Clinical trial NCT00120458: Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety
Official title: Black Cohosh Therapy for Menopause-Related Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Anxiety Disorder
Menopause
Keywords: Black Cohosh
Cimicifuga
Anxiety
Women
Complementary and Alternative Medicine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Office of Dietary Supplements (ODS)
First posted: 2005-07-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Score on Hamilton Anxiety Rating Scale
timeFrame: 12 Weeks
Secondary outcomes:
measure: Quality of life and functional outcome ratings
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Depression Research Unit, University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jay D. Amsterdam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amsterdam JD, Yao Y, Mao JJ, Soeller I, Rockwell K, Shults J. Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. J Clin Psychopharmacol. 2009 Oct;29(5):478-83. doi: 10.1097/JCP.0b013e3181b2abf2.