Four-day, twice daily, quadruple therapy with amoxicillin, clarithromycin,tinidazole and omeprazole to cure Helicobacter pylori infection: A pilot study

Background. The best regimen for the treatment of Helicobacter pylori infec tion has yet to be defined. Four-day quadruple therapy with tetracycline, m etronidazole, bismuth, and a proton pump inhibitor has been shown to obtain a very high cure rate. However, the fact that it must be taken four times daily may interfere with compliance. The objective of the study was to test the efficacy and tolerability of a new 4-day therapy with 4 drugs taken ev ery 12 hours to cure H. pylori infection. Patients and Methods. Fifty-six consecutive patients with peptic ulcer dise ase and H. pylori infection were treated with an oral 4-day course with ome prazole (20 mg/12 hours), clarithromycin (500 mg/12 hours), amoxicillin (1 g/12 hours) and tinidazole (500 mg/12 hours). Efficacy of the treatment was determined at least 2 months after therapy either by biopsy (in the case o f gastric ulcer) or by C-13-urea breath test. A second breath test was perf ormed at least 6 months after therapy. Results. Two patients were lost to follow-up. Forty-nine of the remaining 5 4 patients were cured at the first control [intention-to-treat cure rate: 8 7.5% (CI 95% 75-94%); per protocol cure rate: 90.7% (CI 95% 81-98%)]. Forty -three of these 49 cured patients returned for a second C-13 urea breath-te st at 6-12 months. Two of them were not cured, giving a long-term cure rate of 85.5% per protocol and 73.2% by intention-to-treat. Compliance was good , although 25 patients had mild side effects. Conclusion. This particular four-day therapy is well tolerated, easy to fol low, and achieves an acceptably high cure rate.