Clarithromycin vs. Gemifloxacin in Quadruple Therapy Regimens for Empiric Primary
Treatment of Helicobacter pylori Infection: A Randomized Clinical Trial.
Author(s): Masoodi M(1), Talebi-Taher M(2), Tabatabaie K(3), Khaleghi S(4), Faghihi AH(1),
Agah S(1), Asadi R(3).
Affiliation(s): Author information:
(1)Associate professor, Colorectal Research Center, Rasoul-e-Akram General
Hospital, Iran University of Medical Sciences, Tehran, Iran. (2)Associate
professor, Antimicrobial Resistance Research Center, Infectious Diseases
Department, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences,
Tehran, Iran. (3)Researcher, Rasoul-e-Akram General Hospital, Iran University of
Medical Sciences, Tehran, Iran. (4)Assistant professor, Colorectal Research
Center, Rasoul-e-Akram General Hospital, Iran University of Medical Sciences,
Tehran, Iran.
Publication date & source: 2015, Middle East J Dig Dis. , 7(2):88-93
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.
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