针灸治疗溃疡性结肠炎随机对照试验文章的规范表述要素研究

Study on the normative statements elements of randomized controlled trial literature on ulcerative colitis treated by acupuncture and moxibustion

目的:通过评价针灸治疗溃疡性结肠炎随机对照试验(RCT)文章的质量,探索针灸临床研究文献规范表达的基本要素,为针灸现代文献质量评价提供参考思路。方法:检索1998年1月到2012年12月中国期刊全文数据库、万方数据库和维普数据库中针灸治疗溃疡性结肠炎的RCT文章,最终纳入文献53篇。根据临床试验报告统一标准(CONSORT)与针刺临床试验干预措施报告标准(STRICTA)声明对每一篇纳入文献的表述情况进行记录并对主成分进行分析。结果:归纳出针灸RCT文章表述要素主要包括"随机化""干预细节""结局指标"和"前言与讨论"4个方面,并总结列出具体的表述要素项目。结论:针灸治疗溃疡性结肠炎RCT文章质量需要提高,其评价标准需进一步改进;同时需要建立符合中医针灸特色的评价体系以客观反映针灸的现状。

Objective： Through evaluating the quality of randomized controlled trial （RCT） literature of ulcerative colitis treated by acupuncture and moxibustion, to explore basic elements of normative statements on literature of acupuncture- moxibustion clinical study, so as to provide reference ideas for quality evaluation of acupuncture-moxibustion modem literature. Methods： RCT literatures on ulcerative colitis （UC） treated by acupuncture and moxibustion from January 1998 to December 2012 were retrieved from CNKI, WANFANG and V1P database, 53 articles were included finally. According to CONSORT and STRICTRA, statements were recorded and the principal components were analyzed on each selected article. Results： The statements elements of acupuncture-moxibustion RCT literature were concluded that there were four aspects of ＇randomization＇, ＇intervention in the details＇, ＇outcome indicator＇ and introduction and discussion＇. Moreover, the specific statements elements items were summarized and listed. Conclusion： The improvement on quality of RCT literature on UC treated by acupuncture and moxibustion is required, as well as the evaluation standards, meanwhile, the evaluation system conform to acupuncture- moxibustion characteristics should be established to objectively reflect the situation of acupuncture and moxibustion.