Black cohosh therapy for menopause-related anxiety

Summary

Principal Investigator: J D Amsterdam
Abstract: DESCRIPTION (provided by applicant): About 65-85% of women experience menopause-related psychological and vasomotor symptoms, and nearly 30% (or 15 million women) seek medical attention for these symptoms. While not life-threatening, menopause can cause substantial distress. To date, most attention has focused on the vasomotor symptoms (e.g., hot flushes). However, nearly 40% of menopausal women do not have hot flushes, while 90% complain of anxiety symptoms (e.g., nervousness, irritability, fatigue, muscle aches, mood liability, depression, and low libido). Until recently, hormone replacement therapy (HRT) has been the mainstay for controlling the symptoms of menopause. Recent reports, however, of increased health risks of HRT (including an increased incidence of breast cancer, heart disease, stroke, and dementia) have had a major impact on the public's perception of the safety and desirability of HRT. Now that there are serious questions regarding the risk/benefit ratio of HRT, increasing numbers of women are seeking alternative treatments. The focus of this R21 grant is to specifically study the benefit of Black Cohosh for the non-vasomotor, psychological symptoms of menopause. There is compelling biochemical and behavioral evidence indicating that Black Cohosh has a direct action on central neurotransmitter and receptor function involved in anxiety, and that it may also have anti-anxiety effect. Results from this study will be used to determine the optimum sample size necessary to establish the efficacy of Black Cohosh in a future, fully powered efficacy trial. In this grant, we will ask: Is Black Cohosh a safe and effective treatment for Generalized Anxiety Disorder (GAD) Due to Menopause (DSMIV 293.89)? To answer this question, 50 women with GAD Due to Menopause, who are not using HRT, will receive randomized, double-blind treatment with either (i) Black Cohosh 20 mg BID, or (ii) placebo. We hypothesize that Black Cohosh will have a superior anti-anxiety efficacy compared to placebo, and a comparable safety profile to placebo. We will also ask: Does Black Cohosh confer an enhanced quality of life (QOL) compared to placebo in women with GAD Due to Menopause? To answer this question, specific QOL, well-being, and sexual performance measures will be obtained during double-blind treatment with Black Cohosh and placebo. We hypothesize that Black Cohosh will result in superior QOL measures compared to placebo.
Funding Period: 2005-09-01 - 2008-06-30
more information: NIH RePORT

Top Publications

  1. ncbi Venlafaxine versus lithium monotherapy of rapid and non-rapid cycling patients with bipolar II major depressive episode: a randomized, parallel group, open-label trial
    Jay D Amsterdam
    Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, United States
    J Affect Disord 112:219-30. 2009
  2. ncbi Differences in serotonin transporter binding affinity in patients with major depressive disorder and night eating syndrome
    J D Lundgren
    Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania School of Medicine, Philapelphia, PA, USA
    Eat Weight Disord 14:45-50. 2009
  3. pmc Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause
    Jay D Amsterdam
    Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA 19104 3309, USA
    J Clin Psychopharmacol 29:478-83. 2009

Detail Information

Publications3

  1. ncbi Venlafaxine versus lithium monotherapy of rapid and non-rapid cycling patients with bipolar II major depressive episode: a randomized, parallel group, open-label trial
    Jay D Amsterdam
    Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, United States
    J Affect Disord 112:219-30. 2009
    ..We hypothesized that lithium would have superior efficacy to venlafaxine, with fewer syndromal and sub-syndromal hypomanic and mixed mood conversions in the rapid cycling BP II MDE patients...
  2. ncbi Differences in serotonin transporter binding affinity in patients with major depressive disorder and night eating syndrome
    J D Lundgren
    Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania School of Medicine, Philapelphia, PA, USA
    Eat Weight Disord 14:45-50. 2009
    ..There are similarities between MDD and NES in affective symptoms, appetite disturbance, nighttime awakenings, and, particularly, response to selective serotonin reuptake inhibitors (SSRIs)...
  3. pmc Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause
    Jay D Amsterdam
    Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA 19104 3309, USA
    J Clin Psychopharmacol 29:478-83. 2009
    ..We hypothesized that black cohosh would be superior to placebo in reducing anxiety symptoms of menopause, with a comparable tolerability profile to placebo...