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Wissenschaft - Klinische Studien | |||||
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Vom 19. 20. Oktober 2001 fand im Pillsbury Auditorium, Hennepin
County Medical Center, Minnesota das 8. jährliche Symposion der Society
of Acupuncture Research statt. DESCRIPTION AND VALIDATION OF A NON-INVASIVE PLACEBO ACUPUNCTURE PROCEDURE KJ Sherman, CJ Hogeboom, DC Cherkin, RA Deyo Objective: To evaluate a simulated acupuncture technique for use in randomized controlled trials assessing the efficacy of acupuncture for low back pain. Setting: The clinic of an accredited acupuncture college in Seattle, Washington. Subjects: Acupuncture-naïve enrollees of Group Health Cooperative who had visited their primary care provider with a complaint of back pain that persisted for at least three months. Experimental Design: In the first experiment, subjects received six insertions of real needles and six pokes with a toothpick in a guidetube in a two-period crossover design. In the second experiment, subjects were randomized to receive either a complete treatment with real acupuncture needles or a simulated treatment using a toothpick in a guidetube. Outcomes: In the first experiment, we compared subjects perceptions about which implement was used for each "insertion" while in the second, we compared the perceptions (e.g., acupuncturists warmth and caring, the reasonableness of acupuncture as a treatment) of those who received an acupuncture treatment using needles with those receiving simulated acupuncture. Results: In the first experiment, the toothpick "insertions" were perceived as slightly more like real needling than the real needling (mean ratings of 2.8 and 2.1, respectively; p = 0.08). In the second experiment, 52% percent of those receiving the simulated needling vs. 65% of those receiving real acupuncture believed they were "definitely" or "probably" receiving real acupuncture (p=0.33). Perceptions of acupuncture, as measured by a credibility questionnaire, were similar in the two groups. Those receiving real acupuncture were more likely to report immediate pain relief, and this was the factor most predictive of the subjects belief about which treatment they had received (p=0.02). Conclusions: The simulated acupuncture procedure evaluated in this study represents a reasonable control treatment for acupuncture-naïve individuals in randomized controlled trials assessing the efficacy of acupuncture for low back pain. VALIDITY OF NEWLY DEVELOPED SHAM NEEDLE UNIT: A RANDOMISED CONTROLLED PRE-CLINICAL TRIAL Jongbae Park, Adrian R White, Clare Stevinson, Edzard Ernst Background: To test the effectiveness of acupuncture, a sham control is essential, but so far no sufficiently satisfactory method is available. A new sham control method has been developed, and requires validation. Objective: To compare the frequency of acupuncture specific sensation (Deqi) between real and sham acupuncture. Methods: The study was designed as a subject-assessor-blind, randomised controlled trial. Sixty-three healthy, acupuncture naïve, life-long English speaking adult volunteers were randomly assigned to either real or sham acupuncture. Acupuncture needling was performed in either left or right Hegu (LI4) for 30 seconds using a real needle or the Park Sham Needle. The Park tube was used in both groups. After receiving acupuncture needling, each subject was interviewed with structured questions and completed the questionnaire. The interview procedure was video-recorded, and the videotapes were sent to acupuncture experts. The primary endpoint was whether or not the volunteers experienced Deqi judged by three experts through reviewing the video recording of the interview. Results: Sixty subjects were included in the analysis. The mean (SD) age was 37.1 years (16.7), and male/female ratio was 14/46. Based on judgement on 10 randomly selected subjects, the inter-reviewer reliability (IRR) of all 13 reviewers was 0.52. For 40 (66.67%) subjects there was complete agreement among all three judges, and these subjects were included in the primary and secondary analyses. The relative risk of experiencing Deqi with real acupuncture to that with sham acupuncture was 15.38. The subjects who received real acupuncture were significantly more likely to experience Deqi than those who received sham acupuncture (p=0.000001). There were significant differences between Deqi and non-Deqi in the following sensations: Aching (p <0.0001), dull (p = 0.003), heavy (p = 0.045), hurt (p = 0.002), numb (p = 0.022), radiating (p = 0.001), spreading (p = 0.002), throbbing (p = 0.011), and tingling (p = 0.039). Conclusion: These findings suggest that the sham control method produces a negligible amount of specific stimulation, therefore it can be a bona fide control for controlled acupuncture trials. Wider usage of this method can be recommended.
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