Efficacy of Kuntai capsules with low-dose Femoston for perimenopausal syndrome: a meta-analysis.

Background: Kuntai capsule (KTC) has been widely used to treat perimenopausal syndrome (PMS). However, evidence on its combination with low-dose Femoston (FMT) remains insufficient. This meta-analysis aimed to compare the clinical efficacy and safety of KTC plus low-dose FMT versus low-dose FMT alone in the treatment of PMS. Methods: Eight databases were searched from inception to October 30, 2025, for randomized controlled trials (RCTs) comparing KTC combined with low-dose FMT versus low-dose FMT alone in the treatment of PMS. Two reviewers independently screened studies, extracted data, and assessed bias risk with the RoB 1.0 tool. Meta-analyses were performed using RevMan 5.4 and Stata 15.0. The robustness of the results was evaluated by trial sequential analysis (TSA), and the certainty of the evidence was assessed using the GRADE approach. Results: Ten RCTs comprising 1,057 participants were included. Compared with low-dose FMT alone, adjunctive KTC significantly improved the clinical response rate [ Conclusion: Based on current evidence, KTC combined with low-dose FMT may have potential advantages in improving PMS-related symptoms, sex hormone levels, and lipid profiles, with an acceptable short-term safety profile in patients. However, the certainty of evidence across the outcome measures, as assessed by GRADE, was not high. Therefore, these findings should be interpreted with caution, and further verification through high-quality, large-sample randomized controlled trials is warranted. Systematic review registration: https://inplasy.com/inplasy-2025-11-0002/, identifier INPLASY2025110002.