Systematic Evaluation And Clinical Intervention Study Of Acupuncture Treatment For Chronic Insomnia

Insomnia is characterized by recurrent attacks and chronic persistent tendencies.ICSD-3 and DSM-V presented in 2014 focus on the classification of course of disease instead of old-fashioned etiological classification.Chronic insomnia get more attention for its pathological model is a combination of neurophysiology and psychological behavior.Single medicine or psychological therapy fails to meet clinical need.However,as non-pharmaceutical therapy with traditional Chinese medicine specialty,acupuncture have advantages on treating chronic insomnia and looking forward to more evidence supported.This paper is consist of systematic review and clinical research,evaluates clinical effectiveness of acupuncture on chronic insomnia,explores clinical feasibility and efficacy advantage of non-pharmaceutical therapy scheme combination of traditional Chinese medicine and modern psychology.Study 1:Purpose:evaluate research literature of randomized control clinical trial on chronic insomnia treated with acupuncture.Problems of the researches and effective and frequently-used acupoint are found.Evaluate clinical effectiveness of acupuncture versus positive-effect drug.Method:search relevant database domestic and overseas(including CNKI,VIP,Wan-Fang,CBMdisc,PubMed,Cochrane Library),trail registration website and academic service platform.Search since the time of establishment to 31st August,2017.Collect papers of RCT treating chronic insomnia of acupuncture compared to western medicine.Screen out qualified literature according to inclusion and exclusion criteria.Evaluate RCT quality,analyze researches according to Cochrane standard and extract data.Induce and subgroup the treatment and rules of acupoint selection.Meta-analysis is done with RevMan5.3 to analyze clinical effectiveness,and come to a conclusion.Result:Result of systematic review:27 chronic insomnia treating RCT studies are considered,2 in English and 25 in Chinese.The total number of cases is 2148.The number of acupoints used to treatment is 22.Sishencong,Shenmen,Anmian,Sanyinjiao,Baihui,Neiguan,Shenting,Yintang,Shenmai,Zhaohai are top 10 acupoints,stated in the order of operating frequency.According to authentic assessment standard,6 fit A grade,8 fit B grade,13 fit C grade.14 papers make specific description of random method correctly.6 of them illustrate allocation concealment method,only 1 is completely correct.For the special form of treatment forbid blinding,only 3 of them mention it.All 27 of them meet data integrity and no selective reporting.All of them illustrate baseline information,while 2 do not mention baseline comparison,5 of them record side effects,4 of them record following study.7 of them report exits.All 27 do not state sample size basis and intentional analysis.25 of them specify statistical method.Result of Meta-analysis1.Effective rate's influence of acupuncture versus western medicine.Effective rate of 22 studies is meta analyzed.Total number of cases is 1800,916 of acupuncture and 884 of western medicine.For heterogeneity test,I2=0%,P=0.09,analyz with fixed effect model,with OR 3.16,95%CI[2.39,4.17],with statistical difference(Z=8.08,P<0.00001),forest plots show OR>1,fails to intersect with equivalent line.2.PSQI score's influence f acupuncture versus western medicine.PSQI total score of 20 studies is meta analyzed.Total number of cases is 1613,823 of acupuncture and 790 of western medicine.For heterogeneity test,I =87%,P<0.00001,analyze with randomized effect model,effect size MD is-2.09,95%CI[-2.77,-1.40],with statistical difference(Z=5.98,P<0.00001),forest plots show combined effect rests in treatment group,fails to intersect with equivalent line.Sensitivity analysis result correspond with earlier result after the elimination of low quality studies.Subgroup analysis is conduct according to acupoint selection method,it's found that in mind-regulating group(I2=12%,P=0.33),Jiaji points group(I2=34%,P=0.22),Ren du meridien group(I2=0%,P=0.96),homogeneity is well in each study.Pool sample statistics and analyze,mind-regulating group(MD=-2.16,95%CI[-2.79,-1.53]),Jiaji points group(MD=-1.20,95%CI[-1.84,-0.57]),Ren du meridien group(MD=-4.87,95%CI[-5.50,-4.24])has statistical difference between each subgroup(mind-regulationg group Z=6.71,P<0.00001;Jiaji points group Z=3.70,P<0.0002;Ren du meridien group Z=15.26,P<0.00001)?Analyze subgroup according to acupuncture method,find that electric acupuncture group's homogeneity is better(I2=24%,P=0.26),analyze with fixed effect model(MD=-1.79,95%CI[-2.40,-1.19]),result is statistical difference(Z=5.79,P<0.00001).3.Publication biasFor studies with good homogeneity,paint funnel plot and observe quality after meta-analysis used fixed effect model,it shows certain extent of asymmetry.Conclusion:acupuncture is effective on curing insomnia.Compared to western medicine group,electric acupuncture group improve sleep quality better,select mind-regulating acupoints,Jiaji points,Ren du meridien to treat insomnia.It has advantages over western calming and soporific medicine in improving sleep quality.Probable effective acupoits are Sishencong,Shenmen,Anmian,Sanyinjiao,Baihui,Neiguan.But considering insufficient quality of clinical trial methods,we should be skeptical towards forward conclusion.Study 2:Purpose:explore subjective and objective evaluation index of sleep quality,daytime function,sleep cognition and emotional condition of electric acupuncture mind-regulating method unit group CBT treatment.Observe clinical effectiveness and the superior and inferior of combination treatment and single treatment,explore the best no-drug therapy scheme.Method:prospect randomized control clinical study method is used,the research designer respond for isolation blinding and insurance for researchers' qualification and quality of research.According to inclusion and exclusion criteria,patients with chronic insomnia is randomly divided into 3 groups.Single electric acupuncture group,single group CBT group and combination group;For electric acupuncture group,12 electric acupuncture treatments are conducted and 4 group activity is done,lasts for 4 weeks,followed for 2 weeks.Evaluate PSQI,ISI,ESS before and 2 weeks,4 weeks after treatment and followed 2 weeks,total 4 timing.Evaluate PSG,DBAS-16,HAMA,HAMD before and after treatment.At the same time,record sleep diary to monitor sleep condition.Summarize and evaluate changes of index,observe clinical effectiveness in multiple timings and perspectives synthetically.Result:1.General information and baseline comparison 94 patients are include,31 for electric acupuncture group,with 1 loss;32 for group CBT group,with 2 loss;31 for combination group,with no loss.18 of them are male,76 are female.No significant statistical difference between 3 groups in sex,age,marriage condition,course,degree of education,use of sedatives and score of PSQI,ISI,ESS,DBAS-16,HAMD,HAMA before treatment.2.Total score of PSQI and factor score comparisonPSQI comparison in group:compared to the score before treatment,scores all of the groups in observing timing significantly decline,with statistical difference.PSQI comparison between group:2 weeks and 4 weeks after treatment,no statistical significance is found between 3 groups of total score of PSQI;At the time 2 weeks after finish the treatment,there is statistical difference between 3 groups(P<0.05),well combination group is lower than electric acupuncture group(P<0.0167).No statistical difference is found in factors of PSQI total sleep time,sleep efficacy,sleep disorder,hypnotic during the treatment and follow-up period.Sleep quality factor of combination group is lower than electric acupuncture group 2 weeks after treatment(P<0.0167).Sleep latency test factor of combination group is lower than electric acupuncture group at the time of 4 weeks of treatment and 2 weeks after treatment(P<0.0167).Daytime function factor of electric group is lower than group CBT group 2 weeks after the treatment(P<0.0167),and that of combination group is lower than group CBT group 2 weeks in the follow-up period(<0.0167).3.Comparison of total score of ISIComparison of total score of ISI in groups:3 groups of that during observation timing and follow-up timing all decline with statistical difference.Comparison between groups:No statistical difference 2 weeks and 4 weeks after treatment;2 weeks of the follow-up peiod,there is statistical difference between 3 groups(P<0.05),that of combination group is lower than electric acupuncture group(P<0.0167).4.Comparison of total score of ESSComparison of total score of ESS in groups:Compared with that before treatment,score declines in 2 weeks and 4 weeks after treatment of electric acupuncture group,that of group CBT group rises after 4 weeks of treatment.No change found in combination group.Comparison between groups:there is statistical difference between 3 groups of total score of ESS 2 weeks and 4 weeks after treatment(P<0.05,P<0.01),group CBT group is higher than electric acupuncture group(P<0.0167).5.Other observational indexCompare in-group before and after treatment total score of DBAS-16 and find the group CBT group and combination group both decline(P<0.01);comparison among groups has difference(P<0.05),electric acupuncture group is higher than group CBT group,electric acupuncture group is higher than combination group(P<0.0167).Compare in-group before and after treatment total score of HAMA,all of them decline(P<0.01);comparison among groups has difference(P<0.05),electric acupuncture group is higher than combination group,group CBT group is higher than combination group(P<0.0167).Compare in-group before and after treatment total score of HAMD,all of them decline(P<0.01);comparison among groups has difference(P<0.05),electric acupuncture group is higher than combination group,group CBT group is higher than combination group(P<0.0167).No difference is found in any index of PSG between groups before the treatment.After treatment,total sleep time(TST),sleep efficiency(SE)increase,awake time(AT)decrease;Compare after treatment between groups find combination group's sleep latency(SL)is shorter(P<0.0167)than electric acupuncture group.Compare sleep ingredients between groups,find REM period of electric acupuncture group after treatment is longer than that of group CBT group,NREM3 period in group CBT group is longer than electric acupuncture group(P<0.0167).Conclusion:1.Electric acupuncture mind-regulating method have effect on chronic insomnia,the effect of improving sleep quality and emotion fairly equals to group CBT,and better in improving daytime function.2.Effect of combination of electric acupuncture mind-regulating and group CBT lasts longer compared to single electric acupuncture mind-regulating therapy,has better effect on daytime function compared to single group CBT,better in improving emotion compared to each single group.3.Effect of electric acupuncture mind-regulating method exist independent of correcting cognition,mechanism of improving sleep differs from group CBT,and the time start to work differs,the combination increase synergetic effect on clinical treatment.