RANITIDINE BISMUTH CITRATE PLUS CLARITHROMYCIN 7-DAY REGIMEN IS EFFECTIVE IN ERADICATING HELICOBACTER-PYLORI IN PATIENTS WITH DUODENAL-ULCER

Background: No clinical study has been performed to-date to evaluate t he efficacy of the dual therapy of ranitidine bismuth citrate (RBC) pl us clarithromycin (C) 500 mg b.d. given for 7 days for the eradication of H. pylori. Aim: To assess the eradication rates achieved by treatm ent with RBC 400 mg b.d. for 28 days combined with clarithromycin 500 mg b.d. for 7 days in H. pylori-positive duodenal ulcer patients. Meth ods: One hundred and twelve H. pylori-positive patients with endoscopi cally proven active duodenal ulcer were included in a multicentre, ope n, randomized trial. H, pylori infection was initially detected by CLO -test and histology on antral and corpus biopsies, and by C-13-urea br eath test (UBT). Patients were included if at least two of the tests w ere positive for H, pylori infection. Patients were randomized to rece ive RBC 400 mg b.d. for 4 weeks combined with clarithromycin 500 mg b. d. for the first 7 days (Group A) or 14 days (Group B). A second endos copy was performed at least 28 days after the end of therapy for the a ssessment of ulcer healing and H, pylori infection. Eradication was as sumed if all the tests (CLO-test, histology and UBT) were negative for H, pylori. Results: Fifty patients in Group A and 55 in Group B were assessed for H. pylori eradication and ulcer healing. The eradication rates according to intention-to-treat analysis were 75% in Group A and 80% in Group B. Considering only those patients with evaluable data a t least 28 days after the end of therapy, H, pylori eradication was ac hieved in 84% and 82% in Group A and B, respectively. No statistically significant difference in eradication was found between the two group s by Mantel-Haenszel test, Only one patient, in Group A, was withdrawn because of adverse events (epigastric pain and pruritus).