Digestive and Liver Disease 39 (2007) 806–810 Alimentary Tract Helicobacter pylori eradication with either quadruple regimen with lactoferrin or levofloxacin-based triple therapy: A multicentre study A. Zullo a,∗ , V. De Francesco b , G. Scaccianoce c , G. Manes d , C. Efrati e , C. Hassan a , G. Maconi d , D. Piglionica c , C. Cannaviello e , C. Panella b , S. Morini a , E. Ierardi b a Gastroenterology and Digestive Endoscopy, “Nuovo Regina Margherita” Hospital, Rome, Italy b Section of Gastroenterology, Department of Medical Sciences, University of Foggia, Foggia, Italy c Digestive Endoscopy, “Umberto I” Hospital, Altamura, Bari, Italy d Department of Gastroenterology, “L. Sacco” University Hospital, Milan, Italy e Endoscopy Unit, “Israelitico” Hospital, Rome, Italy Received 27 January 2007; accepted 21 May 2007 Available online 23 July 2007 Abstract 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 13 C-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 mg, 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. © 2007 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. Keywords: Eradication; Helicobacter pylori; Lactoferrin; Levofloxacin; Therapy 1. Introduction H. pylori eradication rate following standard 7-day triple therapies is decreasing worldwide [1,2], and a cure rate as low as 25–45% has been recently reported [3,4]. Such a phe- ∗ Corresponding author at: Ospedale Nuovo Regina Margherita, Gastroen- terologia ed Endoscopia Digestiva, Via E. Morosini, 30, 00153 Rome, Italy. Tel.: +39 06 58446608; fax: +39 06 58446533. E-mail address: zullo66@yahoo.it (A. Zullo). nomenon mainly depends on primary bacterial resistance, particularly against clarithromycin [5]. Recent studies have found a prevalence rate of primary clarithromycin resistance as high as 22–31.5% in Italy [6–8]. The updated European guidelines suggest the use of a 14-day triple therapy or a 7-day quadruple therapy as first-line treatment in those geographic areas where primary clarithromycin resistance is higher than 20–30% [9]. However, a meta-analysis study has clearly shown that the 14-day triple therapy offers only a modest improvement over the 7-day therapy in terms of H. pylori 1590-8658/$30 © 2007 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.dld.2007.05.021