Sequential therapy for 10 days versus triple therapy for 14 days in the eradication ofHelicobacter pyloriin the community and hospital populations: a randomised trial.
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 ofHelicobacter pylori.We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies.



We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects withH pyloriinfection 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 negative13C-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.



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.



S10 was not superior to T14 in areas with low clarithromycin resistance.



NCT01607918.
Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Jyh-Ming
JM
Liou
Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Chieh-Chang
CC
Chen
Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan.
Chi-Yang
CY
Chang
Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Mei-Jyh
MJ
Chen
Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Chien-Chuan
CC
Chen
Departments of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University College of Medicine, Yun-Lin, Taiwan.
Yu-Jen
YJ
Fang
Departments of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University College of Medicine, Yun-Lin, Taiwan.
Ji-Yuh
JY
Lee
Departments of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University College of Medicine, Yun-Lin, Taiwan.
Tsung-Hua
TH
Yang
Department of Medicine, National Yang-Ming University, School of Medicine, and Taipei Veterans General Hospital, Taipei, Taiwan.
Jiing-Chyuan
JC
Luo
Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Jeng-Yih
JY
Wu
Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
Tai-Cherng
TC
Liou
Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
Wen-Hsiung
WH
Chang
Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan.
Yao-Chun
YC
Hsu
Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan.
Cheng-Hao
CH
Tseng
Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
Chun-Chao
CC
Chang
Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taitung, Taiwan.|Department of Nursing, Meiho University, Pingtung, Taiwan.
Ming-Jong
MJ
Bair
Lienchiang County Government and Health Bureau of Lienchiang County, Nangan Hsiang, Lienchiang County, Matsu, Taiwan.
Tzeng-Ying
TY
Liu
Lienchiang County Government and Health Bureau of Lienchiang County, Nangan Hsiang, Lienchiang County, Matsu, Taiwan.
Chun-Fu
CF
Hsieh
Lienchiang County Government and Health Bureau of Lienchiang County, Nangan Hsiang, Lienchiang County, Matsu, Taiwan.
Feng-Yun
FY
Tsao
Department of Pathology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Chia-Tung
CT
Shun
Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.|School of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.
Jaw-Town
JT
Lin
Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.|Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
Yi-Chia
YC
Lee
Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Ming-Shiang
MS
Wu
D000328:Adult; D000553:Ambulatory Care / Q000706:statistics & numerical data*; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D001944:Breath Tests / Q000379:methods; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D064747:Lansoprazole / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin
ANTIBIOTIC THERAPY; HELICOBACTER PYLORI - TREATMENT