You may recall in 2002 when news that the WHI  study was stopped  due to unexpected increased incidence of  heart attacks and stroke,  media coverage caused multitudes of women to abandon their hormone therapy cold-turkey.    Lots of women did not understand that the risk may not have actually applied to them personally.   It is a pretty complicated issue to be covered in a headline.   Now new data from the Women’s Health Initiative (WHI) regarding estrogen plus progestin hormone therapy and breast cancer published in Journal of American Medical Association (JAMA) on 10/20/10 (Chlebowski RT, et al) has experts buzzing.

 The study:  ”Estrogen Plus Progestin and Breast Cancer Incidence and Mortality in Postmenopausal Women“ is a further analysis of the Women’s Health Initiative randomized study of postmenopausal women taking conjugated equine estrogen plus medroxyprogesterone acetate, conjugated equine estrogen  alone or placebo (sugar pill).    After a follow-up of 11 years,  it is found that  the women taking estrogen with progestin had increase risk of  invasive breast cancer compared with women taking placebo.   Even more important was the evidence that women on the combined hormones had a  higher risk of dying from the disease. Ok, I know this is scary, but before you trash your hormones…

This is what you need to consider:

•  A 2004 report published in JAMA on the estrogen-alone component of the WHI found no increase in breast cancer risk among women with hysterectomy over an average of 7 years of randomized treatment.  
• The absolute risk  amounts to 2.6 deaths from breast cancer (in the combined hormone group) vs 1.3 deaths (in the placebo group) per 10,000 women per year.
• While the absolute risk of breast cancer death  is small, it is  increased for women taking combined estrogen plus daily progestin.
• Experts continue to recommend hormone therapy for menopause symptoms only, using the lowest dose for the shortest period of time.

This is what you should do:   

• If you have had a hysterectomy and are on estrogen only, don’t sweat it.
• Weigh the risks and benefits. Can you manage your symptoms with life style changes?   Exercise, weight, stress and alcohol management can make a huge difference.  It takes more committment than taking a pill but the rewards are worthwhile.   
• Consider a trial off your hormones every 6-12 months. Things change. Maybe your symptoms have too.
• Lower your dose.  Use the lowest effective dose, for the shortest period of time.
• If  life is so much better with hormones that you decide to continue, there are other ways you can reduce your risks.  To repeat: Exercise, weight, stress and alcohol management can make a huge difference. 

Remember that if you have a uterus, taking estrogen alone can cause cancer of the lining of the uterus.  Progestins are needed to prevent that from happening.  Good for the uterus, bad for the breasts.  So researchers continue their quest for answers to the following questions:

• Do the same risks for breast cancer apply for different kinds of progestins such as micronized progesterone?
• Can risk safely be reduced by reducing exposure to progestins by taking them intermittently,  like every 3 months instead of daily?

Stay tuned, talk to your health care provider and keep asking your own questions.

written by Deborah McBain, CNM MSN

These are the latest recommendations from  the National Endocrine Society:   The following was taken from a recent Medscape report.  The bottom line is that for certain groups of women, namely healthy women younger than 60, benefits of hormone therapy may very well outweigh the risks.   And so the pendulum begins to swing again…

June 29, 2010 — A new Endocrine Society scientific statement published in the July 2010 issue of the Journal of Clinical Endocrinology & Metabolism evaluates benefits and risks for postmenopausal hormone replacement therapy (HRT), now known as menopausal hormone therapy (MHT). The statement, entitled “Postmenopausal Hormone Therapy: An Endocrine Society Scientific Statement,” was also posted online ahead of print on June 21 and presented in San Diego, California, at ENDO 2010: The 92nd Annual Meeting & Expo.

Although MHT was in widespread use in the 1990s in hopes of lowering cardiovascular disease risk as well as to treat menopausal symptoms, the Women’s Health Initiative (WHI) Study showed that MHT was actually associated with an increased risk for heart disease, stroke, and breast cancer. However, recent evidence suggests that these risks may be affected by time after onset of menopause when MHT was started, a factor not considered in the WHI assessment of MHT safety and efficacy.

“Before the WHI, MHT was believed to prevent heart disease, fractures, memory loss and dementia in addition to relieving uncomfortable menopausal symptoms,” said task force chair Richard J. Santen, MD, professor of medicine at the University of Virginia in Charlottesville, in a news release. “Following the WHI reports of increased health risks associated with MHT, MHT use declined by 80%. New data however [show] that these health risks may not apply to all women using MHT, and that MHT may in fact be very beneficial to some women.”

Controversy regarding WHI’s applicability to women just entering menopause stems from the fact that the average age of participants was 63 years, and only 3.5% of the women were aged 50 to 54 years, which is the age range when women typically decide whether to start MHT. Furthermore, the WHI did not address menopausal symptom relief. Therefore, this scientific statement considered new data from later studies evaluating the effects of MHT in women aged 50 to 55 years.

Compared with women who begin MHT after age 60 years, those who begin MHT a short time after onset of menopause at ages 50 to 59 years appear to benefit. According to recent evidence, women in the short-time group using MHT for 5 years had a 30% to 40% reduction in mortality risk and no increased cardiovascular disease risk. In addition, they had a 90% decrease in hot flashes, overactive bladder, or other menopausal symptoms.

“Some women in the short-time group still developed breast cancer but only with the combination of estrogen plus a progestogen, not with estrogen alone,” Dr. Santen said. “This may be due to the stimulation and uncovering of very small, undiagnosed breast cancers, rather than causing these cancers de novo.”

Conclusions Reached

Evaluation of the new data along with WHI evidence led the task force to reach the following conclusions, with level of evidence A:

• “Standard-dose” estrogen used with or without a progestogen is associated with marked reduction in frequency and severity of hot flashes. For many women, lower doses of estrogen are also effective.
• For symptoms of vaginal atrophy, very low doses of vaginal estradiol are effective.
• Symptoms of overactive bladder may be reduced by estrogen given vaginally or systemically.
• Vaginal estrogen is associated with lower rates of recurrent urinary tract infections.
• For women in late postmenopause, estrogen given with or without a progestogen is as effective as bisphosphonate therapy for preventing early postmenopausal bone loss and increasing bone mass.
• Use of estrogen alone and estrogen plus a progestogen is associated with a lower incidence of hip and vertebral fractures.
• Treatment with the selective estrogen receptor modulator raloxifene is associated with increased bone mineral density and lower rates of vertebral, but not hip, fractures.
• Use of MHT containing estrogen plus a progestogen is linked to a lower risk for colon cancer.
• Raloxifene is associated with a lower risk for breast cancer.
• Mammographic density is increased in women taking estrogen alone or with a progestogen.
• Sexual function is improved by physiologic amounts of transdermal testosterone, but not by dehydroepiandrosterone.
• Risk for venothrombotic episodes is approximately doubled in women using MHT, and this risk is multiplicative with baseline risk factors such as age, increased body mass index, thrombophilias, surgery, and immobilization.
• Use of raloxifene is associated with an increased incidence of venothrombotic episodes.
• Raloxifene is not associated with any increase in stroke risk.
• In older women with preexisting vascular disease, hormone use does not reduce stroke incidence.
• Although continuous estrogen plus a progestogen does not cause endometrial cancer, estrogen alone without a progestogen is associated with an increased incidence in endometrial cancer. 
• Risk for gallbladder disease is increased in women using estrogen alone or with a progestogen.
• MHT started after age 60 years does not improve memory.

“It is important to remember that most women considering MHT are between the ages of 50 and 55 and in this group MHT may have many benefits,” Dr. Santen concluded. “Physicians and their patients need to re-think the use of [MHT] based on data pertinent to the 50-55 year old and therapy should be individualized based on symptoms and underlying risks of breast cancer and heart disease.”

written by Deborah McBain, CNM MSN

In the most recent issue of Obstetrics & Gynecology, Jan Shifren and Isaac Schiff reviewed the literature about the use of hormone therapy (HT) in the menopause. The principle indication for hormone therapy remains the treatment of hot flushes and night sweats. Benefits generally outweigh the risks for healthy women with bothersome symptoms who elect to HT at the time of menopause. Although hormone therapy increases the risk of coronary heart disease, recent analyses confirm that this increased risk occurs primarily in older women and those a number of years beyond menopause. These findings do not support a role for HT in the prevention of heart disease but provide reassurance regarding the safety of use for hot flushes and night sweats in otherwise healthy women at this difficult time of life. An increased risk of breast cancer with extended use is another reason short-term  treatment is advised.

Hormone therapy prevents and treats osteoporosis but is rarely used solely for this indication. Estrogen is as effective as the other treatments for osteoporosis, so most women using HT for menopausal symptoms will not need additional treatment for their bones except for adequate calcium and vitamin D intake. If only vaginal symptoms are present, low-dose local estrogen therapy is preferred. There are creams, pills, and an estrogen ring which can be used to treat vaginal symptoms. They are all equally effective and which is used may be based on the woman’s preference. The risk profile for vaginal therapy is very different from systemic therapies, and there is no data that suggests a link between use of vaginal estrogen and the development of breast cancer or heart disease. There are safety studies up to 1 year showing no adverse endometrial effects, but studies of long-term effects of low-dose vaginal estrogen therapy are lacking. Therefore, women using vaginal estrogen therapy should report any vaginal bleeding and should undergo thorough evaluation.

Contraindications to HT use include breast or endometrial cancer, cardiovascular disease, history of blood clots, and active liver disease. Alternatives to HT is advised for women with or at increased risk for these conditions. The lowest effective estrogen dose should be used for the shortest duration necessary. Women should be informed of the potential benefits as well as the risks of all therapeutic options. Care should be individualized, based on a woman’s medical history, needs, and preferences.

written by Charla Blacker, MD

When a post menopausal woman comes in to my clinic complaining of vaginal dryness or pain with intercourse, I get excited.  No, I am not a sicko.  I am excited because I  know I can usually fix the problem and make a big difference in her quality of life.  That  is very satisfying.  Women are very grateful and I become their hero. So what is going on “down there”?  Well, I’ve got bad news and good news.

The bad news is that unless you are taking hormones, sooner or later it is going to happen.  It is called vaginal atrophy.  It means the skin and tissue in the vaginal area gets thinner and more fragile.  It is caused by the decrease in estrogen which occurs during menopause.   It can cause a feeling of dryness, itching and pain with sexual activity.  The good news is that there is help for this problem.

Even women who may not be appropriate candidates for systemic estrogen may be able to safely use local estrogen creams with good result.  There are many estrogen recepters in the vaginal area which means that a very little amount of estrogen is needed to get relief from symptoms.  Because the amount needed is small, the side effects and risks are small as well.  Often just a small pearl size amount of estrogen cream a couple times a week is all that is needed to maintain vaginal  tissue health.  Other factors which contribute to vaginal health are important to consider too. 

• It is important to check for and treat any vaginal infections like bacterial vaginosis, candida vaginitis (yeast) or even sexually transmitted diseases.  Treating these conditions may clear up symptoms.
•  Maintaining sexual activity of any kind helps  good blood flow and lubrication, keeping vaginal tissues healthy.  I call it the “ use it or lose it” factor.   Widows or divorced women who may enter a sexual relationship after many years of abstinence are often greatly dismayed with their discomfort and greatly relieved that there is effective help for their problem.
• Over- the- counter vaginal moisturizers and lubricants can offer a good starting point for help with dryness  or discomfort during intercourse.  There are many good products on the shelves of any drug store.  If after trying these, you still are not getting relief, see your physician or practitioner.  They may end up being your hero.

written by Deborah McBain, CNM MSN

One of the most important and controversal questions regarding hormone therapy (HT) for postmenopausal women is “ Does Hormone Therapy reduce or increase risk for heart disease?”  An important study is underway that may help answer this question.     The Kronos Early Estrogen Prevention Study- KEEPS is designed to address  whether or not  risk depends on the age of the woman when beginning HT.  It will also seek to answer whether  patches are any safer than pills.  Observational studies have long suggested that HT can offer protection against heart disease in some women.    In 2002 another very large and important study- (WHI) Women’s Health Initiative  not only failed to show protection but was stopped when participants showed increased incidents of heart attack and stroke.  The average age of women in WHI was 63 and 12 years past menopause with 20% over the age of 70.  KEEPS will attempt to address whether it was the older age of the WHI participants that made the difference by studying a younger group of women who more recently entered menopause.   The age range for KEEPS participants is 42-58 and 6 -36 months from onset of menopause.  KEEPS will also use different types of hormones than were used in WHI including bio-identical formulas.    Women and those of us who advise them are anxious to see  if  KEEPS can offer guidance when making decisions about HT.  Keep a watch out for results from this study as it comes out in the media.  The only way we can know the truth about what is safe and effective is through studies like this.  If you want to know more about this study, go to their web site www.keepstudy.org 

The importance of heart disease prevention for women can hardly be overemphasized. Coronary heart disease is the single greatest killer of American women, extinguishing more lives (approximately one death per minute) than the next seven leading causes of female mortality.  In other words heart disease accounts for 45% of deaths in women.  Compare this to breast cancer which causes 4% of deaths in women or all cancers which accounts for about 21%.  This is in sharp contrast to the perceptions of most women who see cancer,  particularly breast cancer as the biggest threat.  Women should be aware that far more is known about risk factors for heart disease than for cancer and in general, heart disease risk factors are more susceptible to interventions.

written by Deborah McBain, CNM MSN

I continue to get questions about and requests for bioidentical and compounded  hormones.  Follow this link for a nice summary of the evidence of safety and consenses among medical experts on this hot topic or read the article below.

http://www.medscape.com/viewarticle/711157?src=mp&spon=24&uac=127271SY. 

Question: Many patients ask me to prescribe compounded hormones, which they believe are safer. Some bring in saliva test results, and complicated charts and graphs with a suggested prescription attached. How should I respond?

Response from Susan J. Wysocki, RNC, NP, FAANP President and CEO, National Association of Nurse Practitioners in Women’s Health, Washington, DC

There is no evidence that so-called bioidentical hormones compounded in a pharmacy are safer than other hormone products. Furthermore, unlike insulin or thyroid hormone, female hormones cannot be titrated to customize a formula for an individual woman.^[1] Female hormone levels are very dynamic and no single measurement can capture what the hormone levels might be the next day or even later on the same day. In some circumstances, blood levels may help a clinician understand why a woman might not be responding to therapy.^[1] Overall, however, the woman herself is her own best “bioassay” for determining whether she needs hormonal therapy or when the dosage should be adjusted. Listening to her describe her menopausal symptoms and how well she has responded to therapy gives the clinician the best idea of what is going on in the target tissues.

In January of 2008 the FDA sent warnings to a number of large compounders of bioidentical hormone replacement therapy (BHRT) products, expressing concern about these manufacturers’ claims about the safety, effectiveness, and superiority of their products. In that same memo, the US Food and Drug Administration (FDA) warned about the use of estriol, a weak estrogen that has not been approved by the FDA for use in any product.^[2] Nevertheless, countless Websites, celebrities, other individuals, and pharmacies continue to make claims about BHRT. The FDA considers the term BHRT a marketing term.

Saliva tests are not a valid measure of female hormone levels. Female hormones that are found in saliva do not reflect what might be going on in the target tissues — including the brain, the bones, etc.^[2] It is in my opinion that these tests and products are a waste of money that would be better spent on something like a massage. Again, listening to a woman and what she says about her symptoms is the best way to “titrate” female hormones.

There are several issues about which clinicians should be aware. First of all, compounded products do not come with the class labeling that is mandated for any other menopausal hormone product, including warnings, black box, and other information. The absence of this label places on clinicians the burden of describing to the patient and documenting all these warnings. Second, there is no guarantee of the contents or purity of the compounded products. There is not enough oversight by the FDA to inspect all compounding pharmacies to determine if their products contain what they claim to contain.

Overall, there are no studies that demonstrate the superiority of any hormone product over another — compounded or not. The labels for all FDA- approved menopausal hormones are the same. There are some intriguing data from a case-controlled study of transdermal estrogens (not a compounded product) that suggest that there are fewer associated risks for blood clots even among women who are at higher risk for blood clots.^[3] The results are biologically plausible because of the lack of first-pass liver effect. However, as intriguing as these data are, I caution clinicians about making any absolute statements about the safety of transdermals. We need more data.

A wide variety of FDA-approved products is available to American women. These include oral forms, various transdermal forms, and a systemic vaginal ring. A wide range of doses is available. Many products fit the definition of bioidentical as used by the compounding pharmacies. Most of these products are covered by insurance. Compounding is very legitimate when a patient cannot take or tolerate FDA-approved medicines.

Ultimately, the clinician’s job is to help the menopausal woman ameliorate her symptoms, feel well, and have a good quality of life. The current range of FDA- approved options meets the needs of most women. Compounding claims have been a marketing ploy to seduce women and clinicians into taking or prescribing something for which the evidence of benefit is lacking.

written by Deborah McBain, CNM MSN

Test your knowledge of menopause.  Learn all this and more at one of our Menopause Support Circles.  Meetings are held in 4 locations and 4 dates this month. Facilitators are expert  Henry Ford Health System physicians and nurse-practitioners ready to answer your questions.

1.  You know you have reached menopause officially when:

A.  you have not had a menstrual period for 12 months.

B.  you can’t remember when you had your last menstrual period

C.  you’ve had it up to here with your husband, your kids, your boss, your life…

D.  you can’t remember…

2.  The cause of menopause is:

A. a natural decline in estrogen production by the ovaries

B. surgical removal of  the uterus

C. surgical removal of the brain

D. a natural shriveling of the brain

3.  Perimenopause is:

A. a time immediately before menopause  and when symptoms of menopause are occurring.

B. when symptoms are often more severe than actual menopause

C. characterized by heavy, light, short, long, irregular, regular, painless or painful  periods.

D.  Hell

4.  Hormone  therapy is:

A.  the only good treatment for menopause

B.  dangerous therapy for any woman unless “bioidentical”

C.  prescribed to keep the heart, bones and skin healthy.

D.  reasonably safe  for healthy women whose hot flashes are bothersome.

5.  Once menopause is reached it will last until:

A. you stop having hot flashes, about 6 years

B.  you die.

C. you go on hormone therapy.

D. Age 70

Answers:

1.  A, natural menopause is diagnosed retrospectively after no menstrual period for one year.  There is no reliable blood test for menopause.  2.  A,  surgical menopause occurs with removal of the ovaries.  3.  A is most correct.  B, C, D can be true for many women but some women just sail through these changes without a lot of problems.  4.  D,  see the other posts on this blog for more information on hormone therapy and alternatives. 5. B,  Menopause means menses ( periods) stop.  You never go back.  You will be there until you die.  That’s not a bad thing.  It’s a natural part of the life process.  Understanding the process of menopause will help you develop a strategy for coping with the physical changes and recommit to a healthy life style.  Although change can be challenging, it is also a time for reflection and re-evaluation.  Approach menopause with positive thinking.  Science has confirmed this can be helpful in reducing hot flashes, insomnia and pain.

written by Deborah McBain, CNM MSN

Much confusion exists among consumers about the term “bioidentical hormones”.  Strictly used this term simply means hormones which are identical to those produced by the body.  As a marketing term it often refers to custom-compounded hormones.  These are drugs made by a compounding pharmacist from a individualized prescription.  What is the truth about bioidenticals?  Are they better or safer?  This is what you should know.

1.  Many well-tested brand name products containing bioidentical hormones are approved and available commercially.  Cost for these approved products are often covered by prescription insurance plans.

2. All hormonal drugs contain filler ingredients to hold drugs together such as for pellets suppositories or tablets or provide a vehicle to administer such as gel, cream or liquid.  Custom-compounded hormones can vary greatly and are not tested for batch standardization, purity, safety or efficacy.  Commercially approved formulations have been tested and  are subject to regulation.

3.  FDA investigations have found some compounding pharmacies have made false and misleading claims about the safety and effectiveness of individually compounded hormones.

4.  Salivary or hair testing used to adjust custom hormone levels is not justified on any scientific basis.  This may be recommended by practitioners who advocate custom-compounding.  Beware of this because these same practitioners may profit monetarily from selling the services and products they are advocating.  Many health care systems have worked very hard to eliminate the influence of drug companies on the practitioners who prescribe the drugs.  You want drugs prescribed for your benefit, not for the benefit of the practitioner.

5.   There is no evidence that bioidentical hormones or custom-compounded drugs are safer or work better than other hormones or commercial drugs.   It is presumed they carry at least the same risks as any other hormones.  Custom-compounding has the advantage of offering doses, ingredients or routes of administration not available commercially but carries the risk of being untested and at greater cost to the consumer.  Be smart about where you get your information,  who is writing your prescriptions and mixing your drugs and who is apt to benefit the most.

written by Deborah McBain, CNM MSN