ONE-WEEK TRIPLE THERAPY WITH RANITIDINE BISMUTH CITRATE, CLARITHROMYCIN AND METRONIDAZOLE VERSUS 2-WEEK DUAL THERAPY WITH RANITIDINE BISMUTH CITRATE AND CLARITHROMYCIN FOR HELICOBACTER-PYLORI INFECTION - A RANDOMIZED, CLINICAL-TRIAL

Objective: The aim of this study was to compare the efficacy and side effects of l-wk triple therapy with ranitidine bismuth citrate (RBC) 4 00 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg b .i.d., to 2-wk dual therapy with RBC 400 mg b.i.d. and clarithromycin 500 mg b.i.d. for H. pylori infection in a randomized, clinical trial. Methods: Patients (18-80 yr) with a culture proven H, pylori infectio n were randomized to one of these regimens. Side effects were scored o n a semiquantitative scale. Endoscopy was performed greater than or eq ual to 4 wk after treatment. Antral biopsy samples were taken for hema toxylin-eosin stain (HE), rapid urease test, and culture and corpus sa mples for culture and HE. Two weeks after the endoscopy, a C-13-urea b reath test was performed. Eradication failure was defined as detection of H. pylori by culture or by at least two other tests. Results: A to tal of 104 patients, 54 men, age 54 +/- 14 yr! (36 duodenal ulcer, 16 gastric ulcer, and 52 functional dyspepsia) were included. Gender, age , and diagnosis were comparable in both groups. Fourteen of 52 patient s in both triple and dual therapy, respectively, had significant side effects, but all patients completed the course. Eradication results we re 49 of 52 (94%; 95% CI: 84-99%) and 50 of 52 (96%; 95% CI: 87-100%) on intention to treat analysis and 44 of 46 (96%; 95% CI: 85-99%) and 48 of 49 (98%; 95% CI: 89-100%) on per protocol analysis for triple an d dual therapy respectively. Conclusion: Both regimens are very effect ive and well tolerated in the treatment of H. pylori infection. The tr iple regimen has the advantage of being shorter. (Am J Gastroenterol 1 998;93:1228-1231. (C) 1998 by Am. Coll. of Gastroenterology).