| Objective:To explore the theoretical basis of insomnia from liver depression and spleen deficiency,according to Shugan Jianpi,Jieyu Anshen method,formulate Xiaoyao Anshen formula,evaluate its clinical efficacy in the treatment of insomnia,deepen the theoretical understanding of insomnia from liver depression and spleen deficiency,and broaden the thinking and method of traditional Chinese medicine in the treatment of insomnia.Methods:To review the related literature of insomnia treated by Chinese and Western medicine,and to explore the etiology,pathogenesis,syndrome differentiation,treatment and prescription of insomnia of liver depression and spleen deficiency type.Methods:84 patients were randomly divided into treatment group and control group,42 cases in each group.The treatment group was treated with Xiaoyao Anshen Decoction,and the control group was treated with dexzopiclone combined with oxazepam for 8 weeks.The sleep time(H),sleep time(H),Pittsburgh sleep index(PSQI)score and TCM syndrome score were compared before and 2,4,6 and 8 weeks after treatment to evaluate the clinical efficacy of Xiaoyao Anshen Decoction in the treatment of insomnia with liver depression and spleen deficiency.Results:1.A total of 80 patients completed the study,statistical analysis.Before treatment,there was no significant difference in the baseline data of gender,age,personality,occupation,education level and insomnia severity between the two groups(P>0.05).2.Insomnia efficacy evaluation:(1)Comprehensive efficacy:after 2 weeks,4 weeks,6 weeks and 8 weeks of treatment,the total effective rates of the treatment group were 27.5%,37.5%,62.5%and 87.5%,respectively,while the total effective rates of the control group were 80.0%,92.5%,95.0%and 95.0%.The rank sum test showed that the comprehensive efficacy of the control group was better than that of the treatment group 2 weeks,4 weeks and 6 weeks after treatment(P<0.05).After 8 weeks of treatment,the comprehensive efficacy of the two groups was equivalent(P>0.05),indicating that the comprehensive efficacy of Xiaoyao Anshen Decoction in the treatment of insomnia of liver depression and spleen deficiency type was equivalent to that of Western medicine.(2)Sleep time:the sleep time of the two groups at different time points after treatment was significantly shorter than that before treatment(P<0.01),and the effect of shortening sleep time in the control group was better than that in the treatment group(P<0.05).It shows that Xiaoyao Anshen Decoction can significantly shorten the sleep time of insomnia patients,but the curative effect is inferior to that of Western medicine control group.(3)Sleep duration:after treatment,the sleep duration of the two groups increased significantly(P<0.01).After 2 weeks,4 weeks and 6 weeks of treatment,the effect of increasing sleep duration of the control group was better than that of the treatment group(P<0.05).After 8 weeks of treatment,the effect of increasing sleep duration of the two groups was similar(P>0.05).It shows that Xiaoyao Anshen Decoction can significantly increase the sleep duration of patients,and with the increase of treatment course,the curative effect is equivalent to that of Western medicine control group.(4)PSQI score:①Comparison of total PSQI score:after treatment,the total PSQI score of the two groups was significantly lower than that before treatment(P<0.01).There was no significant difference in the total score of PSQI between the two groups(P>0.05).②Comparison of PSQI component factor scores:after treatment,the hypnotic drug score of the control group increased,while the hypnotic drug score of the treatment group remained unchanged,except for this single item,the other component factor scores of the two groups decreased significantly(P<0.01).There was no significant difference in sleep efficiency and daytime dysfunction between the two groups(P>0.05).The scores of sleep quality,sleep time,sleep disorder and sleep time decreased more significantly in the control group(P<0.05).It shows that Xiaoyao Anshen formula can significantly reduce the total score of PSQI,improve sleep efficiency and daytime dysfunction,and the curative effect is equivalent to that of Western medicine.(5)Syndrome curative effect:The total effective rates of the treatment group were 22.5%,72.5%,100.0%and 100.0%respectively,while those of the control group were 22.5%,47.5%,77.5%and 82.5%respectively.Compared with the control group,the curative effect of TCM syndrome in the treatment group was significantly better(P<0.01).② Comparison of syndrome scores:after 8 weeks of treatment,the TCM syndrome scores of the two groups were significantly decreased,and the treatment group was better than the control group(P<0.01).③Symptom score comparison:after 8 weeks of treatment,the scores of the two groups were significantly decreased,and the scores of stomachache/flank distension,less food and abdominal distension in the treatment group were significantly decreased compared with those before treatment(P<0.05).Insomnia,emotional depression/anxiety/irritability,loose stool,emotional depression/careless diet were associated with more severe symptoms,good Taixi,chest tightness,mental fatigue Compared with before treatment,the decreased degree of fecal adhesiveness/disharmony scores were all P<0.01.In the control group,the symptom aggravation score of depression/eating carelessly decreased compared with that before treatment(P<0.05),and the scores of insomnia,depression/anxiety/irritability,loose stool,good Taixi,chest tightness and mental fatigue decreased compared with that before treatment(P<0.01).Compared with the two groups,the improvement of loose stools,emotional depression/eating carelessly in the treatment group was significantly better than that in the control group(P<0.01).It is suggested that Xiaoyao Anshen formula can significantly improve the syndrome of liver depression and spleen deficiency,especially in the improvement of gastrointestinal symptoms.3.Safety evaluation:there were 7 cases of drowsiness,3 cases of dry mouth and 2 cases of dizziness in the control group.There was no obvious adverse reaction in the treatment group,indicating that Xiaoyao Anshen formula was safe.Conclusion:Xiaoyao Anshen Decoction can shorten the sleep time,increase the sleep time and reduce the PSQI score of insomnia patients.Although its curative effect is not as fast as that of Western medicine,with the increase of course of treatment,the curative effect is gradually equivalent to that of Western medicine,and it can significantly improve the syndrome of liver depression and spleen deficiency,and improve the quality of sleep and life of patients.In addition,Xiaoyao Anshen formula has less adverse reactions and high acceptance. |
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