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. Setting: Outpatient Menopausal Clinic. Study Design: 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. Conclusion: 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.

Keywords::

• Endometrial thickness
• isoflavones
• lactobacillus
• menopausal symptoms
• mammographic density

Acknowledgement

The authors have no financial affiliation (e.g. employment, direct payments, stock holdings, retainers, consultantship, patient-licensing arrangements, or honoraria) or involvement with any commercial organization with direct financial interest in the subject or material discussed in this manuscript. The authors have no financial interest in any aspect of the work and did not receive any financial support. Any other potential conflict of interest also is disclosed.

Declaration of Interest: C. Benvenuti MD, ScD is consultant for Rottapharm Madaus.