2-week triple therapy for Helicobacter pylori infection is better than 1-week in clinical practice: a large prospective single-center randomized study.
BACKGROUND
Proton pump inhibitor (PPI)-based triple therapies are considered the standard regimens for Helicobacter pylori eradication, but the optimal duration of these regimens is still controversial. The aim of this study was to compare the efficacy of 1-week versus 2-week triple therapies in H. pylori-positive patients.


METHODS
A total of 486 consecutive H. pylori-positive patients were randomized to receive omeprazole, 20 mg b.i.d., clarithromycin 500 mg b.i.d., and either amoxicillin 1 g b.i.d. or metronidazole 500 mg b.i.d. for 1 or 2 weeks. Upper gastrointestinal endoscopy and histology were performed at entry and 2 months after the end of therapy. H. pylori status was defined according to histology and urea breath test.


RESULTS
At intention-to-treat analysis, 2-week therapy with omeprazole, amoxicillin, and clarithromycin achieved a significantly higher eradication rate than 1- or 2-week regimens with metronidazole (70% versus 52%, p = .003, versus 56%, p < .01) and the same therapy for 1-week (70% versus 57%, p = .05). At per-protocol analysis, 2-week therapy with omeprazole, amoxicillin, and clarithromycin showed a significantly higher eradication rate than 1-week of amoxicillin and metronidazole (77% versus 62%; p = .03) but no difference with 1-week same regimen (66%) or 2-week metronidazole and clarithromycin regimen (72%). Compliance and tolerability were good for all regimens.


CONCLUSIONS
Two-week therapies, independently of antibiotic combination, lead to a significant increase of H. pylori eradication rate compared to 1-week therapies, with same compliance and tolerability, even if, taking account of low-eradication rates, one must question whether the triple therapy should still be used.
Paoluzi
Paolo
P
Gastroenterology Unit, Department of Clinical Sciences, University of Rome La Sapienza, Rome, Italy. paolo.paoluzi@uniroma1.it
Iacopini
Federico
F
Crispino
Pietro
P
Nardi
Francesco
F
Bella
Antonino
A
Rivera
Margherita
M
Rossi
Pina
P
Gurnari
Maurizio
M
Caracciolo
Francesco
F
Zippi
Maddalena
M
Pica
Roberta
R
D000284:Administration, Oral; D000658:Amoxicillin / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D007558:Italy; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors; D017494:Proton Pumps / Q000627:therapeutic use*
D000890:Anti-Infective Agents; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D017494:Proton Pumps; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole