Vertigo with acute vestibular migrane condition - case study
Black Cohosh Powerpoint
1. A Review of the Benefits and Risks
of Black Cohosh
(Cimicifuga racemosa syn Actaea racemosa)
in the Treatment of Vasomotor Irregularities
Resulting from Menopause
by Noelani Fox
for Issues in Nutrition and Health
at The University of Texas at Austin
November 22, 2011
2. Introduction
• Menopause and Hot Flashes
• Associated Risks
• Evaluation Scales
• Traditional and Alternative Treatments
• Black Cohosh
Methods
• Literature Search
• Inclusion / Exclusion
• Outcome Measures
Results
• Efficacy
• Safety
3. Discussion
• Effectiveness and Safety
• Concurrence and Disagreement
• Conflict
• Strengths / Weaknesses
• Conclusion
References
5. ◦ 12 months of Menopause:
amenorrhea a fact of life
◦ Many, varied symptoms
Hot flashes
◦ 2/3 of women between Night sweats
Profuse sweating
40 and 60 Headaches
Depression
Irritability
Sleep disorders
◦ 80% severe Vaginal dryness
Heart discomfort
Anxiety
Sexual dysfunction
◦ Vasomotor symptoms are Bladder problems
the most common Joint pain
Muscular discomfort
6. ◦ 12 months of Menopause:
amenorrhea a fact of life
◦ Many, varied symptoms
Hot flashes
◦ 2/3 of women between Night sweats
Profuse sweating
40 and 60 Headaches
Depression
Irritability
Sleep disorders
◦ 80% severe Vaginal dryness
Heart discomfort
Anxiety
Sexual dysfunction
◦ Vasomotor symptoms are Bladder problems
the most common Joint pain
Muscular discomfort
7. Risks
Associated ◦ Greater aortic calcification
with Hot ◦ Coronary artery calcification
Flashes
◦ Higher cholesterol levels
Longer history
◦ Higher blood pressure
of hot flashes
correlated
with: ◦ Increased BMI
◦ Reduced dilation of right
brachial artery
8. Risks
Associated ◦ Greater aortic calcification
with Hot ◦ Coronary artery calcification
Flashes
◦ Higher cholesterol levels
Longer history
◦ Higher blood pressure
of hot flashes
correlated
with: ◦ Increased BMI
◦ Reduced dilation of right
brachial artery
9. Kupperman Index
◦ Developed 1953
◦ Eleven symptoms
Scale of 0 (none) to
3 (severe)
• Menopause Rating Scale
• Developed 1990’s
• Eleven symptoms
• Three subscales
• Scale of 0 (none) to
4 (severe)
Evaluation Scales
10. Symptoms Factor Severity Numerical conversion
(factor × severity)
Vasomotor
Paraesthesia
Insomnia
Nervousness
Melancholia
Vertigo
Weakness (fatigue)
Arthralgia and myalgia
Headaches
Palpitations
Formication
Menopausal index (sum)
0 (none)=0, S (slight)=1, M (moderate)=2, and + (severe)=3
Kupperman Index
11. Symptoms
Somatic 1 Hot flushes, night sweats (episodes of sweating)
2 Heart discomfort (unusual awareness of heart beat, heart skipping,
heart racing, tightness)
3 Sleep problems (difficulty in falling asleep, difficulty in sleeping
through, waking up early)
4 Depressive mood (feeling down, sad, on the verge of tears, lack of
Psychological
drive, mood swings)
5 Irritability (feeling nervous, inner tension, feeling aggressive)
6 Anxiety (inner restlessness, feeling panicky)
7 Physical and mental exhaustion (general decrease in performance,
impaired memory, decrease in concentration, forgetfulness)
8 Sexual problems (change in sexual desire, in sexual activity and
satisfaction)
Urogenital
9 Bladder problems ((difficulty in urinating, increased need to urinate,
bladder incontinence)
10 Dryness of vagina (sensation of dryness or burning in the vagina,
difficulty with sexual intercourse)
11 Joint and muscular discomfort (pain in the joints, rheumatoid
Som
complaints)
Menopause Rating Scale
12. ◦ Hormone Replacement Therapy
• Estrogen and progestin
◦ Women’s Health Initiative
• 16,608 women
• Terminated 3 years early
◦ Breast cancer
◦ Stroke
◦ Pulmonary embolism
Traditional Therapy (HRT)
13. Alternatives to Hormone
Replacement
Over 80 trials reviewed
20 alternative treatments
Botanical Extracts
Multibotanicals
Pharmaceuticals
14. History
Used in US for over 100 years
◦ Coughs and colds
◦ Constipation
◦ Fatigue
◦ Rheumatism
Menstrual maladies since 1950’s
Black Cohosh
15. Mechanism of Action
Estrogen-receptor mediation unlikely
Thermogenesis regulated by serotonergic receptors
◦ Nω-methylserotonin
Binds to receptors
Induces cAMP activity
Prevents serotonin reuptake
Black Cohosh
16. Safety
Hepatic perfusion and liver function
◦ No change in blood flow
◦ No negative change in liver enzymes
Lipid and glucose profiles
◦ No effect on glucose or insulin
◦ No effect on lipids or fibrinogen
Black Cohosh
18. Menopause • 47,873
Hot flash • 1,659
Black cohosh • 104
English
language • 99
Currency
(post 2005) • 70
Literature Search
19. Inclusion Exclusion
Original study Reviews
Monopreparation of Black Meta-analyses
Cohosh
Hot flashes as primary or Related to breast cancer
secondary outcome measure survivors
Assessment of safety or risk Published previous to 2005
factors
Criteria for Consideration
20. Efficacy Safety
◦ Self assessment ◦ Adverse events
Kupperman Index
◦ Liver function
Menopause Rating
Scale ◦ Lipid profiles
Frequency of hot
◦ Endometrial changes
flashes
Severity of hot flashes
Outcome Measures
32. 60 150
40 100
20 50 Total
Total
0 0
Adverse Adverse
Events Events
6800
5100 200
Total 150
3400
100
Total
1700 Adverse 50
Events
0 Adverse
0
Events
Black
Cohosh
Adverse Events
33. Liver function
◦ AST, ALT
◦ γ-glutamyl transpeptidase
◦ GOT, GPT
Heart rate, blood pressure, weight
Total cholesterol
◦ HDL, LDL
Laboratory Measures
34. No change in estradiol study
Clinically irrelevant change in tibolone
study
◦ Both peri- and postmenopausal women on
tibolone
◦ Only perimenopausal women on black cohosh
Endometrial Change
36. Five of six studies found reductive effect
◦ Equivalent to HRT
◦ More effective than SSRI, placebo
◦ Effective as monopreparation or combination
Good tolerability and safety
◦ Low rate of adverse events
Less common than HRT, comparable to placebo
None serious
◦ No adverse effect on liver, cardiovascular
function
Overview of Efficacy and Safety
37. Cumulative findings consistent with literature
One of six studies found no significant
benefit to Black Cohosh vs placebo
◦ Only study with crossover design
◦ Shortest treatment period
◦ Enhanced placebo effect?
Concurrence and Disagreement
38. Hans-Heinrich Henneicke-von Zepelin
◦ Co-author of three studies
Ute Stammwitz
◦ Co-author of one study
Schaper and Brümmer, Salzgitter, Germany
◦ Manufacturer of Remifemin®
Conflict of Interest
39. Strengths Weaknesses
◦ Current studies ◦ Reliance on self
◦ Peer reviewed reporting of symptoms
◦ Reputable journals ◦ Short term treatment
◦ Monopreparation as ◦ All studies not same
one treatment formulation
◦ Range of locations/ ◦ Limited to six studies
populations ◦ English language only
(US, China, Turkey, Ger ◦ PubMed only
many and Italy) database searched
Strengths and Weaknesses
40. Effective alternative
◦ Reduce health risk
Long history of hot flashes
Hormone replacement therapy
◦ Maintain higher quality of life
Conclusion
41. Safe for short term use
◦ Additional trials needed
Recommend Black Cohosh as valid
alternative for management of vasomotor
irregularities in menopausal women
Conclusion
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and fluoxetine in the treatment of postmenopausal symptoms: A
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2. Bai W, Henneicke-von Zepelin HH, Wang S, Zheng S, Liu J, Zhang Z, Geng L, Hu L, Jiao
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black cohosh extract in Chinese women with menopausal symptoms: A
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31-41
3. Pockaj BA, Gallagher JG, Loprinzi CL, Stella PJ, Barton DL, Sloan JA, Lavasseur BI, Rao
RM, Fitch TR, Rowland KM, Novotny PJ, Flynn PJ, Richelson E, Fauq AH, Phase III double-
blind, randomized, placebo-controlled crossover trial of black cohosh in the
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Review Articles
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menopausal symptoms, Altern Ther Health Med, 2010; 16(1): 36-44
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perfusion and liver function, Fertil Steril, 2009; 92(5):1780-1782
E. Powell SL, Godecke T, Nikolic D, Chen SN, Ahn S, Dietz B, Farnsworth NR, van Breemen RB, Lankin DC, Pauli GF, Bolton JL, In
vitro serotonergic activity of black cohosh and identification of Nω-methylserotonin as a potential active constituent, J
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disease, Circulation, 2008; 118: 1234-1240
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References
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findings: Randomized, placebo-controlled trial of black cohosh, multibotanical herbs, and dietary soy for vasomotor
symptoms: The Herbal Alternatives for Menopause (HALT) Study, Menopause, 2008; 15(1): 51-58
D. Sammartino A, Tommaselli GA, Gargano V, di Carlo C, Attianese W, Nappi C, Short-term effects of a combination of
isoflavones, lignans and Cimicifuga racemosa on climacteric-related symptoms in postmenopausal women: A double-
blind, randomized, placebo-controlled trial, Gynecol Endocrinol, 2006; 22(11): 646-650
E. Spangler L, Newton KM, Grothaus LC, Reed SD, Ehrlich K, LaCroix AZ, The effects of black cohosh therapies on
lipids, fibrinogen, glucose and insulin, Maturitas, 2007; 57: 195-204
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with black cohosh, multibotanicals, soy, hormone therapy, or placebo: A randomized trial, Ann Intern Med, 2006; 145:
869-879
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References