Effect of sulglycotide in the prevention of duodenal ulcer relapse.

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of sulglycotide, a gastroprotective drug, as maintenance treatment for patients with duodenal ulcer. DESIGN: A randomized double-blind study. METHODS: A total of 119 patients with recently healed duodenal ulcers were randomly allocated, in a double-blind fashion, to receive sulglycotide 200 mg twice daily (60 patients) or placebo (59 patients) for 1 year. Patients underwent clinical assessment every third month and endoscopy at 6 and 12 months, or earlier if relapse was suspected. RESULTS: The cumulative endoscopic relapse rates, compared using the log rank test, were 37 and 52% after 6 and 12 months, respectively, in the sulglycotide group and 62 and 71% (P = 0.03), respectively, in the placebo group. CONCLUSIONS: Sulglycotide is moderately effective as a maintenance treatment for duodenal ulcer disease.