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Apparent Efficacy and Safety of Low Dose Naltrexone in Australian Patients with Active Crohn's Disease

Title
Apparent Efficacy and Safety of Low Dose Naltrexone in Australian Patients with Active Crohn's Disease
Publication Type
Abstract/Poster/Letter
Research Type
Human
Reported as
Clinical Trial
Date
October 01, 2013
Authors
Jackson, BD; Lewis, DJ; Beswick, L; Van Langenberg, D; Sparrow, M; Gibson, PR
Institution
Alfred Health; Eastern Health
Link
Abstract

INTRODUCTION: Open label and randomised controlled trial evidence indicates that low dose naltrexone (LDN), a strong opioid antagonist, has efficacy in reducing inflammatory activity in patients with Crohn’s disease. All evidence has come from one institution.

AIM: To examine local experience with LDN on disease activity and adverse events in patients with Crohn’s disease.

METHODS: Patients from Alfred and Eastern Healthwith Crohn’s disease who have been treated with LDN were identified from pharmacy records from March 2010 until April 2013. Disease activity was assessed by global physician assessment as documented in outpatient letters, and by endoscopic changes. Naltrexone was used at a dose of 4.5 mg once daily orally and was prepared by the hospital pharmacy into either a liquid or tablet form.

RESULTS: Fourteen patients were identified as using LDN (3 from The Alfred and 11 from Eastern Health). Patients were refractory to (n = 12) or unwilling to take immunomodulators (n = 2). Duration of therapy was a median of 5 (range 1-35) months. Clinical improvement occurred in 36% (5/14) of the patients and endoscopic improvement in four out of five patients who had a colonoscopy following the introduction of LDN. The clinical effect occurred within the first week in those who responded to LDN and persisted throughout the treatment course. Adverse effects occurred in three patients and these comprised of agitation, gastrointestinal symptoms and marginal hyperbilirubinaemia.

CONCLUSIONS: As per previous reports, LDN appears to be efficacious in a proportion of Australian patients with Crohn’s disease, particularly in those who were not taking immunomodulators. As a relatively inexpensive and well tolerated therapy, it may be a useful alternative treatment option to conventional immunomodulator therapy in active Crohn’s disease.