Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: A multicenter, randomized, double-dummy study

Background: The optimal treatment regimen for eradication of Helicobacter p ylori in patients with duodenal ulcer has yet to be determined. Based on a search of MEDLINE (R), no studies have been performed comparing a proton pu mp inhibitor-based triple therapy regimen with a ranitidine bismuth citrate (RBC)-based dual therapy regimen, both containing clarithromycin. Objective: This study was undertaken to compare the efficacy of lansoprazol e (LAN)based triple therapy with that of RBC-based dual therapy in H pylori -infected patients with duodenal ulcer. Methods: Patients were randomized to receive either 1 week of triple therap y with LAN 30 mg BID, clarithromycin 500 mg BID, and tinidazole 500 mg BID, followed by 3 weeks of LAN 30 mg BID, or 2 weeks of dual therapy with RBC 400 mg BID plus clarithromycin 500 mg BID, followed by 2 weeks of RBC 400 m g BID. Eradication of H pylori was defined as negative results on both the urease quick test and histologic examination greater than or equal to4 week s after the end of treatment. Duodenal healing and recurrence rates were as sessed endoscopically at 8 weeks and 6 months. A per-protocol (PP) analysis was conducted for each efficacy end point. Also conducted were an intent-t o-treat (ITT) analysis in which patients with missing data were considered failures, and an observed analy-sis (OBS), which included patients: with an evaluable result after treatment, regardless of compliance. Results: One hundred eighty-five patients (126 men, 59 women; age range, 18 -76 years; mean age, 43 years) were enrolled and randomized to treatment. I n the LAN and RBC groups, respectively, H pylori eradication rates were 92. 6%, 93.1%, and 72.8% versus 78.6%, 77.9%, and 64.5% in the PP (P = 0.02), O BS (P = 0.01), and ITT analyses. The corresponding duodenal ulcer healing r ates were 98.6%, 98.7%, and 83.7% versus 90.8%, 91.5%, and 81.7%; these dif ferences were not statistically significant. Side effects were mild, occurr ing in 20.7% of LAN patients and 17.2% of RBC patients. Ulcer recurred in 2 RBC patients. No difference was observed between treatments in terms of th e occurrence of gastritis or improvement of symptoms. Conclusion: Based on the results of the PP and OBS analyses, LAN-based trip le therapy was superior to RBC-based dual therapy for the eradication of H pylori in patients with duodenal ulcer.