Has the impact of Helicobacter pylori therapy on ulcer recurrence in the United States been overstated? A meta-analysis of rigorously designed trials.

OBJECTIVE

The aim of this study was to assess the effect of H. pylori eradication 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 for H. pylori therapy in the U.S., and H. pylori investigators, 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 of H. pylori therapy for duodenal ulcer, scheduled endoscopic follow-up exams for > or = 6 months, and H. pylori cure documented > or = 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 with H. pylori eradication was 20%.

CONCLUSION

Results of North American studies of highest methodological quality confirm that H. pylori eradication 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.