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 Nanchang 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 13 C-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.