Study On The Clinical Efficacy And Safety Of Wuling Capsule In The Treatment Of Insomnia

Objective:Comparing the PSQI score before and after treatment to evaluate the clinical efficacy of Wuling capsule.The Treatment Emergent Symptom Scale(TESS)is used to assess the safety of Wuling capsule.And the last aim of this study is to guide the clinical application of Wuling capsule.Method:The research progress of TCM and Western Medicine on insomnia and the literature on the basic and clinical research of Wuling capsule were studied,and the project was designed.According to the inclusion and exclusion criteria of experimental design,71 cases of insomnia patients were included since September to December,in 2017.The 71 patients were randomly divided into the treatment group and the control group.36 cases in treatment group were treated with Wuling capsule;35 cases in control group were given estazolam.The course of treatment was 4 weeks.The general data of sex,age and course of disease were collected in two groups of patients.The two groups were treated with PSQI scores before and after treatment,and laboratory examinations such as blood routine,liver function and renal function,and TESS score.The PSQI score and PSQI reduction rate and the incidence of adverse reactions were compared between the two groups.Result:The difference in age,sex,course of disease and PSQI score before treatment in the two groups was not statistically significant,and P>0.05 was comparable.In the treatment group,the average score of PSQI after treatment was significantly lower than that before treatment(6.88±2.58 vs 1.08±2.50),and the difference was statistically significant(t=8.70,P<0.01).In the control group,the average PSQI score after treatment was significantly lower than that before treatment(8.29± 2.69 vs11.83±2.29),and the difference was also statistically significant(t=6.01,P<0.01).After treatment,the total score of PSQI in the treatment group was significantly lower than that of the control group(6.88 ±2.58 vs 8.29 +±2.69),and the difference was statistically significant(t=6.79,P<0.01).The average reduction rate of the treatment group was(42.30±20.01)%,and the average reduction rate of the control group was(30.00±19.33)%,and the difference was statistically significant(t=2.66,P<0.01).The effective rate of the treatment group was 69.44%,and the effective rate of the control group was 54.29%.The effective rate of the treatment group was higher than that of the control group,but the difference was not statistically significant,P>0.05.In the treatment group,3 patients had adverse reactions and the incidence of adverse reactions was 8.3%,and 4 cases in the control group had adverse reactions and the incidence of adverse reactions was 11.4%.The difference of adverse reaction between the two groups was not statistically significant,P>0.05.Conclusion:Both Wuling capsule and estazolam can improve the symptoms of insomniacs,improve the quality of sleep and reduce the PSQI score.Nevertheless the overall treatment effect of Wuling capsule is not inferior to estazolam,and less adverse reaction,high safety,It's worth the further research and promotion.