title: A Randomized Controlled Study Comparing Reverse Hybrid Therapy and Standard Triple Therapy for Helicobacter pylori Infection.
abstract: Reverse hybrid therapy is an 1-step 2-phase treatment for Helicobacter pylori (H. pylori) infection with less cost than standard triple therapy. We conducted a randomized, controlled study to compare the efficacies of standard triple therapy and reverse hybrid therapy in the treatment of H. pylori infection. From October 2012 to March 2015, consecutive H. pylori-infected subjects were randomly allocated to receive either a reverse hybrid therapy (pantoprazole plus amoxicillin for 12 days and clarithromycin plus metronidazole for the initial 7 days) or a standard triple therapy (pantoprazole plus amoxicillin and clarithromycin for 12 days). H. pylori status was assessed 6 weeks after treatment. Additionally, antibiotic resistances and host CYP2C19 genotypes were examined and analyzed. A total of 440 H. pylori-infected patients were randomly assigned to receive either a reverse hybrid (n = 220) or a standard triple therapy (n = 220). The reverse hybrid group had a higher eradication rate than standard triple group either by intention-to-treat (93.6% vs. 86.8%; P = 0.016) or per-protocol analysis (95.7% vs. 88.3%; P = 0.005). The 2 patient groups exhibited similar frequencies of overall adverse events (14.1% vs. 9.5%) and drug compliance (96.8% vs. 98.6%). Clarithromycin resistance was an independent risk factor predicting eradication failure in standard triple group (P < 0.001), but not in reverse hybrid group. CYP2C19 genotypes did not affect the eradication rates in both groups. Reverse hybrid therapy can be considered for first-line treatment of H. pylori infection since the new therapy achieves a higher eradication rate than standard triple therapy with similar tolerability and less pharmaceutical cost.
authors.affiliation: From the Division of Gastroenterology, Kaohsiung, Taiwan (P-IH, S-SK, W-CC, H-CY, H-MW, K-HL, J-S C, F-WT); Department of Internal Medicine, Kaohsiung, Taiwan; Department of Nuclear Medicine, Kaohsiung, Taiwan (N-JP); Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan; Division of Gastroenterology, Kaohsiung, Taiwan (D-CW); Department of Internal Medicine and Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Department of Medicine, Kaohsiung, Taiwan (D-CW); Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Institute of Biomedical Sciences, Kaohsiung, Taiwan (AC), National Sun Yat-Sen University, Kaohsiung, Taiwan; Division of Hepato-Gastroenterology, Kaohsiung, Taiwan (S-KC); and Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Ping-I
authors.initials: PI
authors.lastname: Hsu
authors.forename: Sung-Shuo
authors.initials: SS
authors.lastname: Kao
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
authors.forename: Wen-Chi
authors.initials: WC
authors.lastname: Chen
authors.forename: Nan-Jing
authors.initials: NJ
authors.lastname: Peng
authors.forename: Hsien-Chung
authors.initials: HC
authors.lastname: Yu
authors.forename: Huay-Min
authors.initials: HM
authors.lastname: Wang
authors.forename: Kwok-Hung
authors.initials: KH
authors.lastname: Lai
authors.forename: Jin-Shiung
authors.initials: JS
authors.lastname: Cheng
authors.forename: Angela
authors.initials: A
authors.lastname: Chen
authors.forename: Seng-Kee
authors.initials: SK
authors.lastname: Chuah
authors.forename: Feng-Woei
authors.initials: FW
authors.lastname: Tsay
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000235:genetics; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D016037:Single-Blind Method
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D000077402:Pantoprazole; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D017291:Clarithromycin