Efficacy and safety of oral naltrexone treatment for pruritus of cholestasis, a crossover, double blind, placebo-controlled study
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.
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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”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [192]
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Effect of oral naltrexone on pruritus in cholestatic patients
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- Authors
- Terg, R., Coronel, E., Sordá, J., Muñoz, A. E., & Findor, J.
- Affiliations
- Universidad del Salvador (AR)
- Universidad de Buenos Aires (AR)
- Corresponding author
- Terg, Rubén
- ORCID
- Muñoz, Alberto E
- Venue
- Journal of Hepatology
- Publisher
- Elsevier BV
- Published
- 2002-12
- Volume
- 37
- Issue
- 6
- Pages
- 717-722
- ISSN
- 0168-8278 (ISSN-L)
- OpenAlex
- W2043872663
- Cited by
- 199
- References
- 8
- Citations by year
- 2026: 6 · 2025: 6 · 2024: 12 · 2023: 12 · 2022: 9 · 2021: 12 · 2020: 5 · 2019: 9 · 2018: 7 · 2017: 9 · 2016: 8 · 2015: 9 · 2014: 8 · 2013: 7 · 2012: 5
- FWCI
- 5.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Hepatology (publishedVersion)
- PubMed (publishedVersion)
- 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, opioid antagonists, opioid withdrawal, adverse events, placebo-controlled crossover trial
- MeSH terms
- Administration, Oral, Adult, Aged, Cholestasis, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Naltrexone, Narcotic Antagonists, Pain Measurement, Pruritus, Safety, Cross-Over Studies
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