ArticleJournal of gastroenterology2018
Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study.
Article in Journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- European S2k Guideline on Chronic PruritusActa dermato-venereologica · 2025Guideline
- Cholestatic Pruritus Treatments in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: A Systematic Literature Review.Digestive diseases and sciences · 2023Pooled it
- Efficacy of Treatments for Cholestatic Pruritus: A Systemic Review and Meta-analysis.Acta dermato-venereologica · 2022Pooled it
- Pruritus in Chronic Cholestatic Liver Diseases, Especially in Primary Biliary Cholangitis: A Narrative Review.International journal of molecular sciences · 2025Review
- Review
- Review
- Systematic review: efficacy of therapies for cholestatic pruritus.Therapeutic advances in gastroenterology · 2023Review
- Cholestatic Itch: Our Current Understanding of Pathophysiology and Treatments.American journal of clinical dermatology · 2022Review
- Novel Kappa-Opioid Receptor Agonist for the Treatment of Cholestatic Pruritus: Systematic Review.JMIR dermatology · 2022Article
- APASL clinical practice guidance: the diagnosis and management of patients with primary biliary cholangitis.Hepatology international · 2022Article
- Antipruritic Effects of Kappa Opioid Receptor Agonists: Evidence from Rodents to Humans.Handbook of experimental pharmacology · 2022Article
- Antipruritic Effect of Nalbuphine, a Kappa Opioid Receptor Agonist, in Mice: A Pan Antipruritic.Molecules (Basel, Switzerland) · 2021Article
- Evidence-based clinical practice guidelines for Liver Cirrhosis 2020.Journal of gastroenterology · 2021Review
- Pruritus is common in patients with chronic liver disease and is improved by nalfurafine hydrochloride.Scientific reports · 2021Article
- Cholestasis-Associated Pruritus and Its Pruritogens.Frontiers in medicine · 2021Review
- Current understanding of primary biliary cholangitis.Clinical and molecular hepatology · 2021Review
- Anxiety and Depression in Patients with Primary Biliary Cholangitis: Current Insights and Impact on Quality of Life.Hepatic medicine : evidence and research · 2021Review
- Clinical Management of Primary Biliary Cholangitis-Strategies and Evolving Trends.Clinical reviews in allergy & immunology · 2020Review
- Considerations of elderly factors to manage the complication of liver cirrhosis in elderly patients.World journal of gastroenterology · 2019Review
- [Treatment of chronic pruritus-what is new?]Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2018Review
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundPatients with primary biliary cholangitis (PBC) frequently suffer from pruritus, which can severely impair their health-related quality of life (HRQOL). Nalfurafine hydrochloride, a selective κ-opioid receptor agonist, was recently approved in Japan for refractory pruritus in patients with chronic liver diseases, but it still remains unclear whether this treatment improves the patient-reported outcome (PRO) in PBC patients with refractory pruritus. Herein, we conducted a multicenter, post-marketing, single-arm prospective study to investigate the efficacy of nalfurafine in terms of PRO, and the associations of the efficacy with any clinical characteristics.
methodsAfter screening for pruritus in 496 patients with PBC using PBC-40 and the visual analog scale (VAS), we identified 141 patients with moderate to severe pruritus; these were invited to participate in the study. The participants received 2.5 μg nalfurafine once daily for 12 weeks, and pruritus and HRQOL were assessed in week 12 of this treatment. Generic HRQOL, short form 36, blood chemistries, and serum autotaxin levels were also measured at baseline and at week 12.
resultsForty-four patients participated in this study. The mean PBC-40 itch domain scores and VAS declined during the study period, from 8.56 to 7.63 (P = 0.041) and from 42.9 to 29.3 (P = 0.001) at baseline and at week 12, respectively, indicating a significant effect of nalfurafine. The other domains of PBC-40 and all domains of SF-36 were not significantly altered by this treatment. We failed to find any association between the change in VAS and PBC-40 itch scores and any clinical variable. Serum autotaxin levels were significantly increased during the study period.
conclusionsThis study demonstrated that nalfurafine improved pruritus in patients with PBC, independent of their clinical characteristics, but had a limited effect on the PRO.
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