Background & Aims: A randomized, double-blind, placebo-controlled, multicenter study was conducted to assess the efficacy of 2 g sucralfate suspension in treating gastric mucosal lesions caused by long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). Methods: Only patients given NSAIDs continuously for at least 2 months with positive fecal occult blood (FOB) and endoscopically confirmed mild to moderate mucosal lesions (Lanza scale, grades 2–4) were included. After 1-week run-in phase, patients were stratified into 2 groups according to gastropathy-related symptoms during the preceding 7 days (symptomatic vs. asymptomatic) and randomized to 2 g (10 mL) of sucralfate suspension or placebo twice a day over a 6-week period. NSAIDs were given according to each patient's dosage schedule and always after meals. Results: Twenty-five patients received sucralfate and 25 received placebo. At the end of the study, 68% (17/25) of patients given sucralfate had no lesions (Lanza grade 0) on endoscopy compared with 35% (8/23) in controls (P = 0.042). The Lanza grades in patients given sucralfate were significantly improved compared with the placebo patients (P = 0.022). Conclusions: In this target population selected according to positive FOB test and endoscopic evidence of mucosal injury, chronic administration of sucralfate significantly decreased NSAID-induced gastric erosions.
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2003;1:51-56
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