Half-dose clarithromycin-containing bismuth quadruple therapy is effective and economical in treating Helicobacter pylori infection: A single-center, open-label, randomized trial.

BACKGROUND: Clarithromycin-containing bismuth quadruple therapy has been recommended as the first-line therapy for H pylori infection in China. However, its expensive cost and high antibiotic-related adverse reactions are always haunting us. To find a safer, more cost-effective, and high eradicative strategy for Helicobacter treatment, we investigated the efficacy of 14-day bismuth quadruple therapy and different doses of clarithromycin in the first-line treatment.

METHOD: A total of 210 patients with H pylori infection were recruited and randomly assigned to half-dose clarithromycin group (esomeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 250 mg bid, and bismuth potassium citrate 0.6 g bid) for 14 days or standard-dose clarithromycin group (esomeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and bismuth potassium citrate 0.6 g bid) for 14 days. A 13 C-urea breath test (13 C-UBT) was performed at least 4 weeks after treatment. The eradication rate of H pylori, the incidence of side effects, and the cost-effectiveness of regimens were evaluated in this study.

RESULTS: The eradication frequencies were 86.67% for both groups in the intention-to-treat analysis, while the per-protocol eradication rates were 91% vs. 91.92% (p=0.817). The incidence of adverse events was higher in standard dose group (54.21% vs. 34.29%; p=0.004), especially bitter taste symptom. There was a higher level of costs per person associated with the standard-dose group as compared with half-dose group (￥804.3 vs ￥654.36). The cost-effectiveness ratio of the half dose was less than that of the standard dose (7.55 vs 9.16 CNY per percent).

CONCLUSIONS: A 14-day half-dose clarithromycin-containing bismuth quadruple regimen is as effective as the standard bismuth quadruple therapy at eradicating H pylori, which is better tolerated and more economical. (ChiCTR-ROC-15007406).