Effectiveness and Safety of Chinese Herbal Medicine in Treatment of Perimenopausal Insomnia: A Systematic Review and Meta-Analysis of Randomized Controlled Trails.

This study aimed to evaluate the efficacy and safety of Chinese herbal medicine (CHM) for treating perimenopausal insomnia using data from randomized controlled trials (RCTs). A comprehensive search was conducted in PubMed, Web of Science, Embase, Cochrane Library, Chinese Biomedical Literature Service System (SinoMed), Chinese Science Journals Database (VIP), and Wanfang Database through March 2024. Two reviewers independently performed literature screening, data extraction, and risk-of-bias assessment. The meta-analysis incorporated 20 RCTs with a total of 1700 patients. The results demonstrated that CHM, both as monotherapy and in combination with Western medicine (WM), significantly improved sleep quality and clinical total effective rate in patients with perimenopausal insomnia. Specifically, outcomes such as the Pittsburgh Sleep Quality Index (PSQI) scores, total effective rate, and serum follicle-stimulating hormone (FSH) levels favored CHM, either as monotherapy or combined with WM, over WM alone. However, CHM and WM showed no significant differences in PSQI sleep efficiency, PSQI sleep disorders, or serum luteinizing hormone (LH) levels. Moreover, CHM combined with WM did not demonstrate superiority over WM alone in PSQI overall score or serum estradiol (E2) levels. No severe CHM-related adverse events were reported. These findings suggest that CHM may serve as a safe and effective therapeutic option for managing perimenopausal insomnia. Nonetheless, these conclusions should be interpreted cautiously, and further research with larger sample sizes is needed to validate the efficacy and safety of CHM in this population.