Braga

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  • In contrast with the previous slide of perceived health concerns, this slide shows actual rates for cause of death. What is apparent is that a generalized fear of cancer, and breast cancer specifically, skews postmenopausal women’s understanding of their health risks. Such misinformation often represents a barrier when women make decisions about ET/HT. Although the results of the WHI trial have provided and will continue to provide valuable information on the effects of various preventive strategies on chronic disease in menopausal women, they are unlikely to change this misperception. Anderson RN. Deaths: leading causes for 1999. Natl Vital Stat Rep . 2001;49:1-13.
  • Braga

    1. 1. A PRIMAVERA VEM AÍ… Aproveitem melhores tempos !
    2. 2. estamos hoje expostos a vulcões deestudos explosivosque derramam as cinzas das notícias erradas sobre todo o Mundo…
    3. 3. como a conferência deimprensa sobre o WHI: com notícias muitíssimo quentes…
    4. 4. e…, só mais tarde… a primeirapublicação do WHI (JAMA)…
    5. 5. Os manifestos panfletários…Os seus manifestos panfletários nãoforam transmitidos em primeira mãoaos responsáveis pela saúde dasmulheres. Ao contrário, comunicaram-nos à Imprensa que os aceitouerróneamente como verdadeiros e ospublicou em títulos de caixa alta !Assim conseguiram gerar o pânico naspopulações, e a confusão de riscosrelativos com riscos absolutos!
    6. 6. WHI and breast cancerOnce again, it is apparent that the alarmistreports that spread world-wide whenthe first results of the WHI study werepublished in 2002 were unjustified basedon the more recent further analyses,particularly in peri- and earlypostmenopausal women. Press statement of IMS. April 11, 2006.
    7. 7. As encíclicas…“O que é especialmentepreocupante acerca dasdeclarações e encíclicas dasprescrições é a aceitação cega dainfalibilidade do WHI e do MWS”Sturdee D and MacLennan A –(Editorial) Should epidemiology, the media andquangos determine clinical practice? Climacteric 2004;7:1-2
    8. 8. “Baseado no grupo de estudo do WHI, a WHIimplementação dos resultadospara a clínica tem pouca basecientífica, se é que tem alguma…”Adam Ostrzenski and Katarzyna M Ostrzenska. Am J Obst Gynecol2005;193:1599-604
    9. 9. The women enrolled in WHI and HERSinitiated EPT more than a decade aftermenopause on average, and the majorityof events that produced this patternoccurred in older women.March 2007 position statement of The North AmericanMenopause Society.Menopause 2007;14(2):1-17
    10. 10. Data from large studies such as theWHI and HERS should not beextrapolated to symptomaticpostmenopausal women younger than50 years of age who initiate HT at thattime as these women were notstudied in those trialsMarch 2007 position statement of The North AmericanMenopause Society.Menopause 2007;14(2):1-17
    11. 11. It is not possible to extrapolateconclusions from the study of onecompound, dose, and route ofadministration directly to another.March 2007 position statement of The North AmericanMenopause Society.Menopause 2007;14(2):1-17
    12. 12. The WHI study was not designed, andtherefore was not powered, toinvestigate the consequences ofhormone therapy (HT) in women below60 years of age. Press statement of IMS. February 13, 2006.
    13. 13. e ….os investigadores do WHInão sabem interpretar os seus resultados…a pesar de os apresentaremcomo a verdade…
    14. 14. “O Estudo da Saúde das Enfermeiras (NHS) e outros semelhantes podem estar correctos e o WHI estar equivocado, ou vice-versa” Rossouw J, 2003
    15. 15. ”Pode suceder também que cada um deles esteja equivocado. Talvez o estrogénio das pastilhas não seja a molécula em que nos devamos concentrar” Rossouw J, 2003
    16. 16. “ Se os dois estudos estiverem certos então pode ter sucedido que as mulheres estudadas em ambos fossem diferentes nalgum aspecto que os investigadores não decifraram”. Rossouw J, 2003
    17. 17. WHI(Women´s Health Initiative)O que é que mudou? por Manuel Neves-e-Castro XII Jornadas Minhotas de Ginecologia Março 2007 e-mail: manuel@neves-e-castro.org
    18. 18. NADA !
    19. 19. NADA! e por quê?...porque só agora é que a comunidade científica percebeu o que é o WHI e o que não é o WHI…
    20. 20. desde há 4 anos…a SPM soube e sabe ler o WHI !e por isso se pode verificar que sempreestivemos na vanguarda da leituracorrecta (que agora se confirma), nosconcensos e artigos publicados ! http://www.spmenopausa.pt
    21. 21. O que é que o WHI é ? eO que é que o WHI não é ?
    22. 22. O WHI não foi desenhado para estudar o efeito da THM• em mulheres menopáusicas sintomáticas• durante os primeiros 10 anos após a menopausa
    23. 23. WHI• O WHI foi um estudo desenhado apenas para se verificar se a THM tinha efeitos protectores das doenças cardiovasculares:- em mulheres sem os sintomas frequentes da pós- menopausa (afrontamentos, suores nocturnos, etc)- com mais de 10 anos após a menopausa (a média de idades foi de 63 anos)- submetidas a uma única terapêutica hormonal contínua (0,625mg de estrogéneos equinos conjugados e 2,5 mg de acetato de medroxiprogesterona) que não era ajustada em função da idade (até 80 anos!...) nem dos seus efeitos secundários !
    24. 24. Por que motivo se fez o estudo WHI?Para determinar o efeito a longo prazo dos tratamentoshormonais na:prevenção de doenças cardíacas e fracturas do colo do fémur, epossíveis aumentos de risco para cancro da mama e cancro do cólon. Mensagem do Presidente do Estudo WHI www.hormone.org
    25. 25. Press Statement IMSThe WHI study was not designed, and designedtherefore was not powered, to investigate theconsequences of hormone therapy (HT) inwomen below 60 years of age. Therefore, ageany attempt to present the results of the studyas indicating that HT may inflict damage to theheart in general – a message that was acceptedby many medical societies and regulatory Authoritiesis simply wrong and must be amended. amended
    26. 26. WHIQue vantagens trouxe?
    27. 27. Uma chamada de atenção paraem termos gerais de THM- se estudarem doses mais baixas do E e P- se estudar o benefício/risco a) das vias de administração b) das moléculas de P e E usadas c) da duração das THM- se determinar qual a idade pós-menopáusica segura para se iniciar uma THM
    28. 28. A forma como se interpretaramos resultados em termos de:- Risco Absoluto (RA ou AR)- Risco Relativo (RR ou RR)- Risco Atribuível (RAt ou AtR)- Número Necessário para Causar Dano (NNCD ou NNH)
    29. 29. A MENOPAUSA FOI ATACADA POR UMTERRORISTA HORMONAL !
    30. 30. O Terrorista Hormonal
    31. 31. Quero tomar TH ! O Terrorista Hormonal
    32. 32. Quero tomar TH ! O TerroristaMas alguns Hormonalmédicosdizem queNÃO !...
    33. 33. Homemwoman
    34. 34. HomemMulher
    35. 35. WHI O que se disse e ...O que não se disse...
    36. 36. Quais foram as conclusões do WHI no que se refere a:cancro da mama?doenças cardiovasculares?
    37. 37. Efeito sobre o risco de cancro da mamaWHI aumento do risco: risco RR 1.26 (CI 1.00-1.59); 26% aumento de risco AR 0.38% vs 0.30% (ie, 38 vs 30 casos anualmente por 10.000 mulheres) NÃO SIGNIFICATIVO !HERS aumento do risco: RR 1.27 (CI 0.84-1.94); 27% aumento de risco AR 0.59% vs 0.47% (ie, 59 vs 47 casos anualmente por 10.000 mulheres) NÃO SIGNIFICATIVO !
    38. 38. WHI (JAMA 2002;288:321-331)Results: “the difference reaches “almost nominal statistical significance” (i.e. not statistically different!)Discussion: “the substantial risks for CVD and breast cancer” (?!...) MNC/04
    39. 39. Se os resultados do WHI se calcularem, por ano, como NNT NNHDCV 1428ACV 1250TEV 588Cancro da mama 1250Cancro de Cólon 1667Fracturas osteoporóticas 227(total)Neves-e-Castro M. Menopause in crisis post-Women’s Health Initiative? Aview based on personal clinical experience. Human Reproduction2003;18:2512-8
    40. 40. Women’s Health Initiative (WHI) per 1000 pts over 5 years CHRT no HRT At Risk EventCoronary Heart Disease 17 13 +4Stroke 13 9 +4Pulmonary Embolism 8 4 +4Invasive Breast Cancer 17 13 +4Colorectal Cancer 5 8 -3Hip Fracture 4 6 -2Global Index 82 72
    41. 41. Then, why all this noise?... noiseMainly because the conclusions ofrecent trials were severelymisinterpreted by the medicalprofessionals, the media and by theprofessionalswomen, themselves MNC/05
    42. 42. Are Women in a crisis? YES ! Why?
    43. 43. BecauseWe have a tendency to accept as validthe headlines that circulate in themedia without having critically read thefull papers to which they referWe are not able to explain to ourpatients the meaning of those risks andhow small they are compared to otherrisks to which they are expose MNC/05
    44. 44. To begin with, andin the light of the present evidence,doctors and women should bereassured that the suggested HT’s forthe relief of symptoms in themenopauseare safe and very effective !
    45. 45. Medicina Baseada na Evidência e/ou Evidência Baseada na Medicina ? Manuel Neves-e-Castro
    46. 46. Medicina Baseada na Evidência e/ouMedicina Baseada na Inteligência ? Lucas Viana Machado
    47. 47. Evidence informed practice (A Clínica Informada pela Evidência)• It is clearly time to change “evidence based medicine” to “evidence informed practice”.• I suggest the era of evidence informed rather than evidence based medicine has arrived Glasziou P. Centre for Evidence-Based Medicine. University of Medicine Oxford OX3 7LF. BMJ 2005;330:92
    48. 48. Evidence-Based Medicine implies thatrecommendations should be limited to thewomen for whom the studies are relevant.March 2007 position statement of The North AmericanMenopause Society.Menopause 2007;14(2):1-17
    49. 49. The practice of medicine is ultimatelybased on the interpretation at any onetime of the entire body of evidencecurrently available.March 2007 position statement of The North American MenopauseSociety.Menopause 2007;14(2):1-17
    50. 50. e…eis um exemplo de umCONTRA-SENSO…
    51. 51. Effects of conjugated Equine Estrogen in Postmenopausal Womenwith Hysterectomy. JAMA, 2004;291:1701-1712
    52. 52. Stroke“In women 50-59 years not taking HT,ischemic stroke is expected to occur in3 out of 1000 women during 5 years.Five years use of HT would yield 1additional case of stroke/ 1000 women” women EMAS Statement; 2004.
    53. 53. “Estamos afogadosem informaçãomas famintos desabedoria”sabedoria John Naisbilt
    54. 54. O que é que parece ter mudado na interpretação dos resultados de WHI?No que se refere a: – Cancro da mama? – Doenças cardiovasculares?
    55. 55. O cérebro é como umparaquedas… ambos funcionam melhor quando se abrem ! Lord Thomas Dewar
    56. 56. A Mortalidade Cardiovascular é o dobro daMortalidade por Cancro da Mama
    57. 57. BENEFITS OF HORMONE THERAPY In women less than 60 years old, recently menopausal and without prevalent cardiovascular disease, the initiation of HT does not cause early harm and may reduce cardiovascular morbidity and mortality. Continuation of HT beyond the age of 60 should be decided as a part of the overall risk–benefit analysis. IMS press statement, February 2007
    58. 58. Clinica Cardiovascular da Mulher• 13% das mulheres com idade superior a 45 anos teve uma síndrome coronária aguda• 55% da mortalidade na mulher é devido a doença cardiovascular (cardíaca, cerebral)• As mulheres, representam 62% da mortalidade por Insuficiência Cardíaca• A doença coronária na mulher pré-menopausa é menos prevalente, mantendo-se assim durante 10 a 15 anos até aos 70 anos, altura em que iguala o homem
    59. 59. Hormone replacement therapy and risk for coronary heart disease Long-term HRT use is not associated with increased risk for CHD in the CORA-study. This research even supports the notion that HRT can positively affect a number of risk factors like central adiposity, insulin resistance and blood pressure. HRT may even protect from CHD, but adverse lifestyle habits like heavy smoking and a not sufficiently healthy nutrition can offset the beneficial effects of HRT. Windler E et al. Maturitas 2007 in press.
    60. 60. Hormones and the Heart1 in 3 women will die from coronaryheart disease (CHD) in the USA.1 in 25 women will die from breastcancer Fitzpatrick LA. JCEM 2003;88(12):5609-10
    61. 61. Causes of Death Among Women* Other Cancers Heart Disease 15% Breast Cancer 34% 4% Diabetes 3%Chronic Lower 6% Respiratory Disease 28% 10% Other Cerebrovascular Disease*Percentage of total deaths in 1999 among women aged 65 years and older.Anderson RN. Natl Vital Stat Rep. 2001;49:1-13.
    62. 62. NNH / Year (Number Needed to Harm) (the reciprocal of the AtR, the atributable risk)Coronary Heart Disease WHI (RR 1.29) 1428 HERS (RR 0.99) 5000Breast Cancer WHI (RR 1.26) 1250 HERS (RR 1.27) 833 MNC
    63. 63. “Not everything that canbe counted counts; and not everything that counts can be counted” Albert Einstein
    64. 64. “HRT is associated with a 35% reduction in mortality for women who suffered myocardial infarction”.Shlipack MG, Angeja B, Go AS, et al Circulation 2001;104:2300-2304
    65. 65. Doenças cardiovasculares (WHI )O que estava oculto - com terapêutica combinada (E+P)? - com terapêutica só com E?
    66. 66. Younger Women May Receive Heart Protection From Estrogen Therapy In women ages 50-59 who had undergone a hysterectomy, a significant protective effect of estrogen treatment, when both primary (heart attacks and heart attack death) and secondary (coronary artery bypass surgery, angioplasty, confirmed angina pectoris) cardiac endpoints were considered. Dr. S. Mitchell Harman, director and president of Phoenix-based Kronos Longevity Research Institute (KLRI) in Archives of Internal Medicine 2006;106:357-363
    67. 67. An update of the WHI Study !WHI investigators reported (Feb 2006) astatistically significant (34%) lower risk for thecombined endpoint of myocardial infarction(heart attack), coronary death, coronaryrevascularization and confirmed angina amongwomen who were between the ages of 50 and59 at the start of the study (RR 0.66; 95% CI0.45-0.96). Hsia J et al.Arch Intern Med 2006;166:357-363
    68. 68. Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
    69. 69. Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
    70. 70. Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
    71. 71. Press Statement IMSThe estrogen plus progestogen arm of the WHIand the estrogen-alone arm actually showed thatHT does notincrease the risk of coronary heart disease inthe peri- and early menopause,and may even carry beneficial effects. effects Feb 2006
    72. 72. Hormonas eCancro da Mama
    73. 73. Menopausal women and theirdoctors are scared about the side effects of HRT mainly about breast cancer MNC/05
    74. 74. Cancro da mama (WHI)o que concluiu o WHI ?o que estava oculto no WHI ?
    75. 75. WHI ...A VERDADE !
    76. 76. O fluxo da Verdadecorre através dos seuscanais de enganos ... Rabindarath Tagore,1911
    77. 77. POTENTIAL SERIOUS ADVERSEEFFECTS OF HORMONE THERAPYWomen should be reassured that thepossible risk of breast cancerassociated with HT is small (less than0.1% per annum). IMS press statement, February 2007
    78. 78. POTENTIAL SERIOUS ADVERSEEFFECTS OF HORMONE THERAPYData from the WHI and Nurses’ Health Studysuggest that long-term estrogen-onlyadministration for 7 and 15 years, respectively,does not increase the risk of breast cancer inAmerican women.Recent European observational studies suggestthat risk may increase after 5 years. IMS press statement, February 2007
    79. 79. Breast Cancer Risk in PostmenopausalWomen Using Estrogen-Only Therapy Our nationwide study shows that the use of oral or transdermal estradiol for less than 5 years does not increase the risk of breast cancer, but such a risk appears with increasing duration of use in 2 to 3 extra cases of breast cancer per 1.000 women in 10 years of follow-up. Lyytinen H et al. Obstetrics & Gynecology 2006;108(6):1354-1360
    80. 80. The EMAS 2006/2007 update on clinical recommendations onpostmenopausal hormone therapyTo conclude from these new publications theysuggest the absence of increased risk ofbreast cancer using estrogen only therapyafter short periods of time (less than 10year). An increased risk may exist thereafter,however. Gompel A et al. Maturitas 2007;56(2);227-9
    81. 81. Estrogen and progestogen use in peri- and postmenopausal women In absolute terms, this increased risk was rare in the WHI, being 4 to 6 additional invasive cancers per 10,000 women per year who used EPT for 5 or more years. March 2007 position statement of The North American Menopause Society.Menopause 2007;14(2):1-17
    82. 82. Cancro da Mama WHIC.I. (1.00 – 1.59)ARC 0.30% / 10.000 / yrART 0.38% / 10.000 / yrRR 1.26 (26%)Attributable Risk = 8/10.000 / yr = 1/ 1.250 / yrNNH = 1.250 / yr MNC/04
    83. 83. Cancro da Mama HERSC.I.(0,84-1.94)ARC = 0,59% / 10.000 / yrART = 0,47% / 10.000 / yrRR = 1.27 (27%)Attributable Risk = 12 / 10.000 / yr = 1/ 833 / yrNNH = 833 / yr MNC/04
    84. 84. Breast cancer and the use of HRT Considering 10.000 women on the combination HRT then for each year there would be: Seven additional cases of heart attacks Eight cases of stroke, Eight cases of pulmonary embolus, Eight cases of invasive breast cancer, Six fewer cases of hip fractures Baum M. The Breast 2005;14-178-80
    85. 85. O Cancro da MamaO risco de cancro da mama com osE+P combinados contínuos é mínimo.É necessário tratar 1250 mulheres(NNH) durante 1 ano até que sediagnostique 1 cancro da mama (o queé equivalente ao risco relativo de 23%!)
    86. 86. Cancro da MamaO Risco Relativo aumentado de Cancroda Mama com os estrogénios maisprogestagénios durante 5, 6 anos écomparável ao aumento de risco deCancro da Mama para uma mulher queconsome uma bebida alcoólica por dia ouque tem um Indice de Massa Corporal de24, em comparação com 22.
    87. 87. It must be emphasized that we aretalking about an increased incidence ofthe disease, which does notautomatically translate into an increasein deaths from the disease. Baum M. The Breast 2005;14:178-80
    88. 88. Almost 2/3 of women now diagnosed with breast cancer are likely to survive at least 20 years• Cancer Research UK researchers estimate that 64% of women newly diagnosed with breast cancer in England and Wales will live for at least 20 years - compared with 44% in the early 1990s.• More than 7 out of 10 women (72%) are now predicted to survive for at least 10 years, compared years with 54% diagnosed in the early 1990s.• Survival in women aged 50 to 69 - the age group in which breast cancer is most commonly diagnosed - was even better, with 80% predicted to live for at least 10 years while 72% survived to at least 20 years. Prof. Michel Coleman, London School of Hygiene and Tropical Medicine told reports; Oct.10, 2005.
    89. 89. European Cancer Survival % of patients alive five years after diagnosis Prostate Breast Skin* Colon (F) Colon (M) All (M) All (F)ENGLAND 53.8 73.6 85.6 46.2 45.7 37.1 50.8SCOTLAND 53.6 72.3 90.1 47.2 45.3 35.6 49.5WALES 48.8 69.5 79.1 36.5 40.1 34.7 47.3Austria 83.6 75.4 88.2 58.4 N/A 47.5 57.9Czech Rep. 50.1 64.0 78.1 36.4 38.1 32.3 46.0Denmark 41.5 74.9 88.0 47.6 43.2 33.5 51.2Finland 66.5 81.4 84.0 52.7 54.0 41.4 55.8France 75.2 81.3 85.3 58.7 55.9 44.5 57.9Germany 75.9 75.4 89.9 54.5 50.5 44.1 55.6Iceland 76.2 79.6 90.9 55.2 45.9 N/A N/AItaly 63.9 80.6 82.5 52.1 51.2 41.2 55.6Malta 39.4 74.8 65.0 53.3 35.9 N/A N/ANetherlands 68.4 78.2 87.7 54.0 51.9 42.7 55.7Norway 62.1 77.2 88.4 53.6 51.4 40.0 54.9Poland 38.6 63.1 57.9 28.7 26.3 25.2 40.5Portugal 44.0 71.9 68.9 43.5 49.0 N/A N/ASlovenia 48.8 67.4 70.0 38.8 34.8 31.2 47.0Spain 65.5 78.0 89.8 55.8 55.0 43.9 57.1Sweden 67.4 82.6 90.6 54.4 52.2 42.5 57.6Switzerland 67.0 80.0 91.0 56.3 55.0 43.5 56.7EUROPE 65.4 76.1 84.3 51.0 49.2 40.5 53.6Source: Eurocare study
    90. 90. Extended use of estrogen for10 years increases risks by 0,5%, and by15 years increases risks by 0,9%but..upon cessation of HRT, therelative risk quickly returns to 1.0 !Coombs N J, Taylor R, Wilcken N. and Boyages J. BMJ 2005;331:347-349
    91. 91. Breast Cancer• The diagnosis of a breast cancer after the initiation of a HRT (with a duration of less than 5 years) is only a proof of its growth stimulatory effect (not of its carcinogenic effect)• Therefore, the reversal of the risk to 1 after the cessation of HRT confirms again only its growth promoting effect and denies a carcinogenic effect. Dietel M., Lewis MA. and Shapiro S. Human Reproduction 2005;20:2052-60
    92. 92. Breast Cancer• The doubling time of an initial cancer cell, cell up to the diagnosis of a resultant 1cm tumor, is most likely greater than 10 years.• This is why many dormant cancer cells may exist in a “normal” breast ! MNC/05
    93. 93. Occult Breast CancerClinically occult in situBC’s are frequent inyoung and middle-agedwomen. Nielsen M et al-Br J Cancer 1987;56:814-9
    94. 94. Occult Breast CancerBreast malignancy wasfound in 22 women(20%) Nielsen M et al-Br J Cancer 1987;56:814-9
    95. 95. Thus…• Mammographies give more false negative than false positive results !• A “normal” mammography does not exclude the presence of cancer cells that may “explode” a few months later… MNC/05
    96. 96. Estrogen replacement therapy inpatients with early breast cancer The mortality rates from breast cancer for the ERT users was 4.28% compared with 22.3% in the nonusers. nonusers Natrajan PK and Gambrell RD. Am J Obstet Gynecol 2002;187:289-95
    97. 97. HRT in Breast Cancer Survivors: Survivors results:Matched Analysis174 breast cancer cases taking estrogenmatched 4:1 controls with cancer not taking Estrogen. Cases Controls (ERT/HRT) (no ERT/HRT ) recurrence 17/1000 30/1000 Br cancer 5/1000 16/1000 deaths Total deaths 16/1000 30/1000O’Meara et al, JNCI 2001
    98. 98. “Recurrent breast cancer was found in 9% of HRT users and 15% of nonuser”. O’Meara ES et al.JNCI 2001;93:754-761
    99. 99. Mortality following development of breast cancer while usingoestrogen or oestrogen plus progestin: W Chen, DB Petitti and AM Geiger. British Journal of Cancer 2005;93:392– 398
    100. 100. This study explored survival afterexposure to oestrogen or oestrogenplus progestin at or in the year prior tobreast cancer diagnosis oestrogen plus progestin users had lower all-cause mortality and breast cancer mortality Chen W, Petitti DB and Geiger AM. British Journal of Cancer 2005; 93:392-398
    101. 101. Breast cancer survival after hormone exposure
    102. 102. Overall survival after hormone exposure
    103. 103. Breast Cancer Estrogens and Progestagens• No significant increases in risk was observed in users of estrogens used alone (RR 1.1; 95% CI=0.8-1.6) compared with non exposed women but it was greater in combination with oral progestagens (RR 1.3; CI 1.1-1.5)• The risk was significantly greater (p <0.001)with HRT containing synthetic progestagens (RR 1.69; CI 1.5-1.9) than with HRT containing micronized progesterone (RR 1.0; CI 0.83-1.22) Fournier A et al. Int J Cancer 2005;114:448-454 Fournier A et al. Breast Cancer Res Treat.2007,Feb 27 in press
    104. 104. Reduced hormone therapy usemight be cause of steep decline in breast cancer cases A report presented December 14, 2006, at the 29th San Antonio Breast Cancer Symposium in Houston shows a 7% drop in US breast cancer rates. The analysis suggests a link between the decline in breast cancer and hormone therapy (HT) use.December 2006 position statement of The North American Menopause Society
    105. 105. Recent declines in hormone therapy utilization and breast cancer incidence: clinical and population-based evidenceClarke CA et all. Journal of Clinical Oncology 2006;24(33):e49-50
    106. 106. Reduced hormone therapy use might be cause of steep decline in breast cancer cases Greatest decrease in breast cancer was in the number of ER+/PR+ breast cancers. There was little change in other breast cancers. The greatest decrease also occurred in the women aged 50 to 69, those most likely to be using HT.Gass M. F.NAMS special issue released December 20,2006
    107. 107. Reduced hormone therapy usemight be cause of steep decline in breast cancer cases Their data most likely reflect existing cancers just below the detection limit in 2002 that slowed or stopped their growing.December 2006 position statement of The North American Menopause Society
    108. 108. Reduced hormone therapy usemight be cause of steep decline in breast cancer cases Another finding that is consistent with an effect on preexisting tumors is the fact that not a single study thus far has reported a risk increase for noninvasive disease. If HT were initiating (causing) new tumor formation, one would expect to see an increase in in situ disease.December 2006 position statement of The North American Menopause Society
    109. 109. Analisemos então os Riscos
    110. 110. Há riscos?É indispensável que seja dadainformação sobre as diferenças entreriscos relativos e riscos absolutos umavez que os primeiros são a principal causade desinformação e alarmismo, sendo osfavoritos dos media… MNC/05
    111. 111. E então ...Com saber oQual é a verdadeeQual não é ?
    112. 112. Explain the risks in a way that isunderstandable.... Compare the risks of HRT with other better known risks.... MNC/05
    113. 113. BREAST CANCER Risk factor Relative Increase risk incidenceBody weight-normal weight : obesity 1 : 2.5 + 150%Age at menopause - 42yrs : 52 yrs 1 : 2.0 + 100%Age at menarche – 14 yrs: 11 yrs 1 : 1.3 + 30%Parity – multiparous : nulliparous 1 : 1.3 + 30%Age at first birth – 20 yrs : 35 yrs 1 : 1.4 + 40%Oral contraceptives – never user:ever user 1 : 1.1 + 10%Hormone replacement-never:5 or 1 : 1.3 + 30%more yrsAlcohol consumption-none:≥20 g daily 1 : 1.3 + 30%Serum lipids – normal : raised 1 : 1.6 + 60%Physical activity – activate : inactive 1 : 1.2 + 20% R. Santen, 2004
    114. 114. Exemplos de Risco Absoluto,Risco Relativo, Risco Atribuível• Se comprar um número da lotaria, terá 1 oportunidade em um milhão de ganhar. (risco absoluto).• Se comprar cinco números da lotaria, a oportunidade será cinco vezes maior, ou simplesmente 5 em um milhão.• As oportunidades de ganhar aumentam 5 vezes, (risco relativo).• A diferença entre os dois riscos é de 4 em um milhão (risco atribuível)
    115. 115. Risco atribuível, ou de excesso (que é o mais importante para a clínica) A diferença entre o risco de base, subjacente, e o risco após receber TH é denominada risco atribuível, ou de excesso.
    116. 116. Não confunda…Risco Relativo comRisco Absoluto !
    117. 117. Intervalo de Confiança (C.I.)Um C.I. de 95% significa que há 95% deprobabilidades de que os “valoresverdadeiros” da população estejam entreos dois limites.Se o C.I. cruza a linha de “diferençanula” ao ponto de que o benefício seconverta num risco (i.e.1), pode concluir-se que os resultados não sãoestatísticamente significativos.
    118. 118. Linha de diferença nula Linha de diferença nula Linha de de diferença nula Linha diferença nulaManson J et al. Menopause2006;13(1):139.147
    119. 119. Efeito sobre o risco de cancro da mamaWHI aumento do risco: risco RR 1.26 (CI 1.00-1.59); 26% aumento de risco AR 0.38% vs 0.30% (ie, 38 vs 30 casos anualmente por 10.000 mulheres) NÃO SIGNIFICATIVO !HERS aumento do risco: RR 1.27 (CI 0.84-1.94); 27% aumento de risco AR 0.59% vs 0.47% (ie, 59 vs 47 casos anualmente por 10.000 mulheres) NÃO SIGNIFICATIVO !
    120. 120. Ao ler estudos Epidemiológicos POR FAVOR !Não leiam só os títulos…Não leiam só os resumos…Há que ler os artigos completos!!Devemos ser críticos!Devemos construir os nossos própriosconceitos! MNC
    121. 121. Assessment of theunderstanding of the risks and benefits of hormone replacement therapy (HRT) in primary care physicians Williams RS, Christie D and Sistrom C. Am J. Obstet Gynecol 2005;193:551-6
    122. 122. Respondents that overestimate theincrease or decrease in risk were makingthe error of confusing relative risk withabsolute risk difference. There is a great need for physician education about the attributable risks and benefits of HRT MNC/05
    123. 123. Strategies to help patients understand risks Paling J. BMJ 2003;327:745-8
    124. 124. Risks of women medicated with E+P (5.2 years) women
    125. 125. Risks of women medicated with E only (6.8 years) women
    126. 126. Risks of Breast Canceraccording to different factors
    127. 127. Podem reduzir-seos efeitos secundários ?
    128. 128. There are no really “safe” biological active drugs...There are only “safe” physicians ! Kaminetzy HA 1993
    129. 129. “Aquele que aprende mas não pensa está perdido. O que pensa mas não aprende é perigoso… Confucius
    130. 130. mas…se aprendermos e pensarmos… nem estaremos perdidos nem seremos perigosospara as nossas doentes pós- menopáusicas Wenger NK. Am J Geriatr Cardiol 2000;9:204-9
    131. 131. A práctica Clínica…
    132. 132. Conhecera doença que uma mulher temé tão importante comoconhecera mulher que tem a doença William Osler
    133. 133. Os médicos devem dar ainformação a mulher deve acatar a sua decisão
    134. 134. Os médicos devem dar ainformação a mulher deve fazer o que decidiu
    135. 135. Qual é o melhor tratamento ?• As necessidades e preferências da mulher são decisivas baseadas no conselho do médico• Não deve esquecer-se que apesar de haver muitos tratamentos hormonais disponíveis não são no entanto indispensáveis• Os médicos têm o dever de dar a sua melhor informação independente às suas doentes de modo a que elas possam fazer as escolhas acertadas e assim aderir aos tratamentos• A mulher é quem toma a decisão se o médico não vir contraindicações• Portanto o melhor tratamento é aquele que a mulher escolher MNC
    136. 136. I personally believe that for the healthyearly post menopausal woman the long termHT’s, other than relieving vasomotorsymptoms, may play an important role inimproving QoL and in the prevention of CVD,osteoporosis and Alzheimer, undersurveillance. Systemic (parenteral) estrogens, added estrogens when needed to vaginal progesterone or progestagen loaded IUD’s, may be very IUD’s beneficial, largely overpassing minimal risks. MNC/05
    137. 137. The conclusions of the WHI trial suggestthat the “safe “ woman (NNH between 600- 1000 women) to initiate HT is - between 50-59 years of age - with vasomotor symptoms - less than 10 years after the menopause - being treated with statins - with a good lipid profile and - with a Body Mass Index >25 Neves-e-Castro M. Human Reproduction 2003;18:2512-2518
    138. 138. E...que tal com os produtos “naturais” ?...
    139. 139. Evitar que uma Mulherbeneficie de uma correcta terapêutica hormonal na pós-menopausa pelo receio de raros efeitos secundários não me parece ser uma Medicina satisfatória… M.Neves-e-Castro, 2000
    140. 140. O que é que temosaprendido sobre a Menopausa ?
    141. 141. “Each time we learn something new,the astonishment comes from therecognition that we were wrong before. In truth, whenever we discover a new fact, it involves the elimination of old ones. WE ARE ALWAYS, as it turns out, fundamentally IN ERROR.” Lewis Thomas English Biologist (1913-1993)
    142. 142. As convicções são inimigosmais perigosos da verdade doque as mentiras Friedrich Wilhelm Nietzsche
    143. 143. What has been learned from themajor observational studies and clinical trials? the first lesson systematically administered progestagens may in part suppress some of the beneficial effects of estrogens and may also slightly increase the risk of breast cancer after treatments with duration greater than five years. MNC/05
    144. 144. What has been learned from themajor observational studies and clinical trials?the second lessonestrogens, when given alone tohisterectomized women, did not appear tominimally affect the risk for breast cancerwhen compared with controls MNC/05
    145. 145. What has been learned from themajor observational studies and clinical trials?the third lessonMetabolic effects of estrogens andprogestagens, as a whole, can differdepending on the route of administration, i.e.oral vs. parentheral, and on the combination ofboth, in a sequential regimen or in continuouscombined administration. MNC/05
    146. 146. What has been learned from themajor observational studies and clinical trials?the fourth lessonHormonal treatments are the firstchoice for vasomotor symptom reliefas long as they are needed (on and offassessment). They should not be used forthe secondary prevention of CVD, whenatheroma plaques are already present. MNC/05
    147. 147. What has been learned from themajor observational studies and clinical trials?the fourth lesson (cont.)Conversely, they may protect from CVDif started early during the transitioninto the post menopause.Hormonal treatments are preventive ofosteopenia and osteoporosis at anystage in life MNC/05
    148. 148. The take-home message is: (1) Prescribe postmenopausal hormonal treatments when clinically indicated, if not contraindicated! MNC/02
    149. 149. The take-home message is: (2) The prescription of long-term hormonal treatments must depend always on a benefit/risk analysis in comparison with other non-hormonal medications and strategies. MNC/02
    150. 150. The take-home message is: (3) No answers from ongoing clinical trials are indispensable to practice today a good Medicine ! MNC/02
    151. 151. BENEFITS OF HORMONE THERAPY • HT remains the most effective therapy for vasomotor and estrogen-deficient urogenital symptoms. • Quality of life and sexuality are key factors to be considered in the management of the aging individual. • The administration of individualized HT (including androgenic preparations when appropriate) improves both sexuality and overall quality of life. IMS press statement, February 2007
    152. 152. Recommendations onpostmenopausal hormone therapy• There are no reasons to place mandatory limitations on the length of treatment.• Whether or not to continue therapy should be decided at the discretion of the well-informed hormone user and her health professional, dependent upon the specific goals and an objective estimation of benefits and an objective estimation of benefits and risks. IMS press statement, February 2007
    153. 153. IMS reaction to recent breast cancer data The use of hormones in early menopause and up to age 60 years has a very minor potential for harm, but may carry substantial benefits. Women should decide annually if they wish to continue with treatment after consultation with their caregivers. Press statement of IMS.December 19, 2006.
    154. 154. The new American way … or … a 180º rotation ! … MNC/05
    155. 155. NAMS position statement onestrogen and progestagen use inperi-and postmenopausal women No single trial should be used to set public health policy. The practice of policy medicine must ultimately be based on the interpretation of the entire body of evidence currently available, given that there will never be adequate clinical trials to cover all populations, eventualities, and regimens.
    156. 156. NAMS position statement onestrogen and progestagen use inperi-and postmenopausal women Place no limit on ET/EPT treatment duration, provided it is consistent with duration treatment goals; if monitored regularly, no stipulation is made regarding when to reduce or stop therapy
    157. 157. Key Points:NAMS March 2007Position Statementon Hormone TherapyThe North American Menopause Society.Estrogen and progestogen use in peri- andpostmenopausal women: March 2007 positionstatement of The North American MenopauseSociety. Menopause 2007; In press. Copyright 2007
    158. 158. HT and Vasomotor Symptoms Treatment of moderate to severe vasomotor symptoms (ie, hot flashes, night sweats) remains primary indication for systemic ET/EPT With few exceptions, every systemic ET/EPT product is government approved for this indicationNAMS position statement. Menopause 2007. Copyright 2007
    159. 159. EPT and Breast Cancer Risk Breast cancer risk increases with EPT use beyond 5 years Increased absolute risk in WHI is viewed as rare (4-6 additional invasive cancers/10,000 women/yr when use EPT for ≥5 yrs) (cont’d)NAMS position statement. Menopause 2007. Copyright 2007
    160. 160. ET and Breast Cancer Risk (cont’d) Women in WHI’s ET arm had 8 fewer cases of invasive breast cancer/10,000 women/yr of ET use Available evidence suggests ET for <5 yr has little breast cancer risk impact Limited observational data suggest ET for >15 yr may increase riskNAMS position statement. Menopause 2007. Copyright 2007
    161. 161. 3rd International Symposium of the Portuguese Menopause Society In Celebration of the World Menopause Day The Transatlantic Controversies - The State of the ArtOctober 23, 2004 Fundação Engº António Almeida Oporto – Portugal
    162. 162. A equipe U.S.A. 1 2 3 41. R. Chlebowski 2.J.Rossow 3. R. Lobo 4. Th.Clarkson
    163. 163. A equipe Europeia 1 2 3 41. D.Barlow 2. H. Kuhl 4.P.Kenemans 4. A.Pines
    164. 164. As estrelas da Menopausa ! 5 6 7 8 9 10 11 12 14 15 13 1 2 3 41.D.Barlow, 2.H.Kuhl, 3.P.Kenemans, 4.A.Pines, 5 F.Al-Azzawi, 6.J.Rossouw,7.J.Stevenson, 8.R.Chlebowski, 9.S.Palacios, 10.Th.Clarkson, 11.M.Sousa,12.M.Neves-e-Castro, 13.A.Genazzani, 14.J.Calaf, 15.R.Lobo
    165. 165. 3rd International Symposium of the Portuguese Menopause Society In Celebration of the World Menopause Day Algumas das The TransatlaNCLUSÕES ntic Controversies - The State ofthe Art CONCLUSÃOOctober 23, 2004 Fundação Engº António Almeida Oporto – Portugal
    166. 166. KEEPSKronos Early Estrogen Prevention Studyestudo em curso em mulheres sintomáticas até 10 anos após a menopausa Rexrode K and Manson J. Circulation 2007;115:820-2
    167. 167. ELITEEarly vs. Late Intervention Trial with Estradiol estudo em curso
    168. 168. Não há melhor tratamento paraos sintomas do climatério doque os tratamentos hormonais
    169. 169. •Se és um clínico tens que acreditar quesabes o que ajuda os teus doentes.Caso contrário não podes nem aconselharnem receitar.•Porém, se és um cientista tens que terincertezas: um cientista que deixa de fazerperguntas é um mau cientista… George Pickering;”Physician and scientist” Br.Med.J. 1964;2:1615-9
    170. 170. UMA MULHER no Outono da sua vidamerece um Verão de S.Martinho em vez de um triste Inverno Greenblatt
    171. 171. Comoconcluir ?...
    172. 172. Este não é o fim,nem sequer o princípio do fim, mas talvez seja o fim do princípio ... Winston Churchill
    173. 173. Esperando pormais...
    174. 174. Inscrições IV Simpósio Internacionalque vão encontrar da Sociedade Portuguesa de Menopaus Participantes, até 31 Maio 2007:aqui ! Sócios da SPM e EMAS: € 200,00 Não - Sócios: € 250,00 The Improvement of Participantes, a partir de 31 Maio 2007: Health and Disease Prevention Sócios da SPM e EMAS: € 250,00 Não - Sócios: € 300,00 for the Mid-aged Woman: The State of the Art Para mais informação:visite o nosso website www.spmenopausa.pt em 4th International SymposiumSociedade Portuguesa de MenopausaAv. Almirante Reis nº 62 – 1º Esq.1150-020 Lisboa - PortugalTelf: (+351) 21 3174356 – (+351) 93 6016522 Fax: (+351) 21 3156658e.mail: internationalsymposium@socportmenopausa.mail.pt 20 Outubro 2007 Lisboa . Portugal Hotel venue: Pestana Palace – Hotel e Monumento Nacional Pestana Palace Hotel www.pestana.com
    175. 175. IV Simpósio Internacional da Sociedade Portuguesa deMenopausa Mário de Sousa – President e da SPMLisboa . Portugal, Pestana Palace Hotel, 20 Outubro 2007 The Improvement of Health andDisease Prevention for the Mid-aged Woman: The State of the Art Manuel Neves-e-Castro – Symposium ChairmanSpeakers (confirmados):D. Sturdee (UK): “The hot Flush”;P.van der Weijer (NL): “ Risks of HRT in the 50-59 year agegroup”;R. Lobo (USA): “Metabolic Syndrome aftermenopause and the role of hormones”Anne Gompel (FR ): “ Hyperinsulinemia, obesity and therisk of breast cancer”;D. Herrington (USA): “Postmenopausal heart diseaseprevention: Why the cardiologists have it allwrong?J.C.Gallagher (USA): “The role of rank L in postmenopausal
    176. 176. terminei !... e…
    177. 177. este... já pode acordar…
    178. 178. Obrigado ……por não terem ressonado !

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