中医临床研究2026，Vol.18Issue(17)：76-88,13.DOI:10.3969/j.issn.1674-7860.2026.17.009
中成药治疗功能性消化不良随机对照临床研究的证据图分析
Proprietary Chinese medicine for functional dyspepsia:a randomized controlled clinical literature research with figure-based evidence analysis
摘要
Abstract
Objective:To systematically collect,analyze and evaluate the literature of randomized controlled trials(RCTS)of Proprietary Chinese medicines in the treatment of functional dyspepsia(FD),and summarize the clinical evidence.The aim is to provide references for rational drug use,optimize treatment strategies and inform subsequent research.Methods:Eight Chinese and English databases(China National Knowledge Infrastructure,Wanfang Data Knowledge Service Platform,VIP Network,China Biomedical Literature Database,PubMed,Web of Science,Cochrane Library,Embase Database)from January 2020 to April 2025 were retrieved.The literature on the treatment of FD with Proprietary Chinese medicines included in the databases was statistically analyzed,and the distribution and quality of clinical research evidence were presented through a combination of text and images.Results:A total of 169 RCT studies(166 in Chinese and 3 in English)on the treatment of FD with Proprietary Chinese medicines were finally included,involving 55 kinds of Proprietary Chinese medicines.The sample size was the largest with less than 100 cases,and the treatment courses of the vast majority of studies were concentrated in 14-30 days.The intervention/control measures were mainly proprietary Chinese medicines combined with Western medicines vs.Western medicine alone.A total of 100 outcome measures were applied,with a cumulative usage frequency of 903 times.In the CONSORT declaration(2025)analysis,among the 42 entries,only 7 entries were fully reported,and 6 entries were not reported at all.The overall methodological quality was not high:Only 9 studies mentioned double-blinding,placebo,and simulants,and 3 studies were registered at the Chinese Clinical Trial Registry.Conclusion:Proprietary Chinese medicines are widely used in the clinical treatment of FD and demonstrated certain therapeutic effects.However,most existing studies are single-center,small-sample clinical trials,with general methodological limitations in areas such as trial registration,sample size estimation,and allocation concealment.In the future,large-sample,multicenter,and high-quality clinical studies should be conducted to provide reliable evidence for the use of Proprietary Chinese medicines in the treatment of FD.关键词
功能性消化不良/中成药/随机对照研究/证据图/方法学质量评价Key words
Functional dyspepsia/Proprietary Chinese medicine/Randomized controlled trial/Evidence diagram/Methodological quality evaluation分类
医药卫生引用本文复制引用
唐湘,闫幸,杨应芩,王晶,冀建斌,王红霞,王威..中成药治疗功能性消化不良随机对照临床研究的证据图分析[J].中医临床研究,2026,18(17):76-88,13.基金项目
天津市卫生健康委员会中医中西医结合科研课题(2023133). （2023133）
