General Practice and Primary Care - Theses
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ItemAcupuncture for menopausal hot flushes: an individually randomised sham-controlled trial( 2016)Menopausal hot flushes affect up to 90% of women and pose a significant health and financial burden. Many women are reluctant to use hormone replacement therapy, an effective treatment, because of fear of serious adverse events. Acupuncture is a safe treatment with conflicting evidence for efficacy as a hot flush treatment. The aim of this thesis was to assess the efficacy of acupuncture for menopausal hot flushes. The principal study was a fully powered randomised sham-controlled trial which enrolled women aged over 40 in the late menopausal transition or postmenopause with a moderate hot flush burden, and who met criteria for the Chinese medicine diagnosis of Kidney Yin deficiency. Women were randomised to receive eight weeks of either Chinese medicine needle acupuncture or non-insertive sham acupuncture. The primary outcome was hot flush score at the end of treatment. Secondary outcomes included quality-of-life, anxiety, depression, and adverse events. Women were followed up at 4 and 8 weeks (end of treatment) and at 3 and 6 months post end of treatment. Analysis was by intention-to-treat using mixed effects modelling. 327 women were randomised to real (n=163) or sham acupuncture (n=164). There was no evidence for a between-group difference in hot flush scores at end-of-treatment (mean difference 0·33; 95% CI -1·87 to 2·52; p=0·77) or for secondary outcomes, and no serious adverse events. Both groups improved by an average of 40% from baseline for hot flush score. There was a small, clinically irrelevant difference for hot flush severity at end of treatment. Limitations of the study are that participants were predominantly Caucasian and none had breast cancer or surgical menopause, conditions which predispose to more severe hot flushes. In conclusion, an eight week course of Chinese medicine acupuncture was not superior to non-insertive sham needling for menopausal hot flushes. Women may have improved because of natural resolution of symptoms, frequent therapist interaction, or the placebo effect. A specific effect from acupuncture needling was not demonstrated. Future research may focus on the role of acupuncture in breast cancer survivors.