BACKGROUND:Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting. OBJECTIVE: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs. DESIGN: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954). SETTING: Community in Australia. PARTICIPANTS: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. INTERVENTIONS: 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture. MEASUREMENTS: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models. RESULTS:327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, -1.87 to 2.52]; P = 0.77). No serious adverse events were reported. LIMITATION: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause. CONCLUSION:Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. PRIMARY FUNDING SOURCE: National Health and Medical Research Council.
RCT Entities:
BACKGROUND: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting. OBJECTIVE: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs. DESIGN: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954). SETTING: Community in Australia. PARTICIPANTS: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. INTERVENTIONS: 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture. MEASUREMENTS: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models. RESULTS: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, -1.87 to 2.52]; P = 0.77). No serious adverse events were reported. LIMITATION: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause. CONCLUSION: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. PRIMARY FUNDING SOURCE: National Health and Medical Research Council.
Authors: Eduardo Guilherme D'Alessandro; Alexandre Valotta da Silva; Rebeca Boltes Cecatto; Christina May Moran de Brito; Raymundo Soares Azevedo; Chin An Lin Journal: Med Acupunct Date: 2022-02-14
Authors: Carolyn C Ee; Sharmala Thuraisingam; Marie V Pirotta; Simon D French; Charlie C Xue; Helena J Teede Journal: PLoS One Date: 2017-10-27 Impact factor: 3.240