采用CONSORT和STRICTA评价针灸治疗脑卒中后抑郁症临床试验报告质量

Evaluation on quality of clinical trials reports about treating post-stroke depression with acupuncture and moxibustion by using CONSORT and STRICTA

目的:探讨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)评价针灸治疗脑卒中后抑郁症临床试验的报告质量。方法:系统检索Cochrane图书馆临床对照试验数据库、Pub Med、EMbase、CNKI、CBMdisc和VIP 6个数据库。文种限制为中文和英文,采用国际公认的CONSORT声明和STRICTA进行报告质量评价。结果:共纳入108篇文献。根据CONSORT和STRICTA条目,描述试验设计的有92篇(85%);给出试验开始后试验方法的重大改变及原因的有4篇(4%);援引资料说明选择对照的合理性的有18篇(17%);精确描述对照干预措施的有61篇(56%)。结论:目前针灸治疗脑卒中后抑郁症的临床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 quality of clinical trials reports about treating post-stroke depression with acupuncture and moxibustion by using CONSORT and the international standard interventions reported （STRICTA）. Methods： 6 databases including Cochrane Central Register of Controlled Trials, PubMed, EMbase, CNKI, CBMdisc and VIP were searched systematically. The literature types were restricted to Chinese and English. The internationally recognized CONSORT statement and STRICTA in clinical trials of acupuncture are used to evaluate the quality of reports. Results： 108 articles were included totally. According to CONSORT and STRICTA entries, 92 literatures （85%） were classified as description articles of experimental design. Major changes and reasons of methods were listed in 4 literatures （4%）. 18 literatures （17%） quoted data to explain the rationality of control selection, and 61 literatures （56%） accurately described comparison interventions. Conclusion： The quality of clinical study reports about treating post-stroke depression with acupuncture and moxibustion was generally low at present, so CONSORT statement and STRICTA standard accepted internationally should be adopted to regulate the reports about acupuncture therapy in. future.