针刺治疗血管性痴呆临床随机对照试验的文献报告质量评价

Reporting quality of RCTs of acupuncture for vascular dementia

目的:评价针刺治疗血管性痴呆随机对照试验(RCT)的报告质量。方法:系统检索Cochrane图书馆(Cochrane Libery)、Pub Med、EMbase、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(SinoMed)、维普中文科技期刊数据库(VIP)和万方学术期刊全文数据库(Wanfang)中针刺治疗血管性痴呆的RCT,检索时限为建库至2018年10月31日。采用国际公认的试验报告统一标准CONSORT声明和报告针刺临床试验中干预措施的国际标准STRICTA评价RCT文献的报告质量。结果:共纳入33篇RCTs。CONSORT声明中报告率为0%的条目共12条,如试验开始后对试验方法所作的重要改变、样本量、盲法、试验注册等;报告率低于10%的条目共5条,即描述试验设计、随机方法的类型、隐蔽分组、随机分配序列的实施和受试者流程。基线资料、产生随机分配序列的方法报告率分别为36.36%、57.58%。针刺干预措施中,对针刺细节中进针深度、针刺反应、附加干预的细节、针灸师资历的报告率分别为21.21%、60.61%、27.27%、0%。结论:目前针刺治疗血管性痴呆的RCT报告质量普遍偏低,今后研究者应按照CONSORT声明和STRICTA标准对针刺治疗血管性痴呆的RCT进行规范报告。

Objective To evaluate the reporting quality of randomized controlled trials(RCTs)of acupuncture for vascular dementia.Methods The RCTs of acupuncture for vascular dementia were systematically retrieved from the Cochrane Library,PubMed,EMbase,CNKI,SinoMed,VIP and Wanfang databases from the date of establishment to October 31,2018.The reporting quality of RCT was evaluated based on the internationally-recognized Consolidated Standards for Reporting of Trials(CONSORT)statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture(STRICTA).Results A total of 33 RCTs were included.According to the CONSORT statement,12 items had a reporting rate of 0%,including important changes to methods after trial commencement,sample size,blind method,trial registry,etc.;5 items had a reporting rate of below 10%,including trial design,type of randomization,random allocation sequence,randomization implementation and participant flow.The reporting rate was 36.36%for baseline data and 57.58%for randomization sequence generation.According to the STRICTA statement,the reporting rate was 21.21%for description of acupuncture depth,60.61%for description of acupuncture response,27.27%for description of additional intervention details and 0%for qualification of acupuncturists,respectively.Conclusion At present,the reporting quality of RCTs of acupuncture for vascular dementia is generally low.In the future,the RCTs of acupuncture for vascular dementia should be normatively reported according to the CONSORT statement and STRICTA statement.