Helicobacter pylori eradication with either quadruple regimen with lactoferrin or levofloxacin-based triple therapy:: A multicentre study

Background. Helicobacter pylori eradication rate following standard triple therapy is decreasing worldwide. A quadruple therapy with lactoferrin and a levofloxacin-based triple therapy has been found to achieve a very high (> 90%) cure rate. This study aimed to confirm these encouraging, results. Methods. This was a prospective, open-label, randomised, multicentre, Italian study enrolling consecutive H. pylori infected patients. The infection at entry was assessed by endoscopy and biopsies (histology plus rapid urease test) in all patients, whilst bacterial eradication was assessed by C-13-urea breath test 4-6 weeks after therapy ended. Patients were randomised to receive either a 7-day, triple therapy with rabeprazole 20 mg o.d., levofloxacin 500 mg o.d., and amoxycillin 1 g b.i.d. (4 tablets/day) or a 7-day quadruple therapy comprising of rabeprazole 20 rug, clarithromycin 500 mg, tinidazole 500 mg plus bovine lactoferrin 200 mg, all given twice daily (10 tablets/day). Results. Overall, 144 consecutive patients were enrolled in the study. Following the triple therapy, H. pylori infection was cured in 49 out of 72 (68.1%: 95% CI = 57-79) patients and in 49 out of 71 (69.1 %; 95% CI = 58-80) at intention-to-treat and per protocol analyses, respectively. Following the quadruple regimen, the infection was cured in 52 out of 72 (72.2%; 95% CI = 62-83) and in 52 out of 68 (76.5; 95% CI = 66-87) patients at intention-to-treat and per protocol analyses, respectively. No statistically significant difference emerged between the two therapy regimens. Conclusions. H. pylori eradication rate following both quadruple therapy with lactoferrin and a low-dose PPI, triple therapy with levofloxacin is disappointingly low. (c) 2007 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.