Omeprazole, amoxycillin and metronidazole for the cure of Helicobacter pylori infection.
OBJECTIVE
In two studies, different regimens of omeprazole-amoxycillin-metronidazole were assessed for the eradication of Helicobacter pylori.


METHODS
Randomized, international, multicentre studies with parallel groups.


METHODS
The studies were performed at centres in Canada, Czech Republic, France, Germany, Hungary, Sweden and UK.


METHODS
H. pylori-positive patients with duodenal ulcer disease (active or in remission) were randomized to 7-day treatment with: omeprazole 40 mg once daily, amoxycillin 500 mg three times daily and metronidazole 400 mg three times daily (OAMtid; n = 242); omeprazole 20 mg twice daily, amoxycillin 1000 mg twice daily and metronidazole 800 mg twice daily (OAM800; n = 247); or omeprazole 20 mg twice daily, amoxycillin 1000 mg twice daily and metronidazole 400 mg twice daily (OAM400; n = 127).


METHODS
Eradication of H. pylori.


RESULTS
Intention-to-treat analysis revealed H. pylori eradication rates of 76% (184/242) with OAMtid, 80% (198/247) with OAM800, and 76% (97/127) with OAM400. There was considerable variation in the levels of primary resistance to metronidazole in different countries. The overall eradication rate in patients infected with metronidazole-sensitive H. pylori strains was 85% (313/370), compared with 60% (56/94) in patients harbouring metronidazole-resistant strains (P<0.001). All regimens were generally well tolerated, with mild adverse events occurring in 4-26% of patients (mainly diarrhoea, reversible increase in liver enzymes and headache).


CONCLUSIONS
The OAM combination is effective in curing H. pylori infection. Primary metronidazole resistance may reduce its effectiveness, but an increased daily dosing of metronidazole may partly overcome this problem.
Bayerdörffer
E
E
Medical Department I, Gastroenterology, University Hospital Carl Gustav Carus, Dresden, Germany. Bayerdorffer@t-online.de
Lind
T
T
Díte
P
P
Bardhan
K D
KD
O'Morain
C
C
Delchier
J C
JC
Spiller
R
R
Veldhuyzen van Zanten
S
S
Sipponen
P
P
Mégraud
F
F
Zeijlon
L
L
D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D010406:Penicillins / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D008795:Metronidazole; D000658:Amoxicillin; D009853:Omeprazole