Endometrial, breast and liver safety of soy isoflavones plus Lactobacillus sporogenes in post-menopausal women.

2012-11-30
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 29(3)
- Nicola Colacurci
- Pasquale De Franciscis
- Marco Atlante
- Pasquale Mancino
- Marco Monti
- Giuseppe Volpini
- Claudio Benvenuti

PubMed: 23194023
DOI: 10.3109/09513590.2012.738724

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 65
Population: 130 healthy postmenopausal women suffering from menopausal symptoms
Methods: 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)
Duration: 1 year
Funding: Unclear

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.

Research Insights

Lactobacillus sporogenes→Improved Hepatic Function
After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Effect
Neutral
Effect size
Small
Dose
1 billion spores
Lactobacillus sporogenes→Increased Endometrial Thickness
After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Effect
Neutral
Effect size
Small
Dose
1 billion spores
Lactobacillus sporogenes→Increased Mammographic Density
After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Effect
Neutral
Effect size
Small
Dose
1 billion spores
Lactobacillus sporogenes→Reduced Menopausal Symptoms
menopausal symptoms were progressively and significantly reduced in severity and frequency during treatment with soy isoflavones plus Lactobacillus sporogenes versus calcium plus vitamin D₃
Effect
Beneficial
Effect size
Moderate
Dose
1 billion spores
Soy→Improved Hepatic Function
After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Effect
Neutral
Effect size
Small
Dose
1 billion spores
Soy→Increased Endometrial Thickness
After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Effect
Neutral
Effect size
Small
Dose
1 billion spores
Soy→Increased Mammographic Density
After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Effect
Neutral
Effect size
Small
Dose
1 billion spores
Soy→Reduced Menopausal Symptoms
menopausal symptoms were progressively and significantly reduced in severity and frequency during treatment with soy isoflavones plus Lactobacillus sporogenes versus calcium plus vitamin D₃
Effect
Beneficial
Effect size
Moderate
Dose
1 billion spores

Adverse Events Reported

Lactobacillus sporogenes→Overall tolerability
mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Finding
No significant difference
Magnitude
no significant differences between groups
Significant
No
Soy→Overall tolerability
mammographic density, endometrial thickness and hepatic function did not show significant differences between groups
Finding
No significant difference
Magnitude
no significant differences between groups
Significant
No