Double-blind placebo-controlled evaluation of one year therapy with sucralfate in healed duodenal ulcer.

Forty patients with duodenal ulcer, considered healed at endoscopy, were entered in a double-blind trial and treated for up to one year with sucralfate, 500 mg before breakfast, lunch, supper and 1000 mg on retiring, or with placebo. The subjects were interviewed and endoscopy was performed at 0, 3, 6, 9 and 12 months or at any time if pain recurred and they returned to the clinic. On relapse, the patients were withdrawn from trial. The remission rate maintained by sucralfate was superior to that achieved by placebo. The difference was significant (p less than 0.05) at 6 months (64% vs. 27%) and at 12 months (56% vs. 18%). No important side effects were noted.