RESUMO
BACKGROUND: A combination of an antisecretory agent with two antibiotics is considered the 'gold standard' for Helicobacter pylori eradication. OBJECTIVES: To compare the eradication rates and the safety profile of two short-term triple therapies containing lansoprazole (L) or ranitidine bismuth citrate (RBC) as antisecretory agents. METHODS: One hundred and twelve H. pylori-positive patients either with peptic ulcer (56 duodenal ulcers: 25 active and 31 with a history of ulcer; 13 gastric ulcers: nine active and four with a history of ulcer) or gastritis (43) were included in an open, randomized, controlled trial. H. pylori infection was initially detected by CLO-test and histology on antral and corpus biopsies. H. pylori-positive patients were randomized to receive L plus clarithromycin (C) 250 mg b.d. plus tinidazole (T) 500 mg b.d. (LCT) or RBC plus C 250 mg b.d. and T 500 mg b.d. for 7 days (RbcCT). L or RBC were administered for a further 3 weeks in patients with active peptic ulcers. A second endoscopy was performed at least 6 weeks after the end of therapy for the assessment of H. pylori infection by CLO-test and histology. Eradication was assumed if all the tests were negative for H. pylori. RESULTS: Forty-eight patients in the LCT group and 4 5 in the RbcCT group were assessed for H. pylori eradication. The eradication rates, according to intention-to-treat (ITT) and per protocol (PP) analyses were, respectively, 76.8% and 89.5% for the LCT group, and 73.2% and 91.1% for the RbcCT group. No statistically significant difference in eradication rates was found between the two groups by Mantel-Haenszel test. All peptic ulcers were healed. In patients in whom H. pylori had been eradicated, the severity of gastritis was significantly reduced. Side-effects were rare. One patient in the LCT group and two in the RbcCT group were withdrawn because of adverse events. CONCLUSION: Short-term triple therapy with either lansoprazole or RBC is equally effective and well tolerated.
