Almost monthly, it seems there’s some new antiaging breakthrough hitting the market. Bioidentical human hormone replacement therapy is one of the latest—but it’s not just about cosmetic upkeep. Rather, it goes much deeper, improving overall energy levels, libido, weight maintenance and more.
HHRT has become so popular, in fact, that it’s been touted by some—including aging TV sexpot Suzanne Somers—as a natural weapon against the so-called “over-pharmaceutical-ization” of America. And yet, for all the answers it’s said to provide, HHRT has raised just as many questions.
Human hormone replacement therapy utilizes bioidentical hormones that are virtual molecular matches to those made in the body. Based on age, health and endocrinologic fluctuations, varying levels of hormones may be used to restore the desired balance, thus alleviating the symptoms brought on by the natural decrease in hormone production.
Pharmaceutical synthetic options are available, but the key differences between these and their natural counterparts are the structure and the source. In order for a replacement hormone to fully replicate the function of human hormones, the chemical structure must precisely match the original. Pharmaceutical companies must change the molecular structure of the hormone (which is often derived from horses) to get a patent, because you can’t patent a natural substance. With individualized compounding, the human substance is already present, its dose manipulated to suit a specific need.
But there may be other natural sources present. “The compounds they use may be plant derived,” says Dr. Cheryl Koch, an endocrinologist at Bryn Mawr Hospital. “The claim is that they’re identical to human hormones, which may not be the case if plant-based estrogens are used.”
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As the owner of Exton’s Lionville Natural Pharmacy and Health Food Store, Ben Briggs has seen some pretty wild requests coming through his door.
“I’ve had women come in with jars of estrogen, asking about how they can look younger,” says Briggs, a graduate of the Philadelphia College of Pharmacy and Science and a compounding pharmacist. “I’m not in favor of the Hollywood plan of action.”
For women struggling with menopause, though, Briggs recommends a series of medically prescribed treatments from a primary-care physician. Most often, it’s a combination of estrogen, progesterone and testosterone—and nothing plant based. Compounding is done according to a patient’s “metabolic profile,” a synopsis of physiologic efficiency based on age, medical history, saliva tests and more.
From there, Briggs formulates the lowest appropriate dosage of each FDA-approved hormone and mixes it with a stabilizer to create a dermal cream that’s 99-percent pure.
“Normally, a woman produces 50-100 milligrams of progesterone daily, which rises during the second half of her monthly cycle,” Briggs says. “She’ll produce only a little in the beginning—maybe she’s only making 25 milligrams. So we’ll give her 25 on top of that and decrease throughout her cycle.”
The treatments arrive in a monthlong supply of syringe ispensers and are applied to the skin by the patient. “Its efficiency depends on how long a woman has been on synthetic hormones, because it’ll take the hormone receptors some time to readjust,” says Briggs. “Two to three weeks is when women notice improvements in sleep, mood, weight, hot flashes, night sweats, incontinence and libido.”
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Men may also benefit from testosterone therapy, which has been shown to improve mood, strength, erectile dysfunction and bone mass in clinical trials. At around age 45, Briggs says, men experience a decrease in testosterone production that correlates with the hormonal changes women experience during menopause—though it’s a markedly slower and subtler process.
Over its decades-long history, HHRT has weathered criticism from the medical community. “The substances used by compounding pharmacists may or may not be scrutinized, and the process may not be free of contaminants,” says Koch.
It’s true that the use of compounding hormones is not FDA approved. But the FDA does approve the materials that go into Lionville’s compounding process. “The FDA raided us a little while back,” says Briggs. “They weren’t allowed to be here, but we were advised to let them in. We made a batch, they took the samples, and we never heard back from them.”
The FDA isn’t the only sheriff in town. Pharmacies of any type in Pennsylvania are regulated by the state. And once the compounds leave his pharmacy, Briggs requires continual follow-ups, communication with physicians and blood work to measure each patient’s progress.
Another issue sullying HHRT’s rep is the conflicting and confusing information regarding the use of natural hormones. HHRT can’t be patented, so there’s no financial backing from the pharmaceutical companies. Big backing means big bucks for clinical trials and scientific studies on a much larger scale.
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Regardless, as HHRT’s popularity and legitimacy grow, more research is being done. The most comprehensive analysis to date was published in March 2009 in the highly respected Postgraduate Medical Journal. Results showed that bioidentical hormones are associated with reduced health risks and are more efficacious than their synthetic counterparts.
The review also found that patients undergoing bioidentical HHRT were less likely to experience sleep problems, anxiety, depression and cognitive issues—all side effects of synthetic hormones. HHRT is also associated with a reduced risk for breast cancer and superior cardiovascular protection.
Even so, Koch encourages patients to consider the synthetic route. “Some are under the impression that the pills prescribed by their doctors don’t work or won’t work well for the relief of menopausal symptoms—they do,” she says. “And all the synthetic compounds produced must demonstrate safety and effectiveness to the FDA’s satisfaction.”
As for HHRT, it typically sets patients back $100 per month (if three hormones are needed). And insurance coverage is hardly a given. But it’s worth a shot in many cases, Briggs contends.
“Whatever your belief is, we’re just taking what our creator gave us to help our patients,” he says.
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HHRT: 8 Questions to Consider
1. Is your primary-care physician willing to prescribe HHRT?
2. Is your compounding pharmacist a member of the International Academy of Compounding Pharmacists and/or the Professional Compounding Centers of America?
3. Is your pharmacy board certified for compounding?
4. How long has the pharmacist been in practice?
5. Does the pharmacy dispense mail-order products, or will the pharmacist work with you to establish the proper dose? A pharmacist should work with the patient to establish the right amount of each hormone, rather than supplying a pre-formulated product.
6. Does your insurance offer coverage for HHRT?
7. Does your pharmacist require consistent follow-up testing?
8. Are you being treated for cancer? Estrogen treatments are off-limits to cancer patients.
What Is Estrogen Dominance?
It’s a condition in which a woman might have deficient, normal or excessive estrogen while having little or no progesterone to balance its impact on the body. Side effects include: breast tenderness, weight gain around the hips and stomach, fluid retention, depression, irritability, yeast infections, hair loss, insomnia.