Efficacy and safety of single‐triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole, for the eradication of Helicobacter pylori: an international multicentre study

Abstract

Background : The high prevalence of Helicobacter pylori resistance to metronidazole demands treatments more effective than standard bismuth‐based triple therapy against these strains. Aim : To evaluate the H. pylori eradication rate in both metronidazole‐sensitive and ‐resistant strains following quadruple therapy using single‐triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole. Methods : One hundred and seventy valid patients with duodenal ulcer, gastric ulcer or non‐ulcer dyspepsia were treated in eight centres located in five countries. H. pylori was confirmed at baseline using ¹³C‐urea breath test, histology and/or culture. Patients received three single‐triple capsules q.i.d. and omeprazole, 20 mg b.d., for 10 days. Each capsule contained bismuth biskalcitrate, 140 mg (as 40 mg Bi₂O₃ equivalent), metronidazole, 125 mg, and tetracycline, 125 mg. ¹³C‐Urea breath test was repeated at least 4 and 8 weeks post‐treatment. Results : Overall eradication rates were 93% (158/170) by modified intention‐to‐treat analysis and 97% (142/146) by per protocol analysis. Eradication rates were 93% (40/43) and 95% (38/40) for strains resistant to metronidazole and 95% (82/86) and 99% (75/76) for strains sensitive to metronidazole by modified intention‐to‐treat and per protocol analysis, respectively. Conclusion : This omeprazole–bismuth biskalcitrate–metronidazole–tetracycline 10‐day regimen is a very effective and well‐tolerated treatment, which overcomes metronidazole resistance.