基于世界卫生组织国际临床试验注册平台的针刺镇痛临床试验注册情况特征分析

Characteristics Analysis of Registration of Acupuncture Analgesia Clinical Trials Based on WHO ICTRP

目的:通过检索世界卫生组织国际临床试验注册平台(internationalclinical trial registration platform,ICTRP),分析针刺镇痛临床试验注册情况及发展趋势。方法:检索世界卫生组织ICTRP自建库以来至2020年3月针刺镇痛的临床试验,从纳入试验的注册概况、试验设计、研究疾病、干预措施及结局指标等方面进行描述性分析。结果:针刺镇痛相关研究注册数量呈上升趋势,中国和美国是其主要注册国家。临床试验以干预性研究、平行设计为主,遵循随机(83.4%)和盲法原则(46.6%),其中下背痛研究最多,体针运用最广。结局评价以疼痛及功能恢复相关指标为主,视觉模拟评分量表和关节活动度测量为使用频次最高的结局指标。结论:目前存在科研合作较少、研究内容局限等问题,今后应重视临床试验注册制度,促进高质量研究开展。

Objectives:To analyze the clinical trial registration status and development trend of acupuncture analgesia based on the WHO international clinical trial registration platform(ICTRP).Methods:WHO ICTRP database was searched to collect acupuncture analgesia clinical trials registered from the establishment of the database to March 2020,and the data were extracted for statistical analysis.Results:We find that the number of registrations has been increasing over the years.China and the United States were the main registered countries.The trials were mainly interventional research,and follow the principles of randomization(83.4%)and blinding(46.6%).Among them,low back pain was the most studied disease,and body acupuncture was the most widely used intervention.The outcome was mainly related to pain and functional recovery,and the visual analogue scale and range of joint activity were the most frequently used outcome indicators.Conclusions:At present,there are some problems such as limited scientific research cooperation and research content,but acupuncture analgesia will still be the focus of future research.We should promote the implementation of the clinical trial registration system and promote the development of high-quality clinical trials.