title: Effects of phytoestrogen supplementation in postmenopausal women with dry eye syndrome: a randomized clinical trial.
abstract: OBJECTIVE
  To evaluate the correlation between tear osmolarity and blood levels of 17-β estradiol, estrone, and testosterone in postmenopausal women with dry eye syndrome, and to assess the efficacy and safety of oral supplementation with phytoestrogens, lipoic acid, and eicosapentaenoic acid in this population.
  
  
  METHODS
  Cross-sectional study including 66 postmenopausal women with dry eye syndrome.
  
  
  METHODS
  Sixty-six postmenopausal women with dry eye syndrome were enrolled in a randomized, double-blind, placebo-controlled, crossover study. Patients were divided into 2 groups (groups A and B) and treated, respectively, with phytoestrogen (Bioos, Montegiorgio, Italy) tablets or placebo tablets for 30 days. The 2 treatment periods were separated by a 30-day washout. Patients were examined on days 0 and 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-up time.
  
  
  RESULTS
  At baseline, all patients had low sex hormone levels, which were correlated with high tear film osmolarity values (r = -0.59,-0.61,-0.58, respectively). After 30 days of therapy, the group treated with Lacrisek® (Bioos) had significantly decreased tear osmolarity (P<0.005) and significantly increased tear production evaluated with the Schirmer test and tear film break-up time values (P<0.001) compared with the placebo-treated group.
  
  
  CONCLUSIONS
  Our study confirms that steroid hormones play an important role in ocular surface equilibrium and functions. Consequently, reduced blood levels of these hormones can produce changes at the ocular surface. Phytoestrogen supplementation can significantly improve the signs and symptoms of dry eye syndrome in postmenopausal women.
authors.affiliation: Ophthalmic Clinic II, University of Rome La Sapienza"San't Andrea Hospital, Rome, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Scuderi
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Contestabile
authors.forename: Caterina
authors.initials: C
authors.lastname: Gagliano
authors.forename: Daniela
authors.initials: D
authors.lastname: Iacovello
authors.forename: Luca
authors.initials: L
authors.lastname: Scuderi
authors.forename: Teresio
authors.initials: T
authors.lastname: Avitabile
mesh_terms: D001835:Body Weight; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003430:Cross-Sectional Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000097:blood / Q000188:drug therapy*; D004958:Estradiol / Q000097:blood; D004970:Estrone / Q000097:blood; D005260:Female; D006801:Humans; D008875:Middle Aged; D009994:Osmolar Concentration; D048789:Phytoestrogens / Q000627:therapeutic use*; D017698:Postmenopause / Q000097:blood; D013607:Tablets; D013666:Tears / Q000737:chemistry; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D048789:Phytoestrogens; D013607:Tablets; D004970:Estrone; D013739:Testosterone; D004958:Estradiol