CONTINUOUS MAINTENANCE WITH LOW-DOSE LANSOPRAZOLE VERSUS HELICOBACTER-PYLORI ERADICATION IN THE PREVENTION OF DUODENAL-ULCER RECURRENCE

BACKGROUND/AIMS: Reduction of gastric acid secretion by maintenance tr eatment with antisecretory agents and eradication of H. pylori by anti biotics constitute the most effective therapeutic options in preventin g duodenal ulcer relapse. The aim of this study was to compare the eff ect of a 12-month low-dose lansoprazole maintenance treatment with H. pylori eradication on the rate of ulcer relapse in H. pylori-positive duodenal ulcer patients. METHODOLOGY: After a healing phase with lanso prazole 30 mg/die or lansoprazole 30-60 mgldie plus antibiotics (amoxy cillin, tinidazole and colloidal bismuth subcitrate), 84 patients with healed duodenal ulcer entered the follow-up phase. Thirty-eight patie nts with persistent H. pylori infection received lansoprazole 15 mg at bedtime, whereas 46 in whom H. pylori was eradicated during the acute phase received no active therapy during the 12-month follow-up. The t wo groups were well balanced concerning all demographic characteristic s. Clinical controls were performed every 3 months or sooner in the ev ent of symptomatic relapse. RESULTS: In terms of per protocol analysis , the overall rate of ulcer relapse at 6 months was 5.5% (2/36) in the maintenance group and 0 (0/42) in the antibiotic group. The correspon ding figures at 12 months were 20.5% (7/34) and 5.7% (2/35), respectiv ely (p:ns, 95% CI for the difference -0.30 +0.02). On intent to treat analysis, the rate of ulcer relapse at 6 months was 5.2% (2/38) in the first group and 0% (0/46) in the second group: at 12 months the corre sponding figures were 19.4% (7/36) and 4.3% (2/46), respectively (p= 0 .06; CI 95%: +0.016 + 0.28). No significant side effects were observed during long-term maintenance with lansoprazole. CONCLUSIONS: Continuo us maintenance with low-dose lansoprazole may constitute a valuable al ternative to H. pylori eradication for the prevention of relapse and c omplications in duodenal ulcer patients not suitable for, or who have failed, H. pylori eradication.