临床肝胆病杂志2024，Vol.40Issue(12)：2406-2414,9.DOI:10.12449/JCH241210
2018-2023年中药复方治疗非酒精性脂肪性肝炎的随机对照试验质量评价
Quality assessment of randomized controlled trials of compound traditional Chinese medicine prescriptions in treatment of nonalcoholic steatohepatitis in 2018-2023
摘要
Abstract
Objective To assess the quality of randomized controlled trials(RCTs)of compound traditional Chinese medicine(TCM)prescriptions in the treatment of nonalcoholic steatohepatitis(NASH),and to provide recommendations for standardizing the design and reporting of RCTs in this field.Methods Databases such as PubMed,Web of Science,Embase,the Cochrane Library,CNKI,VIP,and Wanfang Data were searched for RCTs of compound TCM prescriptions in the treatment of NASH published from January 1,2018 to December 31,2023,and the articles were screened and assessed based on the Cochrane risk-of-bias assessment tool(RoB 2),the unified standard for clinical trial reporting(CONSORT 2010),and CONSORT-CHM Formulas 2017 for compound TCM prescriptions.Results A total of 45 articles were finally included,and most of these studies were rated as high-risk bias by RoB 2.0.The analysis based on the CONSORT control checklist showed a relatively low reporting rate for most of the key items regarding the quality of RCT studies.Conclusion A relatively large risk of bias is observed in the clinical studies on compound TCM prescriptions in the treatment of NASH published in the past six years,which may lead to the poor quality of reporting and evidence.It is suggested that the top-level design of clinical studies should be taken seriously in addition to investigating the advantages of TCM,so as to improve the quality of clinical studies.关键词
非酒精性脂肪性肝病/中草药/复方/随机对照试验(主题)Key words
Non-alcoholic Fatty Liver Disease/Drugs,Chinese Herbal/Compounds/Randomized Controlled Trials as Topic引用本文复制引用
姚伟伟,焦睿珉,刘可佳,徐帅,李丽,尤红,赵静洁..2018-2023年中药复方治疗非酒精性脂肪性肝炎的随机对照试验质量评价[J].临床肝胆病杂志,2024,40(12):2406-2414,9.基金项目
北京市重大疑难疾病中西医协同攻关项目(2023BJSZDYNJBXTGG-017) （2023BJSZDYNJBXTGG-017）
北京市高层次公共卫生技术人才建设项目(学科骨干-03-40) （学科骨干-03-40）
首都卫生发展科研专项(2022-2-20213,2022-1-2021) Beijing Key Project of Major Disease by Chinese Medicine and Western Medicine(2023BJSZDYNJBXTGG-017) （2022-2-20213,2022-1-2021）
Beijing High-level Public Health Technical Personnel Construction Project(Discipline backbone-03-40) （Discipline backbone-03-40）
Capital Health Development Scientific Research Project(2022-2-20213,2022-1-2021) （2022-2-20213,2022-1-2021）
