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by Todd Schlapfy


Confused about hormone replacement therapy? There's more to the story that hasn't been told. Since the release of the halted PremPro arm of the Women's Health Initiative study, clinical practices have been inundated with questions from women about what to do now that conventional hormone replacement therapy (HRT) has come into question. It's a serious concern for both prescribers and millions of menopausal women.


While the conclusions of the WHI study are not a shock to those who have followed HRT studies through the years, the size and credibility of the study raises serious doubt about continuing the practice of administering progestins (synthetic progesterone) with estrogens, in general, and PremPro, in particular, for menopausal women with a uterus.


Previous to the WHI study, there had been no controlled trials demonstrating that HRT therapy provided long-term benefits to general health. Perceptions, theories and treatment protocols were established based almost entirely on observational studies. The WHI study is among the first to adhere to unbiased scientific standards and be conducted independently of pharmaceutical money. You and I paid for this study with tax dollars.


Five years of carefully analyzed data from the intended 8.5-year study of 16,000 women ages 50-79 taking PremPro were found to have such a significant increase in strokes, heart attacks, breast cancer, cardiovascular disease and the rate of blood clot formation, that the study was stopped. While overshadowed by the multiple risks, the incidence of osteoporotic fractures and colon cancer decreased.


Although other studies have collectively pointed to similar conclusions, the long-held perception that PremPro confers more benefits than risks may be slow to give way to effective and safer choices.





How did we get here? Estrogen replacement therapy (ERT) began in the 1940s, primarily with the introduction of Premarin. It skyrocketed in the late '60s with the release of Dr. Robert Wilson's book, Feminine Forever. A landmark study completed in 1975 and printed in the New England Journal of Medicine was highly critical of the practice of administering ERT to menopausal women with a uterus. It concluded that estrogens unopposed by progesterone increased the risk of uterine cancer.


Recognizing the demonstrated risks of ERT, the pharmaceutical industry sought a solution. Enter progestins -- a synthetic lookalike, but not bio-identical to progesterone. Why not real progesterone? By law, natural substances are not patentable, and therefore cannot be privately owned as commercial property. As an altered molecule, progestins are foreign to a woman's body; as such, they behave differently than bio-identical progesterone, except for their similar effect of reducing the risk of uterine cancer.


Progesterone confers many benefits to human health, especially for a woman. Made from cholesterol, it is a wellspring of an elaborate cascade of hormone production (including estrogens and cortisol) and other functions vital to health -- something progestins cannot do. Unfortunately, the distinction between real progesterone and progestins was lost and progestins became the partner to prescriptions of estrogens for menopausal women with a uterus. Eventually Wyeth, the manufacturer, made it more convenient by combining the two most common estrogen and progestin products, Premarin and Provera, into one, which was named PremPro.


Although the WHI study specifically isolated PremPro in its study, it confers serious concern upon all progestins. Switching to a different progestin combination with an estrogen does not take away the worry. So what to do?


Typically, HRT is administered to relieve the symptoms of menopause, like night sweats, hot flushes, interrupted sleep and mood changes. Unquestionably, ERT or HRT can be a successful answer to those complaints. But at what cost? Bio-identical hormone replacement therapy (BHRT) can be just as effective, measurably safer and health enhancing.


BHRT has been available for many years. Thousands of women in the U.S. and abroad got off HRT years ago and switched to BHRT. Because of the mounting evidence of risks, side effects and poor compliance associated with conventional HRT, greater precision for measurement, formulation, dosing and monitoring of bio-identical hormones is rapidly advancing. Though underway, a large, long-term study of BHRT has yet to be completed (not including BHRT was an unfortunate fumble of the WHI study). However, completed smaller trials of BHRT have been consistent with the hypothesis that BHRT is effective and safer.


True to valued tenets of practicing health care, BHRT can be free of harm and individualized. Through your health care provider, hormone status can be personally assessed. Bio-identical formulations can then be designed and forwarded to a local pharmacist for tailored compounding into a convenient application, eliminating the one-size-fits-all approach. Compliance rises dramatically, hormone balance is restored and health is more assured.


Menopause is an opportunity to not merely relieve symptoms; it's a golden chance to optimize health. Staying faithful to our nature seems to be the most trustworthy path. Lest we forget, science is the student, Nature our mentor. May health care and our medicine be so humble.





Todd Schlapfer is a naturopathic physician and conducts a private practice in Coeur d'Alene. He received his doctorate from the National College of Naturopathic Medicine.