Objective To observe the clinical efficacy and safety of Kuntai Capsules in the treatment of perimenopausal syndrome. Methods Totally 58 patients with perimenopausal syndrome were randomly divided into Kuntai group of 30 cases with Kuntai Capsules orally

2 g each time

3 times per day and Tibolone group of 28 cases with tibolone tablets

1. 25 mg each time

one time a day

for 12 weeks. Kupperman menopause index（ KMI） and hectic fever and perspiration were scored before treatments and on week 4

8 and 12. At the mean time

liver and kidney function

blood lipids

endometrial thickness and serum hormone levels were detected to determine the clinical efficacy

with adverse reactions recorded. Results The clinical efficacy in the two groups showed no significant difference（ P > 0. 05）. The KMI scores and hectic fever and perspiration scores were significantly decreased on week4

8 and 12 compared within groups（ P < 0. 05）

and the liver and kidney function

blood lipids and endometrial thickness before and after indicated no statistical significance（ P > 0. 05）. After treatments

estradiol（ E2） levels in the Tibolone group were significantly higher

while the follicle stimulating hormone（ FSH） levels was lower（ P <0. 05）. The incidence of adverse reactions in the Kuntai group was 30. 00%

which was significantly lower than60. 71% in the Tibolone group（ P < 0. 05）. Conclusion The clinical efficacy of Kuntai Capsules was equivalent to tibolone tablets

which can notedly reduce symptoms with less adverse effects.