Takeaway
- In patients with Helicobacter pylori infection, the eradication rate of 10-day four times daily (q.i.d) esomeprazole-amoxicillin dual therapy was unacceptable (<85%), whereas the 14-day three times daily (t.i.d) dual therapy was borderline acceptable as first-line therapy.
- The efficacy of dual therapy was significantly affected by smoking and poor compliance.
Why this matters
- Several randomised trials demonstrated that high-dose proton pump inhibitor-amoxicillin dual therapy q.i.d. for 14 days achieved an eradication rate of >85%.
- However, there is no clarity whether dual therapy with shorter treatment duration or lower dosing frequency could also attain a satisfactory cure rate
Study design
- In the intention-to-treat (ITT) analysis, 208 patients with H pylori infection were randomly assigned to receive 10-day (esomeprazole 20 mg and amoxicillin 750 mg q.i.d) and 14-day (esomeprazole 20 mg and amoxicillin 1000 mg t.i.d) dual therapy.
- Primary outcome: eradication rate of H pylori infection.
- Secondary outcomes: frequency of adverse events and patient compliance.
- Funding: The National Natural Science Foundation of China and others.
Key results
- In the ITT analysis, the eradication rates for 10-day q.i.d and 14-day t.i.d dual therapy were 79.8% (95% CI, 70.2-87.4%) and 83.5% (95% CI, 74.3-90.5%), respectively, as first-line therapy (P=.512).
- For rescue therapy, the eradication rates were 80% (95% CI, 44.4-97.5%) and 76.9% (95% CI, 46.2-95.0%) for 10-day q.i.d and 14-day t.i.d dual therapy, respectively (P=1.000).
- In multivariate analysis, the efficacy of esomeprazole-amoxicillin dual therapy was affected by smoking (OR, 0.4; 95% CI, 0.2-0.8; P=.017) and patients’ compliance (OR, 13.0; 95% CI, 1.1-146.2; P=.040).
- The prevalence of adverse events was 5.9% and 5.0% for 10-day q.i.d and 14-day t.i.d dual therapy, respectively.
References
References