Titre du document / Document title

Efficacy and safety of oral naltrexone treatment for pruritus of cholestasis, a crossover, double blind, placebo-controlled study

Auteur(s) / Author(s)

TERG Rubén ⁽¹⁾ ; CORONEL Emma ⁽¹⁾ ; SORDA Juan ⁽²⁾ ; MUNOZ Alberto E. ⁽¹⁾ ; FINDOR Jorge ⁽²⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Unidad de Heppatología, Hospital de Gastroenterología Bonorino Udaondo, Escuela de Medicina, Universidad del Salvador, Avenida Caseros, 2061 (1264), Buenos Aires, ARGENTINE
⁽²⁾ Hospital de Clínicas, Escuela de Medicina, Universidad de Buenos Aires, Buenos Aires, ARGENTINE

Résumé / Abstract

Background/Aims: To assess the efficacy and safety of naltrexone for the short and long term treatment of pruritus of cholestasis. Methods: Twenty patients with pruritus and cholestasis were included. A baseline pruritus score was obtained over 1 week. Patients were then randomized to receive 50 mg/day of naltrexone or placebo for 2 weeks. Subsequently, a 1-week washout period ensued and patients were crossed over to the other therapy for 2 additional weeks. Pruritus was assessed daily with a visual analogue scale (VAS) from 0 to 10. Patients whose pruritus decreased >50% of basal with naltrexone received naltrexone 50 mg/day for 2 additional months. Results: Mean basal VAS was similar in both groups. VAS showed greater and more significant changes with naltrexone than with placebo (P < 0.0003).In nine out of 20 patients (45%) receiving naltrexone, pruritus decreased >50% compared to basal value, including five whose pruritus disappeared completely. No significant changes were observed in serum biochemistry. Most of the adverse events that occurred during the first 48 h of naltrexone therapy were consistent with opioid withdrawal-like phenomena and spontaneously disappeared 2 days after starting treatment. Conclusions: Naltrexone can be considered as an alternative option to treat pruritus of cholestasis. In the current study, side effects were transient and did not require specific medication.

Revue / Journal Title

Journal of hepatology   ISSN 0168-8278   CODEN JOHEEC 

Source / Source

2002, vol. 37, n^o6, pp. 717-722 [6 page(s) (article)] (41 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier, Oxford, ROYAUME-UNI  (1985) (Revue)

Mots-clés d'auteur / Author Keywords

Cholestasis ; Pruritus ; Naltrexone ;

Localisation / Location

INIST-CNRS, Cote INIST : 20706, 35400010686476.0020