Effects of genistein on hot flushes in early postmenopausal women: A randomized, double-blind EPT- and placebo-controlled study

  • Crisafulli A
  • Marini H
  • Bitto A
 et al. 
  • 11

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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 17β-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. © 2004 The North American Menopause Society.

Author-supplied keywords

  • adult
  • article
  • clinical trial
  • controlled clinical trial
  • controlled study
  • double blind procedure
  • drug safety
  • endometrium
  • estradiol
  • estrogen deficiency
  • estrogen receptor
  • estrogen therapy
  • female
  • follitropin
  • genistein
  • hormone substitution
  • hot flush
  • human
  • major clinical study
  • menopausal syndrome
  • norethisterone acetate
  • phytoestrogen
  • placebo
  • postmenopause
  • randomized controlled trial
  • side effect
  • transvaginal echography
  • treatment outcome

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Authors

  • A Crisafulli

  • H Marini

  • A Bitto

  • D Altavilla

  • G Squadrito

  • A Romeo

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