Clinical efficacy of sucralfate in the treatment of gastric ulcer.

We performed a randomized, single-blind study in Japan to investigate the efficacy and safety of two dosage regimens of sucralfate granules, 2 g, twice daily (b.i.d. group, n = 30) and 1 g, 4 times daily (q.i.d. group, n = 27), on ulcer healing in 57 patients with endoscopically proven gastric ulcer. Endoscopy was performed after 4 weeks and, if complete healing was not achieved, again after an additional 4 weeks. Of 57 patients, 11 were excluded from the statistical analysis because of protocol violation (six in b.i.d. group, five in q.i.d. group). Of 46 patients eligible for the analysis of healing rates, four patients in the b.i.d. group (all at 8 weeks) and five patients in the q.i.d. group (two at 4 weeks and three at 8 weeks) were withdrawn due to patients' inconvenience. As the possibility that the withdrawals were due to the treatment failures could not be denied, we used the Kaplan-Meier method and generalized Wilcoxon test/logrank test for the calculation and evaluation of healing rates in this study, respectively. Healing rates at 4 and 8 weeks were 50% and 94% in the b.i.d. group and 35% and 68% in the q.i.d. group. There was no significant difference in healing rates between the groups. No serious adverse effect was observed in either group. These results suggest that the 2 g b.i.d. dose of sucralfate in granule form is at least as effective as the conventional dose of 1 g q.i.d. in the treatment of active gastric ulcers and could lead to better patient compliance.