Evaluation of first-line bismuth-containing 7-day concomitant quintuple therapy for Helicobacter pylori eradication.

OBJECTIVE: Helicobacter pylori (H. pylori) infection is difficult to cure, mainly due to antibiotic resistance. This study aimed to determine the efficacy and safety of 7-day bismuth-containing concomitant quintuple regimen for H. pylori eradication. METHODS: Conducted from August 2015 to February 2016 at the First Affiliated Hospital of Nan-chang University, this prospective trial enrolled 70 untreated patients who were positive for H. pylori. The patients received 7-day quintuple therapy consisting of bismuth subcitrate 220 mg, esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1 g and metronidazole 400 mg, each was given twice daily. All patients underwent a C-13-urea breath test at 4 weeks after treatment. RESULTS: A total of 70 patients at a mean age of 43.5 years, including 36 men, were included in this trial. One person who violated the protocol was further excluded. The treatment compliance rate was 99.6%. The overall eradication rates of the 7-day bismuth-containing concomitant quintuple therapy were 75.4% (intention-to-treat analysis) and 86.7% (per-protocol analysis). The prevalence of side effects was 31.9%, including a bitter taste (23.2%), nausea (4.3%), dizziness (2.9%), diarrhea (2.9%), limb asthenia (2.9%), skin rash (1.4%), numbness of the tip of the tongue (1.4%) and insomnia (1.4%). CONCLUSIONS: The 7-day bismuth-containing concomitant quintuple therapy may not be superior to traditionally widely accepted therapy due to its lack of acceptable efficacy and high rate of side effects.