Antioxidant Therapy does not reduce pain in patients with Chronic Pancreatitis: The ANTICIPATE study.

Link to article at PubMed

Antioxidant Therapy does not reduce pain in patients with Chronic Pancreatitis: The ANTICIPATE study.

Gastroenterology. 2012 Jun 5;

Authors: Siriwardena AK, Mason JM, Sheen AJ, Makin A, Shah N

Abstract
BACKGROUND AND 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 for 6 months while receiving either Antox version1.2 or matched placebo (2 tablets, 3 times daily). The primary analysis was baseline-adjusted change in pain score at 6 months, assessed by an 11-point numerical 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-VAS), 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%CI: -1.44 to 0.72, p=0.509). 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% CI, 1.05-0.82; P=0.808). Measures of quality of life were similar between groups, as was opiate use and numbers of hospital admissions and outpatient visits. Blood levels of vitamin C and E, ?-carotene, and selenium were significantly increased in the antioxidant group. CONCLUSIONS: 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.

PMID: 22683257 [PubMed - as supplied by publisher]

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