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Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: a randomised trial
- Source :
- Gut
- Publication Year :
- 2015
- Publisher :
- BMJ Publishing Group, 2015.
-
Abstract
- Objective Significant 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. Design We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naive 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. Results The 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. Conclusions S10 was not superior to T14 in areas with low clarithromycin resistance. Trial registration number NCT01607918.
- Subjects :
- Adult
Male
medicine.medical_specialty
HELICOBACTER PYLORI - TREATMENT
Lansoprazole
CYP2C19
Pharmacology
Drug Administration Schedule
Helicobacter Infections
03 medical and health sciences
0302 clinical medicine
Clarithromycin
Internal medicine
Metronidazole
medicine
Ambulatory Care
Humans
Adverse effect
Breath test
biology
medicine.diagnostic_test
Helicobacter pylori
business.industry
Gastroenterology
Amoxicillin
Proton Pump Inhibitors
biology.organism_classification
ANTIBIOTIC THERAPY
Anti-Bacterial Agents
Hospitalization
Treatment Outcome
Breath Tests
030220 oncology & carcinogenesis
030211 gastroenterology & hepatology
Drug Therapy, Combination
Female
Drug Monitoring
business
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 14683288 and 00175749
- Volume :
- 65
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Gut
- Accession number :
- edsair.doi.dedup.....c8df09f4a21af66f445f8201593884d0