Triple therapy for Helicobacter pylori eradication is more effective than long-term maintenance antisecretory treatment in the prevention of recurrence of duodenal ulcer: a prospective long-term follow-up study

Background: The effectiveness of Helicobacter pylori eradication treatment and long term acid suppression maintenance in the natural course of duodena l ulcer has not been directly compared. Aim: To compare in a prospective randomized study the effectiveness of H. p ylori eradication on the prevention of recurrence of duodenal ulcer with lo ng-term maintenance acid suppression therapy. Methods: One hundred and four teen duodenal ulcer patients were randomized to the treatment over a 12-mon th period. Fifty-seven of them received triple therapy consisting of 1 g su cralfate q.d.s. for 28 days, 300 mg metronidazole q,d.s. for 14 days and 25 0 mg clarithromycin q.d.s, for 14 days. Another 57 received 20 mg omeprazol e q.d.s, for 12 months. An upper endoscopy was performed before treatment, at 6 weeks. and 2, 6 and 12 months after the first endoscopy. Side-effects were self-recorded and clinical follow-ups were arranged for up to 4.25 yea rs. Results: The ulcer healing rate was 90.2% (95% confidence interval (95% CI) : 79-97%) in the omeprazole group at 6 weeks as compared to 83.3% (95% CI: 70-93%) in the triple therapy group (P = 0.38). There was a higher success rate of pain control in the omeprazole group. Side-effects were more freque ntly reported and compliance was poorer in the triple therapy group during the first 4 weeks. During follow up, more relapses were seen in the omepraz ole group (9.8%, 95% CI: 3-21%) than the triple therapy group (4.2%, 95% CI : 1-13%) at 1 year (P = 0.44). All relapses were due to the persistence of H. pylori infection. At the 1 year follow-up, none of the patients who were H. pylori negative had an endoscopic relapse compared to 7 out of 56 patie nts who remained H. pylori positive (12.5%, 95% CI: 5-24%, P = 0.018). Afte r a mean follow-up of 4.07 years, none of those who remained H. pylori nega tive had an ulcer relapse while the 11 out of 41 who remained H, pylori pos itive had an ulcer relapse (26.8%, 95% CI 14-43, P = 0.0005). Conclusions: Both regimens were highly effective in healing ulcers, The era dication of H. pylori infection was associated with more side-effects and p oor compliance but was more effective than the maintenance therapy in reduc ing the recurrence of duodenal ulcers, For the prevention of ulcer recurren ce, testing of H. pylori status after triple therapy is more important than maintenance therapy.