Cimicifuga racemosa dried ethanolic extract in menopausal disorders: a double-blind placebo-controlled clinical trial

Maturitas. 2005 Aug 16;51(4):397-404. doi: 10.1016/j.maturitas.2004.10.003. Epub 2004 Dec 10.


Objectives: To compare the efficacy and safety of the black cohosh root extract Cr 99 with placebo in women with climacteric complaints.

Methods: A multicenter, randomized, placebo-controlled, double-blind, parallel group study was conducted in 122 menopausal women (intention-to-treat population) with > or =3 hot flashes a day, treated over 12 weeks. Two main efficacy measures - weekly weighted score of hot flashes and Kupperman Index - and secondary efficacy variables, e.g. Menopause Rating Scale, were defined. Routine safety laboratory parameters and adverse events were documented.

Results: The primary efficacy analysis showed no superiority of the tested black cohosh extract compared to placebo. However, in the subgroup of patients with a Kupperman Index> or =20 a significant superiority regarding this index could be demonstrated (P<0.018). A decrease of 47% and 21% was observed in the black cohosh and placebo group, respectively. The weekly weighted scores of hot flashes (P<0.052) and the Menopause Rating Scale (P<0.009) showed similar results. Prevalence and intensity of the adverse events did not differ in the two treatment groups.

Conclusions: The results indicate a superiority of the tested Cimicifuga racemosa extract compared to placebo in patients with menopausal disorders of at least moderate intensity according to a Kupperman Index > or =20, but not in the intention-to-treat population as a whole.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Cimicifuga*
  • Double-Blind Method
  • Female
  • Hot Flashes / drug therapy*
  • Humans
  • Menopause / drug effects*
  • Middle Aged
  • Phytotherapy*
  • Placebos
  • Plant Extracts / administration & dosage
  • Plant Extracts / therapeutic use*
  • Treatment Outcome


  • Placebos
  • Plant Extracts