Sucralfate tablets 1 g twice a day for the prevention of duodenal ulcer recurrence.
Sucralfate 1 g twice daily was found to be significantly better than placebo for the prevention of duodenal ulcer recurrence. This was a double-blind, randomized, placebo-controlled, parallel groups study. A total of 254 patients with a history of two or more duodenal ulcers, the most recent event diagnosed within three months of study entry, were entered into the trial after healing was documented. Patients received sucralfate 1 g twice daily or placebo for four months, or until recurrence. Endoscopies and symptom assessments were scheduled monthly and at investigator discretion upon symptom development. Treatment groups were comparable with regard to number of patients, age, sex, smoking status, and ulcer history. Traditional ulcer prevalence and point prevalence analyses were performed. Traditional ulcer prevalence included all ulcers found at scheduled visits and interim recurrences. Point prevalence included only ulcers found at scheduled visits. In the traditional analysis, sucralfate was significantly better than placebo in reducing ulcer recurrence for all months of the study. The life table estimate of the cumulative percent with ulcer at four months was 42 percent for the sucralfate group and 63 percent for the placebo group (p = 0.002). At four months, there were 49 recurrences among 122 patients in the sucralfate group and 71 among 117 patients for the placebo group. In the point prevalence analysis, sucralfate was significantly better than placebo in reducing ulcer recurrence at Months 2 through 4. The life table estimate of the cumulative percent with ulcer at four months was 36 percent for the sucralfate group and 55 percent for the placebo group (p = 0.005). At four months, there were 38 recurrences among 114 patients in the sucralfate group and 54 among 104 patients for the placebo group. Both analyses demonstrated that sucralfate 1 g twice daily was significantly better than placebo for the prevention of duodenal ulcer recurrence. Symptom development was associated with recurrence in both treatment groups. Smoking was associated with a greater tendency to recur in placebo-treated patients only.
Bynum
T E
TE
Department of Medicine, Harvard Medical School, Boston, Massachusetts.
Koch
G G
GG
D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004381:Duodenal Ulcer / Q000473:pathology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011897:Random Allocation; D012008:Recurrence; D013392:Sucralfate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D013392:Sucralfate