A United States multicentre trial of dual and proton pump inhibitor‐based triple therapies for Helicobacter pylori

Abstract

Background: One‐week proton pump inhibitor‐based triple therapies are very popular in the US despite limited US data documenting efficacy. We assessed 1‐week proton pump inhibitor triple therapies for Helicobacter pylori, and compared them to dual antibiotic therapies (to assess benefit of omeprazole) and to omeprazole–amoxycillin (to assess benefit of clarithro‐ mycin) in a large, randomized, US multicentre study. Methods: Healthy subjects who were H. pylori‐positive by rapid serological test and ¹³C‐urea breath test were randomly assigned to (i) omeprazole (O) 20 mg b.d. + amoxycillin (A) 1 g t.d.s. for 14 days (OA); (ii) A 1 g b.d. + clarithromycin (C) 500 mg b.d. for 7 days (AC); (iii) C 250 mg b.d. + metronidazole (M) 500 mg b.d. for 7 days (CM); (iv) O 20 mg b.d. + C 250 mg b.d. + M 500 mg b.d. for 7 days (MOC); or (v) O 20 mg b.d. + C 500 mg b.d. + A 1 g b.d. for 7 days (OAC). Repeat breath tests were done at 6 weeks to assess H. pylori status. Results: Three hundred and two H. pylori‐positive subjects at 25 centres received medication. Intention‐to‐treat cure rate was significantly higher for OAC (82%) than for MOC (67%), CM (59%), AC (18%) or OA (58%). Per‐protocol cure rates were 85% for OAC and 75% for MOC. Discontinuation of therapy due to a side‐effect occurred in 0–3% of each study group. Conclusions: One‐week twice‐daily triple therapy with omeprazole, amoxycillin and clarithromycin provides the best rate of eradication of the five regimens studied. However, treatment in the US for 7 days may be unable to achieve eradication rates of ≥ 90% with proton pump inhibitor‐based triple therapy.