Antioxidant therapy does not reduce pain in patients with chronic pancreatitis: the ANTICIPATE study.
OBJECTIVE
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 antioxidant therapy (Antox version 1.2, Pharma Nord, Morpeth, UK) or matched placebo (2 tablets, 3 times/day). 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 assessments of clinical and diary pain scores, scores on quality-of-life tests (the European Organization for Research and Treatment of Cancer [EORTC-QLQ-C30], Quality of Life Questionnaire-Pancreatic modification [QLQ-PAN28], European Quality of Life questionnaire [EuroQOL EQ-5D], and European Quality of Life questionnaire - Visual Analog Score [EQ-VAS]), levels of antioxidants, use of opiates, and adverse events. Analyses, reported by intention to treat, were prospectively defined by protocol.


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 [CI], -1.44 to 0.72; P = .509). Average daily pain scores from diaries were also similar (3.05 for the placebo group and 2.93 for the antioxidant group, a difference of 0.11; 95% CI, 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.


CONCLUSIONS
Administration of antioxidants to patients with painful chronic pancreatitis of predominantly alcoholic origin does not reduce pain or improve quality of life, despite causing a sustained increase in blood levels of antioxidants.
Hepatobiliary Surgery Unit, Manchester Royal Infirmary, Manchester, United Kingdom. Electronic address: ajith.siriwardena@cmft.nhs.uk.
Ajith K
AK
Siriwardena
Durham Clinical Trials Unit, School of Medicine & Health, Wolfson Research Institute, Durham University, Durham, United Kingdom.
James M
JM
Mason
Hepatobiliary Surgery Unit, Manchester Royal Infirmary, Manchester, United Kingdom.
Aali J
AJ
Sheen
Department of Gastroenterology, Manchester Royal Infirmary, Manchester, United Kingdom.
Alistair J
AJ
Makin
Hepatobiliary Surgery Unit, Manchester Royal Infirmary, Manchester, United Kingdom.
Nehal S
NS
Shah
D000328:Adult; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004739:England; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D019512:Pancreatitis, Alcoholic / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D050500:Pancreatitis, Chronic / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000975:Antioxidants