ObjectiveSignificant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies.DesignWe conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test.ResultsThe eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism.ConclusionsS10 was not superior to T14 in areas with low clarithromycin resistance.Trial registration numberNCT01607918.
Properly designed empirical therapy, based on medication history, is an acceptable alternative to genotypic resistance-guided therapy for eradication of refractory H pylori infection after consideration of accessibility, cost, and patient preference. ClinicalTrials.gov ID: NCT01725906.
This study aimed to evaluate the survival rate of women with breast cancer (BC) comparing persistence versus interruption and adherence versus non-adherence to adjuvant hormonal therapy (HT) in Asian population. Newly-diagnosed BC women from 2003 to 2010 were retrospectively identified from the Taiwan National Health Insurance Research Database. HT prescriptions were extracted to define treatment interruption and medication possession ratio. Their impacts on mortality were estimated by Cox regression with time dependent covariates. Interruption (HR: 1.32; 95% CI: 1.20, 1.46; P<0.0001) and non-adherence (HR: 1.45; 95% CI: 1.32, 1.59; P<0.0001) to adjuvant HT were significantly associated with increased mortality. Interruption to tamoxifen in younger patients and in patients receiving surgery (OP) with adjuvant chemotherapy (CT) was associated with increasing mortality rate when compared with their counterparts. Non-adherence to AIs in both younger and senior age groups and in OP with CT group also resulted in increasing risk. Treatment interruption and non-adherence to adjuvant HT were found to be associated with the increasing all-cause mortality of the Asian BC women; a greater impact of interruption and non-adherence on mortality was especially found in the younger BC population.
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