HELICOBACTER-PYLORI ERADICATIONTHERAPY WI TH A BISMUTH CITRATE AMOXICILLIN-COMBINATION IN ONE TABLET

The efficacy of a new combination preparation containing bismuth citra te amoxicillin in one tablet was compared with the efficacy of bismuth citrate monotherapy in a randomised double-blind study on the eradica tion of Helicobacter pylori. The study involved 70 H pylori positive ( antrum biopsies showing a positive urease test) patients with non-ulce r dyspepsia and chronic gastritis. the treatment period was 14 days; 3 5 patients in group 1 received 2 tablets tid containing the bismuth ci trate amoxicillin combination (BIAM tablet; 250 mg amoxicillin base an d 120 mg bismuth); 35 patients ingroup 2 were treated with 2 tablets t id containing bismuth citrate (BI tablet; 120 mg bismuth). Total daily dose was therefore 1500 mg amoxicillin + 720 mg bismuth in group 1 pa tients resp. 720 mg bismuth in group 2 patients. 4 weeks after therapy H. pylori could not be histologically detected in the antrum of 22 pa tients (63%) in group 1 and 8 patients (24%) in group 2. Thus in group 1 (BIAM) a significantly higher eradication rate (p<0,001) was shown than in group 2 (BI). Inflammation characterized by the infiltration o f polymorphonuclear cells was significantly (p<0,01) less pronounced i n group 1 (BIAM) than in group 2 (BI) 4 weeks after the end of treatme nt. Gastrointestinal distress was quantified by evaluation of 13 diffe rent symptoms using a fourpoints scale at the beginning of the study a nd after 2 and 6 weeks. The sum of scores decreased by 81% in group1 ( BIAM) and 71% in group 2 (BI) after 6 weeks.