Randomized study comparing omeprazole with ranitidine as anti-secretory agents combined in quadruple second-line Helicobacter pylori eradication regimens

Background: Few data are available on the efficacy of second-line H. pylori eradication regimens. Aim: To compare the efficacy of either omeprazole or ranitidine in a second -line quadruple regimen in patients with duodenal ulcer or erosive duodenit is. Patients and methods: A total of 37 patients with erosive duodenitis and 11 9 with duodenal ulcer who have failed eradication of H. pylori with double or triple regimens, without metronidazole, were randomly assigned to receiv e tripotassium dicitrato bismuthate 600 mg t.d.s. + metronidazole 500 mg t. d.s. + tetracycline hydrochloride 500 mg t.d.s. combined with either omepra zole 20 mg b.d. (group O, 78 patients) or ranitidine 300 mg b.d. (group R, 78 patients) for 14 days. H. pylori eradication was verified by histology, rapid urease test and C-13-urea breath test. Statistics: t-test, chi(2)-test. Results: A total of 143 patients had a post-treatment endoscopy. Eradicatio n rates were: intention-to-treat: group O 77% (67-87), group R 76% (66-85), P=0.85; per protocol analysis: group O 86% (77-95), group R 82 (71-93), P= 0.58. Side-effects were frequent but mild. Conclusions: Omeprazole 20 mg b.d. and ranitidine 300 mg b.d. were equally effective as antisecretory agents combined in a second-line quadruple eradi cation regimen.