Prospective Randomised Study of a 14 day Clarithromycin Triple Regimen and a 14 Day Bismuth based Quadruple Regimen for Helicobacter Pylori Eradication.

Abstract

Background and aims: Helicobacter pylori (H. pylori) is a grade I carcinogen, responsible for the development of 89% of non-cardia gastric cancers. All infected patients have an indication for treatment. The ideal first line therapy has not been defined yet. The objective of this study was to evaluate the effectiveness and safety of 14 day bismuth based quadriple and 14 day triple regimens in treatment naive H. pylori infected patients.

Methods: Computer based random allocation of patients was used to assign to either a 14 day triple regimen (group 1, esomeprazole 40 mg BID, amoxicillin 1000 mg BID and clarythromycin 500 mg BID ) or a 14 day bismuth based quadruple regimen (group 2, esomeprazole 40 mg BID, amoxicillin 500 mg QID, metronidazole 400 mg QID and bismuth oxide 120 mg QID).

Results: Altogether 201 patients were included, 101 to group 1 and 100 to group 2. Average age of patients were 75 years of age ( ± 18 years). Twenty five patients were lost to follow up (12.4%), 176 were available for analysis ( 91 patients from group 1 and 85 from group 2). Eradication rate was 94.5% in the first group and 97,6% in the second group (NS). Side effects were reported in 22.8% in the first treatment group and in 24% in the second treatment group (NS). The majority of side effects were mild and did not resulted in any discontinuation of treatment.

Conclusions: Clarithromycin based triple regimen can still be the first line H. pylori regimen in Slovenia. Bismuth based quadruple regimen is to be used in future H. pylori screen and treat programs as the methodology of primary gastric cancer prevention.