Efficacy of sucralfate for duodenal ulcers: a multicenter, double-blind trial.

Sucralfate, a new drug for the treatment of duodenal ulcer, was tested in a multicenter, double-blind, placebo-controlled study. Fifty-five patients with endoscopically documented duodenal ulcers completed the trial successfully. Patients were treated four times daily with 1 g of sucralfate or placebo identical in appearance and taste. They were seen weekly for reinforcement of instructions, assessment of compliance, and clinical evaluation. The patients were reevaluated endoscopically at the end of the second and fourth weeks of therapy. After 4 weeks, 22 of 24 (91.7%) sucralfate-treated patients and 18 of 31 (58.1%) placebo-treated patients showed complete healing of duodenal ulcers (chi 2 = 7.70; p less than 0.01). Relief from ulcer discomfort paralleled the results of healing. We conclude that sucralfate is an effective agent for the treatment of duodenal ulcer.