Clinical Study On The Treatment Of Primary Insomnia By Acupunture Combined With Cognitive Behavioral Therapy

Objective:1.To evaluate the subjective and obj ective clinical efficacy of acupuncture in the treatment of primary insomnia through systematic review and meta-analysis(Meta)methods.To provide evidence-based evidence for acupuncture treatment of primary insomnia through analyzing the therapeutic effects and characteristics of acupuncture.2.To evaluate the clinical efficacy of acupuncture combined with cognitive behavioral therapy(CBT)on primary insomnia through observing the changes of Pittsburgh sleep quality index(PSQI)score,Self-Rating Anxiety Scale(SAS)score,Self-rating depression scale(SDS)score and the obj ective data of actigraphy of patients with primary insomnia.Methods:1.Randomized controlled clinical trials of acupuncture in the treatment of primary insomnia from the establishment to January 2022 of the China National Knowledge Infrastructure(CNKI),Wanfang database,VIP database,PubMed,EMBASE,EB SCO MEDLINE,Cochrane Central Register of controlled trials(central)and Ovid were searched.Meta-analysis was conducted using R language version 4.1.3 to evaluate the subjective and obj ective therapeutic effect of acupuncture on primary insomnia.2.72 eligible patients with primary insomnia will be randomly assigned at a 1:1 ratio to either the experimental group or the control group.The intervention includes an experimental group that will participate in 4 weeks of acupuncture combined with CBT and a control group that will undergo combined sham acupuncture with CBT.The primary outcome is the change in PSQI score,assessed using the self-rated questionnaire.The secondary outcome is the change in scores of the SAS,SDS,and objective indicators recorded by means of actigraphy.Subjective data will be gathered at baseline,the first week,the second week,the end of the 4-week treatment period and at the 1-month follow-up.Objective data will be collected throughout the treatment period.The changes of subj ective and objective data of patients were compared within and between groups,and the differences between the subjective and objective results were analyzed.Results:1.Meta-analysis results showed that the acupuncture group was significantly superior than the sham acupuncture,placebo acupuncture and blank control group in terms of increasing the objective total sleep time,improving sleep efficiency,reducing the number of awakenings and reducing the wake-up time after sleep,with statistical significance.The subjective reduction of PSQI and ISI scores in acupuncture group was significantly better than that in control group,with statistical significance.2.PSQIComparison in the group:Compared with the baseline data,the PSQI total score and each factor score of the two groups at the 1st,2nd,4th week of treatment and 1 month after treatment were significantly different(P<0.05).The PSQI total score of the experimental group at each time point of treatment was significantly different from that of the previous time point(P<0.0 1).Except for the sleep disturbances score,there was no significant difference between the 2nd week and the 1st week of treatment,and the scores of other factors were significantly different at each time point of treatment compared with the previous time point(P<0.05).Compared with the end of treatment,there was no significant difference in sleep quality,sleep latency,sleep efficiency and sleep disturbances scores in the experimental group at follow-up(P>0.05),and only in the score of sleep latency in the control group(P>0.05).Comparison between groups:There was no significant difference in PSQI total score between the two groups in the 1st week and the 2nd week of treatment(P>0.05),but there was a significant difference in the 4th week of treatment and follow-up(P<0.01).The difference of PSQI total score between the two groups at each time point compared with baseline was significant at the 2nd week,the 4th week and follow-up(P<0.05).The difference of PSQI total score between the two groups at each time point compared with the previous time point was significant at the 2nd,4th week and follow-up(P<0.05).There were significant differences in sleep quality scores between the two groups from the 2nd week of treatment to follow-up(P<0.05).Sleep time score between the two groups at the 4th week of treatment was significantly different(P<0.05).There were significant differences in sleep duration and sleep efficiency scores between the two groups at each time point compared with the baseline(P<0.05).Sleep disturbance score between the two groups only at the 1st week of treatment was significantly different(P<0.05).Daytime dysfunction scores were significant differences between the two groups at each time point(P<0.05).3.SAS、SDSComparison in the group:The SAS total scores of the two groups were significantly different at each time point compared with the baseline(P<0.05).The SDS total score of the experimental group was significantly different from the baseline at each time point(P<0.05).The total scores of SAS and SDS in the experimental group during the treatment period were significantly different from the previous time point(P<0.05).The SAS total score of the control group was significantly different at each time point compared with the previous time point(P<0.05).There were significant differences in the SDS total score of the control group at the 2nd week of treatment compared with the 1st week,and the 4th week of treatment compared with the 2nd week(P<0.05).Comparison between groups:There were significant differences in the SAS total score between the two groups at each time point of treatment and the difference between each time point and the baseline(P<0.05).The difference of SAS total score between the two groups at each time point was significantly different from the previous time point in the 1st week of treatment and follow-up(P<0.05).There was a significant difference between the two groups in the SDS total score at each time point compared with the baseline(P<0.05).4.Objective evaluationComparison in the group:There were significant differences in TST,SE,SA,SOL,and WASO of the two groups at each time point compared with the baseline(P<0.01).Except for SA,which had no significant difference between the 2nd week and the 1st week of treatment(P>0.05),the other obj ective indicators in the experimental group had significant differences at each time point compared with the previous time point(P<0.0 1).Except for SA and WASO,which had no significant difference between the 2nd week and the 1st week of treatment(P>0.05),the other objective indicators in the control group were significantly different from the previous time point at each time point(P<0.01).Comparison between groups:TST between the two groups was significantly different at the 4th week of treatment(P<0.05).There were significant differences in TST between the two groups at each time point and baseline and between each time point and the previous time point(P<0.05).SE between the two groups was significantly different in the 2nd and 4th week of treatment compared with the baseline and in the 2nd week compared with the 1st week of treatment(P<0.0 1).S A between the two groups was significantly different at the each time point compared with the baseline(P<0.05).There was significant difference in SOL between the two groups at each time point(P<0.05),and difference between each time point and baseline(P<0.01).There were significant differences in WASO between the two groups at the 4th week of treatment compared with the baseline(P<0.05),and difference between the 2nd week and the 1st week(P<0.01).5.Subjective and objective consistency evaluationThere was a significant positive correlation of 0.01 level between subjective and objective TST and SE in the experimental group at each time point during the treatment period.The subjective and objective TST in the control group had a significant positive correlation of 0.01 level at each time point in the treatment period,and SE had a significant correlation of 0.05 level.Conclusion:1.Literature research found that acupuncture can significantly improve the symptoms of primary insomnia both objectively and subjectively,and the frequency of acupuncture treatment is an important factor affecting the objective sleep duration.2.Acupuncture or non-meridian acupuncture combined with CBT can effectively treat primary insomnia both subjectively and objectively.In terms of improving sleep quality,prolonging sleep duration,reducing the number of awakenings at night,improving sleep efficiency,and improving anxiety and depression,the efficacy of acupuncture group was significantly better than that of non-meridian acupuncture group.3.The subj ective and obj ective effects of acupuncture or non-meridian acupuncture combined with CBT were consistent on prolonging total sleep time and improving sleep efficiency.4.Acupuncture combined with CBT is safe,effective and stable in the treatment of primary insomnia,which is worthy of clinical promotion.