Efficacy of rifabutin-based triple therapy as second-line treatment to eradicate helicobacter pylori infection

José M Navarro-Jarabo¹ , Nuria Fernández¹ , Francisca L Sousa² , Encarnación Cabrera³ , Manuel Castro⁴ , Luz M Ramírez⁵ , Robin Rivera¹ , Esther Ubiña¹ , Francisco Vera¹ , Isabel Méndez¹ , Francisco Rivas-Ruiz⁶ , José L Moreno⁷ and Emilio Perea-Milla⁶

¹Unidad de Aparato Digestivo, Hospital Costa del Sol, Ctra Nacional 340, km 187, 29600 Marbella, Spain

²Sección de Aparato Digestivo, Hospital de Motril, Av. Enrique Martín Cuevas, S/N 18600 Motril, Spain

³Servicio de Aparato Digestivo, Hospital General de Especialidades de Jaén, Avda. del Ejército Español, 10. 23007 Jaén, Spain

⁴Servicio de Aparato Digestivo, Hospital Universitario Ntra. Sra. de Valme, Ctra. de Cádiz km. 548,9, 41014 Sevilla, Spain

⁵Sección de Aparato Digestivo, Hospital Comarcal Valle de los Pedroches, Juan del Rey Calero s/n, 14400 Pozoblanco, Córdoba, Spain

⁶Unidad de Apoyo a la Investigación, Hospital Costa del Sol, Ctra Nacional 340, km 187, 29600 Marbella, Spain

⁷Unidad de Farmacia, Hospital Costa del Sol, Ctra Nacional 340, km 187, 29600 Marbella, Spain

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BMC Gastroenterology 2007, 7:31doi:10.1186/1471-230X-7-31


Published:	25 July 2007

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).

Conclusion

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.

Trial Registration

Current Controlled Trials ISRCTN81058036