Abstract: Objective:To observe the clinical effects and safety of the Kuntai capsule combined with estrogen in the treatment of menopause syndrome(MPS).Methods:One hundred and sixty MPS patients were randomly divided into the control group and observation group according to the random number method(80 cases each group).The control group was treated with conventional drug(2 mg/d of pentanoic acid estradiol),and the observation group was treated with 1 mg/d of pentanoic acid estradiol(once a day) combined with Kuntai capsule(4 granules/time,3 times/d) by oral.After 10 d of treatment,two groups were treated with medroxyprogesterone acetate(2 mg/time,once a day) by oral for 3 treatment cycles.The Kupperman symptom score,serum level of estrogen(E₂),vaginal cell mature value,endometrial thickness and blood lipid in two groups between before and after treatment were compared,and the digestive tract,vaginal bleeding and breast pain symptoms in two groups were recorded.Results:After treatment,the Kupperman scores in two groups significantly decreased compared with before treatment(P<0.01),which in observation group was more significant(P<0.01).After 3 months of treatment,the total effective rate in observation group(90.0%) was higher than that in control group(72.5%)(P<0.01).After treatment,there were significant changes in follicle stimulating hormone,luteinizing hormone and E₂(P<0.01),and the improvement of follicle stimulating hormone and E₂ in observation group was better than that in control group(P<0.05).The adverse reaction rate in observation group(3.75%) was lower than that in control group(12.50%)(P<0.05).Conclusions:Kuntai capsule combined with small dose of estrogen replacement therapy in treating MPS can significantly improve the patient's clinical symptoms,which is safe and worthy of clinical promotion.