To establish the efficacy of PPI therapy for ulcer bleeding in the United States, do we need more patients or more PPI [corrected].

Proton pump inhibitor (PPI) therapy is widely used in the management of patients with ulcer bleeding. However, most randomized controlled trials (RCTs) have been conducted outside of the United States. Jensen and colleagues have conducted the first United States-based RCT to compare a PPI with an H(2)-receptor antagonist following appropriate endoscopic hemostatic treatment for patients with ulcer bleeding. Unfortunately, the trial had to be discontinued prematurely because of problems with enrolment. There was a statistically nonsignificant difference in rebleeding rates between the two treatment arms. A type II statistical error probably explains this apparent lack of efficacy. However, U.S. patients may also require higher doses of PPI for adequate control of intragastric acidity.