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Treatment of bleeding peptic ulcers with omeprazole.

Reference Khuroo MS, Yattoo GN, Javid G, Khan BA, Shah AA, Gulzar GM, Sodi JS. A comparison of omeprazole and placebo for bleeding peptic ulcer. N Engl J Med 1997; 336:1054 8.

Clinical question Is omeprazole useful in decreasing morbidity and mortality in patients with bleeding peptic ulcers?

Background Acute upper gastrointestinal tract bleeding results in significant morbidity and mortality. Clinical trials of histamine [H.sub.2]-receptor antagonist treatment in patients with bleeding peptic ulcers have not demonstrated benefit)i Previous study of omeprazole has not demonstrated benefit in patients with upper gastrointestinal bleeding from all sites, including ulcers as well as esophageal erosions, tears, and varices. The purpose of this study was to compare omeprazole with placebo only in patients with bleeding peptic ulcers who did not require surgery.

Population studied The population studied consisted of the 220 consecutive patients with endoscopy confirmed upper gastrointestinal bleeding from duodenal, gastric, or stomal ulcers, selected from a total of 869 patients presenting with upper gastrointestinal bleeding. Exclusion criteria included severe terminal illness; severe bleeding requiring emergency surgery; and bleeding from a Mallory-Weiss tear, varices, erosions, tumors, or an unknown source. The average age of the patients was 58 (SD [+ or -] 8) years.

Study design and validity The study is a doubleblind, placebo-controlled trial of omeprazole or placebo administered orally every 12 hours for 5 days. Patients in both groups also were allowed to receive a liquid antacid. A follow-up endoscopy was done at 72 hours if there was a suspicion of further bleeding. Endoscopic therapy for patients with continued or recurrent bleeding was not used.

Power analysis showed that the sample size could demonstrate a 50% reduction of recurrent bleeding or need for surgery in the treatment group. The study was not powerful enough to identify a difference in mortality rates.

Outcomes measured The authors evaluated four outcomes: (1) continued bleeding as determined by bloody nasogastric aspirate, shock, or the need to transfuse at least 3 units of blood within 4 hours; (2) recurrence of bleeding as defined by hematemesis, melena, or both, with shock or at least a 2-g drop in hemoglobin over a 24-hour period after initial stabilization; (3) the need for surgery as determined by shock on presentation or bleeding (continued or recurrent) in which the patient required 4 or more units of blood within 4 hours; and (4) death.

Results Omeprazole had a significant effect on several of the outcomes of this study. Continued bleeding or further bleeding occurred in 12 (10.9%) patients treated with omeprazole vs 40 (36.4%) patients treated with placebo P [is less than] .001) Eight patients (7.3%) in the omeprazole group and 26 patients (23.6%) in the placebo group needed surgery to control the bleeding (P [is less than] .001) Thirty two patients (29.1%) in the omeprazole group and 78 patients (70.9%) in the placebo group received transfusions (P[ is less than] .001). Mortality rates (1.8% of the omeprazole treated group and 5.5% of the placebo-treated group) were not different between the two groups, although the study size probably was too small to find a difference if one existed. In the subgroup of patients with arterial spurting or oozing, omeprazole therapy was not associated with reductions in further bleeding and surgery.

Recommendations for clinical practice This well-designed clinical trial demonstrates that oral omeprazole for 5 days is effective in reducing morbidity but not mortality of patients with endoscopy-proven acute gastrointestinal bleeding due to peptic ulcers. A previous large trial of omeprazole versus placebo for upper gastrointestinal bleeding from any source showed no benefit. It appears that only the subset of patients with upper gastrointestinal bleeding due to bleeding peptic ulcers can expect improved outcomes with omeprazole therapy.

Endoscopic treatment modalities are also available in most clinical settings in the United States. Further prospective studies are needed to compare omeprazole vs endoscopic therapy and combined therapy for patients with bleeding peptic ulcers.


[1.] Walt RP, Cottrell J, Mann SG, Freemantle NP, Langman MJ. Continuous intravenous famotidine for haemorrhage from peptic ulcer. Lancet 1992; 340:105-62.

[2.] Daneshmend TK, Hawkey CJ Langman MSJ, Logan RFA, Long RG, Walt RR Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial. BMJ 1992; 304:143-7.
Laura Munkel, MD
Linda French, MD
Oakwood Hospital Family Practice
Residency Program
Dearborn, Michigan
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Title Annotation:Journal Club
Author:Munkel, Laura; French, Linda
Publication:Journal of Family Practice
Date:Jul 1, 1997
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