title: Model validity of randomised placebo-controlled trials of individualised homeopathic treatment.
abstract: BACKGROUND
  Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated.
  
  
  OBJECTIVE
  As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment.
  
  
  METHODS
  From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary.
  
  
  RESULTS
  Nineteen trials were judged overall as 'acceptable' MVHT, nine as 'uncertain' MVHT, and four as 'inadequate' MVHT.
  
  
  CONCLUSIONS
  These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with 'uncertain' or 'inadequate' MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.
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: Belgian Homeopathic Medicines Registration Commission, FAMHP, Rue Taille Madame 23, B-1450 Chastre, Belgium. Electronic address: michelvw@homeopathy.be.
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. Electronic address: jjacobs@igc.org.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Jacobs
authors.affiliation: Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel. Electronic address: oberbaum@netvision.net.il.
authors.forename: Menachem
authors.initials: M
authors.lastname: Oberbaum
authors.affiliation: Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK. Electronic address: helmut.roniger@uclh.nhs.uk.
authors.forename: Helmut
authors.initials: H
authors.lastname: Roniger
authors.affiliation: Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA. Electronic address: joyce.frye@gmail.com.
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. Electronic address: rkmanchanda@gmail.com.
authors.forename: Raj K
authors.initials: RK
authors.lastname: Manchanda
authors.affiliation: Boiron, 20 Rue de la Liberation, 69110 Sainte Foy-lès-Lyon, France. Electronic address: laurence.terzan@boiron.fr.
authors.forename: Laurence
authors.initials: L
authors.lastname: Terzan
authors.affiliation: Boiron, 20 Rue de la Liberation, 69110 Sainte Foy-lès-Lyon, France. Electronic address: gchaufferin@orange.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Chaufferin
authors.affiliation: Department of Clinical Medicine, Universidade Federal de Uberlândia, Uberlândia, Brazil. Electronic address: dantasoliveiraflavio@gmail.com.
authors.forename: Flávio
authors.initials: F
authors.lastname: Dantas
authors.affiliation: Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK. Electronic address: peter.fisher@uclh.nhs.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Fisher
mesh_terms: D032921:Consensus; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008962:Models, Theoretical; D010919:Placebos / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D012196:Review Literature as Topic
chemical_list: D010919:Placebos
keywords: Individualised homeopathy; Model validity; Randomised controlled trial; Systematic review