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A United States multicentre trial of dual and proton pump inhibitor‐based triple therapies for Helicobacter pylori
Author(s) -
LAINE L.,
FRANTZ J. E.,
BAKER A.,
NEIL G. A.
Publication year - 1997
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1997.00230.x
Subject(s) - medicine , omeprazole , helicobacter pylori , proton pump inhibitor , clarithromycin , gastroenterology , metronidazole , discontinuation , group b , amoxicillin , breath test , urea breath test , antibiotics , helicobacter pylori infection , microbiology and biotechnology , biology
Background: One‐week proton pump inhibitor‐based triple therapies are very popular in the US despite limited US data documenting efficacy. We assessed 1‐week proton pump inhibitor triple therapies for Helicobacter pylori , and compared them to dual antibiotic therapies (to assess benefit of omeprazole) and to omeprazole–amoxycillin (to assess benefit of clarithro‐ mycin) in a large, randomized, US multicentre study. Methods: Healthy subjects who were H. pylori ‐positive by rapid serological test and 13 C‐urea breath test were randomly assigned to (i) omeprazole (O) 20 mg b.d. + amoxycillin (A) 1 g t.d.s. for 14 days (OA); (ii) A 1 g b.d. + clarithromycin (C) 500 mg b.d. for 7 days (AC); (iii) C 250 mg b.d. + metronidazole (M) 500 mg b.d. for 7 days (CM); (iv) O 20 mg b.d. + C 250 mg b.d. + M 500 mg b.d. for 7 days (MOC); or (v) O 20 mg b.d. + C 500 mg b.d. + A 1 g b.d. for 7 days (OAC). Repeat breath tests were done at 6 weeks to assess H. pylori status. Results: Three hundred and two H. pylori ‐positive subjects at 25 centres received medication. Intention‐to‐treat cure rate was significantly higher for OAC (82%) than for MOC (67%), CM (59%), AC (18%) or OA (58%). Per‐protocol cure rates were 85% for OAC and 75% for MOC. Discontinuation of therapy due to a side‐effect occurred in 0–3% of each study group. Conclusions: One‐week twice‐daily triple therapy with omeprazole, amoxycillin and clarithromycin provides the best rate of eradication of the five regimens studied. However, treatment in the US for 7 days may be unable to achieve eradication rates of ≥ 90% with proton pump inhibitor‐based triple therapy.