摘要
目的通过评价针灸治原发性痛经的临床随机对照试验的质量,为日后临床研究开展提供一定的方法学借鉴,进一步提高临床试验质量。方法利用计算机全面检索中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普(VIP)、万方(WF)、Pubmed、Embase、Cochrane Library数据库,辅以手工检索相关期刊及参考文献,筛选出符合研究标准的文献,采用Jadad量表、Cochrane偏倚风险评估工具、CONSORT声明进行质量评价。结果共纳入RCT238篇。依据Jadad量表进行评价,78篇(32.77%)具体描述了随机序列产生的方法,219篇(92.02%)试验未提及盲法实施。依照Cochrane偏倚风险评估工具进行评估,不存在选择性报道偏倚,201篇(84.45%)存在其他偏倚来源。参照CONSORT声明对文献进行质量报告,结果显示229篇(96.22%)受试者符合纳入标准,226篇(94.96%)描述了准确的干预措施,可重复试验。但是226篇(96.96%)未采用合适的分配隐藏,224篇(94.12%)的结局指标未描述效应大小及精确度。结论现阶段临床试验质量较低,探其原因一方面来自于临床研究者对临床试验方法学掌握不够,另一方面来自于针灸的临床研究难度较高,在盲法的实施上存在一些瓶颈。
Objective To evaluate the quality of randomized controlled clinical trials for acupunture therapy for primary dysmenorrhea and provide a reference for future clinical research and further improve the quality of clinical trials.Methods Seven databases including CBM,CNKI,VIP,WF,Pubmed,Embase and the Cochrane Library databases were searched electronically,supplemented by manual search related references,the qualified documents were selected.The Jadad scale,the Cochrane collaboration’s tool for assessing risk of bias and CONSORT statement were respectively used for evaluating the quality of the RCT.Results A total of 238 RCTs were included.According to the Jadad scale,78 studies(32.77%)specifically described the methods of generating random sequences,and 219 studies(92.02%)did not mention the implementation of blind methods.According to the Cochrane collaboration’s tool for assessing risk of bias,there was no selective reporting bias,and 201 studies(84.45%)had other sources of bias.Quality reports were made in reference to the CONSORT statement.It showed that 229 studies(96.22%)met inclusion criteriaand 226(94.96%)described accurate interventions that could be repeated.However,226(96.96%)did not adopt appropriate allocation concealment,and 224(94.12%)did not describe the effect size and accuracy.Conclusion Now the quality of clinical trials is relatively low,for one due to the clinical researchers who are insufficient understanding of clinical trial methodology,for another due to the difficulty of clinical studies on acupuncture,which has some bottlenecks in the implementation of blind methods.
作者
杨骏
熊俊
袁婷
王雪
YANG Jun;XIONG Jun;YUAN Ting;WANG Xue(Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,Jiangxi,China;The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang 330006,Jiangxi,China)
出处
《辽宁中医杂志》
CAS
2020年第1期157-162,共6页
Liaoning Journal of Traditional Chinese Medicine
基金
江西省杰出青年人才资助计划(20171BCB23093)
国家自然科学基金面上项目(81573835).
关键词
针灸
原发性痛经
方法学质量评价
报告质量
acupuncture
primary dysmenorrhea
methodologicalquality assessment
report quality
作者简介
杨骏(1994-),女,江西吉安人,硕士研究生,研究方向:循证针灸学及其方法学研究;通讯作者:熊俊(1983-),男,江西南昌人,副教授、副主任医师,硕士研究生导师,博士,研究方向:循证针灸学及其方法学研究,E-mail:xiongjun196071@163.com。
