Levofloxacin- versus metronidazole-based rescue therapy for H. pylori infection in Japan.
BACKGROUND
The ideal second-line treatment regimens for Helicobacter pylori infection may differ between the areas, countries and races.


OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
Metronidazole-based triple therapy is recommended as second-line therapy in Japan, and levofloxacin-based therapy can be an alternative treatment option.
Matsumoto
Y
Y
Division of Diabetes, Digestive and Kidney Diseases, Department of Clinical Molecular Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
Miki
I
I
Aoyama
N
N
Shirasaka
D
D
Watanabe
Y
Y
Morita
Y
Y
Toyoda
M
M
Mitani
T
T
Miyachi
H
H
Tamura
T
T
Kasuga
M
M
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D007564:Japan; D064704:Levofloxacin; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D011446:Prospective Studies
D000900:Anti-Bacterial Agents; D008795:Metronidazole; D064704:Levofloxacin; D015242:Ofloxacin