| Objective:This thesis aims to investigate insomnia from anxiety and Qi stagnation,deficiency of heart and spleen,observing and evaluating the clinical efficacy and safety of modified Miaoxiang powder.This work provides the clinical evidence for the application of modified Miaoxiang powder in insomnia treatment,as well as broadens the treatment way in insomnia.Contents and Methods:Using a randomized controlled experiment,70 patients who met the inclusion criteria with insomnia of anxiety and Qi stagnation,deficiency of heart and spleen,were randomly divided into treatment and control groups.35 people in the treatment group were treated with modified Miaoxiang powder decoction combined with zopiclone(Sanchen);the other 35 people in the control group were only treated with zopiclone(Sanchen with the same usage and dosage in the treatment group).The changes of scores of Pittsburgh Sleep Quality Index(PSQI),Multidimensional Fatigue Indicator(MFI-20)and traditional Chinese medicine syndrome score before and after treatment in the two groups during the 4-week treatment period were recorded.Then statistical analysis was used to evaluate the clinical efficacy and safety of the two methods using SPSS 26.0.Results:There were 5 cases of exfoliation during the treatment,leaving 33 and 32 cases in the treatment and control groups for statistics,respectively.The observation results are as follows:1.Before treatment:the two groups were compared in terms of general information,PSQI,MFI-20 and TCM syndrome.The P statistic value is larger than 0.05,indicating that there are no significant statistical differences and the data is comparable.2.Intra-group comparison:all the scores of the two groups were improved after 4-week treatment compared with those before treatment with the statistical difference(P<0.05).3.Inter-group comparison:all the scores of the treatment group are better than those of the control group with the statistical difference(P<0.05),especially in reducing the TCM syndromes,such as worry,sleepless,palpitated,frequent sighing,depressed and unhappy,dizzy,forgetful,pale complexion,fatigue,as well as decreased appetite and loose stool.4.Over efficacy after treatment:(1)Efficacy of sleeping quality:the effective ratio of the treatment group is 93.94%on the basis of PSQI,which is better than that of the control group with the effective ratio of 87.50%(P<0.05).(2)Efficacy in daytime:the effective ratio of the treatment group was 90.91%on the basis of MFI-20 score,which is much better than that of the control group(81.25%).(3)TCM syndrome efficacy:the effective ratio of the treatment group was 90.91%,which is much larger than that of the control group(78.13%).All the differences between the treatment and control groups were statistically significant(P<0.05).5.Safety analysis:patients in both groups had no obvious adverse reactions during the treatment,indicating the good safety of the treatment.Conclusion:Modified Miaoxiang Powder not only effectively improves the sleeping quality and prolongs the sleeping time of insomnia patients with anxiety and Qi stagnation,deficiency of heart and spleen,but also relieves their symptoms of traditional Chinese medicine,such as worry,sleepless,palpitated,frequent sighing,depressed and unhappy,dizzy,forgetful,pale complexion,tired and weak,as well as decreased appetite and loose stool.The prescription is reasonable,effective and reliable,and there is no obvious adverse reaction during the medication.This thesis provides a valuable guidance for clinical diagnosis and treatment of insomnia. |