Efficacy and security of traditional Chinese medicine in the treatment of perimenopausal insomnia in the Chinese population: a systematic review and meta-analysis of randomized controlled trials
Year: 2026
Type: review
Study designs: Systematic Review, Meta-Analysis
Abstract: Background: Traditional Chinese medicine (TCM) has been widely applied in the management of perimenopausal insomnia (PMI), yet comprehensive evidence on its efficacy and safety remains insufficient. We aimed to systematically evaluate the therapeutic effects and safety of TCM interventions in PMI treatment. Methods: Randomized controlled trials (RCTs) that compared TCM interventions with Western medicine for patients with PMI were searched across eight databases from inception to August 1, 2025. Methodological quality, risk of bias, and certainty of evidence were assessed using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines and Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Meta-analysis was performed using RevMan 5.4 and R 4.4.2 software. Results: A total of 48 RCTs involving 5,037 patients were included. Meta-analysis showed that TCM was superior to Western medicine in overall efficacy (RR = 1.20, 95% CI [1.17, 1.23]) and had fewer adverse reactions (RR = 0.30, 95% CI [0.24, 0.38]). Besides, TCM interventions significantly improved Pittsburgh Sleep Quality Index (PSQI) score (MD = -2.57, 95% CI [-3.01, -2.14]), reduced luteinizing hormone (LH) (MD = -4.51, 95% CI [-6.15, -2.87]) and follicle-stimulating hormone (FSH) (MD = -8.67, 95% CI [-10.96, -6.38]), increased estradiol (E2) level (MD = 9.64, 95% CI [7.45, 11.82]), and decreased Kupperman Menopausal Index (KMI) score (MD = -6.01, 95% CI [-8.56, -3.47]), Traditional Chinese Medicine Syndrome (TCMS) score (SMD = -2.27, 95% CI [-3.49, -1.05]), Self-Rating Anxiety Scale (SAS) score (MD = -4.77, 95% CI [-5.77, -3.76]), and Self-Rating Depression Scale (SDS) score (MD = -2.96, 95% CI [-5.80, -0.12]). Conclusion: TCM interventions demonstrate notable efficacy and safety in managing PMI by improving sleep quality, hormonal balance, and mental health. However, methodological limitations and heterogeneity warrant further validation through large-scale, multicenter, rigorously designed RCTs. Systematic review registration: PROSPERO registration number CRD420251127129.
Source: Frontiers in Neurology
Authors: Denghui Yang, Dan Chen, Jieru Peng, Yifei Peng, Chunxia Yang, Jungang Sun
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7130517820