RANDOMIZED CLINICAL-TRIAL COMPARING 2 ONE-WEEK TRIPLE-THERAPY REGIMENS FOR THE ERADICATION OF HELICOBACTER-PYLORI INFECTION AND DUODENAL-ULCER HEALING

Objective: One-week triple therapy has been shown to be effective in H elicobacter pylori eradication and duodenal ulcer healing. However, th e optimal therapeutic combination has not yet been identified. Bismuth -containing regimens have the advantage of requiring only one antibiot ic. It has been suggested that high doses of omeprazole improve the ba ctericidal efficacy of antimicrobial regimens against H. pylori. We ev aluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing. Methods: On an intention-to-t reat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b .i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated wit h omeprazole and clarithromycin at the same doses plus amoxicillin Ig b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient receive d follow-up treatment. Results: H. pylori eradication rates achieved i n the OCB and OCA groups were similar whether by intention-to-treat (8 2.4% vs 88.9%; p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OC A in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92 .2% vs 92.1%), respectively (p = 0.98). Conclusions: High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloida l bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradi cation in these therapeutic combinations. (C) 1998 by Am. Coll. of Gas troenterology.