中国中医药信息杂志2025，Vol.32Issue(6)：58-65,8.DOI:10.19879/j.cnki.1005-5304.202409322
基于CONSORT声明、STRICTA和SHARE清单的针刺治疗痛经随机对照试验报告质量评价
Report Quality Evaluation of Randomized Controlled Trials on Acupuncture for Dysmenorrhea Based on the CONSORT Statement,STRICTA and SHARE Checklist
摘要
Abstract
Objective To evaluate the quality of the reports of randomized controlled trials(RCT)on acupuncture treatment of dysmenorrhea.Methods RCT English and Chinese literature about acupuncture for the treatment of dysmenorrhea was systematically retrieved from PubMed,EMbase,Cochrane Library,CNKI,SinoMed,Wanfang Data and VIP from the establishment of the databases to March 31,2024.Based on the CONSORT statement,STRICTA,and SHARE,RCTs for acupuncture treatment of dysmenorrhea that met the inclusion criteria were evaluated and statistically analyzed.Results Totally 28 RCTs were included.According to the analysis and statistics,although the reporting rate of the basic implementation points of RCT was satisfactory,reporting rates of the CONSORT statement,STRICTA and SHARE related to the implementation details of blind method,the demarcation of outcome indicators and statistical analysis,the determination method of sample size,the rationality analysis of sham acupuncture and the implementation details were still below 50%or even 0%.Among them,the items with a reporting rate less than 30%were mainly the identification of the title,the integrity of the trial design,the comprehensiveness of the outcome indicators,the comprehensiveness of the statistical analysis,the rationality analysis of acupuncture treatment,the operation details of false acupuncture,and the full report of the trial information.Conclusion At present,the quality of RCT reports on the treatment of dysmenorrhea with sham acupuncture as control at home and abroad is generally low,especially in the rationality of sham acupuncture,implementation methods and statistical analysis of outcome indicators,etc.It is suggested that the CONSORT statement,STRICTA and SHARE should be strictly followed when designing clinical trial protocols in the future,with multi-stage self-evaluation,timely adjustment and improvement of the program design,in order to improve the safety,authenticity and scientificity of the program.关键词
原发性痛经/继发性痛经/针刺/报告质量评价/CONSORT声明/STRICTA/SHAREKey words
primary dysmenorrhea/secondary dysmenorrhea/acupunncture/report quality evaluation/CONSORT statement/STRICTA/SHARE分类
医药卫生引用本文复制引用
焦梓桐,李仲贤,彭敏,张潘,周鹏..基于CONSORT声明、STRICTA和SHARE清单的针刺治疗痛经随机对照试验报告质量评价[J].中国中医药信息杂志,2025,32(6):58-65,8.基金项目
广东省重点领域研发计划(2020B1111100007) （2020B1111100007）
深圳市宝安区中医药临床专项(2023ZYYLCZX-4) （2023ZYYLCZX-4）
深圳市宝安区中医药发展基金会项目(2022KJCX-ZJZL-1) （2022KJCX-ZJZL-1）
深圳市"医疗卫生三名工程"项目(SZZYSM202311013) （SZZYSM202311013）
