Objective:
The aim of this study was to assess the effect ofH. pylorieradication on ulcer recurrence in North American duodenal ulcer patients by examining only treatment studies that met rigorous methodologic criteria.
Methods:
Data sources were computerized bibliographic searches from 1983, review of reference lists, communication with companies that manufacture medications used forH. pyloritherapy in the U.S., andH. pyloriinvestigators, review of open presentations to the Food and Drug Administration, and review of abstracts from annual scientific meetings. Criteria for study inclusion were double blind, randomized North American trials ofH. pyloritherapy for duodenal ulcer, scheduled endoscopic follow-up exams for ≥6 months, andH. pyloricure documented ≥4 wk after completion of therapy by at least two endoscopic biopsy tests. Seven relevant trials were identified. Data were abstracted independently and disagreement was resolved by consensus. We obtained missing data and identified erroneous assessments through contact with an author or sponsor of all studies.
Results:
The common odds ratio for ulcer recurrence was 0.20 (95% CI, 0.13–0.31) and 2.8 patients would need to be successfully treated to prevent one ulcer recurrence at 6 months. The pooled ulcer recurrence rate at 6 months in patients withH. pylorieradication was 20%.
Conclusion:
Results of North American studies of highest methodological quality confirm thatH. pylorieradication markedly decreases ulcer recurrence. Nevertheless, 20% of patients in these studies had ulcer recurrence within 6 months, despite successful cure of infection and no reported use of NSAIDs. Non-H. pylori, non-NSAID ulcers may be more common in the U.S. than previously believed.
