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Volume 38, No. 2

Beyond Hormone Replacement Therapy: Now What? Healthy Options

In July 2002, the National Institutes of Health Women's Health Initiative announced that PremPro, a synthetic form of conventional/pharmaceutical hormone replacement therapy (HRT), increases the risk of breast cancer, blood clots, stroke, and heart attack. This news sent shock waves through the ranks of women of peri-menopausal and menopausal age because those who were taking these drugs had expected possible "minor" side effects - but certainly none of these devastating illnesses. In fact, the proponents of the commonly used forms of HRT had often assured women that these drugs actually prevented heart attacks and also atherosclerosis, which is one of the predisposing conditions for thrombotic stroke.

Many women abruptly stopped taking their PremPro or other pharmaceutical HRT. When they asked their physicians what they should do, most were offered no other alternatives. One of my patients had been on PremPro for close to 20 years and had had a stroke in her early 70s that left her weaker on one side and necessitated her walking with a walker. When she asked her then-physician if she should stop her PremPro, he answered: "Well, you've got to die of something!" Hopefully, not too many women were given similar advice. However, the many women, who were given the impression that their choices were limited to pharmaceutical HRT or no treatment at all, do deserve better advice. Since most of the other available options fall outside the experience and medical school training of most mainstream western physicians, these choices are often completely overlooked or trivialized.

Frequently a woman first comes to me with various versions of the following dilemma:

  • "I'm on PremPro but am afraid to stop. My hot flashes were so disabling." or
  • "My older sister suffered so terribly with depression and sleeplessness. I see myself following right behind her." etc.

    Then, first of all we look together for evidence of other medical issues that might be causing or exaggerating her symptoms. I carefully listen to which symptoms are most distressing, embarrassing, disruptive, and/or frightening to her. I question her thoroughly about her diet, lifestyle, sleep patterns, and family history, and try to ascertain which symptoms have highest priority for treatment and how fast she hopes to see results. A woman having embarrassing, drenching hot flashes every half-hour in an occupation with lots of public exposure, usually wants relief yesterday. But a woman who has much milder versions of the difficult symptoms experienced by her mother or sister, might be willing to take a more gradual, methodical approach. Of course, a woman, who has frequent, distressing symptoms, and for whom natural HRT in the form of TriEst and Progesterone (to be discussed later) seems warranted, will still benefit gradually from diet and lifestyle changes, nutritional supplements, etc. In addition, these measures will benefit other aspects of her health and will allow her to use less of the hormones and for a shorter duration.

First, I give my patients a sheet with the following headings for our discussion:

Lifestyle (food, exercise, etc.)
The first entry under "lifestyle," dietary changes that will improve peri- & menopausal symptoms includes: minimizing sugars and simple carbs, caffeine and alcohol; and maximizing water intake, whole grains, fruits and vegetables, olive oil, fish, lean meat, and soy products. An added advantage: these changes will also benefit the cardiovascular, digestive, and immune systems, for starters.

Lifestyle changes should also include moderate, enjoyable, sustainable exercise; attention to psycho-spiritual issues (meditation, yoga or tai chi, therapy, journaling, etc.), good sleep and bedtime routines, as well as the avoidance of caffeine, news programs, and/or telephone calls too late in the evening.

Nutritional Supplementation
The next step is nutritional supplements that positively impact menopausal symptoms. These include extra strength B-Complex, Vitamin E, essential fatty acids (flax seed or oil, fish oil, evening primrose oil or borage oil), magnesium, and trace minerals. Once again, these supplements will also have other benefits, including improved blood lipid levels, blood pressure, and bone density, to name a few. In addition, soy isoflavones can be taken in capsule or powder form.

Western/ "simple" herbs
I often refer to Western herbs as "simple herbs," because they are usually utilized singly and can be used successfully by many people without specialized training. These include vitex (i.e., chasteberry), alfalfa, red clover, wild yam, and my favorite: black cohosh, which can be used in standardized form (Remifemin) or in a variety of other preparations (drops, teas, capsules). With products such as these, a woman should simply follow the instructions on the label for an average dose and gradually adjust up or down as symptoms warrant.

Oriental Medicine/Chinese herbs
Oriental Medicine, whose tools include Chinese herbs and acupuncture, is a very powerful and ancient discipline that works to balance the flow of energy (known as "qi" or "chee") through well-documented channels in the body known as meridians. The Oriental Medical doctor aims to restore balanced energy flow in each individual, knowing that symptoms will improve when this is accomplished. Therefore, symptoms are regarded as clues as to where the imbalance is occurring, rather than as isolated problems to fix or suppress with drugs.

"Natural" Can Be Deceptive
Before we continue, we need to discuss some terms. "Natural" is often used to imply "coming from a source in nature," or "working in a way that mimics nature." However, this term is often misused and I always encourage my patients to be cautious about what the term means in each specific instance. Some of the hormones involved in this discussion might qualify as natural according to the above definitions, but a discerning patient/client or practitioner may still have valid reasons to object to their use. Similarly, a skin cream or a food might claim to be "natural," but when you read the label, many of the ingredients are obviously synthetic chemicals. Because the term "natural" tends to be used in a number of often poorly defined or ambiguous ways, it behooves us to dig a little deeper into identifying sources and mechanisms of action of the substance in question to make sure we are getting exactly what we want -- without artificial, synthetic chemical ingredients.

Another term needing definition is "bio-identical." "Bio-identical" means "molecularly identical to a biological substance or hormone." This is less loosely used than "natural," but can still be misused. Later in this discussion, we will see how these terms can be used and misused.

Natural progesterone
Next on our list are over-the-counter (O.T.C.), low dose (up to approximately 1.6%) progesterone creams, which are commonly called, "natural" progesterone. The progesterone in these creams is bio-identical to human progesterone and is manufactured starting with wild yam or soy precursors. PMS (Premenstrual Syndrome) is common in peri-menopausal women, who often find low dose progesterone cream useful, when used in a cyclic fashion, to anticipate and prevent symptoms of relative estrogen excess (fluid retention, breast tenderness, irritability).

In addition, natural or bio-identical O.T.C. progesterone is very effective in many women for eliminating or lessening the intensity of typical menopausal symptoms, i.e., hot flashes, night sweats, vaginal dryness. The late John Lee, MD, has pioneered the use of natural progesterone in both O.T.C. and prescription-strength dosages and has written and lectured extensively about his more than 20 years of clinical experience. He has also documented the ability of natural (bio-identical) progesterone to build bone mass, which is not a property of pharmaceutical versions of progesterone (progestins, e.g., Provera®)

Bio-identical HRT
The final step in our progression is "bio-identical" hormone replacement therapy (HRT) or "Natural HRT." In this case, both terms rightfully apply. Bio-identical HRT is composed of various combinations of hormones of identical molecular structure to those produced by human female ovaries, in similar amounts and proportions to each other. In addition to human progesterone, women produce numerous versions of estrogen. The three most common are estriol (E3), estradiol (E2) and estrone (E1). Estrone and estradiol, E1 and E2, are strong stimulants of the breast and uterine lining and also can cause fluid retention, heightened emotional states, and breast tenderness. In women's bodies, E1 and E2 each comprise only 3-10% of the circulating estrogens. The remaining 80%-90% of circulating human estrogen is estriol (E3), a milder, less stimulatory hormone that, in a healthy woman with stable hormonal cycles, occupies the majority of tissue receptors for estrogen and prevents the more "pushy" E1 and E2 from having too much influence. Bio-identical human progesterone has a complementary effect to that of estrogen, acting to dispel fluid retention, help the uterine lining shed, stabilize emotions, and resolve breast tenderness. Again, in a healthy menstruating woman, the ebb and flow of estrogen and progesterone balance each other's effects and maintain a fluid but stable balance. Dr. Lee very eloquently describes this as the "dance of the hormones" in his writings. (See reference.)

When the hormones start to cycle at lower levels and less predictably in peri-menopause, this harmonious balance may be disrupted or thrown off at various times. Effects of lower than usual estrogen (hot flashes, night sweats, dry skin, vaginal dryness, sleep disruption) may predominate. Conversely, estrogen excess symptoms (because of lower than usual progesterone levels) may predominate, manifesting as fluid retention, moodiness, or increased PMS. Some unfortunate women experience a mixture of estrogen excess and deficiency symptoms. They often are the most desperate of all for relief. Bio-identical progesterone in prescription doses (3-10% cream or equivalent oral doses) may give relief, but in some women the estrogen deficiency symptoms persist and the next step would be to add an estrogen. Tri-Est is a combination of 10% E1, 10% E2, and 80% E3. Bi-Est is a combination of E2 (10-20%) and E3 (80-90%). The mildest version is 100% E3. All of these bio-identical estrogens are used in combination with natural progesterone, with very rare exceptions. All are available in both cream and capsule form from compounding pharmacies. Doses can be varied to suit an individual woman's needs and blood or saliva levels can be monitored in indicated situations. (Go to www.iacpx to find a compounding pharmacist near you. There is also a toll-free number that is available 24x7. That number is 800-927-4227)

Jonathan Wright, MD, who still practices at the Tahoma Clinic in Kent, WA, developed TriEst more than 20 years ago and has reported on its benefits and lack of side effects in his practice for more than 2 decades. (See reference.)

Some commonly asked questions:

Why don't the drug (pharmaceutical) companies make bio-identical HRT?
Since a naturally-occurring molecule (like bio-identical HRT) cannot be patented, the drug companies would not be able to patent these products. Hence, they would have much lower profit margins.

My gynecologist says that my hormone patch is natural. Is this true?
Not exactly; but if he or she claimed it was bio-identical, that could be true. Many extended-release patches are made with estradiol, or E2. However, Mother Nature has better sense than to use this hormone in isolation, and always has E2 molecules greatly outnumbered by the E3 (estriol). So the use of Estradiol as the only estrogen source is bio-identical, but not natural.

You just said hormones had to be patentable to be profitable. How can an estradiol patch (or pills) be patentable?
Because the "delivery system" (or vehicle for the hormone) is patentable. So the patch itself, which releases measured amounts of estradiol over several days time, is patentable. Tri-Est cream has to be applied twice a day; Estrace® patches are applied twice weekly.
On the other hand, Prometrium® capsules contain only bio-identical progesterone in a patentable micronized form (another delivery system). Their manufacturer can call them both bio-identical and natural.

What is so bad about using pharmaceutical hormones? Most doctors are familiar with them and my insurance drug plan covers them. What's the harm?
The harm is that our bodies' enzyme systems, which evolved over many, many millennia and which can very efficiently break down and excrete any hormone our bodies makes, are completely stymied when presented with chemically altered imitators. These imitators can occupy cellular hormone receptors, and cause hormonal effects, but the enzyme systems can't dismantle them efficiently, or possibly not at all, so they persist in the tissues for much longer periods of time and have persistent effects on the cells that they influence.

It really is not surprising that an estrogen imitator, which stimulates breast tissue, would be associated with an increased incidence of cancer in those very tissues. The two hormones most extensively monitored in the Women's Health Initiative, Premarin and Provera, are perfect examples. Premarin is conjugated (chemically modified) horse estrogen, obtained from pregnant mares' urine. Before modification, it is natural and bio-identical for horses, but it certainly doesn't qualify as either for humans. Provera is medroxyprogesterone, again, a chemically modified version of progesterone, which is neither natural nor bio-identical for humans.

Is there an equivalent study to the Women's Health Initiative (WHI) for the use of bio-identical hormones?
Unfortunately, no. The best, published data we have is that of Doctors Lee, Wright, Northrup, and other physicians (See references.), who have used these hormones in their practices for decades. However, these are not double-blind, prospective studies of thousands of women like those of WHI. The likelihood of a large-scale prospective study on non-patentable HRT being funded appears exceedingly slim at this time. The experience of physicians familiar with these hormones is most encouraging, however, and leaves most practitioners and patients convinced that this is a much safer and also very effective form of HRT.

Needless to say, many of the women, who are motivated to seek out bio-identical HRT, are also likely to make lifestyle and nutritional changes that support their quest and are also more likely to be using supplements, herbs, and other forms of treatment that increase the momentum towards a more stable hormonal climate.

Many times I have recommended bio-identical HRT to tide women over a challenging time, and have watched them taper smoothly off the bio-identical hormones as the other changes they've made gradually exert their effect. And time is on our side in this process, since menopause is a natural progression that will eventually end, leaving us feeling relieved that the turmoil is over, but grateful for our increasing wisdom and trust in the natural order inherent in the process.

Women should find a doctor with whom to work, who understands and is thoroughly comfortable with the benefits of all these options. Such a doctor will help them to choose which options - and combination of options - are best for them. Most women can be helped not only to survive - but thrive, during their menopausal years without pharmaceutical HRT - and with the additional benefits of this more comprehensive approach to health.


by Constance A. Catellani, MD, who graduated in 1977 from the University of Illinois at Chicago Medical School, completed both her internship and residency at Michael Reese Hospital, and is Board Certified in both Internal Medicine and Emergency Medicine. Dr. Catellani spent several years at Rush Presbyterian St. Luke's Hospital as an emergency room teaching physician. From 1993 to 1995, she practiced at the Chicago Holistic Center, the forerunner of the American Holistic Center. Along with several partners, she established The Miro Center for Integrative Medicine in Evanston in 1995, and later joined Wellspring Integrative Medicine in Evanston. Dr. Catellani now has a private practice in Skokie.

Prescription for Nutritional Healing, by Dr. J. Balch, & Phyllis Balch, C.N.C.
Radical Healing, by Dr. Rudolph Ballentine
Osteoporosis -- Prevention & Treatment by Dr. Alan Gaby
Optimal Wellness by Dr. Ralph Golan
The Web That Has No Weaver by Ted Kaptchuk
What Your Doctor May Not Have Told You About Menopause by Dr. John Lee
Dr. Susan Love's Hormone Book by Dr. Susan Love
Encyclopedia of Natural Medicine by M. Murray, N.D. & J. Pizzorno, N.D.
Strong Women Stay Young by Dr. Miriam Nelson
Women's Bodies, Women's Wisdom by Dr. Christiane Northrup
Nutrition & Healing. Vol. 9, Issue 9, September 2002 (cover story on HRT) by Dr. Jonathan Wright



Article from NOHA* NEWS, Winter 2004

*The American Nutrition Association was formerly known as the Nutrition for Optimal Health Association [NOHA].

For informational purposes only - not intended as medical advice, diagnosis or treatment, nor an endorsement by the American Nutrition Association®. Use permitted for non-profit and non-commercial uses or by healthcare professionals in their practice, with attribution to Other use only with written ANA℠ permission. Views expressed are those of the author and not necessarily those of the ANA℠. Works by a listed author subject to copyrights as marked. © 2010 ANA℠