近10年CONSORT系列报告标准评价针灸随机对照试验的运用现状分析

Analysis of Application of Acupuncture and Moxibustion RCT in CONSORT Series Report Standard Evaluation in Recent 10 Years

目的总结近10年国内外运用CONSORT系列报告标准评价针灸随机对照试验(randomized controlled trial,RCT)的现状。方法计算机检索CNKI、VIP、WF、CBM、WF、Cocharane Library、PubMed等大型文献数据库,筛选合格文献,采集文献信息,从发表年份、出版语种、研究类型、病症种类、干预方式、评价方法、报告形式等方面进行综合分析。结果共纳入65篇,其中使用单一标准的有15篇,采用联合标准有50篇。应用2001版CONSORT的10篇(15.38%),应用2010版的CONSORT的有41篇(63.08%),运用STRICTA的有60篇(92.31%),采用STRICTOM有4篇(6.15%)。在评价方法上由两位研究者独立进行评价,如遇分歧通过协商或第3位研究者解决48(73.85%)。采用二分法或赋值评分(0~1)的有56篇(86.15%),采用三分法或赋值评分(0~3)的有8篇(12.31%),采用四分法有1篇(1.54%)。结果使用图表结合文字描述有56篇(86.15%)。研究类型主要为二次研究,干预方式中针刺有16篇,灸法4篇,针灸43篇,针刺结合其他2篇。疾病集中在神经系统、肌肉骨骼系统和结缔组织疾病、消化系统疾病为主。结论研究者越来越重视CONSORT系列报告标准衡量针灸RCT的报告质量和规范性,但是运用方法存在一些不足,需要进一步提高。

Objective To summarize the status quo of acupuncture and moxibustion RCT using CONSORT series reporting criteria at home and abroad in recent 10 years.Methods Large domestic and foreign literature databases such as CNKI,VIP,WF,CBM,WF,Cocharane Library,PubMed and so on were searched by computer.The qualified articles were screened,and literature information was collected.Comprehensive analysis was conducted from the aspects of publication year,language,research type,disease type,intervention mode,evaluation method and report form.Results A total of 65 articles were included,including 15 articles using a single evaluation standard and 50 articles using combined evaluation standard.About CONSORT statement edition,10 articles(15.38%)used 2001 edition and 41 article(63.08%)used 2010 edition.At the same time,60 articles(92.31%)used STRICTA and 4 articles(6.15%)used STRICTOM.In terms of evaluation methods,two researchers should independently evaluate the paper.In case of disagreement,48 articles(73.85%)were settled by negotiation or a third researcher,56 articles(86.15%)were rated as the second-level or assignment score as 0~1;8 articles(12.31%)were rated as the third-level or assignment score as 0~3 and 1 article(1.54%)was rated as the fourth-level.The results showed that 56 articles(86.15%)used the combination of chart and text description.The research type was mainly secondary study.There were 16 articles for acupuncture,4 articles for moxibustion,43 articles for acupuncture and moxibustion,and 2 articles for the combination of acupuncture and moxibustion.The diseases studied were mainly diseases of nervous system,musculoskeletal system,connective tissue system and digestive system.Conclusion Researchers pay more and more attention to CONSORT series reporting standards to measure the quality and standardization of acupuncture RCT report,but there are some deficiencies in the application methods,which need to be further improved.