# 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

## TL;DR

This study finds that traditional Chinese medicine is more effective and safer than Western medicine for treating insomnia in perimenopausal women in China.

## Contribution

A systematic review and meta-analysis of RCTs evaluating TCM's efficacy and safety for perimenopausal insomnia in the Chinese population.

## Key findings

- TCM showed better overall efficacy and fewer adverse reactions compared to Western medicine.
- TCM improved sleep quality, hormonal balance, and mental health metrics in perimenopausal women.
- Results suggest TCM interventions reduce anxiety and depression scores in PMI patients.

## Abstract

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.

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.

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]).

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.

PROSPERO registration number CRD420251127129.