Bioidenticals: Are They Safe?

Bioidenticals: Are They Safe?

Menopausal women and their doctors are reporting good results with bioidentical hormones, but use of these plant-based substances is unregulated, leaving some experts worried.

By Alison Johnson – Hampton Roads Health Journal, August 2009
Amy Dodd understands some people see her as a guinea pig—in fact, she uses that term herself. The hormones that Dodd, 57, has taken for about a year to fight hot flashes and falling energy levels aren’t backed by comprehensive or long-term safety studies. While doctors who prescribe them say small studies and patient evidence suggest they’re no riskier than standard synthetic hormone replacement therapy—and perhaps less so—others aren’t convinced they’re the right answer for women dealing with symptoms of menopause and aging.

But Dodd—along with her older sister and several of her friends—have embraced the medications, known as compounded bioidentical hormones. They and their doctors believe the plant-based hormones, mixed by pharmacists to mimic the natural hormones that are in a woman’s body before menopause, are a reliable addition to the list of treatment options for women who are suffering through menopause.

“My quality of life is just so good right now that I don’t think about it,” says Dodd, who lives in Chesapeake. “I have had tremendous results. I feel better overall, I’m not as foggy and I have more stamina and energy. The hot flashes, which I’d had every day, went away.” Asked how long she’d stay on bioidenticals, Dodd responds: “I will take them as long as my doctor recommends it. I feel very confident with her guiding me because she is really monitoring me. She has spent a lot of time with me right from the beginning and has tailored this treatment to me.”

Bioidentical hormones recently have grabbed headlines thanks to attention from celebrity fitness guru Suzanne Somers, a strong proponent, and Oprah Winfrey. Local women and doctors who use and prescribe the pills, gels and creams say they’ve had remarkable results with the products, which aren’t regulated by the Food and Drug Administration.

But many in the medical community are wary of that growing popularity, worrying about the lack of quality control and standardization of ingredients and doses, which the FDA requires for medications it approves. The American Medical Association recently stressed that there is no credible evidence that bioidenticals are safer than traditional estrogen and progesterone treatments. The group also is concerned about for-profit businesses making unproven claims and possibly selling unsafe products.

Compounded bioidenticals—which are different from hormones that are approved by the FDA—rely on an individual pharmacist’s work, rather than on set guidelines for production as based on rigorous clinical trials, says Dr. David Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School in Norfolk and a past president of the North American Menopause Society.

“I’m not knocking the compounding pharmacists,” says Archer, also director of EVMS’ Clinical Research Center. “I’m just saying that there is a greater variability involved that has never been tested or assessed.” Patients also shouldn’t believe there are no risks of serious problems with bioidenticals, just as there are with synthetic hormones, Archer adds. Those dangers include a higher risk of stroke and blood clots. “The implication that if you get something ‘tailor-made’ for you and ‘exactly like your body makes,’ then you’ll have no side effects—that really is not accurate,” he says.

Doctors who prescribe bioidenticals say women are getting significant relief and, in their experience, not dealing with side effects. In some cases, patients feel so much better that they can wean off antidepressants prescribed for post-menopausal mood swings. Some of the doctors are so confident about the treatment that they take compounded hormones themselves.

“I can’t tell you how many women have walked through my door and just said, ‘Thank you,’” says Dr. Linda Long, a gynecologist and co-owner of Synergy, an integrative medical center in Chesapeake that specializes in bioidentical hormones. “Maybe 20 years from now we’ll realize this was not the right thing to do, and [today] we have conversations with every patient about the possible risks. But I have people telling me they have a new life. I see women who are no longer willing to put up with these problems and suffer in silence.”

Menopause and hormone replacement therapy
Due to falling levels of the sex hormones estrogen and progesterone leading up to and after menopause, women can suffer from problems that include hot flashes, night sweats, insomnia, vaginal dryness, loss of libido, concentration problems and increased anxiety and irritability. “These are huge quality-of-life issues,” says Dr. Jennifer Krup, a physician and co-owner of the RejuvinAge center in Virginia Beach.

The majority of women who look into hormone replacement therapy, also known as HRT, are 40 and older. For many years, doctors prescribed the medicines Premarin or Prempro, both synthetic hormones, without worry and often with good results. Premarin is a mixture of estrogens made from the urine of pregnant horses, while Prempro is a combination of horse estrogens and synthetic progesterone. Doctors believed that the drugs, in addition to easing menopausal symptoms, also helped protect women against heart disease, osteoporosis, dementia and skin wrinkling.z

The picture changed in 2002 with the release of data from a large federal study called the Women’s Health Initiative. It showed that the common combination of estrogen and progesterone in HRT actually didn’t guard against heart disease and in fact raised the risk of breast cancer, stroke and blood clots. Later research indicated HRT patients who develop certain types of cancer are more likely to die than cancer patients not on the therapy. Alarmed, about 85 percent of women on treatment stopped it within a month.

Synthetic hormones have hardly disappeared. For some patients, the symptoms of menopause are so debilitating that HRT seems well worth the risk. And depending on an individual woman’s medical history, that risk actually can be very low (or may not apply at all, since most women now taking HRT use hormones in different combinations and for shorter lengths of time than in the past). Doctors today do follow one general guideline: Use the lowest dose of medication for the shortest possible period.

Many doctors also encourage women to try lifestyle changes before considering any form of HRT. Eating plenty of fruits and vegetables, limiting sweets and exercising regularly can make an enormous difference, says Dr. Jacquelyn Paykel, an OB/GYN with WomanCare of Williamsburg. Paykel has all of her patients keep detailed food diaries, for example. “I believe we’ve got to take a multi-faceted approach to wellness in women,” she says.

The rise of bioidentical hormones
Over the past decade or so, an alternative—bioidentical hormones—began spreading through Europe and the West Coast of the United States. The medications have the same molecular structure as hormones produced by a woman’s body before the hormonal fluctuations leading to menopause.

The Food and Drug Administration has approved some bioidentical-based therapies, including estradiol products (estrogen) and Prometrium (progesterone). Most of Dr. Paykel’s patients are on those pills rather than compounded products, largely because insurance generally covers them. She follows the lowest-dose-possible approach but overall prefers them to Premarin and Prempro: “Why wouldn’t you? You’re replacing something that was already in your body.”

Pharmacies also can blend bioidenticals based on prescriptions written to match an individual patient’s exact hormonal needs. Doctors determine those with regular blood work and by taking a woman’s age and medical history into account. Dosages aren’t limited; a woman who needs more progesterone to sleep better, for example, may be prescribed a higher dose of that hormone than a woman suffering hot flashes due to a lack of estrogen.

“Each treatment is as unique as the person,” Dr. Long notes. “It’s never cookie-cutter. Compliance is really high because they know it’s making them feel better. These are ladies who are suffering, whose relationships are suffering, and this is improving their lives. It’s hard to argue with those results.” The main side effects she has seen are water retention, bloating, breast tenderness and acne. Those usually resolve in four to six weeks after her team has determined ideal dosages, Long says.

Small studies from Europe show the hormones don’t appear to carry the same risk as older forms of HRT, Long says. So do doctors’ experiences on the West Coast, where bioidenticals have been in use for more than 10 years, Krup adds. Still, patients who choose the therapy should be sure the pharmacy they use is accredited through the Pharmacy Compounding Accreditation Board, a national nonprofit that has set safety standards (compounding pharmacies also are regulated by states). “If I hear someone has placed an Internet order, I cringe,” Krup says. Patients also should be prepared to pay out of pocket for much or all of what can be a pricey treatment—an average of about $150 a month, according to Krup’s office.

The American Medical Association adds that women should be wary of anyone who promotes bioidenticals as weight loss or “anti-aging” pills. Local doctors generally avoid the “anti-aging” term altogether. But, they add, many patients do feel younger—and even look younger—once they’re more rested, have energy to exercise and don’t feel as stressed. “So then the question becomes: what does ‘anti-aging’ mean?” Dr. Krup asks.

Making a choice
With so many complex options, how does a woman know what to do? Dr. Paykel simply likes the idea that there are more treatment choices—and that menopausal symptoms, once frequently swept under the rug, are getting more attention. “My goal is to educate women about the difference between the treatments, but it’s really about what the woman wants,” she says. “Knowledge is power.”

Dr. Krup, who is on bioidenticals herself and has about 350 patients on them at any given time, says finding the best treatment takes research and sometimes a see-how-it-goes approach. “I don’t like the term ‘better,’” she says. “I like, ‘More helpful for some people.’ If you’re on traditional medical treatment and feel fabulous, why change? But if not, we offer an alternative that for me and many of my patients has worked wonders.”

As for safety research, all doctors do wish there was more. They argue that there isn’t because pharmaceutical companies don’t sell compounded bioidenticals, can’t patent them and thus have no financial incentives to fund large-scale studies. Krup recognizes they’re not a “risk-free treatment”—nothing is, she says—but she believes they are “generally less of a risk, because you’re not putting foreign substances into your body. I just have no scientific proof.”

For Madelyn Reass of Norfolk, the “proof” is the simple fact that she feels much better on her current regimen of bioidenticals. Reass, 62, started going into menopause in her early 40s. She tried standard HRT but gained weight and felt sluggish and bloated. In recent years, since starting bioidenticals, she has dropped 50 pounds and seen her energy skyrocket (she has combined the therapy with regular exercise and a diet low in unhealthy carbohydrates.). She has had no noticeable side effects.

“You could speak to 100 different doctors and get 100 different opinions,” says Reass. “I’ve learned in my life that I have to do my own research and make up my own mind about what’s best for me. I think all women should know what their options are. It may not be for you, but it may be just what you’re looking for.”

Into the future
Large-scale testing of compounding bioidenticals is unlikely to come anytime soon due to the cost of funding a clinical trial, Dr. Archer believes. “I just don’t see anyone going out of their way to do one,” he says. “Unless there is scientific data, the medical community can’t really judge this.” For women who want treatment for menopausal symptoms, he generally would recommend an FDA-approved estrogen; he also suggests trying deep breathing at the start of a hot flash, wearing loose clothing and avoiding triggers such as alcohol and caffeine. Acupuncture and herbs also have worked for some people, although study results have been mixed. “There are so many factors involved with individual patients,” Dr. Archer says.

Dr. Krup believes bioidenticals will spread and gradually gain greater acceptance. “It will take time, but I really do foresee it coming,” she says. Dr. Paykel predicts an overall greater emphasis on body-mind-spirit health that includes bioidenticals. And Dr. Long thinks Oprah Winfrey and Suzanne Somers “struck a real chord” that won’t soon fade away because the boomer population isn’t willing to suffer symptoms in silence.

In the meantime, many women aren’t waiting for an official verdict. Amy Dodd’s sister, 65-year-old Susan Goode of Chesapeake, started on bioidenticals in March after consulting Dr. Linda Long. Goode had been on standard HRT for at least 15 years in the past—she went through abrupt menopause at age 49—before the Women’s Health Initiative data scared her off.

Now each night, she applies an estrogen gel and testosterone cream and takes a progesterone pill prescribed by Dr. Long. Goode’s goals are to feel better overall, protect her bone strength and increase her libido. She already has noticed a difference with the latter. “That’s a huge thing for women, although it’s a topic that’s in the closet,” she says. “You want to feel that same drive as when you were younger.”

Her regular doctor, Goode says, is OK with the approach. “I’m not sure he thinks it’s better than what he’d do, but he respects me being on it as long as I feel well,” she says. The lack of long-term safety studies doesn’t bother her. “I’m not afraid of this,” she states.

Neither is Amy Dodd. “I have a lot of confidence in my doctor,” she says, “and I have a lot of confidence in what I am doing for myself.”


Menopause is a disease.
No, it’s a natural, universal part of life.

During menopause, the body stops producing hormones.
The ovaries stop releasing eggs, not hormones. Production of estrogen and progesterone slows, but it doesn’t stop.

As a woman’s estrogen and progesterone levels decline, so does her interest in sex.
Women of all ages can experience low libido for a variety of reasons, but sex during and after menopause can be just as, if not more, satisfying and fulfilling as it was before. Many menopausal women experience vaginal dryness and pain during intercourse, but these symptoms can often be treated successfully.

Menopause sets in by age 50.
In 2006, the average age for female menopause to begin was 51 or 52, but some women experience it as young as 40 (and in some rare cases even earlier).

It’s a signal that the end of life is fast approaching.
Today the average female life expectancy in the U.S. is nearly 81 years, making menopause more a sign of mid-life than old age.

Hormone Replacement Therapy (HRT) is needed to help prevent osteoporosis and other diseases.
According to the Mayo Clinic, hormone therapy can be a short-term solution to quell the not-so-pretty symptoms of menopause such as hot flashes, sleep problems and vaginal dryness, but it should not be used long-term due to recent data that suggests it could increase a woman’s risk for blood clots, heart disease, cancer, stroke and dementia.

All women experience uncomfortable symptoms during menopause.
It’s estimated that as many as 15 percent of menopausal women experience only one symptom: loss of menstruation.

Menopause affects only women.
Sorry, Charlie. Andropause, known as “male menopause,” is marked by fluctuating hormones and decreased sex drive.

When you lose your menses, you lose your mind.
While changes in hormones can affect concentration, forgetfulness is more a sign of aging or stress than menopause.

Menopause is brief; it only lasts a few months or a year.
While menopause is officially reached after 12 months without menstruation, the process can take several years