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Menopausa
  o ponto da situação

                   por

     Manuel Neves-e-Castro
                  Lisboa
XXVI Curso Pós-Graduado de Endocrinologia e
                 Andrologia


               Junho 2005
Matern.alfredo da costa
Terrorista
Hormonal
Quero fazer
   TH !




              Terrorista
              Hormonal
Quero fazer
           TH !




                      Terrorista
Mas todos             Hormonal
os médicos
dizem que
NÃO!
O que é que temos
aprendido sôbre a
   Menopausa?
         por


Manuel Neves-e-Castro
        Lisboa



      Junho 2005
Matern.alfredo da costa
As discussões sobre o
  climatério são devidas a:
• Uma falta de cultura que impede uma crítica
  correcta dos resultados publicados
• Uma má prática da Medicina que ignora a
  mulher na sua totalidade
• “Lobbies” politicos do NIH …
• Uma falta de honestidade científica
  manifestada por muitos dos relatores do WHI
• “Lobbies” de várias indústrias farmacêuticas
  através da actividade de muitos médicos bem
  conhecidos que se oferecem… para transmitir
  as suas mensagens…
                                            MNC
3rd International Symposium
                                                         of the
                                     Portuguese Menopause Society
                                          In Celebration of the World Menopause Day




  The Transatlantic Controversies - The State of the Art
October 23, 2004    Fundação Engº António Almeida                  Oporto – Portugal
The Menopausal
                        “Stars”...

                                                                    14       15
         5       6    7       8       9    10    11       12
                                                               13

                                                                         4
                                  2                   3


                 1




1.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
“MATURITAS” Special Issue
       VOL. 51/1.(May 2005)
    “Menopausal Health in 2005”
PART 1. Women’s health after WHI.
Reports from the Amsterdam Menopause
Symposium, October 2-4, 2004.
PART 2. Transatlantic confrontation of
options.
Proceedings of the III International Symposium
of the Portuguese Menopause Society
October 23, 2004.
             Guest-editor: M. Neves-e-Castro.
The U.S.A. “team”




     1              2             3                 4




1. R. Chlebowski,   2.J.Rossow,   3. R. Lobo,   4. Th.Clarkson
The USA Vision

Chair: M.Neves-e-Castro and Mario de Sousa

09.00-09.30 –Controversies about HRT – Lessons from Monkey Models

            Th.Clarkson, Wake Forest Univ.

09.30-10.00 – Appropriate Use of Hormones Should Alleviate Concerns
             Regarding CV and Breast Cancer Risks
             R.Lobo, Columbia Univ

10.00-10.30 –Implications of clinical trials for CVD in younger women
            Jacques Rossouw, NIH/NHLBI/WHI

10.30-11.00 Coffee Break

11.00-11.30 – Menopausal Therapy and Cancer Risk in the WHI
             R.Chlebowski, WHI

11.30-12.00 - The state of the Art in the USA
             L.Speroff,Portland.Or

12.00-13.00 - Debate and Discussion
The European “team”



       1             2               3       4




1. D.Barlow,   2. H. Kuhl,   3.P.Kenemans,   4. A.Pines
The European Vision

Chair: Mario de Sousa and M. Neves-e-Castro

14.30-15.00 – WHI and Cardioprotection: Looking Beyond the Figures
             A.Pines, Il

15.00-15.30 – Hormone Therapy and Breast Cancer:
             What is the Problem?
             P.Kenemans,Nl

15.30-16.00 – Do Estrogens Really Increase Breast Cancer Risk?
             H. Kuhl, D

16.00-16.30 –Coffee Break

16.30-17.00 Strategy in Osteoporosis Management Following WHI
           D.Barlow, UK

17.00-18.00 Debate and Discussion
Chair:A. Genazzani (I) and J.Calaf (Sp)

18.00 -      Conclusions
             M.Neves-e-Castro
Conclusões
Acreditamos que no que se refere às
DCV’s,quer os estudos experimentais
em primatas como a evidência clínica
sugerem fortemente que os TH’s
podem ser preventivos se iniciados
muito precocemente após a
menopausa,de preferência depois de
um regime de contraceptivos orais
durante a premenopausa
Clarkson TB. Fertil Steril 2004;81:1498-1501
Grodstein F et al. N Engl J Med 2000;343:530-537
Stampfer MJ. NAMS 2004;PS#2
Victory R et al. Fertil Steril 2004;82:O-130
O grupo de “estrogénios isolados” do WHI
sugere fortemente que uma medicação
apenas com estrogénios é destituida de
riscos como parece até ser protectora em
relação ao cancro da mama.

Resultados idênticos foram verificados em
estudos de gravidez após cancro da mama e
em TH’s nas sobreviventes de cancro da mama.

Gelber s et al. J Clin Oncol 2001;19:1671-1675
WHI Group J Am Med Assoc 2004;291:1701-1712
O’Meara et al. J N C I 2001
DiSaia et al. Am J Clin Oncol 2000
Nananda F Col et al.J Clin Oncol;2001:19:2357-2363
Em estudos recentes não se
verificou,nos tratamentos combinados
contínuos qualquer risco aumentado
de DCV’s ou de cancro da mama.

Esta diferença em relação ao WHI deve-
se a que as mulheres eram mais
novas,sintomáticas,e com menor pêso
corporal
                Heikkinen J. NAMS 2004, Abstract LB38
                Lobo R. Arch Int Med 2004;164:482-484
Acentuamos a necessidade de
    implementar medidas colaterais muito
          importantes tais como:

•   normalização do peso corporal
•   abstenção de tabaco
•   baixo consumo de alcool
•   execício
•   Dieta Mediterrânica
    etc.
                                      MNC
Em conclusão,
  e à luz da evidência actual,

deve dar-se aos médicos e às
mulheres a garantia de que os TH’s
para o alívio dos sintomas da
menopausa são seguros e muito
eficazes

                                 MNC
Matern.alfredo da costa
WHI
What Was the WHI Study
         designed to do?
Long-term effect of hormone therapy on the

prevention of
   heart disease and
   hip fractures and
on monitoring possible increases in risk for
   breast cancer and
   colon cancer.


                           Message from the President on WHI Study
                                                 www.hormone.org
White woman’s risk of death between
the ages of 50 and 94 are:

 31.0% from heart disease
  2.8% from breast cancer
  2.8% from hip fracture

   Brinton LA, Schairer C. N Engl J Med.1997;336:1769-1775
Matern.alfredo da costa
Matern.alfredo da costa
Effect on the risk of breast
            cancer

WHI Nonsignificant increased risk
    RR 1.26 (CI 1.00-1.59); 26% increased risk
    AR 0.38% vs 0.30% (ie, 38 vs 30 events
    annually per 10.000 women)
HERS Nonsignificant increased risk
    RR 1.27 (CI 0.84-1.94); 27% increased risk
    AR 0.59% vs 0.47% (ie, 59 vs 47 events
    annually per 10.000 women)
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” (?!...)
Thus…


 “The breast cancer findings are
 reported as statistically
 insignificant but are regarded as
 clinically relevant !”


           Utian W. Menopause Management 2003;12:9-10
WHI results calculated as
                            NNT/1 year             NNH/1 year
CHD                                                        1428
Stroke                                                     1250
VTE                                                          588
Breast Cancer                                               1250
Colon Cancer                          1667
Osteoporotic fractures                 227
(totals)

Neves-e-Castro M. Menopause in crisis post-Women’s Health Initiative? A
view based on personal clinical experience. Human Reproduction
2003;18:2512-8
“Women considering taking CEE should be
counseled about an increased risk of stroke
but can be reassured about no excess risk
of heart disease or breast cancer for at
least 6.8 years of use.”

Effects of conjugated Equine Estrogen in Postmenopausal Women with
Hysterectomy. JAMA 2004;291:1701-1712
Effects of conjugated Equine Estrogen in Postmenopausal Women
with Hysterectomy.JAMA, 2004;291:1701-1712
Why Was the Study Stopped?
• Small increase in the risk of strokes, which put
  healthy women at risk and made it
  unacceptable to continue with the study.

• No increased risk for breast cancer and a
  decrease in the risk of hip fractures.


                       Message from the President on WHI Study
                                             www.hormone.org
Stroke

“In women 50-59 years not taking HT,
ischemic stroke is expected to occur in
3 out of 1000 women during 5 years.
Five years use of HT would yield 1
additional case of stroke/ 1000 women”

                          EMAS Statement; 2004.
NAMS position statement on
estrogen and progestagen use in
peri-and postmenopausal women

 Revised breast cancer statements indicate
 that the risk of breast cancer probably
 increases with EPT use but not with ET
 use.
Second thoughts on the WHI study: the effect of age on the safety HRT




                                     Studd J. Climacteric 2004;7:412-414
O “braço” do WHI com estrogénios
isolados foi interrompido!


                 Porquê ? ! …
• Parece que se tivesse havido mais
  um caso de cancro da mama no
  grupo placebo os resultados deste
  estudo teriam sido considerados
  como estatisticamente muito
  significativos…

                                 MNC
Portanto…
 o grupo WHI/NIH teria sido forçado a
 declarar que:

• Os estrogénios não induzem o
  cancro da mama , e que

• Os estrogénios protegem a mama
  contra o cancro !
                                   MNC
Porque é que os investigadores
não quiseram que o estudo fosse
terminado e pudesse chegar a
conclusões tão importantes?

Seria pela necessidade de alguns
investigadores continuarem a
receber milhões de dólares?
                              MNC
Million Women Study

The follow-up for breast cancer
diagnosis was just over 2½ years,
meaning that these breast cancers
were almost certainly pre-existent at
the start of the observational period.

      Press Release from the British Menopause Society, 2003
Matern.alfredo da costa
Matern.alfredo da costa
Occult Breast Cancer
               in
      medicolegal autopsies

   Breast malignancy was
   found in 22 women
(20%)
             Nielsen M et al-Br J Cancer 1987;56:814-9
Occult Breast Cancer
Malignancy was significantly more frequent
among women

. aged more than 40 years
. with late age at first full-term pregnancy
. with alcohol abuse
. with steatosis or cirrhosis of the liver
                    Nielsen M et al-Br J Cancer 1987;56:814-9
Breast Cancer
MWS data compared to other publish data
           MWS           GPRD          Beral           Ross    Weiss         WHI
           (2003)        (2002)       (1997)          (2000)   (2002)       (2003)



EPT        2.00     1.211         1.152           1.243        1.22     1.26

ET         1.30     0.97          0.992           1.063        0.84     ongoing
                                                                        4


Tibolone   1.45     1.02
                    1
                        Seq EPT   2
                                      ≤ 5 y use   3
                                                   Per 5y               4
                                                                            >6y
                                                  use
HRT and RR of DEATH from
       BREAST CANCER
              (MW Study,2003)

• AR never users     238/2894 = 0.0822
• AR current users   191/3202 = 0.0597
• RR = 0.0597/0.0822 = 0.73


• RR for mortality = 1.22
• RR for morbidity =1.66
• RR for dying from BC = 1.22/1.66 = 0.73
Fatal Breast Cancers
                         Case-death     Case-No death


      Current use           191              3011             3203



      Never use             238              2656             2894



                    RR=0.71 (95% CI 0.58-0.87)
Million Women Study Collaborators. Breast Cancer and hormone replacement
therapy in the Million Women Study. Lancet 2003;362:419-427
Matern.alfredo da costa
Matern.alfredo da costa
Matern.alfredo da costa
“Recurrent breast cancer was
found in 9% of HRT users
and 15% of nonuser”.

                    O’Meara ES et al
Estrogen replacement therapy in
patients with early breast cancer
  The mortality rates from breast cancer for
  the ERT users was 4.28% compared with
  22.3% in the nonusers.



  Natrajan PK and Gambrell RD. Am J Obstet Gynecol 2002;187:289-95
O que é que aprendemos com os
principais estudos observacionais e
          ensaios clinicos?
1ª.lição
  Os progestagénios administrados por via
  sistémica podem em parte suprimir alguns
  dos efeitos benéficos dos estrogénios e
  podem tambem aumentar ligeiramente o
  risco de cancro da mama após
  tratamentos com uma duração superior a
  cinco anos
                                       MNC
O que é que aprendemos com os
principais estudos observacionais e
          ensaios clinicos?
2ª.lição

 Os estrogénios quando administrados
 isoladamente em mulheres histerectomizadas
 não afectaram minimamente o risco para o
 cancro da mama quando comparado com os
 controlos

                                         MNC
O que é que aprendemos com os
principais estudos observacionais e
          ensaios clinicos?
3ª.lição

 Os efeitos metabólicos dos estrogénios e
 progestagénios, como um todo, podem diferir
 em função da via de administração i.e. oral vs.
 parentérica, e da combinação de ambos em
 regimes de administração sequencial ou
 combinada contínua

                                              MNC
Relative risks associated with use of
        different hormones by women
                                                  Cases   Person/     Age-adjusted RR
                                                          Years         (CI – 95%)
Estrogens used alone
Transdermal                                         29     8.961        1.2 (0.8 – 1.8)
Oral                                                 2     1.204        0.6 (0.2 – 2.4)
Estrogens combined with oral progesterone
Estrogens combined with micronized progesterone     55    21.994        0.9 (0.7 – 1.2)
Transdermal                                         55    20.685        0.9 (0.7 – 1.2)
Oral                                                 0     1.385
Estrogens combined with synthetic progestins
Transdermal                                        187     46.252       1.4 (1.2 – 1.7)
Oral                                                80     20.504       1.4 (1.1 – 1.8)




                                          Fournier A et al. Int J Cancer 2005;114:448-54
Progesterone and Breast Cancer
 Combinations containing micronized
 progesterone appeared to be
 associated with a significantly lower
 breast cancer risk than those
 containing synthetic progestagens.


             Fournier A et al. Int J Cancer 2005;114:448-54
O que é que aprendemos com os
principais estudos observacionais e
          ensaios clinicos?
4ª.lição

 Os tratamentos hormonais são a primeira
 escolha para a abolição dos sintomas
 vasomotores enquanto necessários. Não
 devem ser usados para a prevenção secundária
 da DCV, quando já houver placas de ateroma.

                                          MNC
O que é que aprendemos com os
principais estudos observacionais e
          ensaios clinicos?
4ª.lição (continuação)
  Os estrogénios podem proteger contra
  DCV’s se iniciados precocemente
  durante a transição para a pós
  menopausa.
  Os tratamentos hormonais são
  preventivos da osteopenia e osteoporose
  em qualquer fase da vida

                                      MNC
Postmenopausal hormone therapy: critical
   reappraisal and unified hypothesis




                                83:558-66
Postmenopausal former oral contraceptives
   users may have lower rates of heart
                disease
  702 postmenopausal women enrolled in the
  WISE.
  Use of oral contraceptive in the past was
  an independent negative predictor of
  CAD severity (p=0.04 after adjustment for
  smoking, aspirin use, lipid lowering medication, and
  socioeconomic variables )
 14th Annual Meeting of the North American Menopause Society. Abstract
   P-51
Combined effect of oral contraceptive
 use and hormone replacement therapy
on breast cancer risk in postmenopausal
                women

  The increase in risk with CHRT was
  stronger in women who had never used
  OC’s in the past than in women who had
  used OC’s


      Norman SA et al. Cancer Causes Control 2003;14(10):933-43
Discussion

The results of this study show a strong
association of current HT with reduced
odds of severe coronary artery
calcification, an indicator of
atherosclerotic plaque burden.


          Barrett-Connor E et al. Menopause 2005;12:40-48
Discussion

The protective association of HT with
CACS was greater in longer versus
shorter duration users and tended to be
stronger in those whose HT use began
early in postmenopause.



          Barrett-Connor E et al. Menopause 2005;12:40-48
O que é que aprendemos com os
principais estudos observacionais e
          ensaios clinicos?
5ª.lição

  Os estrogénios podem evitar lesões
  degenerativas do SNC uma vez que, até à
  data, são os únicos agentes com efeito no
  crescimento dos neurónios



                                              MNC
Postmenopausal Estrogen Use
Affects Risk for Parkinson Disease

 • Estrogen therapy has been associated
   with improved cognitive functioning, a
   reduced risk of dementia in women
   with Parkinson disease (PD), and a
   decreased risk of Alzheimer disease.
 • Postmenopausal estrogen therapy may be
   associated with a reduced risk of PD in
   women.
                Currie LJ et al. Arch Neurol 2004;61(6):886-8
IADRD: Estrogens Exhibits
Neuroprotective effect in preliminary
     analysis of Swedish Data
   Preliminary analysis of data from the Swedish
   Twin Registry suggests that estrogen is
   neuroprotective and the effect is not related
   to length of estrogen therapy.
   Estrogen use was significantly related to better
   cognitive functioning (odds ratio [OR]=0.43 95%
   confindence interval [CI]=0.26, 0.70)

                    Peck P. DG News Stockholm, July 24, 2002.
Matern.alfredo da costa
Como se podem reduzir os
   riscos potenciais ?
Dimitrakakis C et al. Menopause 2004;11:531-535
A physiologic role for testosterone
in limiting estrogenic stimulation of
             the breast.
  These findings suggest that treatment with
  a balanced formulation including all
  ovarian hormones may prevent or reduce
  estrogenic cancer risk in the treatment of
  girls and women with ovarian failure.


            Dimitrakakis C et Al. Menopause 2003;10(4):292-8
Quais são os melhores tratamentos
durante e para além do climatério?

  Não tem sido prestada a devida
  atenção a outras intervenções
  farmacológicas (não hormonais) e a
  estratégias que se verificou serem
  importantes para a prevenção de tais
  doenças e para a manutenção ou
  melhoria da saúde


                                         MNC
Matern.alfredo da costa
A TH não é possivel …


 • Quando não é desejada pela mulher

 • Quando a mulher não sente a sua
   necessidade

 • Quando há contraindicações



                                       MNC
Intervenções Farmacológicas


    • Sintomáticas

    • Perventivas
      – primárias
      – Secundárias



                          MNC
Nurses’s Health Study
        from 1980 to 1994 CHD ↓ 31%

    ↓   Smoking                             ↓   13%
    ↑   Obesity                             ↑    8%
    ↑   THS                                 ↓    9%
    ↑   Better nutrition                    ↓   16%


Hu FB, Grodstein F et al. Trends in the Incidence of Coronary Heart Disease
and Changes in Diet and Lifestyle in Women. NEJM 2000;343:530-537.
“It appears that half of the
benefits in the prevention of
cardiovascular diseases are
not hormone related”!


 Mosca L, Grundy SM, Judelson D, et al. Circulation 99;99:2480-4
Association between alcohol
   consumption and postmenopausal
            breast cancer
results of a case-control study in Montreal, Quebec, Canada
    Women who started to drink wine on or
    before the age of 40 were at a 2.5 times
    increased risk (95% CI 1.4-4.4).
    CONCLUSIONS: Our findings provide
    further support for a positive association
    between the risk of postmenopausal
    breast cancer and alcohol
    consumption.

             Lenz SK et al.Cancer Causes Control 2002;13(8):701-10
Mediterranean Diet, Lifestyle
 Factors, and 10-Year Mortality in
Elderly European Men and Women
The combination of 4 low risk factors lowered
the all-cause mortality rate to 0.35 (95% CI,
0.28-0.44). In total, lack of adherence to this
low-risk pattern was associated with a
population attributable risk of 60% of all
deaths, 64% of deaths from coronary heart
disease, 61% from cardiovascular diseases,
and 60% from cancer.
                       Knoops K et al. JAMA 2004;292:1433-9
The Polymeal
Franco O et al. BMJ 2004;329:1447-50
Doctors could retrain as
Polymeal chefs or wine advisers

The Polymeal—an evidence based menu that
includes wine, fish, dark chocolate, fruits,
vegetables, garlic, and almonds—promises to be an
effective, safe, cheap, and tasty solution to reducing
cardiovascular morbidity and increasing life
expectancy.
Polymeal could reduce cardiovascular disease by
more than 75%.

                          Franco O et al. BMJ 2004;329:1447-50
Tea, circulating estrogens and
         breast cancer
 Levels were

13% lower in regular green-tea drinkers
 (25.8 pg/ml)

19% higher in regular black tea drinkers
 (35.0 pg/ml).
                    Wu A. et al. Carcinogenesis 2005.
Tea, circulating estrogens and
         breast cancer
 “We recently provided the first set of human
 evidence that breast cancer risk is
 significantly inversely associated with tea
 intake, largely confined to intake of green tea.”

 “Green tea may have down-regulatory effects
 on circulating sex-steroid hormones,
 whereas black tea may have up-regulatory
 effects .”
                           Wu A. et al. Carcinogenesis 2005
RELATIVE RISK OF BREAST CANCER BY
            BODY WEIGHT


                                 Weight (Kg)
  Age at
 Diagnosis                <60          60-69   70+
   35-49                  1.00          0.54   1.16
   50-59                  1.00          1.22   1.43
   60-69                  1.00          1.61   1.81

from deWaard et al ,1964,1978
HU FB et al. NEJM 2004;351:2694-2703
HU FB et al. NEJM 2004;351:2694-2703
HU FB et al. NEJM 2004;351:2694-2703
Recreational Physical Activity
and the Risk of Breast Cancer in
   Postmenopausal Women
Women who engaged in the equivalent of 1.25
to 2.5 hours per week of brisk walking had an
18% decreased risk of breast cancer (RR,
0.82; 95% CI, 0.68-0.97) compared with
inactive women.
                    McTiernan A et al. JAMA 2003;290:1331-6
Aspirin could be used to prevent
             cancer

Three recently published studies indicate
that aspirin, already enjoying a second
lease of life in the prevention of heart
disease, may soon become a first line of
defense against cancer.

                       London O. BMJ 2003;326:565
Breast Cancer and Nonsteroidal
     Anti-Inflammatory Drugs:
       Prospective Results
from the Women’s Health Initiative1
 COX-2 induction may promote breast
 cancer development by enhancing local
 estrogen biosynthesis, and COX-2
 inhibition may reverse the process.



           Harris R et al. Cancer Research 2003;63:6096-6101
Inhibitory effect of statins on the
proliferation of human breast cancer
                 cells.

   Atorvastatin and fluvastatin were able
   to inhibit the proliferation of MCF-7
   cells in the absence of estradiol.
   This effect seems to depend on an
   apoptotic statin effect.

      Muck AO et al. Int J Clin Pharmacol Ther 2004;42(12):695-700
Inhibitory effect of statins on the
proliferation of human breast cancer
                 cells.

   The present data indicate that statins
   may possess anticancerogenic
   properties concerning the development
   of breast cancer in postmenopausal
   women.

      Muck AO et al. Int J Clin Pharmacol Ther 2004;42(12):695-700
The Polypill
Wald N and Law M. BMJ 2003;326:1419-25
A strategy to reduce
cardiovascular disease by more
            than 80%

One third of people taking this pill from age 55
would benefit, gaining on average about 11
years of life free from an IHD event or
stroke.


                     Wald N and Law M. BMJ 2003;326:1419-25
Wald N and Law M. BMJ 2003;326:1419-25
O que pensam os outros?...


  Após uma viragem de
  180º em dois anos…
  a NAMS (North American
  Menopause Society)
  acaba de concluir…
NAMS position statement on
estrogen and progestagen use in
peri-and postmenopausal women
 No single trial should be used to set
 public health policy. The practice of
 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.
NAMS position statement on
estrogen and progestagen use in
peri-and postmenopausal women

 Place NO LIMIT on ET/EPT treatment
 duration, provided it is consistent with
 treatment goals; if monitored regularly,
 NO stipulation is made regarding when
 to reduce or stop therapy
Há riscos?
É indispensável que seja dada
informação sôbre as diferenças entre
riscos relativos e riscos absolutos uma
vez que os primeiros são a principal causa
de desinformação e alarmismo, sendo os
favoritos dos media…


                                      MNC
Matern.alfredo da costa
Matern.alfredo da costa
Matern.alfredo da costa
Matern.alfredo da costa
Matern.alfredo da costa
Analisem-se
    os factores de risco

•   Cardiovasculares
•   Oncológicos
•   Ósseos
•   SNC



                           MNC
Years of healthy life can be increased 5-
          10 years, W O says
                       H

    W need to concentrate on the
      e
    major risks if we are to improve
    healthy life expectancy by about 10
    years, and life expectancy by even
    m ore.


    A n Lo p e z , Ph. D. , WHO Se nio r Sc ie nc e A v is o r a nd c o -
      la                                             d
    d ire c to r o f the WHO re p o rt (2 0 0 2 )
Welty F. Menopause 2004;11(4):484-94
As mulheres não são
   estatísticas…
Têm que ser tratatadas
  individualmente !
Evidence based medicine: does it
      make a difference?

 Like any technology, evidence based
 medicine carries risks and benefits and
 can be used appropriately or
 inappropriately.


           Schon CR et al. BMC Health Serv Res 2003;3(1):14
Evidence informed practice
• 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
  Oxford OX3 7LF. BMJ 2005;330:92
Medicina Baseada na Evidência

             e/ou
Evidência Baseada na Medicina ?
                     Manuel Neves-e-Castro
Medicina Baseada na Evidência

              e/ou
Medicina Baseada na Inteligência ?
                        Lucas Viana Machado
“Aquele que aprende
   mas não pensa
    está perdido.
 O que pensa mas
   não aprende
   é perigoso…
      Confucius
Se aprendermos e
  pensarmos…
 nem estaremos perdidos
 nem seremos perigosos
para as nossas doentes pos-
      menopausicas

    Wenger NK. Am J Geriatr Cardiol 2000;9:204-9
“Each time we learn something new,
the astonishment comes from the
recognition 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)
Quais são as melhores recomendações
   do médico da mulher climatérica
 1.  Explicar o que se está passando no seu corpo durante
     o climatério e pós menopausa
 2. Ocupação mental
 3. Exercicio fisico
 4. Alimentação adequada (consumo moderado de vinho
     tinto e abundante de: peixe, vegetais, frutos, soja,
     leite, alho, chocolate, etc)
 5. Manter o índice de massa corporal dentro dos limites
     normais
 6. Manter um perímetro normal da cintura
 7. Abstenção do tabaco
 8. Manter uma pressão arterial normal
 9. Manter os lípidos sanguíneos nos valores normais
     (estatinas)
 10. Exame mamário (palpação, inspecção mamografia)
Qual é o melhor tratamento ?
Matern.alfredo da costa
Qual é o melhor tratamento ?
• Em termos gerais é o que estiver sensatamente
  indicado, se não contraindicado, após uma
  análise de benefícios e riscos, de todas as
  estratégias e intervenções, hormonais ou não
  hormonais

• Deve estar dirigido a objectivos e alvos
  específicos que serão avaliados regularmente
  de modo a determinar a sua eficácia e a
  verificar a eventual ocorrência de quaisquer
  efeitos secundários, uma condição que
  determinará a sua duração
                                             MNC
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 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
Mensagens Finais
            (1)

• Prescrevam tratamentos
  hormonais na pós menopausa
  quando clínicamente indicados,
  se não houver contraindicações


                               MNC
Mensagens Finais
             (2)

• A prescrição de tratamentos
  hormonais de longa duração
  depende sempre de uma análise
  benefício/risco em comparação com
  medicações não hormonais e
  estratégias não medicamentosas

                                MNC
Mensagens Finais
            (3)

• Não são indispensáveis
  quaisquer respostas dos
  ensaios clínicos em curso para
  que se possa hoje praticar uma
  boa Medicina

                              MNC
HT appears to be the best form of
   pharmacologic treatment
 to improve brain function, as well as
 to reduce the risk of colon cancer. It is
 probably the best preventive strategy
 for osteoporosis.
 With this in mind …
 limiting HT to the treatment of
 climacteric symptoms only is
 unjustified.

     Kopernik G and Shoham Z. Fertil Steril 2004;81(6):1458-1477
Evitar que uma mulher
beneficie de
um bom tratamento
hormonal pós menopáusico
só pelo receio de efeitos
secundários raros
não parece ser uma
Medicina satisfatória …
                Manuel Neves-e-Castro
Mortality Associated with HRT in
  younger and older women

 Hormone Replacement Therapy reduced
 total mortality in trials with mean age of
 participants under 60 years.
 No change in mortality was seen in trials
 with mean age over 60 years.

          Salpeter SR et al. J Gen Intern Med 2004;19:791-804
Por isso …
Vários ilustres colegas , “especialistas” em
menopausa:
 H . Schneider (Alemanha)
 A . Genazzani (Itália)
 P . Kenemans (Holanda)
 e tambem eu próprio,
continuamos a fazer tratamentos hormonais
de longa duração às nossas consortes com
os seguintes resultados:
Schneider   Genazzani   Neves-e-Castro   Kenemans
Estou muito grato …
por terem tido a paciência
de me ouvirem,
sem dormir…

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Matern.alfredo da costa

  • 1. Menopausa o ponto da situação por Manuel Neves-e-Castro Lisboa XXVI Curso Pós-Graduado de Endocrinologia e Andrologia Junho 2005
  • 4. Quero fazer TH ! Terrorista Hormonal
  • 5. Quero fazer TH ! Terrorista Mas todos Hormonal os médicos dizem que NÃO!
  • 6. O que é que temos aprendido sôbre a Menopausa? por Manuel Neves-e-Castro Lisboa Junho 2005
  • 8. As discussões sobre o climatério são devidas a: • Uma falta de cultura que impede uma crítica correcta dos resultados publicados • Uma má prática da Medicina que ignora a mulher na sua totalidade • “Lobbies” politicos do NIH … • Uma falta de honestidade científica manifestada por muitos dos relatores do WHI • “Lobbies” de várias indústrias farmacêuticas através da actividade de muitos médicos bem conhecidos que se oferecem… para transmitir as suas mensagens… MNC
  • 9. 3rd International Symposium of the Portuguese Menopause Society In Celebration of the World Menopause Day The Transatlantic Controversies - The State of the Art October 23, 2004 Fundação Engº António Almeida Oporto – Portugal
  • 10. The Menopausal “Stars”... 14 15 5 6 7 8 9 10 11 12 13 4 2 3 1 1.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
  • 11. “MATURITAS” Special Issue VOL. 51/1.(May 2005) “Menopausal Health in 2005” PART 1. Women’s health after WHI. Reports from the Amsterdam Menopause Symposium, October 2-4, 2004. PART 2. Transatlantic confrontation of options. Proceedings of the III International Symposium of the Portuguese Menopause Society October 23, 2004. Guest-editor: M. Neves-e-Castro.
  • 12. The U.S.A. “team” 1 2 3 4 1. R. Chlebowski, 2.J.Rossow, 3. R. Lobo, 4. Th.Clarkson
  • 13. The USA Vision Chair: M.Neves-e-Castro and Mario de Sousa 09.00-09.30 –Controversies about HRT – Lessons from Monkey Models Th.Clarkson, Wake Forest Univ. 09.30-10.00 – Appropriate Use of Hormones Should Alleviate Concerns Regarding CV and Breast Cancer Risks R.Lobo, Columbia Univ 10.00-10.30 –Implications of clinical trials for CVD in younger women Jacques Rossouw, NIH/NHLBI/WHI 10.30-11.00 Coffee Break 11.00-11.30 – Menopausal Therapy and Cancer Risk in the WHI R.Chlebowski, WHI 11.30-12.00 - The state of the Art in the USA L.Speroff,Portland.Or 12.00-13.00 - Debate and Discussion
  • 14. The European “team” 1 2 3 4 1. D.Barlow, 2. H. Kuhl, 3.P.Kenemans, 4. A.Pines
  • 15. The European Vision Chair: Mario de Sousa and M. Neves-e-Castro 14.30-15.00 – WHI and Cardioprotection: Looking Beyond the Figures A.Pines, Il 15.00-15.30 – Hormone Therapy and Breast Cancer: What is the Problem? P.Kenemans,Nl 15.30-16.00 – Do Estrogens Really Increase Breast Cancer Risk? H. Kuhl, D 16.00-16.30 –Coffee Break 16.30-17.00 Strategy in Osteoporosis Management Following WHI D.Barlow, UK 17.00-18.00 Debate and Discussion Chair:A. Genazzani (I) and J.Calaf (Sp) 18.00 - Conclusions M.Neves-e-Castro
  • 17. Acreditamos que no que se refere às DCV’s,quer os estudos experimentais em primatas como a evidência clínica sugerem fortemente que os TH’s podem ser preventivos se iniciados muito precocemente após a menopausa,de preferência depois de um regime de contraceptivos orais durante a premenopausa Clarkson TB. Fertil Steril 2004;81:1498-1501 Grodstein F et al. N Engl J Med 2000;343:530-537 Stampfer MJ. NAMS 2004;PS#2 Victory R et al. Fertil Steril 2004;82:O-130
  • 18. O grupo de “estrogénios isolados” do WHI sugere fortemente que uma medicação apenas com estrogénios é destituida de riscos como parece até ser protectora em relação ao cancro da mama. Resultados idênticos foram verificados em estudos de gravidez após cancro da mama e em TH’s nas sobreviventes de cancro da mama. Gelber s et al. J Clin Oncol 2001;19:1671-1675 WHI Group J Am Med Assoc 2004;291:1701-1712 O’Meara et al. J N C I 2001 DiSaia et al. Am J Clin Oncol 2000 Nananda F Col et al.J Clin Oncol;2001:19:2357-2363
  • 19. Em estudos recentes não se verificou,nos tratamentos combinados contínuos qualquer risco aumentado de DCV’s ou de cancro da mama. Esta diferença em relação ao WHI deve- se a que as mulheres eram mais novas,sintomáticas,e com menor pêso corporal Heikkinen J. NAMS 2004, Abstract LB38 Lobo R. Arch Int Med 2004;164:482-484
  • 20. Acentuamos a necessidade de implementar medidas colaterais muito importantes tais como: • normalização do peso corporal • abstenção de tabaco • baixo consumo de alcool • execício • Dieta Mediterrânica etc. MNC
  • 21. Em conclusão, e à luz da evidência actual, deve dar-se aos médicos e às mulheres a garantia de que os TH’s para o alívio dos sintomas da menopausa são seguros e muito eficazes MNC
  • 23. WHI
  • 24. What Was the WHI Study designed to do? Long-term effect of hormone therapy on the prevention of heart disease and hip fractures and on monitoring possible increases in risk for breast cancer and colon cancer. Message from the President on WHI Study www.hormone.org
  • 25. White woman’s risk of death between the ages of 50 and 94 are: 31.0% from heart disease 2.8% from breast cancer 2.8% from hip fracture Brinton LA, Schairer C. N Engl J Med.1997;336:1769-1775
  • 28. Effect on the risk of breast cancer WHI Nonsignificant increased risk RR 1.26 (CI 1.00-1.59); 26% increased risk AR 0.38% vs 0.30% (ie, 38 vs 30 events annually per 10.000 women) HERS Nonsignificant increased risk RR 1.27 (CI 0.84-1.94); 27% increased risk AR 0.59% vs 0.47% (ie, 59 vs 47 events annually per 10.000 women)
  • 29. 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” (?!...)
  • 30. Thus… “The breast cancer findings are reported as statistically insignificant but are regarded as clinically relevant !” Utian W. Menopause Management 2003;12:9-10
  • 31. WHI results calculated as NNT/1 year NNH/1 year CHD 1428 Stroke 1250 VTE 588 Breast Cancer 1250 Colon Cancer 1667 Osteoporotic fractures 227 (totals) Neves-e-Castro M. Menopause in crisis post-Women’s Health Initiative? A view based on personal clinical experience. Human Reproduction 2003;18:2512-8
  • 32. “Women considering taking CEE should be counseled about an increased risk of stroke but can be reassured about no excess risk of heart disease or breast cancer for at least 6.8 years of use.” Effects of conjugated Equine Estrogen in Postmenopausal Women with Hysterectomy. JAMA 2004;291:1701-1712
  • 33. Effects of conjugated Equine Estrogen in Postmenopausal Women with Hysterectomy.JAMA, 2004;291:1701-1712
  • 34. Why Was the Study Stopped? • Small increase in the risk of strokes, which put healthy women at risk and made it unacceptable to continue with the study. • No increased risk for breast cancer and a decrease in the risk of hip fractures. Message from the President on WHI Study www.hormone.org
  • 35. Stroke “In women 50-59 years not taking HT, ischemic stroke is expected to occur in 3 out of 1000 women during 5 years. Five years use of HT would yield 1 additional case of stroke/ 1000 women” EMAS Statement; 2004.
  • 36. NAMS position statement on estrogen and progestagen use in peri-and postmenopausal women Revised breast cancer statements indicate that the risk of breast cancer probably increases with EPT use but not with ET use.
  • 37. Second thoughts on the WHI study: the effect of age on the safety HRT Studd J. Climacteric 2004;7:412-414
  • 38. O “braço” do WHI com estrogénios isolados foi interrompido! Porquê ? ! …
  • 39. • Parece que se tivesse havido mais um caso de cancro da mama no grupo placebo os resultados deste estudo teriam sido considerados como estatisticamente muito significativos… MNC
  • 40. Portanto… o grupo WHI/NIH teria sido forçado a declarar que: • Os estrogénios não induzem o cancro da mama , e que • Os estrogénios protegem a mama contra o cancro ! MNC
  • 41. Porque é que os investigadores não quiseram que o estudo fosse terminado e pudesse chegar a conclusões tão importantes? Seria pela necessidade de alguns investigadores continuarem a receber milhões de dólares? MNC
  • 42. Million Women Study The follow-up for breast cancer diagnosis was just over 2½ years, meaning that these breast cancers were almost certainly pre-existent at the start of the observational period. Press Release from the British Menopause Society, 2003
  • 45. Occult Breast Cancer in medicolegal autopsies Breast malignancy was found in 22 women (20%) Nielsen M et al-Br J Cancer 1987;56:814-9
  • 46. Occult Breast Cancer Malignancy was significantly more frequent among women . aged more than 40 years . with late age at first full-term pregnancy . with alcohol abuse . with steatosis or cirrhosis of the liver Nielsen M et al-Br J Cancer 1987;56:814-9
  • 47. Breast Cancer MWS data compared to other publish data MWS GPRD Beral Ross Weiss WHI (2003) (2002) (1997) (2000) (2002) (2003) EPT 2.00 1.211 1.152 1.243 1.22 1.26 ET 1.30 0.97 0.992 1.063 0.84 ongoing 4 Tibolone 1.45 1.02 1 Seq EPT 2 ≤ 5 y use 3 Per 5y 4 >6y use
  • 48. HRT and RR of DEATH from BREAST CANCER (MW Study,2003) • AR never users 238/2894 = 0.0822 • AR current users 191/3202 = 0.0597 • RR = 0.0597/0.0822 = 0.73 • RR for mortality = 1.22 • RR for morbidity =1.66 • RR for dying from BC = 1.22/1.66 = 0.73
  • 49. Fatal Breast Cancers Case-death Case-No death Current use 191 3011 3203 Never use 238 2656 2894 RR=0.71 (95% CI 0.58-0.87) Million Women Study Collaborators. Breast Cancer and hormone replacement therapy in the Million Women Study. Lancet 2003;362:419-427
  • 53. “Recurrent breast cancer was found in 9% of HRT users and 15% of nonuser”. O’Meara ES et al
  • 54. Estrogen replacement therapy in patients with early breast cancer The mortality rates from breast cancer for the ERT users was 4.28% compared with 22.3% in the nonusers. Natrajan PK and Gambrell RD. Am J Obstet Gynecol 2002;187:289-95
  • 55. O que é que aprendemos com os principais estudos observacionais e ensaios clinicos? 1ª.lição Os progestagénios administrados por via sistémica podem em parte suprimir alguns dos efeitos benéficos dos estrogénios e podem tambem aumentar ligeiramente o risco de cancro da mama após tratamentos com uma duração superior a cinco anos MNC
  • 56. O que é que aprendemos com os principais estudos observacionais e ensaios clinicos? 2ª.lição Os estrogénios quando administrados isoladamente em mulheres histerectomizadas não afectaram minimamente o risco para o cancro da mama quando comparado com os controlos MNC
  • 57. O que é que aprendemos com os principais estudos observacionais e ensaios clinicos? 3ª.lição Os efeitos metabólicos dos estrogénios e progestagénios, como um todo, podem diferir em função da via de administração i.e. oral vs. parentérica, e da combinação de ambos em regimes de administração sequencial ou combinada contínua MNC
  • 58. Relative risks associated with use of different hormones by women Cases Person/ Age-adjusted RR Years (CI – 95%) Estrogens used alone Transdermal 29 8.961 1.2 (0.8 – 1.8) Oral 2 1.204 0.6 (0.2 – 2.4) Estrogens combined with oral progesterone Estrogens combined with micronized progesterone 55 21.994 0.9 (0.7 – 1.2) Transdermal 55 20.685 0.9 (0.7 – 1.2) Oral 0 1.385 Estrogens combined with synthetic progestins Transdermal 187 46.252 1.4 (1.2 – 1.7) Oral 80 20.504 1.4 (1.1 – 1.8) Fournier A et al. Int J Cancer 2005;114:448-54
  • 59. Progesterone and Breast Cancer Combinations containing micronized progesterone appeared to be associated with a significantly lower breast cancer risk than those containing synthetic progestagens. Fournier A et al. Int J Cancer 2005;114:448-54
  • 60. O que é que aprendemos com os principais estudos observacionais e ensaios clinicos? 4ª.lição Os tratamentos hormonais são a primeira escolha para a abolição dos sintomas vasomotores enquanto necessários. Não devem ser usados para a prevenção secundária da DCV, quando já houver placas de ateroma. MNC
  • 61. O que é que aprendemos com os principais estudos observacionais e ensaios clinicos? 4ª.lição (continuação) Os estrogénios podem proteger contra DCV’s se iniciados precocemente durante a transição para a pós menopausa. Os tratamentos hormonais são preventivos da osteopenia e osteoporose em qualquer fase da vida MNC
  • 62. Postmenopausal hormone therapy: critical reappraisal and unified hypothesis 83:558-66
  • 63. Postmenopausal former oral contraceptives users may have lower rates of heart disease 702 postmenopausal women enrolled in the WISE. Use of oral contraceptive in the past was an independent negative predictor of CAD severity (p=0.04 after adjustment for smoking, aspirin use, lipid lowering medication, and socioeconomic variables ) 14th Annual Meeting of the North American Menopause Society. Abstract P-51
  • 64. Combined effect of oral contraceptive use and hormone replacement therapy on breast cancer risk in postmenopausal women The increase in risk with CHRT was stronger in women who had never used OC’s in the past than in women who had used OC’s Norman SA et al. Cancer Causes Control 2003;14(10):933-43
  • 65. Discussion The results of this study show a strong association of current HT with reduced odds of severe coronary artery calcification, an indicator of atherosclerotic plaque burden. Barrett-Connor E et al. Menopause 2005;12:40-48
  • 66. Discussion The protective association of HT with CACS was greater in longer versus shorter duration users and tended to be stronger in those whose HT use began early in postmenopause. Barrett-Connor E et al. Menopause 2005;12:40-48
  • 67. O que é que aprendemos com os principais estudos observacionais e ensaios clinicos? 5ª.lição Os estrogénios podem evitar lesões degenerativas do SNC uma vez que, até à data, são os únicos agentes com efeito no crescimento dos neurónios MNC
  • 68. Postmenopausal Estrogen Use Affects Risk for Parkinson Disease • Estrogen therapy has been associated with improved cognitive functioning, a reduced risk of dementia in women with Parkinson disease (PD), and a decreased risk of Alzheimer disease. • Postmenopausal estrogen therapy may be associated with a reduced risk of PD in women. Currie LJ et al. Arch Neurol 2004;61(6):886-8
  • 69. IADRD: Estrogens Exhibits Neuroprotective effect in preliminary analysis of Swedish Data Preliminary analysis of data from the Swedish Twin Registry suggests that estrogen is neuroprotective and the effect is not related to length of estrogen therapy. Estrogen use was significantly related to better cognitive functioning (odds ratio [OR]=0.43 95% confindence interval [CI]=0.26, 0.70) Peck P. DG News Stockholm, July 24, 2002.
  • 71. Como se podem reduzir os riscos potenciais ?
  • 72. Dimitrakakis C et al. Menopause 2004;11:531-535
  • 73. A physiologic role for testosterone in limiting estrogenic stimulation of the breast. These findings suggest that treatment with a balanced formulation including all ovarian hormones may prevent or reduce estrogenic cancer risk in the treatment of girls and women with ovarian failure. Dimitrakakis C et Al. Menopause 2003;10(4):292-8
  • 74. Quais são os melhores tratamentos durante e para além do climatério? Não tem sido prestada a devida atenção a outras intervenções farmacológicas (não hormonais) e a estratégias que se verificou serem importantes para a prevenção de tais doenças e para a manutenção ou melhoria da saúde MNC
  • 76. A TH não é possivel … • Quando não é desejada pela mulher • Quando a mulher não sente a sua necessidade • Quando há contraindicações MNC
  • 77. Intervenções Farmacológicas • Sintomáticas • Perventivas – primárias – Secundárias MNC
  • 78. Nurses’s Health Study from 1980 to 1994 CHD ↓ 31% ↓ Smoking ↓ 13% ↑ Obesity ↑ 8% ↑ THS ↓ 9% ↑ Better nutrition ↓ 16% Hu FB, Grodstein F et al. Trends in the Incidence of Coronary Heart Disease and Changes in Diet and Lifestyle in Women. NEJM 2000;343:530-537.
  • 79. “It appears that half of the benefits in the prevention of cardiovascular diseases are not hormone related”! Mosca L, Grundy SM, Judelson D, et al. Circulation 99;99:2480-4
  • 80. Association between alcohol consumption and postmenopausal breast cancer results of a case-control study in Montreal, Quebec, Canada Women who started to drink wine on or before the age of 40 were at a 2.5 times increased risk (95% CI 1.4-4.4). CONCLUSIONS: Our findings provide further support for a positive association between the risk of postmenopausal breast cancer and alcohol consumption. Lenz SK et al.Cancer Causes Control 2002;13(8):701-10
  • 81. Mediterranean Diet, Lifestyle Factors, and 10-Year Mortality in Elderly European Men and Women The combination of 4 low risk factors lowered the all-cause mortality rate to 0.35 (95% CI, 0.28-0.44). In total, lack of adherence to this low-risk pattern was associated with a population attributable risk of 60% of all deaths, 64% of deaths from coronary heart disease, 61% from cardiovascular diseases, and 60% from cancer. Knoops K et al. JAMA 2004;292:1433-9
  • 82. The Polymeal Franco O et al. BMJ 2004;329:1447-50
  • 83. Doctors could retrain as Polymeal chefs or wine advisers The Polymeal—an evidence based menu that includes wine, fish, dark chocolate, fruits, vegetables, garlic, and almonds—promises to be an effective, safe, cheap, and tasty solution to reducing cardiovascular morbidity and increasing life expectancy. Polymeal could reduce cardiovascular disease by more than 75%. Franco O et al. BMJ 2004;329:1447-50
  • 84. Tea, circulating estrogens and breast cancer Levels were 13% lower in regular green-tea drinkers (25.8 pg/ml) 19% higher in regular black tea drinkers (35.0 pg/ml). Wu A. et al. Carcinogenesis 2005.
  • 85. Tea, circulating estrogens and breast cancer “We recently provided the first set of human evidence that breast cancer risk is significantly inversely associated with tea intake, largely confined to intake of green tea.” “Green tea may have down-regulatory effects on circulating sex-steroid hormones, whereas black tea may have up-regulatory effects .” Wu A. et al. Carcinogenesis 2005
  • 86. RELATIVE RISK OF BREAST CANCER BY BODY WEIGHT Weight (Kg) Age at Diagnosis <60 60-69 70+ 35-49 1.00 0.54 1.16 50-59 1.00 1.22 1.43 60-69 1.00 1.61 1.81 from deWaard et al ,1964,1978
  • 87. HU FB et al. NEJM 2004;351:2694-2703
  • 88. HU FB et al. NEJM 2004;351:2694-2703
  • 89. HU FB et al. NEJM 2004;351:2694-2703
  • 90. Recreational Physical Activity and the Risk of Breast Cancer in Postmenopausal Women Women who engaged in the equivalent of 1.25 to 2.5 hours per week of brisk walking had an 18% decreased risk of breast cancer (RR, 0.82; 95% CI, 0.68-0.97) compared with inactive women. McTiernan A et al. JAMA 2003;290:1331-6
  • 91. Aspirin could be used to prevent cancer Three recently published studies indicate that aspirin, already enjoying a second lease of life in the prevention of heart disease, may soon become a first line of defense against cancer. London O. BMJ 2003;326:565
  • 92. Breast Cancer and Nonsteroidal Anti-Inflammatory Drugs: Prospective Results from the Women’s Health Initiative1 COX-2 induction may promote breast cancer development by enhancing local estrogen biosynthesis, and COX-2 inhibition may reverse the process. Harris R et al. Cancer Research 2003;63:6096-6101
  • 93. Inhibitory effect of statins on the proliferation of human breast cancer cells. Atorvastatin and fluvastatin were able to inhibit the proliferation of MCF-7 cells in the absence of estradiol. This effect seems to depend on an apoptotic statin effect. Muck AO et al. Int J Clin Pharmacol Ther 2004;42(12):695-700
  • 94. Inhibitory effect of statins on the proliferation of human breast cancer cells. The present data indicate that statins may possess anticancerogenic properties concerning the development of breast cancer in postmenopausal women. Muck AO et al. Int J Clin Pharmacol Ther 2004;42(12):695-700
  • 95. The Polypill Wald N and Law M. BMJ 2003;326:1419-25
  • 96. A strategy to reduce cardiovascular disease by more than 80% One third of people taking this pill from age 55 would benefit, gaining on average about 11 years of life free from an IHD event or stroke. Wald N and Law M. BMJ 2003;326:1419-25
  • 97. Wald N and Law M. BMJ 2003;326:1419-25
  • 98. O que pensam os outros?... Após uma viragem de 180º em dois anos… a NAMS (North American Menopause Society) acaba de concluir…
  • 99. NAMS position statement on estrogen and progestagen use in peri-and postmenopausal women No single trial should be used to set public health policy. The practice of 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.
  • 100. NAMS position statement on estrogen and progestagen use in peri-and postmenopausal women Place NO LIMIT on ET/EPT treatment duration, provided it is consistent with treatment goals; if monitored regularly, NO stipulation is made regarding when to reduce or stop therapy
  • 101. Há riscos? É indispensável que seja dada informação sôbre as diferenças entre riscos relativos e riscos absolutos uma vez que os primeiros são a principal causa de desinformação e alarmismo, sendo os favoritos dos media… MNC
  • 107. Analisem-se os factores de risco • Cardiovasculares • Oncológicos • Ósseos • SNC MNC
  • 108. Years of healthy life can be increased 5- 10 years, W O says H W need to concentrate on the e major risks if we are to improve healthy life expectancy by about 10 years, and life expectancy by even m ore. A n Lo p e z , Ph. D. , WHO Se nio r Sc ie nc e A v is o r a nd c o - la d d ire c to r o f the WHO re p o rt (2 0 0 2 )
  • 109. Welty F. Menopause 2004;11(4):484-94
  • 110. As mulheres não são estatísticas…
  • 111. Têm que ser tratatadas individualmente !
  • 112. Evidence based medicine: does it make a difference? Like any technology, evidence based medicine carries risks and benefits and can be used appropriately or inappropriately. Schon CR et al. BMC Health Serv Res 2003;3(1):14
  • 113. Evidence informed practice • 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 Oxford OX3 7LF. BMJ 2005;330:92
  • 114. Medicina Baseada na Evidência e/ou Evidência Baseada na Medicina ? Manuel Neves-e-Castro
  • 115. Medicina Baseada na Evidência e/ou Medicina Baseada na Inteligência ? Lucas Viana Machado
  • 116. “Aquele que aprende mas não pensa está perdido. O que pensa mas não aprende é perigoso… Confucius
  • 117. Se aprendermos e pensarmos… nem estaremos perdidos nem seremos perigosos para as nossas doentes pos- menopausicas Wenger NK. Am J Geriatr Cardiol 2000;9:204-9
  • 118. “Each time we learn something new, the astonishment comes from the recognition 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)
  • 119. Quais são as melhores recomendações do médico da mulher climatérica 1. Explicar o que se está passando no seu corpo durante o climatério e pós menopausa 2. Ocupação mental 3. Exercicio fisico 4. Alimentação adequada (consumo moderado de vinho tinto e abundante de: peixe, vegetais, frutos, soja, leite, alho, chocolate, etc) 5. Manter o índice de massa corporal dentro dos limites normais 6. Manter um perímetro normal da cintura 7. Abstenção do tabaco 8. Manter uma pressão arterial normal 9. Manter os lípidos sanguíneos nos valores normais (estatinas) 10. Exame mamário (palpação, inspecção mamografia)
  • 120. Qual é o melhor tratamento ?
  • 122. Qual é o melhor tratamento ? • Em termos gerais é o que estiver sensatamente indicado, se não contraindicado, após uma análise de benefícios e riscos, de todas as estratégias e intervenções, hormonais ou não hormonais • Deve estar dirigido a objectivos e alvos específicos que serão avaliados regularmente de modo a determinar a sua eficácia e a verificar a eventual ocorrência de quaisquer efeitos secundários, uma condição que determinará a sua duração MNC
  • 123. 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 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
  • 124. Mensagens Finais (1) • Prescrevam tratamentos hormonais na pós menopausa quando clínicamente indicados, se não houver contraindicações MNC
  • 125. Mensagens Finais (2) • A prescrição de tratamentos hormonais de longa duração depende sempre de uma análise benefício/risco em comparação com medicações não hormonais e estratégias não medicamentosas MNC
  • 126. Mensagens Finais (3) • Não são indispensáveis quaisquer respostas dos ensaios clínicos em curso para que se possa hoje praticar uma boa Medicina MNC
  • 127. HT appears to be the best form of pharmacologic treatment to improve brain function, as well as to reduce the risk of colon cancer. It is probably the best preventive strategy for osteoporosis. With this in mind … limiting HT to the treatment of climacteric symptoms only is unjustified. Kopernik G and Shoham Z. Fertil Steril 2004;81(6):1458-1477
  • 128. Evitar que uma mulher beneficie de um bom tratamento hormonal pós menopáusico só pelo receio de efeitos secundários raros não parece ser uma Medicina satisfatória … Manuel Neves-e-Castro
  • 129. Mortality Associated with HRT in younger and older women Hormone Replacement Therapy reduced total mortality in trials with mean age of participants under 60 years. No change in mortality was seen in trials with mean age over 60 years. Salpeter SR et al. J Gen Intern Med 2004;19:791-804
  • 130. Por isso … Vários ilustres colegas , “especialistas” em menopausa: H . Schneider (Alemanha) A . Genazzani (Itália) P . Kenemans (Holanda) e tambem eu próprio, continuamos a fazer tratamentos hormonais de longa duração às nossas consortes com os seguintes resultados:
  • 131. Schneider Genazzani Neves-e-Castro Kenemans
  • 132. Estou muito grato … por terem tido a paciência de me ouvirem, sem dormir…