Sequential therapy for 10â
days versus triple therapy for 14â
days in the eradication of Helicobacter pylori in the community and hospital populations: a randomised trial.
Gut
; 65(11): 1784-1792, 2016 11.
Article
in En
| MEDLINE
| ID: mdl-26338825
ABSTRACT
OBJECTIVE:
Significant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10â days (S10) versus triple therapy for 14â 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 naïve to treatment were randomised (11) to receive S10 (lansoprazole and amoxicillin for the first 5â days, followed by lansoprazole, clarithromycin and metronidazole for another 5â days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14â days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6â 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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Helicobacter pylori
/
Helicobacter Infections
/
Clarithromycin
/
Lansoprazole
/
Ambulatory Care
/
Amoxicillin
/
Hospitalization
/
Metronidazole
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
En
Journal:
Gut
Year:
2016
Type:
Article
Affiliation country:
Taiwan