Objective:To compare the efficacy and the safety of Remifemin in the treatment of climacteric complaints with Tibolon. Methods:According to the standards,a total of 244 patients were randomly allocated to receive either two tablets of Remifemin or one tablet of Tibolon daily for 12 weeks. This double-blind parallel clinical trial was adopted to compare the Kupperman’s score,Kupperman’s reaction ratio and side effect between the two groups. Results:There was no significant difference between two groups in Kupperman’s scores and Kupperman’s reaction ratio(P > 0.05),but there was significant difference on compound frequency Kupperman’s score and side effect by non-inferiority trial(P < 0.0001). Remifemin showed less side effect compared with Tibolon.(P < 0.001). Conclusion:Remifemin should be effective and safe in relief of climacteric symptoms.