摘要
系统评价中药治疗亚健康随机对照试验文献的方法学质量,为改进该领域研究设计、提高临床试验水平及进行系统评价提供参考。计算机全面检索9个中外数据库(检索时限为建库时间至2016年2月29日),收集关于中药治疗亚健康的临床随机对照试验文献,根据Cochrane Handbook 5.1进行文献筛选、资料提取,再结合CONSORT声明和CONSORT for traditional Chinese medicine(TCM)声明进行质量评价。该研究共纳入72篇文献,对其进行了质量评价,67个(93.05%)研究描述了组间基线资料可比性,39个(54.17%)研究报告了统一的诊断标准,28个(38.89%)研究报告了统一的疗效标准;4个(5.55%)研究提到为多中心研究、19个(26.38%)研究交代了随机分配方法、6个(8.33%)研究运用了随机分配隐藏、15个(20.83%)研究采用了盲法;3个(4.17%)研究详细报告样本含量的估算,5个(6.94%)研究样本总量>200;19个(26.38%)研究报告了病例退出、脱落、失访的人数,但只有2个研究采用了ITT分析;10个(13.89%)研究报告了随访结果;所有研究均未报告试验注册及试验方案,48个(66.7%)研究报告了所有期望的结局指标;26个(36.11%)研究报告了不良反应和不良事件;4个研究(5.56%)报告了依从性。该评价的中药治疗亚健康随机对照临床试验研究质量总体不高,均存在不同程度的方法学缺陷,因此仍有必要强调随机、对照、盲法等原则在随机对照试验研究中的正确运用,同时按照国际规范标准进行报告。
To evaluate the methodological quality of the randomized controlled trials（ RCTs） for traditional Chinese medicines for treatment of sub-health,in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI,CBM,VIP,Wanfang,EMbase,Medline,Clinical Trials,Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29,2016. Cochrane Handbook 5. 1 was used to screen literatures and extract data,and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study,67（ 93. 05%） trials described the inter-group baseline data comparability,39（ 54. 17%） trials described the unified diagnostic criteria,28（ 38. 89%） trials described the unified standards of efficacy,4（ 5. 55%） trials mentioned the multi-center study,19（ 26. 38%） trials disclosed the random distribution method,6（ 8. 33%） trials used the random distribution concealment,15（ 20. 83%） trials adopted the method of blindness,3（ 4. 17%） study reported the sample size estimation in details,5（ 6. 94%） trials showed a sample size of more than two hundred,19（ 26. 38%） trials reported the number of withdrawal,defluxion cases and those lost to follow-up,but only 2 trials adopted the ITT analysis,10（ 13. 89%） trials reported the follow-up results,none of the trial reported the test registration and the test protocol,48（ 66. 7%） trials reported all of the indicators of expected outcomes,26（ 36. 11%） trials reported the adverse reactions and adverse events,and 4（ 5. 56%） trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low,with methodological defects in different degrees. Therefore,it is still necessary to emphasize the correct application of principles such as blindness,randomization and control in RCTs,while requiring reporting in accordance with international standards.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2016年第21期4041-4050,共10页
China Journal of Chinese Materia Medica
基金
国家自然科学基金项目(81403324)
关键词
亚健康
随机对照试验
中药
方法学
质量评价
sub-health
randomized controlled trial
traditional Chinese medicine
methodology
quality evaluation
