Role of maintenance sucralfate in prevention of duodenal ulcer recurrence.
Fifty-nine patients who had duodenal ulcers that were healed following sucralfate administration in a dose of 1 g four times a day were randomly entered into a double-blind, placebo-controlled, 12-month maintenance study to determine whether sucralfate 1 g twice daily prevents recurrence of duodenal ulceration. Patients were assessed endoscopically at four, eight, and 12 months after healing or earlier if clinical relapse occurred. Of the original 59 patients, 53 showed healing with six weeks of therapy, and the remaining six patients required 10 weeks of treatment. Nine patients were subsequently lost to follow-up because of non-compliance, leaving 50 patients for the analysis, 24 who received sucralfate and 26 who received placebo. There were 10 ulcer recurrences in the sucralfate group and the ulcers in 14 (58 percent) patients remaining healed at the end of 12 months. In contrast, there were 21 recurrences in the placebo group with the ulcers in five patients (19 percent) remaining healed at 12 months. Patients who received placebo experienced recurrence more quickly than those who received sucralfate and there was no difference between the two groups in terms of symptomatic and asymptomatic recurrence. There was no alteration in serum aluminium and phosphate levels throughout the study. Smoking seemed to have no adverse effect on recurrence once initial healing had been achieved. Sucralfate is, therefore, an effective and safe maintenance treatment for duodenal ulcer disease.
Bolin
T D
TD
University of New South Wales, Gastrointestinal Unit, Prince of Wales Hospital, Sydney, Australia.
Davis
A E
AE
Duncombe
V M
VM
Billington
B
B
D000535:Aluminum / Q000097:blood; D004341:Drug Evaluation; D004381:Duodenal Ulcer / Q000097:blood / Q000473:pathology / Q000517:prevention & control*; D004384:Duodenoscopy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000097:blood; D011897:Random Allocation; D013392:Sucralfate / Q000008:administration & dosage / Q000627:therapeutic use*
D010710:Phosphates; D013392:Sucralfate; D000535:Aluminum