采用CONSORT和STRICTA评价针刺治疗更年期综合征随机对照试验报告质量

Assessment of the Reporting Quality of Randomized Controlled Trials on Acupuncture for Perimenopausal Syndrome with the CONSORT Statement and STRICTA

目的:探讨采用CONSORT声明和STRICTA标准评价国内针刺治疗更年期综合征临床随机对照试验质量。方法:系统检索CNKI、CBM、VIP和WANFANG 4个数据库,手工检索所有中文针灸期刊与中医药核心期刊,纳入针刺治疗更年期综合征的随机对照试验,并采用国际公认的CONSORT声明和报告针刺临床试验中干预措施的国际标准(STRICTA)进行报告质量评价。结果:共纳入37篇文献。根据CONSORT条目,纳入的文献中,12篇(32.43%)描述了研究背景;11篇(29.73%)正确描述了产生随机分配序列的方法 ;仅1篇(2.70%)描述了实施者流程;尚没有文献提及分配隐藏机制、实施及样本量的计算。根据STRICTA条目,在37篇文献中有8篇(21.62%)报道了针刺深度;16篇(43.24%)提及针刺反应;15篇(40.54%)提及针具类型;6篇(16.22%)报告了治疗师的专业技能。结论:目前针刺治疗更年期综合征的随机对照试验研究报告质量普遍不高。今后应采用CONSORT声明和STRICTA标准进行规范报告。

Objective：To assess the quality of clinical randomized controlled trials of acupuncture treatment of Perimenopausal Syndrome with CONSORT（Consolidated Standards for Reporting of Trials）statement and STRICTA（Standards for Reporting Interventions in Controlled Trials of acupuncture）as criteria.Methods：Four databases including CNKI（China National Knowledge Infrastruc-ture）,CBM（China Biomedicine Database disc）,VIP（a full text issues database of China）and WANFANG（another full text is-sues database of China）were searched systematically.Manual retrieval was to select all Chinese acupuncture journals and core journals of traditionals Chinese medicine,literatures about acupuncture treatment of menopause syndrome in a randomized controlled trial were chosen.And we used the internationally recognized CONSORT statement and reporting the acupuncture in clinical trials of intervention measures of international standard（STRICTA）to report on the quality evaluation.Results：All participants included 37 articles.According to the items in the CONSORT statement,12（32.43%）RCTs described the research background;11（29.73%）mentioned the method of generating the random sequence rightly;only 1（2.70%）RCT described the process of executor;none of the RCTs reported the calculation of allocation concealment mechanism,implementation and sample size.In regard to the items in STRICTA,only 8（21.62%）RCTs reported the depths of insertion;16（43.24）RCTs mentioned the acupuncture reaction;but only 15（40.54%）mentioned needles type;only 6（16.22%）RCTs mentioned the therapists professional skill.Conclusion：At present the reporting quality of RCTs of acupuncture for Perimenopausal Syndrome is not high.In the future,the CONSORT statement and STRICTA standards should be used to do regulate report.