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Antioxidant therapy does not reduce pain in patients with chronic pancreatitis : The ANTICIPATE study.

Siriwardena, A. K. and Mason, J. M. and Sheen, A. J. and Makin, A. and Shah, N. (2012) 'Antioxidant therapy does not reduce pain in patients with chronic pancreatitis : The ANTICIPATE study.', Gastroenterology., 143 (3). pp. 655-663.


Background & Aims: We investigated whether antioxidant therapy reduces pain and improves quality of life in patients with chronic pancreatitis. Methods: We performed a double-blind, randomized, controlled trial that compared the effects of antioxidant therapy with placebo in 70 patients with chronic pancreatitis. Patients provided 1 month of baseline data and were followed up for 6 months while receiving either Antox version 1.2 (Pharma Nord, Morpeth, UK) or matched placebo (2 tablets, 3 times/d). The primary analysis was baseline-adjusted change in pain score at 6 months, assessed by an 11-point numeric rating scale. Secondary analyses included alternative analyses of clinic and diary pain scores, scores on quality-of-life tests (the EORTC-QLQ-C30, QLQ-PAN28, EuroQOL EQ-5D, and EQ visual analog score), levels of antioxidants, use of opiates, and adverse events. Analyses, reported by intention to treat, were prospectively protocol-defined. Results: After 6 months, pain scores reported to the clinic were reduced by 1.97 from baseline in the placebo group and by 2.33 in the antioxidant group but were similar between groups (−0.36; 95% confidence interval, −1.44 to 0.72; P = .509). Average daily pain scores from diaries were also similar (3.05 for the placebo group, 2.93 for the antioxidant group, a difference of 0.11; 95% confidence interval, 1.05–0.82; P = .808). Measures of quality of life were similar between groups, as was opiate use and number of hospital admissions and outpatient visits. Blood levels of vitamin C and E, β-carotene, and selenium were increased significantly in the antioxidant group. Conclusi1ons: In patients with painful chronic pancreatitis of predominantly alcoholic origin, antioxidant therapy did not reduce pain or improve quality of life, despite causing a sustained increase in blood levels of antioxidants. Trial registration: ISRCTN-21047731.

Item Type:Article
Keywords:Randomized clinical trial, Pancreatitis therapy, Treatment response, Efficacy.
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Publisher statement:NOTICE: this is the author’s version of a work that was accepted for publication in Gastroenterology. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Gastroenterology, 143/3, 2012, 10.1053/j.gastro.2012.05.046
Record Created:21 Aug 2012 09:35
Last Modified:02 Nov 2012 14:59

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