Sv. Van Zanten et al., Bismuth-based triple therapy with bismuth subcitrate, metronidazole and tetracycline in the eradication of Helicobacter pylori: A randomized, placebocontrolled, double-blind study, CAN J GASTR, 14(7), 2000, pp. 599-602
OBJECTIVE: To determine the rate of Helicobacter pylori eradication followi
ng bismuth-based triple therapy with colloidal bismuth subcitrate, tetracyc
line hydrochloride and metronidazole.
PATIENTS AND METHODS: One hundred and eleven patients were randomly assigne
d, in a two to one ratio, to colloidal bismuth subcitrate 120 mg qid plus m
etronidazole 250 mg qid plus tetracycline 500 mg qid (Gastrostat), or match
ing placebo tablets and capsules for 14 days. Presence or absence of H pylo
ri was documented by histology at entry and at least 28 days after treatmen
t. Patients had dyspeptic symptoms with or without a history of peptic ulce
r. Patients with any previous attempt(s) at eradication of H pylori, who us
ed bismuth, antibiotics, H, receptor antagonists or proton pump inhibitors
in the previous four weeks were excluded.
RESULTS: Fifty three of 59 (90%) patients on bismuth-based treatment and on
ly one of 35 (3%) on placebo achieved eradication by per protocol analysis.
Fifty-three of 65 (82%) patients on bismuth-based treatment achieved eradi
cation, while only two of 34 (5%) achieved eradication on placebo by intent
ion to treat analysis. Eradication rates for bismuth-based treatment across
sites ranged from 83% to 100%. Only two patients in the bismuth based trea
tment group (4%) and one in the placebo group (3%) discontinued treatment b
ecause of adverse events.
CONCLUSIONS: Colloidal bismuth subcitrate plus metronidazole plus tetracycl
ine, given in the doses studied for 14 days, is safe and highly effective a
gainst H pylori infection and would be appropriate as a first-line therapy