MI Prince
Oral antioxidant supplementation for fatigue associated with primary biliary cirrhosis: results of a multicentre, randomized, placebo-controlled, cross-over trial
Prince, MI; Mitchison, HC; Ashley, D; Burke, DA; Edwards, N; Bramble, MG; James, OF; Jones, DE
Authors
HC Mitchison
D Ashley
DA Burke
N Edwards
MG Bramble
OF James
DE Jones
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.
Citation
Prince, M., Mitchison, H., Ashley, D., Burke, D., Edwards, N., Bramble, M., …Jones, D. (2003). Oral antioxidant supplementation for fatigue associated with primary biliary cirrhosis: results of a multicentre, randomized, placebo-controlled, cross-over trial. Alimentary Pharmacology and Therapeutics, 17(1), 137-143. https://doi.org/10.1046/j.1365-2036.2003.01398.x
Journal Article Type | Article |
---|---|
Publication Date | Jan 1, 2003 |
Deposit Date | Dec 1, 2008 |
Journal | Alimentary Pharmacology and Therapeutics |
Print ISSN | 0269-2813 |
Electronic ISSN | 1365-2036 |
Publisher | Wiley |
Peer Reviewed | Peer Reviewed |
Volume | 17 |
Issue | 1 |
Pages | 137-143 |
DOI | https://doi.org/10.1046/j.1365-2036.2003.01398.x |
You might also like
Downloadable Citations
About Durham Research Online (DRO)
Administrator e-mail: dro.admin@durham.ac.uk
This application uses the following open-source libraries:
SheetJS Community Edition
Apache License Version 2.0 (http://www.apache.org/licenses/)
PDF.js
Apache License Version 2.0 (http://www.apache.org/licenses/)
Font Awesome
SIL OFL 1.1 (http://scripts.sil.org/OFL)
MIT License (http://opensource.org/licenses/mit-license.html)
CC BY 3.0 ( http://creativecommons.org/licenses/by/3.0/)
Powered by Worktribe © 2024
Advanced Search