BACKGROUND AND AIM: Controversies remain over the need for antiulcer treatment following 1-week eradication triple therapy for Helicobacter pylori-positive peptic ulcers. The usefulness of combination therapy for gastric ulcers in Japanese patients, which consists of H. pylori eradication followed by gastroprotective therapy with rebamipide, was therefore evaluated. METHODS: The study was conducted in 52 H. pylori-positive patients with an endoscopically-proven open gastric ulcer. All patients received 1-week triple therapy (lansoprazole, amoxicillin and clarithromycin) followed by 7-week rebamipide therapy. After completion of the combination therapy, all patients underwent evaluation of ulcer healing by endoscopy, gastric ulcer symptoms and H. pylori eradication by rapid urease test and (13)C-urea breath test. RESULTS: The ulcer healing rates were 85.7% (36/42) at 8 weeks, 83.3% (30/36) in eradicated patients and 100% (6/6) in non-eradicated patients. The overall gastrointestinal symptom-free rate improved from 19.0% at baseline to 88.1% at 8 weeks. H. pylori was effectively eradicated in 85.7% (36/42) of patients. CONCLUSIONS: The results suggested that the combination therapy for open gastric ulcer was safe, well-tolerated and effective. However, data from a double-blind placebo-controlled study is necessary to confirm these findings.
RCT Entities:
BACKGROUND AND AIM: Controversies remain over the need for antiulcer treatment following 1-week eradication triple therapy for Helicobacter pylori-positive peptic ulcers. The usefulness of combination therapy for gastric ulcers in Japanese patients, which consists of H. pylori eradication followed by gastroprotective therapy with rebamipide, was therefore evaluated. METHODS: The study was conducted in 52 H. pylori-positive patients with an endoscopically-proven open gastric ulcer. All patients received 1-week triple therapy (lansoprazole, amoxicillin and clarithromycin) followed by 7-week rebamipide therapy. After completion of the combination therapy, all patients underwent evaluation of ulcer healing by endoscopy, gastric ulcer symptoms and H. pylori eradication by rapid urease test and (13)C-urea breath test. RESULTS: The ulcer healing rates were 85.7% (36/42) at 8 weeks, 83.3% (30/36) in eradicated patients and 100% (6/6) in non-eradicated patients. The overall gastrointestinal symptom-free rate improved from 19.0% at baseline to 88.1% at 8 weeks. H. pylori was effectively eradicated in 85.7% (36/42) of patients. CONCLUSIONS: The results suggested that the combination therapy for open gastric ulcer was safe, well-tolerated and effective. However, data from a double-blind placebo-controlled study is necessary to confirm these findings.