I’ve heard it said that you know you’re a veteran physician when you have seen the pendulum make a broad sweep and come back again. In my 30 years of practice this has certainly proven true with Hormonal Replacement Therapy (HRT).

When I started my medical practice in the early 1970’s, the belief was widely held by physicians that women should be placed on HRT. However, in the late 1970’s, studies began appearing in our medical journals reporting that women who still had their uterus and were taking estrogen alone had a significantly increased risk of developing uterine cancer. Physicians quickly responded by discontinuing estrogen prescriptions for all menopausal women. If they could not get their patients off the estrogen, they were forced to schedule annual endometrial biopsies to make certain their women patients were not developing early signs of uterine cancer. This obviously discouraged most physicians, including me, to stop recommending HRT for menopausal women.

In the early 1980’s, however, research results demonstrated that women who took HRT actually decreased their risk of developing osteoporosis. Along with these studies, other clinical studies were showing that if women took progestin (a synthetic progesterone) with estrogen, they could actually decrease the risk of developing uterine cancer. Estrogen builds up the tissue in the uterus and progestin tears it down. It was believed that only the so-called "unopposed" estrogen truly increased the risk of uterine cancer.

By prescribing a combination of estrogen and progestin for the menopausal woman, the risk of developing osteoporosis was decreased while the risk of uterine cancer was not increased. The pendulum again began swinging back to the side of the overwhelming majority of physicians recommending HRT.

By the 1990’s, many reports began to emerge claiming further health benefits of taking hormone replacement therapy. The most well-publicized benefits were apparent decreases in the risk of developing heart attacks and strokes. The FDA allowed these claims to be promoted because of what is known as "secondary findings." Although studies showed that HRT had a positive effect on the patient’s cholesterol levels, there were no studies that truly showed that these patients suffered fewer heart attacks. Women taking HRT experienced a drop in their total cholesterol and LDL or "bad" cholesterol, while at the same time they showed an increase in the HDL or "good" cholesterol. Since elevated cholesterol levels were a known risk of cardiovascular disease, this allowed the pharmaceutical companies to make the claim that "HRT reduces the risk of heart attacks and strokes." A short time later, studies further showed the promising effects of HRT also reducing the risk of developing Alzheimer’s dementia.

Again physicians began pushing the use of HRT so aggressively that it could be even considered malpractice if one did not recommend HRT to each and every patient entering menopause. It should come as no surprise then that Premarin became the number one "most prescribed medication" in the world. This is really impressive when you consider that Premarin is used only in women who had entered menopause.

Pharmaceutical companies had done a great job in convincing all of us the fountain of youth awaited those who took HRT. Physicians began treating menopause as a disease, requiring life-long medication. The public, were soon convinced this was the right thing to do and women all across the world faithfully began taking their HRT, simply trusting their physicians were right.

The Bubble Begins to Burst
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All seemed well until in the mid 1990’s several studies began appearing in main-line medical journals regarding a significant increased risk of developing breast cancer in patients who’d been taking HRT. This risk developed after patients had been on HRT for a period of greater than five years and was significantly higher the longer the patient had been taking HRT. Combining the results of several of these studies, researchers felt the risk of developing breast cancer was 40% greater in those women who’d been taking both estrogen and progestin for longer than 10 years.

I vividly recall a full-page add that appeared in the USA Today (the day following the release of the study just mentioned) showing all of the benefits of taking estrogen; however, there was absolutely no mention of the increased risk of breast cancer. Pharmaceutical representatives would come into my office trying to convince me that the benefits of HRT far outweighed the increased risk of breast cancer. Though in the minority, I was not convinced.

It was at this time I quit recommending HRT except for short-term use to aid patients through difficult times around menopause. I would mainly recommend natural hormones produced by compounding pharmacists, which were becoming popular. "Compounding" means the pharmacist would make hormones the "old fashioned way"—from scratch using natural estrogen and natural progesterone. Natural hormones are marketed independently of synthetic ones because drugs must be synthetic in order to gain approval through the FDA. Natural products cannot obtain a patent and therefore offers no financial incentive for pharmaceutical companies to produce them. (See my recommendations at the end of the newsletter.)

Unfortunately, medical journals continued to publish negative reports regarding HRT. There was increasing evidence that women taking HRT had an increased risk of developing ovarian cancer, gall bladder disease, blood clots, and pulmonary emoblism. Of course, the news was not always bad for HRT. Some evidence of decreased risk of colon cancer in patients taking HRT was also found. Studies continued to support the benefit of decreasing the risk of osteoporosis and physicians remained convinced of the associated decreased risk of developing a heart attack and stroke in their patients who were taking HRT.

The Women’s Health Initiative (WHI) and the Heart and Estrogen/progestin Replacement Study (HERS)
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Since the health benefits of HRT were still uncertain, the government funded two major studies to determine once and for all whether there was truly a decreased risk of cardiovascular disease in women who were taking HRT and whether the health benefits were significant enough to outweigh all risks. These two studies were known as the Women’s Health Initiative (WHI) and the Heart and Estrogen/progestin Replacement Study (HERS).

These studies brought immediate concern. During the first year of both studies, a marked increase became apparent in the number of heart attacks and strokes in the patients taking HRT compared to the control group of women who were taking nothing. Researchers originally believed this was just a fluke and that in time they would begin to see a decline in the actual risk of developing a cardiovascular event.

In the summer of 2002, the Journal of the American Medical Association (JAMA) reported the 5-year results of these two studies. Not only was there no evidence of decreased risk of heart attack or stroke in women taking HRT, there was strong evidence that it could possibly increase the risk of heart attack or stroke, especially in the first year of its use. These studies showed a decreased risk in the development of hip fractures and colon cancer. However, there was also an increased risk of invasive breast cancer, ovarian cancer, pulmonary embolism, heart attacks, and strokes.

Researchers concluded that the overall health risks of Hormone Replacement Therapy exceeded the benefits. The use of HRT was recommended by the researchers to be discontinued for the primary prevention of chronic diseases. In fact, these two clinical trials were terminated three years early because it was obviously placing patients in the HRT study group at too great of a risk.

Why Were Physicians so Surprised by these Results?
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For years physicians passionately recommended HRT to their patients believing in its far-reaching benefits. Since HRT actually decreases total cholesterol and LDL cholesterol, while at the same time increasing HDL cholesterol, this should decrease the patient’s risk of have a cardiovascular risk—right?

Unfortunately, this logic has been proven wrong in the case of HRT. It has been known for years (although just now becoming public knowledge) that heart disease is NOT a disease of cholesterol, but instead an inflammatory disease of the artery. In fact, over half of the patients who suffer heart attacks, have normal cholesterol levels. Studies indicate that checking for the amount of inflammation in the artery, especially in women, is a much better predictor of heart disease than is cholesterol. Inflammation in the arteries can be measured very effectively and inexpensively by doing a test called a highly-sensitive C-Reactive Protein (hsCRP). Although HRT lowers cholesterol levels, studies reveal that C- Reactive Protiens (CRP’s) increased by 80% in women who take hormone replacement therapy. This explains why women who begin taking HRT actually have an increased risk of a heart attack or stroke. Although HRT has a positive effect on cholesterol it also causes a significant increase in the inflammation of the arteries. Any benefit of decreasing cholesterol is easily overwhelmed by the increase in inflammation of one’s arteries.

Where Does This Leave You?
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There are two sides of the coin when it comes to hormone replacement therapy. The first is possible symptomatic relief of your menopausal symptoms. The second is the question of whether you should use HRT in order to prevent or reduce your risk of osteoporosis other degenerative diseases. The pendulum has now definitely switched back to the side of not using HRT for preventative measures for osteoporosis. The risks are undoubtedly greater than the benefits. However, on the flip side, careful use of hormonal replacement will still be recommended for those women trying to relieve menopausal symptoms. Still, you need to know safer and better choices are available.

Menopause is a difficult time in almost every woman’s life. In fact, I have found that the 3 to 4 years before a woman actually stops having her periods (called the perimenopausal time) is the most difficult time for some women. You see, your ovaries don’t just quit working one day. They actually "sputter" and the hormonal output can vacillate up and down significantly during this time, creating emotional instability, mental fogginess, hot flashes, night sweats, and vaginal dryness. Some women simply need hormonal support during this perimenopausal time and following actual menopause (ovarian failure). However, there is a safer approach than simply taking synthetic estrogens/progestins. I would like to detail a simple, logical approach, which can help the overwhelming majority of women during this most difficult time.

First Step: I find that many of my patients can get needed relief by taking phytoestrogens. Phytoestrogens occur naturally in our foods and in some herbs and have the ability to "bind an estrogen site" within the body without having any estrogen effect. Clinically, they have been shown to reduce many menopausal symptoms while at the same time proving very safe. Some of the most common and best-studied phytoestrogens are:

• Soy isoflavones
• Black Cohosh
• Licorice Root
• Dong Quai

You can get these from your local health food store and you should take the recommended amounts found on the bottles.

Second Step: If the phytoestrogens do not provide adequate relief, I recommend a trial of natural progesterone cream. Unlike the synthetic progestin drugs, natural progesterone has been shown to decrease breast cancer and while still possibly helping to preserve bone and possibly increase bone density. Many women do not ovulate during the last year or two before menopause. Because the follicle produced following ovulation is where the progesterone is produced, this means these women are not making any progesterone at this time. This may explain many of the perimenopausal symptoms. By using one of the natural progesterone creams (such as yam cream), many of these symptoms may be relieved. These natural progesterone creams are also available form your local health food store.

Third Step: I still have patients whose perimenopausal and menopausal symptoms are not relieved with steps one and two. In these cases, I recommend using a natural estrogen and natural progesterone cream or drops. These need to be prescribed by your physician and are produced by a compounding pharmacist. Many local pharmacists are actually starting to do this. Some of the larger facilities currently providing this service are:

• Belmar Lab—Lakeview, Colorado—800-525-9473
• Women’s Health Center—Madison, Wisconsin—800-279-5708
• Rx Compound Centre—Columbia, TN—931-388-399

What if I am Already Taking Estrogen/Progestin?
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Many women have long passed the menopausal time but are still taking synthetic estrogens and progestins with their doctor’s insistence that significant health benefits are being provided. For the past seven years, I have encouraged my patients to get off synthetic hormones and all hormones if possible. This is not necessarily an easy task, however. Premarin, for instance, is so potent that women can suffer dramatically if they stop taking it abruptly. I literally anticipate six months to slowly wean my patients off estrogen/progestin. I am now seeing many patients who want me to help them get off HRT because they know I’ve been able to help many of their friends.

Similarly, switching patients to natural estrogen and progesterone creams can sometimes be difficult. I have found that patients do well by slowly decreasing the dose of the synthetic HRT while at the same time adding natural Triest or Biest creams along with natural progesterone. If my patients seem to be transitioning smoothly, I then take them off synthetic HRT as quickly as possible.

During the past six months, I’ve been prescribing Estrogen/Progesterone /Testosterone drops (EPT drops) produced by the Rx Compound Centre listed above. These drops are absorbed amazingly well and are potent enough to compete with synthetic HRT. I have actually been able to simply switch my patients from their synthetic HRT to the EPT drops. Once a day, patients place 1 to 4 drops (dose varies depending on symptoms) on the inside of the forearm and then rub forearms together (much like ladies do when trying a new perfume). After the switch is made from synthetic HRT to EPT drops, women can slowly start decreasing the dose and eventually just quit. This approach has proven very effective in many of my patients. If you choose this treatment, you will need a physician who is willing to order these drops for you and then work with you until you have gradually come off HRT.

Conclusion:
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The verdict is in. The potential harm of hormone replacement therapy far outweighs its health benefits. If you are currently taking HRT, you need to come off as soon as possible. Most physicians are having trouble with this change and may resist your decision to quit. However, the evidence is conclusive. Once you are through your change of life, I feel strongly that you should discontinue all hormone therapy. I can’t state strongly enough: synthetic HRT should be avoided entirely due to the increased risk of a heart attack and stroke in the very first year of HRT. In addition, the increased risk of invasive breast cancer becomes stronger with each passing day you are on hormone replacement therapy.

• Writing Group for the Women’s Health Initiative Investigators. "Risks and Benefits of Estrogen Plus Progestin in Health Postmenopausal Women." New England Journal of Medicine, 288 (2002), 321-333.
• Lacey, J. V.; P. J. Mink, et al. "Menopausal Hormone Replacement Therapy and Risk of Ovarian Cancer." New England Journal of Medicine, 288 (2002), 334-341.
• Zhang, Y.; et al. "Bone mass and the risk of Breast Cancer among menopausal women." New England Journal of Medicine, 336 (1997): 611-617
• Steinberg, K. A., et al. "A meta-analysis of the effect of estrogen replacement therapy and the risk of breast cancer." JAMA 265 (1991): 1985-1990
• Grady, D., et al. for the HERS Research Group. "Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study Follow-up (HERS II)" JAMA 288 (2002): 49-57