Levofloxacin-based sequential therapy versus classic triple therapy in Helicobacter pylori eradication: A randomized clinical trial

Abstract

Introduction: During the past two decades, eradication rates with triple therapy for Helicobacter (H.) pylori eradication have decreased. The decline of effectiveness of the triple therapy have led to investigations to achieve more effective and safe therapeutic strategies. Sequential, concomitant and hybrid therapeutic regimens are new therapies that have been introduced over the past two decades. The purpose of this study was to compare levofloxacin-based sequential therapy versus classic triple therapy in H. pylori eradication in a randomized clinical trial. Methods: All eligible cases were divided into two groups using a randomized block method. The first group (classic group) was treated with triple therapy; patients received omeprazole, amoxicillin and clarithromycin for 14 days. The second group received the levofloxacin-based sequential (lev-seq) regimen; the patients were treated with omeprazole and amoxicillin for the first 7 days and then with omeprazole, levofloxacin and metronidazole for the latter 7 days. In this clinical trial, 200 patients with H. pylori infection were enrolled. Ultimately, 192 patients completed the study. Of these, 95 patients (46 males and 49 females) were treated with triple therapy (classic group) and 97 patients (46 males and 51 females) were treated with the lev-seq regimen. The average age in the classic group and lev-seq groups were 41.4±12.4 years and 40.2±11.8 years, respectively. Results: The levofloxacin based sequential regimen was more effective than triple therapy regimen. It is recommended that the lev-seq regimen be used as the first-line therapy, especially in areas with high levels of resistance to clarithromycin (over 20%). Conclusion: Further studies with large numbers of samples are required to be conducted in different parts of the country for further evaluation of efficacy of this regimen. Peer Review Details Peer review method: Single-Blind (Peer-reviewers: 02) Peer-review policy Plagiarism software screening?: Yes Date of Original Submission: 05 November 2017 Date accepted: 25 November 2017 Peer reviewers approved by: Dr. Lili Hami Editor who approved publication: Dr. Phuc Van Pham