中华中医药杂志2025，Vol.40Issue(6)：2677-2682,6.
功能性胃肠病临床试验中药复方安慰剂模拟制作的关键问题与对策
Key issues and strategies for simulating the production of traditional Chinese medicine compound placebo in clinical trials of functional gastrointestinal diseases
摘要
Abstract
Traditional Chinese medicine has obvious characteristics and advantages in treating functional gastrointestinal diseases(FGIDs),but it also faces many problems,the most important of which is the lack of high-quality evidence-based medical evidence and rigorous randomized,double-blind,placebo-controlled trials in corresponding clinical reports.The prerequisite for conducting randomized controlled trials(RCTs)of traditional Chinese medicine that meet the requirements is the need for effective placebos.Therefore,how to make standardized Chinese medicine compound placebos is a difficult problem that must be solved when traditional Chinese medicine moves towards internationalization.Traditional Chinese medicine decoction is currently the most widely used dosage form in clinical practice.During RCT research,the key to ensuring the success of the experiment is to ensure that the color,qi,and taste of the decoction placebo are consistent with the experimental drug.Establishing a standardized model for producing traditional Chinese medicine compound decoction placebos,achieving consistency in sensory indicators such as color,qi,and taste as much as possible,and objectively and quantitatively evaluating them,is very meaningful.With the mature application of Intelligent Sensory Technology,including electronic eyes,electronic noses,and electronic tongues,the construction of a new placebo production and evaluation system for traditional Chinese medicine compound decoction will provide technical support for conducting rigorous RCT research on the treatment of FGIDs with traditional Chinese medicine compound.关键词
功能性胃肠病/随机对照试验/中药复方/安慰剂/智能感官技术Key words
Functional gastrointestinal diseases(FGIDs)/Randomized controlled trials(RCT)/Traditional Chinese medicine compound formula/Placebo/Intelligent sensory technology(IST)引用本文复制引用
吕林,黄开月,王凤云,马祥雪,郭绍举,康楠,李娟娟,王晓鸽,唐旭东..功能性胃肠病临床试验中药复方安慰剂模拟制作的关键问题与对策[J].中华中医药杂志,2025,40(6):2677-2682,6.基金项目
中国中医科学院创新工程(No.CI2021A01003),中国中医科学院优秀青年科技人才培养专项(No.ZZ13-YQ-006),国家自然科学基金项目(No.81873297),中国中医科学院中医药科技重大成果引导项目(No.ZZ13-ZD-02) （No.CI2021A01003）
