Efficacy and Safety of Astaxanthin in the Management of Oral Submucous Fibrosis: A Preliminary Randomized Controlled Trial

Abstract

Background: Oral submucous fibrosis (OSMF) is a chronic, potentially malignant disorder characterized by progressive fibrosis of the oral mucosa, leading to restricted mouth opening and discomfort. This study investigates the efficacy and safety of astaxanthin, a potent antioxidant and anti-inflammatory carotenoid, in the comprehensive management of OSMF.Methods: A randomized, double-blind, placebo-controlled trial was conducted with 68 eligible participants diagnosed with OSMF. Participants were randomly assigned to the experimental group (astaxanthin capsules, 5 mg twice daily) or the control group (placebo capsules) for 12 weeks. Primary outcomes included changes in mouth opening and burning sensation assessed by Visual Analog Scale (VAS). Adverse events were monitored to evaluate safety.Results: The experimental group demonstrated a statistically significant improvement in mouth opening compared to the control group over the 12-week intervention (p < 0.001). Additionally, the experimental group reported a significant reduction in burning sensation, as indicated by VAS scores (p < 0.001). Adverse events were generally mild and comparable between groups. Conclusion:This study suggests that astaxanthin may have a positive impact on mouth opening and burning sensation in individuals with OSMF. The safety profile observed supports the feasibility of astaxanthin as a potential therapeutic adjunct in OSMF management. Further research with larger sample sizes and extended follow-up periods is warranted to validate these findings.