Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

Phase 4

Completed

• Conditions: Generalized Anxiety Disorder; Menopause
• Interventions: Dietary Supplement: Black cohosh

• Registration Number: NCT00120458
• Lead Sponsor: University of Pennsylvania

Brief 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.

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-14
• Study First Submitted QC: 2005-07-14
• Study First Posted: 2005-07-18
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Black cohosh	Anxiolytic Therapy
2	Black cohosh	Anxiolytic Therapy

Primary Outcome Measures

Name	Time	Method
Score on Hamilton Anxiety Rating Scale	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life and functional outcome ratings	12 Weeks

Trial Locations

Locations (1)

Depression Research Unit, University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States