Effects of Genistein on Hot Flushes in Early Postmenopausal Women: A Randomized, Double-Blind EPT- And Placebo-Controlled Study

Menopause. Jul-Aug 2004;11(4):400-4. doi: 10.1097/01.gme.0000109314.11228.e5.

Abstract

Objective: We evaluated and compared the effects of the phytoestrogen genistein, estrogen-progestogen therapy (EPT), and placebo on hot flushes and endometrial thickness in postmenopausal women.

Design: Ninety healthy, postmenopausal women, 47 to 57 years of age, were randomly assigned to receive for 1 year continuous EPT (n = 30; 1 mg 17beta-estradiol combined with 0.5 mg norethisterone acetate), the phytoestrogen genistein (n = 30; 54 mg/day), or placebo (n = 30). Endometrial safety was evaluated by intravaginal ultrasounds at baseline, 6 and 12 months.

Results: By comparison with placebo, daily flushes reduced significantly by a mean of 22% (95% CI: -38 to -6.2; P < 0.01) after 3 months, by a mean of 29% (95% CI: -45 to -13; P < 0.001) after 6 months, and by a mean of 24% (95% CI: -43 to -5; P < 0.01) after 12 months of genistein treatment. Flush score decreased by a mean of 53% (95% CI: -79 to -26; P < 0.001) after 3 months, by a mean of 56% (95% CI: -83 to -28; P < 0.001) after 6 months, and by a mean of 54% (95% CI: -74 to -33; P < 0.001) after 12 months of EPT, as compared with placebo. No side effect was observed on the uterus of the participants.

Conclusions: The present study confirms that genistein might have positive effects on hot flushes without a negative impact on endometrial thickness and suggests a future role of this phytoestrogen as a strategically therapeutic alternative in the management of postmenopausal symptoms.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Double-Blind Method
  • Endometrium / diagnostic imaging
  • Endometrium / drug effects
  • Estrogen Replacement Therapy
  • Female
  • Genistein / administration & dosage
  • Genistein / therapeutic use*
  • Hot Flashes / prevention & control*
  • Humans
  • Middle Aged
  • Postmenopause / drug effects*
  • Postmenopause / physiology
  • Ultrasonography

Substances

  • Genistein