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 gr
ade 1 and 2 were initially healed with antiscretory therapy before ent
ering the study, They were randomly allocated to sucralfate suspension
2 g BID or placebo for 6 months, Symptoms were monitored monthly, End
oscopy was performed at the end of the trial or earlier in case of cli
nical suspension of relapse, Results: The two treatment groups mere we
ll matched, We were able to analyze 88 sucralfate- and 93 placebo-trea
ted patients, There was a significant reduction in the endoscopic rela
pse rate (31% in the sucralfate group vs, 65% in the placebo group, p
< 0.001), This reduction was especially obvious for symptomatic relaps
es (10% vs, 34%, respectively,p < 0.001), Conclusion: This is the firs
t study to show that sucralfate suspension is capable of preventing re
current reflux esophagitis in patients with solitary or confluent eros
ions previously healed with antisecretory therapy.