摘要
目的:基于CONSORT非药物随机对照试验扩展声明(2017)和CONSORT-STRICTA,评价当前国内外针刺治疗更年期抑郁症的随机对照试验的质量,为今后进行高质量临床研究提供改进依据。方法:计算机检索CNKI、CBM、VIP、WF、Pub Med、MEDLINE、Cochrane Library和Embase,查找所有相关文献,并由两位评价者根据纳入和排除标准进行筛选,最后采用CONSORT非药物随机对照试验扩展声明(2017)和CONSORT-STRICTA进行文献质量评价。结果:共纳入合格RCT试验25篇。CONSORT评价显示:文题提示为RCT为0篇(0%)、所有文章均无依从性相关阐述0篇(0%)、对样本量的估算2篇(8%)、分配隐藏4篇(16%)、随机方法2篇(8%)、随机方法实施2篇(8%)、盲法报告3篇(12%)、统计学方法阐述较简单、缺少受试者流程图等;STRICTA条目评价发现:对治疗场所、针灸师背景、选择对照合理解释25篇文献均是零报道。结论:针灸治疗更年期抑郁症的临床研究RCT质量偏低,应根据非药物随机对照临床试验扩展声明(2017)和CONSORT-STRICTA进行严格临床实验设计,以提高研究质量,进一步证实针刺治疗更年期抑郁症的疗效。
Objective:Based on CONSORT-NPTs(2017)and CONSORT-STRICTA,to evaluate the quality of randomized controlled trials about current acupuncture treatment of menopausal depression to provide a basis for improvement in high quality clinical research in the future.Methods:By computer retrieval,CBM,CNKI,VIP,WF,Pub Med,MEDLINE,the Cochrane Library and Embase were used to find out all relevant documents which were screeened by two evaluators according to include and exclude standard.At last,the quality of literature was evaluated by CONSORT-NPTs(2017)and CONSORT-STRICTA.Results:A total of 25 qualified RCTs.CONSORT evaluation showed that the articles with title prompting for RCT was 0(0%)and all articles had no compliance related explanation(0%).For the estimation of sample size,there were 2 articles(8%).There were 2 articles which mentioned the random method(8%)and 4 articles mentioned the allocation concealment(16%).The blinded reports were3(12%).The statistical methods explanation was simple and there were lack of the flow chart.STRICTA item evaluation found that the treatment place,acupuncturist background and reasonable explain were not mentioned in all the 25 articles.Conclusion:RCT about acupuncture in the treatment of menopausal depression has low quality.The clincial desgine should be strictly based on CONSORT-NPTs(2017)and CONSORT-STRICTA in order to improve the quality and further confirm the curative effect of acupuncture treatment of menopausal depression.
作者
曹乾安
章海凤
徐桂兴
黄志军
董志威
刘志彬
敖琪
毛强健
付勇
CAO Qian'an;ZHANG Haifeng;XU Guixing;HUANG Zhijun;DONG Zhiwei;LIU Zhibin;AO Qi;MAO Qiangjian;FU Yong(Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,Jiangxi,China;The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang 330006,Jiangxi,China;No.2 People's Hospital Jiangxi,Nanchang 330029,Jiangxi,China)
出处
《辽宁中医杂志》
CAS
2019年第12期2490-2495,共6页
Liaoning Journal of Traditional Chinese Medicine
基金
国家自然科学基金项目(81760889).
关键词
更年期抑郁症
针刺
方法学
质量评价
menopausal depression
acupuncture
methodological
quality assessment
作者简介
曹乾安(1993-),男,江西九江人,中医师,硕士研究生,研究方向:针灸循证医学研究。;通讯作者:付勇(1977-),男,江西南昌人,主任中医师,博士研究生导师,博士,研究方向:针灸循证医学研究,E-mail:fuyong1125@163.com。
