Beschreibung:
<jats:sec><jats:title>Background.</jats:title><jats:p>The combination of ranitidine bismuth citrate (RBC) and clarithromycin (CLR) was compared with each treatment alone for the eradication of <jats:italic>H. pylori</jats:italic> and healing of duodenal ulcers in patients infected with <jats:italic>H. pylori.</jats:italic></jats:p></jats:sec><jats:sec><jats:title>Methods.</jats:title><jats:p>This two‐phase, randomized, double‐blind, placebo‐controlled, multicenter study evaluated 203 patients with an active duodenal ulcer treated with either (1) RBC 400 mg BID for 4 weeks plus CLR 500 mg TID for the first 2 weeks; (2) RBC 400 mg BID for 4 weeks plus placebo TID for the first 2 weeks; (3) placebo BID for 4 weeks plus CLR 500 mg TID for the first 2 weeks; or (4) placebo BID for 4 weeks plus placebo TID for the first 2 weeks. Patients with healed ulcers after treatment entered a 24‐week observation phase for the assessment of <jats:italic>H. pylori</jats:italic> and ulcer relapse.</jats:p></jats:sec><jats:sec><jats:title>Results.</jats:title><jats:p>Four‐week ulcer healing rates were higher with RBC + CLR (71%) and RBC alone (66%) compared with placebo (15%;<jats:italic>p</jats:italic> < 0.05) and CLR alone (49%). <jats:italic>H. pylori</jats:italic> eradication rates were significantly higher with RBC + CLR (86%) compared with RBC alone (0%, <jats:italic>p</jats:italic> < .001) or CLR alone (24%, <jats:italic>p</jats:italic> < .001). Ulcer recurrence rates after 6 months were lower in patients eradicated of <jats:italic>H. pylori</jats:italic> infection (17%) compared with patients who remained infected (43%). All treatments were well tolerated.</jats:p></jats:sec><jats:sec><jats:title>Conclusions.</jats:title><jats:p>Ranitidine bismuth citrate plus clarithromycin is a simple, convenient, and well‐tolerated dual therapy regimen that is effective in eradicating <jats:italic>H. pylori</jats:italic> and healing duodenal ulcers in patients infected with <jats:italic>H. pylori.</jats:italic> The eradication of <jats:italic>H. pylori</jats:italic> in patients with healed ulcers significantly reduces the rate of ulcer relapse.</jats:p></jats:sec>