title: Efficacy of levofloxacin and rifaximin based quadruple therapy in Helicobacter pylori associated gastroduodenal disease: a double-blind, randomized controlled trial.
abstract: The aim of this study was to evaluate the efficacy of levofloxacin and rifaximin based quadruple regimen as first-line treatment for Helicobacter pylori infection. A prospectively randomized, double-blinded, parallel group, comparative study was performed. Three hundred consecutive H. pylori positive patients were randomized to receive: omeprazole, amoxicillin, clarithromycin (OAC); omeprazole, amoxicillin, levofloxacin (OAL); and omeprazole, amoxicillin, levofloxacin, rifaximin (OAL-R). The eradication rates in the intention to treat (ITT) and per protocol (PP) analyses were: OAC, 77.8% and 85.6%; OAL, 65.3% and 73.6%; and OAL-R, 74.5% and 80.2%. The eradication rate achieved with OAC was higher than with OAL on the ITT (P = 0.05) and PP analysis (P = 0.04). OAL-R regimen was not inferior to OAC. The frequency of moderate to severe adverse effects was significantly higher in OAC treatment group. Especially, diarrhea was most common complaint, and there was a significantly low rate of moderate to severe diarrhea with the rifaximin containing regimen. In conclusion, the levofloxacin and rifaximin based regimen comes up to the standard triple therapy, but has a limited efficacy in a Korean cohort. The rifaximin containing regimen has a very high safety profile for H. pylori eradication therapy.
authors.affiliation: Department of Internal Medicine, St. Vincent Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
authors.forename: Kang Hyun
authors.initials: KH
authors.lastname: Choi
authors.forename: Woo Chul
authors.initials: WC
authors.lastname: Chung
authors.forename: Kang-Moon
authors.initials: KM
authors.lastname: Lee
authors.forename: Chang Nyol
authors.initials: CN
authors.lastname: Paik
authors.forename: Eun Jung
authors.initials: EJ
authors.lastname: Kim
authors.forename: Bong Koo
authors.initials: BK
authors.lastname: Kang
authors.forename: Ju Hyun
authors.initials: JH
authors.lastname: Oak
authors.forename: Sung Hoon
authors.initials: SH
authors.lastname: Jung
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D009853:Omeprazole / Q000008:administration & dosage; D010437:Peptic Ulcer / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D012294:Rifamycins / Q000008:administration & dosage*; D000078262:Rifaximin
chemical_list: D000900:Anti-Bacterial Agents; D012294:Rifamycins; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole; D000078262:Rifaximin