The Climacteric Woman   Treatment options in 2006 :what has experience taught me                by Manuel Neves-e-Castro, ...
I am- an empathic person- a medical doctor (a “G.P.”)- a feminologist (gender medicine)- a gynecologist (diseases of women...
for sure , I am nota menopausologist ...
Is there a Menopausal          Medicine?There is only ONE Medicine (L.Speroff)There are only TWO Medicines (M.N.C.):      ...
Therefore,what we must learn, is…how to practice a  GOOD MEDICINE!               mnc/05
Looking after a menopausal woman is amost fascinating, gratifying and complex vivid experience in the life of a physician....
DefinitionA Climacteric woman is a woman (gender based medicine) is an ageing person (geriartrics) is perimenopausal (horm...
We must manage ourClinical Practice by objectives:                     objectives-Critical Objectives (C.O.)-Specific Obje...
Critical Objectivesa) The diagnosis of healthb) The identification of risk factorsc) The presence of symptoms   • gender r...
Critical Objectivesd) The treatment of symptomse) The elimination of risk factorsf) The diagnosis of diseasesg) The treatm...
Specific Objectives         (S.O.)1. CVD and metabolic diseases a) obesity b) dislipidemias c) hypertension d) insulin res...
S.O.2. CNS a) vasomotor symptoms b) mood, sleep c) sexual disfunctions, libido, etc
S.O.3. Bone a) osteoarticular, etc
S.O.4. Reproductive organs   - vaginal discharges   - atrophic vaginitis   - fibroids   - meno and metrorrhagia,     etc
S.O.5. Breast lumps and tenderness, etc
S.O.6. Bladder   incontinence   chronic cystitis,   etc
S.O.7.Contraception
S.O. Targets1.   exercise2.   nutrition3.   mental health4.   sexual conseling5.   pharmacotherapy     a) hormonal     b) ...
S.O. Projects   (treatments)            P, E+P, E           Androgens            Ca + vit D    Bisfosfonates, Strontium   ...
In postmenopausal women with ischemicheart disease, six months of therapy withtibolone significantly improved stressmyocar...
Causes of Death Among Women*                       Other Cancers                                                          ...
To begin with,andin the light of the present evidence,doctors and women should bereassured that the suggested HT’s forthe ...
There are controversies about thepresent management of theclimacterium which are due to:• a lack of culture that prevents ...
Convictions are moredangerous enemies of thruththan lies           Friedrich Wilhelm Nietzsche
Many women taking hormones wereurged by their physicians to stop takingthese medications immediately ordecided to stop tak...
Based on the WHI study group,implementation of the resultsinto clinical practice has little, ifany, scientific basis.Adam ...
The applicability of the WHIfindings to women between age of51.1 and 56.1 years and younger isunknown...              Ostr...
“W I: Now that the dust has settled…”  H • To publish data that may or may not   be entirely true or certainly   premature...
Lessons from the WHI“…most articles and broadcast segmentstended to focus exclusively on either the sm allabsolute risks o...
Effects of conjugated Equine Estrogen in Postmenopausal Womenwith Hysterectomy.JAMA, 2004;291:1701-1712
Stroke“In women 50-59 years not taking HT,ischemic stroke is expected to occur in3 out of 1000 women during 5 years.Five y...
Biased opinionsbe they pro or con,dishonor the professionandharm our patients.Sacket DL. The arrogance of preventive medic...
Then, why all this noise?...                     noiseMainly because the conclusions ofrecent trials were severely misinte...
“We are drowning in information, but starved for knowledge”                 knowledge                  John Naisbilt
then...how is Medicine practicedtoday?
There are two types of medical            practice:– the Medicine for one individual, at a  time (Clinical Medicine)      ...
Who are the actors ?                           •   Is a clinicianThe practitioner           •   Sees patients in the offic...
Concerns of theDoctor of an individual    •Absolute risk reduction(practitioner)                           •Absolute risk ...
Practioners are guided:• by the best available information that  can be extrapolated with validity to  their patients, and...
Public Health doctors are guided bywhat epidemiologists suggest ...but ...Most epidemiologists only establishassociations ...
But ... today ...many                • Act in their offices as if they werepractitioners         public health doctors...a...
thus ...  both,the practitioners who act as if they  were public health doctors,  and the public health doctors who act  a...
Hormones and the Heart1 in 3 women will die from coronaryheart disease (CHD) in the USA.1 in 25 women will die from breast...
Effect on the risk of CHDWHI Significant increased risk    RR 1.29 (CI 1.02-1.63); 29 % increased risk    AR 0.37% vs 0.30...
NNH / Year   (Number Needed to Harm)      (the reciprocal of the AR,or of the atributable AR)Coronary Heart Disease     WH...
“Not everything that can becounted counts;and not everything thatcounts can be counted”                    Albert Einstein
“HRT is associated with a  35% reduction in mortality  for women who suffered  myocardial infarction”.Shlipack MG, Angeja ...
Hormone replacement therapy:      where to now?Recent studies suggest HRT may inhibitthe process of atherosclerosis inheal...
Recent reports did not find, forcontinuous combined treatments, anyincreased risk of either CHD or breastcancer.The differ...
Manson et al reported a nonstatiscallysignificant decreased relative risk ofcardiovascular events in hormonetherapy users ...
“At the moment, I believe we can say withrelative certainty that hormone therapy in    younger postmenopausal women       ...
Younger Women May Receive Heart Protection From              Estrogen Therapy    In women ages 50-59 who had undergone a  ...
An update of the WHI Study !WHI investigators reported (Feb 2006) astatistically significant (34%) lower risk for thecombi...
Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
Press Statement IMSThe estrogen plus progestogen arm of the WHIand the estrogen-alone arm actually showed thatHT does noti...
Press Statement IMSAlso, in a subgroup of women demographicallysimilar to those in the WHI, there was nosignificant relati...
Press Statement IMSThe WHI study was not designed, and                        designedtherefore was not powered, to invest...
Breast Cancer
Menopausal women and theirdoctors are scared about the side         effects of HRT   mainly about breast cancer           ...
Breast cancer and the use of HRT  Considering 10.000 women on the  combination HRT then for each year  there would be:    ...
It must be emphasized that we aretalking about an increased incidence ofthe disease, which does notautomatically translate...
Extended use of estrogen for10 years increases risks by 0,5%, and by15 years increases risks by 0,9%but..upon cessation of...
Breast Cancer• The diagnosis of a breast cancer after the  initiation of a HRT (with a duration of less than 5  years) is ...
Breast Cancer• The doubling time of an initial cancer  cell, up to the diagnosis of a resultant  cell  1cm tumor, is most ...
Occult Breast CancerClinically occult in situBC’s are frequent inyoung and middle-agedwomen.          Nielsen M et al-Br J...
Occult Breast CancerBreast malignancy wasfound in 22 women(20%)       Nielsen M et al-Br J Cancer 1987;56:814-9
Thus…• Mammographies give more false  negative than false positive results !• A “normal” mammography does not  exclude the...
Estrogen replacement therapy inpatients with early breast cancer  The mortality rates from breast cancer for  the ERT user...
“Recurrent breast cancer was found in 9% of HRT users and 15% of nonuser”.             O’Meara ES et al.JNCI 2001;93:754-761
Mortality following development of      breast cancer while usingoestrogen or oestrogen plus progestin:   W Chen, DB Petit...
This study explored survival afterexposure to oestrogen or oestrogenplus progestin at or in the year prior tobreast cancer...
Breast cancer survival after hormone             exposure
Overall survival after hormone          exposure
Breast cancer survival after hormone             exposure
Overall survival after hormone          exposure
A menopausal woman expects  from her attending physicianto be receptive to all of her complains,to understand her psychic ...
Many Doctors fail to persuade  them to go on with HRT, in   despite of telling that the benefits are far greater than     ...
One may easily conclude thatwithout an adequate technique ofcommunication, using the properlanguage,there is no possible h...
then...let us talk about     Risks...     Risks
Are there risks?It is crucial that information be givenabout the difference between relativerisks and absolute risks, sinc...
Risks of women medicated with E+P (5.2 years)                              women
Risks of women medicated with E only (6.8 years)                                women
Risks of Breast Canceraccording to different factors
Nurses’s Health Studyfrom 1980 to 1994 CHD ↓ 31%    ↓   Smoking                             ↓   13%    ↑   Obesity        ...
“It appears that half of thebenefits in the prevention ofcardiovascular diseases arenot hormone related”! Mosca L, Grundy ...
Can side effects be minimized ?
First of all, there are many differentpost-menopausal hormonetherapies: different estrogens,therapiesdifferent progestins,...
Second, there are those who knowand those who do not know totailor-make it to a particular womanand to monitor its efficac...
Third, there are those who thinkthat the menopause is a disease tobe treated solely with sexhormones…         Neves-e-Cast...
Hippocrates promoted specific diets to prevent and cure diseases, such as illnesses of the heart.Lyons AS et al. In Medici...
The PolymealFranco O et al. BMJ 2004;329:1447-50
Doctors could retrain asPolymeal chefs or wine advisersThe Polymeal—an evidence based menu thatincludes, wine, fish, dark ...
The PolypillWald N and Law M. BMJ 2003;326:1419-25
Wald N and Law M. BMJ 2003;326:1419-25
One third of people taking this pill from age55 would benefit, gaining on average about11 years of life free from an IHD e...
Moderate exercise cuts breast   cancer biomarkers in  postmenopausal women Increased physical activity significantly reduc...
Aspirin could be used to prevent             cancerThree recently published studies indicatethat aspirin, already enjoying...
but,not necessarily…    necessarily
NAMS!NAMSWhy?..Why.
There are no really “safe” biological active drugs...There are only “safe” physicians !    Kaminetzy HA 1993
In conclusion …and to make a long story        short…
What are the best recommendations of    the climacteric woman’s doctor? 1.  Understand what is happening to the body durin...
My Message is:.To prescribe postmenopausal hormonal treatments when clinically indicated, if not contraindicated. No answe...
“Each time we learn something new, theastonishment comes from the recognitionthat we were wrong before…I truth, whe ne ve ...
Let us not medicalize theMenopause..instead…  Let us holistically  approach the Climacteric  and Ageing Women.            ...
To know the disease that a woman hasis as important asto knowthe woman who has the disease                     William Osler
What about the best treatments during the climacterium and           beyond?There is a general tendency to considerthat se...
What about the best treatments during the climacterium and           beyond?However, little attention is paid to otherphar...
Which is the best treatment?In general terms, is the one that is wiselyindicated, if not contraindicated, afterbalancing b...
Which is the best treatment?Patient needs and preferences are decisive, based on                                        de...
I personally believe that for the healthyearly post menopausal woman the long termHT’s, other than relieving vasomotorsymp...
Continuous combined parenteralestrogen substitution and intrauterine        progestogen delivery:     the ideal HST combin...
Continuous intrauterine compared    with cyclic oral progestinadministration in perimenopausal               HRT This meth...
Relationship between breast cancer and      use of the levonorgestrel-IUD  These results suggest that the use of  the levo...
The conclusions of the WHI trial suggest that the“safe “ woman (NNH between 600-1000 women)                to initiate HT ...
This is precisely the profile of the greatmajority of women who come forconsultation after their menopause.Therefore it se...
Postmenopausal hormone therapy: critical   reappraisal and unified hypothesis                             83:558-66
Do others agree ?
“He who learns,but does not think      is lost.He who thinks, but does not learn is   dangerous”.   dangerous             ...
If we both learn and think          we will        neither be lost        nor dangerous  to our postmenopausal women      ...
NAMS position statement onestrogen and progestagen use inperi-and postmenopausal women Revised breast cancer statements in...
NAMS position statement onestrogen and progestagen use inperi-and postmenopausal women Place no limit on ET/EPT treatment ...
If there are no incoming contraindicationswe see no reason to establish a time limitto the duration of therapy, mainly if ...
Evidence informed practice• It is clearly time to change “evidence based  medicine” to “evidence informed practice”.      ...
What has been learned from themajor observational studies and        clinical trials? the first lesson systematically admi...
What has been learned from themajor observational studies and        clinical trials?  the second lesson  estrogens, when ...
What has been learned from themajor observational studies and        clinical trials? the third lesson Metabolic effects o...
What has been learned from themajor observational studies and        clinical trials? the fourth lesson Hormonal treatment...
What has been learned from themajor observational studies and        clinical trials? the fourth lesson (cont) Conversely ...
What has been learned from themajor observational studies and        clinical trials? the fifth lesson Estrogens may preve...
Preventing a woman from thebenefits of a sound postmenopausal hormone therapy because of the fear of rare side effects doe...
A             WOMAN     in the autumn of her lifedeserves an indian summer       rather than a winter of discontent ...   ...
This is was what she taught me…
This is was what she taught me…                          DIXIT
This is was what she taught me…                          DIXIT                         Thank                           you
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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.
  • Firenze 2

    1. 1. The Climacteric Woman Treatment options in 2006 :what has experience taught me by Manuel Neves-e-Castro, MD from Lisbon, Portugal 12th World Congress of Gynecological Endocrinology Firenze,March 2-5 2006
    2. 2. I am- an empathic person- a medical doctor (a “G.P.”)- a feminologist (gender medicine)- a gynecologist (diseases of women)- an endocrinologist (hormones)But, despite the invitation to...
    3. 3. for sure , I am nota menopausologist ...
    4. 4. Is there a Menopausal Medicine?There is only ONE Medicine (L.Speroff)There are only TWO Medicines (M.N.C.): a BAD Medicine and a GOOD Medicine
    5. 5. Therefore,what we must learn, is…how to practice a GOOD MEDICINE! mnc/05
    6. 6. Looking after a menopausal woman is amost fascinating, gratifying and complex vivid experience in the life of a physician. MNC/2005
    7. 7. DefinitionA Climacteric woman is a woman (gender based medicine) is an ageing person (geriartrics) is perimenopausal (hormone deficient)
    8. 8. We must manage ourClinical Practice by objectives: objectives-Critical Objectives (C.O.)-Specific Objectives (S.O.)-S.O. Targets (S.O.T.)-S.O. Projects (S.O.P.)
    9. 9. Critical Objectivesa) The diagnosis of healthb) The identification of risk factorsc) The presence of symptoms • gender related • age related • hormone related
    10. 10. Critical Objectivesd) The treatment of symptomse) The elimination of risk factorsf) The diagnosis of diseasesg) The treatment of diseases
    11. 11. Specific Objectives (S.O.)1. CVD and metabolic diseases a) obesity b) dislipidemias c) hypertension d) insulin resistance etc
    12. 12. S.O.2. CNS a) vasomotor symptoms b) mood, sleep c) sexual disfunctions, libido, etc
    13. 13. S.O.3. Bone a) osteoarticular, etc
    14. 14. S.O.4. Reproductive organs - vaginal discharges - atrophic vaginitis - fibroids - meno and metrorrhagia, etc
    15. 15. S.O.5. Breast lumps and tenderness, etc
    16. 16. S.O.6. Bladder incontinence chronic cystitis, etc
    17. 17. S.O.7.Contraception
    18. 18. S.O. Targets1. exercise2. nutrition3. mental health4. sexual conseling5. pharmacotherapy a) hormonal b) non-hormonal
    19. 19. S.O. Projects (treatments) P, E+P, E Androgens Ca + vit D Bisfosfonates, Strontium Statins IACE Diuretics α and β Blockers Aspirin Serm’s Tibolone Gabapantin Psychotherapy etcroutes, schemes of administration
    20. 20. In postmenopausal women with ischemicheart disease, six months of therapy withtibolone significantly improved stressmyocardial perfusion and the "amountof ischemia."Campisi R et al. J Am College Cardiol 2006;47:559-564
    21. 21. 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.
    22. 22. 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 !
    23. 23. There are controversies about thepresent management of theclimacterium which are due to:• a lack of culture that prevents a correct criticism of the published results• a bad practice of medicine that ignores the woman in her totality (holism)• political lobbies from the NIH• a lack of scientific honesty manifested by many of the WHI writers• lobbies from several pharmaceutical industries through the activities of many well known doctors that “offer” themselves to transmit their “messages”
    24. 24. Convictions are moredangerous enemies of thruththan lies Friedrich Wilhelm Nietzsche
    25. 25. Many women taking hormones wereurged by their physicians to stop takingthese medications immediately ordecided to stop taking them on their own. Petitti DB. JAMA. 2005;294:245-246.
    26. 26. Based on the WHI study group,implementation of the resultsinto clinical practice has little, ifany, scientific basis.Adam Ostrzenski and Katarzyna M Ostrzenska. Am J Obst Gynecol2005;193:1599-604
    27. 27. The applicability of the WHIfindings to women between age of51.1 and 56.1 years and younger isunknown... Ostrzenski A and Ostrzenska KM. Am J Obst Gynecol 2005;193:1599-604
    28. 28. “W I: Now that the dust has settled…” H • To publish data that may or may not be entirely true or certainly premature is a disservice to the medical profession and, most important, to our patients. • The majority of the data that were published is not statistically significant even at the nominal level. Creasm W et al. Am JObst Gynecol 2003;189:621-626 an T.
    29. 29. Lessons from the WHI“…most articles and broadcast segmentstended to focus exclusively on either the sm allabsolute risks or the larger relative risks,neglecting the more even-handed picture thatpresented both.Since the sharply increased relative risks gotthe most play, news coverage about the trial’sfindings had an alarming cast.” De nz e r S. Editorial. A I rn M d . 2 0 0 3 ; 1 3 8 : 3 5 2 -3 5 3 nn nte e
    30. 30. Effects of conjugated Equine Estrogen in Postmenopausal Womenwith Hysterectomy.JAMA, 2004;291:1701-1712
    31. 31. 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.
    32. 32. Biased opinionsbe they pro or con,dishonor the professionandharm our patients.Sacket DL. The arrogance of preventive medicine. Can Med Assoc J2002;167:363-364
    33. 33. Then, why all this noise?... noiseMainly because the conclusions ofrecent trials were severely misinterpretedby the medical professionals, the media professionalsand by the women, themselves MNC/05
    34. 34. “We are drowning in information, but starved for knowledge” knowledge John Naisbilt
    35. 35. then...how is Medicine practicedtoday?
    36. 36. There are two types of medical practice:– the Medicine for one individual, at a time (Clinical Medicine) Medicine– the Medicine for many individuals, the population, at the same time, (Social Medicine,Public Health Medicine) MNC/05
    37. 37. Who are the actors ? • Is a clinicianThe practitioner • Sees patients in the office • Treats individuals • Works in Hospitals • Is not a clinicianThe public health doctor • Does not see patients in an office • Does not treat individuals • Works in a Public Health department
    38. 38. Concerns of theDoctor of an individual •Absolute risk reduction(practitioner) •Absolute risk increase •Benefit/risk analisysThe Public Health Doctor •Relative risk reduction •Relative risk increase •Cost/benefit analysis
    39. 39. Practioners are guided:• by the best available information that can be extrapolated with validity to their patients, and• by their accumulated experience MNC/05
    40. 40. Public Health doctors are guided bywhat epidemiologists suggest ...but ...Most epidemiologists only establishassociations of events and seldomdetermine cause/effect relationships MNC/05
    41. 41. But ... today ...many • Act in their offices as if they werepractitioners public health doctors...and many • GIVE ADVISE in their departmentspublic health as if they were clinicians,in andoctors office ... This is wrong!
    42. 42. thus ... both,the practitioners who act as if they were public health doctors, and the public health doctors who act as if they were clinicians, should not overemphasize theepidemiological associations of eventsthat are not necessarily cause/effectfindings
    43. 43. 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
    44. 44. Effect on the risk of CHDWHI Significant increased risk RR 1.29 (CI 1.02-1.63); 29 % increased risk AR 0.37% vs 0.30% (ie, 37 vs 30 events annually per 10.000 women)HERS Nonsignificant decreased risk RR 0,99 (CI 0.84-1.17); 1% decreased risk AR 3.66% vs 3.68% (ie, 366 vs 368 events annually per 10.000 women)
    45. 45. NNH / Year (Number Needed to Harm) (the reciprocal of the AR,or of the atributable AR)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
    46. 46. “Not everything that can becounted counts;and not everything thatcounts can be counted” Albert Einstein
    47. 47. “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
    48. 48. Hormone replacement therapy: where to now?Recent studies suggest HRT may inhibitthe process of atherosclerosis inhealthy arteries soon after menopause,and observational studies (NHS,updated2006) in younger women starting HRTstrongly suggest a potentialcardiovascular benefit Mikkola TS, Clarkson TB. Cardiovasc Res 2002;53:605-19.
    49. 49. Recent reports did not find, forcontinuous combined treatments, anyincreased risk of either CHD or breastcancer.The difference from WHI being thatwomen were younger, symptomaticand with lower body weightsHeikkinen J. NAMS 2004, Abstract LB38Lobo R. Arch Int Med 2004;164:482-484
    50. 50. Manson et al reported a nonstatiscallysignificant decreased relative risk ofcardiovascular events in hormonetherapy users who were <10 years fromthe onset of menopause. Manson JE et al. JAMA 2002;288:321-33
    51. 51. “At the moment, I believe we can say withrelative certainty that hormone therapy in younger postmenopausal women results in lower coronary heart disease events and total mortality.” Salpeter S. Climacteric 2005;8:307-310
    52. 52. 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
    53. 53. 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
    54. 54. Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
    55. 55. Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
    56. 56. Hsia J, Langer RD, Manson J et al. Conjugated equine estrogens and coronary heartdisease. Arch Int Med 2006;166:357-65
    57. 57. 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
    58. 58. Press Statement IMSAlso, in a subgroup of women demographicallysimilar to those in the WHI, there was nosignificant relation between HT and CHD amongwomen who initiated therapy at least 10 yearsafter the menopause(RR = 0.87, 95% CI 0.69–1.10 for estrogen alone; RR = 0.90, 95% CI 0.62–1.29 for estrogen with progestogen). Feb 2006
    59. 59. 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
    60. 60. Breast Cancer
    61. 61. Menopausal women and theirdoctors are scared about the side effects of HRT mainly about breast cancer MNC/05
    62. 62. 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
    63. 63. 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
    64. 64. 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
    65. 65. 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
    66. 66. Breast Cancer• The doubling time of an initial cancer cell, up to the diagnosis of a resultant cell 1cm tumor, is most likely greater than 10 years.• This is why many dormant cancer cells may exist in a “normal” breast ! MNC/05
    67. 67. Occult Breast CancerClinically occult in situBC’s are frequent inyoung and middle-agedwomen. Nielsen M et al-Br J Cancer 1987;56:814-9
    68. 68. Occult Breast CancerBreast malignancy wasfound in 22 women(20%) Nielsen M et al-Br J Cancer 1987;56:814-9
    69. 69. 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
    70. 70. 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
    71. 71. “Recurrent breast cancer was found in 9% of HRT users and 15% of nonuser”. O’Meara ES et al.JNCI 2001;93:754-761
    72. 72. 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
    73. 73. This study explored survival afterexposure to oestrogen or oestrogenplus progestin at or in the year prior tobreast cancer diagnosisoestrogen plus progestin usershad lower all-cause mortality andbreast cancer mortalityChen W, Petitti DB and Geiger AM. British Journal of Cancer 2005; 93:392-398
    74. 74. Breast cancer survival after hormone exposure
    75. 75. Overall survival after hormone exposure
    76. 76. Breast cancer survival after hormone exposure
    77. 77. Overall survival after hormone exposure
    78. 78. A menopausal woman expects from her attending physicianto be receptive to all of her complains,to understand her psychic and physical concerns,to support her insecurity andto help overcome her crisis. crisis MNC/05
    79. 79. Many Doctors fail to persuade them to go on with HRT, in despite of telling that the benefits are far greater than any potential risk MNC/05
    80. 80. One may easily conclude thatwithout an adequate technique ofcommunication, using the properlanguage,there is no possible helpThus,physicians must acquire expertise inthe technique of communication MNC/05
    81. 81. then...let us talk about Risks... Risks
    82. 82. Are there risks?It is crucial that information be givenabout the difference between relativerisks and absolute risks, since the latter risksare the major cause of misinformation andalarmism, being the favorites of themedia… MNC/05
    83. 83. Risks of women medicated with E+P (5.2 years) women
    84. 84. Risks of women medicated with E only (6.8 years) women
    85. 85. Risks of Breast Canceraccording to different factors
    86. 86. Nurses’s Health Studyfrom 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 HeartDisease and Changes in Diet and Lifestyle in Women. NEJM2000;343:530-537.
    87. 87. “It appears that half of thebenefits in the prevention ofcardiovascular diseases arenot hormone related”! Mosca L, Grundy SM, Judelson D, et al. Circulation 99;99:2480-4
    88. 88. Can side effects be minimized ?
    89. 89. First of all, there are many differentpost-menopausal hormonetherapies: different estrogens,therapiesdifferent progestins, differentroutes of administration, differentregimens, which have differentprofiles. Neves-e-Castro M. Maturitas 2001;38(3):235-237
    90. 90. Second, there are those who knowand those who do not know totailor-make it to a particular womanand to monitor its efficacy in thetargets that have justified itsselection. Neves-e-Castro M. Maturitas 2001;38(3):235-237
    91. 91. Third, there are those who thinkthat the menopause is a disease tobe treated solely with sexhormones… Neves-e-Castro M. Maturitas 2001;38(3):235-237
    92. 92. Hippocrates promoted specific diets to prevent and cure diseases, such as illnesses of the heart.Lyons AS et al. In Medicine: an illustrated History. New York:Abradale Press,1990:20719
    93. 93. The PolymealFranco O et al. BMJ 2004;329:1447-50
    94. 94. Doctors could retrain asPolymeal chefs or wine advisersThe Polymeal—an evidence based menu thatincludes, wine, fish, dark chocolate fruits,vegetables, garlic, and almonds—promises to be an almondseffective, safe, cheap, and tasty solution to reducingcardiovascular morbidity and increasing lifeexpectancy.Polymeal could reduce cardiovascular disease bymore than 75%. Franco O et al. BMJ 2004;329:1447-50
    95. 95. The PolypillWald N and Law M. BMJ 2003;326:1419-25
    96. 96. Wald N and Law M. BMJ 2003;326:1419-25
    97. 97. One third of people taking this pill from age55 would benefit, gaining on average about11 years of life free from an IHD event orstroke. Wald N and Law M. BMJ 2003;326:1419-25
    98. 98. Moderate exercise cuts breast cancer biomarkers in postmenopausal women Increased physical activity significantly reduces serum estrogens in postmenopausal women and thus may reduce the risk of breast cancer. McTiernan A. Cancer Res 2004;364:2923-8
    99. 99. Aspirin could be used to prevent cancerThree recently published studies indicatethat aspirin, already enjoying a secondlease of life in the prevention of heartdisease, may soon become a first line ofdefense against cancer. London O. BMJ 2003;326:565
    100. 100. but,not necessarily… necessarily
    101. 101. NAMS!NAMSWhy?..Why.
    102. 102. There are no really “safe” biological active drugs...There are only “safe” physicians ! Kaminetzy HA 1993
    103. 103. In conclusion …and to make a long story short…
    104. 104. What are the best recommendations of the climacteric woman’s doctor? 1. Understand what is happening to the body during the climacteric and the postmenopause 2. Mental occupation 3. Physical exercise 4. Proper nutrition (moderate consumption of red wine, and abundant fish, vegetables, fruits, soy, milk, garlic, chocolate, etc) 5. Keep the body mass index (BMI) within normal limits 6. Keep a normal girdle/hip ratio, waist circumference 7. Refrain from smoking 8. Keep a normal blood pressure 9. Keep the blood lipids within normal values (statins?) 10. Examine the breasts (palpation, inspection, mammography)
    105. 105. My Message is:.To prescribe postmenopausal hormonal treatments when clinically indicated, if not contraindicated. No answers from ongoing clinical trials are indispensable to practice today a good Medicine MNC/05
    106. 106. “Each time we learn something new, theastonishment comes from the recognitionthat we were wrong before…I truth, whe ne ve r we d is c o ve r a ne w fa c t, it ninvo lve s the e lim ina tio n o f o ld o ne s . . .thus,as it turns out,WE ARE ALWAYS IN ERROR ! ” Le wis Tho m a s Eng lis h Bio lo g is t (1 9 1 3 -1 9 9 3 )
    107. 107. Let us not medicalize theMenopause..instead… Let us holistically approach the Climacteric and Ageing Women. MNC /05
    108. 108. To know the disease that a woman hasis as important asto knowthe woman who has the disease William Osler
    109. 109. What about the best treatments during the climacterium and beyond?There is a general tendency to considerthat sex steroid hormones are the onlyinstruments with which to treat womenwhen they enter in the climacteric phaseof their lives… MNC/05
    110. 110. What about the best treatments during the climacterium and beyond?However, little attention is paid to otherpharmacological interventions (nonhormonal) and strategies that have beenshown to be important for theprevention of such diseases and tomaintain or improve health. MNC/05
    111. 111. Which is the best treatment?In general terms, is the one that is wiselyindicated, if not contraindicated, afterbalancing benefits and risks, of all strategiesand interventions, hormonal or not.It must be aimed at specific objectives andtargets that will be monitored at regular intervalsin order to determine its efficacy and to estimatethe occurrence of any side effects, a conditionthat will determine its duration. MNC/05
    112. 112. Which is the best treatment?Patient needs and preferences are decisive, based on decisivethe doctors’ advice. Let it not be forgotten that althoughmany treatments are available, they are neverthelessnot indispensable. Doctors have the duty to give their indispensablebest unbiased information to their patients so that theymay make the right choices and then be compliant. compliantThe woman is the decision maker, if the doctorsees no contraindication.thus,the best treatment is what a wellinformed woman has chosen. MNC/05
    113. 113. 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 ofCVD, osteoporosis and Alzheimer, undersurveillance.Systemic (parenteral) estrogens, added estrogenswhen needed to vaginal progesterone orprogestagen loaded IUD’s, may be very IUD’sbeneficial, largely overpassing minimalrisks. MNC/05
    114. 114. Continuous combined parenteralestrogen substitution and intrauterine progestogen delivery: the ideal HST combination?Wildemeersch D, Janssens D and Weyers S. Maturitas 2005;51:207-214
    115. 115. Continuous intrauterine compared with cyclic oral progestinadministration in perimenopausal HRT This method of HRT with the Lng-IUD’s as progestin delivery system is efficient in protecting the endometrium against hyperplasia, and will make withdrawal bleedings unnecessary. Boon J et al. Maturitas 2003;46:69-77
    116. 116. Relationship between breast cancer and use of the levonorgestrel-IUD These results suggest that the use of the levonorgestrel-releaing intrauterine system is not associated with an increased risk of breast cancer Backman T et al. Obstet & Gynecol 2005;106:813-7
    117. 117. The conclusions of the WHI trial suggest that 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
    118. 118. This is precisely the profile of the greatmajority of women who come forconsultation after their menopause.Therefore it seems that what mostgynecologists are doing to theirpredominant population of patients is notunsafe and contributes not only to agood quality of life but to prevention, aswell. Neves-e-Castro M. Human Reproduction 2003;18:2512-2518
    119. 119. Postmenopausal hormone therapy: critical reappraisal and unified hypothesis 83:558-66
    120. 120. Do others agree ?
    121. 121. “He who learns,but does not think is lost.He who thinks, but does not learn is dangerous”. dangerous Confucius
    122. 122. If we both learn and think we will neither be lost nor dangerous to our postmenopausal women patients” Wenger NK. Am J Geriatr Cardiol 2000;9:204-9
    123. 123. NAMS position statement onestrogen and progestagen use inperi-and postmenopausal women Revised breast cancer statements indicate that the risk of breast cancer probably increases with EPT use but not with ET use.
    124. 124. 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
    125. 125. If there are no incoming contraindicationswe see no reason to establish a time limitto the duration of therapy, mainly if there isa recovery of symptoms after itsdiscontinuationCochrane B, NAMS 2004, P53IMS www.imsociety.orgNAMS www.menopause.org
    126. 126. Evidence informed practice• It is clearly time to change “evidence based medicine” to “evidence informed practice”. 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
    127. 127. 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.
    128. 128. What has been learned from themajor observational studies and clinical trials? the second lesson estrogens, when given alone to histerectomized women, did not appear to minimally affect the risk for breast cancer when compared with controls MNC/05
    129. 129. What has been learned from themajor observational studies and clinical trials? the third lesson Metabolic effects of estrogens and progestagens, as a whole, can differ depending on the route of administration, i.e. oral vs. parentheral, and on the combination of both, in a sequential regimen or in continuous combined administration. MNC/05
    130. 130. What has been learned from themajor observational studies and clinical trials? the fourth lesson Hormonal treatments are the first choice for vasomotor symptom relief as long as they are needed (on and off assessment). They should not be used for the secondary prevention of CVD, when atheroma plaques CVD are already present. MNC/05
    131. 131. What has been learned from themajor observational studies and clinical trials? the fourth lesson (cont) Conversely ,they may protect from CVD if started early during the transition into the post menopause. menopause Hormonal treatments are preventive of osteopenia and osteoporosis at any stage in life MNC/05
    132. 132. What has been learned from themajor observational studies and clinical trials? the fifth lesson Estrogens may prevent degenerative lesions of the CNS since, so far, they seem to be the only available drugs with nerve growth effects MNC/05
    133. 133. Preventing a woman from thebenefits of a sound postmenopausal hormone therapy because of the fear of rare side effects does not seem to be satisfactory Medicine... M.Neves-e-Castro, 2000
    134. 134. A WOMAN in the autumn of her lifedeserves an indian summer rather than a winter of discontent ... Robert B Greenblatt
    135. 135. This is was what she taught me…
    136. 136. This is was what she taught me… DIXIT
    137. 137. This is was what she taught me… DIXIT Thank you

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