title: Concomitant and hybrid therapy for Helicobacter pylori infection: A randomized clinical trial.
abstract: OBJECTIVE
  This study aimed to validate the equivalence of first-line concomitant and hybrid regimens for Helicobacter pylori infection in an era of increasing antibiotic resistance. The study also aimed to assess regimen compliance.
  
  
  METHODS
  H. pylori-infected patients from six hospitals in Korea were randomly assigned to either concomitant or hybrid regimens. The concomitant regimen consisted of 20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg metronidazole, twice daily for 10 days. The hybrid regimen consisted of a 5-day dual therapy (20 mg of esomeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day quadruple therapy (20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily).
  
  
  RESULTS
  Eradication rates for concomitant and hybrid therapy were 78.6% (187/238) and 78.8% (190/241) in the intention-to-treat analysis, and 89.8% (176/196) and 89.6% (181/202) in the per protocol analysis. For both analyses, 95% confidence intervals fell within the ± 8% equivalence margin. Adherence was better in the hybrid group (95.0%) than in the concomitant group (90.1%), a difference that was borderline significant (P = 0.051). Adverse event rates were higher in the concomitant group than in the hybrid group for nausea (15.8% vs 8.8%; P = 0.028) and regurgitation (17.6% vs 10.7%; P = 0.040).
  
  
  CONCLUSIONS
  As compared with concomitant therapy, hybrid therapy offered similar efficacy, better compliance, and fewer adverse events. Hybrid therapy could be a reasonable first-line treatment option for H. pylori in areas with high antibiotics resistance.
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
authors: Jun
authors: J
authors: Heo
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
authors: Seong Woo
authors: SW
authors: Jeon
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
authors: Jin Tae
authors: JT
authors: Jung
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
authors: Joong Goo
authors: JG
authors: Kwon
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
authors: Dong Wook
authors: DW
authors: Lee
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Daegu Fatima Hospital, Daegu, Korea.
authors: Hyun Soo
authors: HS
authors: Kim
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Dongguk University Gyeongju Hospital, Gyeongju, Korea.
authors: Chang Hun
authors: CH
authors: Yang
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Dongguk University Gyeongju Hospital, Gyeongju, Korea.
authors: Jeong Bae
authors: JB
authors: Park
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
authors: Kyung Sik
authors: KS
authors: Park
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
authors: Kwang Bum
authors: KB
authors: Cho
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
authors: Si Hyung
authors: SH
authors: Lee
authors: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
authors: Byung Ik
authors: BI
authors: Jang
mesh_terms: D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology*; D016481:Helicobacter Infections; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D064098:Esomeprazole
keywords: Helicobacter pylori; peptic ulcer diseases; stomach; treatment and antimicrobial resistance