Omeprazole versus placebo for bleeding peptic ulcer [Classics Series]

Classics Series, Landmark Trials in Medicine

1. Patients presenting with upper gastrointestinal bleeds experienced significantly lower risk of continued bleeding and need for surgery to control bleeding when treated with omeprazole as compared with placebo.

2. There was no significant difference in mortality between the two groups, though the omeprazole group had significantly lower red cell transfusion requirements.

Original Date of Publication: April 1997

Study Rundown: Upper gastrointestinal bleeding is a common cause of hospitalization. While endoscopy has long been an important component of managing upper gastrointestinal bleeds, there were no well-studied medical therapies at the time this trial was conducted. It had been shown that platelet function is poorer in low pH, thus, it was thought that reducing gastric acidity would help control bleeding. Prior studies with H2-receptor antagonists demonstrated mixed results, as intravenous famotidine was not shown to be effective. The purpose of this trial was to explore whether treatment with a proton pump inhibitor would improve mortality and need for surgery in patients presenting with upper gastrointestinal bleeds. In summary, patients treated with omeprazole had significantly lower rates of continued bleeding and surgery for ongoing bleeding compared to those being treated with placebo. There was no significant difference between the two groups in bleeding-related mortality 30 days after admission.

Click to read study in NEJM

In-Depth [randomized controlled trial]: This trial was conducted at a single tertiary care centre in India. A total of 220 patients were randomized to either treatment with oral omeprazole 40 mg Q12H for 5 days of matching placebo. After appropriate resuscitation, all patients underwent upper endoscopy within 12 hours after admission. Patients with duodenal, gastric or stomal ulcers and stigmata of recent hemorrhage (i.e., arterial spurting, visible vessel, oozing from ulcer, adherent clot to ulcer) were considered eligible for the trial. Exclusion criteria were severe terminal illness that made endoscopy dangerous or undesirable, profuse hemorrhage with persistent shock necessitating emergent surgical intervention, or bleeding from a Mallory-Weiss tear/varices/erosion/tumours/unknown source. Endpoints studied were continued bleeding, recurrent bleeding, surgery, and mortality within 30 days after admission from causes related to bleeding or treatment.

The risk of continued bleeding was significantly higher in the placebo group compared to the omeprazole group (OR 4.7; 95%CI 2.7-7.4). The risk of surgery to control bleeding was also significantly higher in the placebo group (OR 3.9; 95%CI 1.7-8.5). There was no significant difference between the two groups in terms of the risk of mortality. Patients in the omeprazole group required significantly fewer units of blood transfused per patient (p<0.001).

Image: PD

©2015 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. No article should be construed as medical advice and is not intended as such by the authors, editors, staff or by 2 Minute Medicine, Inc.