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Oral naltrexone treatment for cholestatic pruritus: A double-blind, placebo-controlled study
Open accessAbstract
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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“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 [191]
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Metadata
- 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
- bronze
- doi.org
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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