Improving the quality of reporting of randomized controlled trials evaluating herbal interventions: implementing the CONSORT statement [corrected]

BACKGROUND: Given that herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized controlled trials (RCTs), such RCTs must clearly report the specifics of the intervention. OBJECTIVE: Our objective was to develop recommendations for reporting RCTs of herbal medicine interventions. METHODS: 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 phone calls and a consensus meeting. Three phases were conducted: (1) Premeeting item generation via telephone calls, (2) Consensus meeting, and (3) Postmeeting feedback. Sixteen experts participated in premeeting phone calls for item generation, and 14 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. RESULTS: After extensive discussion, the group decided that context-specific elaborations of nine Consolidated Standards of Reporting Trials (CONSORT) items to RCTs of herbal medicines were necessary: Item 1 (Title and Abstract), 2 (Background), 3 (Participants), 4 (Interventions), 6 (Outcomes), 15 (Baseline data), 20 (Interpretation), 21 (Generalizability), and 22 (Overall evidence). DISCUSSION: 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