Ke. Monkemuller et Bi. Hirschowitz, Prospective evaluation of ranitidine bismuth citrate-based triple therapy for the treatment of Helicobacter pylori infection, ALIM PHARM, 13(5), 1999, pp. 661-665
Background: There is a need for effective and inexpensive therapy for Helic
obacter pylori with good patient compliance.
Aim: To evaluate a simplified twice daily schedule for treating H. pylori.
Methods: Patients infected with H. pylori (positive by CLO- and C-13-urea b
reath tests [UBT]) and not previously treated with anti-H. pylori therapy w
ere treated with ranitidine bismuth citrate (RBC) and two inexpensive antib
iotics (metronidazole, tetracycline) twice daily for 14 days in an open-lab
el study. Eradication was established by a negative UBT 4 weeks after endin
g therapy.
Results: Twenty men and 30 women (age 54 +/- 14 years, range 26-74) were in
cluded in the study. Five patients were prematurely withdrawn (side-effects
2, took additional antibiotics 2 and surgery 1) and one patient was lost t
o follow-up; therefore, 44 (88%) patients completed the H. pylori eradicati
on protocol, Per protocol (PP) cure rate was 82% (36/44 patients, 95% CI: 6
8-95%), and intention-to-treat cure rate was 72% (36/50 patients, 95% CI: 5
8-82%). Five patients (10%) developed side-effects during therapy, most com
monly nausea (3 patients). Four weeks after the end of treatment, 78% (PP)
of patients were symptomatically improved.
Conclusions: A 2-week course of twice-daily RBC-based triple therapy was we
ll tolerated, eradicated H. pylori in 72% (ITT) and 82% (PP) of patients, r
espectively, and relieved symptoms in 78%.