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FACT
Focus on Alternative and Complementary Therapies

An RCT trial to evaluate the credibility of a sham acupuncture design

Zhang HW1, Tang JL1, Tong J2
1Department of Community and Family Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China
2Guangzhou University of Traditional Chinese Medicine, No. 12, Jichang Road, Guangzhou, Guangdong, 510405, China

Background

Valid sham acupuncture is highly desirable for RCTs of acupuncture. Retractable non-invasive sham acupuncture is probably among the most promising ones. RCTs showed that it could successfully mask naive patients who have never received any acupuncture treatment. The question of whether or not it could be similarly successful in experienced patients who have received acupuncture treatment remains unanswered. Experienced patients are in the majority in China.

Objective

To evaluate the credibility of retractable non-invasive sham acupuncture in both naive and experienced persons.

Methods

An RCT was conducted in which the subjects and data collectors, except the acupuncturists, were kept blind to the allocation of the treatment. The subjects were randomised to receive the real acupuncture treatment or the placebo on the acupoint Hegu. After the treatment, they were asked to make a guess on which treatment they had just received, real or sham acupuncture. The feelings of pain, soreness, numbness, heaviness and spreading during the treatment were also recorded.

Preliminary results

In naive patients, the proportions of those who thought they had received real acupuncture treatment were 67 and 44%, respectively, in the real and sham acupuncture groups. In experienced subjects, these proportions were 58 and 26%, respectively, in the real and sham acupuncture groups. The scores of pain, soreness, numbness, heaviness and spreading in the real acupuncture group were all higher than in the sham acupuncture group in both naive and experienced subjects.

Conclusion

The ability to blind retractable non-invasive placebo acupuncture seems slightly better in naive patients than in experienced patients. The implications of the large proportion of patients who can guess correctly the sham acupuncture require further studies in both naive and experienced subjects.

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