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Acupuncture for hot flushes in perimenopausal and postmenopausal women: a randomised, sham-controlled trial [with consumer summary] |
Kim DI, Jeong JC, Kim KH, Rho JJ, Choi MS, Yoon SH, Choi S-M, Kang KW, Ahn HY, Lee MS |
Acupuncture in Medicine 2011 Dec;29(4):249-256 |
clinical trial |
9/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVES: To determine the effect of acupuncture in treating hot flushes 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 flushes 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 flush scores at week 7, measured by multiplying the hot flush frequency and severity, were the primary outcome. Hot flush 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 flush 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 versus 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 significantly different effects on the hot flush scores but showed partial benefits on the hot flush severity. Further consideration is needed to develop appropriate strategies for distinguishing non-specific effects from observed overall effectiveness of acupuncture for hot flushes. Whether acupuncture has point-specific effects for hot flushes should be also considered in designing future researches.
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