Published online Sep 28, 2015. doi: 10.3748/wjg.v21.i36.10435
Peer-review started: January 21, 2015
First decision: February 10, 2015
Revised: April 12, 2015
Accepted: July 8, 2015
Article in press: July 8, 2015
Published online: September 28, 2015
Processing time: 250 Days and 23 Hours
AIM: To evaluate the efficacy of sequential vs hybrid therapy in patients with Helicobacter pylori (H. pylori) infection.
METHODS: From March 2013 to May 2014, one hundred and seventy-five H. pylori infected patients who had not been treated for H. pylori before were randomized to receive either sequential therapy (rabeprazole 20 mg and amoxicillin 1 g twice daily for 5 d, followed by rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 5 d) or hybrid therapy (rabeprazole 20 mg and amoxicillin 1 g for 7 d, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 d). H. pylori status was confirmed by positive results of both rapid urease test and histology examination or a positive result of culture. Eradication efficacy was assessed by follow-up endoscopy with rapid urease test and histological examination 8 wk after the end of anti-H. pylori therapy, or 13C-urea breath test at least 4 wk after completion of treatment. The primary outcome was H. pylori eradication by intension-to-treat (ITT) and per-protocol (PP) analyses.
RESULTS: One hundred and sixty-seven patients (83 patients in the sequential group and 84 patients in the hybrid group) completed the study. The compliance rates were 97.6% and 97.7% for the two groups, respectively. The eradication rate was 78.2% for the sequential group and 92% for the hybrid group by ITT analysis (P = 0.01). The eradication rate was 81.9% for the sequential group and 96.4% for the hybrid group by PP analysis (P = 0.01). Univariate analysis for the clinical and bacterial factors did not identify any risk factors associated with treatment failure. Severe adverse events were observed in 2.3% of patients in the sequential group and 2.4% of those in the hybrid group.
CONCLUSION: Due to a grade A (> 95%) success rate for H. pylori eradication by PP analysis, similar compliance and adverse events, hybrid therapy seems to be an appropriate eradication regimen in Taiwan.
Core tip: The ideal therapy regimen for Helicobacter pylori (H. pylori) infection should achieve an eradication rate ≥ 90% on per-protocol analysis. Both the hybrid and sequential therapies have shown eradication rates superior to the standard triple therapy in several studies. To the best of our knowledge, this is the first study on the comparison between hybrid therapy and sequential therapy in Taiwan population. Hybrid regimen is a more effective therapy for H. pylori eradication than sequential regimen.