, Louis Bolk Institute, Driebergen, The Netherlands
7   Department of Health Sciences, Mid-Sweden University, Sundsvall, Sweden
8   National Information and Knowledge Centre for Integrative Medicine, The Netherlands
,
Raj K. Manchanda
9   Central Council for Research in Homoeopathy, India
,
Flávio Dantas
10   Faculty of Medicine, Federal University of Uberlândia, Uberlândia, Brazil
,
Menachem Oberbaum
11   Shaare Zedek Medical Center, Jerusalem, Israel
,
Joyce Frye
12   Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD, USA
,
Helmut Roniger
13   Royal London Hospital for Integrated Medicine, London, UK
,
Stephan Baumgartner
14   Institute of Integrative Medicine, University of Witten-Herdecke, Germany
,
Robbert van Haselen
15   International Institute for Integrated Medicine, Kingston, UK
,
Ton Nicolai
3   Independent Researcher
,
Peter Fisher
13   Royal London Hospital for Integrated Medicine, London, UK
› Author Affiliations

Subject Editor:
Further Information

Publication History

Received01 February 2017
revised23 June 2017

accepted31 July 2017

Publication Date:
02 January 2018 (online)

Background: The comprehensive systematic review of randomised placebo-controlled trials (RCTs) in homeopathy requires examination of a study's model validity of homeopathic treatment (MVHT) as well as its risk of bias (extent of reliable evidence).

Objective: To appraise MVHT in those RCTs of non-individualised homeopathy that an associated investigation had judged as ‘not at high risk of bias’.

Design: Systematic review.

Methods: An assessment of MVHT was ascribed to each of 26 eligible RCTs. Another 49 RCTs were ineligible due to their high risk of bias.

Main outcome measures: MVHT and the prior risk of bias rating per trial were merged to obtain a single overall quality designation (‘high’, ‘moderate’, ‘low’), based on the GRADE principle of downgrading.

Results: The trials were rated as ‘acceptable MVHT’ (N = 9), ‘uncertain MVHT’ (N = 10) and ‘inadequate MVHT’ (N = 7); and, previously, as ‘reliable evidence’ (N = 3) and ‘non-reliable evidence’ (N = 23). The 26 trials were designated overall as: ‘high quality’ (N = 1); ‘moderate quality’ (N = 18); ‘low quality’ (N = 7).

Conclusion: Of the 26 RCTs of non-individualised homeopathy that were judged ‘not at high risk of bias’, nine have been rated ‘acceptable MVHT’. One of those nine studies was designated ‘high quality’ overall (‘acceptable MVHT’ and ‘reliable evidence’), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

Highlights

• The study appraised model validity of homeopathic treatment (MVHT).

• The sample comprised 26 randomised controlled trials (RCTs) of non-individualised homeopathy that were ‘not at high risk of bias’.

• MVHT and risk of bias rating per trial were merged to obtain a single overall quality designation (‘high’, ‘moderate’, ‘low’).

• The 26 trials were designated overall as: ‘high quality’ (N = 1); ‘moderate quality’ (N = 18); ‘low quality’ (N = 7).

• Only one study was designated ‘high quality’ overall (‘acceptable MVHT’ and ‘reliable evidence’).