A Randomised Double-Blind Placebo-Controlled Clinical Trial of Fish Oil (Omega-3) in Sjögren's Syndrome Patients in Erbil-Iraq.

Introduction: Sjögren's syndrome (SS) is an autoimmune condition that primarily targets glands that are exocrine. Fish oil supplements have been explored for their potential to decrease pain, reduce stiffness in the morning, and improve joint tenderness among rheumatic disease patients.

Aim of study: to assess effectiveness of omega-3 fatty acids for controlling symptoms of dry eye and dry mouth in individuals diagnosed with Sjögren's syndrome.

Patients and methods: A randomised, double-blind, placebo-controlled clinical trial was conducted over a two-month period. clinical trial registration (ID: NCT05005806). Dry eye symptoms were assessed using a six-point scoring system (0-3). Dry mouth symptoms were evaluated using a visual analogue scale (VAS). Secondary outcomes included Schirmer's test and sialometry test.

Results: The analysis included a total of 104 people with Sjögren's syndrome. The mean score of dry eye symptoms was significantly lower in omega-3 Group (4.85 ± 4.10 SD, 95% CI: 3.75, 5.95) compared to the placebo group (8.27 ± 5.72 SD, 95% CI: 6.60, 9.93; P value = 0.001). Schirmers test after treatment, improved significantly to normal values in both groups which was slightly better among the omega-3 group. Sialometry tests indicated normalisation of salivary flow rate in the omega-3 group (2.07 ± 1.67 SD, 95% CI: 1.63, 2.52) (P value = 0.053).

Conclusion: Omega-3 fatty acids effectively improved dry mouth and dry eye symptoms. Furthermore, this led to significant normalisation of salivary flow rate. While Schirmer's test results improved in both groups, the differences between the omega-3 and placebo groups were insignificant.