Abstract： Objective： To observe the clinical effect of modified Zhibai Dihuang Decoction combined with Femoston on perimenopausal syndrome and its effect on sex hormones. Methods ： A total of 120 patients with perimenopausal syndrome were divided into the treatment group and the control group according to the random number table method，with 60 cases in each group. The control group was given Femoston and the treatment group was additionally treated with modified Zhibai Dihuang Decoction based on the treatment of the control group. Before and after treatment，the traditional Chinese medicine (TCM) syndrome scores， modified Kupperman scores， and the levels of sex hormones， serum calcium and vitamin D3 were compared between the two groups. The clinical effects and safety in both groups were also evaluated. Results： The total effective rate was 95.00% in the treatment group， higher than that of 76.67% in the control group (P＜0.05). After treatment，the TCM syndrome scores，modified Kupperman scores， and the levels of follicle- stimulating hormone (FSH)， and luteinizing hormone (LH) in the two groups were lower than those before treatment (P＜0.05)，and the levels of estradiol (E2)，serum calcium and vitamin D3 were higher than those before treatment (P＜0.05)；after treatment，the TCM syndrome scores，modified Kupperman scores，and the levels of FSH and LH in the treatment group were lower (P＜ 0.05)，and the levels of E2，serum calcium and vitamin D3 in the treatment group were higher than those in the control group (P＜0.05). There were no adverse reactions during the treatment in the two groups. Conclusion：Modified Zhibai Dihuang Decoction combined with Femoston has a significant curative effect on perimenopausal syndrome， which can regulate the levels of sex hormones of patients， and enhance the absorption of calcium，with high safety.