Sucralfate maintenance therapy in reflux esophagitis. Sucralfate Investigational Working Team.

OBJECTIVE

to prove in a double-blind placebo-controlled multinational trial the effects of sucralfate suspension 2 g BID and placebo in the prevention of recurrent reflux esophagitis.

METHODS

One hundred and eighty-four patients from 16 centers with reflux esophagitis Savary grade 1 and 2 were initially healed with antisecretory therapy before entering the study. They were randomly allocated to sucralfate suspension 2 g BID or placebo for 6 months. Symptoms were monitored monthly. Endoscopy was performed at the end of the trial or earlier in case of clinical suspension of relapse.

RESULTS

The two treatment groups were well matched. We were able to analyze 88 sucralfate- and 93 placebo-treated patients. There was a significant reduction in the endoscopic relapse rate (31% in the sucralfate group vs. 65% in the placebo group, p < 0.001). This reduction was especially obvious for symptomatic relapses (10% vs. 34%, respectively, p < 0.001).

CONCLUSION

This is the first study to show that sucralfate suspension is capable of preventing recurrent reflux esophagitis in patients with solitary or confluent erosions previously healed with antisecretory therapy.