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Complement Ther Med. 2016 Apr;25:120-5. doi: 10.1016/j.ctim.2016.01.005. Epub 2016 Jan 20.

Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment.

Author information

1
British Homeopathic Association, Hahnemann House, 29 Park Street West, Luton LU1 3BE, UK. Electronic address: rmathie@britishhomeopathic.org.
2
Formerly, LMHI Research Secretary, Rue Taille Madame 23, B-1450 Chastre, Belgium.
3
School of Public Health and Community Medicine, University of Washington, Seattle, WA 98195, USA.
4
Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
5
Formerly, Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
6
Central Council for Research in Homeopathy, Department of AYUSH, Ministry of Health & Family Welfare, Government of India, New Delhi 110058, India.
7
Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK.
8
Department of Clinical Medicine, Universidade Federal de Uberlândia, Uberlândia, Brazil.
9
Department of Biomedical Engineering, University of Strathclyde, Glasgow, UK.
10
Formerly, Karl und Veronica Carstens-Stiftung, Essen, Germany.
11
Homeopathy Research Institute, London, UK.
12
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
13
Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.

Abstract

BACKGROUND:

To date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT).

OBJECTIVES:

The purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results.

DESIGN:

Systematic review with meta-analysis.

METHODS:

As previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study.

MAIN OUTCOME MEASURES:

For each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation ('high', 'moderate, "low", 'very low'), based on the GRADE principle of 'downgrading'.

RESULTS:

Merging the assessment of MVHT and RoB identified three trials of 'high quality', eight of 'moderate quality', 18 of 'low quality' and three of 'very low quality'. There was no association between a trial's MVHT and its RoB or its direction of treatment effect (P>0.05). The three 'high quality' trials were those already labelled 'reliable evidence' based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy.

CONCLUSION:

Accommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.

KEYWORDS:

Individualised homeopathy; Meta-analysis; Model validity; Randomised placebo-controlled trials; Systematic review

PMID:
27062959
DOI:
10.1016/j.ctim.2016.01.005
[Indexed for MEDLINE]

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