Relief of hot flushes with new plant-derived 10-component synthetic conjugated estrogens.
OBJECTIVE
A study was conducted to evaluate the safety and efficacy of 3 different doses of synthetic conjugated estrogens B, a new plant-derived 10-component conjugated estrogens product, for the treatment of menopausal vasomotor symptoms.


METHODS
This was a randomized, double-blind, placebo-controlled trial. Highly symptomatic menopausal women (N = 281) received 12 weeks of a once-daily oral treatment with 0.3 mg, 0.625 mg, or 1.25 mg of 10-component synthetic conjugated estrogen or placebo. Patients recorded the daily frequency and severity of hot flushes. Statistical analyses compared results at weeks 4, 8, and 12 with baseline values.


RESULTS
Statistically significant reductions (P <.05) in the frequency and severity of vasomotor symptoms were observed for all 3 dosage strengths of 10-component synthetic conjugated estrogen compared with placebo. The most commonly reported adverse events in all treatment groups were headaches. No difference in the incidence of treatment-related adverse events was seen between placebo and 10-component synthetic conjugated estrogen groups.


CONCLUSIONS
The 0.3-mg, 0.625-mg and 1.25-mg dose strengths of 10-component synthetic conjugated estrogen significantly reduced the frequency and severity of vasomotor symptoms compared with placebo, and were well tolerated during this 12-week study.


METHODS
I
Utian
Wulf H
WH
Rapid Medical Research, The Cleveland Clinic, Cleveland, Ohio, USA. Utian@menopause.org
Lederman
Samuel A
SA
Williams
Brenda M
BM
Vega
Rhonda Y
RY
Koltun
William D
WD
Leonard
Thomas W
TW
D000284:Administration, Oral; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D045166:Estradiol Congeners / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy / Q000379:methods; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D019584:Hot Flashes / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008593:Menopause / Q000187:drug effects / Q000502:physiology; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage*; D011336:Probability; D011379:Prognosis; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D045166:Estradiol Congeners; D004966:Estrogens, Conjugated (USP); D010936:Plant Extracts