A randomized controlled trial of antioxidant supplementation for pain relief in patients with chronic pancreatitis.

Double-blind, randomized, placebo-controlled trial in a tertiary care center. Participants: chronic pancreatitis with significant abdominal pain; placebo n=56, antioxidant n=71. Baseline: age 29.6±9.3 vs 31.3±11.4 years; male:female 39:17 vs 47:24; etiologies alcoholic:idiopathic 15:41 vs 25:46.

Antioxidant supplementation: selenium 600 μg/day (organic), ascorbic acid 0.54 g/day, beta-carotene 9000 IU/day, vitamin E (alpha-tocopherol) 270 IU/day, methionine 2 g/day; duration 6 months.

Antioxidant supplementation significantly reduced pain and oxidative stress in chronic pancreatitis over 6 months. Primary outcome: number of painful days per month decreased more with antioxidants (6 months: placebo 3.36±4.35 vs antioxidant 1.68±2.80; P=0.012; reduction in painful days per month 4.15; 95% CI 2.07–6.23; P<0.001). Secondary outcomes favored antioxidants: fewer oral analgesic tablets per month (P<0.001) and higher proportion pain-free (32% vs 13%; P=0.009). Hospitalization need decreased but not significantly (P=0.411). Oxidative-stress markers improved with antioxidants: TBARS decreased (P<0.001); FRAP increased (P=0.038). Antioxidant status improved with higher vitamins A, C, E; SOD decreased; no severe adverse events. Authors conclude antioxidants relieve abdominal pain and reduce oxidative stress in CP; longer-term effects and optimal composition require further study.

Single-center study; moderate sample size; 6-month duration; some loss to follow-up; generalizability to all CP etiologies uncertain; long-term safety and durability of benefit not established.