Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

Study Overview
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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.

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.

Official Title
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Black Cohosh Therapy for Menopause-Related Anxiety

Conditions
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Generalized Anxiety Disorder, Menopause

Intervention / Treatment
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* Dietary Supplement: Black cohosh


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Anxiolytic Therapy | Dietary Supplement: Black cohosh<br>* 32 to 128 mg (black cohosh) 1 to 4 capsules daily (placebo)<br>|
| Placebo Comparator: 2<br>Anxiolytic Therapy | Dietary Supplement: Black cohosh<br>* 32 to 128 mg (black cohosh) 1 to 4 capsules daily (placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Hamilton Anxiety Rating Scale |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and functional outcome ratings |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Black Cohosh, Cimicifuga, Anxiety, Women, Complementary and Alternative Medicine