Cited by 343Liver Diseases and ImmunityDermatology and Skin DiseasesPediatric Hepatobiliary Diseases and Treatments

Oral naltrexone treatment for cholestatic pruritus: A double-blind, placebo-controlled study

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Wolfhagen, FH, Sternieri, E, Hop, WC, Vitale, G, Bertolotti, M, Van Buuren, HR·1997·Gastroenterology

Abstract

Background & aims The efficacy of currently available therapeutic agents for cholestatic pruritus is often disappointing. The aim of this study was to assess the antipruritic effect of naltrexone, an oral opiate receptor antagonist. Methods Sixteen patients with pruritus of chronic cholestasis were randomized to receive naltrexone (4-week course of 50 mg naltrexone daily) or placebo. Pruritus, quality of sleep, fatigue (using visual analogue scales), side effects, and liver function were assessed every 2 weeks. Serum naltrexone and 6 beta-naltrexol concentrations in all patients and 5 healthy controls were measured during the first day of naltrexone treatment. Results Mean changes with respect to baseline were significantly different, in favor of the naltrexone group, for daytime itching (-54% vs. 8%; P < 0.001) and nighttime itching (-44% vs. 7%, P = 0.003). In 4 naltrexone-treated patients, side effects (transient in 3 cases) consistent with an opiate withdrawal syndrome were noted. No deterioration of the underlying disease was observed. Naltrexone and 6 beta-naltrexol levels did not differ between patients and controls, and there was no significant association with treatment response. Conclusions For patients with cholestatic liver disease and itching, refractory to regular antipruritic therapy, oral naltrexone may be an effective and well-tolerated alternative.

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Crossref · 10.1053/gast.1997.v113.pm9322521

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  • Opiate antagonists (oral naltrexone and parenteral naloxone) are increasingly used as third-line therapy as they reduce the sensation of itching and scratching activity.

    “Opiate antagonists (oral naltrexone and parenteral naloxone) are increasingly used as third-line therapy as they reduce the sensation of itching and scratching activity.186 190–192”

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Authors
Wolfhagen, F., Sternieri, E., Hop, W., Vitale, G., Bertolotti, M., & Van Buuren, H.
Affiliations
Erasmus MC (NL)
Venue
Gastroenterology
Publisher
Elsevier BV
Published
1997-10
Volume
113
Issue
4
Pages
1264-1269
ISSN
0016-5085 (ISSN-L)
OpenAlex
W2008756039
Cited by
343
References
10
Citations by year
2026: 7 · 2025: 4 · 2024: 10 · 2023: 12 · 2022: 12 · 2021: 9 · 2020: 7 · 2019: 9 · 2018: 11 · 2017: 9 · 2016: 15 · 2015: 15 · 2014: 14 · 2013: 5 · 2012: 7
FWCI
6.93
Type
journal article
Language
en
Open access
Locations
  • Gastroenterology (publishedVersion)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
  • RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
  • IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
Topics
  • Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
  • Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
  • Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
Keywords
naltrexone, cholestatic pruritus, chronic cholestasis, antipruritic therapy, opioid antagonists, opioid withdrawal, sleep quality, fatigue, drug tolerability
MeSH terms
Administration, Oral, Adult, Aged, Cholestasis, Double-Blind Method, Fatigue, Female, Humans, Liver Cirrhosis, Biliary, Male, Middle Aged, Naltrexone, Narcotic Antagonists, Placebos, Pruritus, Cholangitis, Sclerosing

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