Alimentary pharmacology & therapeutics · 1996
Sucralfate gel versus placebo in patients with non-erosive gastro-oesophageal reflux disease.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Simon B, Ravelli G P, Goffin H
Аннотация
BACKGROUND: Gastro-oesophageal reflux disease, a term used to refer to chest symptoms that result from reflux of gastric acid into the oesophagus, occur at least daily in 7% and every 3 days in 33% of the population.
METHODS: One hundred and forty-one patients with moderate to severe gastro-oesophageal reflux symptoms occurring at least three times per week (but no oesophageal erosions or ulcers at endoscopy) were treated in this randomized, double-blind, placebo-controlled study at six trial centres. Treatment was given for 6 weeks and consisted of daily doses of either 1 g sucralfate gel b.d. or placebo. The evaluation of efficacy was based on data of 139 patients.
RESULTS: The responder rate 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 dyspepsia and gastro-oesophageal reflux disease symptoms was better for sucralfate gel than for placebo with 45% of patients treated with sucralfate 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 by 10% of sucralfate patients and 7% of placebo patients.
CONCLUSION: In this trial, we demonstrated a statistically significant superiority of sucralfate gel at a dosage of 1 g b.d. compared to placebo in the treatment of patients with gastro-oesophageal reflux disease. Sucralfate gel was well tolerated.
METHODS: One hundred and forty-one patients with moderate to severe gastro-oesophageal reflux symptoms occurring at least three times per week (but no oesophageal erosions or ulcers at endoscopy) were treated in this randomized, double-blind, placebo-controlled study at six trial centres. Treatment was given for 6 weeks and consisted of daily doses of either 1 g sucralfate gel b.d. or placebo. The evaluation of efficacy was based on data of 139 patients.
RESULTS: The responder rate 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 dyspepsia and gastro-oesophageal reflux disease symptoms was better for sucralfate gel than for placebo with 45% of patients treated with sucralfate 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 by 10% of sucralfate patients and 7% of placebo patients.
CONCLUSION: In this trial, we demonstrated a statistically significant superiority of sucralfate gel at a dosage of 1 g b.d. compared to placebo in the treatment of patients with gastro-oesophageal reflux disease. Sucralfate gel was well tolerated.