Document Type

Journal Article


Claudia M. Witt, Institute for Complementary and Integrative Medicine, University Hospital Zurich
Mikel Aickin, Department of Family and Community Medicine, University of Arizona
Daniel Cherkin, Group Health Research Institute
Chun T. Che, Department of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago
Charles Elder, Kaiser Permanente Northwest, Center for Health Research
Andrew Flower, Complementary and Integrated Medicine Research Unit, Department of Primary Care, University of Southampton
Richard Hammerschlag, Research Department, Oregon College of Oriental Medicine
Jian-Ping Liu, Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine
Lixing Lao, Complementary Medicine Program and Integrative Medicine, University of Maryland Medical Center
Steve Phurrough, Centers for Medicare and Medicaid Services
Cheryl Ritenbaugh, Department of Family and Community Medicine, University of Arizona
Lee H. Rubin, Research Department, Oregon College of Oriental Medicine
Rosa Schnyer, School of Nursing, The University of Texas at Austin
Peter M. Wayne, Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School
Shelly R. Withers, The Institute for Integrative Health
Bian Zhao-Xiang, School of Chinese Medicine, Hong Kong Baptist UniversityFollow
Jeanette Young, Patient stakeholder
Brian M. Berman, Center for Integrative Medicine, University of Maryland, School of Medicine
Alan Bensoussan
Benno Brinkhaus
Francesco Cardini
Kevin Chen
George Lewith
Klaus Linde
Hugh MacPherson
Richard L. Nahin
Jed Weissberg


School of Chinese Medicine


Effectiveness guidance document (EGD) for Chinese medicine trials: A consensus document




Background: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.Methods: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.Results: Recommendations were developed for " using available data" and " future clinical studies" . The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.Conclusion: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. © 2014 Witt et al.; licensee BioMed Central Ltd.


Chinese medicine research, Comparative effectiveness research, Effectiveness guidance document

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BioMed Central



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