Chung-wah Cheng, MPH; Tai-xiang Wu, MPH; Hong-cai Shang, MD, PhD; You-ping Li, MPH; Douglas G. Altman, PhD; David Moher, PhD; Zhao-xiang Bian, MD, PhD; for the CONSORT-CHM Formulas 2017 Group *
Acknowledgment: The authors thank all those who contributed to the development of CONSORT-CHM Formulas, both in its draft and final forms (Appendix 1). They also thank Mr. Liang Dai for analyzing the citation and endorsements of the draft version of CONSORT-CHM Formulas and collecting publications that demonstrated good reporting, Dr. Martha Dahlen for her critical English editing, and Dr. Liz Chee for her back translation from Chinese to English.
Financial Support: The development of CONSORT-CHM Formulas 2017 was funded in part from the Hong Kong Hospital Authority, HKSAR (HA/09-10/01).
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2977.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Requests for Single Reprints: Zhao-xiang Bian, MD, PhD, Chair Professor, Director, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Hong Kong SAR, China; e-mail, email@example.com.
Current Author Addresses: Ms. Cheng: Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, P.R. China.
Prof. Wu: Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.
Prof. Shang: Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, P.R. China.
Prof. Li: Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.
Prof. Altman: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.
Prof. Moher: Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
Author Contributions: Conception and design: Z.X. Bian, Y.P. Li, D. Moher, T.X. Wu.
Analysis and interpretation of the data: Z.X. Bian, C.W. Cheng, D. Moher, T.X. Wu.
Drafting of the article: Z.X. Bian, C.W. Cheng, D. Moher, T.X. Wu.
Critical revision for important intellectual content: D.G. Altman, Z.X. Bian, C.W. Cheng, Y.P. Li, D. Moher, H.C. Shang.
Final approval of the article: D.G. Altman, Z.X. Bian, C.W. Cheng, Y.P. Li, D. Moher, H.C. Shang, T.X. Wu.
Obtaining of funding: Z.X. Bian.
Administrative, technical, or logistic support: Y.P. Li, T.X. Wu.
Collection and assembly of data: Z.X. Bian, C.W. Cheng.
Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine (TCM) interventions. The general reporting quality of randomized controlled trials (RCTs) of CHM formulas is disappointing, although CONSORT (Consolidated Standards of Reporting Trials) Statement extensions for herbal medicinal interventions and acupuncture interventions are available. A group of TCM clinical experts, methodologists, epidemiologists, and editors has developed this CONSORT Extension for CHM Formulas (CONSORT-CHM Formulas 2017) through a comprehensive process, including publication of the draft version, solicitation of comments, revision, and finalization.
The CONSORT 2010 Statement was extended by introducing the idea of TCM Pattern and the features of CHM formulas. One new checklist subitem, keywords, was added to facilitate indexing and data searching. Seven of the 25 CONSORT checklist items, namely title and abstract, background and objectives, participants, interventions, outcomes, generalizability, and interpretation, are now elaborated, and the explanation of harms specific to CHM formulas is revised. Illustrative examples and explanations are also provided. The group hopes that CONSORT-CHM Formulas 2017 can improve the reporting quality of RCTs of CHM formulas.
Cheng C, Wu T, Shang H, et al, for the CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167:112–121. [Epub ahead of print 2 May 2017]. doi: https://doi.org/10.7326/M16-2977
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Published: Ann Intern Med. 2017;167(2):112-121.
Published at www.annals.org on 2 May 2017
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