Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00120458
First received: July 14, 2005
Last updated: March 1, 2010
Last verified: March 2010

July 14, 2005
March 1, 2010
July 2005
December 2008   (final data collection date for primary outcome measure)
Score on Hamilton Anxiety Rating Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Score on Hamilton Anxiety Rating Scale after 12 weeks
Complete list of historical versions of study NCT00120458 on ClinicalTrials.gov Archive Site
Quality of life and functional outcome ratings [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Quality of life and functional outcome ratings after 12 weeks
Not Provided
Not Provided
 
Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety
Black Cohosh Therapy for Menopause-Related Anxiety

This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women.

Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.

During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. Data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. This study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women.

This study will last 12 weeks. Participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. Self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Generalized Anxiety Disorder
  • Menopause
Dietary Supplement: Black cohosh

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)

  • Experimental: 1
    Anxiolytic Therapy
    Intervention: Dietary Supplement: Black cohosh
  • Placebo Comparator: 2
    Anxiolytic Therapy
    Intervention: Dietary Supplement: Black cohosh
Amsterdam JD, Yao Y, Mao JJ, Soeller I, Rockwell K, Shults J. Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. J Clin Psychopharmacol. 2009 Oct;29(5):478-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently experiencing menopause or postmenopausal
  • Have symptoms of menopause-related anxiety

Exclusion Criteria:

  • Any form of generalized anxiety disorder (GAD) unrelated to menopause
  • Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped
  • Alcohol or drug dependence within 3 months prior to study entry
  • Allergy to black cohosh
  • History of hormone replacement therapy
  • Current use of vaginal estrogen cream or phytoestrogens
  • Current use of tranquilizers, antidepressants, or antianxiety therapies
  • Abnormal uterine bleeding
  • History of estrogen-dependent cancer
  • History of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer
  • Rapidly growing uterine fibroids
  • Abnormal finding upon gynecological examination that would interfere with the study
  • Abnormal breast examination or mammogram
  • Any unstable medical condition
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120458
R21 AT002289-01A1, R21AT002289-01A1
Yes
Jay D. Amsterdam, M.D., University of Pennsylvania
University of Pennsylvania
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Office of Dietary Supplements (ODS)
Principal Investigator: Jay D. Amsterdam, MD University of Pennsylvania
University of Pennsylvania
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP