采用CONSORT声明和STRICTA评价针刺治疗颈痛随机对照试验英文文献报告质量

目的采用CONSORT和STRICTA标准评价针刺治疗颈痛随机对照试验(RCT)英文文献的报告质量。方法计算机检索CENTRAL、PubMed和EMbase,文种限制为英文,查找有关针刺治疗颈痛的RCT,并追溯纳入文献的参考文献。检索时限为2006年1月~2010年12月。由2位评价者根据纳入与排除标准独立进行文献筛选,并采用国际公认的CONSORT声明和STRICTA标准评价报告质量。结果最终纳入14篇文献。根据CONSORT条目,9篇(64.3%)描述了各组的基线情况和临床特征;7篇(50.0%)提及产生随机分配序列的方法;6篇(42.9%)分配方案隐藏充分,其中4篇详细描述了具体的分配方案隐藏方法;8篇(57.1%)采用盲法的文献中2篇采用双盲;2篇(14.3%)提及样本含量的计算。根据STRICTA条目,5篇(35.7%)文献提及用针数目;有12篇(85.7%)提及针具型号,只有4篇(28.6%)提及针刺深度;4篇文献(28.6%)报告了治疗师的资历,亦提及医师的临床实践时间。结论本研究纳入的2006~2010年针刺治疗颈痛英文文献中,根据CONSORT声明和STRICTA标准的条目,研究报告质量仍然存在不少问题。今后应提倡采用国际公认的CONSORT声明和STRICTA标准对针刺治疗的RCT进行规范报告。

Reporting Quality of English Randomized Controlled Trials on Acupuncture for Neck Disorders by the CONSORT Statement and STRICTA

ObjectiveTo evaluate the reporting quality of randomized controlled trials （RCTs） on acupuncture for neck disorder. MethodsThree databases including CENTRAL （Issue 3, 2010）, MEDLINE and EMbase from January 2006 to December 2010 were searched electronically, and only English articles were included. A manual search for further references was conducted from those references initially identified. We identified 14 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）.ResultsFinally 14 RCTs were included. Regarding the CONSORT statement, 9 （64.3%） RCTs described the baseline demographic and clinical characteristics in each group. Only 7 （50.0%） studies mentioned how the random sequence was generated. Only 6 （42.9%） RCTs had adequate allocation concealment, with 4 RCTs which described the concealment in detail. Only 8 （57.1%） RCTs used blinding, including 2 described as double-blind. Only two （14.3%） RCTs reported how the sample size was calculated. Corresponding to the items in STRICTA, 5 （35.7%） RCTs reported the numbers of needles inserted. The others just indicated the acu-points. The needle type, model and the thickness of needles were reported in 12 （85.7%） RCTs, but only 4 （28.6%） mentioned the depths of insertion. There were only 4 RCTs （28.6%） that reported the background of the acupuncture practitioners and the duration of their training. ConclusionThe RCTs of acupuncture for neck disorder meeting the criteria for the CONSORT statement and STRICTA still have room for improvement. Promoting the use of the CONSORT statement and STRICTA should help to improve the reporting quality of acupuncture related research, and hence to elucidate the scientific understanding of acupuncture.