title: A Triple and Quadruple Therapy with Doxycycline and Bismuth for First-Line Treatment of Helicobacter pylori Infection: A Pilot Study.
abstract: BACKGROUND
  Tetracycline-containing triple therapy has been suggested as an alternative first-line therapy for H. pylori infection.
  
  
  OBJECTIVE
  To evaluate the effect of two dosages of doxycycline (DOX) associated with amoxicillin and esomeprazole with and without bismuth subcitrate as first-line treatment of H. pylori infection.
  
  
  METHODS
  Helicobacter pylori-positive patients underwent a 10-day therapy randomized into four groups: Group A received esomeprazole, amoxicillin, and DOX-100 mg b.i.d. (EAD-100), Group B a quadruple therapy with esomeprazole, amoxicillin, DOX-100 mg b.i.d. and bismuth subcitrate (EADB-100), Group C a triple therapy with esomeprazole, amoxicillin, and DOX-200 mg b.i.d. (EAD-200) and Group D a quadruple therapy with esomeprazole, amoxicillin, DOX-200 mg b.i.d., and bismuth subcitrate (EADB-200). Success was accessed by (13)C urea breath test 2 months after the end of treatment. The number of patients to be recruited for each group had to be at least 50 subjects. Treatment success of 80% or less was considered unacceptable. Stopping rules therefore were anytime six failures had occurred.
  
  
  RESULTS
  In the EAD-100 group and in EAD-200 group, the recruitment was stopped at the 14th and 15th patient, respectively. Fifty-two patients entered in the EADB-100 group and 51 in the EADB-200 group. Intention to treat eradication was in EADB-100 group 46/52 (88.5%, 95% CI 76.6-95.6); in the EADB-200 group 47/51 (92.1%, 95% CI: 81.1-97.8) (n.s.). Side effects were absent.
  
  
  CONCLUSIONS
  The adjunction of bismuth subcitrate to a triple therapy that includes esomeprazole, amoxicillin, and DOX in patients who are treated for the first time for the H. pylori infection potentiates the therapeutic effect. This regimen, however, deserves to be optimized in terms of duration and dose of DOX.
authors: Digestive Physiopathology Unit, Pescara Civic Hospital, G. d'Annunzio University, Via Fonte Romana 8, 65124, Pescara, Italy.
authors: Antonio Francesco
authors: AF
authors: Ciccaglione
authors: Department of Drug Sciences, G. d'Annunzio University, Via dei Vestini, 66013, Chieti, Italy.
authors: Luigina
authors: L
authors: Cellini
authors: Digestive Physiopathology Unit, Pescara Civic Hospital, G. d'Annunzio University, Via Fonte Romana 8, 65124, Pescara, Italy.
authors: Laurino
authors: L
authors: Grossi
authors: Department of Medicine and Aging Sciences, G. d'Annunzio University, Via dei Vestini, 66013, Chieti, Italy.
authors: Lamberto
authors: L
authors: Manzoli
authors: Digestive Physiopathology Unit, Pescara Civic Hospital, G. d'Annunzio University, Via Fonte Romana 8, 65124, Pescara, Italy.
authors: Leonardo
authors: L
authors: Marzio
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001729:Bismuth / Q000008:administration & dosage*; D004318:Doxycycline / Q000008:administration & dosage*; 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*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D004318:Doxycycline; D064098:Esomeprazole; D001729:Bismuth
keywords: DOX; Helicobacter pylori infection; amoxicillin; bismuth subcitrate; first-line therapy; quadruple therapy