Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

Menopause Clinical Trial

Official title:

Black Cohosh Therapy for Menopause-Related Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120458
• Other study ID #: R21AT002289-01A1
• Secondary ID: R21AT002289-01A1
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2005
• Last updated: March 1, 2010
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2010
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder
• Menopause

Intervention

Dietary Supplement:
• Black cohosh
32 to 128 mg (black cohosh) 1 to 4 capsules daily (placebo)

Locations

Country	Name	City	State
United States	Depression Research Unit, University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Hamilton Anxiety Rating Scale		12 Weeks	No
Secondary	Quality of life and functional outcome ratings		12 Weeks	No