Optimal treatment of Helicobacter pylori with ranitidine bismuth citrate (RBC): a randomized comparison between two 7-day triple therapies and a 14-day dual therapy.

OBJECTIVE: We investigated two promising 1-wk RBC-triple therapies in comparison to the already well investigated 2-wk RBC dual therapy. METHODS: We conducted two randomized, open, parallel group studies in 13 hospitals in the Netherlands. H. pylori-positive patients without active ulceration were randomized to 14-day RBC 400 mg b.i.d. plus clarithromycin 500 mg b.i.d. (n = 56) or to either 7-day RBC 400 mg b.i.d. plus tetracycline 500 mg q.i.d. plus metronidazole 500 mg t.i.d. (n = 63) in study 1, or to 7-day RBC 400 mg b.i.d. plus amoxycillin 1000 mg b.i.d. plus clarithromycin 500 mg b.i.d. (n = 49) in study 2. At least 6 wk later patients were reendoscoped with antral and corpus biopsies for CLOtest, culture, and histology, and cure was assumed if all tests were negative. RESULTS: Results from the studies were pooled. All regimens were well tolerated with only 1 drop-out because of side effects. Cure rates per protocol/intention to treat were 96%/95% for RBC-CLA dual therapy, 89%/86% for RBC-TET-MET triple therapy, and 93%/92% for RBC-AMO-CLA triple therapy. From 126 patients, a pretreatment antibiogram was available. Metronidazole resistance did not affect the performance of RBC-CLA or RBC-AMO-CLA. In the RBC-TET-MET group, 97% (32/33) with a metronidazole sensitive strain were cured vs 57% (four of seven) with a resistant strain. Of three patients with a pretreatment clarithromycin resistant strain; one failed RBC-CLA dual therapy and two failed RBC-AMO-CLA triple therapy. CONCLUSIONS: All regimens were well tolerated and achieved comparable and very high cure rates. Statistical or clinical relevant differences were not detected. All three regimens can be used as initial anti-Helicobacter therapy and can compete with 7-day PPI-triple therapies. More data are needed on the influence of antimicrobial resistance on the performance of individual triple therapies. The local prevalence of antimicrobial resistance will determine which regimen should be chosen for a certain geographical area.