Tags

Type your tag names separated by a space and hit enter

Antioxidant therapy does not reduce pain in patients with chronic pancreatitis: the ANTICIPATE study.
Gastroenterology 2012; 143(3):655-663.e1G

Abstract

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 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.

Authors+Show Affiliations

Hepatobiliary Surgery Unit, Manchester Royal Infirmary, Manchester, United Kingdom. Electronic address: ajith.siriwardena@cmft.nhs.uk.Durham Clinical Trials Unit, School of Medicine & Health, Wolfson Research Institute, Durham University, Durham, United Kingdom.Hepatobiliary Surgery Unit, Manchester Royal Infirmary, Manchester, United Kingdom.Department of Gastroenterology, Manchester Royal Infirmary, Manchester, United Kingdom.Hepatobiliary Surgery Unit, Manchester Royal Infirmary, Manchester, United Kingdom.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22683257

Citation

Siriwardena, Ajith K., et al. "Antioxidant Therapy Does Not Reduce Pain in Patients With Chronic Pancreatitis: the ANTICIPATE Study." Gastroenterology, vol. 143, no. 3, 2012, pp. 655-663.e1.
Siriwardena AK, Mason JM, Sheen AJ, et al. Antioxidant therapy does not reduce pain in patients with chronic pancreatitis: the ANTICIPATE study. Gastroenterology. 2012;143(3):655-663.e1.
Siriwardena, A. K., Mason, J. M., Sheen, A. J., Makin, A. J., & Shah, N. S. (2012). Antioxidant therapy does not reduce pain in patients with chronic pancreatitis: the ANTICIPATE study. Gastroenterology, 143(3), pp. 655-663.e1. doi:10.1053/j.gastro.2012.05.046.
Siriwardena AK, et al. Antioxidant Therapy Does Not Reduce Pain in Patients With Chronic Pancreatitis: the ANTICIPATE Study. Gastroenterology. 2012;143(3):655-663.e1. PubMed PMID: 22683257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antioxidant therapy does not reduce pain in patients with chronic pancreatitis: the ANTICIPATE study. AU - Siriwardena,Ajith K, AU - Mason,James M, AU - Sheen,Aali J, AU - Makin,Alistair J, AU - Shah,Nehal S, Y1 - 2012/06/05/ PY - 2012/01/03/received PY - 2012/05/07/revised PY - 2012/05/14/accepted PY - 2012/6/12/entrez PY - 2012/6/12/pubmed PY - 2012/11/7/medline SP - 655 EP - 663.e1 JF - Gastroenterology JO - Gastroenterology VL - 143 IS - 3 N2 - 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 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. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/22683257/Antioxidant_therapy_does_not_reduce_pain_in_patients_with_chronic_pancreatitis:_the_ANTICIPATE_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(12)00813-X DB - PRIME DP - Unbound Medicine ER -