Cure of Helicobacter pylori-positive active duodenal ulcer patients: a double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy

Aims. To compare a two-week dual therapy to a one-week triple therapy for t he healing of duodenal ulcer and the eradication of the Helicobacter pylori infection. Patients and Methods. A total of 165 patients with active duodenal ulcer we re enrolled in the study. At entry, endoscopy; clinical examination and lab oratory tests were performed, Histology and the rapid urease test were used to diagnose Helicobacter pylori infection. Patients received either lansop razole 30 mg plus amoxycillin 1 g bid for two weeks (two-week, dual therapy ) or lansoprazole 30 mg plus amoxycillin 1 g plus tinidazole 500 mg bid for one week plus lansoprazole qd for an additional week tone-week, triple the rapy). Two and twelve months after cessation of therapy, endoscopy and clin ical assessments were repeated. Results. Duodenal ulcer healing and Helicobacter pylori eradication were bo th significantly greater (p<0.0001) in the triple therapy group (healing: 9 8.6%; Helicobacter pylori cure rate: 72.6%) than in the dual therapy group (healing: 77.3%; Helicabacter pylori cure rate: 33.3%). Ulcers healed more frequently in Helicobacter pyloricured than in Helicobacter pylori-not cure d patients (94.9% vs. 77.2%; p<0.0022). After one year, Helicobacter pylori eradication was re-confirmed in 46/58 patients previously treated with the triple therapy and in 10/40 patients treated with the dual therapy (p<0.00 01). Only three duodenal ulcer relapses were observed throughout follow-up: all were in Helicobacter pylori-not cured patients. Conclusions. Triple therapy was more effective than dual both in curing Hel icobacter pylori infection and healing active duodenal ulcers. The speed of ulcer healing obtained after only 7 days of antibiotics and 14 days of pro ton pump inhibitors confirmed that longer periods of anti ulcer therapy wer e not necessary. Helicobacter pylori-not cured patients had more slowly hea ling ulcers which were more apt to relapse when left untreated.