Objective:To observe therapeutic effect of Chinese drug for regulating the function of the liver and spleen on peri-climacterium insomnia.Methods:Sixty-eight cases were randomly divided into a treatment group of 36 cases and a control group of 32 cases according to the sequence of visting.The treatment group was treated with oral administration of TCM decoction for regulating the liver and spleen

and the control group was given diazepam and oryzanol before sleeping

for 28 days.Results:The therapeutic effect on insomnia was similar in the two groups

but the recurrent rate of insomnia in the control group was significantly higher than that in the treatment group（P<0.05） at following servey of 3 months

indicating that Chinese drug has a better after-effect.After treatment

all indexes of QOL in the treatment group significantly improved （P<0.05 or P<0.01）.Physiologic function（PF）

body pain（BP）

general health（GH） vatality（VT） and mental health（MH） in the control group were significantly improved after treatment]（P<0.05）

but the different values of VT

PF

BP and MH before and after treatment in the treatment group were more remarkable than those in the control group（P<0.05 or P<0.01）.Conclusion:Chinese drug for regulating the function of the liver and spleen has definite therapeutic effect on pre-climacterium insomnia

and it can improve quality of life of the patient with better after-effect.