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

• Published in: Gut Vol. 65; no. 11; pp. 1784 - 1792
• Main Authors: Liou, Jyh-Ming, Chen, Chieh-Chang, Chang, Chi-Yang, Chen, Mei-Jyh, Chen, Chien-Chuan, Fang, Yu-Jen, Lee, Ji-Yuh, Yang, Tsung-Hua, Luo, Jiing-Chyuan, Wu, Jeng-Yih, Liou, Tai-Cherng, Chang, Wen-Hsiung, Hsu, Yao-Chun, Tseng, Cheng-Hao, Chang, Chun-Chao, Bair, Ming-Jong, Liu, Tzeng-Ying, Hsieh, Chun-Fu, Tsao, Feng-Yun, Shun, Chia-Tung, Lin, Jaw-Town, Lee, Yi-Chia, Wu, Ming-Shiang
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.11.2016; BMJ Publishing Group
• Series: Original article
• Subjects: Adult; Ambulatory Care - statistics & numerical data; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Antibiotics; Asymptomatic; Breath tests; Breath Tests - methods; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Drug Administration Schedule; Drug Monitoring - methods; Drug resistance; Drug Therapy, Combination - methods; Female; Gastric cancer; Helicobacter Infections - diagnosis; Helicobacter Infections - drug therapy; Helicobacter Infections - microbiology; Helicobacter Pylori; Helicobacter pylori - drug effects; Helicobacter pylori - isolation & purification; Hospitalization - statistics & numerical data; Humans; Infections; Lansoprazole - administration & dosage; Lansoprazole - adverse effects; Male; Meta-analysis; Metronidazole - administration & dosage; Metronidazole - adverse effects; Proton Pump Inhibitors - administration & dosage; Proton Pump Inhibitors - adverse effects; Treatment Outcome; Matsu Island; Latin America; ANTIBIOTIC THERAPY; HELICOBACTER PYLORI - TREATMENT
• ISSN: 0017-5749; 1468-3288; 1468-3288
• DOI: 10.1136/gutjnl-2015-310142

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.