| ObjectiveTaking the randomized controlled trial of moxibustion in the treatment of allergic rhinitis as the research object,the methodological evaluation tool was used systematically to evaluate the quality of the included studies.On the basis of the classic meta-analysis,the cumulative meta-analysis was selected to evaluate the dynamic change trend of the combined results in time and sample size.At the same time,the use of trial sequential analysis(TSA)to estimate the required information size and test the authenticity of the meta-analysis results to provide more reliable evidence-based evidence for the clinical treatment of allergic rhinitis by acupuncturists.Methods1 Literature retrieval:Clinical randomized controlled trials from CNKI(1979-2021),CBM(1979-2021),VIP(1989-2021),Wanfang(1998-2021),Pub Med(1966-2021),Embase(1980-2021)and Cochrane Library were searched in a comprehensive electronic way.Search time was up until January 2021.2 Quality evaluation:We collected clinical randomized controlled trials of moxibustion treatment on allergic rhinitis comprehensively.The Cochrane Risk Assessment Tool for Bias 2.0(Ro B2.0)was selected to evaluate the methodological quality of RCTs.CONSORT guidelines and STRICTOM criteria were selected to evaluate the reporting quality of RCTs.3 Literature screening and data extraction:First screening:The Note Express3.2.0 software was used for the first review,and the duplicates were eliminated.Then manually conducted a second double check based on basic information such as the author and title.Second screening:Initially browsed the title and abstract,and excluded literatures that were obviously inconsistent with this research.Such as:experimental studies,case reports,etc.Screening again:For studies that cannot be determined to be included,we chose to download the full text to decide whether to include.Such as:before and after self-control test,etc.Determine the included studies:Determined the number of RCTs to be included in accordance with the preset eligible criteria.Used Excel software to extract data of the literature.4 Statistical analysis:4.1 Classic meta-analysis:Rev Man5.4.1 software was selected for the meta-analysis of the data.RR and SMD were used to analyze the binary data and continuous data.The effect size was 95%CI.When the number of combined articles was greater than 10,the Egger method of STATA12.0 software was selected to detect publication bias.4.2 Cumulative meta-analysis:The statistical analysis software was STATA12.0.Firstly,judged the magnitude of heterogeneity according to the magnitude of P value and I~2value.A meta-analysis method in which qualified studies were ranked and accumulated in a certain order.The cumulative factors were usually selected for publication time and sample size.The test criteria selected were RR,SMD,and 95%CI.The effect size and 95%CI were used to assess whether the difference in outcome effect was statistically significant(P<0.05).We analyzed the data results to observe whether the research results of moxibustion treatment of AR had a time trend and whether they changed with the increase of sample size.4.3 TSA analysis:The statistical software TSAv0.9 developed by Copenhagen Trial Unit was selected for trial sequential analysis.Ⅰerror probability forα=0.05 andⅡerror probability forβ=0.1 were selected.The statistical efficiency was 80%.Required information size(RIS)was the sample size.TSA analysis method was selected based on the important outcome indicators to estimate the required information size to verify the authenticity of the results of meta-analysis.Results1 Quality evaluation:Sixty RCTs were included.There were 32 RCTs(53.33%)giving detailed randomization methods.Six RCTs(10%)reported specific allocation concealment methods.The description of blinding was not enough.There were 35 RCTs(58.33%)recorded the eligibility criteria of the subjects.Fourteen RCTs(23.33%)distinguished primary and secondary outcome indicators in the description of the outcome indicators.2 Classical Meta analysis:Sixty RCTs were included.A total of 6376patients(trial group VS control group=3221:3031).Analyzing the results of meta-analysis,it was concluded that in terms of improving the total effective efficiency.Compared with the control group,the curative effect of moxibustion was better(RR=1.22,95%CI[1.10,1.35]).In terms of improving symptom scores.Compared with the control group,the score of the moxibustion group was lower(SMD=0.89,95%CI[0.52,1.26]).In terms of improving RQLQ scores.Compared with the control group,the moxibustion group had a lower score(SMD=1.22,95%CI[0.61,1.83]).In terms of improving IgE scores.Compared with the control group,the score of the moxibustion group was lower(SMD=-9.31,95%CI[-12.48,-6.15]).3 Cumulative Meta analysis:3.1 Total effective rate:A total of 29 RCTs were included,with a sample size of 2809 cases.Cumulative factors were based on publication time and sample size.The results showed that:the change of RR value tended to be stable,and the 95%CI gradually narrowed,indicating that the accuracy was continuously improved.3.2 Symptom score:A total of 14 RCTs were included,with a sample size of 1688 cases.Cumulative factors were based on publication time and sample size.The results showed that the change of SMD value tended to be stable,and the 95%CI narrowed gradually,indicating that the accuracy was continuously improved.3.3 RQLQ score:a total of 12 RCTs were included,with a sample size of 885 cases.Cumulative factors were based on publication time and sample size.The results showed that:the change of SMD value tended to be stable,and the 95%CI narrowed gradually,indicating that the accuracy was continuously improved.3.4 IgE:A total of 4 RCTs were included,with a sample size of 287cases.Cumulative factors were based on publication time and sample size.The results showed that:the change of SMD value tended to be stable,and the 95%CI narrowed gradually,indicating that the accuracy was continuously improved.4 TSA analysis:4.1 TSA results based on total effective rate showed:RIS=24911>2949.It indicated that the sample size had not yet reached the required information size.However,the Z value crossed the traditional boundary value and the TSA boundary value.It showed that the current conclusion was basically affirmative,supporting the curative advantage of moxibustion,and no more clinical trials were needed to verify its authenticity.4.2 TSA results based on symptom score showed:RIS=1286<1897.It indicated that the sample size had reached the required information size.And the Z-curve crossed the traditional boundary value after the inclusion of the second study,and crossed the TSA boundary value after the inclusion of the third study.It indicated that the results of meta-analysis were stable,and the conclusion was affirmative,and no more clinical trials were needed to verify its authenticity.Conclusion1 At present,the quality of RCT on the treatment of AR by moxibustion at home and abroad needs to be improved.It is recommended that future clinical studies should strictly follow the CONSORT statement and STRICTOM standards for standardized reports.2 From the meta-analysis,it is concluded that moxibustion treatment of AR is better than conventional treatment in terms of total effective rate,symptom score,RQLQ score and IgE score improvement.Cumulative meta-analysis shows that the results of the research merger have a dynamic trend of time and sample size.TSA analysis confirms that the conclusion is basically certain,and further RCT is basically difficult to change the conclusion. |