天津中医药大学学报2025，Vol.44Issue(5)：435-443,9.DOI:10.11656/j.issn.1673-9043.2025.05.08
针刺治疗原发性痛经随机对照试验结局指标现状分析
Analysis of the current status of outcome indicators in a randomised controlled trial of acupuncture for primary dysmenorrhea
摘要
Abstract
[Objective]To analyse the current status of the use of outcome indicators in randomized controlled trials(RCTs)of acupuncture for primary dysmenorrhea(PD),in order to provide a basis for future clinical studies on acupuncture for PD and for the construction of a core set of indicators.[Methods]China Knowledge Network(CNKI),Wanfang Data Knowledge Service Platform(Wangfang),Wipro Chinese Journal Database(VIP),China Biomedical Literature Service System(SinoMed),PubMed,EMbase,Cochrane Library,and Web of Science databases were searched for articles published from 1 January 2014 to 19 March 2024,RCTs on acupuncture for PD,were extracted,classified and analysed for their outcome indicators to form an indicator domain for acupuncture for PD.[Results]A total of 56 studies were included,with a total of 49 outcome indicators and a frequency of 172 uses.In the order of frequency of the outcome indicators,the indicator domains they belonged to were symptoms/signs(64.53％),physical and chemical examination(18.60％),long-term prognosis(11.63％),safety events(2.91％),quality of life(2.33％),satisfaction indicators(1.16％),and traditional Chinese medicine(TCM)illnesses(0.58％),and no economic indicators were reported in any of the included studies.[Conclusion]The current status of the use of outcome indicators exists a high risk of bias,methodological quality to be improved,unclear distinction between primary/secondary outcome indicators,over-reliance on subjective outcome indicators,lack of objective outcome indicators,neglect of indicators of Chinese medical conditions,failure to reflect the characteristics of TCM,neglect of the evaluation of the quality of life,and the lack of indicators of the evaluation of economics,in the future,we should accelerate the construction of the core set of indicators of PD treated by acupuncture to improve the RCT quality and recognition,and maximise the value of individual RCTs.关键词
针刺/原发性痛经/随机对照试验/结局指标/核心指标集/RoB2.0Key words
acupuncture/primary dysmenorrhoea/randomised controlled trial/outcome indicator/core outcome set/RoB2.0分类
中医学引用本文复制引用
张嘉程,毛泽芳,王晓宇,刘高新丽,苏志超,宁静,王金贵..针刺治疗原发性痛经随机对照试验结局指标现状分析[J].天津中医药大学学报,2025,44(5):435-443,9.基金项目
国家中医药管理局中医药传承与创新"百千万"人才工程(岐黄学者)项目(885022) （岐黄学者）
2024年高水平中医药重点学科-推拿学(2024ZDXK002). （2024ZDXK002）
