title: A Comparison between Hybrid and Concomitant Regimens forHelicobacter PyloriEradication: A Randomized Clinical Trial.
abstract: BACKGROUNDHelicobacter pylori (H. pylori)is one of the most common bacterial infections worldwide. We designed a study to compare the efficacy of 14-day hybrid regimen with 10-day concomitant therapy forH. pylorieradication in Iran. METHODS 252 patients with naïveH. pyloriinfection were randomly divided to receive either hybrid regimen (pantoprazole 40 mg, and amoxicillin 1 gr twice daily for 14 days, accompanied by clarithromycin 500 mg, and metronidazole 500 mg, twice daily just during the last 7 days) or concomitant regimen (pantoprazole 40 mg, amoxicillin 1 gr, clarithromycin 500 mg, and metronidazole 500 mg, all twice daily for 10 days). 8 weeks after therapy,14C- urease breath test was performed to confirm eradication. RESULTS According to intention to treat analysis, the eradication rates were 87.3% (95% CI: 81.4-93.1) and 80.9% (95% CI: 74-87.8) in hybrid and concomitant groups, respectively (p=0.38). Per-protocol eradication rates were 89.3% (95% CI: 83.8-94.7) and 83.1% (95% CI: 76.3-89.8), respectively (p=0.19). The rates of severe side effects were not statistically different between the two groups (4% vs. 8.7%). CONCLUSION 14-day hybrid therapy can be considered as a nearly acceptable regimen with few severe side effects in Iran. However, it seems that the efficacy of this therapy is decreasing as the resistance rates to antibiotics are increasing. We suggest further studies to assess the efficacy of a more prolonged concomitant therapy forH. pylorieradication in Iran.
authors.affiliation: Assistant Professor, Department of Gastroenterology, Golestan University of Medical Sciences, Gorgan, Iran.
authors.forename: Saman
authors.initials: S
authors.lastname: Alhooei
authors.affiliation: Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: Hafez
authors.initials: H
authors.lastname: Tirgar Fakheri
authors.affiliation: Associate Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: Vahid
authors.initials: V
authors.lastname: Hosseini
authors.affiliation: Associate Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: Iradj
authors.initials: I
authors.lastname: Maleki
authors.affiliation: Associate Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: Tarang
authors.initials: T
authors.lastname: Taghvaei
authors.affiliation: Assistant Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: Seyed Mohammad
authors.initials: SM
authors.lastname: Valizadeh
authors.affiliation: Fellow of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: Zohreh
authors.initials: Z
authors.lastname: Bari