Effect of Fenugreek on Severe Evaporative Dysfunctional Tear Syndrome

Purpose: To value the role of postmenopausal insufficiently level of 17 β Estradiol, Estrone, Testosterone in the pathogenesis of Dysfunction Tear Syndrome (DTS), investigating the relationship between tear osmolarity and serum sex hormones level in women with severe evaporative DTS, and value the efficacy and safety of oral phytoestrogens (fenugreek) in the treatment of these patients. Methods: Twenty-two postmenopausal women were enrolled in a double-blind, randomized, placebo-controlled, two-period cross-over trial of oral preparation of phytoestrogens (fenugreek seed extract 200 mg containing diosgenin 1.3%, steroidal saponins 50% and alkaloids, as characterized by HPCL method and gravimetric method). The participants were examined at day 0 and day 30 of each period. The tests performed included laboratory blood analysis, tear osmolarity measurement, Schirmer test, Tear Film Break Up Time (TF-BUT). Results: At baseline the lowest circulating levels of 17 β Estradiol, Estrone, and Testosterone were correlated to the highest levels of tear film osmolarity in 22 postmenopausal women (rs = -0.59, -0.61, -0.58, respectively). After 30 days of treatment we observed a significant (p<0.05) decrease of tear osmolarity and a significant increase of Schirmer’s and TF-BUT values (p< 0.001) in the fenugreek treated groups in both periods, in comparison with placebo. Conclusions: This study showed that tear osmolarity is correlated negatively with sex hormone levels, suggesting an important role of these hormones in the pathogenesis of postmenopausal DTS which it is more common the involvement of Meibomain Glands, and a daily treatment with oral phytoestrogens (fenugreek 200 mg) improved significantly signs and symptoms of severe evaporative DTS in postmenopausal women, without any significant side effect.