198241 Evidence issues in traditional Chinese medicine: A case study of acu-point injection for treatment of dysmenorrhea

Monday, November 9, 2009

Christine Wade, MPH , Institute of East/West Medicine, New York, NY
Maria Chao, DrPH , Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, OH
Francesco Cardini, MD , Obstetrics & Gynecology, University of Verona, Verona, Italy
Background: In environments of limited funds and evidence, efforts to advance safe and effective treatments for women's health conditions must be concerted and efficient. Criteria proposed for selecting traditional medicine treatments to study, include historic use, transferability across cultures and replicability of the study design. Building on these criteria, Cardini et al. (2006) proposed a framework to identify, prioritize, and design study protocols. In addition, treatments with unknown effect mechanisms must document larger effects, fewer side effects, or more practical service delivery than standard treatments in order to be considered viable options.

Methods: Results from clinical studies of an innovative treatment for primary dysmenorrhea (acupuncture point injection treatment of Vitamin K in Spleen 6/San Yin Jiao, developed at the Menstrual Disorder Center at the Obstetric & Gynecology Hospital of Fudan University in Shanghai, China) are interpreted and compared within a rubric of Hill's criteria for causality and evaluated in a framework of Cardini's priorities and methods for clinical research on traditional medicine.

Results: Data from different types of studies of the same treatment answer different research questions and also contribute to broader theoretical questions about acupuncture innovation, mechanism of action, service delivery of acupuncture treatments, transfer of traditional medicine treatments across cultures and ethical issues in studies of pain conditions.

Conclusion: Given the evidence base developed in the portfolio of studies discussed here, future clinical trial design options include comparing treatments in groups formed by randomization to active treatments or assignment by symptom severity (regression discontinuity) in international collaborative studies.

Learning Objectives:
Learning Objectives 1. Describe criteria for prioritizing research of traditional medicine treatments such as acu-injection for dysmenorrhea. 2. Assess study design and evidence issues of traditional medicine treatments in relation to Hillís criteria for causality and Cardiniís priorities and methods. 3. Compare alternative clinical trial designs for traditional medicine treatments based on existing evidence.

Keywords: Alternative Medicine/Therapies, Research Agenda

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: MPH. Project Director NIH/NCCAM Planning Grant for an International Center for Traditional Chinese Medicine and Womenís Health (2003-05), `Cardini F, Wade C, Regalia A, Gui S, Wang L, Raschetti R, Kronenberg F. Clinical research in traditional medicine: priorities and methods. Complementary Therapies in Medicine doi:10.1016/j.ctim.2006.07.003 2006 Wang L, Cardini F, Zhao W, Regalia AL, Wade C, Forcella E, Yu J. Vitamin K Acupuncture Point Injection for Severe Primary Dysmenorrhea: An International Pilot Study. Medscape General Medicine. December 27, 6(4), 2004. Available at: http://www.medscape.com/viewarticle/494022
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.