Sucralfate suspension 1 g four times per day in the short-term treatment of active duodenal ulcer

Abstract

Sucralfate suspension 1 g/10 ml four times per day was found to be significantly better than placebo for the healing of active duodenal ulcer. An eight-week, double-blind, randomized, placebo-controlled, parallel-group multicenter study was conducted. A total of 292 patients were evaluated. Ulcer healing was evaluated by endoscopy and symptom assessment occurred at baseline and at two, four, and eight weeks, or upon symptom worsening as determined by the investigator. Healing was defined as complete re-epithelialization of the crater, without residual erosion. Patients completed eight weeks of treatment regardless of whether or not they were healed at two or four weeks. Treatment groups were comparable with regard to age, sex, ulcer history, cigarette smoking, alcohol and caffeine consumption, ulcer size, and ulcer symptoms. Analysis of procedurally correct cases demonstrated that sucralfate suspension was significantly more effective in healing duodenal ulcers than placebo at two, four, and eight weeks. Ulcer-healing rates efficacy analysis are as follows. At two weeks, the healing rate of sucralfate suspension was 22 of 125 patients (18 percent) and the healing rate of placebo suspension was eight of 130 patients (6 percent; p = 0.006). At four weeks, 58 of 114 patients (51 percent) for sucralfate and 38 of 112 patients (34 percent) for placebo (p = 0.011) were healed. At eight weeks, 80 of 105 (76 percent) for sucralfate and 53 of 100 (53 percent) for placebo (p = 0.001) were healed. Sucralfate-treated patients experienced significantly greater reductions in both daytime and nighttime pain scores at two weeks. A significant difference between treatment groups was also found for daytime symptoms at four weeks. At four and eight weeks, patients who smoked cigarettes had significantly lower healing rates than those who did not, regardless of treatment group. Sucralfate suspension was found to be effective for the treatment of active duodenal ulcer.