Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2002; 7: 104
For clinical trials of acupuncture, it would be desirable to have a sham procedure that is indistinguishable from the real treatment, yet inactive. The Park Sham Device is a device that telescopes instead of penetrating the skin. It requires validation.
To test whether the new device is (1) indistinguishable from real needles and (2) inactive. The study design comprised two subject- and assessor-blind, randomised controlled trials. Study 1: 58 patients included in a clinical trial of acupuncture for acute stroke. Study 2: 63 healthy, acupuncture naive, adult volunteers.
Real or sham acupuncture using the Park Sham Device. Settings were a district general hospital and a university laboratory. Measurements: (1) the form of treatment that patients believed they had received; (2) experience of de qui, as judged by three acupuncture experts.
In Study (1), no patient in either group believed they had been treated with the sham needle. In Study (2), in 40 volunteers for whom experts achieved consensus, the relative risk of experiencing de qui with real acupuncture to that with Park Sham Device was 15.38 [95% confidence interval (CI) 2.26–104.86]. The inter-rater reliability of all 13 experts, calculated from their judgements on 10 subjects selected by randomisation, was 0.52 (95% CI 0.19–0.61).
Results suggest that the new Park Sham Device is both indistinguishable from real acupuncture and inactive. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de qui, a major concept underlying traditional Chinese acupuncture.
