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

Homeopathy. 2017 Nov;106(4):194-202. doi: 10.1016/j.homp.2017.07.003. Epub 2017 Sep 13. Mathie RT1, Van Wassenhoven M2, Rutten ALB3, Klein-Laansma CT4, Eizayaga J5, Pla I Castellsagué A6, Jong MC7, Manchanda RK8, Dantas F9, Oberbaum M10, Frye J11, Roniger H12, Baumgartner S13, van Haselen R14, Nicolai T15, Fisher P16. Author information 1 Homeopathy Research Institute, 142 Cromwell Road, London SW7 4EF, UK. Electronic address: robertmathie@hri-research.org. 2 Belgian Homeopathic Medicines Registration Committee, FAMHP (Federal Agency for Medicines and Health Products), Belgium. Electronic address: Michelvw@homeopathy.be. 3 Independent Researcher. Electronic address: praktijk@dokterrutten.nl. 4 Department Nutrition & Health, Louis Bolk Institute, Driebergen, The Netherlands. Electronic address: ctlaansma@planet.nl. 5 Department of Homeopathy, Maimonides University, Buenos Aires, Argentina. Electronic address: jose.eizayaga@gmail.com. 6 Research Sub-committee, European Committee for Homeopathy, Belgium. Electronic address: pla.c.anna@gmail.com. 7 Department Nutrition & Health, Louis Bolk Institute, Driebergen, The Netherlands; Department of Health Sciences, Mid-Sweden University, Sundsvall, Sweden; National Information and Knowledge Centre for Integrative Medicine, The Netherlands. Electronic address: m.jong@louisbolk.nl. 8 Central Council for Research in Homoeopathy, India. Electronic address: rkmanchanda@gmail.com. 9 Faculty of Medicine, Federal University of Uberlândia, Uberlândia, Brazil. Electronic address: dantas@ufu.br. 10 Shaare Zedek Medical Center, Jerusalem, Israel. Electronic address: oberbaum@netvision.net.il. 11 Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: joyce.frye@gmail.com. 12 Royal London Hospital for Integrated Medicine, London, UK. Electronic address: helmut.roniger@uclh.nhs.uk. 13 Institute of Integrative Medicine, University of Witten-Herdecke, Germany. Electronic address: stephan.baumgartner@uni-wh.de. 14 International Institute for Integrated Medicine, Kingston, UK. Electronic address: vanhaselen@intmedi.com. 15 Independent Researcher. Electronic address: tonnicolai@me.com. 16 Royal London Hospital for Integrated Medicine, London, UK. Electronic address: peter.fisher@uclh.nhs.uk. Abstract 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. Copyright © 2017 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved. KEYWORDS: Model validity; Non-individualised homeopathy; Randomised placebo-controlled trials; Risk of bias; Systematic review PMID: 29157469 DOI: 10.1016/j.homp.2017.07.003