CURE OF GASTRIC-ULCER DISEASE AFTER CURE OF HELICOBACTER-PYLORI INFECTION - GERMAN GASTRIC-ULCER STUDY

Background: Helicobacter pylori infection: is associated with gastric ulcer disease in about 75% of cases. Objective: The aim of this study was to determine whether H. pylori eradication reduces gastric ulcer r elapse rates. Design: The study was randomized, controlled, multicentr ic and investigator blinded, and was conducted at three university hos pitals, two teaching hospitals, and by six practising gastroenterologi sts. Methods: During a period of 1 year 152 patients with gastric ulce rs were randomly assigned to one of two treatment regimens: omeprazole 20 mg daily in the morning for 8 weeks (74 patients), or bismuth subs alicylate 600 mg three times daily for 8 weeks combined with 500 mg am oxicillin twice daily and 1000 mg tinidazole twice daily for the first 10 days (triple therapy) (78 patients). Follow-up examinations were p erformed 6, 12 and 18 months after treatment and whenever ulcer sympto ms occurred. Results: Of the 152 randomized patients five were exclude d because of gastric cancer, 10 missed follow-up examinations and seve n receiving triple therapy terminated treatment because of side effect s. Of the remaining 130 patients, five of 69 (7.2%) in the omeprazole and six of 61 (9.8%) in the triple group were H. pylori negative. Afte r 8 weeks' therapy, the gastric ulcer was healed in 85.9% (omeprazole) and in 81.8% (triple) in H. pylori-positive patients, and in 80% (ome prazole) and 16.7% (triple) in H. pylori-negatives. H. pylori was erad icated in 8.1% of the patients who received omeprazole monotherapy and in 78.2% recieving triple therapy, and in 8.1% and 69.4% in an intent ion-to-treat analysis. The subsequent relapse rates during a follow-up period of 12 months were 50% in the omeprazole group and 4% in the tr iple group. Gastric ulcer relapse was observed in 49% of patients who were H. pylori positive and in 2% who were H. pylori negative after tr eatment. Conclusion: The data show that the presence of H. pylori is a n important predictor of gastric ulcer relapse and that eradication of H. pylori may heal gastric ulcer disease.