Objective: To observe the clinical efficacy of Shugan Jianpi Anshen Formula,to explore a better treatment plan for patients with insomnia of liver depression and spleen deficiency type,and reduce the pain of insomnia.Methods: This study selected 66 patients with insomnia of liver depression and spleen deficiency type who were treated in the outpatient and inpatient department of the Department of Encephalopathy of Anhui Hospital of Traditional Chinese Medicine from October 2021 to October 2022.They were randomly divided into control group and observation group,with 33 cases in each group.The control group took Dexzopiclone tablets orally,and the observation group added Shugan Jianpi Anshen Formula to the control group.They were treated for 4 weeks continuously and were followed up 2 weeks after the treatment.Compare the scores of various scales and PSG monitoring results before and after treatment,and evaluate the effectiveness of Shugan Jianpi Anshen Formula.Results:A total of 66 patients were included in this study.During the study period,2 patients fell out of the control group and 3 patients fell out of the observation group.Finally,61 patients completed the clinical study,with a drop-out rate of 7.6%.1.Before entering the clinical study,there was no statistical difference between the two groups in terms of gender,age,course of the disease,TCM syndrome score,PSQI score,and PSG monitoring results,which was comparable(P>0.05).2.Clinical efficacy evaluation:(1)The total score of TCM syndrome: after the intervention,the total effective rate of the control group was 35.5%,and that of the observation group was 93.3%,the difference was statistically significant(P<0.05).The total score of TCM syndrome in the two groups was lower than that before treatment(P<0.01);The inter-group comparison showed that the observation group was superior to the control group in all items.(2)PSQI total score: after the intervention,the total effective rate of the control group was 77.4%,and that of the observation group was 90.0%,the difference was statistically significant(P<0.05).The total score of PSQI in the two groups was lower than that before treatment,and the difference between the two groups was statistically significant(P<0.01);Inter-group comparison showed that the improvement of each item in the observation group was better than that in the control group(P<0.05),especially in the comparison of sleep time and daytime function score(P<0.01).(3)PSG monitoring results: After treatment,the PSG monitoring results of patients in the two groups were improved compared with those before treatment,P<0.01,the difference was statistically significant;Compared with the control group,the observation group was superior to the control group in other monitoring indicators except the total sleep time difference was not statistically significant(P>0.05).(4)Comparison after treatment and 2 weeks after the end of treatment: the TCM syndrome score and PSQI score of patients in the two groups increased compared with that after treatment,but the total score of the control group increased more significantly.3.The satisfaction of patients was investigated.The satisfaction of the control group was 80.65%,and that of the observation group was 93.33%.There was a statistical difference between the two groups(P<0.05).4.There were no obvious adverse reactions and no obvious abnormal changes in safety indicators in both groups during the treatment.Conclusion:1.The combination of Shugan Jianpi Anshen Formula and Dexzopiclone can not only improve the quality of sleep but also regulate the clinical symptoms of liver depression and spleen deficiency.2.It was found that the combination of Shugan Jianpi Anshen Formula and Dexzopiclone has more advantages in long-term efficacy. |