Robert T Mathie1, Michel Van Wassenhoven2, Jennifer Jacobs3, Menachem Oberbaum4, Helmut Roniger5, Joyce Frye6, Raj K Manchanda7, Laurence Terzan8, Gilles Chaufferin9, Flávio Dantas10, Peter Fisher11. 1. British Homeopathic Association, Hahnemann House, 29 Park Street West, Luton LU1 3BE, UK. Electronic address: rmathie@britishhomeopathic.org. 2. Belgian Homeopathic Medicines Registration Commission, FAMHP, Rue Taille Madame 23, B-1450 Chastre, Belgium. Electronic address: michelvw@homeopathy.be. 3. School of Public Health and Community Medicine, University of Washington, Seattle, WA 98195, USA. Electronic address: jjacobs@igc.org. 4. Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel. Electronic address: oberbaum@netvision.net.il. 5. Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK. Electronic address: helmut.roniger@uclh.nhs.uk. 6. Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA. Electronic address: joyce.frye@gmail.com. 7. 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. 8. Boiron, 20 Rue de la Liberation, 69110 Sainte Foy-lès-Lyon, France. Electronic address: laurence.terzan@boiron.fr. 9. Boiron, 20 Rue de la Liberation, 69110 Sainte Foy-lès-Lyon, France. Electronic address: gchaufferin@orange.fr. 10. Department of Clinical Medicine, Universidade Federal de Uberlândia, Uberlândia, Brazil. Electronic address: dantasoliveiraflavio@gmail.com. 11. Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK. Electronic address: peter.fisher@uclh.nhs.uk.
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.
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.