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
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Menopause
Dietary Supplement: Black cohosh
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Black Cohosh Therapy for Menopause-Related Anxiety

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Score on Hamilton Anxiety Rating Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life and functional outcome ratings [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Anxiolytic Therapy
Dietary Supplement: Black cohosh

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)

Placebo Comparator: 2
Anxiolytic Therapy
Dietary Supplement: Black cohosh

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120458

Locations
United States, Pennsylvania
Depression Research Unit, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Jay D. Amsterdam, MD University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jay D. Amsterdam, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00120458     History of Changes
Other Study ID Numbers: R21 AT002289-01A1, R21AT002289-01A1
Study First Received: July 14, 2005
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Black Cohosh
Cimicifuga
Anxiety
Women
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 21, 2014