A COMPARISON OF OMEPRAZOLE AND PLACEBO FOR BLEEDING PEPTIC-ULCER

Background The role of medical treatment for patients with bleeding pe ptic ulcers is uncertain. Methods We conducted a double-blind, placebo -controlled trial in 220 patients with duodenal, gastric, or stomal ul cers and signs of recent bleeding, as confirmed by endoscopy. In 26 pa tients the ulcers showed arterial spurting, in 34 there was active ooz ing, in 35 there were nonbleeding, visible vessels, and in 125 there w ere adherent clots. The patients were randomly assigned to receive ome prazole (40 mg given orally every 12 hours for five days) or placebo. The outcome measures studied were further bleeding, surgery, and death . Results Twelve of the 110 patients treated with omeprazole (10.9 per cent) had continued bleeding or further bleeding, as compared with 40 of the 110 patients who received placebo (36.4 percent) (P<0.001). Eig ht patients in the omeprazole group and 26 in the placebo group requir ed surgery to control their bleeding (P<0.001). Two patients in the om eprazole group and six in the placebo group died. Thirty-two patients in the omeprazole group (29.1 percent) and 78 in the placebo group (70 .9 percent) received transfusions (P<0.001). A subgroup analysis showe d that omeprazole was associated with significant reductions in recurr ent bleeding and surgery in patients with nonbleeding, visible vessels or adherent clots, but not in those with arterial spurting or oozing. Conclusions In patients with bleeding peptic ulcers and signs of rece nt bleeding, treatment with omeprazole decreases the rate of further b leeding and the need for surgery. (C) 1997, Massachusetts Medical Soci ety.