title: Clarithromycin vs. Gemifloxacin in Quadruple Therapy Regimens for Empiric Primary Treatment of Helicobacter pylori Infection: A Randomized Clinical Trial.
abstract: BACKGROUND Eradication of Helicobacter pylori infection plays a crucial role in the treatment of peptic ulcer. Clarithromycin resistance is a major cause of treatment failure. This randomized clinical trial aimed at evaluating the efficacy of a clarithromycin versus gemifloxacin containing quadruple therapy regimen in eradication of H.pylori infection. METHODS In this randomized double blind clinical trial (RCT 2012102011054N2), a total of 120 patients were randomized to two groups of 60 patients each. Patients with proven H.pylori infection were consecutively assigned into two groups to receive OBAG or OBAC in gastroenterology clinic in Rasoul-e- Akram General Hospital in Tehran, Iran. The patients in the OBAG group received omeprazole (20 mg) twice daily, bismuth subcitrate (240 mg) twice daily, amoxicillin (1 gr) twice daily, and gemifloxacin (320 mg) once daily, and those in the OBAC group received omeprazole (20 mg) twice daily, 240 mg of bismuth subcitrate twice daily, amoxicillin (1 gr) twice daily, and clarithromycin (500 mg) twice daily for 10 days. RESULTS Five patients from each group were excluded from the study because of poor compliance, so 110 patients completed the study. The intention-to-treat eradication rate was 61.6% and 66.6% for the OBAC and OBAG groups, respectively. According to the per protocol analysis, the success rates of eradication of H.pylori infection were 67.2% and 72.7% for OBAC and OBAG groups, respectively (p=0.568). CONCLUSION The results of this study suggest that gemifloxacin containing regimen is at least as effective as clarithromycin regimen; hence, this new treatment could be considered as an alternative for the patients who cannot tolerate clarithromycin.
authors.affiliation: Associate professor, Colorectal Research Center, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Mohsen
authors.initials: M
authors.lastname: Masoodi
authors.affiliation: Associate professor, Antimicrobial Resistance Research Center, Infectious Diseases Department, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Mahshid
authors.initials: M
authors.lastname: Talebi-Taher
authors.affiliation: Researcher, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Khadijeh
authors.initials: K
authors.lastname: Tabatabaie
authors.affiliation: Assistant professor, Colorectal Research Center, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Siamak
authors.initials: S
authors.lastname: Khaleghi
authors.affiliation: Associate professor, Colorectal Research Center, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Amir-Hossein
authors.initials: AH
authors.lastname: Faghihi
authors.affiliation: Associate professor, Colorectal Research Center, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Shahram
authors.initials: S
authors.lastname: Agah
authors.affiliation: Researcher, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Reyhaneh
authors.initials: R
authors.lastname: Asadi
keywords: Clarithromycin; Gemifloxacin; H.pylori; Iran