Chinese herbal medicine Xiangsu Hewei Granules in treating non-erosive gastroesophageal reflux disease with liver stomach stagnation heat syndrome: A multicentre, randomized, double-blind, placebo-controlled trial.

Zhi-Min Chen; Junxiang Li; Zhijun Huang; Gang Zhao; Xiaohua Hou; Chaoxia Liu; Yan Leng; Huizhen Li; Wenxia Zhao; Bin Yu; Yunlian Hu; Tao Zhang; Long Zhao; Yaoming Zeng; Yibin Chen; Na Liu; Hua-Fang Chen

doi:10.1016/j.jep.2026.122141

PubMed · 42372807

Chinese herbal medicine Xiangsu Hewei Granules in treating non-erosive gastroesophageal reflux disease with liver stomach stagnation heat syndrome: A multicentre, randomized, double-blind, placebo-controlled trial.

Zhi-Min Chen·Junxiang Li·Zhijun Huang·Gang Zhao·Xiaohua Hou·Chaoxia Liu·Yan Leng·Huizhen Li·Wenxia Zhao·Bin Yu·Yunlian Hu·Tao Zhang·Long Zhao·Yaoming Zeng·Yibin Chen·Na Liu·Hua-Fang Chen

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Abstract

ETHNOPHARMACOLOGICAL RELEVANCE: Xiangsu Hewei Granules are an herbal preparation that has shown potential for controlling symptoms of nonerosive gastroesophageal reflux disease (NERD) in preliminary studies. However, high-quality randomized controlled evidence for its use in NERD remains lacking. AIM: To verify the efficacy and safety of Xiangsu Hewei Granules in treating NERD with liver stomach stagnation heat syndrome. MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled, multicentre phase III trial included 480 patients (aged 18-65 years) with confirmed NERD (GerdQ≥8; negative H. pylori) and traditional Chinese medicine (TCM) liver stomach stagnation heat syndrome. Patients were randomized 3:1 to receive either Xiangsu Hewei Granules or placebo, thrice daily for 8 weeks. The primary outcomes were the effective rate of the response based on visual analog scale (VAS) scores for heartburn and acid regurgitation at week 8. The secondary outcomes included reductions in the TCM syndrome score, etc. RESULTS: 479 participants (mean age 48.5 years, SD10.2; 54.3% female) entered the full analysis set and safety set (360 tests group; 119 control group, 1 participant in the control group withdrawing before medication). At week 8, compared with the control group, the test group demonstrated significantly better effective rate of VAS score response for heartburn(76.39% vs 21.01%, 95% CI 55.38 (45.98, 62.94) %, p < 0.01),acid regurgitation (79.72% vs 23.53%, 95% CI56.39 (46.90, 64.12) %, p < 0.01), and TCM syndrome score (69.23% vs 30.13%, p < 0.01) at week 8. CONCLUSION: In this selected population of NERD patients with liver-stomach stagnation heat syndrome (e.g., negative H. pylori, no pH-impedance phenotype, and low anxiety/depression scores), Xiangsu Hewei Granules demonstrated efficacy and safety in improving heartburn, acid regurgitation, and TCM syndrome scores. However, generalizability to the broader NERD population and its comparative effectiveness against standard proton pump inhibitor therapy require further investigation.

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Zhi-Min Chen, Junxiang Li, Zhijun Huang, Gang Zhao, Xiaohua Hou, Chaoxia Liu, Yan Leng, Huizhen Li, Wenxia Zhao, Bin Yu, Yunlian Hu, Tao Zhang, Long Zhao, Yaoming Zeng, Yibin Chen, Na Liu, Hua-Fang Chen. 2026-06-29. Chinese herbal medicine Xiangsu Hewei Granules in treating non-erosive gastroesophageal reflux disease with liver stomach stagnation heat syndrome: A multicentre, randomized, double-blind, placebo-controlled trial.. https://doi.org/10.1016/j.jep.2026.122141

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Adolescent subject Adult subject Aged subject Clinical Trial, Phase III subject Double-Blind Method subject Drugs, Chinese Herbal subject Female subject Humans subject Journal Article subject Journal Article; Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase III resource Liver stomach stagnation heat syndrome subject Male subject Medicine, Chinese Traditional subject Middle Aged subject Multicenter Study subject Non-Erosive Reflux Disease subject

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