Clinical Study On The Treatment Of Chronic Insomnia With Modified Suanzaoren Decoction Combined Cognitive Behavioral Therapy

BackgroundInsomnia is a common public health problem that seriously affects people's lives because of its chronic,susceptibility and high recurrence.The incidence of insomnia is increasing year by year,and the age of patients is younger.Insomnia is mainly characterized by persistent difficulty falling asleep,easy to wake up or wake up early,accompanied by obvious daytime functional impairment and decreased quality of life.Insomnia,whether primary or secondary to other diseases,can be treated as a single disease over time.In view of this,the DSM-V defines insomnia,which lasts for more than three months,as chronic insomnia.Studies have shown that chronic insomnia is highly associated with depression and overstress without effective treatment.In addition,chronic insomnia significantly increases the risk of other diseases such as cardiovascular disease,stroke,hypertension and obesity,and consumes a lot of medical resources and causes a lot of pain to patients.As the current international standard non-drug therapy,insomnia cognitive behavioral therapy(CBTI)is the treatment of choice for the treatment of chronic insomnia.CBTI consists of a range of therapeutic elements including:stimulation control therapy(SRT),sleep restriction therapy(SCT),sleep hygiene education,relaxation training,and cognitive reconstruction.Although CBTI is effective,there are some problems.CBTI only intervenes for "maintenance factors" and does not involve"biological susceptibility" intervention,which is the root cause of many stubborn insomnias that are difficult to cure.In the analysis of the treatment path,we also found that the oral administration of Suanzaoren Decoction in the treatment can make the patient feel psychologically compensated on the one hand,and can also play the role of soothe the nerves on the other hand.Based on the results of previous studies,we believe that Suanzaoren Decoction has a positive intervention effect on emotional and physical problems caused by high anxiety and susceptibility factors.Therefore,it is of great clinical significance to explore an effective treatment for "bio-susceptibility factors" of chronic insomnia to compensate for the more comprehensive treatment of CBTI that only emphasizes the intervention of "maintenance factors".Purposes(1)Solving the problems of excessive arousal anxiety and daytime fatigue in CBTI therapy,thus promoting the localization of the therapy(2)Improve the therapeutic effect of insomnia and indirectly improve the efficacy of traditional Chinese medicine.(3)Exploring the mode of cooperation between drugs and behavioral therapy to improve and stabilize the clinical efficacy of insomnia.MethodsThe randomized digital table method was used to randomly assign the subjects to the two groups:32 patients in the decoction group(Suanzaoren decoction combined with supportive psychotherapy)and 31 patients in the combined group(Suanzaoren decoction combined with cognitive behavioral therapy).Among them,it should be noted that supportive psychotherapy is a placebo treatment.This topic was designed using a randomized controlled trial.The patients with chronic insomnia treated by the Department of Psychological Sleep of Guang'anmen Hospital of China Academy of Chinese Medical Sciences(differentiation of hepatic blood deficiency)were included in the study.63 eligible subjects were randomly divided into 32 groups of decoction group and 31 cases of combined group.The course of treatment is 6 weeks.The following data were measured at 0 weeks of treatment(inclusion),2 weeks of treatment,and 6 weeks of treatment(outgroup):Pittsburgh Sleep Quality Index(PSQI),Insomnia Severity Index(ISI)The Sleep Personal Beliefs and Attitudes Scale(DBAS),the Self-rating Anxiety Scale(SAS),and the Montgomery Depression Rating Scale(MADRS).and all subjects were required to record a sleep diary throughout the course of treatment.The efficacy was judged by comparing the above data.A useful exploration was performed using a Near-infrared Spectroscopy(fNIRS).Results(1)Pittsburgh Sleep Quality Index(PSQI):Combined with 2 weeks of treatment,the combined group improved the indicators significantly.The Suanzaoren decoction group also showed significant improvement compared with the previous one.After 6 weeks of treatment,the combined group received continuous improvement.There was no significant difference in the rate of reduction between the two groups(P>0.05).(2)Insomnia Severity Index(ISI):After 2 weeks and 6 weeks of treatment,the two groups showed significant improvement,but the improvement of the drug group was not as good as that of the combination group.(3)Sleep Personal Beliefs and Attitudes Scale(DBAS):After treatment with Suanzaoren Decoction for 2 weeks,only the "expectation of sleep" and "drugs" were statistically significant and showed a good trend.After 6 weeks,all the items in the Suanzaoren decoction group improved,which were statistically significant.This is related to the onset characteristics of traditional Chinese medicine.The improvement of the combined group was more obvious and statistically significant(P<0.05).(4)Self-rating anxiety scale(SAS)and Montgomery Depression Rating Scale(MADRS):After 6 weeks of treatment,both the combined group and the decoction group improved significantly,but the combined group improved more.And statistically significant(P<0.05).There was no statistical difference in the adjustment of depression in the Suanzaoren decoction group.However,anxiety symptoms can be improved to some extent(P<0.05).After 6 weeks of treatment there was still no significant improvement in depressive symptoms.The combined group showed significant improvement in anxiety and depressive symptoms.(5)Sleep diary:After 2 weeks and 6 weeks of treatment,the decoction group showed significant improvement,and there were statistical differences.The efficacy of the combined group improved significantly,and the shortening of the "sleeping latency"was the most obvious,and there was statistical difference(P<0.05).After 6 weeks of treatment,both the decoction group and the combination group improved significantly,but the combined group improved more.The statistics were significantly different(P<0.05).(6)Functional Near-infrared Spectroscopy(fNIRS):For the changes of fNIRS before and after treatment in 10 subjects in the combined group,the non-parametric test showed significant changes in the integral value.The difference was(P<0.01),but the difference in center of gravity value was not statistically significant(P>0.05).ConclusionOn the whole,Suanzaoren Decoction combined with cognitive behavioral therapy for chronic insomnia is superior to the simple use of Suanzaoren Decoction.