Oral naltrexone treatment for cholestatic pruritus: A double-blind, placebo-controlled study
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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.
“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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LaSalle, L., Rachelska, G., & Nedelec, B. (2008) · Burns · doi:10.1016/j.burns.2007.10.009 · Cited by 49 · see citing works
Pruritus and fatigue in primary biliary cirrhosis
Bergasa, N. V. (2003) · Clinics in Liver Disease · doi:10.1016/s1089-3261(03)00105-3 · Cited by 48 · see citing works
Clinical features and management of primary biliary cirrhosis
Crosignani, A., Battezzati, P. M., Invernizzi, P., Selmi, C. F., Prina, E., & Podda, M. (2008) · World Journal of Gastroenterology · doi:10.3748/wjg.14.3313 · Cited by 46 · see citing works
Efficacy of naltrexone on acetylcholine‐induced alloknesis in atopic eczema
Heyer, G., Groene, D., & Martus, P. (2002) · Experimental Dermatology · doi:10.1034/j.1600-0625.2002.110508.x · Cited by 46 · see citing works
PRIMARY BILIARY CIRRHOSIS AND PRIMARY SCLEROSING CHOLANGITIS
Angulo, P., & Lindor, K. D. (1999) · Clinics in Liver Disease · doi:10.1016/s1089-3261(05)70084-2 · Cited by 46 · see citing works
Are Peripheral Opioid Antagonists the Solution to Opioid Side Effects?
Bates, J. J., Foss, J. F., & Murphy, D. B. (2004) · Anesthesia & Analgesia · doi:10.1213/01.ane.0000090147.97636.77 · Cited by 46 · see citing works
Management of Pruritus in Primary Biliary Cholangitis: A Narrative Review
Trivedi, H. D., Lizaola‐Mayo, B., Tapper, E. B., & Bonder, A. (2017) · The American Journal of Medicine · doi:10.1016/j.amjmed.2017.01.037 · Cited by 45 · see citing works
Sleep disorder in patients with chronic liver disease: a narrative review
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Brewer, C. L., & Wong, V. S. (2004) · Addiction Biology · doi:10.1080/13556210410001674130 · Cited by 44 · see citing works
Diagnosis and management of chronic pruritus: An expert consensus review
Rajagopalan, M., Saraswat, A., Godse, K. V., Shankar, D. K., Kandhari, S., Shenoi, S. D., Tahiliani, S. T., & Zawar, V. (2017) · Indian Journal of Dermatology · doi:10.4103/0019-5154.198036 · Cited by 43 · see citing works
The pruritus of cholestasis: From bile acids to opiate agonists: Relevant after all these years
Bergasa, N. V. (2017) · Medical Hypotheses · doi:10.1016/j.mehy.2017.11.002 · Cited by 43 · see citing works
- 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
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