Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2005; 10: 20
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 telephone calls for item generation and fourteen participants attended a consensus meeting in Toronto, Ontario, Canada in June, 2004. During the consensus meeting a modified Delphi technique was used to aid the discussion and debate of the 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: 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 the 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.
This study was funded in part by an operating grant from the Canadian Institutes of Health Research, Clinical Trials Divisions, grant number ATF-66679. Joel J Gagnier is supported by a post-graduate fellowship from the Canadian Institutes of Health Research and the Natural Health Products Directorate.
