MF101, a selective estrogen receptor beta modulator for the treatment of menopausal hot flushes: a phase II clinical trial.
OBJECTIVE
To determine the optimal dose, safety, and efficacy of an estrogen receptor beta selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes.


METHODS
A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks.


RESULTS
The effects of 5 g/day of MF101 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03).


CONCLUSIONS
Treatment with 10 g/day of MF101 reduces the frequency of hot flushes. Trials with higher doses are planned.
Grady
Deborah
D
University of California, San Francisco, San Francisco, CA 94115, USA. Deborah.Grady@ucsf.edu
Sawaya
George F
GF
Johnson
Karen C
KC
Koltun
William
W
Hess
Rachel
R
Vittinghoff
Eric
E
Kristof
Margaret
M
Tagliaferri
Mary
M
Cohen
Isaac
I
Ensrud
Kristine E
KE
D004305:Dose-Response Relationship, Drug; D004717:Endometrium / Q000187:drug effects / Q000473:pathology; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008593:Menopause; D008796:Metrorrhagia / Q000139:chemically induced; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage* / Q000009:adverse effects
C517398:MF101 extract; D010936:Plant Extracts; D020845:Selective Estrogen Receptor Modulators