Sucralfate in Duodenal Ulcer Disease: A Double-Blind Trial

Abstract

Seventy-five patients with endoscopically confirmed duodenal ulcer disease received either sucralfate (34 patients) or placebo (41 patients) for 6 weeks in a double-blind clinical trial. Nineteen males and 15 females received sucralfate, and 29 males and 12 females received placebo. At 6 weeks significantly more complete ulcer healing had occurred in patients receiving sucralfate (82.4%) compared with those receiving placebo (24.4%). The sucralfate group had a significant reduction in their symptoms after 1 week of the drug intake, compared to the placebo group in which the reduction did not reach significance. Constipation, nausea, dry mouth, and skin rash occurred more in patients taking sucralfate compared to the placebo group; in one patient constipation was severe enough to stop the medicine and drop out of the trial. Systemic aluminum toxicity, hypophosphatemia, and diarrhea were not reported in any patient in the sucralfate group. MM Shennak, TM Al-Sheikh, MT Abu-Rajab, Sucralfate in Duodenal Ulcer Disease: A Double-Blind Trial. 1988; 8(6): 443-447 MeSH KEYWORDS: Sucralfate; Duodenal ulcer Sucralfate is the basic aluminum salt of sucrose substituted with eight sulfate groups.1 The sucrose part of the molecule binds to the defective mucosa and forms a protective barrier at the ulcer site.2-4 Sucralfate appears to have six to seven times greater affinity for the ulcer crater than for normal mucosa.5-8 Possible mechanisms of action of sucralfate at the ulcer site include protection of the ulcer from acid, reduction of peptic activity, and absorption of bile acids. 4,9-14 Sucralfate is poorly absorbed from the gastrointestinal tract. 9,15,16 Subjects and MethodsStudy tablets containing either sucralfate or placebo were packaged by the manufacturer in numerically labeled containers. The sucralfate tablets contained 1000 mg of the active agent. The placebo tablets contained only inert ingredients consisting of cornstarch, magnesium stearate, and microcrystalline cellulose. The identity of the study medications was unknown to the investigators, their staffs, and the patients. The patients received no other medications and were asked not to take any other antiulcer medicine.Ninety-six patients with active duodenal ulcer disease confirmed by endoscopy participated in the study. Mean age in the sucralfate patient group was 39.32 ± 12.43 years and in the placebo patients was 39.24 ± 12.91 years. The youngest patient was 18 years old, and the oldest 70 years. They were examined and evaluated within 24 hours of ulcer detection, informed of the plan and purpose of the study, and asked to participate. The evaluation consisted of a complete medical history, physical examination, and laboratory studies including complete relevant blood, stool,