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Oral antioxidant supplementation for fatigue associated with primary biliary cirrhosis: Results of a multicentre, randomized, placebo-controlled, cross-over trial

Lookup NU author(s): Dr Martin Prince, Dr Nia Edwards, Dr Michael Bramble, Emeritus Professor Oliver James, Professor David Jones

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Abstract

Background: We have previously reported, in an uncontrolled trial, an improvement in fatigue scores in patients with primary biliary cirrhosis given oral antioxidant supplementation. We now present data from a controlled trial. Patients and methods: Sixty-one patients with primary biliary cirrhosis-associated fatigue were randomized into a double-blind, placebo-controlled, cross-over trial. Participants received 12 weeks each of placebo and antioxidant supplementation (vitamins A, C and E, selenium, methionine and ubiquinone) in random order, separated by a 4-week washout period. The primary trial outcome (fatigue) was assessed using the Fisk scale. Other symptoms of primary biliary cirrhosis were measured using Likert and visual analogue scales. Results: Forty-four patients completed both arms of the trial. No significant changes in fatigue were recorded in the active phase of treatment (median improvement in Fisk score, 1; P=0.61). Small improvements in Fisk scores were recorded during placebo therapy (median improvement, 4; P = 0.03). Neither medication was associated with improvement in any other symptoms related to primary biliary cirrhosis. Adverse effects were more common during active therapy and were mild and self-limiting. One patient died from unrelated causes during active treatment. Conclusions: Although oral antioxidant supplementation appears to be safe, we could not find any evidence for a beneficial effect on fatigue or other liver-related symptoms.


Publication metadata

Author(s): Prince MI, Mitchison HC, Ashley D, Burke DA, Edwards N, Bramble MG, James OFW, Jones DEJ

Publication type: Article

Publication status: Published

Journal: Alimentary Pharmacology and Therapeutics

Year: 2003

Volume: 17

Issue: 1

Pages: 137-143

ISSN (print): 0269-2813

ISSN (electronic): 1365-2036

Publisher: Wiley-Blackwell

URL: http://dx.doi.org/10.1046/j.1365-2036.2003.01398.x

DOI: 10.1046/j.1365-2036.2003.01398.x

PubMed id: 12492743


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