Tytgat G N, Koelz H R, Vosmaer G D
Academisch Medisch Centrum, afd. Gastro-enterologie, Amsterdam.
Ned Tijdschr Geneeskd. 1995 Nov 25;139(47):2432-7.
To determine whether the recurrence of reflux oesophagitis can be prevented with sucralfate suspension 2 g daily.
Double-blind, placebo-controlled, multinational drug study.
Sixteen research centres in Switzerland, Germany and the Netherlands.
184 Patients whose earlier reflux oesophagitis Savary-Miller grades I and II were cured by an antisecretory therapy before being included in the study. For 6 months, they were given 2 g of a sucralfate suspension or a placebo twice daily, with random division. The symptoms were checked monthly. Endoscopy was performed at the end of the study or when there was a clinical suspicion of recurrence.
Eighty-eight patients of the sucralfate group and 93 of the placebo group could be evaluated. The proportion of endoscopical recurrence was significantly reduced (31 in the sucralfate group as against 55 in the placebo group; p < 0.001). This decrease was particularly clear where symptomatic recurrences were concerned (10 and 34%, respectively; p < 0.001).
This is the first trial that demonstrates that sucralfate suspension can prevent recurrences of reflux oesophagitis in patients with solitary or confluent erosions previously cured with an antisecretory therapy.
