title: Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment.
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).
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: British Homeopathic Association, Hahnemann House, 29 Park Street West, Luton LU1 3BE, UK. Electronic address: rmathie@britishhomeopathic.org.
authors.forename: Robert T
authors.initials: RT
authors.lastname: Mathie
authors.affiliation: Formerly, LMHI Research Secretary, Rue Taille Madame 23, B-1450 Chastre, Belgium.
authors.forename: Michel
authors.initials: M
authors.lastname: Van Wassenhoven
authors.affiliation: School of Public Health and Community Medicine, University of Washington, Seattle, WA 98195, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Jacobs
authors.affiliation: Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
authors.forename: Menachem
authors.initials: M
authors.lastname: Oberbaum
authors.affiliation: Formerly, Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
authors.forename: Joyce
authors.initials: J
authors.lastname: Frye
authors.affiliation: Central Council for Research in Homeopathy, Department of AYUSH, Ministry of Health & Family Welfare, Government of India, New Delhi 110058, India.
authors.forename: Raj K
authors.initials: RK
authors.lastname: Manchanda
authors.affiliation: Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK.
authors.forename: Helmut
authors.initials: H
authors.lastname: Roniger
authors.affiliation: Department of Clinical Medicine, Universidade Federal de Uberlândia, Uberlândia, Brazil.
authors.forename: Flávio
authors.initials: F
authors.lastname: Dantas
authors.affiliation: Department of Biomedical Engineering, University of Strathclyde, Glasgow, UK.
authors.forename: Lynn A
authors.initials: LA
authors.lastname: Legg
authors.affiliation: Formerly, Karl und Veronica Carstens-Stiftung, Essen, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Clausen
authors.affiliation: Homeopathy Research Institute, London, UK.
authors.forename: Sian
authors.initials: S
authors.lastname: Moss
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
authors.forename: Jonathan R T
authors.initials: JR
authors.lastname: Davidson
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Lloyd
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.affiliation: Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Fisher
mesh_terms: D015982:Bias; D006705:Homeopathy / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012306:Risk
chemical_list: D010919:Placebos
keywords: Individualised homeopathy; Meta-analysis; Model validity; Randomised placebo-controlled trials; Systematic review