Ranitidine bismuth citrate with clarithromycin versus omeprazole with amoxycillin in the cure of Helicobacter pylori infection.
OBJECTIVE
To compare the efficacy of ranitidine bismuth citrate plus clarithromycin (RBC-C) vs. omeprazole plus amoxycillin (OME-AMO) in the cure of Helicobacter pylori infection.


METHODS
In this double-blind, multicentre, parallel-group study 122 H. pylori-positive patients with active duodenal ulcer or gastritis, with confirmed history of duodenal ulcer, were randomized to treatment with ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. or omeprazole 20 mg b.d. plus amoxycillin 1000 mg b.d. for 14 days, followed by 14 days of ranitidine bismuth citrate 400 mg b.d. or omeprazole 20 mg once daily, respectively, to facilitate ulcer healing. Endoscopy was carried out at the start of the study and 28 days after the end of treatment. At each endoscopy four biopsies were obtained from the antrum and four biopsies from the corpus, for rapid urease test, histology and culture. H. pylori infection was defined as a positive urease test, confirmed by histology or culture. Cure of H. pylori infection was defined as negative urease test, histology or culture from both sites.


RESULTS
Per-protocol, all-patients-treated and intention-to-treat cure rates (95% confidence interval) were, respectively, 90% (81-89%), 90% (82-89%) and 84% (74-93%) for ranitidine bismuth citrate plus clarithromycin, and 39% (27-54%), 44% (31-57%) and 41% (29-53%) for omeprazole plus amoxycillin, P < 0.00001. Both regimens were well tolerated. Eight patients were lost to follow-up, for lack of efficacy (one patient), adverse events (three patients) or refusal of second endoscopy (four patients).


CONCLUSIONS
Ranitidine bismuth citrate 400 mg b.d. with clarithromycin 500 mg b.d. is superior to omeprazole 20 mg b.d. with amoxycillin 1000 mg b.d. Ranitidine bismuth citrate with clarithromycin is the first dual therapy with high cure rates and good tolerance, and is easy to take. It may therefore prove a suitable first-line treatment in H. pylori infection.
Kolkman
J J
JJ
Medical Spectrum Twente, Enschede, The Netherlands.
Tan
T G
TG
Oudkerk Pool
M
M
Van Kleef
W A
WA
Geraedts
A A
AA
Timmerman
R J
RJ
Crobach
L F
LF
Nicolai
J J
JJ
Wolff
A A
AA
Van Der Laan
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use*; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D011899:Ranitidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014945:Wound Healing / Q000187:drug effects
D000897:Anti-Ulcer Agents; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D017291:Clarithromycin; D009853:Omeprazole; D001729:Bismuth