Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Generalized Anxiety Disorder Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Anxiolytic Therapy

Group Type EXPERIMENTAL

Black cohosh

Intervention Type DIETARY_SUPPLEMENT

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)

2

Anxiolytic Therapy

Group Type PLACEBO_COMPARATOR

Black cohosh

Intervention Type DIETARY_SUPPLEMENT

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)

Interventions

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Black cohosh

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No