title: Fourteen- vs seven-day bismuth-based quadruple therapy for second-line Helicobacter pylori eradication.
abstract: OBJECTIVE
  To compare the efficacy of 14- and 7-d bismuth-based quadruple therapies as second-line eradication treatment for Helicobacter pylori (H. pylori) infection.
  
  
  METHODS
  Between 2004 and 2014, the medical records of 790 patients who had experienced failure of first-line proton pump inhibitor (PPI)-based eradication therapy and were then treated with bismuth-based quadruple therapy were retrospectively reviewed. Those who received bismuth-based quadruple therapy [PPI, bismuth, metronidazole, and tetracycline (PBMT)] for either 7 d or 14 d were assigned to a PBMT-7 group (n = 543) or a PBMT-14 group (n = 247), respectively. The eradication rates for both groups were determined by intention-to-treat (ITT) and per-protocol (PP) analyses. ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated. Successful eradication therapy for H. pylori infection was defined as a negative (13)C-urea breath test 4 wk after the end of eradication treatment.
  
  
  RESULTS
  The overall ITT eradication rate was 69.1% (546/790). Final ITT eradication rates were 67.4% (366/543; 95%CI: 63.1%-71.7%) in the PBMT-7 group and 72.8% (180/247; 95%CI: 67.4%-78.2%) in the PBMT-14 group (P = 0.028). The overall PP eradication rate was 80.0% (546/682), and the final PP eradication rates were 78.2% (366/468; 95%CI: 72.1%-84.0%) in the PBMT-7 group and 84.1% (180/214; 95%CI: 76.8%-90.8%) in the PBMT-14 group (P = 0.009). The H. pylori eradication rates in the PBMT-14 group were significantly higher than in the PBMT-7 group according to both ITT (P = 0.028) and PP analysis (P = 0.009). Compliance was similar in both groups (PBMT-7 group: 97.9%; PBMT-14 group: 96.4%). Adverse event rates were 10.7% (51/478) and 17.1% (38/222) in the PBMT-7 and PBMT-14 groups, respectively (P = 0.487).
  
  
  CONCLUSIONS
  The 14-d bismuth-based quadruple therapy is a significantly more effective second-line eradication treatment for H. pylori infection than the 7-d alternative.
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea.
authors.forename: Jae Jin
authors.initials: JJ
authors.lastname: Hwang
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea.
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea.
authors.forename: Ae-Ra
authors.initials: AR
authors.lastname: Lee
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea.
authors.forename: Hyuk
authors.initials: H
authors.lastname: Yoon
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea.
authors.forename: Cheol Min
authors.initials: CM
authors.lastname: Shin
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea.
authors.forename: Young Soo
authors.initials: YS
authors.lastname: Park
authors.affiliation: Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea.
authors.forename: Nayoung
authors.initials: N
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001944:Breath Tests; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage; D005260:Female; 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; D008499:Medical Records; D055118:Medication Adherence; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D064750:Rabeprazole / Q000008:administration & dosage; D012074:Remission Induction; D012189:Retrospective Studies; D013752:Tetracycline / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D009942:Organometallic Compounds; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D064750:Rabeprazole; D013752:Tetracycline; C002791:bismuth tripotassium dicitrate; D064098:Esomeprazole
keywords: Bismuth; Eradication rate; Helicobacter pylori; Second-line treatment; Treatment failure