Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine

Background: Randomised 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 tri...

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Main Authors: Katharina Gaertner (Author), Klaus von Ammon (Author), Philippa Fibert (Author), Michael Frass (Author), Martin Frei-Erb (Author), Christien Klein-Laansma (Author), Susanne Ulbrich-Zuerni (Author), Petra Weiermayer (Author)
Format: Book
Published: Elsevier, 2023-09-01T00:00:00Z.
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Summary:Background: Randomised 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. Objectives: This paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy. Methods: Identification 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. Results: Recommendations 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. Conclusions: The formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.
Item Description:0965-2299
10.1016/j.ctim.2023.102961