459 The Effect of Rebamipide in Patients With Gastroesophageal Reflux Disease, Including Non-Erosive Reflux Disease: A Multi-Center, Randomized, Single-Blind, Placebo-Controlled Study (RENERD Study)

Abstract

INTRODUCTION: Gastroesophageal reflux disease (GERD) is a chronic and frequently relapsing disease. The etiology of non-erosive reflux disease (NERD) remains unclear, but it has been reported to manifest histologic changes such as dilated intercellular spaces (DIS) and inflammatory cells infiltration in the esophageal mucosa. In this study, we investigated the effect of rebamipide, a mucosal protective agent, in the recurrence of symptoms in GERD patients during proton pump inhibitor (PPI) and also examined histologic changes in the esophageal mucosa of NERD patients. METHODS: A total of 139 patients with GERD including 50 patients with NERD were enrolled in this study and were treated randomly with either PPI plus rebamipide (rebamipide group) or PPI plus placebo (placebo group) during 8 weeks. We compared the change of symptom score at 8 weeks in both groups using a GERD questionnaire. In addition, we analyzed histologic findings such as DIS, inflammatory cells infiltration, and basal cell hyperplasia in the esophageal mucosa of NERD patients, and we compared the histologic changes at 8 weeks in both groups. RESULTS: After 8 weeks, the mean decreases in the total symptom score in the rebamipide group were greater than those in the placebo group in GERD patients, but not statistically significant (-4.4 ± 2.7 vs. -3.9 ± 3.1, P = 0.382). However, the proportion of at least a 50% decrease in the total symptom score in the rebamipide group was significantly higher than that in the placebo group (74.1% vs. 51.7%, P = 0.020). With regard to histologic changes in NERD patients, the severity of DIS in the rebamipide group was significantly improved compared to that in the placebo group after 8 weeks (P = 0.024), and also the lymphocytes counts were more decreased in the rebamipide group compared to the placebo group (P = 0.026). CONCLUSION: Rebamipide, a mucosal protective agent, might be helpful in attenuating the recurrence of symptoms in GERD patients. It could also improve histologic abnormalities in the esophageal mucosa of NERD patients.