The Natural Connection

Since childhood, I have been fascinated by the penny arcade games at the County Fair. My particular favorite for many years was the one where little ducks marched along nose to tail, all in a line, until you “shot” a few with a pop gun. Then they dove under water, only to resurface and march back again in the opposite direction, but with the eventual same result. I always wondered why some duck just didn’t wise up and realize that marching mindlessly along with the others would bring him nothing but trouble, and take off in his own direction.  

Medical experts sometimes remind me of those little plastic arcade ducks. Seems like they often get marching off one after the other, all in the same direction, when perhaps it would be smarter for one to duck under water and take another path. The last decade of expert recommendations on Hormone Replacement Therapy (HRT) for menopausal women is a good example. 

In 1992, after analysis of a series of observational studies indicating a possible cardiac benefit of estrogen replacement to post-menopausal women, three major organizations-- The American College of Physicians, the American College of Family Medicine, and the US Preventive Services Task Force-- published guidelines encouraging physicians to prescribe hormone replacement to virtually all American women over the age of fifty.  

The guidelines were quite emphatic in recommending that all women, except those at the highest risk for breast cancer, “deserved a trial of hormone replacement therapy”. Physicians who quietly questioned the need or wisdom of mass-medication for a natural life transition were vilified in the medical press, and labeled “irresponsible” or worse, by medical editors. 

Doctors, wanting to do what was considered best for their patients, marched along in orderly rows to write 45 million prescriptions for estrogen for American women in 2001 alone. Meanwhile, patients tried to follow their doctors’ advice. Premarin, a popular hormone made from pregnant mare’s urine, is still the nation’s third best selling drug. 

Besides the proposed benefits to the heart, estrogen was promoted as a bone-builder, mood enhancer, brain-saver, and cancer preventive, among other things. However, very little solid research was conducted to support the claims of the benefits of HRT, or its risks, until recently. 

An observational study is one that is done by merely “observing” the health characteristics of a given group of patients. It was observed that women who used estrogen therapy after menopause seemed healthier. But it was never questioned whether it was the hormone therapy, or some other factor perhaps, that accounted for the difference in health. It is known that women who use HRT, in the words of one researcher, tend to be “healthier, wealthier, and have a better health profile” to begin with. 

A randomized, controlled study is a much more accurate way to determine the benefit or risk of a drug. In these studies, patients are randomized to receive either the study drug, or often a placebo (“sugar pill”). Over the past few years, a series of randomized, controlled studies on the effects of estrogen replacement revealed some surprising data. 

Contrary to previous opinion, women who receive HRT do not appear to gain any positive cardiac benefit. In fact, in a large study called HERS, financed by the manufacturers of Premarin in 1998, women with heart disease who took HRT actually had more blood clots, and a transient increase in heart attacks over controls. Because no randomized trial of HRT has ever shown a reduced risk of heart attacks or other serious cardiac events in any group of postmenopausal women, The American Heart Association in 2001 recommended against prescribing HRT to prevent cardiovascular disease.  

While chronic estrogen use is known to help improve bone density, and may help decrease the incidence of fractures, long term use is associated with the increase in breast cancer, especially when estrogen is used in combination with progesterone as is necessary in women who have not had a hysterectomy. There are multiple other medications now on the market that a woman can use to safely protect her bones that do not have this associated risk of breast cancer.  

Women who use HRT actually report decreased quality of life and increased depression, compared to those who do not take hormones, unless they are also experiencing hot flashes, according to a study recently published in JAMA. Because short term use of HRT (less than five years), has not been shown to increase the incidence of breast cancer, brief use of estrogen for control of symptoms appears to be safe. 

And although estrogen is frequently prescribed for symptoms of urinary incontinence, it’s use does not seem to change the disease, and may even make it worse. Claims that HRT decreases colon cancer or Alzheimer’s Disease are similarly unproven to date. 

This increased evidence regarding the risks of HRT has convinced some of the previously most ardent supporters of HRT to duck under cover and head in the opposite direction. The lead author of the 1992 Guidelines, Deborah Grady MD, MPH from the University of California at San Francisco now says, “ Several years ago, I thought that preventive hormone therapy should be prescribed to most postmenopausal women, except those at high risk of breast cancer…Recent evidence that HRT does not reduce risk of Coronary Heart Disease, and the availability of other effective treatments for prevention of osteoporotic fractures have drastically altered my approach, as well as that of others. The very disturbing possibility is that those observational studies were just all wrong.”  

A recent symposium sponsored by the Office of Women’s Health research at the NIH resulted in the development of an International Position Paper on Women’s Health and Menopause, which will be published in book form in June 2002. Early information indicates that the new guidelines will radically differ from those published a decade ago. There will be more emphasis on the use of diet and lifestyle changes during the menopause, rather than prescription HRT, for instance. “This is a good time for those who have believed in estrogen’s benefit to take a second look”, says UCSF physician Dr. Steven Cummings, “and a time for women who are taking estrogen to ask themselves and their doctors why”. 

Whether the new International Guideline turns out to be a positive change and improvement in the medical care of the millions of postmenopausal women in our country, or just another about-face of plastic ducks in the medical penny arcade, only time will tell. Meanwhile, cotton candy, anyone?  

For further information on Women's Health, write to The Natural Connection, c/o Dr. Pauline Bellecci, PO BOX 777, Waycross, GA 31501 or visit our on-line Patient Education library at www.swampdocs.com

©2000-2003 Pauline M. Bellecci, MD