| Objective:To evaluate the efficacy and safety of “ Jiawei Sanxiang Decoction” in the treatment of insomnia caused by “Yu Re Rao Shen”,and to explore its mechanism of action,so as to provide new syndrome differentiation and treatment methods for the remedy of insomnia.Methods:70 patients with insomnia who met the inclusion criteria were randomly divided into treatment group and control group by randomized controlled trial.Among them,35 patients in the treatment group were treated with “Jiawei Sanxiang Decoction”.In the control group,35 patients were treated with Shumian capsule,and the therapeutic effect was evaluated after4 weeks of treatment.The changes in scores of Pittsburgh Sleep Quality Index(PSQI),Multidimensional Fatigue Scale(MFI-20)and TCM Syndrome Scale were observed before and after treatment to evaluate the efficacy and safety of the two groups.Results:There were 4 cases of abscission during treatment,34 cases in the treatment group and 32 cases in the control group were included in the statistics.The observation results were as follows: 1.Efficacy of insomnia:after statistical analysis,the effective rate of the treatment group was94.12%,and the effective rate of the control group was 75.00%,the difference was statistically significant,the treatment group was better than the control group(P<0.05).2.Therapeutic effect of sleep quality: Comparison between PSQI evaluation groups showed that the effective rate of the treatment group was 91.18%,and the effective rate of the control group was 68.75%,the difference was statistically significant,the treatment group was better than the control group(P<0.05).3.Daytime functional efficacy: MFI-20 evaluation showed that the effective rate of the treatment group was 97.06%,and the effective rate of the control group was 68.75%,the difference was statistically significant,the treatment group was better than the control group(P<0.05).4.Therapeutic effect of TCM syndromes: the effective rate of the treatment group was 94.12%,and the effective rate of the control group was 68.75%.There was a significant difference between the two groups,and the treatment group was better than the control group(P<0.05).5.Safety observation: There was no obvious adverse reaction during medication in the two groups,and the safety was good.Conclusion:Jiawei Sanxiang Decoction can significantly improve the sleep quality of patients,prolong the sleep time,and significantly improve the symptoms and signs of patients.The formulation of “ Jiawei Sanxiang Decoction” is rigorous,and the curative effect is considerable,and the prescription has no obvious toxic and side effects,which is worthy of clinical promotion and application. |
