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

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

Joel J. Gagnier, ND, MSc;
Heather Boon, PhD;
Paula Rochon, MD, MPH;
David Moher, PhD;
Joanne Barnes, PhD, MRPharmS FLS;
Claire Bombardier, MD; and
for the CONSORT Group*

From University of Toronto, Institute for Evaluative Sciences, Institute for Work and Health, and Toronto General Research Institute, Toronto, Canada; Children's Hospital of Eastern Ontario, Ottawa, Canada; and University of London, London, United Kingdom.

Abstract

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 Standards 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 recommendations have been developed to improve the reporting of RCTs using herbal medicine interventions.

Article and Author Information

*The members of the CONSORT Group are listed on the following Web site: http://www.consort-statement.org/Profiles/profiles.html.
Acknowledgments: The authors thank Greer Palloo for aiding in the preparation for the June meeting, and Jaime DeMelo, ND, and Cyndi Gilbert for assisting Joel Gagnier, ND, MSc, and Claire Bombardier, MD, during the actual meeting procedures.
Grant Support: This study was funded in part by an operating grant from the Canadian Institutes of Health Research, Clinical Trials Divisions (ATF-66679). Dr. Gagnier is supported by a postgraduate fellowship from the Canadian Institutes of Health Research and the Natural Health Products Directorate.
Potential Financial Conflicts of Interest: Grants received: J. Barnes (Lichtwer Pharma); Grants pending: J. Barnes (Lichtwer Pharma); Royalties: J. Barnes (Pharmaceutical Press, Churchill Livingstone).
Requests for Single Reprints: Joel J. Gagnier, ND, MSc, 5955 Ontario Street, Unit 307, Windsor, Ontario N81S W6, Canada; e-mail, j.gagnier{at}utoronto.ca.
Current Author Addresses: Dr. Gagnier: 5955 Ontario Street, Unit 307, Windsor, Ontario N81S W6, Canada.
Dr. Boon: University of Toronto, Faculty of Pharmacy, 19 Russell Street, Toronto, Ontario M5S 2S2, Canada.
Dr. Rochon: Baycrest Centre, 3560 Bathurst Street, Toronto, Ontario M6A 2E1, Canada.
Dr. Moher: Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Room 210, Ottawa, Ontario K1H 8L1, Canada.
Dr. Barnes: Centre for Pharmacognosy and Phytotherapy, University of London School of Pharmacy, 29/39 Brunswick Square, London WC1N 1AX, United Kingdom.
Dr. Bombardier: Institute for Work and Health, 481 University Avenue, Suite 800, Toronto, Ontario M5G 2E9, Canada.