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Journal of Traditional Chinese Medicine >

2025 , Vol. 45 >Issue 5: 1106 - 1118

DOI: https://doi.org/10.19852/j.cnki.jtcm.20250107.001

Original Articles

Hewei Jiangni recipe (和胃降逆方) improved the quality of life in patients with cold-heat mixed nonerosive reflux disease: a randomized, double-blinded study

  • Xiaosi ZHANG ,
  • Shuangyuan ZHANG ,
  • Hanqing CHEN ,
  • Zhengdao LIN ,
  • Chune XIE ,
  • Junxiang LI ,
  • Xiaohong LI
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  • 1 Gastroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China
    2 Department of Spleen and Gastroenterology, Shenzhen Bao'an Traditional Chinese Medicine Hospital Group, Shenzhen 518133, China

Received date: 2024-08-22

  Accepted date: 2024-12-30

  Online published: 2025-03-18

Supported by

Fundamental Research Funds for the Central Universities: Research on the Mechanism of Hewei Jiangni Recipe on Nonerosive Gastroesophageal Reflux Based on the Correlation Analysis of Gut Microbiota and Metabolites(2020-JYB-ZDGG-128);National Natural Science Foundation of China: Exploring the Molecular Mechanism of "Hewei Jiangni Fang" Intervention in Non-erosive Reflux Disease Esophageal Hypersensitivity from the Perspective of Mas-related Gene X2/Stromal Interaction Molecule 1/Cell Adhesion Molecule 1 Pathway Regulation of Mast Cell/Dorsal Root Ganglion Communication Based on the "Xinkai-Kujiang" Method(82374401)

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Abstract

OBJECTIVE: To evaluate the safety and efficacy of Hewei Jiangni recipe (和胃降逆方, HWJNR) for treating nonerosive gastroesophageal reflux (NERD) with cold-heat complex syndrome and to clarify its mechanism based on correlation analyses of intestinal flora and metabolites.

METHODS: Seventy-two patients with NERD and the Traditional Chinese Medicine (TCM) syndrome of intermingled heat and cold were randomly assigned to either the TCM group or the Western Medicine group, each receiving 8 weeks of treatment. The primary outcome was the score of the gastroesophageal reflux disease questionnaire (GERD-Q). Additionally, 10 healthy individuals were recruited. Mechanistic outcomes included correlation analyses of intestinal flora and metabolites in healthy individuals and NERD participants before and after treatment.

RESULTS: After 8 weeks, the effectiveness rate was 90% in the TCM group and 86.67% in the Western Medicine group (P >0.05). Compared with omeprazole, the TCM group significantly improved quality of life and alleviated symptoms such as loss of appetite, fatigue, bowel sounds, and coldness in the hands and feet (P < 0.05). Dysregulation of intestinal flora and metabolic pathways in NERD patients was restored to balance after TCM treatment, which appeared related to the TCM regulation of "cold and heat disorders."

CONCLUSION: HWJNR was clinically as effective as omeprazole and demonstrated advantages in improving quality of life.

Key words： non-erosive gastroesophageal reflux disease; randomized controlled trial; Hewei Jiangni recipe; Chinese herbal medicine; gut microbiota

Cite this article

Xiaosi ZHANG , Shuangyuan ZHANG , Hanqing CHEN , Zhengdao LIN , Chune XIE , Junxiang LI , Xiaohong LI . Hewei Jiangni recipe (和胃降逆方) improved the quality of life in patients with cold-heat mixed nonerosive reflux disease: a randomized, double-blinded study[J]. Journal of Traditional Chinese Medicine, 2025 , 45(5) : 1106 -1118 . DOI: 10.19852/j.cnki.jtcm.20250107.001

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