Abstract
OBJECTIVE: Perimenopausal insomnia (PMI) significantly compromises the quality of life and the physical and mental wellbeing of perimenopausal women. Although many randomized controlled trials (RCTs) indicate that acupuncture alleviates PMI symptoms, comprehensive evidence on its efficacy and safety is lacking. We conducted a meta-analysis to systematically evaluate the therapeutic efficacy and safety of acupuncture for PMI, aiming to provide robust, evidence-based guidance for clinical practice. METHODS: A total of 12 trials were included in the study, involving 499 participants in the acupuncture group and 495 in the control group, all of which provided data for the meta-analysis. Quality assessment was performed using the Cochrane Risk of Bias (ROB) tool. RevMan version 5.4 and Stata 18.0 software were used for meta-analysis and sensitivity analysis. RESULTS: A total of 10 studies were included, with the random-effects model showing that acupuncture significantly improved sleep quality compared to the drug control group, as evidenced by a reduction in Pittsburgh Sleep Quality Index (PSQI) scores [mean difference (MD) = -2.26, 95% confidence interval (CI) (-4.23 to -0.29), p < 0.00001]. Subgroup analyses revealed that acupuncture outperformed Estazolam (MD = -2.89, p < 0.00001). However, it did not outperform alprazolam (MD = -2.30, p = 0.27) or diazepam (MD = -6.55, p < 0.00001). Compared to sham acupuncture, acupuncture resulted in a significantly greater reduction in PSQI scores (MD = -4.85, p = 0.0001). Acupuncture also led to reductions in luteinizing hormone (LH) (MD = -6.55, p < 0.00001) and follicle-stimulating hormone (FSH) (MD = -12.12, p = 0.002), and an increase in estradiol (E2) levels (MD = 11.96, p < 0.00001). One study reported a significant improvement in Insomnia Severity Index (ISI) scores (MD = -3.64, p = 0.0003). Adverse event data were reported in only 4 of the 12 studies. CONCLUSION: Current evidence of low to moderate quality suggests that acupuncture may offer potential benefits and demonstrate good safety for PMI. However, these findings require further validation through large-scale, multicenter, double-blind RCTs using standardized protocols. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/, Identifier (CRD42018092917).