Seven-day triple therapy with ranitidine bismuth citrate or omeprazole andtwo antibiotics for eradication of Helicobacter pylori in duodenal ulcer: a multicentre, randomized, single-blind study

Aim: To investigate the efficacy of a 1-week triple therapy with amoxycilli n, clarithromycin, and omeprazole or ranitidine bismuth citrate (RBC) in cu ring Helicobacter pylori infection and healing duodenal ulcers. Methods: One hundred and ninety-two consecutive out-patients with duodenal ulcer, in whom H. pylori infection was confirmed by histology and a urease biopsy test, were randomly assigned to a 1-week treatment with either 400 m g b.d. ranitidine bismuth citrate (RAC group) or 20 mg omeprazole b.d. (OAC group) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d. Results: Eradication of H. pylori was successful in 77% (per protocol) and 61% (intention-to-treat) of the patients in the RAC group and in 79% (per p rotocol) and 70% (intention-to-treat) of those in the OAC group. The differ ence was not significant. Per protocol analysis showed ulcers were healed i n 97% of patients in the RAC group and 96% in the OAC group. Adverse effect s were seen in four patients in each group: they caused discontinuation of the therapy in one patient of the OAC group. Conclusions: Eradication rates obtained in this study were lower than those expected on the basis of previously reported studies. The two 1-week treat ment regimens were equally effective in healing H. pylori associated duoden al ulcer disease.