title: Efficacy of rifabutin-based triple therapy as second-line treatment to eradicate helicobacter pylori infection.
abstract: BACKGROUND
  Rifabutin has been found to be effective in multi-resistant patients after various treatment cycles for Helicobacter pylori (HP) infection, but it has not been analysed as a second-line treatment. Therefore, we seek to compare the effectiveness of a treatment regimen including rifabutin versus conventional quadruple therapy (QT).
  
  
  METHODS
  Open clinical trial, randomised and multi-centre, of two treatment protocols: A) Conventional regime -QT- (omeprazole 20 mg bid, bismuth citrate 120 mg qid, tetracycline 500 mg qid and metronidazole 500 mg tid); B) Experimental one -OAR- (omeprazole 20 mg bid, amoxicillin 1 gr bid, and rifabutin 150 mg bid), both taken orally for 7 days, in patients with HP infection for whom first-line treatment had failed. Eradication was determined by Urea Breath Test (UBT). Safety was determined by the adverse events.
  
  
  RESULTS
  99 patients were randomised, QT, n = 54; OAR, n = 45. The two groups were homogeneous. In 8 cases, treatment was suspended (6 in QT and 2 in OAR). The eradication achieved, analysed by ITT, was for QT, 38 cases (70.4%), and for OAR, 20 cases (44.4%); p = 0.009, OR = 1.58. Of the cases analysed PP, QT were 77.1%; OAR, 46.5%; p = 0.002. Adverse effects were described in 64% of the QT patients and in 44% of the OAR patients (p = 0.04).
  
  
  CONCLUSIONS
  A 7-day rifabutin-based triple therapy associated to amoxicillin and omeprazole at standard dose was not found to be effective as a second-line rescue therapy. The problem with quadruple therapy lies in the adverse side effects it provokes. We believe the search should continue for alternatives that are more comfortably administered and that are at least as effective, but with fewer adverse side effects.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN81058036.
authors.affiliation: Unidad de Aparato Digestivo, Hospital Costa del Sol, Ctra Nacional 340, Marbella, Spain. jnavarro@hcs.es
authors.forename: José M
authors.initials: JM
authors.lastname: Navarro-Jarabo
authors.forename: Nuria
authors.initials: N
authors.lastname: Fernández
authors.forename: Francisca L
authors.initials: FL
authors.lastname: Sousa
authors.forename: Encarnación
authors.initials: E
authors.lastname: Cabrera
authors.forename: Manuel
authors.initials: M
authors.lastname: Castro
authors.forename: Luz M
authors.initials: LM
authors.lastname: Ramírez
authors.forename: Robin
authors.initials: R
authors.lastname: Rivera
authors.forename: Esther
authors.initials: E
authors.lastname: Ubiña
authors.forename: Francisco
authors.initials: F
authors.lastname: Vera
authors.forename: Isabel
authors.initials: I
authors.lastname: Méndez
authors.forename: Francisco
authors.initials: F
authors.lastname: Rivas-Ruiz
authors.forename: José L
authors.initials: JL
authors.lastname: Moreno
authors.forename: Emilio
authors.initials: E
authors.lastname: Perea-Milla
mesh_terms: D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D009942:Organometallic Compounds / Q000627:therapeutic use; D017828:Rifabutin / Q000627:therapeutic use*; D013752:Tetracycline; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D008795:Metronidazole; D017828:Rifabutin; D000658:Amoxicillin; D013752:Tetracycline; C002791:bismuth tripotassium dicitrate; D009853:Omeprazole