Tags

Type your tag names separated by a space and hit enter

Cimicifuga racemosa dried ethanolic extract in menopausal disorders: a double-blind placebo-controlled clinical trial.
Maturitas. 2005 Aug 16; 51(4):397-404.M

Abstract

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.

Authors+Show Affiliations

Institute of Pharmaceutical Biology, University of Basel, Switzerland. susanne@frei-kleiner.chNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16039414

Citation

Frei-Kleiner, S, et al. "Cimicifuga Racemosa Dried Ethanolic Extract in Menopausal Disorders: a Double-blind Placebo-controlled Clinical Trial." Maturitas, vol. 51, no. 4, 2005, pp. 397-404.
Frei-Kleiner S, Schaffner W, Rahlfs VW, et al. Cimicifuga racemosa dried ethanolic extract in menopausal disorders: a double-blind placebo-controlled clinical trial. Maturitas. 2005;51(4):397-404.
Frei-Kleiner, S., Schaffner, W., Rahlfs, V. W., Bodmer, C. h., & Birkhäuser, M. (2005). Cimicifuga racemosa dried ethanolic extract in menopausal disorders: a double-blind placebo-controlled clinical trial. Maturitas, 51(4), 397-404.
Frei-Kleiner S, et al. Cimicifuga Racemosa Dried Ethanolic Extract in Menopausal Disorders: a Double-blind Placebo-controlled Clinical Trial. Maturitas. 2005 Aug 16;51(4):397-404. PubMed PMID: 16039414.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cimicifuga racemosa dried ethanolic extract in menopausal disorders: a double-blind placebo-controlled clinical trial. AU - Frei-Kleiner,S, AU - Schaffner,W, AU - Rahlfs,V W, AU - Bodmer,Ch, AU - Birkhäuser,M, Y1 - 2004/12/10/ PY - 2004/07/13/received PY - 2004/10/20/revised PY - 2004/10/21/accepted PY - 2005/7/26/pubmed PY - 2006/7/22/medline PY - 2005/7/26/entrez SP - 397 EP - 404 JF - Maturitas JO - Maturitas VL - 51 IS - 4 N2 - 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. SN - 0378-5122 UR - https://www.unboundmedicine.com/medline/citation/16039414/Cimicifuga_racemosa_dried_ethanolic_extract_in_menopausal_disorders:_a_double_blind_placebo_controlled_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5122(04)00360-3 DB - PRIME DP - Unbound Medicine ER -