Study objective: To compare Helicobacter pylori eradication therapy with antisecretory therapy alone on the risk of hospitalization for a major ulcer event.
Design: Retrospective, population-based cohort study.
Data source: The 2000-2006 National Health Insurance database in Taiwan.
Patients: A total of 838,176 patients diagnosed with a gastrointestinal ulcer and who filled at least one prescription for antiulcer therapy, either H. pylori eradication therapy (331,364 patients [39.53%]) or antisecretory therapy alone (506,812 patients [60.47%]), between January 1, 2001, and December 31, 2006.
Measurements and main results: The primary outcome was hospitalization for a major ulcer event, defined as a gastrointestinal ulcer with hemorrhage and/or perforation. Cox proportional hazards models, adjusted for demographic and clinical characteristics, were used to compare the risk of hospitalization for a major ulcer event between the group receiving H. pylori eradication therapy (triple or quadruple combination therapy that includes an antisecretory agent) and the group receiving antisecretory therapy alone (histamine₂-receptor blocker or proton pump inhibitor). The H. pylori eradication therapy group was divided into initial users (combination therapy received immediately after gastrointestinal ulcer diagnosis) and late users (combination therapy received after antisecretory therapy with time lag ≤ 180 days, 181-365 days, or > 365 days from ulcer diagnosis). A secondary analysis was conducted in the three late H. pylori eradication therapy subgroups to determine if risk of hospitalization for major ulcer events differed by timing of receipt of therapy. Compared with the antisecretory therapy alone group, the H. pylori therapy group (initial users) had a significantly decreased risk of hospitalization for major ulcer events (adjusted hazard ratio [AHR] 0.57, 95% confidence interval [CI] 0.54-0.59, p<0.001). However, later use of H. pylori therapy was associated with a higher risk of hospitalization for major ulcer events (time lag 181-365 days, AHR 1.68, 95% CI 1.51-1.86, p<0.001; > 365 days, AHR 1.74, 95% CI 1.67-1.80, p<0.001) compared with those who received H. pylori therapy within 6 months (≤ 180 days) after gastrointestinal ulcers were diagnosed.
Conclusion: Helicobacter pylori therapy given within 6 months of a diagnosis of gastrointestinal ulcer was associated with a reduced risk of hospitalization for major ulcer events. Our findings extend the evidence from clinical trials that report the value of H. pylori eradication therapy in reducing ulcer recurrence by documenting the real-world benefit of reducing the risk of hospitalization for major gastrointestinal ulcer events.