Omeprazole once or twice daily with clarithromycin and metronidazole for Helicobacter pylori eradication in a Canadian community practice

BACKGROUND: Triple therapy for one week with omeprazole, clarithromycin ant i metronidazole (OCM) is accepted worldwide as a first line therapy for Hel icobacter pylori eradication. It is unclear whether omeprazole needs to be given once or twice daily. OBJECTIVES: To assess the efficacy and safety of these regimens in a single centre, Canadian practice. METHODS: Histologically proven H pylori-positive patients were treated for seven days with clarithromycin 250 mg bid and metronidazole 500 mg bid, and randomly allocated to omeprazole 20 mg either once or twice daily in this open, cohort study. Endoscopy with histology (two antrum and two body biops ies, Giemsa stain) was done four weeks or longer after the pills were compl eted to assess H pylori eradication. RESULTS: Whether omeprazole was given once or twice daily, eradication was high and the same in both arms. All-patients-treated eradication was 85% (3 9 of 46 in the omeprazole once daily group and 41 of 48 in the omeprazole t wice daily group) and intent-to-treat eradication was 80% (39 of 49 in the omeprazole once daily group and 41 of 51 in the omeprazole twice daily grou p). Side effects were frequently seen, suffered by 65% to 69% of patients t reated. However, these were mild and compliance was high, with 94% of patie nts taking all of their Fills. Mild side effects included loose stools, tas te disturbance, nausea, headache and upper or lower gastrointestinal gas. O nly one patient (1%) from the omeprazole once daily arm stopped taking metr onidazole due to excessive perspiring. CONCLUSIONS: In this community practice, OCM triple therapy was effective w hether omeprazole was given once or twice daily. For those with financial c onstraint, omeprazole 20 mg once daily can be considered. The regimens were well tolerated without serious adverse events.