The safety and efficacy of
sucralfate (an
aluminum salt of
sucrose sulfate) in
duodenal ulcer treatment were assessed in a double-blind, placebo-controlled, multicenter study. Out-patients received two 500 mg
sucralfate tablets or placebo
tablets after meals and at bedtime. Endoscopic examinations were performed in 216 patients, either after 2 weeks or 4 weeks, or both, to evaluate healing. After 2 weeks, 35% (37 of 105) of th
sucralfate patients had complete healing, compared to 25% (26 of 106) of the placebo patients (p = 0.0225, Mantel-Haenszel). After 4 weeks, the
sucralfate and placebo rates were 75% (82 of 109) and 64% (68 of 107), respectively (p = 0.0383). Patients in the
sucralfate group reported greater reduction in both diurnal and nocturnal
pain each week than those in the placebo group. No serious side effects were reported with
sucralfate use; the most common complaint was
constipation in 2.6% of the
sucralfate patients assessed. Laboratory tests--conducted pretreatment, after 2 weeks, and after 4 weeks--revealed no evidence of adverse effects. The nonsystemic agent appears to represent a unique, safe, and effective mode of treatment for
duodenal ulcer.