Title : Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
Abstract:
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.
Keywords: Guidelines, Homeopathy, RCT, Randomised Controlled Trial, Recommendations, Veterinary Homeopathy.
Audience Take Away Notes
- The recommendations provide systematic methodological guidance for homeopathic RCTs, espe. with individualized homeopathy. The compilated recommendations may serve to better plan, design, conduct and report RCTs in homeopathy in addition to the SPIRIT-checklist. Whereby, the specific challenges of the individualized homeopathic approach need special attention, including possibilities to reproduce the individualized HMP selection, and to reflect daily homeopathic practice.
- Replication of RCTs increases the credibility and recognition of the results by the academic community and enables to conduct systematic reviews and/or meta-analysis of particular interventions. Hereby, the various innovative and previously tested designs that were presented in this paper, each one suitable for a different type of research question, are to be considered.
- These recommendations could be use by other all other complex medical disciplines to expand their research and to assure methodological quality.
