Published online Jul 14, 2015. doi: 10.3748/wjg.v21.i26.8132
Peer-review started: December 31, 2014
First decision: January 22, 2015
Revised: February 5, 2015
Accepted: March 18, 2015
Article in press: March 19, 2015
Published online: July 14, 2015
AIM: 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 13C-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).
CONCLUSION: 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.
Core tip: This study evaluated the efficacy of 14-d bismuth-based quadruple therapy compared with a corresponding 7-d quadruple therapy as second-line eradication treatment of Helicobacter pylori (H. pylori) infection in South Korea. H. pylori eradication rates in the 14-d treatment group were significantly higher than in the 7-d treatment group for both the intent-to-treat and per-protocol analysis. The high eradication rate, excellent compliance, and safety of the 14-d regimen suggest its potential suitability as a second-line eradication treatment. The 14-d bismuth-based quadruple therapy is a significantly more effective second-line eradication treatment than the 7-d alternative for H. pylori infection in Korean patients.