Efficacy of sucralfate in treatment of non-ulcer dyspepsia. A double-blind placebo-controlled study.

The object of this study was to assess the efficacy of sucralfate in the treatment of non-ulcer dyspepsia (NUD). The diagnosis of NUD was made by exclusion. All patients underwent an upper gastrointestinal endoscopy and abdominal ultrasound, and blood tests were done as clinically indicated. Patients with a history of peptic ulcer disease were not included. Symptomatic assessment was made at the beginning and at the end of the study. The patients registered their most prominent dyspeptic symptoms and whether they improved, were unchanged, or worsened. The study was double-blind. Placebo or 1 g sucralfate four times daily was given for 3 weeks. Over a 2-year period 104 patients were included in the study; 56 received sucralfate and 48 placebo. Nine patients were excluded because of poor compliance or side effects, six from the sucralfate group and three from the placebo group. The sucralfate and placebo groups were comparable with regard to symptom and clinical variables. Global assessment of symptoms showed that in the sucralfate group 34 improved (68%), 11 were unchanged, and 5 were worse. In the placebo group 31 improved (69%), 11 were unchanged, and 3 were worse. There was no statistically significant difference between the groups. The 3-week course of sucralfate in patients with NUD did not show symptomatic improvement over placebo.

RCT Entities:   Population Interventions Outcomes