title: Efficacy of moxifloxacin-based sequential and hybrid therapy for first-line Helicobacter pylori eradication.
abstract: OBJECTIVE
  To evaluate the efficacy of moxifloxacin-based sequential therapy (MBST) versus hybrid therapy as a first-line treatment for Helicobacter pylori (H. pylori) infection.
  
  
  METHODS
  From August 2014 to January 2015, 284 patients with confirmed H. pylori infection were randomized to receive a 14-d course of MBST (MBST group, n = 140) or hybrid (Hybrid group, n = 144) therapy. The MBST group received 20 mg rabeprazole and 1 g amoxicillin twice daily for 7 d, followed by 20 mg rabeprazole and 500 mg metronidazole twice daily, and 400 mg moxifloxacin once daily for 7 d. The Hybrid group received 20 mg rabeprazole and 1 g amoxicillin twice daily for 14 d. In addition, the Hybrid group received 500 mg metronidazole and 500 mg clarithromycin twice daily for the final 7 d. Successful eradication of H. pylori infection was defined as a negative (13)C-urea breath test 4 wk after the end of treatment. Patient compliance was defined as "good" if drug intake was at least 85%. H. pylori eradication rates, patient compliance with treatment, and adverse event rates were evaluated.
  
  
  RESULTS
  The eradication rates in the intention-to-treat (ITT) analysis were 91.4% (128/140; 95%CI: 90.2%-92.9%) in the MBST group and 79.2% (114/144; 95%CI: 77.3%-80.7%) in the Hybrid group (P = 0.013). The eradication rates in the per-protocol (PP) analysis were 94.1% (128/136; 95%CI: 92.9%-95.6%) in the MBST group and 82.6% (114/138; 95%CI: 80.6%-84.1%) in the Hybrid group (P = 0.003). The H. pylori eradication rate in the MBST group was significantly higher than that of the Hybrid group for both the ITT (P = 0.013) and the PP analyses (P = 0.003). Both groups exhibited full compliance with treatment (MBST/Hybrid group: 100%/100%). The rate of adverse events was 11.8% (16/136) and 19.6% (27/138) in the MBST and Hybrid group, respectively (P = 0.019). The majority of adverse events were mild-to-moderate in intensity; none were severe enough to cause discontinuation of treatment in either group.
  
  
  CONCLUSIONS
  MBST was more effective and led to fewer adverse events than hybrid therapy as a first-line treatment for H. pylori infection.
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea.
authors.forename: Jae Jin
authors.initials: JJ
authors.lastname: Hwang
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea.
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea.
authors.forename: Hyuk
authors.initials: H
authors.lastname: Yoon
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea.
authors.forename: Cheol Min
authors.initials: CM
authors.lastname: Shin
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea.
authors.forename: Young Soo
authors.initials: YS
authors.lastname: Park
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea.
authors.forename: Nayoung
authors.initials: N
authors.lastname: Kim
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000472:pathogenicity; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D000077266:Moxifloxacin; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D064750:Rabeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D056910:Republic of Korea; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D064750:Rabeprazole; D017291:Clarithromycin; D000077266:Moxifloxacin
keywords: Eradication; First-line treatment; Helicobacter pylori; Hybrid therapy; Moxifloxacin; Sequential therapy