SYMPTOMATIC AND ENDOSCOPIC DUODENAL-ULCER RELAPSE RATES 12 MONTHS FOLLOWING HELICOBACTER-PYLORI ERADICATION TREATMENT WITH OMEPRAZOLE AND AMOXICILLIN WITH OR WITHOUT METRONIDAZOLE

Aim: To determine the effect of Helicobacter pylori eradication with o meprazole and amoxycillin, with or without metronidazole, on the 12-mo nth course of duodenal ulcer disease. Methods: In a randomized, double -blind study, conducted in 19 hospitals, 105 H. pylori positive duoden al ulcer patients were healed and symptom-free following either omepra zole dual therapy (omeprazole 40 mg o.m. + amoxycillin 500 mg t.d.s., OA, eradication rate 46%, n = 52) or omeprazole triple therapy (omepra zole 40 mg o.m. + amoxycillin 500 mg t.d.s. + metronidazole 400 mg t.d .s., OAM, eradication rate 92%, n = 53) for 2 weeks, followed by 2 wee ks of omeprazole 20 mg o.m. and a 12-month untreated follow-up period, after which time all patients were endoscoped. Endoscopic and symptom atic relapse rates, and effect on H. pylori status measured using C-13 -urea breath test, were determined. Results: During the 12-month untre ated follow-up period, the life-table endoscopic relapse rates were 12 % (95% CI: 2-22%) and 2% (95% CI: 0-6%) for OA and OAM patients, respe ctively. By 12 months, life-table symptomatic relapse rates were 22% ( 95% CI: 13-37%) and 19% (95% CI: 8-30%) for OA and OAM, respectively, In the 12 months untreated follow-up period, 2/69 (3%, 95% CI: 0-7%) p atients rendered H. pylori negative had an endoscopic relapse at the e nd of the 12-month follow-up period, compared with 5/31 (16%, 95% CI: 3-29%) patients remaining H. pylori positive (P = 0.03 between H. pylo ri positive and negative groups), Twelve of 69 (17%, 95% CI: 8-26%) pa tients rendered H. pylori negative relapsed symptomatically, compared with 9/31 (29%, 95% CI: 13-45%) patients remaining H. pylori positive (P = N.S. between groups), There was a significant improvement in epig astric pain (P = 0.0001), nausea and vomiting (P < 0.05) between entry to the study and 1, 6 and 12 months post-treatment for both treatment groups. Conclusions: OAM eradicates H. pylori in significantly more p atients than OA, but successful H. pylori eradication with either OAM or OA predisposes to low endoscopic and symptomatic relapse rates for duodenal ulcer patients when followed up for 12 months.