Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: randomized, controlled, double-blind pilot study

Gynecol Endocrinol. 2007 Feb;23(2):117-22. doi: 10.1080/09513590701200900.

Abstract

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.

Conclusion: 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Cimicifuga
  • Dietary Supplements
  • Double-Blind Method
  • Drugs, Chinese Herbal
  • Dyssomnias / drug therapy
  • Female
  • Hot Flashes / drug therapy*
  • Hot Flashes / etiology
  • Humans
  • Menopause / drug effects*
  • Middle Aged
  • Milk Thistle
  • Panax
  • Phytotherapy*
  • Pilot Projects
  • Plant Extracts / therapeutic use*
  • Plant Preparations / therapeutic use*
  • Sleep Wake Disorders / drug therapy
  • Sleep Wake Disorders / etiology
  • Trifolium
  • Vitex

Substances

  • Drugs, Chinese Herbal
  • Plant Extracts
  • Plant Preparations
  • dong quai