LONG-TERM TREATMENT OF PATIENTS WITH GASTRIC-ULCER - SUCRALFATE VERSUS RANITIDINE VERSUS NO TREATMENT - AN INTERIM-REPORT AT THE END OF YEAR-1 OF A 3-YEAR MULTICENTER, RANDOMIZED STUDY

This multicenter, prospective, randomized, open, long-term study compared the efficacy of sucralfate (1 g twice daily) versus ranitidine (150 mg once daily) versus no therapy in patients with gastric ulcer. The results at the end of the first of a scheduled 3-year follow-up are reported. Two hundred ninety patients with healed GU entered the 3-year, open study. Ninety patients were randomly assigned to receive sucralfate, 105 to receive ranitidine, and 95 to receive no treatment. The three groups proved well matched in terms of standard clinical data. Fifty patients were withdrawn from the study during the first year; a gastric neoplasm was diagnosed in four patients. At months 3, 6, and 12 of therapy, the remission rates were, respectively, 94.8%, 86.2%, and 79.6% with sucralfate; 98.9%, 91.6%, and 82.5% with ranitidine; and 89.3%, 80.7%, and 66.9% with no treatment. Sucralfate was as effective as ranitidine (P = NS), and both drugs produced higher cumulative remission rates than no treatment (P < 0.06 and P < 0.01, respectively). We conclude that 1 g of sucralfate twice daily was as effective as 150 mg of ranitidine once daily in maintaining GU remission for 1 year; both treatments led to a better outcome than no treatment.