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

Randomized controlled trial in patients with chronic pancreatitis and significant abdominal pain treated at a tertiary care academic center. The active antioxidant arm randomized 76 participants, with 66 analyzed for 6-month pain outcomes and 62 with 6-month biomarker data; etiologies included alcoholic and idiopathic chronic pancreatitis.

Daily oral antioxidant capsules were given for 6 months and matched to placebo capsules in appearance. The regimen contained organic selenium, ascorbic acid, beta-carotene, alpha-tocopherol, and methionine; the source reports doses of 600 g organic selenium, 0.54 g ascorbic acid, 9000 IU beta-carotene, 270 IU alpha-tocopherol, and 2 g methionine.

Daily antioxidant supplementation reduced pain and improved oxidative stress markers versus placebo over 6 months. Painful days per month fell from 9.14 Ϯ 7.60 to 1.68 Ϯ 2.80 in the antioxidant group versus 7.21 Ϯ 5.34 to 3.36 Ϯ 4.35 with placebo; the reduction was 7.37 Ϯ 6.75 versus 3.21 Ϯ 3.99, with a mean difference of 4.15 (2.07, 6.23; P < .001). One third (23/71) of patients in the antioxidant group became pain free. Oxidative stress and antioxidant status also improved, including lower TBARS at 6 months (3.61 Ϯ 2.37 vs 5.43 Ϯ 2.69; P = .001) and higher vitamin A, vitamin C, vitamin E, FRAP, E-SOD, and E-TGSH values. Adverse events were reported but no deaths or discontinuations due to adverse effects occurred.

The trial was single-center with a relatively small sample and substantial attrition at 6 months, especially for biomarker analyses. Multiple secondary endpoints were assessed, and generalizability is limited by the specific chronic pancreatitis population and mixed etiologies. The source reports an atypical selenium dose unit, which should be interpreted cautiously.