基于CONSORT和STRICTOM评价针刺治疗变应性鼻炎随机对照试验中文报告质量

Evaluation of Chinese Report Quality of Randomized Controlled Trial of Acupuncture in the Treatment of Allergic Rhinitis Based on CONSORT and STRICTOM

使用CONSORT和STRICTOM标准对国内针刺治疗变应性鼻炎临床随机对照试验进行质量报告。通过计算机检索中国知网(CNKI)、万方(WF)、维普(VIP)和中国生物医学文献数据库(CBM)4个数据库,再手工查找相关中医类期刊,最后纳入符合标准的文献97篇,采用CONSORT声明和STRICTOM标准对纳入文献进行质量评价。经数据统计后,发现国内文献大多存在一些问题:随机原则无法贯彻和方法叙述不清、盲法使用率低、分配隐藏少、无样本量估算、试验都没有注册、针刺细节描述不足、对照原理解释不清、无针刺治疗师资历等。为提高针刺临床随机试验外部真实性和确保内部真实性,提高文章质量,应将CONSORT声明和STRICTOM标准引入针刺临床随机试验设计并贯彻执行。

Use CONSORT and STRICTOM standards to report the quality of domestic randomized controlled trials of acupuncture in the treatment of allergic rhinitis.CNKI,WanFang,VIP and CBM 4 databases were searched by computer,and then relevant TCM journals were searched manually.Finally,97 literatures meeting the standards were included.The quality of the included literatures was evaluated by CONSORT statement and strictom standard.After data statistics,it is found that most domestic literatures have some problems:the random principle cannot be implemented and the method description is unclear,the utilization rate of blind method is low,the distribution is hidden less,there is no sample size estimation,the trials are not registered,the description of acupuncture details is insufficient,the explanation of control principle is unclear,and there is no qualification of acupuncture therapist.The author believes that in order to improve the external authenticity of acupuncture clinical randomized trials,ensure the internal authenticity and improve the quality of articles,CONSORT statement and strictom standard should be introduced into the design and implementation of acupuncture clinical randomized trials.