Bioidentical Hormone Therapy, Part 1: What’s Safe? What’s Smart?

I’ve been prescribing bioidentical hormone therapy since 1994. In the 25+ years since that first prescription for bioidentical hormones, we have evidence for and against their use. This has led to confusion, misinformation, and even guidelines from mainstream medical societies that are not consistently evidence-based.¹ Fortunately, a masterful new book sets the record straight: Tapestry of Health by Daniel Monti MD and Anthony Bazzan MD. In this book, you’ll learn about the new paradigm of integrative medicine and how it applies to men and women, particularly over the age of 40. You’ll discover the latest synthesis on topics that matter most, from healthy weight loss, intimacy and libido issues, to bioidentical hormone therapy. I believe in their work so strongly that I wrote the Foreword!

What Are the Symptoms of Perimenopause and Menopause?

Women face many symptoms in perimenopause: mood swings, irritability, insomnia, changes in menstruation (irregular, cramping), weight gain, loss of libido, breast soreness, vaginal dryness and discomfort, night sweats, hot flashes, depression, anxiety. Menopause takes the process further as hormonal loss leads to heart disease, osteoporosis, breast cancer, and urinary incontinence.

Is Hormone Therapy Necessary During Menopause?

“The midlife dip in hormones can be manageable for some but is a free fall for others.”

Dr. Daniel Monti and Dr. Anthony Bazzan, Tapestry of Health

Many women are fortunate enough to get their hormones under control through wellness strategies and lifestyle changes. As Dr. Bazzan and Dr. Monti describe in their book, when a woman comes in seeking help for her symptoms, they offer a variety of evidence-based nutritional and wellness plans to help her balance her hormones. However, as the doctors point out, the “midlife dip in hormones can be manageable for some but is a free fall for others.”

This is when they turn to bioidentical hormone therapy to help women cope with their menopausal symptoms and improve their quality of life.

Bioidentical vs Non-Bioidentical Hormones

Not all forms of hormones are the same. It is important to make clear this distinction because much of the confusion, mistrust and fear that surrounds hormone therapy is due in large part to the lack of understanding of the difference between bioidentical and non-bioidentical hormones. Many of the guidelines rely on a limited definition of bioidentical hormones as creams or pellets created in compounding pharmacies.¹

In the words of Drs. Monti and Bazzan, “bioidentical hormones are sometimes referred to as ‘natural hormones’ to distinguish them from the ‘synthetic’ non-bioidentical hormones used in basic hormone replacement therapy (HRT). Bioidentical hormones are synthetic too in that they are synthesized in labs; however, their formulas are structurally identical to hormones produced by human ovary, adrenal and testicular glands, whereas non-bioidentical hormones are structurally different.”

What Are the Risks of Menopausal Hormone Therapy?

Two key components of addressing the risks of hormone therapy for women in perimenopause or menopause are the type of hormone prescribed as well as the age of the woman.

Let’s look at the type of hormone first. Two of the major studies on hormone therapy for women in menopause are the HERS Study² and The Women’s Health Initiative Hormone Trial (WHI),³ both of which administered Premarin, conjugated equine estrogen, derived from pregnant mare urine together, with a form of synthetic progestin called medroxyprogesterone acetate.

Now let’s look at the age of the women in these trials. In the HERS trial, the median age was 67; in the WHI trial, the average age was 63.
Both studies showed an increased risk of blood clots, cardiovascular disease (CVD) and cardiac events and strokes. The WHI study showed a risk increase such that the trial was stopped three years early.

Almost overnight, doctors stopped prescribing HRT to women for menopausal symptoms and women came to fear the very mention of hormone therapy. Bioidentical hormones got tarred with the same brush. However, according to Dr. Bazzan, what these major hormone trials showed is that it was highly potent, oral, non-human hormones that in aggregate created a problem. Furthermore, the women were on average 10 years past menopause (their final menstrual period), an age where cardiovascular disease and other chronic disease events are more likely.

Are Bioidentical Safer than Non-Bioidentical Hormones?

Twenty years have passed since these large hormone therapy trials. Since then there have been many more studies and we have realized many things.

Hormone therapy is not indicated for primary or secondary prevention of cardiovascular disease.⁴

While there is no indication for using estradiol for prevention of heart disease, studies using natural estrogen (not Premarin) show that it probably does not hurt the heart when given early not late after menopause, as shown by the Early vs. Late Treatment (Elite) trial. In this study, 643 postmenopausal women were stratified by time since menopause (“early” was defined as < 6 years, and “late” as >=10 years. The treatment was 1 mg oral bioidentical estrogen (estradiol) plus 45 mg vaginal progesterone each day for 10 days per month versus placebo. After a median of 5 years, the early group had the lowest progression of subclinical atherosclerosis (CIMT). Low CIMT progression not seen in Late Postmenopause. In their secondary outcome, coronary calcium score did not differ significantly between either postmenopause group and placebo. The trial confirms the “critical window” hypothesis that treating early is better for subclinical atherosclerosis, comparable to what was found in WHI.

Based on the guideline, the official age to stop taking hormone therapy is 65.

Conclusion

Drs. Monti and Bazzan point out in their book that it is impossible to make a blanket statement that bioidentical hormone replacement therapy is 100 percent safe. While they have a lot of success with bioidentical hormone replacement therapy (BHRT), they make it abundantly clear that a thorough health assessment is essential to evaluate risk factors including those for heart disease and history of breast cancer.

On the whole, they treat menopausal or near-menopausal women who want to reverse some of the unwanted changes from getting older that affect bone health, sleep, vitality and quality of life. Or women who are looking for a short-term solution for coping with severe menopausal symptoms.

If you want to learn more about the Hormone Balancing Plan from Drs. Monti and Bazzan, you can find this and much more in their new book Tapestry of Health. Purchase it now on Amazon, Barnes and Noble, or your local independent bookseller.

1. Santoro N, et al. Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement. J Clin Endocrinol Metab. 2016;101(4):1318-1343; The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728-753; Pinkerton JV. Hormone Therapy: Key Points from NAMS 2017 Position Statement. Clin Obstet Gynecol. 2018;61(3):447-453.
2. Hulley S, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998;280(7):605-613; Grady D, et al. Cardiovascular Disease Outcomes During 6.8 Years of Hormone Therapy: Heart and Estrogen/Progestin Replacement Study Follow-up (HERS II). JAMA. 2002;288(1):49–57.
3. ^{Rossouw JE, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333; Manson JE et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353-68; Manson, JoAnn E et al. “Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women’s Health Initiative Randomized Trials.” JAMA vol. 318,10 (2017): 927-938. doi:10.1001/jama.2017.11217}
4. Marjoribanks J, et al. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2017;1(1):CD004143. Published 2017 Jan 17.