采用CONSORT和STRICTA评价针刺治疗急性缺血性脑卒中随机对照试验报告质量

Assessing the Reporting Quality of Randomized Controlled Trials on Acupuncture for Acute Ischemic Stroke Using the CONSORT Statement and STRICTA

目的探讨采用CONSORT和STRICTA标准评价针刺治疗急性缺血性脑卒中随机对照试验的报告质量。方法系统检索Cochrane图书馆临床对照试验数据库(2005年第4期)、PubMed(1980～2005.12)、EMbase(1984～2005.12)、CNKI(1994～2005.12)、CBMdisc(1980～2005.12)和VIP(1989～2005.12)6个数据库。文种限制为中文和英文。手工检索已纳入文献的参考文献。纳入针刺治疗急性缺血性脑卒中的随机对照试验,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74篇文献。根据CONSORT条目,在针刺治疗急性缺血性脑卒中的报告中,54篇(72.97%)描述了各组的基线情况和临床特征;26篇(35.14%)提及产生随机分配序列的方法,其中4篇(5.41%)提及用计算机产生随机分配序列;仅有6篇(8.11%)分配方案隐藏充分,其中5篇采用密封不透光的信封,1篇采用中心随机分组;8篇(10.81%)采用盲法的文献中5篇采用双盲;4篇(5.41%)提及样本含量的计算,多数文献样本含量较小;仅5篇(6.76%)文献采用意向治疗(ITT)分析法。根据STRICTA,4篇(5.41%)文献提及用针数目;有35篇(47.30%)提及针具型号,只有26篇(35.14%)提及针刺深度;6篇文献(8.11%)报告了治疗师的资历,其中仅有1篇(1.35%)提及医师的临床实践时间,没有1篇提及治疗师的训练时间。结论目前针刺治疗急性缺血性脑卒中的研究报告质量普遍较低。今后应采用国际公认的CONSORT声明和STRICTA标准对针刺疗法进行规范报告。

Objective To evaluate the reporting quality of randomized controlled trials （RCTs） on acupuncture for acute ischemic stroke. Methods Six databases including The Cochrane Central Register of Controlled Trials （CENTRAL, Issue 4, 2005）, MEDLINE （1966 to December 2005）, EMbase （1984 to December 2005）, China National Knowledge Infrastructure （CNKI, 1994 to December 2005）, China Biomedicine Database disc （CBMdisc, 1980 to December 2005）, VIP （a full text issues database of China, 1989 to December 2005） were searched systematically. Handsearch for further references was conducted. Language was limited to Chinese and English. We identified 74 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials （CONSORT） statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture （STRICTA） . Results In regard to the items in the CONSORT statement, 54 （73%） RCTs described baseline demographic and clinical characteristics in each group. Twenty-six （35%） mentioned the method of generating the random sequence, with 4 （5%） using a computer allocation. Only 6 （8%） RCTs had adequate allocation concealment, with 5 RCTs using sealed opaque envelopes and 1 RCT using centralized computer allocation. Only 8 （11%） RCTs used blinding, including 5 described as double-blind. Four （5%） RCTs reported the sample size calculation and 5 （7%） RCTs reported that an intention-to-treat （ITT） analysis. In regard to the items in STRICTA, only 4 （5%） RCTs reported the numbers of needles inserted. In 35 （47%） RCTs the needle type was reported, but only 26 （35%） mentioned the depths of insertion. Only 1 （1%） RCT mentioned the length of clinical experience and 6 （8%） RCTs reported the background of the acupuncture practitioners, but none stated the duration of their training. Conclusion The reporting quality of RCTs of acupuncture for acute ischemic stroke was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.