title: Endometrial, breast and liver safety of soy isoflavones plus Lactobacillus sporogenes in post-menopausal women.
abstract: OBJECTIVE
  To assess the safety of a nutraceutical compound containing soy isoflavones and Lactobacillus sporogenes on endometrium, breast and liver function.
  
  
  METHODS
  Outpatient Menopausal Clinic.
  
  
  METHODS
  130 healthy postmenopausal women suffering from menopausal symptoms were randomized to receive soy isoflavones 60 mg and Lactobacillus sporogenes 1 billion spores (group E: 65 women) or calcium and vitamin D₃ (group C: 65 women). Safety of the treatment was assessed at baseline and after 1 year taking into account endometrial thickness, mammographic density, serum levels of transaminases, γ-GT and bilirubin. Efficacy of the treatment was evaluated rating the score of menopausal symptoms at baseline and every 3 months. The statistical analysis was carried out with χ², Fisher exact's test and ANOVA.
  
  
  RESULTS
  After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups, while menopausal symptoms were progressively and significantly reduced in severity and frequency during treatment with soy isoflavones plus Lactobacillus sporogenes versus calcium plus vitamin D₃.
  
  
  CONCLUSIONS
  A 12 months treatment with a nutraceutical compound based on isoflavones and Lactobacillus sporogenes at the recommended doses is safe for endometrium, mammary glands and liver function in postmenopausal women.
authors.affiliation: Department of Obstetrics, Gynaecology and Reproductive Sciences - Second University of Naples - Largo Madonna delle Grazie 1, Naples, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Colacurci
authors.forename: Pasquale
authors.initials: P
authors.lastname: De Franciscis
authors.forename: Marco
authors.initials: M
authors.lastname: Atlante
authors.forename: Pasquale
authors.initials: P
authors.lastname: Mancino
authors.forename: Marco
authors.initials: M
authors.lastname: Monti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Volpini
authors.forename: Claudio
authors.initials: C
authors.lastname: Benvenuti
mesh_terms: D001940:Breast / Q000254:growth & development; D001943:Breast Neoplasms / Q000517:prevention & control; D000075202:Contraindications; D019587:Dietary Supplements / Q000009:adverse effects; D004714:Endometrial Hyperplasia / Q000517:prevention & control; D004717:Endometrium / Q000254:growth & development; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D005260:Female; D048550:Hepatic Insufficiency / Q000517:prevention & control; D019584:Hot Flashes / Q000503:physiopathology / Q000517:prevention & control*; D006801:Humans; D007529:Isoflavones / Q000009:adverse effects / Q000627:therapeutic use*; D007778:Lactobacillus; D008099:Liver / Q000254:growth & development; D008875:Middle Aged; D017698:Postmenopause; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012639:Seeds / Q000737:chemistry; D012720:Severity of Illness Index; D013025:Glycine max / Q000737:chemistry*
chemical_list: D007529:Isoflavones