OMEPRAZOLE COUPLED WITH 2 ANTIBIOTICS FOR HELICOBACTER-PYLORI ERADICATION AND PREVENTION OF ULCER RECURRENCE

Background: Numerous therapeutic trials aimed at eradicating Helicobac ter pylori (HP) from the gastric mucosa and preventing ulcer recurrenc e have been carried out; however, an optimal treatment has not yet bee n established with carefully controlled randomized studies. Objective: The aim of our study was to evaluate the efficacy of an association o f omeprazole (OM) coupled with two antibiotics in the eradication of H P and prevention of duodenal ulcer (DU) recurrence. Methods: One hundr ed and eighty three patients with active DU were randomized under doub le-blind conditions to receive either OM 20 mg for 4 wk plus amoxycill in 3 g daily and metronidazole 1 g daily during the 2nd and 3rd wk (91 patients, group A) or OM 20 mg for 4 wk plus matching placebo (92 pat ients, group B). Endoscopy was performed before and at the end of the 4-wk treatment as well as 2, 6, and 12 months later. Biopsies were tak en from the duodenum, antrum, and gastric body at each endoscopic exam ination for HP histologicai detection and for evaluation of inflammato ry changes according to the Sydney system. Results:. After 4 wk, 84/86 patients (98%) of group A and 80/86 (93%) of group B were healed of t heir ulcers. The percentage of eradication was 90% in group A and 1% i n group B. During a 12-month follow-up, DU relapsed in 4/63 (6%, inclu ding two of three reinfected cases) HP-eradicated group A patients, 4/ 8 (50%) HP-noneradicated group A patients, and 52/65 (80%) persistentl y HP-positive group B patients. Rapid, complete, and persistent suppre ssion of gastroduodenitis activity and gastric surface epithelium lesi ons was observed in most HP-eradicated group A patients, whereas a tra nsient decrease of bacterial colonization and inflammatory scores in t he antrum and a transient worsening of corpus gastritis were found in group B patients. Conclusions: The combined therapy with amoxycillin, metronidazole, and omeprazole is highly effective in both HP eradicati on and prevention of duodenal ulcer recurrence.