Improving the Quality of Reporting of Randomised Controlled Trials Evaluating Herbal Interventions: Implementing the CONSORT Statement

Our objective was to develop suggestions for reporting RCTs of herbal medicine interventions. We identified and invited potential participants with expertise in clinical trial methodology, clinical trial reporting, pharmacognosy, herbal medicinal products, medical statistics, and/or herbal product manufacturing, to participate in a consensus development meeting. Three phases were conducted: 1. Pre-meeting item generation, 2. Consensus meeting, and 3. Post-meeting feedback. Sixteen individuals participated in pre-meeting phone calls for item generation and fourteen participants attended a consensus meeting in Toronto, Ontario, Canada in June of 2004. During the consensus meeting a modified Delphi technique was used to aid discussion and debate of information required for reporting RCTs of herbal medicines. After extensive discussion the group decided that context-specific explanations of existing CONSORT items were necessary. This resulted in elaborating nine items to RCTs of herbal medicines: Item 1 (Title and Abstract), 2 (Background), 3 (Participants), 4 (Interventions), 6 (Outcomes), 15 (Baseline data), 20 (Interpretation), 21 (Generalisability), 22 (Overall evidence). The elaboration of Item 4 of the CONSORT statement outlines specific information required for complete reporting of the herbal medicine intervention. The reporting suggestions presented will support clinical trialists, editors and reviewers in reporting and reviewing RCTs of herbal medicines, and readers in interpreting the results. Acknowledgements: This study was funded in part by an operating grant from the Canadian Institutes of Health Research, Clinical Trials Divisions; Grant number: ATF-66679. Dr. Gagnier is supported by a post-graduate fellowship from the Canadian Institutes of Health Research and the Natural Health Products Directorate.