Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine |
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| Affiliation: | 1. Institute of Complementary and Integrative Medicine IKIM, University of Bern, Freiburgstr. 46, CH-3010 Bern, Switzerland;2. Department of Psychology and Pedagogic Science, St Mary’s University, Twickenham, UK;3. em. Medical University of Vienna, Department of Medicine I, A-1090 Vienna, Austria;4. Louis Bolk Institute, Health and Nutrition, Kosterijland 3-5, NL-3981 AJ Bunnik, the Netherlands;5. WissHom: Scientific Society for Homeopathy, Wallstraße 48, DE-06366 Koethen, Germany;6. Institute of Integrative Medicine, University of Witten/Herdecke, Gerhard-Kienle-Weg 4, DE-58313 Herdecke, Germany;7. Institute for Homeopathic Research, Columbusgasse 20, A-1100 Vienna, Austria;1. Institute of Complementary and Integrative Medicine IKIM, University of Bern, Freiburgstr. 46, CH-3010 Bern, Switzerland;2. Department of Psychology and Pedagogic Science, St Mary’s University, Twickenham, UK;3. em. Medical University of Vienna, Department of Medicine I, A-1090 Vienna, Austria;4. Louis Bolk Institute, Health and Nutrition, Kosterijland 3-5, NL-3981 AJ Bunnik, the Netherlands;5. WissHom: Scientific Society for Homeopathy, Wallstraße 48, DE-06366 Koethen, Germany;6. Institute of Integrative Medicine, University of Witten/Herdecke, Gerhard-Kienle-Weg 4, DE-58313 Herdecke, Germany;7. Institute for Homeopathic Research, Columbusgasse 20, A-1100 Vienna, Austria |
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| Abstract: | BackgroundRandomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking.ObjectivesThis paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy.MethodsIdentification of the homeopathy-specific requirements for RCTs by reviewing literature and experts’ communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy.ResultsRecommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented.ConclusionsThe formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy. |
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| Keywords: | Randomised controlled trial RCT Homeopathy Veterinary homeopathy Recommendations Guidelines |
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