title: Feasibility of shortening 14-day hybrid therapy while maintaining an excellent Helicobacter pylori eradication rate.
abstract: BACKGROUND
  The need for new effective Helicobacter pylori eradication therapy has focused efforts on the development and optimization of regimens with excellent eradication rates such as 14-day hybrid therapy. This study evaluated whether the duration of hybrid therapy could be reduced while maintaining a high eradication rate and to examine the effect of antibiotic resistance on outcome.
  
  
  METHODS
  Three separate multicenter pilot studies were carried out concurrently. To reduce selection bias, eligible subjects were randomized to 10-day, 12-day, or 14-day hybrid therapy consisting of esomeprazole 40 mg and amoxicillin 1 gm twice daily for 10, 12, or 14 days plus clarithromycin 500 mg, and metronidazole 500 mg twice daily for the final 7 days. The primary outcome was H. pylori eradication per-protocol assessed at least 8 weeks after therapy.
  
  
  RESULTS
  A total of 220 subjects were entered. The per-protocol analyses contained 60, 61, 61 subjects in the 10-, 12- and 14-day therapy studies, respectively. The eradication rates, per-protocol, were similar: 95% (95% confidence interval (CI); 89.5-100%) for 10-day, 95.1% (95% CI; 89.7-100%) for 12-day, and 93.4% (95% CI; 87.2-99.7%) for 14-day hybrid therapies. Antibiotic resistance was infrequent; however, all metronidazole or clarithromycin resistances were cured with 12- and 14-day therapies.
  
  
  CONCLUSIONS
  These results suggest that in regions of moderate to low clarithromycin and/or metronidazole resistance it may be feasible to shorten hybrid therapy to 10 or 12 days. Further study is needed to compare hybrid and concomitant therapy in regions with moderate-to-high clarithromycin and/or metronidazole resistance.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Department of Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Division of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.
authors.forename: Jeng-Yih
authors.initials: JY
authors.lastname: Wu
authors.forename: Ping-I
authors.initials: PI
authors.lastname: Hsu
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
authors.forename: David Y
authors.initials: DY
authors.lastname: Graham
authors.forename: Wen-Ming
authors.initials: WM
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination / Q000379:methods; D064098:Esomeprazole / Q000008:administration & dosage; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D010865:Pilot Projects; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D064098:Esomeprazole
keywords: 14-day hybrid therapy; Helicobacter pylori eradication; amoxicillin; clarithromycin; clinical trial; metronidazole