In five subsequent open clinical studies, 180 patients with Helicobacter pylori (HP)-associated ulcer disease (n = 163) or severe functional dyspepsia (n = 17) requiring therapy were treated with either 40 mg omeprazole plus 4 x 500 mg amoxicillin suspension for 1 wk (group I, n = 35), 2 x 40 mg omeprazole plus 4 x 500 mg amoxicillin for 1 wk (group II, n = 50), 2 x 20 mg omeprazole plus 4 x 500 mg amoxicillin for 2 wk (group III, n = 62), 2 x 20 mg omeprazole (day 1-14) and 4 x 500 mg amoxicillin (day 8-14) (group IV, n = 22) or with 2 x 20 mg omeprazole for 2 wk (group V, n = 11). The HP eradication rates determined with a biopsy urease test, microscopy of a mucosal smear, specific culture, and histology after modified GIEMSA staining in the 5th wk after discontinuation of study medication were 61.3% in group I, 61.7% in group II, 82.8% in group III, 28.6% in group IV, and 0% in group V. Apart from clinical insignificant pharyngeal paresthesias (n = 6), nine patients (5.7%) with combined therapy complained of important side effects (stomatitis: n = 3, diarrhea: n = 3, allergic exanthema: n = 3) that led to termination of amoxicillin treatment in four cases (2.5%). We conclude that omeprazole-enhanced amoxicillin antibiosis is a simple and effective approach to the eradication of HP colonization.
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