| Purpose and significance:To evaluate the efficacy and safety of Zhuangshui Ningshen Decotion in the treatment of insomnia patients with hyperactivity of fire due to yin deficiency,by observing the changes of clinical symptoms,Pittsburgh sleep quality index scale scores,TCM syndrome scores and laboratory index before and after treatment.Methods:In this study,a randomized controlled trial was adopted.A total of 84 eligible insomniacs were included and randomly assigned to the observation group(n=42)and control group(n=42).The observation group was treated with Zhuangshui Ningshen Decotion combined with Dexzopiclone tablets,while the control group was treated with Dexzopiclone tablets for 4consecutive weeks.The scores of Pittsburgh sleep quality index scale scores and TCM syndrome scores and laboratory indexes were used as the observation indexes,evaluated once before treatment and once after the 4 weeks of treatment.At last,the observation indicators were performed with relevant statistical analysis,so as to evaluate the clinical efficacy and safety of Zhuangshui Ningshen Decoction.Result:1.A total of 84 cases were included in this study,of which 76 cases completed clinical observation,4 cases fell out in the observation group and 4 cases in the control group,with a shedding rate of 9.52%.2.Before treatment,there was no statistically significant difference between the two groups of patients in gender,occupation,age,disease duration,PSQI scores,TCM syndrome scores,and single TCM symptom distribution(P>0.05),and they were comparable.3.Clinical efficacy: the significant curative rate was 65.79% with total effective rate of89.74% in the observation group,while the significant curative rate of the control group was39.47% with total effective rate was 73.68%,which statistically significant differences(P<0.05)between the two groups.4.After treatment,significant improvements were observed in the PSQI scores and TCM syndrome scores in the pre-and post-treatment intra-group in both groups(P<0.05).The PSQI scores was decreased from 14.68±3.43 to 6.00±3.43 in the observation group and from15.16±3.38 to 7.89±4.13 in the control group,with significant differences between the two groups(P<0.05).TCM syndrome scores: the TCM syndrome scores decreased from20.68±10.07 to 10.05±5.25 in the observation group,and from 21.58±10.70 to 13.42±8.12 in the control group,which were significantly different between the two groups(P<0.05).5.In this clinical observation,no obvious adverse events occurred in two groups,no significant abnormal changes were observed in the laboratory indexes in two groups before and after treatment,and there was no significant difference between the groups before and after treatment(P>0.05).Conclusion:1.Zhuangshui Ningshen Decoction is effective in the treatment of insomnia patients with hyperactivity of fire due to yin deficiency.It has more advantages in reducing PSQI scores and TCM syndrome score than simply using Dexzopiclone tablets,and can better improve patients with hyperactivity of fire due to yin deficiency.2.Zhuangshui Ningshen Decotion has high safety in the treatment of Insomnia with hyperactivity of fire due to yin deficiency. |