Healing Effect of Rebamipide in Addition to Omeprazole for Gastric Ulcer: Preliminary Results of a Randomized, Double-blind, Placebo-controlled Trial
Sawinee Jiriyasin, MD1, Chalermrat Bunchorntavakul, MD1
Affiliation : 1 Division of Gastroenterology and Hepatology, Department of Medicine, Rajavithi Hospital, Bangkok, Thailand
Background : Rebamipide is a mucoprotective agent which has anti-oxidative and anti-inflammatory effects, as well as the ability
to increase mucosal blood flow. From theoretical basis, addition of rebamipide to proton pump inhibitors (PPI) may facilitate the
healing of gastric ulcer (GU).
Objective : To compare the GU healing rates between treatment with a combination of rebamipide plus omeprazole and omeprazole
monotherapy.
Materials and Methods: This double-blind, randomized, placebo-controlled trial was conducted at Rajavithi Hospital, Bangkok
between 2018 to 2019. Patients with GU size 0.5 to 3 cm were randomly assigned into either combination group (omeprazole 20
mg OD + rebamipide 100 mg TID) or PPI monotherapy group (omeprazole 20 mg OD + placebo). Primary endpoint was healed GU
after 4 weeks of treatment determined by follow-up esophagogastroduodenoscopy.
Results : A total of 70 patients were randomized and 64 completed the present study. The proportion of patients with non-steroidal
anti-inflammatory drugs (NSAIDs) use and Helicobacter pylori positive were 42.9% and 68.6% in the combination group, 62.9%
and 60% in the PPI group, without statistically significant difference. Overall, healed GU occurred in 77.1% in the combination
group, and 60% in the PPI group, as intention-to-treat analysis (p = 0.198). Mean change of size of GU was -0.8 cm (-1, -0.60) in
the combination group, and -0.68 cm (-0.81, -0.55) in the PPI group (p = 0.3). In subgroups analysis, patients with the presence of
H. pylori, atrophic gastritis and/or intestinal metaplasia, NSAIDs use and current smoking have higher rates of healed GU by the
combination therapy compared with PPI alone (p>0.05). There were no differences in compliance and treatment side effects between
the two groups.
Conclusion : Treatment with rebamipide plus PPI has a trend toward improved GU healing, compared with PPI monotherapy,
especially in subgroup of patients with features of difficult to heal GU (presence of H. pylori, atrophic gastritis, intestinal metaplasia,
NSAIDs and smoking).
DOI: 10.35755/jmedassocthai.2020.S08.12064
Keywords : Gastric ulcer, Mucoprotective drug, Omeprazole, Peptic ulcer disease, Proton pump inhibitor, Rebamipide
