Efficacy of Melatonin on Serum Pro-inflammatory Cytokines and Oxidative Stress Markers in Relapsing Remitting Multiple Sclerosis.
Level 2 - randomized trial
Individual randomized, double-blind, placebo-controlled trial
PubMed 30595364 · doi:10.1016/j.arcmed.2018.12.004
What was done
A double-blind, randomized, placebo-controlled trial evaluated oral melatonin (25 mg daily for 6 months) as an adjunct therapy in 36 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) who were concurrently treated with Interferon β-1b (IFNβ-1b). Serum inflammatory cytokines, oxidative stress markers, clinical efficacy outcomes, and adverse effects were assessed.
What was found
Compared to placebo, melatonin administration led to statistically significant reductions in serum concentrations of inflammatory cytokines and oxidative stress markers: TNF-α decreased by 18% (p < 0.05), IL-1β by 34.8% (p < 0.05), IL-6 by 34.7% (p < 0.05), lipoperoxides (LPO) by 39.9% (p < 0.05), and nitric oxide catabolites (NOC) by 24% (p < 0.05). There was no significant difference between groups in clinical efficacy outcomes or adverse effect rates.
Why it matters
Melatonin may serve as an effective adjuvant antioxidant and anti-inflammatory agent for biochemical modulation in RRMS, though its ability to improve functional or clinical neurological outcomes remains unproven.
Limits
The study had a very small sample size (n = 36) and a relatively short follow-up duration (6 months). All participants were on background IFNβ-1b therapy, limiting generalizability to untreated patients or other disease-modifying therapies. The abstract reports biochemical changes but notes no detectable clinical benefits, and specific clinical endpoints measured are not detailed.
Cited by
- supports A clinical trial in multiple sclerosis patients found that 25 mg/day of melatonin for 6 months reduced serum concentrations of pro-inflammatory cytokines and biomarkers of oxidative stress.