4013.0: Tuesday, November 14, 2000 - 8:30 AM

Abstract #6031

Devising an appropriate control group in a study of acupuncture and stroke rehabilitation

Howard Moffet, MPH, American College of Traditional Chinese Medicine, 455 Arkansas Street, San Francisco, CA 94107, 415-345-0102, hmoffet@actcm.edu, Larry Scherwitz, PhD, Center for Complementary Research Institute, California Pacific Medical Center, 2300 California St., Suite 204, San Francisco, CA 94115, and Scott Rome, MD, Acute Regional Rehabilitation Center, California Pacific Medical Center, 45 Castro St, San Francisco, CA 94114.

Objective: To rigorously evaluate the efficacy of acupuncture for stroke rehabilitation. Method: Reviewed the randomized controlled clinical trials evaluating the efficacy of acupuncture and designed a study to address the challenge of placebo control. Results: Eight of nine randomized trials have shown that acupuncture treatment appears to benefit stroke recovery. However, these studies have not adequately controlled for the placebo response, so it is not clear whether the acupuncture treatment itself specifically treats post-stroke paralysis. The challenge of controlling for placebo responses is that while the patients can be blinded to experimental condition, the acupuncturists cannot. Accordingly, this study of acute stroke patients maintains the therapist’s intent to heal, but directs the intention in a control group to the co-morbid problem of insomnia. Using procedures to maintain double blinding (of patient and outcomes assessor), stroke patients receiving standard stroke rehabilitation therapy are randomized to three groups: 1) acupuncture designed to treat paralysis, 2) acupuncture designed to treat insomnia, and 3) no acupuncture treatment. The hypothesis is that a treatment specific for paralysis will have a significantly better outcome than a treatment not specific to paralysis, e.g. a treatment for insomnia. Conclusions: There is a logical alternative to “sham” or “placebo” acupuncture control groups which preserves the acupuncturist’s intention to benefit the patient and tests the specific effects of acupuncture treatments for post-stroke paralysis. The validity of this model is being tested in an on-going pilot study.

Learning Objectives: Participants will 1) be aware of the principle studies on acupuncture and stroke rehabilitation 2) be able to describe the unique methodological issues of controlled trials in acupuncture research 3) be able to appreciate a new approach to the issues describe above (2)

Keywords: Strokes, Treatment Efficacy

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: none
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

The 128th Annual Meeting of APHA