Important Facts

Of Hormones and Ford Explorers

6 June 2003

Imagine, if you would, the following scenario. The Ford Explorer has been recalled by the manufacturer due to a rear-wheel defect. This is big news in all the media outlets. You are not concerned because you drive a Chrysler Newport.

But, to your surprise, you receive a call three days later from your family doctor telling you that you should immediately stop driving your car because the problem with the Explorer means that all cars are dangerous to your health and well-being. Sounds ridiculous, but, in fact, it's happening all over America with respect to hormone replacement therapy (HRT) since the publication of the Women's Health Initiative (WHI) study last summer and again over the past month.

What you have heard is that the WHI study, a very large medical study, has demonstrated that HRT not only doesn't help protect postmenopausal women from heart disease, rather it increases their risks of heart disease, stroke, breast cancer, and Alzheimer's Disease, and, furthermore, doesn't do anything for their quality of life. Primary-care healthcare providers have told their patients to "throw away your hormones" regardless of which hormones they were on or who put them on the therapy. The problem with all of this, and the reason for the Explorer analogy, is that the WHI study was not a study of HRT. It was a study of a specific product called Prempro, a product that combines horse-derived estrogen and an extremely potent progestin called MPA in a single pill. A product that is totally different from the 40-plus other presently available HRT products in the US. Those of us who specialize in peri and postmenopausal care have been well aware over the past 10 to 15 years that MPA, the synthetic progestin used in Prempro, is too strong and can act to reduce many of the benefits estrogens may provide. This is the principle reason so many other natural and synthetic progestins have been developed to allow avoidance of MPA use in HRT. These newer and safer progestins have been widely used in Europe, where they use little, if any, MPA, and have been used here in the US by practitioners who understand the differences and how to make most optimum use of these options. It is thoroughly inappropriate to extend the WHI study results to any other kind of HRT.

While, over the years, I have discouraged the use of Prempro by healthcare providers and patients alike, a few words about the study itself are in order. The wrong combination, wrong population and wrong continuation make this study less valid than it has been presented.

1. There are far better and safer combinations of HRT available, including patches, gels, creams, vaginal rings or tablets as well as different oral preparations and combinations that are plant based and often bio-identical to the naturally occurring hormones.
2. Almost 70% of the study's participants were between the ages of 60 and 79. Prevention needs to start much earlier, i.e. the 50's.
3. Almost half of the women taking the Prempro stopped taking the drug during the study, yet their results still appeared in the drug arm of the study, significantly altering the validity of the study. They stopped the Prempro because if you give the same HRT to 8000 women without tailoring therapy to their individual needs and concerns, when they complain of bleeding, bloating, weight gain and headaches and there is no ability to alter their therapy due to the study, they will stop the therapy.

Recently, three or four "new studies" have been published also showing "harm" or "no benefit" from HRT. These are not new studies. They are more information from this same WHI study with the problems listed above. Of special interest in one of these recent reports is the finding that HRT does not increase quality of life (QOL) in postmenopausal women. Most of my patients have found this conclusion amusing or totally ridiculous. While only 12% of the women in the study had any menopausal symptoms (which were relieved by the HRT), the other 88% who had no symptoms were frequently annoyed by the side effects mentioned above, hence the supposed decrease in QOL. Many of my patients repeat time and again the incredible difference they feel on their HRT in the areas of energy, sleep, sexuality, skin and genital health, mental focus, word finding and memory to name but a few.

If the WHI study had come out 25 years ago, I would have been the first to agree that it was an HRT study, because at that time the only available HRT was Premarin and Provera (MPA), later combined into Prempro. Today, however, with a large number of options available to allow proper individualization of therapy, it remains thoroughly inappropriate to call the WHI study an "HRT study" and thus throw out the baby with the bathwater.

Some important points:

1. Every medical study is but one piece of a puzzle. Some of these puzzles take 25 pieces, some 75 pieces. Only the completed puzzle gives the final answer. Unfortunately, the media presents each study as a completed puzzle, which can be totally confusing and contradictory to the public. There is a large body of data on the benefits of appropriate estrogen, progesterone and other hormone therapy combinations. All these studies are part of this enlarging puzzle as we often see in the field of medicine.
2. Menopause is not a disease; it is a natural transition in a women's lifetime. We ought not be treating it with medicines, and we're not. What we are treating is a very unnatural phenomenon; the extension of life expectancy for women in this country to the mid-eighties. We did not naturally evolve this phenomenon. It has taken place over the past 50 to 75 years due to better nutrition, water supply, sewage disposal, and a myriad of medical advances including antibiotics, anti-hypertensive and cholesterol-lowering drugs, blood replacement, safer anesthesia and surgery, etc. Many women are suddenly living much longer and will spend anywhere from 30 to 50 years beyond their menopause, something they rarely did before. Estrogens are normally involved in so many organ systems other than the reproductive tract that this loss can have an important impact throughout the body. At my graduation from medical school, the commencement speaker cautioned, "We've taught you how to treat disease. We should have taught you how to prevent it." That is what we are trying to accomplish.
3. The general practitioner, internist, or primary care physician is not the appropriate healthcare provider to consult with to individualize both the decision whether or not to go on, stay on or come off of HRT, as well as the actual therapy decided upon. They cover so many areas of medical care that they certainly can't be expected to be current in such a vast area of growing and changing information and options. Even many general Ob-Gyn's find it difficult to cover this topic, and managed care makes it difficult for them to spend the appropriate consultation time needed. Seek out a gynecologist, physician or nurse practitioner who specializes in and has the time to spend with peri and postmenopausal patients. This is where individualization thrives.
4. 4) Finally, everyone and their uncle have jumped on the "natural" bandwagon. This or that herb or special vitamin combination will "cure all your menopausal problems now that HRT is bad for you". The multi-billion dollar herbal industry in this country is totally unregulated. What's on the label is not necessarily in the jar, and what's in the jar is not necessarily on the label. We are finally beginning to see studies on herbal and other alternative therapies, many of which have shown no difference between herb and placebo effect, but we've got a long way to go and many more studies to do. Herbs are drugs and should be treated as such with appropriate caution and care.

Alan M. Altman MD