Current Status and Strategic Recommendations for Randomized Controlled Trials on Functional Dyspepsia-Irritable Bowel Syndrome Comorbidity：from a Real-World Research Perspective

DAI Ning; JIANG Linlin; ZHANG Huie; LU Fang

doi:10.13288/j.11-2166/r.2026.09.005

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Current Status and Strategic Recommendations for Randomized Controlled Trials on Functional Dyspepsia-Irritable Bowel Syndrome Comorbidity：from a Real-World Research Perspective

更新时间：2026-05-08

- Current Status and Strategic Recommendations for Randomized Controlled Trials on Functional Dyspepsia-Irritable Bowel Syndrome Comorbidity：from a Real-World Research Perspective
  增强出版
- Journal of Traditional Chinese Medicine Vol. 67, Issue 9, Pages: 946-950(2026)
- 作者机构：
  
  中国中医科学院西苑医院，北京市海淀区西苑操场1号，100091
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2026.09.005
  CLC：
- Received：30 October 2025，
  
  Revised：2026-01-30，
  
  Accepted：10 January 2026，
  
  Published：02 May 2026
- 稿件说明：
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戴宁,姜琳琳,张慧娥等.真实世界研究视角下功能性消化不良-肠易激综合征共病随机对照试验的现状分析及对策建议[J].中医杂志,2026,67(09):946-950.

DAI Ning,JIANG Linlin,ZHANG Huie,et al.Current Status and Strategic Recommendations for Randomized Controlled Trials on Functional Dyspepsia-Irritable Bowel Syndrome Comorbidity：from a Real-World Research Perspective[J].Journal of Traditional Chinese Medicine,2026,67(09):946-950.
戴宁,姜琳琳,张慧娥等.真实世界研究视角下功能性消化不良-肠易激综合征共病随机对照试验的现状分析及对策建议[J].中医杂志,2026,67(09):946-950. DOI： 10.13288/j.11-2166/r.2026.09.005.

DAI Ning,JIANG Linlin,ZHANG Huie,et al.Current Status and Strategic Recommendations for Randomized Controlled Trials on Functional Dyspepsia-Irritable Bowel Syndrome Comorbidity：from a Real-World Research Perspective[J].Journal of Traditional Chinese Medicine,2026,67(09):946-950. DOI： 10.13288/j.11-2166/r.2026.09.005.

摘要

通过分析功能性消化不良（FD）-肠易激综合征（IBS）共病随机对照试验（RCT）的现状，发现目前FD-IBS共病RCT主要存在FD与IBS亚型报告不足，联合用药风险的评估不充分，缺乏复合、客观、远期指标，对指南的证据支持薄弱的问题。认为在今后FD-IBS共病的临床研究中，应进一步加强真实世界研究的应用，并可通过采用复合结局指标与长期随访提升证据质量，重视患者的意愿及自我管理提高证据的可用性。针对中医药干预FD-IBS共病临床研究中存在的问题，提出应夯实中医药特色疗效评价基础以体现中医辨证论治的优势，优化真实世界研究设计从而更好地辅助临床决策，引入智能化客观评价技术提高中医临床疗效评价的客观性和准确性。

Abstract

By analyzing the current status of randomized controlled trials （RCTs） on functional dyspepsia （FD） and irritable bowel syndrome （IBS） comorbidity， we identified several critical issues which include insufficient repor-ting of FD and IBS subtypes， inadequate risk assessment of drug combination， lack of composite， objective， and long-term outcomes， and weak evidence support for clinical practice guidelines. It is suggested that future clinical research on FD-IBS comorbidity should further strengthen the application of real-world studies. The use of composite outcomes and long-term follow-up is recommended to improve the quality of evidence， while greater attention should be paid to patients' preferences and self-management to enhance the applicability of findings. Based on the existing issues in clinical studies of traditional Chinese medicine （TCM） for FD-IBS comorbidity， we propose to consolidate the foundation of TCM-specific efficacy evaluation to better reflect the advantages of syndrome differentiation and treatment， optimize real-world study designs to better support clinical decision- making， and introduce intelligent objective evaluation technologies to improve the objectivity and accuracy of TCM clinical efficacy assessment.

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