AB0791 A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CLINICAL TRIAL OF FISH OIL (OMEGA 3) IN SJOGREN’S SYNDROME PATIENTS IN ERBIL-IRAQ
Authors: Z. Al-Rawi, A. Jalal, I. Hikmet
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Sjogren's syndrome (SS) is an autoimmune disorder affecting mainly the exocrine glands. Sjogren's syndrome led to dryness of the main mucosal surfaces, such as the mouth, eye, skin, nose, and vagina. The poly unsaturated fatty acids omega-3(ω-3 FA) have been associated with several illnesses such as cancer, cardiovascular and autoimmune diseases and their balance at the cellular membranes can result in anti-inflammatory action. Fish oil supplements might help to reduce pain, improve morning stiffness, and relieve joint tenderness in people with rheumatic diseases. <h3>Objectives:</h3> <b>Objective of the study</b> to evaluate the role of Dietary supplementation of omega-3 fatty acids in the management of dry eye and dry mouth symptoms and signs in patients with Sjogren's syndrome. <h3>Methods:</h3> A Randomized double-blind placebo-controlled clinical trial of two months' duration was done from the 4th September 2021 to 7th February 2023 at Rheumatology outpatient's clinic, Rizgary Teaching Hospital, Erbil-Iraq. Clinical Trial registration ID at clinical trial gov. (NCT05005806) There were two patients visits at baseline and at last visit after 2 months.End points were in subject symptoms of dry eye include six symptoms and a score from 0-3, 0 when absent, 1 sometime present, 2 frequently present, 3 always present (score 0-6 mild, 6-12 moderate, 12-18 severe).visual analogue scale and measurement of dry mouth by inventory xerostomia score which calculated by visual analogue scale from 1 to 5 (never to very often) had symptoms and secondary outcomes were schirmer's test; was considered normal when tearing is ›5ml/5min and Sialometry test measured of salivary flow, unstimulated whole saliva was collected for the period of 15 minutes, the volume was recorded and considered normal flow when equal or more than 1.5ml/ 15min. <h3>Results:</h3> one hundred twenty-six patients with primary Sjogren's syndrome diagnosed according to American European Consensus Group criteria were assessed for eligibility 2016(ACR-EULAR) were enrolled in study and only one hundred four patients were analyzed. The main eye symptoms that become better post treatment in Omega 3 were itching, mucous discharge &amp; photophobia (P values =0.02, 0.00,0.00) respectively. Those in Omega 3 group their mean of dry eye symptoms became lower (4.85 ± 4.10 SD, CI %95; 3.75, 5.95) than in Placebo Group (8.27±5.72 SD, CI %95; 6.60, 9.93). (P value = 0. 001). Schirmers test at baseline of Omega 3 and Placebo group were (2.38±2.13&amp; 2.69±3.94) respectively, after treatment results improved significantly to normal values in both groups which was slightly better among Omega group compared to Placebo, but the differences were insignificant. Sialometry test post intervention became normalized in Omega 3 group (2.07±1.67SD,95%CI;1.63, 2.52) compared to placebo group (1.55 ± 0.83 SD, %CI;1.31,1.79), and P value was significant (0.053). <h3>Conclusion:</h3> Omega 3 was effective in improving Dry mouth symptoms, dry eye symptoms especially (itching, mucous discharge &amp; photophobia) of Sjogren's syndrome patients, and Sialometry test was significantly improved and normalized in Omega 3 treated group in comparison to Placebo Group. The Schirmer test improved significantly during last visit in comparison to baseline in both groups, but it was slightly better in Omega 3 compared to placebo group, without significant differences. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>