A Review of the Benefits and Risks                          of Black Cohosh(Cimicifuga racemosa syn Actaea racemosa)in the...
Introduction• Menopause and Hot Flashes• Associated Risks• Evaluation Scales• Traditional and Alternative Treatments• Blac...
Discussion• Effectiveness and Safety• Concurrence and Disagreement• Conflict• Strengths / Weaknesses• ConclusionReferences
Introduction
◦ 12 months of             Menopause:  amenorrhea               a fact of life◦ Many, varied symptoms                     ...
◦ 12 months of             Menopause:  amenorrhea               a fact of life◦ Many, varied symptoms                     ...
RisksAssociated           ◦ Greater aortic calcificationwith Hot             ◦ Coronary artery calcificationFlashes       ...
RisksAssociated           ◦ Greater aortic calcificationwith Hot             ◦ Coronary artery calcificationFlashes       ...
   Kupperman Index    ◦ Developed 1953    ◦ Eleven symptoms      Scale of 0 (none) to       3 (severe)                  ...
Symptoms                       Factor   Severity   Numerical conversion                                                   ...
SymptomsSomatic         1   Hot flushes, night sweats (episodes of sweating)                2   Heart discomfort (unusual ...
◦ Hormone Replacement Therapy   • Estrogen and progestin ◦ Women’s Health Initiative   • 16,608 women   • Terminated 3 yea...
Alternatives to HormoneReplacement                        Over 80 trials reviewed                        20 alternative ...
History   Used in US for over 100 years    ◦   Coughs and colds    ◦   Constipation    ◦   Fatigue    ◦   Rheumatism   M...
Mechanism of Action   Estrogen-receptor mediation unlikely   Thermogenesis regulated by serotonergic receptors    ◦ Nω-m...
Safety   Hepatic perfusion and liver function    ◦ No change in blood flow    ◦ No negative change in liver enzymes   Li...
Methods
Menopause                     • 47,873       Hot flash                 • 1,659      Black cohosh              • 104       ...
Inclusion                    ExclusionOriginal study                 ReviewsMonopreparation of Black       Meta-analysesCo...
   Efficacy                         Safety    ◦ Self assessment                 ◦ Adverse events       Kupperman Index ...
Results
1   2   3                    Aaa                    Bbb                    Ccc                    Ddd                    Z...
Fluoxetine                          Tibolone30                                  30     25.1        25.2                   ...
Fluoxetine                          Tibolone30                                  30     25.1        25.2                   ...
Placebo                                         Combination Therapy                                                Monothe...
Placebo                                         Combination Therapy                                                Monothe...
Placebo                                         Combination Therapy                                                Monothe...
Low-dose estradiol           Placebo14                          1812                          1610                        ...
Low-dose estradiol          Placebo14                         1812                         1610                         14...
ResultsSafety
   Gastrointestinal distress                Allergic skin reactions                Infections                Sleep dis...
60                              15040                              10020                               50       Total     ...
   Liver function    ◦ AST, ALT    ◦ γ-glutamyl transpeptidase    ◦ GOT, GPT   Heart rate, blood pressure, weight   Tot...
   No change in estradiol study   Clinically irrelevant change in tibolone    study    ◦ Both peri- and postmenopausal w...
Discussion
   Five of six studies found reductive effect    ◦ Equivalent to HRT    ◦ More effective than SSRI, placebo    ◦ Effectiv...
   Cumulative findings consistent with literature   One of six studies found no significant    benefit to Black Cohosh v...
   Hans-Heinrich Henneicke-von Zepelin    ◦ Co-author of three studies   Ute Stammwitz    ◦ Co-author of one study   Sc...
   Strengths                      Weaknesses    ◦ Current studies               ◦ Reliance on self    ◦ Peer reviewed   ...
   Effective alternative    ◦ Reduce health risk       Long history of hot flashes       Hormone replacement therapy   ...
   Safe for short term use    ◦ Additional trials needed   Recommend Black Cohosh as valid    alternative for management...
1.   Oktem M, Eroglu D, Karahan HB, Taskintuna N, Kuscu E, Zeyneloglu HB, Black cohosh     and fluoxetine in the treatment...
A.   Rossouw J, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SAA, Howard     BV...
A.   Uebelhack R, Blohmer JU, Graubaum HJ, Busch R, Gruenwald J, Wernecke KD, Black cohosh and St. John’s wort for     cli...
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Presentaton of in depth review of literature on efficacy and safety of Black Cohosh as alternative to hormones for menopause symptom therapy

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Black Cohosh Powerpoint

  1. 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. 2. Introduction• Menopause and Hot Flashes• Associated Risks• Evaluation Scales• Traditional and Alternative Treatments• Black CohoshMethods• Literature Search• Inclusion / Exclusion• Outcome MeasuresResults• Efficacy• Safety
  3. 3. Discussion• Effectiveness and Safety• Concurrence and Disagreement• Conflict• Strengths / Weaknesses• ConclusionReferences
  4. 4. Introduction
  5. 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. 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. 7. RisksAssociated ◦ Greater aortic calcificationwith Hot ◦ Coronary artery calcificationFlashes ◦ Higher cholesterol levels Longer history ◦ Higher blood pressure of hot flashes correlated with: ◦ Increased BMI ◦ Reduced dilation of right brachial artery
  8. 8. RisksAssociated ◦ Greater aortic calcificationwith Hot ◦ Coronary artery calcificationFlashes ◦ Higher cholesterol levels Longer history ◦ Higher blood pressure of hot flashes correlated with: ◦ Increased BMI ◦ Reduced dilation of right brachial artery
  9. 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. 10. Symptoms Factor Severity Numerical conversion (factor × severity)VasomotorParaesthesiaInsomniaNervousnessMelancholiaVertigoWeakness (fatigue)Arthralgia and myalgiaHeadachesPalpitationsFormicationMenopausal index (sum) 0 (none)=0, S (slight)=1, M (moderate)=2, and + (severe)=3Kupperman Index
  11. 11. SymptomsSomatic 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 ofPsychological 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, rheumatoidSom complaints)Menopause Rating Scale
  12. 12. ◦ Hormone Replacement Therapy • Estrogen and progestin ◦ Women’s Health Initiative • 16,608 women • Terminated 3 years early ◦ Breast cancer ◦ Stroke ◦ Pulmonary embolismTraditional Therapy (HRT)
  13. 13. Alternatives to HormoneReplacement  Over 80 trials reviewed  20 alternative treatmentsBotanical Extracts Multibotanicals Pharmaceuticals
  14. 14. History Used in US for over 100 years ◦ Coughs and colds ◦ Constipation ◦ Fatigue ◦ Rheumatism Menstrual maladies since 1950’sBlack Cohosh
  15. 15. Mechanism of Action Estrogen-receptor mediation unlikely Thermogenesis regulated by serotonergic receptors ◦ Nω-methylserotonin  Binds to receptors  Induces cAMP activity  Prevents serotonin reuptakeBlack Cohosh
  16. 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 fibrinogenBlack Cohosh
  17. 17. Methods
  18. 18. Menopause • 47,873 Hot flash • 1,659 Black cohosh • 104 English language • 99 Currency (post 2005) • 70Literature Search
  19. 19. Inclusion ExclusionOriginal study ReviewsMonopreparation of Black Meta-analysesCohoshHot flashes as primary or Related to breast cancersecondary outcome measure survivorsAssessment of safety or risk Published previous to 2005factorsCriteria for Consideration
  20. 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 flashesOutcome Measures
  21. 21. Results
  22. 22. 1 2 3 Aaa Bbb Ccc Ddd ZzzResultsEfficacy Measures
  23. 23. Fluoxetine Tibolone30 30 25.1 25.2 24.7 24.725 2520 18.5 2015 13 15 11.2 11.210 10 7.7 7.5 Baseline Baseline 5 5 4 weeks 0 12 Weeks 0 12 weeksKupperman Index
  24. 24. Fluoxetine Tibolone30 30 25.1 25.2 24.7 24.725 2520 18.5 2015 13 15 11.2 11.210 10 7.7 7.5 Baseline Baseline 5 5 4 weeks 0 12 Weeks 0 12 weeksKupperman Index
  25. 25. Placebo Combination Therapy Monotherapy Combination Difference in Therapy treatment in favor Base- Mo 3 Mo 6 Base- Mo 3 Mo 6 of Black Cohosh line line 0.52 0.33 0.25 0.56 0.34 0.25 (p=0.027) Flashes ± ± ± ± ± ± Hot 0.21 0.19 0.16 0.21 0.19 0.16 ◦ Covariates 0.31 0.21 0.16 0.42 0.26 0.19 eliminated (p=0.02) Total MRS Psyche ± ± ± ± ± ± 0.22 0.18 0.14 0.23 0.18 0.15 ◦ Confounders 0.30 0.20 0.16 0.36 0.24 0.18 considered (p<0.001) ± ± ± ± ± ± Score 0.17 0.14 0.11 0.17 0.14 0.12Menopause Rating Scale
  26. 26. Placebo Combination Therapy Monotherapy Combination Difference in Therapy treatment in favor Base- Mo 3 Mo 6 Base- Mo 3 Mo 6 line line of Black Cohosh 0.52 0.33 0.25 0.56 0.34 0.25 (p=0.027) Flashes ± ± ± ± ± ± 0.21 0.19 0.16 0.21 0.19 0.16 Hot ◦ Covariates 0.31 0.21 0.16 0.42 0.26 0.19 eliminated (p=0.02) Total MRS Psyche ± ± ± ± ± ± 0.22 0.18 0.14 0.23 0.18 0.15 ◦ Confounders 0.30 0.20 0.16 0.36 0.24 0.18 considered (p<0.001) ± ± ± ± ± ± Score 0.17 0.14 0.11 0.17 0.14 0.12Menopause Rating Scale
  27. 27. Placebo Combination Therapy Monotherapy Combination Difference in Therapy treatment in favor Base- Mo 3 Mo 6 Base- Mo 3 Mo 6 line line of Black Cohosh 0.52 0.33 0.25 0.56 0.34 0.25 (p=0.027) Flashes ± ± ± ± ± ± 0.21 0.19 0.16 0.21 0.19 0.16 Hot ◦ Covariates 0.31 0.21 0.16 0.42 0.26 0.19 eliminated (p=0.02) Total MRS Psyche ± ± ± ± ± ± 0.22 0.18 0.14 0.23 0.18 0.15 ◦ Confounders 0.30 0.20 0.16 0.36 0.24 0.18 considered (p<0.001) ± ± ± ± ± ± Score 0.17 0.14 0.11 0.17 0.14 0.12Menopause Rating Scale
  28. 28. Low-dose estradiol Placebo14 1812 1610 14 8 TTSE2 12 6 10 Placebo 4 Black 8 2 0 Cohosh 6 Black 4 Cohosh 2 0Symptom Diary
  29. 29. Low-dose estradiol Placebo14 1812 1610 14 8 12 6 TTSE2 10 Placebo 4 Black 8 2 0 Cohosh 6 Black 4 Cohosh 2 0Symptom Diary
  30. 30. ResultsSafety
  31. 31.  Gastrointestinal distress  Allergic skin reactions  Infections  Sleep disturbances  Gynecological  HeadachesAdverse Events
  32. 32. 60 15040 10020 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 CohoshAdverse Events
  33. 33.  Liver function ◦ AST, ALT ◦ γ-glutamyl transpeptidase ◦ GOT, GPT Heart rate, blood pressure, weight Total cholesterol ◦ HDL, LDLLaboratory Measures
  34. 34.  No change in estradiol study Clinically irrelevant change in tibolone study ◦ Both peri- and postmenopausal women on tibolone ◦ Only perimenopausal women on black cohoshEndometrial Change
  35. 35. Discussion
  36. 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 functionOverview of Efficacy and Safety
  37. 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. 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. 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 searchedStrengths and Weaknesses
  40. 40.  Effective alternative ◦ Reduce health risk  Long history of hot flashes  Hormone replacement therapy ◦ Maintain higher quality of lifeConclusion
  41. 41.  Safe for short term use ◦ Additional trials needed Recommend Black Cohosh as valid alternative for management of vasomotor irregularities in menopausal womenConclusion
  42. 42. 1. Oktem M, Eroglu D, Karahan HB, Taskintuna N, Kuscu E, Zeyneloglu HB, Black cohosh and fluoxetine in the treatment of postmenopausal symptoms: A prospective, randomized trial, Adv Ther, 2007; 24: 1055-10682. Bai W, Henneicke-von Zepelin HH, Wang S, Zheng S, Liu J, Zhang Z, Geng L, Hu L, Jiao C, Liske E, Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: A randomized, double blind, parallel-controlled study versus tibolone, Maturitas, 2007; 58: 31-413. 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 management of hot flashes: NCCTG Trial N01CC, J Clin Oncol, 2006; 24: 2836-28414. Osmers R, Friede M, Liske E, Schnitker J, Freudenstein J, Henneicke-von Zepelin HH, Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms, Obstet Gynecol, 2005; 105: 1074-10835. Nappi R, Malavasi B, Brundu B, Facchinetti F, Efficacy of Cimicifuga racemosa on climacteric complaints: A randomized study versus low-dose transdermal estradiol, Gynecol Endocrinol, 2005; 20(1): 30-356. Briese V, Stammwitz U, Friede M, Henneicke-von Zepelin HH, Black cohosh with or without St. John’s wort for symptom specific climacteric treatment- Results of a large- scale, controlled, observational study, Maturitas, 2007; 57: 405-414Review Articles
  43. 43. A. Rossouw J, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SAA, Howard BV, Johnson KC, Kotchen JM, Ockene J, Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative Randomized Controlled Trial, JAMA, 2002; 288(3): 321-333B. Dog TL, Menopause: A review of botanical dietary supplements, Am J Med, 2005; 118: 98S-108SC. Shams T, Setia MS, Hemmings R, McCusker J, Sewitch M, Ciampi A, Efficacy of black cohosh-containing preparations on menopausal symptoms, Altern Ther Health Med, 2010; 16(1): 36-44D. Nasr A, Nafeh H, Influence of black cohosh (Cimicifuga racemosa) use by postmenopausal women on total hepatic perfusion and liver function, Fertil Steril, 2009; 92(5):1780-1782E. 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 Agric Food Chem, 2008; 56:11718-11726F. Thurston RC, Kuller LH, Edmundowicz D, Matthews KA, History of hot flashes and aortic calcification among postmenopausal women, Menopause, 2010;17(2):256-261G. Gast GCM, Grobbee DE, Pop VJM, Keyzer JJ, Wijnands-van Gent CJM, Samsioe GN, Nilsson PM, van der Schouw YT, Menopausal complaints are associated with cardiovascular risk factors, Hypertension, 2008; 51:1492-1498H. Thurston RC, Sutton-Tyrrell K, Everson-Rose SA, Hess R, Matthews KA, Hot flashes and subclinical cardiovascular disease, Circulation, 2008; 118: 1234-1240I. Mahady GB, Fabricant D, Chadwick LR, Dietz B, Black cohosh: An alternative therapy for menopause? Nutr Clin Care, 2002; 5: 283-289J. Cheema D, Coomarasamy A, El-Toukhy T, Non-hormonal therapy of post-menopausal vasomotor symptoms, Arch Gynecol Obstet, 2007; 276: 463-469K. Rotem C, Kaplan B, Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep, Gynecol Endocrinol, 2007; 23(2): 117-122References
  44. 44. A. Uebelhack R, Blohmer JU, Graubaum HJ, Busch R, Gruenwald J, Wernecke KD, Black cohosh and St. John’s wort for climacteric complaints: A randomized trial, Obstet Gynecol, 2006; 107: 247-255B. Chung DJ, Kim HY, Park KH, Jeong KA, Lee SK, Lee YI, Hur SE, Cho MS, Lee BS, Bai SW, Kim CM, Cho SH, Hwang JY, Park JH, Black cohosh and St. John’s wort (GYNO-Plus®) for climacteric symptoms, Yonsei Med J, 2007; 48(2): 289-294C. Reed SD, Newton KM, LaCroix AZ, Grothaus LC, Grieco VS, Ehrlich K, Vaginal, endometrial, and reproductive hormone 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): 51-58D. 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): 646-650E. 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: 195-204F. Newton KM, Reed SD, LaCroix AZ, Grothaus LC, Ehrlich K, Guiltinan J, Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: A randomized trial, Ann Intern Med, 2006; 145: 869-879G. Heinemann LAJ, DoMinh T, Strelow F, Gerbsch S, Schnitker J, Schneider HPG, The Menopause Rating Scale (MRS) as outcome measure for hormone treatment? A validation study, Health Qual Life Outcomes, 2004; 2: 67H. Metintas S, Arýkan I, Kalyoncu C, Ozalp S, Menopause Rating Scale as a screening tool in rural Turkey, Rural Remote Health, 2010;1230 (Accessed 11/4/2011)I. ZEG Berlin. MRS - Menopause Rating Scale. (Online) no date, http://www.menopause-rating-scale.info/ (Accessed 11/4/2011).J. Heinemann K, Ruebig A, Potthoff P, Schneider HPG, Strelow F, Heinemann LAJ, Thai DM, The Menopause Rating Scale (MRS) scale: A methodological review, Health Qual Life Outcomes, 2004; 2:45, http://www.hqlo.com/content/2/1/45 (Accessed 11/4/2011).K. Alder E, The Blatt-Kupperman menopausal index: a critique, Maturitas, 1998; 29:1:19-24References
  45. 45. Questions?

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