| Objective:This study aims to observe the improvement of Longdan Xiegan decoction Wufang and Longdan Xiegan decoction Meifang on nocturnal insomnia and daytime functional symptoms in patients with insomnia of liver-qi stagnation and fire-transforming type,to explore the efficacy and safety of the theory of yin-yang differentiation and treatment in the treatment of insomnia,including the clinical efficacy of night sleep quality and daytime functional symptoms.To provide new schemes and ideas for enriching the clinical treatment of insomnia,and to provide reliable evidence-based basis for the theory of yin-yang differentiation and treatment of insomnia.Methods:This study adopts a randomized controlled trial method which patients were recruited through the outpatient and ward departments of the Department of Cerebrology at Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine,or through advertising and online channels.According to the inclusion and exclusion criteria,60 patients with insomnia of liver-qi stagnation and fire-transforming type were screened out,and informed consent were signed.The patients were randomly divided into experimental group and control group,the ratio of patients in the two groups was 1:1.The experimental group was given one bag of Longdan Xiegan decoction Wufang Granules orally at 7 am(Maoshi),and one bag of Longdan Xiegan decoction Meifang Granules orally at 7 pm(Youshi).The control group was treated with modified Longdan Xiegan decoction(i.e.Longdan Xiegan decoction Meifang)granules,one bag was taken orally in the morning and the other in the evening.The course of treatment for both groups was 28 days.AIS score and TCM syndrome score were collected on the day of treatment and at the end of treatment from two groups of patients to evaluate the clinical efficacy and record the adverse reactions during the treatment process.SPSS 26.0 software was used for statistical analysis to compare the effectiveness and safety of two therapeutic schemes for insomnia between the experimental group and the control group.Results:Baseline data:This study ultimately enrolled 54 patients with insomnia of liver-qi stagnation and fire-transforming type,with 27 patients in the experimental group and 27 patients in the control group.Before treatment,the data of age,gender,nature of work,course of insomnia,comorbidities with underlying diseases,past use of insomnia medications,SAS score,SDS score,depression severity index,AIS score and TCM syndrome score were statistically compared between the two groups of patients,there was no significant difference in baseline data between the experimental group and the control group(P>0.05),indicating the comparability between the two groups.Clinical efficacy evaluation:(1)AIS score:After treatment,the total AIS scores and scores of each item in the experimental group and the control group decreased compared to before treatment,and the difference was statistically significant(P<0.05).After treatment,the AIS score of the two groups were compared between groups.The total AIS scores and the total daytime functional symptom scores of the experimental group was 6.00± 2.70,0.78±1.09,respectively.The total AIS scores and the total daytime functional symptom scores of the control group was 8.93 ±3.19,2.63 ± 1.15,respectively.There was a statistically significant difference in the efficacy of the two groups in improving AIS score(P<0.05),and the therapeutic effect of the experimental group was better.It is suggested that both treatment schemes can effectively reduce AIS score,in addition,the experimental group was superior to the control group in improving AIS total scores and daytime functional symptom(daytime mood,daytime physical function,daytime sleepiness)scores.(2)TCM syndrome score:After treatment,the total scores and each item scores of TCM syndrome score in the experimental group and the control group decreased compared to before treatment,and the difference was statistically significant(P<0.05).After treatment,the TCM syndrome score of the two groups were compared between groups.The total scores of TCM syndrome score in the experimental group was 8.04±3.24,while the total scores of TCM syndrome score in the control group was 11.11 ± 4.71.The difference in the efficacy of improving TCM syndrome score between the two groups was statistically significant(P<0.05),and the treatment effect of the experimental group was better.The results showed that the two treatment schemes were effective in improving the TCM syndrome score,and the improvement effect of the experimental group was better than that of the control group in the aspects of dreaminess,red eyes,dizziness and the total scores of TCM syndrome score.(3)Clinical efficacy evaluation of insomnia:After treatment,in the experimental group,4 cases were cured,18 cases were significantly improved,4 cases were effective,and 1 case was ineffective,the total effective rate was 96.3%;in the control group,0 cases were cured,9 cases were significantly improved,12 cases were effective,and 6 cases were ineffective,the total effective rate was 77.8%.The difference in clinical efficacy between the two groups was statistically significant(P<0.05),and the clinical efficacy of insomnia in the experimental group was more significant than that in the control group.(4)Evaluation of TCM syndrome improvement:After treatment,in the experimental group,3 cases were cured,18 cases were significantly effective,5 cases were effective,1 case was ineffective,the total effective rate was 96.3%;in the control group,0 cases were cured,12 cases were significantly improved,10 cases were effective,and 5 cases were ineffective,the total effective rate was 81.5%.There was no statistically significant difference in the effective rate of TCM syndrome between the two groups(P>0.05).The two treatment schemes had good clinical efficacy in improving the TCM syndrome of insomnia of liver-qi stagnation and fire-transforming type.Safety evaluation:there were no adverse events in the experimental group and the control group during the course of treatment,suggesting that the two therapeutic schemes have good safety in clinical application.Conclusions:Based on the theory of Yin-yang differentiation and treatment,taking Longdan Xiegan decoction Wufang and Meifang at a suitable time,and taking modified Longdan Xiegan decoction in the morning and evening can effectively reduce AIS score and TCM syndrome score,the two treatment schemes have a good clinical therapeutic effect on insomnia of liver-qi stagnation and fire-transforming type.The experimental group outperformed the control group in terms of AIS score,daytime functional symptom score,TCM syndrome score and clinical effective rate.Overall,the theory of yin-yang differentiation and treatment can effectively improve the clinical efficacy of insomnia,with particularly significant clinical effects in improving daytime functional symptoms,and has a good safety,it is worthy of further clinical application. |
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