| Abstract: | Objective: To compare self-reported perceptions of the credibility of traditional Chinese medicine(TCM) acupuncture and a shallowneedling sham procedure, and to explore whether study subjectscan distinguish between real acupuncture and sham acupuncture in controlled clinical trials for headache when they are exposed to both.Methods: Thirty-seven patients with frequent headaches and no prior experience with acupuncture received both a TCM acupuncture treatment and a sham acupuncture procedure in random order.Study participants were not informed that one of the treatments was intended to be a sham procedure.The main outcome measure was patient-perceived credibility of each procedure as assessed by the Acupuncture Credibility Scale.Results: The TCM acupuncture treatment was associated with mean credibility scale scores of 21.2(SD=4.0), whereas the sham acupuncture procedure was associated with a mean scale score of 19.6(SD=4.6).The difference in mean scores associated with the two protocols was 1.6(95% CI: 0.6-2.6; P=0.002).Mean credibility scale scores increased from the first to second treatment for TCM acupuncture, but decreased for the sham acupuncture procedure.Conclusion: The clinical significance of a 1.6-point difference on a 30-point scale is unclear, but the observation that study participants may be able to distinguish between TCM and sham acupuncture protocols after a single exposure to each provides support for the policy of excluding patients with prior experience with acupuncture from participation in clinical trials that involve a sham acupuncture control. |
