Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: randomized, controlled, double-blind pilot study.
OBJECTIVE
To determine the efficacy and safety of the herbal formula Phyto-Female Complex (SupHerb, Netanya, Israel; ingredients: standardized extracts of black cohosh, dong quai, milk thistle, red clover, American ginseng, chaste-tree berry) for the relief of menopausal symptoms.


METHODS
A randomized, double-blind, placebo-controlled trial in 50 healthy pre and postmenopausal women, aged 44-65 years, to whom oral Phyto-Female Complex or matched placebo was prescribed twice daily for 3 months. A structured questionnaire on the frequency and intensity of menopausal symptoms was administered weekly from one week before throughout the 3-month treatment period, followed by biochemical tests, breast check, and transvaginal ultrasonography.


RESULTS
The women receiving Phyto-Female Complex reported a significantly superior mean reduction in menopausal symptoms than the placebo group. The effect of treatment improvements in menopausal symptoms increased over time; by 3 months there was a 73% decrease in hot flushes and a 69% reduction of night sweats, accompanied by a decrease in their intensity and a significant benefit in terms of sleep quality. Hot flushes ceased completely in 47% of women in the study group compared with only 19% in the placebo group. There were no changes in findings on vaginal ultrasonography or levels of relevant hormones (estradiol, follicle-stimulating hormone), liver enzymes or thyroid-stimulating hormone in either group.


CONCLUSIONS
Phyto-Female Complex is safe and effective for the relief of hot flushes and sleep disturbances in pre- and postmenopausal women, at least for 3 months' use.
Rotem
Carmela
C
Felsenstein Medical Research Center, Beilinson Campus, Petah Tiqva, Israel.
Kaplan
Boris
B
D029971:Angelica sinensis; D031885:Cimicifuga; D019587:Dietary Supplements; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal; D020920:Dyssomnias / Q000188:drug therapy; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D020944:Silybum marianum; D005894:Panax; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D028321:Plant Preparations / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000188:drug therapy / Q000209:etiology; D029921:Trifolium; D020950:Vitex
D004365:Drugs, Chinese Herbal; D010936:Plant Extracts; D028321:Plant Preparations; C044613:angelicae sinensis extract