Prospective evaluation of ranitidine bismuth citrate-based triple therapy for the treatment of Helicobacter pylori infection

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 Five patients were prematurely withdrawn (side-effects 2, took additional antibiotics 2 and surgery 1) and one patient was lost t o follow-up; therefore, 44 (88%) patients completed the H. pylori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%.