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Herbal Extract Tames Hot Flashes Via Estrogen Receptor-Beta Pathway: Presented at NAMS

By Carole Bullock

DALLAS, TX -- October 9, 2007 -- A new estrogen receptor-beta agonist, an extract from Chinese herbs, led to fewer and less severe hot flushes in postmenopausal women. This result of a phase II trial was reported at the North American Menopause Society (NAMS) 18th annual meeting.

The study was presented by Deborah Grady, MD, Professor of Medicine at the University of California, San Francisco, San Francisco, CA.

"The current treatment for hot flashes is not very good, so there are new studies looking at drugs that would be as effective but avoid the side effects. One of these is the estrogen receptor-beta agonist," Dr. Grady said in a presentation on October 5.

"Selective estrogen receptor modulators (SERMs) are one alternative for maintaining bone mineral density without promoting breast cancer, but they don't suppress hot flashes," she pointed out.

Dr. Grady explained that the estrogen signaling pathways are mediated by two estrogen receptors, alpha and beta. Previous research suggests that the beta estrogen receptor produces more selective clinical effects compared with the global effects elicited by estrogens, thus providing a safer alternative for long-term hormone therapy.

"This study was conducted to determine the effect of a selective estrogen receptor-beta agonist extracted from Chinese herbs (MF101) on the frequency and severity of hot flashes in postmenopausal women," Dr. Grady said.

In this phase 2, multicenter, blinded, placebo-controlled trial, 217 healthy postmenopausal women 40 to 60 years of age who reported at least 7 moderate to severe hot flushes per day or 50 per week were randomized to placebo or to 5 or 10 g/d of MF101 in two divided doses for 12 weeks.

The frequency and severity of hot flushes were recorded in a weekly diary. The hot flush score was then calculated as frequency multiplied by severity.

After 12 weeks, hot flush frequency improved by 33% with placebo compared with 39% with lower-dose MF101 (P =.28) and 41% with higher-dose MF101 (P =.17).

The mean hot flush score improved 36% with placebo compared with 43% with lower-dose MF101 (P =.34) and 41% with higher-dose MF101 (P =.45).

Dr. Grady reported an updated secondary analysis in her presentation: At 12 weeks, 26% of the women on placebo experienced a 50% or greater reduction in hot flushes, whereas 33% of those on lower-dose MF101 did so (P =.23), as did 40% of those on higher-dose MF101 (P =.03).

Loose stools were more commonly reported by women assigned to MF101 (12%) compared with those on placebo (3%) (P =.03).

Comparable rates of vaginal bleeding occurred -- 9% among women assigned to MF101 and 10% among those assigned placebo (P =.82).

"In this phase 2 trial, MF101 showed promise as a safe, novel treatment for menopausal hot flushes. Future studies using higher doses of this selective estrogen receptor modulator will further clarify its efficacy and safety," Dr. Grady reported.

[Presentation title: A Novel Selective Estrogen Receptor-Beta Agonist for the Treatment of Menopausal Hot Flushes Abstract S-1.]

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