Does the eradication of Helicobacter pylori prevent peptic ulcer bleeding in adults who are taking low-dose aspirin?
Adults 60 years or older who are taking low-dose aspirin and test positive for H. pylori have fewer peptic ulcer bleeds if the H. pylori is eradicated. This benefit is not evident after 2.5 years.
Randomized controlled trial (double-blinded)
Outpatient (primary care)
These investigators conducted this pragmatic trial in primary care settings in the United Kingdom. The participants were 60 years older, were taking no more than 325 mg aspirin daily, and had H. pylori based on urea breath testing. They were randomized to receive a 1-week H. pylori eradication regimen (lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 400 mg twice daily; n = 2677) or 1 week of matching placebo (n = 2675). After a median of 5 years of follow-up, 12.7% of the intervention patients and 14.5% of the control patients either died or withdrew from the study. After conducting some fancy statistical tests, the authors determined that during the first 2.5 years of follow-up, the eradication group had fewer definite or probable peptic ulcer bleeds than the control group (6 vs 17; 0.92 events per 1000 person-years vs 2.61 events per 1000 person-years). The authors report the number needed to treat as 238 patients (95% CI 184 - 1661). These differences largely evaporated beyond 2.5 years. Some messiness of the study comes from the declining use of aspirin over time and the 10% increased use of proton pump inhibitor medication in both groups (< 3% at baseline).
Henry C. Barry, MD, MS
Michigan State University
East Lansing, MI