Famotidine versus omeprazole in combination with clarithromycin and metronidazole for eradication of Helicobacter pylori--a randomized, controlled trial.
BACKGROUND
One-week low-dose triple therapy is currently considered the gold standard regimen for treatment of Helicobacter pylori infection. However, the mechanisms involved in the synergy between antibiotics and proton pump inhibitors are controversial.


OBJECTIVE
To test the hypothesis that acid suppression represents the crucial mechanism by which the antibacterial activity of antibiotics can be enhanced, and to assess the impact of primary resistance on treatment outcome.


METHODS
One hundred and twenty patients with H. pylori infection and duodenal ulcer, gastric ulcer or non-ulcer dyspepsia were randomly assigned to a 1 week course of either famotidine 80 mg b.d., clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. (FCM group; n = 60) or omeprazole 20 mg o.d., clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. (OCM group; n = 60). Gastroscopy was performed at baseline and 5 weeks after completion of treatment. H. pylori status was assessed by biopsy urease test, histology and culture.


RESULTS
In the intention-to-treat analysis, eradication of H. pylori was achieved in 47 of 60 patients (78%; 95% CI: 66-88%) in the FCM group, compared to 44 of 60 patients (73%; 95% CI: 60-84%) in the OCM group (N.S.). Using per protocol analysis, eradication therapy was successful in 47 of 52 patients (90%; 95% CI: 79-97%) treated with FCM and 44 of 57 patients (77%; 95% CI: 64-87%) treated with OCM (N.S.). Primary metronidazole resistance was present in 27% and primary clarithromycin resistance in 8% of strains. Overall per protocol eradication rates in strains susceptible to both antibiotics and strains with isolated metronidazole resistance were 93% and 84%, respectively. No patient with clarithromycin resistance responded to treatment.


CONCLUSIONS
High-dose famotidine and omeprazole, combined with clarithromycin and metronidazole, are equally effective for eradication of H. pylori. In 1-week low-dose triple therapy, metronidazole resistance has no major impact on eradication rates whereas clarithromycin resistance is associated with a poor treatment outcome.
Gschwantler
M
M
The 4th Department of Internal Medicine, KA Rudolfstiftung, Vienna, Austria. Michael.Gschwantler@kar.magwien.gv.at
Dragosics
B
B
Schütze
K
K
Wurzer
H
H
Hirschl
A M
AM
Pasching
E
E
Wimmer
M
M
Klimpfinger
M
M
Oberhuber
G
G
Brandstätter
G
G
Hentschel
E
E
Weiss
W
W
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004352:Drug Resistance, Microbial; D015738:Famotidine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use*; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000188:drug therapy / Q000382:microbiology
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D004338:Drug Combinations; D008795:Metronidazole; D015738:Famotidine; D017291:Clarithromycin; D009853:Omeprazole