Treatment of acute duodenal and pyloric channel ulcers with sucralfate suspension (2 g/10 ml) twice daily

Objective: To evaluate the efficacy of a new formulation of sucralfate suspension in the healing of duodenal and/or pyloric ulcer in smoking and non-smoking patients. Design: A randomized, double-blind, placebo-controlled parallel group multicentre trial. Setting: Gastroenterology outpatient clinics. Patients: One hundred and eighty-four patients with duodenal or pyloric channel ulcers entered the study. Intervention: Patients were randomized to receive either sucralfate suspension 2 g (10 ml) twice daily or placebo suspension for up to 8 weeks. Main outcome measures: Symptomatic improvement and endoscopie healing was assessed at 2, 4 and 8 weeks. Results: Sucralfate suspension healed 64% of patients in 4 weeks compared with 44% healing on placebo (P = 0.008), and 74% of patients in 8 weeks compared with 55% on placebo (P = 0.009). Sucralfate achieved a therapeutic gain of 30% over placebo in non-smoking patients, but failed to achieve significantly greater overall healing rates than placebo in smokers. Conclusion: Sucralfate suspension 2 g twice a day is effective in healing duodenal ulcers in non-smoking patients.