A randomized trial comparing seven-day ranitidine bismuth citrate and clarithromycin dual therapy to seven-day omeprazole, clarithromycin and amoxicillin triple therapy for the eradication of Helicobacter pylori.
OBJECTIVE
To assess Helicobacter pylori eradication after one week dual ranitidine bismuth citrate-clarithromycin (RBC-C) or triple omeprazole, clarithromycin and amoxicillin (OCA) therapy.


METHODS
In this multicentre Canadian trial, H pylori-positive patients with functional dyspepsia or inactive peptic ulcer disease were randomized to open-label treatment with RBC-C (ranitidine bismuth citrate 400 mg plus clarithromycin 500 mg) or OCA (omezaprole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg), given twice a day for seven days. Treatment allocation was randomly assigned. H pylori infection was confirmed by positive 13C-urea breath test (13C-UBT). H pylori status was reassessed by UBT at least four and 12 weeks after treatment (negative: d13CO2 below 3.5 per mil). Intention-to-treat (ITT) eradication rates were determined for all patients with confirmed H pylori infection. Per protocol (PP) rate was determined for all patients treated with at least two evaluable follow-up visits.


RESULTS
Three hundred five patients were included in the ITT and 222 in the PP analysis. The ITT eradication rates were 66% for RBC-C and 78% for OCA. The PP success rates were 84% for RBC-C and 96% for OCA. The difference for both ITT 12% (95% CI 2 to 22) and PP 12% (95% CI 4 to 19) were statistically significant, P=0.030 and P=0.007, respectively. Treatment was generally well tolerated.


CONCLUSIONS
The eradication rate for the seven-day dual RBC-C regimen was lower than that for OCA.
Veldhuyzen van Zanten
Sander
S
Dalhousie University, Department of Medicine, Halifax, Nova Scotia, Canada. Zanten@dal.ca
Chiba
Naoki
N
Barkun
Alan
A
Fallone
Carlo
C
Farley
Alain
A
Cockeram
Alan
A
Dallaire
Chrystian
C
Simms
Lorinda
L
Nicholls
Barbara
B
D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D017060:Patient Satisfaction; D011899:Ranitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D014508:Urea / Q000032:analysis
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D014508:Urea; D017291:Clarithromycin; D009853:Omeprazole; D001729:Bismuth