OBJECTIVE: We conducted this study to test whether eradication of Helicobac
ter pylori (H. pylori) infection prevents hemorrhage related to duodenal ul
cer.
METHODS: Patients with H. pylori infection and endoscopically proven duoden
al ulcers without ulcer-related hemorrhage were enrolled into four randomiz
ed, double-blind, multicenter studies using the same study protocol. They w
ere treated with clarithromycin plus omeprazole (441 patients), omeprazole
alone (447 patients), or ranitidine alone (263 patients). Success of H. pyl
ori eradication was evaluated by the C-13-urea breath test 4-6 wk after the
last dose of study drug. Follow-up continued at monthly intervals up to 1
yr after the last dose of study drug.
RESULTS: Bleeding due to duodenal ulcer was not observed in any patients wh
o received clarithromycin plus omeprazole, whereas five patients in the ome
prazole treatment group and six patients in the ranitidine treatment group
experienced an episode of ulcer-related hemorrhage during follow-up. All pa
tients who experienced ulcer-related bleeding were male. When compared by b
leeding, there were no significant differences with respect to ethnicity, a
lcohol consumption, or tobacco use. H. pylori infection was no longer detec
table in 68% of patients after treatment with clarithromycin plus omeprazol
e, compared with 5% after treatment with omeprazole alone or 4% after treat
ment with ranitidine alone.
CONCLUSION: In a population of duodenal ulcer patients without predisposing
risk factors for ulcer bleeding, antibiotic eradication or suppression of
H. pylori infection prevented the occurrence of ulcer-related hemorrhage fo
r up to yr after therapy. (C) 1999 by Am. Cell. of Gastroenterology.