Gastroprotective Therapy Does Not Improve Outcomes of Patients With Helicobacter pylori–Negative Idiopathic Bleeding Ulcers

Background & Aims We performed a prospective cohort study to investigate the effects of gastroprotective agents (such as proton pump inhibitors or histamine-2 receptor antagonists) on long-term clinical outcomes of patients with Helicobacter pylori –negative idiopathic bleeding ulcers. Methods Patients with H pylori –negative idiopathic bleeding ulcers were recruited from a single center from April 2002 to March 2009 (n = 663). Age- and sex-matched patients with H pylori –positive bleeding ulcers were used as controls (n = 633). After ulcers had healed, 566 patients in the H pylori –negative idiopathic ulcer cohort received gastroprotective agents at clinicians' discretion, whereas controls received no gastroprotective agent after H pylori eradication therapy. Patients were followed until September 2011 for end points that included recurrent ulcer bleeding and all-cause mortality. Results During the exposed period of 534 person-years, the incidence rates of recurrent ulcer bleeding and death were 3.8 (95% confidence interval [CI], 2.6–5.4) and 21.8 (95% CI, 18.8–25.3) per 100 person-years among the patients given gastroprotective agents, compared with incidence rates of 2.4 (95% CI, 1.6–3.5; P = .08) and 13.8 (95% CI, 11.9–16.0; P H pylori –negative idiopathic ulcers (2.9 and 17.0 per 100 person-years, respectively) than in controls (1.1 and 5.9 per 100 person-years, respectively; P Conclusions Gastroprotective agents do not reduce the risk of recurrent bleeding or mortality for patients with H pylori –negative idiopathic bleeding ulcers.