Kd. Bardhan et al., Ranitidine bismuth citrate with clarithromycin alone or with metronidazolefor the eradication of Helicobacter pylori, ALIM PHARM, 15(8), 2001, pp. 1199-1204
Background: Both triple therapy with ranitidine bismuth citrate (RBC) plus
two antibiotics for 7 days and dual therapy of RBC with clarithromycin for
14 days have been extensively studied; both regimens effectively eradicate
Helicobacter pylori. However, few studies have assessed the efficacy of dua
l therapy given for 7 days.
Aim: To compare the efficacy and safety of RBC 400 mg with clarithromycin 5
00 mg, alone or with metronidazole 400 mg, given twice daily for 7 days for
the eradication of H. pylori.
Methods: This single centre, randomized, double-blind study involved 118 pa
tients with dyspepsia or a history of peptic ulcer disease. H. pylori infec
tion was detected initially by CLO test, and confirmed in 109 patients by u
rea breath test and/or microbiology culture. H. pylori eradication was asse
ssed 4 and 12 weeks after the end of treatment by urea breath test. H. pylo
ri antibiotic susceptibility was assessed pre-study in all patients, and po
st-treatment in patients with a positive post-treatment urea breath test. A
dverse events were recorded throughout the study.
Results: H. pylori was eradicated in 93% of patients who received RBC with
clarithromycin and metronidazole and in 84% of patients who received RBC wi
th clarithromycin (intention-to-treat rates). Per protocol eradication rate
s were 98% and 90% for triple therapy and dual therapy, respectively. The e
radication of metronidazole-resistant H. pylori was achieved in 100% and 88
% of patients following dual therapy and triple therapy, respectively, and
acquired resistance to clarithromycin occurred in only one patient followin
g treatment failure. Both treatments were well-tolerated; only one patient
(2%) was withdrawn from each treatment group due to adverse events.
Conclusions: RBC with clarithromycin and metronidazole is a highly effectiv
e and well-tolerated triple therapy regimen for the eradication of H. pylor
i. RBC with clarithromycin dual therapy has a similar efficacy, and offers
an alternative to triple therapy when there are concerns about treatment wi
th metronidazole or the use of multiple antibiotics. Both regimens are effe
ctive against antibiotic-resistant strains of H. pylori.