对耳穴刺激治疗高血压RCT试验报告质量的CONSORT评价

Evaluation of RCT Reports on Auricular Stimulation for Preventing and Treating Hypertension by CONSORT

目的:采用CONSROT声明对国内利用耳穴刺激防治高血压病的随机对照试验进行科学评价。方法:系统检索中国生物医学文献数据库、中国知网、维普和万方4个数据库,将国内耳穴刺激防治高血压病的随机对照实验文献全部纳入,并采用国际公认的CONSORT声明进行质量评价。结果:共纳入13篇文献。根据CONSORT条目,在所有纳入文献中,有8篇(61.54%)缺乏文题和摘要;10篇(76.92%)提及受试者纳入排除标准;11篇(84.62%)谈到了研究所用的统计学方法 ;12篇(92.31%)报告了各组的人口学和临床基线资料;尚未有文献提及样本含量估计、分配隐藏、盲法及意向性分析。结论:目前国内耳穴刺激质量高血压病的研究报告质量较低。研究者应采用国际公认的CONSORT声明对临床研究进行规范报告。

Objective：To evaluate the RCT reports on auricular stimulation for preventing and treating hypertension by CONSORT.Methods：To search CBM,CNKI,VIP,WANFANG,and gather all the reports for the RCT on stimulating auricular for preventing and treating hypertension,and then evaluate the quality by CONSORT.Result：There were 13 reports in total.According to the CONSORT,there were 8 reports（61.54%）lacking of title and abstract.And there were 10 reports（76.92%）referring to the subjects included exclusion criteria.There were 11 reports（84.62%）mentioning about the statistical methods used in the survey,12 reports（92.31%）reporting the material of the demographic and clinical baseline for each group.But there was no report mentioning the sample estimation,allocation concealment,binding or intention-to-treat analysis（ITT）.Conclusion：At present,the quantity is low for the reports of the RCT of stimulating auricular to preventing and treating hypertension.Researchers should adopt the CONSORT to report clinical studies.