采用CONSORT声明和STRICTA评价针刺治疗抑郁相关睡眠障碍随机对照试验报告的质量

Reporting Quality of Randomized Controlled trials on Acupuncture for Sleep Disorder Associated with Depressive Disorders by the CONSORT Statement and STRICTA

目的:采用国际公认的试验报告统一标准(CONSORT)和报告针刺临床试验中干预措施的国际标准(STRICTA),评价针刺治疗抑郁相关睡眠障碍随机对照试验(RCT)的质量。方法:系统检索Pub Med、SpringerLink、CNKI和万方4个数据库,文种限制为中文和英文,并追溯纳入文献的参考文献。由2位评价者根据纳入与排除标准独立进行文献筛选,使用NoteExpress3.2进行文献管理,再采用CONSORT声明和STRICTA标准进行报告质量评价。结果:最终纳入14篇文献。根据CONSORT条目,11篇描述了各组的基线情况和临床特征;8篇提及产生随机序列的方法;4篇分配方案隐藏充分;4篇采用盲法,且全部为单盲;提及样本含量计算和意向治疗(ITT)分析法的分别为1篇。根据STRICTA条目,13篇文献提及用针数目;8篇提及针具型号,10篇提及针刺深度;1篇文献报告了治疗师的资历。结论:针刺治疗抑郁相关睡眠障碍的随机对照试验的质量有待提高。

Objective： To evaluate the reporting quality of randomized controlled trials （RCT） of acupuncture on the treatment of sleep disorder associated with depressive disorders, using the internationally recognized Consolidated Standards of reporting trials （CONSORT） and reporting of clinical trials of acupuncture intervention measures on in- ternational standards （STRICTA） . Method： Four databases including PubMed, Springer Link, CNKI and Wan fang, Chinese and English were included, and back into the literature references. According to the inclusion and exclusion criteria, 2 reviewers independently screened the literature, and then evaluated the quality of the reports using CON- SORT and STRICTA standards. Results： 14 papers were included in the final. According to the items of CONSORT, 11 （78.6%） described the baseline and clinical characteristics in each group; 8 mentioned method for generating random sequence; 4 allocation was adequately concealed, which 2 described in detail the specific scheme of the hidden method; 4 used blind method, and all of them were single blind; 1 mentioned sample size calculation and 1 used intention to treat（ITT） analysis. According to the items of STRICTA, 13 mentioned the number of needles 8 mentioned the needles＇ type, 10 mentioned needling depth; 1 Literature reported the therapist＇ s qualifications, and also mentioned in the doctor＇ s clinical practice time. Conclusion： It is necessary to improve RCT quality of acupuncture on the treatment of sleep disorder associated with depressive disorders.