title: Comparison of Second-Line Quadruple Therapies with or without Bismuth for Helicobacter pylori Infection.
abstract: The bismuth-based quadruple regimen has been applied in Helicobacter pylori rescue therapy worldwide. The non-bismuth-based quadruple therapy or "concomitant therapy" is an alternative option in first-line eradication but has not been used in second-line therapy. Discovering a valid regimen for rescue therapy in bismuth-unavailable countries is important. We conducted a randomized controlled trial to compare the efficacies of the standard quadruple therapy and a modified concomitant regimen. One hundred and twenty-four patients were randomly assigned into two groups: RBTM (rabeprozole 20 mg bid., bismuth subcitrate 120 mg qid, tetracycline 500 mg qid, and metronidazole 250 mg qid) and RATM (rabeprozole 20 mg bid., amoxicillin 1 g bid., tetracycline 500 mg qid, and metronidazole 250 mg qid) for 10 days. The eradication rate of the RBTM and RATM regimen was 92.1% and 90.2%, respectively, in intention-to-treat analysis. Patients in both groups had good compliance (~96%). The overall incidence of adverse events was higher in the RATM group (42.6% versus 22.2%, P = 0.02), but only seven patients (11.5%) experienced grades 2-3 events. In conclusion, both regimens had good efficacy, compliance, and acceptable side effects. The 10-day RATM treatment could be an alternative rescue therapy in bismuth-unavailable countries.
authors.affiliation: Graduate Institute of Clinical Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Department of Internal Medicine, Kaohsiung Municipal United Hospital, Kaohsiung City 804, Taiwan.
authors.forename: Guang-Hong
authors.initials: GH
authors.lastname: Jheng
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan ; Department of Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Center for Stem Cell Research, Kaohsiung Medical University, Kaohsiung City 807, Taiwan.
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Wu
authors.affiliation: Department of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung City 812, Taiwan.
authors.forename: Hsiang-Yao
authors.initials: HY
authors.lastname: Shih
authors.affiliation: Department of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung City 812, Taiwan.
authors.forename: Meng-Chieh
authors.initials: MC
authors.lastname: Wu
authors.affiliation: School of Medicine, College of Medicine, E-Da Hospital, I-Shou University, Kaohsiung City 824, Taiwan.
authors.forename: Fu-Chen
authors.initials: FC
authors.lastname: Kuo
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan ; Department of Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Center for Stem Cell Research, Kaohsiung Medical University, Kaohsiung City 807, Taiwan.
authors.forename: Huang-Ming
authors.initials: HM
authors.lastname: Hu
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan ; Center for Stem Cell Research, Kaohsiung Medical University, Kaohsiung City 807, Taiwan.
authors.forename: Chung-Jung
authors.initials: CJ
authors.lastname: Liu
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan ; Department of Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Center for Stem Cell Research, Kaohsiung Medical University, Kaohsiung City 807, Taiwan.
authors.forename: Wen-Hung
authors.initials: WH
authors.lastname: Hsu
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Buddhist Tzu Chi General Hospital and School of Medicine, Tzu Chi University, Hualien 970, Taiwan.
authors.forename: Chi-Tan
authors.identifier: 0000-0001-7129-4497
authors.initials: CT
authors.lastname: Hu
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taitung Branch, Taitung City 950, Taiwan.
authors.forename: Ming-Jong
authors.initials: MJ
authors.lastname: Bair
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan ; Department of Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Center for Stem Cell Research, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Department of Internal Medicine, Kaohsiung Municipal Cijin Hospital, Kaohsiung City 812, Taiwan.
authors.forename: Chao-Hung
authors.identifier: 0000-0003-1847-395X
authors.initials: CH
authors.lastname: Kuo
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan ; Department of Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Center for Stem Cell Research, Kaohsiung Medical University, Kaohsiung City 807, Taiwan ; Department of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung City 812, Taiwan ; Center for Infectious Disease and Cancer Research, Kaohsiung Medical University, Kaohsiung City 807, Taiwan.
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, National Yang-Ming University, Kaohsiung 813, Taiwan.
authors.forename: Ping-I
authors.initials: PI
authors.lastname: Hsu
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D001729:Bismuth / Q000008:administration & dosage*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000472:pathogenicity; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D064750:Rabeprazole / Q000008:administration & dosage; D013752:Tetracycline / Q000008:administration & dosage
chemical_list: D008795:Metronidazole; D064750:Rabeprazole; D000658:Amoxicillin; D013752:Tetracycline; D001729:Bismuth