|
Wissenschaft - Klinische Studien | |||||
|
Devising an appropriate control group in a study of acupuncture and stroke rehabilitation Howard Moffet1, Larry Scherwitz2 and Scott Rome2 1American College of Traditional Chinese Medicine, San Francisco, CA, 2California Pacific Medical Center, San Francisco. 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 therapists 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:
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 that preserves the acupuncturists 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. Acupuncture for addicted patients with chronic histories of arrest: A pilot study of the Consortium Treatment Center Lisa C. Russell1, Boyd Sharp2, and Barbara Gilbertson3 1Merle West Center for Medical Research; 2The Consortium Treatment Center; 3Klamath Pain Clinic, Klamath Falls, OR Auricular acupuncture continues to gain popularity as an adjunct to substance abuse treatment. This report describes an outcomes study in a treatment center tailored to the needs of chronic repeat offenders. Thirty-seven patients who received acupuncture (AC) during the early weeks of treatment were followed for 180 days post admission. Data were collected for 4 parameters: (1) program retention, (2) new arrests incurred, (3) drug positive urinalysis results, and (4) number of days needed to progress from entry level to secondary level treatment. These data were compared to archived information from 49 no- acupuncture patients (NA) who had entered the program before acupuncture became available. Chi square tests determined that AC patients exhibited significantly higher program retention than NA patients at 30 (p < 0.0001), 60 (p < 0.002), 90 (p < 0.001), 120 (p < 0.007), and 150 (p < 0.03) days. At 180 days, a higher percentage of AC patients than NA patients remained in treatment, but the difference was not significant. Kaplan Meier survival analysis determined that AC patients had significantly higher cumulative probability of remaining in treatment than did NA patients (p < 0.002). In AC patients, there were decreased numbers of new arrests, drug positive urinalysis results, and days needed to advance in treatment, but the differences were not significant. Fifty-one percent of all patients named methamphetamine as their primary drug of choice. Regardless of treatment group, methamphetamine addicted patients exhibited significantly lower program retention than patients addicted to all other drugs (p < 0.035). In methamphetamine-addicted patients, acupuncture improved program retention for only up to 30 days (p < 0.021). These findings support addition of acupuncture to substance abuse treatment for criminal justice clients and indicate a need for acupuncture research focusing on withdrawal from methamphetamine.
|