Hewei Jiangni recipe improved the quality of life in patients with cold-heat mixed nonerosive reflux disease: a randomized, double-blinded study.

Abstract

Objective: To evaluate the safety and efficacy of Hewei Jiangni recipe (, 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.