Cytokine profiles in patients receiving antioxidant therapy within the ANTICIPATE trial.

AIM: To measure a broad profile of pro- and anti-inflammatory cytokines in patients with clinically proven chronic pancreatitis (CP) taking either antioxidant therapy or placebo as part of the larger ANTICIPATE study.
METHODS: Patients with chronic pancreatitis were recruited to the ANTICIPATE study following informed consent and were randomised to intervention with either antox version 1.2-based antioxidant therapy or placebo. After a separate ethics committee amendment a subgroup of 7 patients from either arm of the study were selected for additional analysis of cytokines. Cytokines were measured at baseline and after 6 mo of either antox therapy or placebo by biochip array and enzyme-linked immunosorbent assay.
RESULTS: Antioxidant therapy and placebo groups were well-matched in terms of age, gender, aetiology of CP, opiate use and disease duration. Baseline antioxidant levels were similar in patients allocated to the antioxidant group as compared to the group allocated to placebo. After 6 mo of antioxidant therapy there was significant elevation in vitamin C levels in the intervention group: 17.6 μg/mL (12.8-29.3 μg/mL) compared to 4.8 μg/mL (1.6-9.1 μg/mL) in placebo (P < 0.001; 95%CI: 9.0-20.2) with similar trends in selenium levels. There was no elevation in a broad array of pro- and anti-inflammatory cytokines in the antioxidant group compared to placebo [interleukin (IL)-1B, IL-4, IL-6, IL-10, tumor necrosis factor-α] either at baseline or after 6 mo of antioxidant therapy.
CONCLUSION: Cytokine levels were low at baseline and at 6 mo despite a significant elevation in plasma antioxidants. In patients with CP, with opiate-dependent abdominal pain, circulating cytokine levels are low suggesting that pain in this disease is not simply a manifestation of inflammation.

RCT Entities:   Population Interventions Outcomes