Helicobacter pylori-negative duodenal ulcers: Prevalence, clinical characteristics, and prognosis - Results from a randomized trial with 2-year follow-up

OBJECTIVE: The proportion of Helicobacter pylori-negative duodenal ulcer di sease appears to be increasing. Data on clinical outcome and prognosis in t his subgroup are lacking. METHODS: Two hundred seventy-six duodenal ulcer patients randomized, irresp ective of H, pylori status, to either eradication therapy or maintenance om eprazole (double-blind, double-dummy design) for 1 yr were studied. Patient s were followed up for a total of 2 yr, with visits performed every 2 month s the first year and every 6 months the following year. Endoscopies for ass essment of ulcer relapse were done at 6 and 12 months or in the event of sy mptomatic relapse. H. pylori status was assessed by culture, immunohistoche mistry, and urea breath test at entry, at 6, 12, and 24 months or at failur e. The primary endpoint was discontinuation, irrespective of reason. Patien ts were considered H. pylori negative if all three tests were negative. Pat ients were considered H. pylori-positive if any of the three diagnostic tes ts were positive. Study staff were blinded to H. pylori results. RESULTS: Thirty-two (12%) patients were H. pylori negative at entry. There were no differences according to H. pylori status for a number of clinical and demographic characteristics. However, H. pylori-negative patients had a shorter history of ulcer symptoms and were more likely to be NSAID users ( 19% vs 1%, p < 0.001). Only 28% of the H. pylori-negative patients complete d the study, as compared with 40% of H. pylori-positive patients (p = 0.000 5). The main reasons for the poorer prognosis in H. pylori-negative patient s were relapse of ulcer/ulcer not healed (35% vs 26%) and relapse of severe dyspepsia symptoms without ulcer relapse (16% vs 7%). H. pylori-negative p atients randomized to eradication therapy left the study early compared wit h H. pylori-negative patients randomized to long-term omeprazole therapy. O utcome in omeprazole-treated patients did not differ according to H. pylori status (P = 0.3). CONCLUSIONS: Clinical characteristics in H, pylori-negative and positive du odenal ulcer patients differ little. Clinical outcome over 2 yr is signific antly poorer in H. pylori-negative patients, especially if treated empirica lly with eradication therapy. These results suggest that H. pylori infectio n should be assessed in all duodenal ulcer patients before treatment is dec ided. (C) 2001 by Am. Cell. of Gastroenterology.