运用CONSORT和STRICTA评价针灸治疗类风湿关节炎RCT报告质量

The Application of CONSORT and STRICTA in Evaluating the Quality of RCT Report on Acupuncture and Moxibustion in the Treatment of Rheumatoid Arthritis

目的评价针灸治疗类风湿关节炎临床随机对照试验的质量报告。方法采用计算机检索与手工检索两种方式。检索中国知网、中国生物医学数据库、维普和万方4个数据库,筛选出符合针灸治疗类风湿关节炎RCT评价标准的文献,运用国际公认的试验报告统一标准CONSORT指南和STRICTA标准进行质量评价。结果共纳入合格文献72篇。大多数文献都采用结构式摘要(79.17%),背景和原理解释(93.06%),以及所有文献都提及针刺种类,但是采用随机方法 (29.17%)以及盲法(5.56%)的文献较少、个别使用随机分配隐藏(5.56%)以及少数明确样本量(2.78%)等问题。结论目前针灸治疗类风湿关节炎的RCT文献报告质量普遍较低,影响了研究结果的可信度和参考价值。为提高针灸临床随机试验可靠性和质量,建议在今后进行临床试验设计、执行、文献报告时,严格遵守执行CONSORT声明和STRICTA标准。

Objective To evaluate the quality of clinical randomized controlled tr ials of acupuncture and moxibustion in treating rheumatoid arthritis. Methods Two kinds of methods of computer retrieval and manual retrieval were used. Retrieval of CNKI, Chinese biomedical database, VIP and Wanfang database, selected in line with the literature of acupuncture and moxibustion in the treatment of rheumatoid arthritis RCT evaluating standard, using internationally recognized the Consolidated Standards of reporting trials CONSORT statement stricta standards and quality evaluation. Results A total of 72 qualified literatures were included. Most of the literatures used structural abstract（ 79.17%）, background and principle interpretation（ 93.06%）, and all references to the type of acupuncture, but the use of random method（29.17%） and blind（5.56%） of the literature, the use of random allocation concealment（5.56%） and a few clear sample sizes（2.78%） and other issues. Conclusion At present, the quality of acupuncture treatment of rheumatoid arthritis is generally low, and the reliability and the reference value of the research results are affected. In order to improve the reliability and quality of clinical randomized trials, it is recommended that the clinical trial design, implementation and documentation of the clinical trials should strictly follow the implementation of CONSORT and STRICTA standards.