摘要
目的评价中医药治疗结直肠癌随机对照试验(RCT)的论文报告质量,并对存在的问题进行探讨。方法双人双机检索1996年1月1日至2018年8月31日中国知网(CNKI)收录的中医药治疗结直肠癌的RCT文献,采用《CONSORT 2010声明:报告平行对照随机临床试验指南的更新》(简称《声明》)清单对所有条目逐一进行报告质量评价,给出"是"或"否"的判断,并将1996年1月1日至2012年12月31日与2013年1月1日至2018年8月31日发表的论文进行对比。结果与1996年1月1日至2012年12月31日相比,2013年1月1日至2018年8月31日发表的中医药治疗结直肠癌的RCT论文报告质量在《声明》2a科学背景、2b目的、4a合格标准、4b场所、17a结局指标的结果/效应估计值及精确性、17b二分类结局的相对和绝对效应值、21推广、25资助这8个条目中显著提升,差异有统计学意义(P<0.05);从7a到11b涉及样本量估算、随机、盲法、分工协作等RCT核心的方法学条目,差异无统计学意义(P>0.05)。结论《声明》发表以后,RCT论文报告质量有一定提升,但核心的方法学条目报告质量仍不高,可能与研究者对《声明》的知晓度偏低有关,也可能与汤药安慰剂制备难度太大使得盲法、随机隐藏等环节无法真正实施有关,建议采用改变剂型等方法来改善此问题,并推荐参考《声明》进行报告。
Objective To evaluate the quality of the papers on the randomized controlled trial(RCT)of colorectal cancer treated by traditional Chinese medicine(TCM),and to discuss the existing problems.Methods The RCT literature on colorectal cancer treated by TCM in Chinese National Knowledge Infrastructure(CNKI)from January 1,1996 to August 31,2018 were searched by two researchers.The CONSORT 2010 Statement:updated guidelines for reporting parallel group randomized trials(referred to as Statement)was used to evaluate the quality of each item one by one,giving a"yes"or"no"judgment.The papers published from January 1,1996 to December31,2012,and from January 1,2013 to August 31,2018 were compared.Results Compared with the period from January 1,1996 to December 31,2012,the quality of RCT papers on TCM treatment of colorectal cancer published from January 1,2013 to August 31,2018 was significantly improved in the 8 items of scientific background(2 a),objective(2 b),eligibility criteria(4 a),site(4 b),outcomes results/effect estimates and accuracy(17 a),dichotomous outcomes relative and absolute effect values(17 b),promotion(21),funding(25)in the Statement(P<0.05);there was no statistical significance from item 7 a to 11 b involved sample size estimation,randomized,blinding,division of labor and other RCT core methodological entries(P>0.05).Conclusion After the publication of the Statement,the reporting quality of the RCT papers has improved,but the reporting quality of the core methodological items is still not high,which may be related to the low awareness of the Statement by the researcher,and may also be that the blinding and random hiding cannot be implemented due to great difficulty in preparing decoction placebo.It is recommended to change the dosage form and other methods to improve the problem,and recommend to refer to the Statement for reporting.
作者
张彤
何文婷
孙颖颖
杨宇飞
ZHANG Tong;HE Wenting;SUN Yingying;YANG Yufei(Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091;Xinjiang Uygur Autonomous Region Chinese Medicine Hospital;Emergency General Hospital)
出处
《中医杂志》
CSCD
北大核心
2019年第22期1924-1928,共5页
Journal of Traditional Chinese Medicine
基金
国家重点研发计划(2017YFC1700604)
关键词
CONSORT声明
中医药疗法
结直肠癌
随机对照试验
论文质量
方法学
CONSORT Statement
traditional Chinese medicine therapy
colorectal cancer
randomized controlled trial
paper quality
methodology
