Sucralfate and ranitidine in the treatment of acute duodenal ulcer. Healing and relapse. Ulcer Study Group.

Healing and relapse of acute duodenal ulcer were investigated in an endoscopically controlled multicenter study using a double-blind design. Patients with acute uncomplicated duodenal ulcer were randomly assigned to treatment with sucralfate (1 g four times per day) or ranitidine (150 mg twice per day) for four to eight weeks. After healing, all anti-ulcer treatment was discontinued except for low-dose antacids needed for occasional upper abdominal pain, and the patients were observed for up to one year. Endoscopy was repeated after one year or at any time earlier if symptoms suggested ulcer relapse. Of the 83 patients who entered the study, 75 (sucralfate 40, ranitidine 35) underwent endoscopy after four weeks and could be fully evaluated. Healing rates after four and eight weeks were similar in the two groups (four- and eight-week healing rates after sucralfate and ranitidine: 78 and 74 percent, and 95 and 94 percent, respectively). Fifty-three patients with healed ulcers (sucralfate 29, ranitidine 24) were observed for up to one year. Duodenal ulcers occurred somewhat later after sucralfate than after ranitidine treatment, but life table analysis showed no significant difference. Thus, this study confirms a similar efficacy of sucralfate and ranitidine in healing of duodenal ulcer. A tendency to delayed relapse early after discontinuation of sucralfate failed to reach statistical significance.

RCT Entities:   Population Interventions Outcomes