Black Box Lift Off, Free the Hormones!
By Dr. Beth Adler
Recently the FDA has lifted the black box warning on hormone replacement therapy (HRT) after many years of misinformation being circulated through the physician and menopausal community. So many women have been led to believe that there is “nothing to be done” about their symptoms, and that they will “just have to deal with it” and suffer in silence.
Misinformed
I can’t tell you how many of my patients have come to me and reported those exact words being said to them at a doctor’s visit. It is heart breaking, especially since there is something that we can do to help improve menopausal symptoms. The lift of the black box warning of HRT is a cause for celebration, because it is my hope that this is the beginning of better HRT training and education for physicians and that hormone replacement therapy will be more approachable and more widely accessible to the women who need it.
Where Did This Misconception Come From?
It all started with a study in the early 2000’s called the Women’s Health Initiative (WHI), stating that hormone replacement therapy was linked to breast cancer and increased cardiovascular risks. However, one thing that was not advertised is how shortly after this study was published, there was a re-evaluation done and the person who performed the study revoked their findings and decided the negative outcomes were based more on causation vs. correlation. Unfortunately, the data from the consolidated studies that showed that HRT use is highly beneficial when given to symptomatic women, did not receive sufficient media coverage and the fear that went along with HRT persisted.
The problems with The Study
After re-analyzing the data, the people who lead the WHI study agreed that their previous study was defectively designed, poorly evaluated, and inadequately reported. Based on the consolidated data that was provided from further studies, researchers concluded that there was not sufficient evidence to link HRT to being the cause of harm to women’s health.
The WHI study only tested synthetic conjugated estrogen either by itself or in conjunction with synthetic progestin. It did not explore the effect, dosages, or delivery method of other types of hormones on women’s bodies, such as bioidentical estradiol and progesterone (closest to what we make in our bodies). WHI focused on women whose average age was 63 years old, often more than 10 years plus from the start of menopause, and women who were asymptomatic. In contrast, many additional observational studies have conveyed that starting HRT close to menopause is where we see the greatest improvement.
What New Evidence Shows
To elaborate, new studies have shown that in groups of younger women (between the ages of 50-59 years of age) or in newly post-menopausal women (within 10 years of them starting menopausal symptoms) HRT had a positive influence on the cardiovascular system, improved bone health, and reduced all-cause mortality. A follow up study called The Study of Women’s Health Across the Nation (SWAN) conveyed that women with menopausal symptoms, specifically hot flashes, had higher occurrences of cardiovascular disease than women without menopausal symptoms, and HRT favorably impacted the cardiovascular risk factors.
Additionally, in the WHI study upon re-analysis, the risk of breast cancer was significantly lower than in placebo users for those women treated with only conjugated estrogen, vs. combined synthetic estrogen and progestin. This led to the theory that progestins (synthetic progesterone) were the actual culprit to the link of HRT and increased risk of breast cancer. However, breast cancer instances increased after the WHI study came out and HRT was stunted.
This begs the question that if HRT was actually harmful to the health of postmenopausal women, then shouldn’t we have seen an improvement in women’s health after they reduced HRT distribution?
That, however, is not what the longstanding evidence demonstrates. Further studies and analyses confirm that the data shows HRT is highly beneficial when given to symptomatic women within 10 years since the onset of menopause or to symptomatic women that are under 60 years of age.
What Can Hormone Replacement Therapy Do For You?
The next step is to discuss what forms of hormone replacement therapy are currently available and how does being deficient in different hormones affect your body?
Some of the signs and symptoms we see with estradiol deficiency are
hot flashes
night sweats
dry skin
bone loss
vaginal dryness
irritability
moodiness
Typically, we like to use estradiol therapy trans dermally or subcutaneously to avoid second pass liver metabolism, which could increase risk factors.
Low progesterone is responsible for difficulty sleeping (especially waking up several times in the night), and increased anxiety. We use oral micronized Progesterone capsules, because we want it to be metabolized in the liver for the calming effects.
Low Testosterone levels in women can lead to fatigue, increased brain fog, difficulty gaining muscle, difficulty losing weight, increased joint pain, decreased sexual libido, and hair loss. We utilize a daily topical cream or subcutaneous testosterone for consistent results.
After individual assessment of symptoms, history, and looking at lab values/blood work, we cater hormone replacement therapy forms and dosages to each person accordingly.