Sucralfate as maintenance treatment for the prevention of duodenal ulcer recurrence

Eighty-eight patients with endoscopically proven and healed duodenal or pyloric ulcer were randomly allocated into a double-blind, placebo-controlled, 12-month maintenance trial to determine whether sucralfate, 1 g twice daily, can be used to prevent a recurrence of ulceration. The patients were assessed endoscopically at three, six, and 12 months, or earlier if a symptomatic relapse occurred. Serum aluminum levels were also monitored. Sixteen patients were excluded from the study during the follow-up: nine of 41 in the sucralfate group, and seven of 47 in the placebo group. The groups did not differ with respect to age, sex, or smoking. The cumulative relapse rates in the sucralfate group were 28 percent after three months, 33 percent after six months, and 45 percent after 12 months, as compared with 49 percent (p less than 0.05), 64 percent (p less than 0.01), and 68 percent (p less than 0.05), respectively, in the placebo group. It is concluded that 1 g sucralfate twice daily is more effective than a placebo and is safe for the maintenance treatment of duodenal and pyloric ulcer disease.