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

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.