Discussion On The Clinical Efficacy Of Acupuncture And Moxibustion In The Treatment Of Primary Insomnia Based On Meta-analysis And TSA Analysis

Objective:Using evidence-based medicine method,on the basis of the classical Meta analysis,according to the published year and sample content system based on the idea of cumulative Meta comprehensive analysis the curative effect of acupuncture treatment for primary insomnia,at the same time,according to the TSA(time sequential analysis method to predict curative effect of acupuncture treatment for primary insomnia in clinical trials in the future,to provide a more favorable evidence acupuncture clinical decision.Methods:1. Literature search:Comprehensive computer retrieval of CBM,CNKI,VIP,WF,Pubmed,Embase and Cochrane Library.The qualifier"insomnia","sleep disorder"or"insomnia"is the key word or title,subject word;The qualifiers for the intervention were"acupuncture"or"moxibustion"as the title,keywords,abstracts or subject words.The key words in English with"insomnia"or"sleep disorder"or"sleep disturbance"or"sleepless"inscription,keywords,or article;Intervention measures"acupuncture"or"moxibustion".2.Literature screening and data extraction:After the names of all the authors of the literature were concealed,the 2 researchers read the literature independently and screened the literature according to the criteria of inclusion and exclusion.If there was any difference between the two researchers in the process of screening and extraction,the third researcher would make a judgment.At last,the data were extracted after the cross-checking of the selected information.3.Statistical analysis:(1)Classic meta-analysis:Meta analysis was performed with Rev Man5.3software.The enumeration data were expressed by odds ratio(OR),and the mean and standard deviation of the measurement data were used to calculate the 95%confidence interval.If the calculated results were P?0.10 and I~2<50%,the heterogeneity was small,and the fixed effect model was used for analysis.If I~2>50%and the heterogeneity is large,it is necessary to conduct subgroup analysis or sensitivity analysis to eliminate the large heterogeneity.(2)Cumulative meta-analysis:Adopting STATA12.0 version,the command program of"Harris"version was implemented,and the classification and evaluation were conducted according to the differences in the control group.Then,the cumulative analysis method was used to conduct the cumulative analysis according to the time and sample size,so as to observe whether the therapeutic effect of acupuncture on primary insomnia has a time trend and whether it changes with the increase of the sample size.(3)The TSA analysis:Stata12.0 software was used for sequential analysis of the test.Set?error probability for?=0.05,?error probability for?=0.2,sample size as expected information(required information size,RIS),to test the cure rate and total effective sequential analysis(TSA).Result:1. Quality evaluation:In 134 articles included in only a few USES the random number table,computer generated random number sequence or the draw methods such as distribution,most description of the fuzzy,and almost all documents are not reliable allocation scheme is put forward,blinded,low utilization rate of the lack of accurate calculation of sample size and so on are prevented research objective and accurate results are obtained.2. Classic meta-analysis:A total of 1997 subjects were included in20 literatures,including 1031 patients in the acupuncture group and 966patients in the western medicine group.Compared with western medicine,acupuncture treatment of primary insomnia was superior to western medicine in cure rate,effective rate and improvement of PSQI score.The specific results are as follows:(1)The cure rate:[OR=2.85,95%CI(2.30,3.52)](2)The efficient rate:[OR=3.89,95%CI(2.90,5.23)](3)The PSQI score:[SMD=-0.80,95%CI(-1.19,-0.42)]3. Cumulative meta-analysis:(1)The cure rate:A total of 19 articles with a cumulative sample size of 1936 were included in the study.After the cumulative analysis in order of time and sample size,the results indicated that the cure rate of the experimental group was higher than that of the control group,and the change trend of time and sample size tended to be stable.(2)The effective rate:A total of 19 articles with a cumulative sample size of 1936 were included in the study.After the cumulative analysis in order of time and sample size,the results indicated that the effective rate of the experimental group was higher than that of the control group and the trend of changes in time and sample size tended to be stable.(3)PSQI score:A total of 11 literatures with a cumulative sample size of 833 cases were included in the study.After the cumulative analysis according to the sequence of time and sample size,the results suggested that the accumulated statistical data was unstable and changeable.4. The TSA analysis:The results of TSA analysis of cure rate and total effective rate indicate that the available evidence is reliable and robust.Conclusion:1.At home and abroad clinical randomized controlled trials of acupuncture treatment for primary insomnia quality is low.It is suggested that similar randomized controlled trials in the future should strictly follow the standard report of CONSORT evaluation and STRICTA standard to improve the reasonable accuracy,so as to provide more favorable basis for clinical decision-making in the future.2.From the classic meta-analysis and cumulative meta-analysis,it can be concluded that acupuncture treatment for primary insomnia is superior to western medicine in cure rate,effective rate and improvement of PSQI score,but the results are unstable and changeable in improving PSQI score,which still needs to be further confirmed by more multicentre large sample size and high-quality randomized controlled clinical trials.TSA analysis confirmed that the conclusion was basically definite,and it was difficult to change the conclusion with further RCT.