RANDOMIZED DOUBLE-BLIND CONTROLLED-STUDY OF RECURRENCE OF GASTRIC-ULCER AFTER TREATMENT FOR ERADICATION OF HELICOBACTER-PYLORI INFECTION

Objective: To determine whether eradication of Helicobacter pylori inf ection reduces recurrence of benign gastric ulceration. Design: Random ised, double blind, controlled study, Patients were randomised in a 1: 2 ratio to either omeprazole 40 mg once daily for eight weeks or the s ame treatment plus amoxycillin 750 mg twice daily for weeks 7 and 8. A 12 month untreated follow up ensued. Setting: Teaching and district g eneral hospitals between 1991 and 1994. Subjects: 107 patients with be nign gastric ulcer associated with H pylori. Main outcome measures: En doscopically confirmed relapse with gastric ulcer (analysed with life table methods), H pylori eradication, and healing of gastric ulcers (M antel-Haenszel test). Results: 172 patients were enrolled, Malignancy was diagnosed in 19; 24 were not infected with H pylori; four withdrew because of adverse events; and 18 failed to attend for start of treat ment, leaving 107 patients eligible for analysis (35 omeprazole alone; 72 omeprazole plus amoxycillin), In the omeprazole/amoxycillin group 93% (67/72; 95% confidence interval 84% to 98%) of gastric ulcers heal ed and 83% (29/35; 66% to 94%) in the omeprazole group (P=0.103). Erad ication of H pylori was 58% (42/72; 46% to 70%) and 6% (2/35; 1% to 19 %) (P<0.001) and relapse after treatment was 22% (16/72) and 49% (17/3 5) (life table analysis, P<0.001), in the two groups, respectively, Th e recurrence rates were 7% (3/44) after successful H pylori eradicatio n and 48% (30/63) in those who continued to be infected (P<0.001). Con clusions: Eradication of H pylori reduces relapse with gastric ulcer o ver one year, Eradication rates achieved with this regimen, however, a re too low for it to be recommended for routine use.