DOUBLE-BLIND TRIAL OF OMEPRAZOLE AND AMOXICILLIN IN THE CURE OF HELICOBACTER-PYLORI INFECTION IN GASTRIC-ULCER PATIENTS

Background: Our aim was to investigate the efficacy of omeprazole and amoxicillin in curing Helicobacter pylori infection in gastric ulcer p atients. Methods: In a double-blind trial 185 H. pylori-positive gastr ic ulcer patients were prospectively randomized to receive 40 mg omepr azole twice daily and either 750 mg amoxicillin three times daily or 7 50 mg amoxicillin placebo three times daily on days 1-14, followed by 20 mg omeprazole daily on days 15-56. Results: Twenty-seven patients w ere excluded because of lack of compliance or missed follow-up examina tions; one patient receiving amoxicillin discontinued treatment owing to side effects. On an intention-to-treat basis, omeprazole/amoxicilli n led to cure of H. pylori infection in 67.1% (47 of 70) of patients n ot using non-steroidal anti-inflammatory drugs (NSAIDs)/aspirin (ASA) and in 46.7% (14 of 30) of those taking NSAIDs/ASA (P < 0.05). With th e omeprazole/placebo regimen, H. pylori infection was cured in 8.8% (n o NSAIDs), and 0% (NSAIDs). Conclusions: The use of NSAIDs/ASA may lim it the efficacy of omeprazole/amoxicillin in curing H. pylori infectio n in gastric ulcer patients.