Effects of Omega-3 Fatty Acid-Rich Zanthoxylum schinifolium Seed Oil in Patients with Dry Eye: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial

Background and Objective: Many clinicians advise the use of supplements of ω-3 FAs, to mitigate symptoms and inflammation in patients with Dry Eye Disease (DED). However, there is little clinical evidence of the ZSO use in DED. The present study was conducted to investigate the potential effect of dietary supplementation with Zanthoxylum schinifolium Seed Oil (ZSO), its clinical efficacy and the safety in the patients with DED. Materials and Methods: Twenty subjects were randomly assigned to the ZSO (n = 10) or the placebo group (n = 10) and were given 4 g/day of ZSO or placebo (soybean oil) for 10 weeks. The outcomes such as efficacy of relieving dry eye symptoms FA composition of the Erythrocyte Membrane (EM), inflammatory and safety were assessed initially at a baseline and after 10 weeks. Improved ocular surface disease index scores and decreased corneal staining scores and tear interleukin-1β levels were observed in the ZSO group after 10 weeks compared with the baseline (p<0.05, respectively). Results: Improved Ocular Surface Disease Index (OSDI) scores and decreased corneal staining scores and tear interleukin-1β levels were observed in the ZSO group after 10 weeks compared with the baseline (p<0.05). After 10 weeks of ZSO supplementation, the ω-3 FA(α-linolenic acid) level of the erythrocyte membrane increased and the ω-6/ω-3 FA ratio decreased, showing a significant difference compared to the placebo group (p<0.05). Conclusion: These results suggested that the use of ZSO as a dietary source of omega-3 fatty acids might have a favorable effect on the FA composition of the EM and attenuate the symptoms in DED patients.