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Objective:To evaluate the efficacy and safety of Heyan Kuntai Capsule(和颜坤泰胶囊,HYKT) and hormone therapy (HT) on perimenopausal syndromes (PMSs).Methods:From 2005 to 2008,390 women with PMSs were recruited from 4 clinic centers.The inclusion criteria included ages 40 to 60 years,estradiol (E2) below 30 ng/L,and follicle stimulating hormone (FSH) above 40 IU/L,etc.The patients were randomly assigned to HYKT group or HT group by random number table method,administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months.During treatment,the patients were interviewed quarterly,Kupperman Menopausal Index (KMI) scores,hot flush scores,insomnia scores,Menopause-Specific Quality of Life (MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively.The last interview was made at the end of 12-month treatment.Results:After treatment,KMI scores of HYKT group and HT group were both significantly decreased compared with baseline (P＜0.01) and there was no significant difference between groups (P＞0.05),except that KMI of HYKT group was higher after 3-month treatment (P＜0.05).After treatment,hot flush and insomnia scores were both improved significantly in two groups (P＜0.01);and HT had a better performance than HYKT in improving hot flush (P＜0.05).MENQOL were significantly improved in both groups after treatment (P＜0.01);but there was no significant difference between two groups (P＞0.05).The incidence of adverse event in the HYKT group was much lower than that in the HT group (P＜0.01).Conclusions:HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions.Although HYKT exerted curative effects more slowly than hormone,it possessed better safety profile than hormone.