Abstract: Objective: To evaluate the efficacy and safety between Kuntai capsule and hormone replacement in treating patients with perimenopausal syndrome. Methods: Such databases as the Cochrane Library, PubMed, CNKI, VIP and Wanfang Data and others were electronically searched. A systemic review and meta-analysis of publication from November 2004 to February 2015 was performed. The review was limited to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome and therapy period was at least 3 months. The primary outcome assessed was the efficacy at 3 month-time point，including the effective rate of Kupperman Menopausal Scores，blood E2 and FSH level. Safety index mainly includes the incidence of adverse reactions（such as gastrointestinal complains，breast distending pain or vaginal bleeding，etc）. Results: Fifteen studies，including 1 243 total participants were included. The total effective rate and change of blood FSH level showed no significant difference between Kuntai capsule group and the hormone replacement therapy group（P＞0.05）. The Kupperman Menopausal Scores and blood E2 level in the hormone replacement therapy group were higher than Kuntai capsule group（P＜0.05）. Adverse reaction，such as gastrointestinal complains，breast distending pain or vaginal bleeding，Kuntai capsule group was inferior to hormone replacement therapy group in terms of adverse reactions（P＜0.05）. Conclusions: The current limited evidence showed that， Kuntai capsule could also improve climacteric symptoms and reduce the incidence of adverse reaction.

Key words: Kuntai capsule, Estrogen replacement therapy, Perimenopause, Drug therapy, Meta-analysis