Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement

Herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized, controlled trials (RCTs). The authors ’ objective was to develop recommendations for reporting RCTs of herbal medicine interventions, based on the need to elaborate on the 22-item CONSORT (Consolidated Stan-dards of Reporting Trials) checklist. Telephone calls were made and a consensus meeting was held with 16 participants in Toronto, Canada, to develop these recommendations. The group agreed on context-specific elaborations of 9 CONSORT checklist items for RCTs of herbal medicines. Item 4, concerning the herbal medicine intervention, required the most extensive elaboration. These recom-mendations have been developed to improve the reporting of RCTs using herbal medicine interventions. Ann Intern Med. 2006;144:364-367. www.annals.or