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

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. This paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy. 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. 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. The formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy. • The recommendations provide systematic methodological guidance for homeopathic RCTs, espe. with individualized homeopathy. • Reflect on a precise research question, research design based on evidence and homeopathy-specific point by point guidance. • Evaluate the effectiveness of homeopathy in daily practice with the TwiCs design and/or reproducible HMP selection strategies,. • Consider replicating successfully conducted homeopathy RCTs including reproducible HMP selection strategies. • For quality assurance: usage of a university-based research infrastructure is essential for high quality homeopathic RCTs. [ABSTRACT FROM AUTHOR]