Gammalinolenic acid treatment of fatigue associated with primary Sjögren's syndrome

Objective: To evaluate the eYcacy of the essential omega-6 fatty acid Gammalinolenic acid (GLA) on fatigue associated with primary Sjo¨ gren’s syndrome. Methods: Ninety patients with primary Sjo¨ gren’s syndrome (with or without signs of autoimmunity) entered a 6-month double blind placebo-controlled randomised trial with high dose GLA (extracted from Evening Primrose Oil ) or corn oil. The primary outcome parameter was fatigue; secondary endpoints were eye dryness, mouth dryness, muscle and joint pain. Results: No statistically signiŽ cant improvement was found in fatigue assessed by Visual Analogue Scale (VAS) or in the time needed for sleeping/resting during a 24-hour period. No diVerences were found between the treatment and placebo group. The same applies to the secondary endpoints: no diVerences in VAS for eye and mouth dryness or pain, no signiŽ cant changes in Schirmer-1-test, van Bijsterveld score, unstimulated whole sialometry (UWS), or use of artiŽ cial tears or analgesics. Only mild side eVects were observed. Conclusion: According to our study results GLA (Evening Primrose oil ) treatment for fatigue in primary Sjo¨gren’s syndrome is ineVective. (Less)