Objective: To observe the clinical efficacy and safety of shugan jianpi decoction in treating menopausal syndrome of liver depression and spleen deficiency.Methods: 48 patients who met the inclusion criteria were divided into two groups with random number table method,24 patients in each group.The treatment group was given shugan jianpi granules.In the control group,tibolong was taken and six weeks later,the changes of modified Kupperman score,TCM symptom effect score and qol in menopause were compared in two groups before and after treatment to evaluate the effect.Results:(1)After treatment,the whole scores of modified Kupperman and qol scores of menopause in the two groups were significantly lower than that before treatment(P <0.05).(2)After treatment,the scores of modified Kupperman symptoms in two groups were compared,and the differences in hot flashes,sweats,paresthesia,insomnia and dreaminess,irritability,dizziness,fatigue,joint muscle and limb pain,headache,heart palpitations,and skin ant sense were statistically significant(P < 0.05).There were statistically significant differences in fatigue,joint muscle pain,limb pain,headache,and skin ant sense(P < 0.01).There was no significant difference in pain during intercourse,urinary symptoms or depression(P > 0.05).(3)The total effective rate of TCM syndromes in the treatment group after treatment was 87.4%,while that in the control group was 54.2%;The total effective rate of TCM syndromes after treatment was compared between the two groups,with statistically significant difference(P < 0.01).(4)The total effective rate of each single symptom treatment group of TCM syndrome was higher than that of the control group.In the treatment group,the effective rate of hot flashes and sweats was 91.7%,and the effective rate of rib pain,diet,fatigue,dry mouth and bitterness was more than 80%.The symptoms of hot flashes,sweating,emotional depression,irritability,loose stool,hand-foot-heart heat,dry mouth and bitter mouth were statistically significant(P < 0.05).There was no statistically significant difference in symptoms of rib pain,fatigue,dizziness,headache,insomnia and multiple dreams(P >0.05).(5)After treatment,scores of each dimension of men-qol in both groups were lower than before treatment.Compared with the two groups,scores of men-qol in all dimensions were statistically significant(P < 0.05),and the treatment group was superior to the control group.(6)The two groups of patients with electrocardiogram,liver and kidney function safety index comparison,before and after treatment no significant changes(P > 0.05),the difference was not statistically significant.Conclusion: Shugan jianpi decoction is made up of jingfang chai hu keel oyster decoction and da bupi decoction under the guidance of syndrome differentiation theory of viscera.The study confirmed that this empirical formula has a good clinical effect in the treatment of liver depression and spleen deficiency type menopause syndrome,and can significantly improve the quality of life of patients,without adverse reactions,which can be further promoted in clinical practice. |