Effects of phytoestrogen supplementation in postmenopausal women with dry eye syndrome: A randomized clinical trial.
Correlation between sex hormone levels and tear film osmolarity and qualitative and quantitative film lacrimal improvement in post menopausal women with dry eye syndrome treated with oral supplementation of phytoestrogen.
ministry of education university and research
66 participants
Sep 1, 2009
Interventional
Conditions
Summary
The aims of our study were to evaluate the correlation between sex hormone levels and tear film osmolarity in postmenopausal women and to assess the efficacy of an oral phytoestrogen supplement in controlling the ocular symptoms of post-menopausal dysfunctional tear syndrome (DTS).
Eligibility
Inclusion Criteria2
- menopause and severe dry eye syndrome.
- Dry eye syndrome is defined as a multifactorial disorder caused by one chronic inflammatory status due to tear film disequilibrium, main symptoms are: photophobia, visual disturbance, extraneous body sensation, difficulties in eye opening at the morning.
Exclusion Criteria1
- Hypersensitivity to one of components of the phytoestrogen supplement being tested, autoimmune disease, and current use of topical anti-inflammatory and/or antibiotic eye therapy
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Interventions
Sixty-six postmenopausal women with dysfunctional tear syndrome (DTS) were enrolled in a randomized, double-blind, placebo-controlled, cross-over study. Patient were divided into two groups (Group A and Group B) and treated respectively with Lacrisek ( alpha lipoic acid100mg,phytoestrogen 200mg, fish oil 240mg),Registered Trademark, tablets or placebo tablets, twice a day for 30 days. The two treatment periods were separated by a 30-day washout. Patients were examined on day 0 and day 30 of each period. Assessments included blood levels of sex hormones, the Schirmer test for tear production, and measurement of tear osmolarity and tear film break-time (T-BUT).
Locations(1)
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ACTRN12611000425998