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A prospective randomized study of amoxycillin and omeprazole with and without metronidazole in the eradication treatment of Helicobacter pylori
Author(s) -
KOIZUMI WASABURO,
TANABE SATOSHI,
HIBI KENICHI,
IMAIZUMI HIROSHI,
OHIDA MASAHITO,
OKABE HARUYA,
SAIGENJI KATSUNORI,
OKAYASU ISAO
Publication year - 1998
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.1998.01559.x
Subject(s) - medicine , omeprazole , metronidazole , helicobacter pylori , regimen , gastroenterology , amoxicillin , rash , abdominal pain , surgery , antibiotics , microbiology and biotechnology , biology
A combination of amoxycillin and omeprazole is often used to treat Helicobacter pylori infection. A three‐drug regimen comprising metronidazole, amoxycillin and omeprazole has been proposed as an alternative therapy. In a prospective, randomized, comparative study, we evaluated these two regimens with respect to safety and efcacy in patients with H. pylori infection. Sixty patients with peptic ulcer (gastric, 32 patients; duodenal, 28 patients) who had a history of ulcer recurrence were randomly assigned to dual therapy with amoxycillin (500 mg three times daily for 2 weeks) and omeprazole (20 mg once daily for 8 weeks) or to triple therapy with metronidazole (500 mg twice daily for 2 weeks) plus amoxycillin and omeprazole, given in the same dosages as dual therapy. Forty‐eight patients completed the protocol; treatment was discontinued because of side effects in nine patients, and three patients dropped out of the study. On the basis of all patients treated, the rate of H. pylori eradication was signicantly higher for triple therapy 20/23 cases, 87.0%; 95% condence interval (CI), 0.664–0.972) than for dual therapy 13/25, 52.0%; 0.313–0.722; P < 0.05). On an intention‐to‐treat basis, the difference between the groups in the rate of H. pylori eradication was marginally signicant ( P = 0.06 [0.028–0.512]). Side effects were reported by ve patients receiving triple therapy (skin rash, one; nausea, two; headache, one; abdominal pain, one), and four patients receiving dual therapy (skin rash, two; abdominal pain, one; diarrhoea, one). All side effects resolved spontaneously after termination of treatment. There was no signicant difference in safety between the two regimens. Triple therapy with metronidazole, amoxycillin, and omeprazole was signicantly more effective for the eradication of H. pylori than dual therapy with amoxycillin and omeprazole alone. The safety of these regimens was similar, and triple therapy was found to be clinically acceptable.