Bioidentical hormone replacement therapy (BHRT) for women has been used for decades to improve women’s quality of life and to relieve symptoms of both menopause and perimenopause (e.g., hot flashes, night sweats, insomnia, insomnia, painful intercourse). Bioidentical hormone replacement therapy is also used to prevent worsening bone loss in osteoporosis for women who are undergoing menopause. However, there is a degree of controversy which surrounds the usage of BHRT, which has interfered with more widespread usage.
What does the fear of HRT stem from?
Hormone replacement therapy for women is widely misunderstood, even by many some healthcare providers. Much of this misunderstanding stems from a research study that was conducted about 20 years ago called the Women’s Health Initiative (WHI). In the WHI Hormone Trials, post-menopausal women were enrolled in a research study which investigated the use of non-isomolecular (sometimes referred to as ‘synthetic’) hormones.
The two hormones investigated in the WHI were conjugated equine estrogens (CEE or Premarin) and medroxyprogesterone acetate (Provera). To sum up the WHI study, women who were typically less than 10 years into menopause did generally well, and a re-evaluation of the trial data showed some potential benefits.
Women who were more than 10 years into menopause had a higher risk of things like heart attacks, given how the CEE causes changes in the body. In the trial arm that combined Premarin and Provera, things became more dangerous, and the study was halted for safety reasons because of an increase in risks such as breast cancer, heart attacks, vascular dementia, and blood clots.
What does the ‘bio-identical’ hormone research show?
More recent research, which has investigated the use of the isomolecular (sometimes referred to as ‘bio-identical’) hormones, such as oral estradiol and oral micronized progesterone, have shown safety and efficacy. The following is a list of resources which I often share with patients, as well as their other healthcare providers, who have worries or fears regarding BHRT:
- CORA (Coronary Risk Factors for Atherosclerosis) – This study showed that hormone replacement therapy (HRT) may be beneficial, and is NOT associated with an increased risk for coronary heart disease (CHD). This study also showed that oral estradiol did not increase the risk of blood clots.
- DOPS (Danish Osteoporosis Prevention Study) – This study showed a reduction in cardiovascular disease (CVD) with oral estradiol, and was one of the longest high-level studies looking at oral estradiol to date, lasting more than 10 years. This also showed no increased risk of blood clots.
- ELITE (Early vs Late Intervention Trial with oral estradiol) – This study showed that treating women with hormones early after menopause rather than later, provided better cardiovascular protection as evidenced by a reduction in atherosclerosis (plaque in the arteries). This also showed that oral estradiol is safe.
- EPAT (Estrogen in the Prevention of Atherosclerosis Trial) – This study looked at the effects of 1 mg oral estradiol, and showed that it was safe, causing no increase in blood clots. The most significant finding was the reduction in carotid intima-media thickness (CIMT), which is the thickness of the lining of the blood vessels; essentially, oral estradiol at just 1 mg/day decreased arterial age.
- EPIC (The European Prospective Investigation into Cancer and Nutrition) – This is a broad study, ongoing since 1993, which revealed a significant finding for women showing that oral micronized progesterone is safer than Provera (the usual standard progestigin) for breast cancer.
- ESTHER (Estrogen and Thromboembolism Risk) – This was an observational trial, which means results were less reliable than some others, but which still provides useful data. This study looked at oral versus transdermal (cream or patch) estradiol with blood clot risk, and also considered micronized progesterone. It was found that the greater risk for blood clots came with increased body mass index (BMI) and that micronized progesterone does not increase clotting.
- PEPI (Postmenopausal Estrogen/Progestin Interventions Trial) – This study looked at a number of factors regarding different hormone treatment regimens’ effects on the female body, especially that oral estrogen decreases CVD risk.
- WEST (Women’s Estrogen for Stroke Trial) – This study examined the relationship between HRT and stroke. After three years on 1 mg of oral estradiol alone, there was a reduction in the incidence of Alzheimer’s disease, with no increased risk of blood clots or breast cancer. There was ultimately no increased risk for stroke with oral estradiol.
The research studies described above, all of which use ‘bio-identical’ hormones, show a reduction in many types of health risk; but, most importantly, demonstrate safety. The most significant aspect of BHRT for women which is not described in these studies, is the profound impact that BHRT can have on women’s quality of life. According to the 2017 hormone therapy position statement of The North American Menopause Society (NAMS) – hormone replacement therapy (HRT) “remains the most effective treatment” for menopause and menopause symptoms.
Hormone replacement therapy has been shown to prevent bone loss and to lower the risk of breaks and fractures. In the words of the NAMS, “HRT treatment should be individualized to identify the most appropriate type, dose, formulation, route of administration, and duration of use, using the best available evidence to maximize benefits and minimize risks, with periodic re-evaluation of the benefits and risks of continuing or discontinuing.”
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