title: Randomized comparison of two non-bismuth-containing second-line rescue therapies for Helicobacter pylori.
abstract: BACKGROUND
  Classical second-line anti-Helicobacter pylori includes proton-pump inhibitor, tetracycline, metronidazole, and bismuth salts, but alternative therapies are required owing to the restricted availability of the latter. Levofloxacin-containing triple therapy is recommended but is expensive. Besides, quinolone resistance in an endemic tuberculosis infection area like Taiwan is concerned. The low in vitro antibiotic resistance to amoxicillin and tetracycline in Taiwanese H. pylori strains implies that in vivo esomeprazole/amoxicillin/tetracycline (EAT) second-line rescue therapy may be effective. This study compared the efficacy of esomeprazole/amoxicillin/levofloxacin (EAL) and EAT second-line eradication therapies and determines the clinical factors influencing the efficacy of salvage regimens.
  
  
  METHODS
  One hundred and twenty-eight patients who failed H. pylori eradication using the standard triple therapy for 7 days are randomly assigned to either EAL group (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, and levofloxacin 500 mg once daily) for 7 days or EAT group (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, tetracycline 500 mg four times daily) for 14 days. Follow-up endoscopy or urea breath test was performed 8 weeks later to assess treatment response.
  
  
  RESULTS
  The eradication rates of EAL and EAT groups were 78.1 versus 75.0%, p = .676 (in intention-to-treat analysis) and 80.3 versus 80%, p = .0964 (per-protocol analysis). Both groups exhibited similar drug compliance (95.3 vs 96.9%, p = .952) but more adverse events in the EAT group (6.3 vs 12.5%, p = .225).
  
  
  CONCLUSIONS
  Despite low in vitro drug resistances to amoxicillin and tetracycline, the efficacy of 14-day EAT regimens attained an unacceptable report card of 75% eradication rates in intention-to-treat analysis and was not even superior to the 7-day EAL regimen. Drug-drug interaction between combined antibiotics should be considered other than in vivo drug resistances.
authors.affiliation: Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Seng-Kee
authors.initials: SK
authors.lastname: Chuah
authors.forename: Ping-I
authors.initials: PI
authors.lastname: Hsu
authors.forename: Kuo-Chin
authors.initials: KC
authors.lastname: Chang
authors.forename: Yi-Chun
authors.initials: YC
authors.lastname: Chiu
authors.forename: Keng-Liang
authors.initials: KL
authors.lastname: Wu
authors.forename: Yeh-Pin
authors.initials: YP
authors.lastname: Chou
authors.forename: Ming-Luen
authors.initials: ML
authors.lastname: Hu
authors.forename: Wei-Chen
authors.initials: WC
authors.lastname: Tai
authors.forename: King-Wah
authors.initials: KW
authors.lastname: Chiu
authors.forename: Shue-Shian
authors.initials: SS
authors.lastname: Chiou
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
authors.forename: Tsung-Hui
authors.initials: TH
authors.lastname: Hu
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000502:physiology*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D013624:Taiwan
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D064098:Esomeprazole