CAJ | 학술논문

目的:以Cochrane图书馆中有关中草药治疗2型糖尿病系统评价中的66个临床随机对照试验为基础,分析在中草药临床随机对照试验研究报告中存在的问题,以及如何提高临床随机对照试验报告的质量.方法:文献检索2005年7月前发表于Cochrane图书馆的纳入随机对照试验最多的系统评价-中草药治疗2型糖尿病系统评价,共包含66个临床随机对照试验.以原有的CONSORT条目为基础,增加有关中医药方面的5项内容,即中医证型、组方依据、复方组成、制剂类型及质量控制.修订后的CONSORT评估表共包含63项条目,并以此为标准评估66篇临床随机对照试验报告的质量.结果:按修改后的CONSORT条目,66篇临床随机对照试验的总体报告率为19%～44%,中位数32%(标准差8%).结论:中草药临床随机对照试验报告的总体质量较低.建议:以CONSORT条目为基础,进行中草药临床随机对照试验报告规范化的研究.同时建议中医药类杂志的编辑要求作者按照规范格式发表临床研究报告.
목적:이Cochrane도서관중유관중초약치료2형당뇨병계통평개중적66개림상수궤대조시험위기출,분석재중초약림상수궤대조시험연구보고중존재적문제,이급여하제고림상수궤대조시험보고적질량.방법:문헌검색2005년7월전발표우Cochrane도서관적납입수궤대조시험최다적계통평개-중초약치료2형당뇨병계통평개,공포함66개림상수궤대조시험.이원유적CONSORT조목위기출,증가유관중의약방면적5항내용,즉중의증형、조방의거、복방조성、제제류형급질량공제.수정후적CONSORT평고표공포함63항조목,병이차위표준평고66편림상수궤대조시험보고적질량.결과:안수개후적CONSORT조목,66편림상수궤대조시험적총체보고솔위19%～44%,중위수32%(표준차8%).결론:중초약림상수궤대조시험보고적총체질량교저.건의:이CONSORT조목위기출,진행중초약림상수궤대조시험보고규범화적연구.동시건의중의약류잡지적편집요구작자안조규범격식발표림상연구보고.
Objective: To discuss the quality of reporting in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the reporting of future clinical studies in this therapeutic area. Methods: A search of the Cochrane Library was conducted to identify RCTs of CHM. A revised CONSORT checklist designed for CHM clinical studies was implemented. The revised CONSORT checklist contained 63 items, including the following new items added specifically for CHM: (1)"syndrome of disease" based on Chinese medicine theories; (2)rationale of CHM formula; (3) formula composition;(4) preparation form of CHM; (5) quality control of CHM. Results: The overall reporting quality of the RCTs as assessed with the revised CONSORT checklist varied between 19% and 44%, with a median score of 32 % (standard deviation 8 %). Conclusion: The overall quality of reporting of RCTs of CHM evaluated with a revised CONSORT checklist was poor, reflecting the need for improvements in reporting future clinical trials in this area. Recommendations: To improve the quality of reporting of RCTs of CHM, we recommend adopting a revised CONSORT checklist that includes items specific to CHM. We also recommend that editors of CHM journals require authors to use a structured approach to presenting their trials as a condition of publication.