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

Colacurci, Nicola; Franciscis, Pasquale De; Atlante, M; Mancino, Pasquale; Monti, Marco; Volpini, Giuseppe; Benvenuti, Claudio

doi:10.3109/09513590.2012.738724

Cited by 28 publications

(37 citation statements)

References 40 publications

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“…The mean difference in MD% was 0.69% for all women combined (−1.10% in postmenopausal women and 1.83% in premenopausal women) (6). No significant differences in mammographic density between soy and placebo groups were reported in two other trials that supplemented soy isoflavones or placebo for 10 months (32 soy vs 34 placebo) (43) and 12 months (65 soy vs 65 placebo) (44). …”

Section: Discussionmentioning

confidence: 87%

Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density

Spicer

García

et al. 2015

Cancer Prevention Research

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Soy supplementation by breast cancer patients remains controversial. No controlled intervention studies have investigated the effects of soy supplementation on mammographic density in breast cancer patients. We conducted a double-blind, randomized, placebo-controlled intervention study in previously treated breast cancer patients (n=66) and high-risk women (n=29). We obtained digital mammograms and breast magnetic resonance imaging (MRI) scans at baseline and after 12 months of daily soy (50 mg isoflavones per day) (n=46) or placebo (n=49) tablet supplementation. The total breast area (MA) and the area of mammographic density (MD) on the mammogram was measured using a validated computer-assisted method, and mammographic density percent (MD% = 100 × MD/MA) was determined. A well-tested computer algorithm was used to quantitatively measure the total breast volume (TBV) and fibroglandular tissue volume (FGV) on the breast MRI, and the FGV percent (FGV% = 100 × FGV/TBV) was calculated. On the basis of plasma soy isoflavone levels, compliance was excellent. Small decreases in MD% measured by the ratios of month 12 to baseline levels, were seen in the soy (0.95) and the placebo (0.87) groups; these changes did not differ between the treatments (P=0.38). Small decreases in FGV% were also found in both the soy (0.90) and the placebo (0.92) groups; these changes also did not differ between the treatments (P=0.48). Results were comparable in breast cancer patients and high-risk women. We found no evidence that soy supplementation would decrease mammographic density and that MRI might be more sensitive to changes in density than mammography.

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Section: Discussionmentioning

confidence: 87%

Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density

Spicer

García

et al. 2015

Cancer Prevention Research

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“…For the evaluation, EFSA selected 43 human studies and 62 animal studies. Among these studies were four epidemiological studies investigating breast cancer incidence (Rebbeck et al , ; Obi et al , ; Brasky et al , ; Boucher et al , ), eight interventional controlled studies, measuring mammographic density (Morabito et al , ; Atkinson et al , ; Marini et al , ; Powles et al , ; Verheus et al , ; Maskarinec et al , ; Colacurci et al , ; Delmanto et al , ), and two interventional controlled studies, investigating histopathological changes (Cheng et al , ; Khan et al , ). These studies did not reveal an association between isoflavone exposure and adverse effects in the mammary gland (EFSA ANS Panel, ).…”

Section: Introductionmentioning

confidence: 99%

The potential health effects of dietary phytoestrogens

Rietjens

Louisse

Beekmann

2016

British J Pharmacology

421

246

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Phytoestrogens are plant‐derived dietary compounds with structural similarity to 17‐β‐oestradiol (E2), the primary female sex hormone. This structural similarity to E2 enables phytoestrogens to cause (anti)oestrogenic effects by binding to the oestrogen receptors. The aim of the present review is to present a state‐of‐the‐art overview of the potential health effects of dietary phytoestrogens. Various beneficial health effects have been ascribed to phytoestrogens, such as a lowered risk of menopausal symptoms like hot flushes and osteoporosis, lowered risks of cardiovascular disease, obesity, metabolic syndrome and type 2 diabetes, brain function disorders, breast cancer, prostate cancer, bowel cancer and other cancers. In contrast to these beneficial health claims, the (anti)oestrogenic properties of phytoestrogens have also raised concerns since they might act as endocrine disruptors, indicating a potential to cause adverse health effects. The literature overview presented in this paper illustrates that several potential health benefits of phytoestrogens have been reported but that, given the data on potential adverse health effects, the current evidence on these beneficial health effects is not so obvious that they clearly outweigh the possible health risks. Furthermore, the data currently available are not sufficient to support a more refined (semi) quantitative risk–benefit analysis. This implies that a definite conclusion on possible beneficial health effects of phytoestrogens cannot be made.Linked ArticlesThis article is part of a themed section on Principles of Pharmacological Research of Nutraceuticals. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.11/issuetoc

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“…Indeed, soy isoflavone tablets easily allow intake in excess of 100 mg isoflavones/d, five times that of isoflavone intake from typical Asian diets 1 . One long-term (3 y) study 2 indicated that soy isoflavone (extract form) intake was safe for the endometrium and breast, another (2 y) study 3 demonstrated that soy hypocotyl isoflavones (80 or 120 mg) did not adversely affect endometrial thickness, and another recent (1 y) study 4 showed that soy isoflavones (60 mg) combined with Lactobacillus sporogenes was safe for the endometrium, mammary glands, and liver function. Indeed, a 2-y study 5 indicated that genistein (54 mg/d), the predominant soybean isoflavone, reduced the mean number of hot flushes/d, but it did not affect the endometrium.…”

Section: Introductionmentioning

confidence: 99%

Soy Isoflavones for Reducing Bone Loss Study

et al. 2015

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Objectives To assess the overall safety and potential endometrial stimulation of soy isoflavone tablets consumed (3-year) by postmenopausal women. To determine the endometrial thickness response-to-treatment among compliant women, taking into account hormone concentrations and other hypothesized modifying factors. Methods We randomized healthy postmenopausal women (45.8–65.0 years) to placebo control or two doses (80 or 120 mg/day) of soy isoflavones at two sites. We used intent-to-treat (N=224) and compliant (>95%; N=208) analyses to assess circulating hormone concentrations, adverse events, and endometrial thickness (via transvaginal ultrasound). Results Median values for endometrial thickness (mm) declined from baseline through 36 mo. Nonparametric ANOVA for treatment differences among groups showed no differences in absolute (or percentage change) endometrial thickness at any time point (Chi-Square p-values ranged from 0.12–0.69), nor in circulating hormones at any time point. A greater number of adverse events for the genitourinary system (p=0.005) was noted in the 80 compared to 120 mg/day group, whereas other systems showed no treatment effects. The model predicting the endometrial thickness response-(using natural logarithm)-to-treatment with compliant women across time points was significant (p<0.0001), indicating that estrogen exposure (p=0.0013), plasma 17 β-estradiol (p=0.0086), and alcohol intake (p=0.023) contributed significantly to the response. Neither the 80 (p=0.57) nor 120 (p=0.43) mg/day dose exerted an effect on endometrial thickness across time. Conclusions Our RCT verified the long-term overall safety of consuming soy isoflavone tablets by postmenopausal women who displayed excellent compliance. We found no evidence of a treatment effect on endometrial thickness, adverse events, or circulating hormone concentrations, most notably thyroid function, during a three year period.

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

Abstract: 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.

Cited by 28 publications

References 40 publications

Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density

Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density

The potential health effects of dietary phytoestrogens

Soy Isoflavones for Reducing Bone Loss Study

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