In June 2004 ABC Founder and Executive Director Mark Blumenthal participated in the first meeting to develop guidelines for reporting controlled trials of botanical medicines. This meeting built upon existing guidelines for reports of controlled trials—the CONSORT guidelines. The internationally recognized CONSORT statement and checklist, developed through consensus methods, provides guidelines for authors of clinical trials and editors of medical journals to help ensure complete reporting of controlled clinical trials. The meeting was held in Toronto and was hosted by Claire Bombardier, MD, from the University of Toronto, Department of Health-Policy Management and Evaluation (HPME) and by Joel Gagnier, ND, whose participation in the meeting serves as part of his work toward completion of a Master of Science degree in Clinical Epidemiology and Health-Care Research, HPME, University of Toronto. The meeting was attended by 14 invited guests from Canada (11), the UK (3), the U.S. (3), and Germany (1).
CONSORT is an acronym for “consolidated standards of reporting trials” and is explained in papers by Altman et al1 and Moher et al.2 (Both Dr. Doug Altman and Dr. David Moher participated in the Toronto meeting.) As stated in both papers, the CONSORT statement outlines the necessary information to be included in reports of controlled trials for accurate and unbiased interpretation. The Altman et al paper describes each item of the CONSORT statement in depth, giving examples and empirical support where possible. The Moher et al paper describes the updated CONSORT.
Due to some of the unique issues related to botanical medicines, an extension of the CONSORT document will provide additional guidelines for enhanced clarity in the reporting of controlled clinical trials conducted on herbs and phytomedicines. This extension, termed ROBOT (Reporting of Botanical Trials) will be published in various medical journals and Web sites, including the ABC website (www.herbalgram.org), and it will be widely disseminated later in 2004 and early in 2005.
1. Altman DG, et al. The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Internal Med. 2001;134(8):663-694.
2. Moher D, et al. The CONSORT statement: Revised recommendations for improving quality of reports of parallel-group randomized trials. Ann Internal Med. 2001;134(8):657-662.