2019—2020针灸随机对照临床试验年度证据分析

Annual evidence report on randomized controlled trials of acupuncture and moxibustion therapy (2019-2020)

关键词:  针灸  随机对照临床试验  证据库  证据报告

Key words:  acupuncture and moxibustion  randomized controlled trial  database  evidence report

摘要:

[目的] 通过对2019年发表于中英文医学期刊的针灸随机对照临床试验（RCT）进行收集和分析评价，对针灸临床证据的生产和转化应用进行阶段性总结，为后续研究的开展和证据使用提供参考。[方法] 通过天津中医药大学循证医学中心创建的针灸临床证据库（ACU-CED）系统，获取2019—2020年度发表的针灸RCT文献并进行统计分析。[结果] 检索共获得7 452篇文献，其中，中文7 310篇，英文142篇，总样本量66万余例。纳入研究覆盖全球22个国家和地区，涉及3 000余个机构，共发表于559个中英文医学期刊。研究共涉及23个疾病系统，其中神经系统疾病和肌肉骨骼/结缔组织病相关研究占比逾40%。干预措施的选择涉及各类针灸疗法，超半数研究采用针灸联合中医或西医类其他疗法的组合方式，对照形式以药物疗法及常规治疗占比较高。大部分研究存在较显著的方法学问题，随机、分配隐藏、盲法等均存在描述不清或者应用错误等情况。此外，研究方案注册和伦理审查批准等方面执行不到位。[结论] 2019—2020年度针灸RCT发文量大，研究疾病谱分布较为集中，研究普遍存在方法学问题。建议按照临床研究注册和发表规范，加强研究设计和实施过程的质量控制；学术期刊应落实出口把关的职责，以进一步提高针灸临床研究质量，服务临床科学决策。

Abstract:

[Objective] Through collection and analysis of randomized controlled trials (RCTs) of acupuncture and moxibustion published in Chinese and English medical journals in 2019,to summarize the production and transformation of clinical evidence,and to provide suggestions for the development of follow-up research. [Methods] RCTs of acupuncture and moxibustion therapy published in 2019-2020 were obtained and statistically analyzed via the clinical evidence database of acupuncture (ACU-CED) system created by the Evidence-based Medicine Center of Tianjin University of Traditional Chinese Medicine. [Results] A total of 7 452 articles were retrieved,including 7 310 in Chinese and 142 in English,with a total sample size of more than 660 000 cases. The included studies covered 22 countries and regions around the world,involved more than 3 000 institutions,and were published in 559 domestic and foreign medical journals. 23 disease systems were involved,with neurological diseases and musculoskeletal/connective tissue diseases accounting for more than 40%. Intervention measures involves various acupuncture and moxibustion therapies,with more than half of the studies used acupuncture combined with other traditional Chinese medicine or western medicine therapies. Drug therapy and conventional treatment were used mostly as controlled groups. Most studies have significant methodological problems,unclear descriptions or application errors existed according to the randomization,allocation concealment,blinding,etc. In addition,the issues of registration and ethical approval were still outstanding. [Conclusions] Numerous RCTs of acupuncture and moxibustion have been published in 2019-2020,and there was a clear advantage in studying the distribution of disease spectrum. There were general methodological problems. It is suggested that the quality control of the research design and process should be strengthened in accordance with the clinical research registration and publication specifications,and academic journals should implement the accusation of export control,in order to further improve the quality of acupuncture clinical research and serve clinical scientific decision-making.