LANSOPRAZOLE AND AMOXICILLIN - OBSERVATIONS ON THE TREATMENT OF HELICOBACTER-PYLORI INFECTION

Symptomatic patients (n = 101) with Helicobacter pylori infection were enrolled into a double-blind, double-dummy study to assess the effica cy of lansoprazole plus amoxycillin in the treatment of H. pylori infe ction. Patients were randomized to either lansoprazole 30 mg once dail y (days 0-28) together with placebo (matched to amoxycillin) three tim es a day (days 0-14) followed by either placebo or amoxycillin 500 mg three rimes daily (days 15-28). Biopsy specimens for culture and histo logy were collected on days 0 and 56 or upon symptomatic relapse. Bloo d for serology was collected at days 0, 56 and 168. A [C-14]-urea brea th test was performed on day 168. Eighty-one (80.2%) patients complete d the 56 day assessment. Of patients treated with lansoprazole plus am oxycillin, 35.1% (13/37) were cured of infection as assessed at day 56 (26.5% on an intention-to-treat basis), compared with 4.8% (2/42) of the placebo group (4% on an intention-to-treat basis). Recrudescence/r e-infection occurred in one patient up on re-evaluation at day 168. An alysis of prognostic factors indicated that smoking and alcohol intake had little impact on the treatment outcome. Inflammation (both acute and chronic) improved in patients treated with lansoprazole plus amoxy cillin. The relatively low efficacy of the treatment may relate to a s ingle daily dose of lansoprazole (30 mg) being prescribed, treatment w ith amoxycillin being commenced 2 weeks after the initiation of lansop razole or accurate assessment of treatment efficacy (both antral and b ody biopsy specimens taken).