The safety of geniVida® genistein has been evaluated in a comprehensive series of safety studies involving acute, subchronic and chronic safety studies. No trials have examined the effects of isoflavones from soyfoods or supplements on tumor recurrence in breast cancer patients, but the clinical data indicate that in contrast to menopausal hormone therapy, isoflavone exposure does not adversely affect markers of breast cancer risk such as breast tissue density and breast cell proliferation.
Further, recent epidemiologic data indicate that the post-diagnosis consumption of isoflavone-rich soyfoods actually improves prognosis and does not interfere with the efficacy of tamoxifen.
Also, three-year data show 54 mg/day genistein does not affect breast tissue density and actually maintained BRCA1 and BRCA2 expression whereas expression decreased in the placebo group.
In another study, using fixed effects model, a meta-analysis of side effects comparing phytoestrogen treatment with placebo and not treatment in randomized controlled trials (174 studies with 9629 participants). Based on the available evidence, phytoestrogen supplements have a
safe side-effect profile. Rates of vaginal bleeding, endometrial hyperplasia, endometrial cancer, and
breast cancer were not significantly increased among phytoestrogen users in the investigated studies.
Thus, the weight of the evidence indicates isoflavone exposure is safe.
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