基于CONSORT声明和STRICTOM评价灸法治疗带状疱疹后遗神经痛随机对照试验报告质量

Quality assessment of randomized controlled trials involving moxibustion therapy for post-herpetic neuralgia based on CONSORT and STRICTOM

目的:采用CONSORT声明和STRICTOM标准评价国内艾灸治疗带状疱疹后遗神经痛临床随机对照试验的报告质量,为今后灸法临床研究与实践改进方向提供证据及参考。方法:采用电子检索国内大型文献数据库,包括中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普中文期刊全文数据库(VIP)、万方数字化期刊群(WF),筛选出符合条件的文献,运用CONSORT声明和STRICTOM标准对其进行质量评价。结果:纳入合格文献52篇,但多数文献存在未交代清楚具体的随机方法、分配隐藏、盲法、样本估算和操作的医生资历等各方面问题,文献报告质量普遍偏低。结论:灸法临床随机对照试验设计应当遵循CONSORT声明与STRICTOM标准,科学设计临床试验,提高文献报告质量。

Objective:To evaluate the report quality of clinical randomized controlled trials involving moxibustion therapy for post-herpetic neuralgia(PHN) by using the CONSORT statement and STRICTOM standard,and to provide evidence and reference for moxibustion clinical research and practice improvement direction in future.Methods:Databases were electronically searched from domestic large literature databases,including CNKI,CBM,VIP and WF.Qualified documents were selected.The CONSORT statement and STRICTOM standards were used for quality evaluation.Results:Fifty-two qualified documents were included.But the specific method of random,allocation concealment method,blinded method,sample estimation method,the operation doctor qualifications and other aspects of problems were not clear in most of the documents.The literature report quality was generally low.Conclusion:The design of clinical randomized controlled trial involving moxibustion therapy should be scientific and followed by the CONSORT statement and STRICTOM standard in order to improve the literature quality.