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Clinical Trial
. 2003 Aug 19;139(4):237-43.
doi: 10.7326/0003-4819-139-4-200308190-00005.

The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison

Joseph J Y Sung  1 , Francis K L Chan, James Y W Lau, Man-Yee Yung, Wai-Keung Leung, Justin C Y Wu, Enders K W Ng, S C Sydney Chung
Affiliations
Clinical Trial

The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison

Joseph J Y Sung et al. Ann Intern Med. .

Abstract

Background: The optimal treatment of ulcers with nonbleeding visible vessels and adherent clots is unclear.

Objective: To compare intravenous omeprazole infusion plus endoscopic therapy with intravenous omeprazole infusion alone for prevention of recurrent bleeding from ulcers with nonbleeding visible vessels or adherent clots.

Design: Single-blind randomized study with blinded evaluation of study end points.

Setting: An endoscopy center in a university hospital in Hong Kong.

Patients: 156 persons with upper gastrointestinal bleeding and ulcers showing nonbleeding visible vessels or adherent clots.

Intervention: Combination of endoscopic therapy and omeprazole infusion versus sham endoscopic therapy and omeprazole infusion.

Measurements: Recurrent ulcer bleeding before discharge and within 30 days.

Results: 78 patients were recruited in each group. Ulcer bleeding recurred before discharge in seven patients who received intravenous omeprazole alone (9%) and no patients who received combined therapy (difference, 9 percentage points [95% CI, 1.7 to 17.6 percentage points]; P = 0.01). The probability of recurrent bleeding within 30 days was 11.6% (9 patients) in the omeprazole-alone group and 1.1% (1 patient) in the combined therapy group (difference, 10.5 percentage points [CI, 1.7 to 19.8 percentage points]; P = 0.009). Patients in the combined therapy group required less transfusion (difference in median units of blood transfused, 1 unit [CI, 0 to 2 units]; P = 0.02). One patient in the combined therapy group had surgery for ulcer perforation. Four patients receiving omeprazole alone (5.1%) and two patients receiving combined therapy (2.6%) died within 30 days.

Conclusion: The combination of endoscopic therapy and omeprazole infusion is superior to omeprazole infusion alone for preventing recurrent bleeding from ulcers with nonbleeding visible vessels and adherent clots.

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