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Randomized, double-blind, placebo-controlled trial of intravenous (n-acetylcysteine, selenium, vitamin c) antioxidant therapy in severe acute pancreatitis

Siriwardena, A.K.; Mason, J.M.; Balachandra, S.; Bagul, A.; Galloway, S.; Formela, L.; Hardman, J.G.; Jamdar, S.

Authors

A.K. Siriwardena

J.M. Mason

S. Balachandra

A. Bagul

S. Galloway

L. Formela

J.G. Hardman

S. Jamdar



Abstract

Background: Based on equivocal clinical data, intravenous antioxidant therapy has been used for the treatment of severe acute pancreatitis. To date there is no randomised comparison of this therapy in severe acute pancreatitis. Methods: We conducted a randomised, double blind, placebo controlled trial of intravenous antioxidant (n-acetylcysteine, selenium, vitamin C) therapy in patients with predicted severe acute pancreatitis. Forty-three patients were enrolled from three hospitals in the Manchester (UK) area over the period June 2001 to November 2004. Randomisation stratified for APACHE-II score and hospital site, and delivered groups that were similar at baseline. Results: Relative serum levels of antioxidants rose while markers of oxidative stress fell in the active treatment group during the course of the trial. However, at 7 days, there was no statistically significant difference in the primary end point, organ dysfunction (antioxidant vs placebo: 32% vs 17%, p = 0.33) or any secondary end point of organ dysfunction or patient outcome. Conclusions: This study provides no evidence to justify continued use of n-acetylcysteine, selenium, vitamin C based antioxidant therapy in severe acute pancreatitis. In the context of any future trial design, careful consideration must be given to the risks raised by the greater trend towards adverse outcome in patients in the treatment arm of this study.

Citation

Siriwardena, A., Mason, J., Balachandra, S., Bagul, A., Galloway, S., Formela, L., …Jamdar, S. (2007). Randomized, double-blind, placebo-controlled trial of intravenous (n-acetylcysteine, selenium, vitamin c) antioxidant therapy in severe acute pancreatitis. Gut, 56(10), 1439-1444. https://doi.org/10.1136/gut.2006.115873

Journal Article Type Article
Publication Date Oct 1, 2007
Deposit Date May 11, 2010
Journal Gut
Print ISSN 0017-5749
Electronic ISSN 1468-3288
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 56
Issue 10
Pages 1439-1444
DOI https://doi.org/10.1136/gut.2006.115873