SUCRALFATE GEL VERSUS PLACEBO IN PATIENTS WITH NONEROSIVE GASTROESOPHAGEAL REFLUX DISEASE

Background: Gastro-oesophageal reflux disease, a term used to refer to chest symptoms that result from reflux of gastric acid into the oesop hagus, occur at least daily in 7% and every 3 days in 33% of the popul ation. Methods: One hundred and forty-one patients with moderate to se vere gastro-oesophageal reflux symptoms occurring at least three times per week (but no oesophageal erosions or ulcers at endoscopy) were tr eated in this randomized, double-blind, placebo-controlled study at si x trial centres. Treatment was given for 6 weeks and consisted of dail y doses of either 1 g sucralfate gel b.d. or placebo. The evaluation o f efficacy was based on data of 139 patients. Results: The responder r ate at Day 42 was statistically significantly higher for the patients treated with sucralfate (71%) than for the placebo patients (29%) (P < 0.0001, Fisher's exact test). The overall response of the non-ulcer d yspepsia and gastro-oesophageal reflux disease symptoms was better for sucralfate gel than for placebo with 45% of patients treated with suc ralfate gel being considered as having a 'good' or 'excellent' overall response compared with 22% of the patients who received placebo (P < 0.0001, Wilcoxon test). Only a few adverse experiences were reported b y 10% of sucralfate patients and 7% of placebo patients. Conclusion: I n this trial, we demonstrated a statistically significant superiority of sucralfate gel at a dosage of 1 g b.d. compared to placebo in the t reatment of patients with gastro-oesophageal reflux disease. Sucralfat e gel was well tolerated.