Maintenance Therapy with Sucralfate Reduces Rate of Gastric Ulcer Recurrence

Seventy-two patients with recently healed gastric ulcers were entered into a double-blind, placebo-controlled, six-month maintenance trial to assess whether sucralfate, 1 g in the morning and 2 g at night, reduces the propensity for recurrent ulceration. Patients were assessed clinically at 0, 6, 12, 18, and 24 weeks. Endoscopy was performed at the time of entry into the study and at 24 weeks, or earlier if clinical relapse occurred during this period. Eleven patients were excluded from the study because they defaulted or for other protocol violations. The other 61 patients were followed for six months or until evidence of ulcer relapse. Endoscopic recurrence was found in five of 31 patients (16 percent) randomly assigned to receive sucralfate and in 21 of 30 patients (70 percent) assigned to receive placebo. Most recurrences occurred during the first 12 weeks, with relapse rates of 10 percent and 53 percent, respectively for the sucralfate- and the placebo-treated groups. Three of the recurrences noted at 24 weeks were asymptomatic; two of these were in the sucralfate-treated group. The results indicate that a 3 g per day maintenance dose of sucralfate offers meaningful protection against recurrent gastric ulceration.