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Low dose of clarithromycin in triple therapy for the eradication of Helicobacter pylori : One or two weeks?
Author(s) -
BO’ N DAL,
MARIO F DI,
BATTAGLIA G,
BUDA A,
LEANDRO G,
VIANELLO F,
KUSSTATSCHER S,
SALANDIN S,
PILOTTO A,
CASSARO M,
RUGGE M
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.1440-1746.1998.01557.x
Subject(s) - clarithromycin , omeprazole , metronidazole , medicine , helicobacter pylori , gastroenterology , group b , antibacterial agent , randomization , antibiotics , randomized controlled trial , microbiology and biotechnology , biology
The aims of this pilot study were: (i) to compare the efcacy of low‐dose clarithromycin (250 mg twice daily) for 1 or 2 weeks; and (ii) to evaluate possible therapeutic advantages in associating the low‐dose clarithromycin with an anti‐secretory agent or tripotassium dicitrate bismuthate (De Nol; Yamanouchi Pharm, Corugate Milano, Italy). A prospective, randomized, open trial was carried out on consecutive outpatients with dyspeptic symptoms and Helicobacter pylori infection. We enrolled 129 patients in one of the following schedules: (A) De Nol 120 mg q.i.d., clarithromycin 250 mg b.i.d. and metronidazole 250 mg q.i.d. for 2 weeks; (B) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d. and metronidazole 250 mg q.i.d. for 2 weeks; or (C) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d. and metronidazole 250 mg q.i.d. for 1 week. Results were evaluated by Per Protocol (PP) and Intention‐To‐Treat analysis (ITT). Eradication rate was 100% after treatment A, 92.6% after treatment B and 86.5% after treatment C by PP and 83.3, 75.7, and 68.1%, respectively by ITT. Side effects were reported by 16 subjects: 26.6% in group A; 9.1% in group B; and 7.5% in group C; in two cases side effects led to the withdrawal of the treatment. In conclusion, 500 mg clarithromycin per day in association with omeprazole and metronidazole, for 1 week gave comparable results to the same schedule for a 2 week period. The use of clarithromycin with bismuth and metronidazole produced a therapeutic gain compared with both of the anti‐secretory schedules, although this was not statistically signicant.