RANITIDINE BISMUTH CITRATE WITH CLARITHROMYCIN VERSUS OMEPRAZOLE WITHAMOXICILLIN IN THE CURE OF HELICOBACTER-PYLORI INFECTION

Aim: To compare the efficacy of ranitidine bismuth citrate plus clarit hromycin (RBC-C) os. omeprazole plus amoxycillin (OME-AMO) in the cure of Helicobacter pylori infection. Methods: In this double-blind, mult icentre, parallel-group study 122 H. pylori-positive patients with act ive duodenal ulcer or gastritis, with confirmed history of duodenal ul cer, were randomized to treatment with ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. or omeprazole 20 mg b.d. plus amoxycillin 1000 mg b.d. for 14 days, followed by 14 days of ranitidin e bismuth citrate 400 mg b.d. or omeprazole 20 mg once daily, respecti vely, to facilitate ulcer healing. Endoscopy was carried out at the st art of the study and 28 days after: the end of treatment. At each endo scopy four biopsies were obtained from the antrum and four biopsies fr om the corpus, for rapid urease test, histology and culture. H. pylori infection was defined as a positive urease test, confirmed by histolo gy or culture. Cure of H, pylori infection was defined as negative ure ase test, histology or culture from both sites. Results: Per-protocol, all-patients-treated and intention-to-treat cure rates (95% confidenc e interval) were, respectively 90% (81-89%), 90% (82-89%) and 84% (74- 93%) for ranitidine bismuth citrate plus clarithromycin, and 39% (27-5 4%), 44% (31-57%) and 41% (29-53%) for omeprazole plus amoxycillin, P < 0.00001. Both regimens were well tolerated. Eight patients were lost to follow-up, for lack of efficacy (one patient), adverse events (thr ee patients) or refusal of second endoscopy (four patients). Conclusio n: Ranitidine bismuth citrate 400 mg b.d. with clarithromycin 500 mg b .d. is superior to omeprazole 20 mg b.d. with amoxycillin 1000 mg b.d. Ranitidine bismuth citrate with clarithromycin is the first dual ther apy with high cure rates and good tolerance, and is easy to take. It m ay therefore prove a suitable first-line treatment in H. pylori infect ion.