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The Lesson for Men and Women
At the time of this writing there has been a flurry of public and scientific commentary on the subject of Hormone Replacement Therapy (HRT) for menopausal and post-menopausal women.  Somewhere between 6 and 20 million women in America have been told that because of the medicine they are taking they could be at risk for heart attacks, strokes, and breast cancer.  Physicians who have prescribed these medicines for many years are hit with the realization that the new information about their routinely prescribed medicines may be leading to serious risks while accomplishing some beneficial effects such as preventing or slowing osteoporosis, reducing the symptoms of menopause such as hot flashes and mood swings, and improving skin and vaginal dryness. 


  
What Actually Happened
Medicine, as scientifically based as it is, has different degrees of scientific soundness.  The general progress in medicine is marked by roller coaster ups and downs -whether it is a medication or a surgical procedure or a new technology.  There is an understandable reason for this.  Someone has an idea - generally considered an hypothesis.  The hypothesis might be simple: women at menopause have less estrogen produced by the ovary and this leads to consequences like hot flashes at the time of menopause.  The hypothesis is then tested by the administration (replacement) of estrogen to perhaps several hundred peri-menopausal women and it is found that menopause is better tolerated by treated women than those who did not get the medicine.  Then drug companies produce lots of drugs with different ratios of estrogen and add progesterone since it decreases some of the adverse effects, and in clinical trials overseen by the FDA they all show that symptoms of menopause are reduced by hormone therapy.  They also find that bone density and osteoporosis are improved with the therapy.  In the natural course of the "science" of medicine millions of women are then given HRT and everyone is pleased - patients, doctors and the drug industry.  Next comes the first downer on the roller coaster, it is noticed by alert physicians that it seems that women on HRT may be having more clotting problems and even a higher incidence of breast cancer.  Both of these adverse outcomes are relatively rare and would never have been noted in the small trials that led to FDA approval, but when millions of patients are taking the drugs then the rare events begin to be noticed. 

Large-scale observational trials are next conducted.  An observational trial is one where women (and their doctors) who are sure that their HRT is good for them enroll in a massive trial designed to follow the health of nurses in New England. Nurses tend to be healthy and aware of healthy living.  Many are on HRT, but because of their healthy lifestyles they avoid things that lead to heart disease and cancer and it appeared in the Nurse Trial that the HRT the nurses were taking protected them from heart disease and cancer.  So doctors believed that HRT is effective in treating menopausal symptoms and can actually have additional benefits like protection against heart disease.  This is logical and fits the observation that young women don't have heart disease therefore older women who replace their waning amounts of estrogen should be protected from heart disease.  We are back on an upward part of the roller coaster ride.  That's where we were for many years until mid-2002!

Now comes the recent disclosure from two very large randomized trials involving women given HRT that was designed to prove once and for all how good HRT is for many things besides the symptoms of menopause.  The two trials - one completed and the other stopped for ethical reasons produces very disturbing results.  There is actually a higher incidence of heart attack and a worrisome incidence of stroke in HRT patients.  Breast cancer is also higher.  We are back on the downer of the roller coaster.  Millions of women are now frightened, doctors are uncertain and the press is having a field day on "how could everyone have been so wrong."  
   
What To Do?
Hormone therapy is going to be examined more closely now.  Because it is effective in certain settings (see table) and because it carries small risk when used for relatively short (less than 5 years) time periods, HRT will still be appropriately prescribed.  Any woman on HRT should consult with her physician and have a thorough discussion about why the drug is being given (the indications), the risks (contraindications) and on an individual basis a decision needs to be made whether to continue or discontinue the medication.  A lesson from all this is that HRT is like almost everything else in medicine - the progress is slow and there are predictable "use cycles" with medicines, surgical procedures and other medical technology.  First comes the idea and feasibility, then cautious optimism, next wild enthusiasm, followed by caution when side effects turn up, next some major adverse experience occurs resulting in drastically reduced use and finally a plateau of appropriate use and adoption occurs.  The most important lesson is that with time and with enough exposures (sufficient experience) nearly all is found out about our medical approach to the prevention and treatment of disease.  It is impossible to know everything prior to widespread use of anything in medicine.   
 
The Pros & Cons of Estrogen/Progesterine Therapy in Menopausal Women

MUSCHealth.com Online Health Library Related Links:
Hormone Therapy

Other Online Resources:
Medline Plus Information on HRT
MedlinePlus: Hormone Replacement Therapy  (National Library of Medicine) 
Hormone Therapy  (American College of Obstetricians and Gynecologists) 
Hormone Therapy Raises Risk of Breast Cancer Recurrence  (American Cancer Society) 
Testosterone Therapy: The Answer for Aging Men?  (Mayo Foundation for Medical Education and Research)

Additional Online Resources outside MUSCHealth.com:
(MedlinePlus, is an excellent source of health information from the world's largest medical library, the National Library of Medicine. Health professionals and consumers alike can depend on it for information that is authoritative and up to date. MedlinePlus has extensive information from the National Institutes of Health and other trusted sources on over 650 diseases and conditions.)
 

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