Efficacy of rifabutin-based triple therapy as second-line treatment to eradicate helicobacter pylori infection.
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.
Navarro-Jarabo
José M
JM
Unidad de Aparato Digestivo, Hospital Costa del Sol, Ctra Nacional 340, Marbella, Spain. jnavarro@hcs.es
Fernández
Nuria
N
Sousa
Francisca L
FL
Cabrera
Encarnación
E
Castro
Manuel
M
Ramírez
Luz M
LM
Rivera
Robin
R
Ubiña
Esther
E
Vera
Francisco
F
Méndez
Isabel
I
Rivas-Ruiz
Francisco
F
Moreno
José L
JL
Perea-Milla
Emilio
E
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
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