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    California Pacific Currents 2000

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    Conducting Complementary Medicine Research: The Art of Evaluating Alternative Therapies

    Larry Scherwitz, Ph.D.

    Physicians at California Pacific Medical Center's Health and Healing Clinic are using unique treatment models that combine conventional Western medicine with complementary approaches. In addition, the Institute of Health and Healing (IHH) is exploring complementary and alternative medicine (CAM) treatments that have seldom been formally evaluated in hospital settings, including massage, guided imagery, and a Japanese acupressure touch therapy called jin shin jytsu.

    To provide the safest, most effective, and comprehensive treatments possible, the IHH is dedicated to evaluating all of the therapies it utilizes. This dedication to rigorous outcomes-based medicine has resulted in a close collaboration with researchers at the Complementary Medicine Research Institute. Research protocols approved by California Pacific's Institutional Review Board evaluate hospital inpatient treatments, including massage, guided imagery, and jin shin jytsu, as well as the efficacy of complementary therapies practiced at the Health and Healing Clinic.

    Challenge of the Chi
    “The challenge and the fun in conducting complementary medicine research is the art of building and implementing the best design to evaluate a therapy,” says Larry Scherwitz, PhD, research director for the IHH and project manager for the Complementary Medicine Research Institute.

    A special challenge in researching the complementary therapies is that many of the CAM therapies practiced include, and even rely on, the therapist's presence and healing intention or mental focus as part of the treatment. In contrast, for drug studies the placebo, or expectation effect, is controlled for by masking the investigator to the group assignment.

    This is not possible where practitioners attempt to heal by transferring energy to the patient. This energy is believed to originate from the therapist's chi, a form of universal or vital energy, which is summoned and applied by a combination of the therapist's intention to heal and mental focus.

    Complementary Therapy for Stroke
    This special challenge of determining the efficacy of a complementary therapy became a reality when Scherwitz was asked by Scott Rome, MD, of the Department of Medicine and director of California Pacific Medical Center's Regional Rehabilitation Center, to evaluate the potential benefits of acupuncture in acute stroke patients. Scherwitz and Josh Piagentini, a licensed acupuncturist for the Health and Healing Clinic, along with Howard Moffet, an acupuncturist and clinical researcher at the American College of Traditional Chinese Medicine, collaborated with Dr. Rome and his clinical staff to design a study to determine whether acupuncture could help stroke patients recovery more quickly.

    With the volunteer assistance of Natalya Piper, MD, Scherwitz reviewed the existing medical literature on acupuncture for stroke. Of the nine published randomized clinical trials, eight showed significant positive results.

    The mechanism by which acupuncture may have helped patients, however, is unknown. It is commonly believed that the chi of the healer, rather than the simple mechanics of needle placement, is the determining factor in acupuncture therapy. A traditional belief is that the needle acts to convey the therapist's chi to stimulate the patient's meridians (hypothetical circuits in the human body) and ultimately heal.

    Healing from Needle Placement or Chi?
    If true, this presents a problem of determining what may have helped stroke patients in previous trials. In the randomized studies, two basic designs were used: standard stroke therapy alone versus standard therapy plus acupuncture; or standard therapy plus acupuncture versus standard therapy plus sham or fake acupuncture.

    In the first design, the therapists' healing intentions may have contributed to the positive results. In the second design, the patients were blinded, but the acupuncturists were not, so those providing a sham service had no healing intentions or expectations. This may have exaggerated the effects of real acupuncture treatment. According to most acupuncturists' beliefs, real acupuncture treatment was beneficial because the directed chi of the acupuncturist added to the benefit of the needle placement.

    These various interpretations may seem trifling when facing the challenge of stroke recovery, but the subtleties are important. If we could learn the relative benefits of exact needle placement versus the therapist's chi, then we could understand better how acupuncture works, and therefore teach, treat, and research it more effectively.

    To address the placebo problem, Scherwitz and colleagues designed a pilot study that maintained the acupuncturist's intention to heal for two common problems of stroke patients: paralysis and insomnia. The acupuncturist treats one group of 10 patients for paralysis; he treats another group of 10 patients for insomnia. Needle placements remain specific to each condition. A third group receives standard therapy only.

    The randomized three-group design provides some interesting possibilities. If patients treated for paralysis sleep as well as those treated for insomnia and both groups sleep better than the control group, then placebo or nonspecific healing intentions may be more important than needle placement. Conversely, if the insomnia-treated group sleeps better than any other and the paralysis group moves better than any other, then the theory of specific needle placement is supported.