Benefits
Helps reduce menopausal hot flashes
In a 12-week randomized, placebo-controlled trial in 109 perimenopausal women (54 on the extract, 55 on placebo), one tablet a day lowered total Menopause Rating Scale II scores, including the hot flush and sweating items, significantly more than placebo. The trial was run by a research group linked to the extract's maker and has not been repeated by an independent team.
Supports overall menopausal symptom relief
In the 12-week trial, the total Menopause Rating Scale II score, which combines hot flush, mood, and physical complaint items, improved more than with placebo. That score is a symptom questionnaire, not a measure of hormone levels, and the results come from women who already had bothersome menopausal symptoms rather than from the general population.
Helps maintain mood and emotional balance
The anxiety, irritability, and depressed mood questions inside the Menopause Rating Scale improved during the 12-week trial in perimenopausal women. These are single items within a menopause symptom questionnaire, not a test of depression or anxiety treatment, and no study has looked at this extract as a stand-alone mood supplement.
May help the sleep item on menopause symptom scores
The sleep problems question inside the Menopause Rating Scale was among the items that improved in the 12-week trial. No study has measured sleep with a dedicated sleep questionnaire or in a sleep lab, so this is a single self-reported item within a menopause symptom score rather than evidence of a sleep aid.
Selectively activates estrogen receptor beta in lab studies
In laboratory cell studies the extract switches on estrogen receptor beta but not estrogen receptor alpha. That is receptor-selective estrogen activity, not an absence of estrogen activity, so describing it as non-estrogenic is misleading. In the 12-week trial, gynecological findings including endometrial biopsies showed no differences from placebo, which is reassuring but covers only 12 weeks in 109 women. Women with a history of breast or endometrial cancer, and women taking hormone therapy or tamoxifen, should talk to their doctor before using this or any other phytoestrogen.
Mechanism of action
Selective ER-beta activation
In cell-based laboratory studies, the aglycones rhapontigenin and desoxyrhapontigenin switch on estrogen receptor beta but not estrogen receptor alpha. This work was done in cells, not in people. Researchers think this receptor pattern may explain the symptom changes seen in the trials, but that link has never been demonstrated directly in humans.
Modulation of hypothalamic thermoregulation
Estrogen receptor beta activity in the brain's temperature control center may help steady the body's thermostat. This is a proposed explanation borrowed from general estrogen biology; nothing in the studies of this extract measured brain or temperature regulation.
Lack of uterotrophic ER-alpha signaling
Because the extract did not switch on estrogen receptor alpha in cell studies, researchers expected no thickening of the uterine lining. In the 12-week trial, gynecological findings including endometrial biopsies showed no differences between the extract and placebo. That is short-term data in 109 women and does not establish long-term uterine safety.
Serotonergic and mood-related signaling
Estrogen receptor beta activity can influence serotonin signaling, which is involved in mood. This is offered as a possible explanation for the mood questions that improved on the menopause symptom questionnaire, but no study of this extract measured serotonin or brain activity.
Clinical trials
Randomized, double-blind, placebo-controlled trial; one enteric-coated ERr 731 tablet daily for 12 weeks, with 54 women on the extract and 55 on placebo.
109 perimenopausal women with climacteric complaints (Menopause Rating Scale II baseline).
Compared with placebo, the extract lowered the total Menopause Rating Scale II score significantly more (P less than 0.0001), along with the hot flush and other symptom items. Gynecological findings, including endometrial biopsies, showed no differences between the two groups over the 12 weeks. The authors are affiliated with a research group linked to the extract's manufacturer.
Multicenter, randomized, double-blind, placebo-controlled confirmatory trial; one ERr 731 tablet daily for 12 weeks.
112 perimenopausal women with menopausal symptoms.
This report describes reductions in the Menopause Rating Scale total score and in hot flush number and severity versus placebo, with no relevant safety signals. It is indexed in PubMed both as a randomized trial and as a meta-analysis, so it may partly re-analyze the earlier data rather than being a fully independent second trial, and it comes from the same manufacturer-linked research group.
Two consecutive 48-week observational, open-label follow-up periods (up to 96 weeks total) in roughly 39 to 51 women. There was no placebo group and no randomization in these periods, so this is not a controlled trial.
Perimenopausal women previously enrolled in the 12-week RCT who continued with open-label ERr 731.
Menopause Rating Scale II scores stayed improved across the 96 weeks and no adverse events were attributed to the extract. Because every participant knew she was taking it and there was no comparison group, these results cannot show that the extract caused the continued improvement, and the group was small (roughly 39 to 51 women).