Menopause - No Flashy Answers

Menopause - No Flashy Answers

Menopause - No Flashy Answers

It's nearly impossible to make a decision about Hormone Replacement Therapy on your own. The data continues to conflict and so much of the decision is based on individual circumstances

   

Menopause - No Flashy Answers

image by: Bill Branson

For decades, women were told that hormone replacement therapy (HRT), usually a combination of estrogen and progestin, was beneficial during and after menopause. In 2002, millions of women worldwide and approximately 38% of menopausal women in the U.S., about 19 million, were taking some type of hormone replacement therapy.1

That is, until July of 2002 when some very disturbing news broke. The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) announced that they had prematurely stopped the Women's Health Initiative, a major clinical trial analyzing the risks and benefits of combined estrogen and progestin in healthy menopausal women.2

More specifically, study leaders had determined that participants in the HRT component of the study were experiencing a greater risk of breast cancer, heart disease and stroke or, in other words, the health risks of taking hormone replacements were now known to outweigh the benefits. Shortly thereafter the Million Women Study in the UK also published results indicating that "the current use of HRT is associated with an increased risk of incident and fatal breast cancer".3

These findings created pandemonium for women and doctors.  Women felt betrayed by the medical community, misled into accepting treatments that placed them at risk.  Doctors were conflicted.  They knew that HRT helped with menopausal symptoms and believed that it also helped to reduce the effects of osteoporosis and the risk of heart disease.  Was it really so fraught with risk?  Medical discussion around the world immediately focused on how to interpret the results of the studies and how to change medical practice patterns based on the new information.  Women did not wait.  Within a short time, 65% of women stopped participating in hormone replacement therapy.4

That was 2002. Since then, there has been a lot of analysis of those study results as well as additional research and there are a few more answers  However, HRT continues to be controversial and its appropriate use is complicated by menopause's unpredictable and protracted nature.  

Here's a quick roadmap of the menopausal journey; you'll need it to follow the controversy over HRT.

Women in their 30's begin to experience a drop in hormone levels.  Although changes related to reduced hormone levels may be too subtle to notice for most women, some women experience PMS, anxiety, fibrocystic breasts, depression and fatigue.

Women in their 40's experience more dramatic fluctuations in hormone levels.  These fluctuations can cause PMS, hot flashes, sleep disturbances, fatigue, intermittent fibroids and night sweats.  This is typically considered the time of "perimenopause." Perimenopause can precede menopause by as much as a decade.  The characteristics of a woman's menstrual cycle often changes at this time as well, including changes in the length and frequency of bleeding and changes in bleeding pattern.  Periods often become more irregular and heavier.

Women in their 50's continue to experience these symptoms as they move towards menopause.  The average U.S. woman experiences menopause at age 51, but the timing varies between age 41 and age 55.  A woman is not considered to have gone through menopause until she has not had period for one year.  Postmenopausal women can continue to experience menopausal symptoms. The reduction in hormone levels that takes place throughout this period affects bone density, heart health and sexual activity.

HRT is used to supplement the body with either estrogen alone or estrogen and progesterone in combination during and after menopause.  As menopause nears, the ovaries slow the production of these hormones.  Lowered or fluctuating estrogen levels create symptoms such as hot flashes and medical conditions such as osteoporosis.  HRT augments hormonal levels during the periods of fluctuation and restores hormone levels after menopause to lessen symptoms and reduce other negative health effects. Progesterone is used along with estrogen in women who still have their uterus in order to reduce the risk of endometrial cancer. 

So, what was this landmark study that created confusion, controversy and dramatic changes in HRT?

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health launched the Women's Health Initiative (WHI) study in 1991. The study involved 161,808 generally healthy postmenopausal women.  These clinical trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer.

On July 9, 2002, NHLBI announced premature termination of one component of the WHI.  This component was designed to assess risks and benefits of hormone therapy (HT) combining estrogen with progestin in healthy postmenopausal women.  The WHI data and safety monitoring board concluded that despite noteworthy benefits, the risks of this combined HRT outweighed the benefits in this study population. The board based their decision on preliminary results, which found that for every 10,000 women taking estrogen plus progestin pills (HRT):5

  • 38 developed breast cancer each year compared to 30 breast cancers for every 10,000 women taking placebo pills each year.
  • 37 had a heart attack compared to 30 out of every 10,000 women taking placebo pills.
  • 29 had a stroke each year, compared to 21 out of every 10,000 women taking placebo pills.
  • 34 had blood clots in the lungs or legs, compared to 16 women out of every 10,000 women taking placebo pills.

These results led to the conclusion that HRT was unsafe to use other than for short-term relief of menopausal symptoms. This was the bombshell news that stopped women and their doctors in their tracks.  From that point forward, there have been further studies, further analysis and continuing debate about hormone replacement therapy, but since then HRT has never been the same.

However, there were problems with the study.

In general, discussion about study design problems are discussed and debated in medical journals; most consumers just want to know how the results affect them.  But, given the enormous reaction to this study, it's useful to look briefly at some of the issues with the study that prompted the strong reactions.6 

The numbers problem- The study shows increased risks, sometimes increased by dramatic numbers such as 33%...but the actual number of lives affected is very small.  For example, according to the WHI, without hormone therapy, three of every 1,200 women aged 55 to 59 will develop breast cancer this year.  With hormone therapy, four out of 1,200 will develop breast cancer this year.  It's a 33% increase, but the absolute risk is pretty minimal (though no less devastating if you are the unlucky additional woman who is affected). To put that risk into perspective, consider that other behaviors like drinking two glasses of wine a night  also increase breast cancer risk by a similar amount.

The age problem - When a person first starts hormone replacement therapy, her risk of blood clots increases slightly.  In healthy women who are in their 50s, this increase is very unlikely to cause problems.  But women in their 60s may be more likely to already have early heart disease or hardening of the arteries, making the risk of blood clots more serious.  The average age of the women participating in the Women's Health Initiative trial was 63, which means that many of the women may have already developed heart disease that was not related to the hormone replacement therapy.

While the researchers in the WHI study felt that it was ethically necessary to stop the aspect of the study that seemed to be creating greater risk, further analysis suggested that the risks and the concerns were less alarming when placed in the proper perspective. The WHI study did in fact continue to collect data with voluntary participation so a lot more information about the effects of HRT has been generated. Plus, many other studies have been conducted during the intervening years as well.

Here is some of the newer thinking 7-12 

Timing - Women under 60 years old and within ten years of menopause can benefit from HRT with much less risk than older women who are more than ten years away from menopause.

Heart Disease - If HRT is initiated within ten years of menopause or in women under 60, it may help reduce the incidence of coronary heart disease.  Estrogen therapy alone delivers better results than combined estrogen and progestin (but women who have not had a hysterectomy need the progestin as well).

Memory - The 2004 WHIMS (Women's Health Initiative Memory Study) study showed that initiating HRT in women over 65 had a negative effect on memory, especially if they were already experiencing a decline. Another study looking at younger women, between the ages of 50 and 63, showed that those on hormone therapy had a lower risk of Alzheimer's disease than those that were not.

Blood Clotting/Stroke - The WHI found an increased risk of blood clotting in women taking HRT.  Further studies suggest that the risk can be reduced or minimized by changing the type of hormone used and the method of delivery.  Transdermal patches seem to eliminate the risk of clotting.

Breast Cancer -  Results from WHI showed that women who used combined HRT on a daily basis had a higher risk of having breast cancer detected at a more advanced stage and were more likely to have breast changes seen on mammograms.  However, most of the increased risk of breast cancer from combined HRT is thought to be due to the progestin. Women who have had hysterectomies should take ERT to avoid that risk due to progestin exposure. Studies have shown a very slight increase in breast cancer among ERT users. In general, these risks apply only to current and recent users. A woman's breast cancer risk is thought to decrease after she stops ERT/HRT and return to that of the general population within 3 years of stopping

Osteoporosis - Currently, HRT is regarded as the acceptable treatment for osteoporosis only after all other treatments have been considered and when all the risks and benefits are carefully explained to the patient.  Women who decide to take HRT to relieve menopausal symptoms should use the lowest effective dose for the shortest possible time.

Cholesterol- Studies continue to indicate that HRT increases good cholesterol while reducing triglycerides.

OK, what about alternative HRT? At this point there are basically three, bio-identical hormones, plant based therapies and anti-depressants.

Bio-identical hormones are medications that contain hormones that are an exact chemical match to those made naturally by humans. They are not found in this form in nature but are made, or synthesized, from a plant chemical extracted from yams and soy. This type of hormone differs from the most common prescription hormone preparations such as Premarin, which is made from the urine of pregnant horses.13

According to the Harvard Health Letter, the body cannot distinguish bio-identical hormones from the ones your ovaries produce.  On a blood test, your total estradiol reflects the bio-identical estradiol you have taken as well as the estradiol your body makes.  On the other hand, Premarin is metabolized into various forms of estrogen that are not measured by standard laboratory tests.

Proponents of bio-identical hormones say that one advantage of bio-identical estrogen over Premarin is that estrogen levels can be monitored more precisely and treatment individualized accordingly.  Skeptics counter that it doesn't matter because no one knows exactly what hormone levels to aim for, and symptoms, not levels, should be treated and monitored.

Until recently, bio-identical hormones were usually provided by compounding pharmacies, pharmacies that create customized ingredient blends to meet an individual's specific needs that cannot be standardized.  Now that there are some companies providing standardized versions of bio-identicals, there is less concern about accuracy and purity.

An American College of Obstetrics and Gynecology (ACOG) committee reviewed the scientific evidence on compounded bio-identical hormone therapy in 2005.  The committee concluded that there was no scientific evidence to support claims of increased efficacy or safety for compounded estrogen or progesterone regimens.  The North American Menopause Society (NAMS) and the Endocrine Society have issued similar statements. But, there are still many doctors and users (including several notable celebrities) who swear by the value of bio-identical hormone therapy.14

Plant-based Therapies - a number of natural supplements have been touted as helping with menopausal symptoms.  These therapies do not receive the same kind of rigorous testing as proprietary treatments do so it's difficult to be certain about effectiveness.  To the extent that supplements have been tested, most of them have been found wanting.  Dong Quai, red clover, evening primrose oil, gingko, ginseng, St. John's Wort, soy and wild yams have not proven effective when tested.

Black Cohosh was deemed ineffective for severe menopausal symptoms but effective for mild symptoms in a 2008 study.  A 2010 study found Black Cohosh to have reduced hot flashes by 26%, though this supplement has also been linked to liver damage.15-17

Anti-depressants - studies have shown that certain antidepressants help relieve hot flashes in the majority of women treated.18

In a randomized, controlled trial of paroxetine (Paxil) for postmenopausal women having at least 14 bothersome hot flashes a week, researchers report that about 60% of women had at least a 50% reduction in the severity and number of hot flashes a day after 6 weeks of treatment.

Venlafaxine (Effexor) lowers the number and severity of hot flashes for most women.  This includes women with severe hot flashes from tamoxifen, a cancer-fighting hormone drug.  In several studies, venlafaxine was most effective for hot flashes when used at a lower dose than is normal for treating depression.

Using antidepressants to treat menopause symptoms is considered an off-label use for these medicines. The U.S. Food and Drug Administration (FDA) has issued an advisory on antidepressant medicines and the risk of suicide.  However, the FDA does not recommend that people stop using these medicines.  Instead, a person taking antidepressants should be watched for warning signs of suicide.  

Here are some of the pros and cons comparing Conventional to Alternative HRT

Hormone Replacement Therapy Pros Cons
Menopause Excellent symptom control; best treatment available for menopausal disorders Slight increase in risk of breast cancer, blood clots/strokes, heart disease, depending on age, length of therapy and age when initiated
Osteoporosis Very effective in reducing the damage from osteoporosis Other risk factors may outweigh benefits, given alternative treatments
Heart disease Can lower cholesterol Other risk factors may outweigh benefits, given alternative treatments

 

Alternative therapies for menopause symptoms Pros Cons
Bio-identical hormones Acts exactly like the hormones the body produces Can be non-standardized; so far, research suggests that they are no more effective nor do they reduce risk
Anti-depressants Can be effective against symptoms side effects including increased risk for suicide
Plant therapies Natural, available without a prescription, may have fewer side effects Most have not proven effective in studies to date

 

If you are still confused, you are in good company

There is still a great deal of controversy over the use of HRT and so much of the decision to use HRT is based on individual circumstances.

In general, doctors are of the opinion that there is still a legitimate role for HRT in the treatment of menopausal symptoms and there is also agreement that women should be on the lowest dose of HRT that is effective for the shortest period of time. Similarly, alternative therapies do not provide straightforward solutions. The right treatment for you depends on several factors including:

  • The severity of your menopausal symptoms. The more severe and life disrupting, the more reasonable it is to assume some additional risk in order to function better day to day.
  • Your age at menopause and whether you have had a hysterectomy or not.

HRT is not recommended for the treatment of osteoporosis unless a woman cannot use any other treatment plus HRT is not recommended to reduce the risk of heart disease because there are effective, non-risk alternatives.19-21  

The Bottom Line

It's nearly impossible to make a decision about HRT on your own. If you are convinced that HRT is for you, then your best strategy is to sit down with your doctor or health care provider and review your personal situation. Together, you can make a decision that weighs the benefits of HRT and the potential risks. In the long run going natural and aging healthy, like our ancestors, may be the best way to go. When it comes to menopause there are no 'flashy' or simple answers!

Published November 14, 2011, updated July 22, 2012


References

  1. Dodge J, Raging Hormones, The Legal Obstacles and Policy Ramifications to Allowing Medical Monitoring Remedies In Hormone Replacement Therapy Suits, Wisconsin Law Journal, Fall 2006
  2. NHLBI Stops Trial of Estrogen Plus Progestin Due to Increased Breast Cancer Risk, Lack of Overall Benefit, NIH News Release, National Heart Lung and Blood Institute, July 2002 
  3. Breast cancer and hormone replacement therapy in the Million Women Study, Million Women Study Collaborators, Lancet 2003; 362:419-427427
  4. Griffin M, HRT: Where are we now? WebMD, Dec 4, 2009 
  5. Questions and Answers about Estrogen-Plus-Progestin Hormone Therapy, National Heart Lung and Blood Institute 
  6. Tan et al, What can we learn from the design faults in the Women's Health Initiative randomized trial? Bulletin of the NYU Hospital for Joint Diseases 2009;67(2):2269
  7. Parvez T, The Menopause and Hormone Replacement, JK Practitioner, Vol.12, No. 1, January-March 2005
  8. Espaland M, Association between Reported Alcohol Intake and Cognition: Results from the Women's Health Initiative Memory Study, American Journal of Epidemiology Volume161, Issue3 Pp. 228-238.
  9. Ulzi, Study finds no blood clot risk with hormone patch, Zimbio, January 2, 2011
  10. Menopausal Hormone Replacement Therapy and Cancer Risk, American Cancer Society
  11. Hormone Replacement Therapy, International Osteoporosis Foundation, January 2010
  12. Pick M, New findings on HRT since the Women's Health Initiative — an individual approach is best, Womentowomen.com
  13. What are bio-identical hormones?  Harvard Health Publications, August 2006
  14. Bioidentical Hormone Therapy, The North American Menopause Society
  15. Menopause and Alternative Therapy, WebMD
  16. Black Cohosh, National Center for Complementary and Alternative Medicine (NCCAM)
  17. Black Cohosh Research Summary, PubMed
  18. Antidepressants for Hot Flashes, WebMD
  19. Hormone therapy, MedlinePlus
  20. Women's Health Initiative Hormone Therapy Study, NIH
  21. Hormone Replacement Therapy and Cardio Vascular Diseases, Heart Consult, May 7 2010

Susan M. Brissette brings 30 years of experience in healthcare, ranging from positions as Chief Executive Officer and Chief Operating Officer in the acute care hospital setting to Senior Executive for a major national healthcare management company. Ms. Brissette holds a BS in Biology from Northeastern University and an MS in Health Policy & Management from the Harvard School of Public Health. She has lectured on healthcare management at the University of Massachusetts, developed a healthcare delivery system for a mining company in Cajamarca, Peru, and recently led the Afghanistan Public Health Redevelopment Task Force for the Washington Harvard Alumni Group. She has consulted on healthcare projects in Poland, Romania, Israel, Kuwait, Peru, Canada, and Mexico. She now owns and operates SB Cass Associates, a healthcare consulting firm located in upstate New York. Ms. Brissette's consulting practice handles client projects ranging from business plan development for clinics, assisted living facilities, and clinical research groups to the development of market research reports for the pharmaceutical and biotechnology industries. She has written dozens of healthcare articles published on the internet and in national professional and consumer journals. She has also authored or edited online courses on HIPAA compliance, corporate security, childhood obesity, and business ethics.
Susan Brissette can be reached at SB Cass Associates [email protected]

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