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 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.