BACKGROUND: The ideal second-line treatment regimens for Helicobacter pylori infection may differ between the areas, countries and races. AIM: The aim was to confirm which was the better regimen for second-line therapy after treatment failure with a standard triple therapy in Japan, a high dosage of levofloxacin- or metronidazole-based therapy. PATIENTS: Sixty outpatients with persistent H. pylori infection after a standard triple therapy were enrolled in this prospective, open-label and randomised trial. METHODS: The subjects were randomly administered levofloxacin (300 mg b.d.)- or metronidazole (500 mg b.d.)-based therapy with lansoprazole (30 mg b.d.) and amoxicillin (1000 mg b.d.) for 7 days, and the cure rates and side effects were analysed. Antimicrobial susceptibility was also examined before second-line therapy using the E-test. RESULTS: Good compliance was obtained without severe side effects in both the groups except for two patients. The cure rates, expressed as intention-to-treat and per-protocol analyses, respectively, were 70.0 and 72.4% in the levofloxacin group, and 96.7 and 100% in the metronidazole group. Each regimen often overcame even clarithromycin-resistant strains. CONCLUSION:Metronidazole-based triple therapy is recommended as second-line therapy in Japan, and levofloxacin-based therapy can be an alternative treatment option.
RCT Entities:
BACKGROUND: The ideal second-line treatment regimens for Helicobacter pyloriinfection may differ between the areas, countries and races. AIM: The aim was to confirm which was the better regimen for second-line therapy after treatment failure with a standard triple therapy in Japan, a high dosage of levofloxacin- or metronidazole-based therapy. PATIENTS: Sixty outpatients with persistent H. pylori infection after a standard triple therapy were enrolled in this prospective, open-label and randomised trial. METHODS: The subjects were randomly administered levofloxacin (300 mg b.d.)- or metronidazole (500 mg b.d.)-based therapy with lansoprazole (30 mg b.d.) and amoxicillin (1000 mg b.d.) for 7 days, and the cure rates and side effects were analysed. Antimicrobial susceptibility was also examined before second-line therapy using the E-test. RESULTS: Good compliance was obtained without severe side effects in both the groups except for two patients. The cure rates, expressed as intention-to-treat and per-protocol analyses, respectively, were 70.0 and 72.4% in the levofloxacin group, and 96.7 and 100% in the metronidazole group. Each regimen often overcame even clarithromycin-resistant strains. CONCLUSION:Metronidazole-based triple therapy is recommended as second-line therapy in Japan, and levofloxacin-based therapy can be an alternative treatment option.
Authors: Javier P Gisbert; Jesús Barrio; Inés Modolell; Javier Molina-Infante; Angeles Perez Aisa; Manuel Castro-Fernández; Luis Rodrigo; Angel Cosme; Jose Luis Gisbert; Miguel Fernández-Bermejo; Santiago Marcos; Alicia C Marín; Adrián G McNicholl Journal: Dig Dis Sci Date: 2014-09-19 Impact factor: 3.199
Authors: Tran T Binh; Seiji Shiota; Lam T Nguyen; Dung D Q Ho; Hai H Hoang; Long Ta; Dung T Trinh; Toshio Fujioka; Yoshio Yamaoka Journal: J Clin Gastroenterol Date: 2013-03 Impact factor: 3.062