Maintenance treatment is not necessary after Helicobacter pylori eradication and healing of bleeding peptic ulcer: a 5-year prospective, randomized, controlled study.

BACKGROUND: It is well accepted that in patients with uncomplicated peptic ulcers, Helicobacter pylori eradication therapy does not need to be followed by further antisecretory treatment. However, it is uncertain whether patients with bleeding peptic ulcers should receive maintenance antiulcer therapy after successful H pylori eradication and ulcer healing. The aim of this 5-year, prospective, randomized, controlled study was to investigate the role of long-term maintenance therapy after successful H pylori eradication and healing of bleeding ulcers. METHODS: A total of 82 consecutive patients with H pylori-associated bleeding peptic ulcers were enrolled in the study. After successful H pylori eradication with the 1-week proton pump inhibitor-based triple therapy and an additional 3-week treatment with 20 mg of omeprazole daily for ulcer healing, the patients were assigned to one of four 16-week maintenance treatment groups as follows: group A received 15 mL of an antacid suspension 4 times daily; group B received 300 mg of colloidal bismuth subcitrate 4 times daily; group C received 20 mg of famotidine twice daily; and group D, the control group, received placebo twice daily. Follow-up included an urea breath test labeled with carbon 13, biopsy-based tests, and repeated endoscopic examination. RESULTS: An analysis of variance revealed no difference in mean age and mean follow-up time among the groups. During a mean follow-up of 56 months, there was no peptic ulcer recurrence among the 3 treatment groups, and all of the patients remained free of H pylori infection during the study period. CONCLUSIONS: In patients with bleeding peptic ulcers, antiulcer maintenance treatment was not necessary to prevent ulcer recurrence after successful H pylori eradication and ulcer healing. In addition, the 1-week proton pump inhibitor-based triple therapy had the efficacy to ensure long-term eradication of H pylori in a region of high prevalence.