Four trials that were not combined in meta-analyses suggested that extracts with high ( > 30 mg/d ) levels of genistein consistently reduced the frequency of hot flushes .
BACKGROUND Vasomotor symptoms , such as hot flushes and night sweats , are very common during the menopausal transition .
Hormone therapy has traditionally been used as a highly effective treatment , but concerns about increased risk of some chronic diseases have markedly increased the interest of women in alternative treatments .
Some of the most popular of these treatments are foods or supplements enriched with phytoestrogens-plant-derived chemicals that have estrogenic action .
OBJECTIVES To assess the efficacy , safety and acceptability of food products , extracts and dietary supplements containing high levels of phytoestrogens when compared with no treatment , placebo or hormone therapy for the amelioration of vasomotor menopausal symptoms ( such as hot flushes and night sweats ) in perimenopausal and postmenopausal women .
Long-term endometrial and breast safety of a specific, standardized soy extract
Objective To assess the effects of an oral soy isoflavone extract ( Phytosoya ® ) on endometrium and breast in postmenopausal women treated for 3 years . Methods A total of 395 postmenopausal women were included in this international prospect i ve , open-label study . The number of patients who completed the 3-year study was 197 . The women were treated for 3 years with a specific , st and ardized soy isoflavone extract ( total 70 mg/day ) .  Endometrial biopsy , transvaginal ultrasonography and mammography  were performed before and after 3 years of treatment . Results No case of hyperplasia/cancer was diagnosed among the 192 interpretable biopsies at 3 years . Only one case of simple hyperplasia was diagnosed among 197 post-baseline interpretable biopsies . The endometrial safety of this extract has been demonstrated ( point estimate 0.5 % ) . There was no statistically significant change in endometrial thickness after 3 years ( 98.4 % inactive or atrophic and 0.3 % proliferative endometrium at 1 year ) . Mammography results showed no notable change from baseline . No patient in any set developed an ACR classification of 4 or 5 after 3 years of treatment . The global safety was rated as either ‘ excellent ’ or ‘ good ’ by 99.1 % of investigators and 99.0 % of patients after 3 years of treatment . The adverse events were as follows : eight patients had metrorrhagia and seven patients had at least one breast adverse event : three patients had ‘ breast pain ’ , two patients reported ‘ breast tenderness ’ and two patients had ‘ hypertrophic breast ’ ( most of them were possibly treatment-related ) . Conclusions As no case of hyperplasia was diagnosed among the 301 interpretable biopsies at 1 year and there was only one case of simple hyperplasia in the 197 post-baseline biopsies at 3 years , the endometrial safety of this extract has been demonstrated . Furthermore , as demonstrated by the lack of change in endometrial thickness associated with the histologic results , we suggest that this extract does not exert a mitogenic effect on the endometrium . These results suggest that daily administration of 70 mg of a specific , st and ardized isoflavone extract for 3 years could be a safe treatment for both endometrium and breast
Four trials that were not combined in meta-analyses suggested that extracts with high ( > 30 mg/d ) levels of genistein consistently reduced the frequency of hot flushes .
BACKGROUND Vasomotor symptoms , such as hot flushes and night sweats , are very common during the menopausal transition .
Hormone therapy has traditionally been used as a highly effective treatment , but concerns about increased risk of some chronic diseases have markedly increased the interest of women in alternative treatments .
Some of the most popular of these treatments are foods or supplements enriched with phytoestrogens-plant-derived chemicals that have estrogenic action .
OBJECTIVES To assess the efficacy , safety and acceptability of food products , extracts and dietary supplements containing high levels of phytoestrogens when compared with no treatment , placebo or hormone therapy for the amelioration of vasomotor menopausal symptoms ( such as hot flushes and night sweats ) in perimenopausal and postmenopausal women .