Bismuth-based triple therapy with bismuth subcitrate, metronidazole and tetracycline in the eradication of Helicobacter pylori: A randomised, placebo controlled, double-blind study
SV van Zanten, A Farley, N Marcon, R Lahaie, A Archambault, R Hunt, R Bailey, D Owen, J Spenard, A Stiglick, N Aimola, P Colin
OBJECTIVE: To determine the rate of Helicobacter
pylori eradication following bismuth-based triple
therapy with colloidal bismuth subcitrate, tetracycline
hydrochloride and metronidazole.
PATIENTS AND METHODS: One hundred and eleven
patients were randomly assigned, in a two to one ratio,
to colloidal bismuth subcitrate 120 mg qid plus metronidazole
250 mg qid plus tetracycline 500 mg qid (Gastrostat),
or matching placebo tablets and capsules for 14 days.
Presence or absence of H pylori was documented
by histology at entry and at least 28 days after treatment.
Patients had dyspeptic symptoms with or without a history
of peptic ulcer. Patients with any previous attempt(s)
at eradication of H pylori, who used bismuth,
antibiotics, H2 receptor antagonists
or proton pump inhibitors in the previous four weeks
RESULTS: Fifty-three of 59 (90%) patients on
bismuth-based treatment and only one of 35 (3%) on placebo
achieved eradication by per protocol analysis. Fifty-three
of 65 (82%) patients on bismuth-based treatment achieved
eradication, while only two of 34 (5%) achieved eradication
on placebo by intention to treat analysis. Eradication
rates for bismuth-based treatment across sites ranged
from 83% to 100%. Only two patients in the bismuth-based
treatment group (4%) and one in the placebo group (3%)
discontinued treatment because of adverse events.
CONCLUSIONS: Colloidal bismuth subcitrate plus
metronidazole plus tetracycline, given in the doses
studied for 14 days, is safe and highly effective against
H pylori infection and would be appropriate
as a first-line therapy for eradication.