Objectives To determine the effect of acupuncture in treating hot fl ushes in perimenopausal or postmenopausal women. Methods The study was a randomised single-blind sham-controlled clinical trial. Perimenopausal or postmenopausal women with moderate or severe hot fl ushes were randomised to receive real or sham acupuncture. Both groups underwent a 4-week run-in period before the treatment. The real acupuncture group received 11 acupuncture treatments for 7 weeks, and the control group underwent sham acupuncture on non-acupuncture points during the same period. Both groups were followed for 8 weeks after the end of treatment period. Changes from baseline in the hot fl ush scores at week 7, measured by multiplying the hot fl ush frequency and severity, were the primary outcome. Hot fl ush frequency, severity and menopause-related symptoms measured with the Menopause Rating Scale Questionnaire were regarded as secondary outcomes. Results 54 participants were randomised into the real acupuncture group (n=27) and the sham acupuncture group (n=27). The mean change in hot fl ush scores was −6.4±5.2 in the real acupuncture group and −5.6±9.2 in the sham group at week 7 from values at the start of the acupuncture treatment (10.0±8.1 vs 11.7±12.6), respectively (p=0.0810). No serious adverse events were observed during the whole study period. Conclusions Compared to sham acupuncture, acupuncture failed to show signifi cantly different effects on the hot fl ush scores but showed partial benefi ts on the hot fl ush severity. Further consideration is needed to develop appropriate strategies for distinguishing non-specifi c effects from observed overall effectiveness of acupuncture for hot fl ushes. Whether acupuncture has pointspecifi c effects for hot fl ushes should be also considered in designing future researches.

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