What has been learned from the major observational
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What has been learned from the major observational Presentation Transcript

  • 1. What has been learned from themajor observational studies and clinical trials? the first lesson systematically administered progestagens may in part suppress some of the beneficial effects of estrogens and may also slightly increase the risk of breast cancer after treatments with duration greater than five years. MNC/05
  • 2. What has been learned from themajor observational studies and clinical trials?the second lessonestrogens, when given alone tohisterectomized women, did not appear tominimally affect the risk for breast cancerwhen compared with controls MNC/05
  • 3. What has been learned from themajor observational studies and clinical trials?the third lessonMetabolic effects of estrogens andprogestagens, as a whole, can differdepending on the route of administration, i.e.oral vs. parentheral, and on the combination ofboth, in a sequential regimen or in continuouscombined administration. MNC/05
  • 4. What has been learned from themajor observational studies and clinical trials?the fourth lessonHormonal treatments are the firstchoice for vasomotor symptom reliefas long as they are needed (on and offassessment). They should not be used forthe secondary prevention of CVD, whenatheroma plaques are already present. MNC/05
  • 5. What has been learned from themajor observational studies and clinical trials?the fourth lesson (cont.)Conversely, they may protect from CVDif started early during the transitioninto the post menopause.Hormonal treatments are preventive ofosteopenia and osteoporosis at anystage in life MNC/05
  • 6. 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…
  • 7. What about the best treatments during the climacterium and beyond?This is assumption is shared by bothwomen and physicians. Otherwise theongoing discussions that have explodedall over the world would not have beencentered only in the risks/benefitassessment of hormonal treatments…
  • 8. What about the best treatments during the climacterium and beyond?The climacteric, due to hormonalcauses and aging, is also a time of theonset of several risk factors fordiseases that may be manifested later inlife, mainly cardiovascular diseases(CVD), osteoporosis, degenerativediseases of the central nervous system(CNS), to name only the major ones thatmay have impact in the duration andquality of life
  • 9. What about the best treatments during the climacterium and beyond?Epidemiological studiesThere are abundant studies that confirmthe increased incidence of suchdiseases in untreated women as well asmany other studies about the benefit/riskanalyses of the hormonal treatments towhich these women have been submitted
  • 10. 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
  • 11. And now…in 2005
  • 12. The new American way …or …a 180º rotation ! … MNC/05
  • 13. NAMS position statement onestrogen and progestagen use inperi-and postmenopausal women No single trial should be used to set public health policy. The practice of 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.
  • 14. NAMS position statement onestrogen and progestagen use inperi-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
  • 15. Are there risks?It is crucial that information be givenabout the difference between relativerisks and absolute risks, since theformer are the major cause ofmisinformation and alarmism, being thefavorites of the media… MNC/05
  • 16. 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
  • 17. Evidence Based Medicine and/orMedicine Based Evidence ? Manuel Neves-e-Castro
  • 18. Evidence Based Medicine orInteligent Based Medicine? Lucas Viana Machado
  • 19. “He who learns, but does not think is lost.He who thinks, but does not learn is dangerous”. Confucius
  • 20. 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
  • 21. “Each time we learn something new,the astonishment comes from therecognition that we were wrong before.In truth, whenever we discover a newfact, it involves the elimination of oldones.WE ARE ALWAYS, as it turns out,fundamentally IN ERROR.” Lewis Thomas English Biologist (1913-1993)
  • 22. 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)
  • 23. What are the best recommendations of the climacteric woman’s doctor? • For vasomotor symptoms and night sweats take a sequential E+P medication, the most inert being an E-patch + oral or vaginal natural progesterone (alternatively, a progestagen loaded IUD). If histeretomyzed take only E (no need for P) • If libido is still down, add testosterone or switch E+P to tibolone. • If breasts are tender and dense, adjust dosages or use tibolone instead of E (+P)
  • 24. What are the best recommendations of the climacteric woman’s doctor? • Use vaginal estrogens if vagina is dry and if there is dispareunia • If osteoporetic one may add bisphosphonates or tibolone • Check stools for occult blood and do the first colonoscopy at age 50 and thereafter at 5 year intervals. • Last but not least, enjoy life and help other women to do what you are doing.
  • 25. 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
  • 26. Which is the best treatment?Patient needs and preferences are decisive, based onthe doctors’ advice. Let it not be forgotten that althoughmany treatments are available, they are nevertheless notindispensable. Doctors have the duty to give their bestunbiased information to their patients so that they maymake the right choices and then be compliant.The woman is the decision maker, if the doctor seesno contraindication.Thus,the best treatment is what she haschosen. MNC/05
  • 27. The take-home message is: (1) Prescribe postmenopausal hormonal treatments when clinically indicated, if not contraindicated! MNC/05
  • 28. The take-home message is: (2) The prescription of long-term hormonal treatments must depend always on a benefit/risk analysis in comparison with other non-hormonal medications and strategies. MNC/05
  • 29. The take-home message is: (3)No answers from ongoing clinicaltrials are indispensable to practicetoday a good Medicine ! MNC/05