title: Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection.
abstract: With the rising prevalence of antimicrobial resistance, the failure rate of the standard triple therapy for Helicobacter pylori infection is increasing. Sequential therapy and concomitant therapy have been recommended to replace standard triple therapy for H. pylori eradication in regions with high clarithromycin resistance. The aim of this prospective, randomized, and controlled study was to simultaneously assess the efficacies of 10-day sequential and 7-day concomitant therapies versus a 7-day standard triple therapy for treating H. pylori infection. Consecutive H. pylori-infected subjects were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin, and metronidazole for a further 5 days), or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin, and metronidazole for 7 days). H. pylori status was confirmed 6 weeks after therapy. Three hundred seven H. pylori-infected participants were randomized to receive triple (n = 103), sequential (n = 102), or concomitant (n = 102) therapies. The eradication rates by an intention-to-treat analysis in the three treatment groups were 81.6% (95% confidence interval [CI], 74.1% to 89.0%), 89.2% (95% CI, 83.2% to 95.2%), and 94.1% (95% CI, 89.5% to 98.7%). The seven-day concomitant therapy had a higher eradication rate than did the 7-day triple therapy (difference, 12.5%; 95% CI, 3.7% to 21.3%). There were no significant differences in the eradication rates between the sequential and standard triple therapies. All three treatments exhibited similar frequencies of adverse events (8.7%, 8.8%, and 13.7%, respectively) and drug compliance (99.0%, 98.0%, and 100.0%, respectively). In conclusion, the seven-day concomitant therapy is superior to the 7-day standard triple therapy for H. pylori eradication. Additionally, it is less complex than the 10-day sequential therapy because the drugs are not changed halfway through the treatment course. (This study has been registered at ClinicalTrials.gov under registration no. NCT1769365.).
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and Faculty of Medicine, School of Medicine, National Yang-Ming University, Kaohsiung, Taipei, Taiwan.
authors: Ping-I
authors: PI
authors: Hsu
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors: Deng-Chyang
authors: DC
authors: Wu
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and Faculty of Medicine, School of Medicine, National Yang-Ming University, Kaohsiung, Taipei, Taiwan.
authors: Wen-Chi
authors: WC
authors: Chen
authors: Department of Pathology, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.
authors: Hui-Hwa
authors: HH
authors: Tseng
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and Faculty of Medicine, School of Medicine, National Yang-Ming University, Kaohsiung, Taipei, Taiwan.
authors: Hsien-Chung
authors: HC
authors: Yu
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and Faculty of Medicine, School of Medicine, National Yang-Ming University, Kaohsiung, Taipei, Taiwan.
authors: Huay-Min
authors: HM
authors: Wang
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and Faculty of Medicine, School of Medicine, National Yang-Ming University, Kaohsiung, Taipei, Taiwan.
authors: Sung-Shuo
authors: SS
authors: Kao
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and Faculty of Medicine, School of Medicine, National Yang-Ming University, Kaohsiung, Taipei, Taiwan.
authors: Kwok-Hung
authors: KH
authors: Lai
authors: Institute of Biomedical Sciences, National Sun Yat-Sen University, Kaohsiung, Taiwan.
authors: Angela
authors: A
authors: Chen
authors: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and Faculty of Medicine, School of Medicine, National Yang-Ming University, Kaohsiung, Taipei, Taiwan Cheng Shiu University, Kaohsiung, Taiwan fwchaie@vghks.gov.tw.
authors: Feng-Woei
authors: FW
authors: Tsay
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects / Q000472:pathogenicity*; D006801:Humans; D008875:Middle Aged; D000077402:Pantoprazole
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000658:Amoxicillin; D000077402:Pantoprazole; D017291:Clarithromycin