Abstract
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 13C‐urea breath test (13C‐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).
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