Bioidentical hormones: Are they safe?

Bioidentical hormones generally refer to supplements of estrogen, progesterone or testosterone that are chemically identical to the body’s own hormones. They’re usually derived from plant sources, such as Mexican wild yam and soy, unlike traditional hormones, which come from sources such as the urine of pregnant horses and are molecularly different to a woman’s own. Compounding pharmacists mix bioidenticals to order, usually into transdermal creams, based on a doctor’s prescription.

Whether from plants or animals, all hormones must be manipulated in a lab to make them usable by the body, which, technically speaking, renders them all “synthesized.”

A fairy-tale treatment?

You can’t help feeling inspired by a success story like this one from Diana Boyes. A salesperson from Georgetown, Ont., she had been suffering through four years of a hormonal hell of her body’s own making. “I had so many hot flashes a day that I wanted to run around naked,” says Boyes, 50. She also had migraines, itchy skin, mood swings, insomnia and brain fog, but she refused to take synthetic hormone replacement therapy (HRT) because of its heightened health risks.

Then Boyes discovered Suzanne Somers’ books on bioidentical hormones. This is amazing, she thought, and last August she found a doctor who prescribed them for her. Within a week on the treatment, Boyes was a changed woman. “My hot flashes started going away. I was sleeping through the night. The mood swings, joint aches and headaches were gone. I could even remember my appointments.” And, as Somers promised, Boyes felt sexier. She confides, “With this stuff you actually like your husband again.”

 

A happy ending? Well, it would seem so – except this isn’t the end. In fact, medical science is only beginning to explore the efficacy and safety of bioidentical hormone therapy versus traditional hormone therapy. And the controversy is heating up faster than a 50-year-old in a polyester turtleneck.

Infomercial queen Somers, whose latest book, Ageless: The Naked Truth about Bioidentical Hormones, came out last fall, sees bioidenticals as a fountain of youth.

But a group of seven physicians (some of whom appear in the book) charges publicly that Somers’ recommendations are misleading and even dangerous. Some people say there’s no scientific evidence that bioidenticals are unsafe – which is true. Others counter there’s no proof that they’re safe, either – which is also true. Some argue there’s no national regulation, either in Canada or the U.S., for custom-compounded bioidentical hormones – and that’s true too. One big multinational drug company is pushing hard to get them off the market – but then, that company has seen its own sales of synthetic hormones drop dramatically.

It’s all enough to make the average midlife woman think, Is it hot in here? Or am I caught in the middle of a fiery debate where I’m going to get burned?

One of the treatment’s strongest proponents is Dr. Alvin Pettle, a former chief of obstetrics and gynecology at Etobicoke General Hospital in Toronto, who now has a busy private practice. “It’s what God’s own hormones were meant to be,” he says. “You can’t beat Mother Nature. Drugs have side effects, synthetic hormones especially.” He doesn’t like to call bioidenticals “drugs” although, when pressed, he reluctantly acknowledges that they are. Pettle has been prescribing bioidenticals for 12 years and sees about 40 women a day, some coming from as far away as Sudbury, Ont., and Manitoba.

Controversy swirls around Pettle, who draws strong reactions from opposing camps. While his satisfied patients, including Diana Boyes, see him as a brilliant maverick, some doctors, off the record, call him opportunistic and criticize him for using unproven drugs to profit off desperate women.

Regulatory bodies weigh in – or don’t

Health Canada doesn’t regulate custom-compounded bioidenticals or even approve them. The U.S. Food and Drug Administration (FDA) cautions that all hormones, whether bioidentical or traditional, must be assumed to carry the same risks – and those include small but significant increases in breast cancer, heart attacks, blood clots and strokes, as found by the 2002 Women’s Health Initiative study.

Last year, in its 2006 Menopause Consensus Report, The Society of Obstetricians and Gynaecologists of Canada came out supporting traditional hormone therapy as a safe and effective treatment for moderate to severe symptoms of menopause, but bioidenticals weren’t even mentioned in the entire lengthy report. Dr. Jennifer Blake, co-editor of the report and chief of obstetrics and gynecology at the New Women’s College Hospital in Toronto, dismisses the whole topic as a non-issue. “There’s a lot of hype about bioidentical hormones,” she says, “but research does not show any advantage to the other hormonal formulations.”

Pettle bristles at that. “That’s absolutely not true,” he says. Indeed, a 1999 double-blind, randomized study of 102 women in the U.S. found that natural progesterone cream reduced hot flashes significantly better than placebo. A 2005 study by the same principal investigator found that natural progesterone cream caused no adverse effects and that women preferred the cream to the standard oral hormones.

“I believe natural progesterone cream is the hormone doctors should fall in love with,” Pettle says. And yet most physicians, if they’re prescribing hormones at all, are staying loyal to the traditional therapy. To Pettle, the reason is obvious: “Who owns these people? Who pays for their dinners? It’s the drug companies.”

Because bioidenticals have the same molecular structure as the body’s own hormones, they can’t be patented, which means drug companies haven’t yet figured out a way to profit from their sales. In 2005, pharmaceutical giant Wyeth asked the FDA to stop pharmacists from compounding and dispensing any products containing a bioidentical sex hormone, citing lack of regulation. Pettle says, “Once the drug companies learn how to patent it, it’ll be the next best thing to sliced bread.”

In an ideal world, all women would sail effortlessly through life’s hormonal changes, whether during PMS, pregnancy, breastfeeding, perimenopause or menopause. But in reality, some midlife women, despite healthy eating, an active lifestyle and supportive relationships, will lose so much quality of life that they need medicinal help. It makes intuitive sense that if a woman must take hormone supplements, bioidenticals are the better choice, but in the absence of hard data many women are hesitant.

And with good reason. It’s happened many times before that potentially harmful hormones were prescribed to millions of women long before the research was complete: just think of DES (diethylstilbestrol) from the 1930s through the 1960s, the Pill with its sky-high hormones in the 1960s, and synthetic HRT from the 1970s onward.

“It’s a minefield out there, and women are very frustrated and very angry,” says Lorna Vanderhaeghe, a Vancouver-based women’s health advocate and author with a bachelor’s degree in biochemistry and a master’s in nutritional science. Vanderhaeghe responds to about 700 emails a week from some of those frustrated and angry women. Her lectures across the continent are always standing-room-only affairs; on a recent Monday evening in a strip plaza north of Toronto, more than 100 women overflowed a tiny space in a health food store to hear her speak, queuing up three deep afterwards to bombard her with questions and buy her own line of non-hormonal nutritional supplements.

Use hormones as a last resort

“Bioidentical hormones are a double-edged sword, and I think women should know that,” says Vanderhaeghe. She believes that for the 10 per cent of women whose menopausal symptoms aren’t helped by lifestyle changes, bioidenticals can help, but only in the lowest dose and for the shortest time to alleviate symptoms. “The biggest misconception is that bioidentical hormones are harmless. I’m not against them, but even tiny amounts of hormones can be very powerful, and they need to be used as drugs.”

As for Suzanne Somers’ claim that they prevent aging, Vanderhaeghe scoffs. “If I showed you a 70-year-old woman who’s been taking hormones for years and another 70-year-old who’s never taken them, you wouldn’t be able to tell the difference.”

While many women think they need more estrogen, Vanderhaeghe says a lot of symptoms attributed to low estrogen may have quite different causes. “Perimenopausal women especially do not need more estrogen, since they’re already estrogen-dominant,” she says. Women in their 40s who complain of fatigue, depression or insomnia may have low thyroid levels and should have their TSH, T3 and T4 levels checked, Vanderhaeghe suggests. She adds that stressed-out women should also be tested for adrenal function and insulin resistance.

Could saliva testing give direction?

While a blood test has been the standard tool for testing hormone levels, there’s new interest in saliva testing. For about $200, many health professionals will sell you a kit in which you spit into a tube that you then mail off to Rocky Mountain Analytical in Calgary, the only accredited such lab in Canada. It tests for estrogen, progesterone, testosterone, the adrenal hormone DHEA and the stress hormone cortisol.

Rocky Mountain claims it can determine the problem in 80 per cent of the women who submit a saliva test. But since women’s hormones, especially before menopause, can fluctuate wildly several times a day, it’s questionable whether treatment can be based solely on a saliva test. Pharmacist Tracy Marsden, vice-president of business development at Rocky Mountain, agrees. “We don’t ever want to treat just a lab test. The saliva test is very accurate in giving a snapshot of the patient at that point in time. But the patient also fills out a form with a bunch of symptoms, and we do an interpretation.”

For instance, If a woman shows high levels of cortisol, which can impact her estrogen, testosterone and progesterone levels, Marsden says the recommendation might be yoga, meditation or Tai Chi – and no hormone supplements at all, bioidentical or otherwise.

Confounding the whole testing issue is the mistaken assumption that there’s an optimum level of hormones for all women and as our own hormones start to diminish, we need to top them back up, just as we top up the fluid levels in a car. In truth, there’s little or no correlation between a woman’s hormone levels and her symptoms. One woman could have almost undetectable levels of sex hormones but have no unpleasant symptoms, while another could have a healthy-looking hormone profile but have debilitating symptoms.

“Saliva tests may well be accurate, but we don’t know how to interpret the results,” says endocrinologist Dr. Jerilynn Prior, founder and scientific director of the Centre for Menstrual Cycle and Ovulation Research in Vancouver. She’s also the author of Estrogen’s Storm Season: Stories of Perimenopause and a professor of endocrinology at the University of B.C. Prior says that because hormones from transdermal creams don’t show up well even in blood tests, diagnosis should be based more on symptoms. She supports bioidentical hormones but advises that even these should be used only in three situations: menopause before age 40, severe hot flashes, or hot flashes along with osteoporosis.

Take risks into consideration

Dr. Prior urges great caution with estrogen, saying it should be prescribed only in transdermal form. “I will never again write another prescription for estrogen by mouth, because of the increase in blood clots, which in severe cases can cause death,” she says. She’s also cautious with testosterone, especially in perimenopausal women. “I saw a woman the other day on testosterone therapy who was growing hair on her face. Soon her voice will start getting deep – and that’s not reversible.”

As for progesterone, Dr. Prior took it herself for seven years to manage severe night sweats and sleep disturbances, stopping once a year to gauge her symptoms. She believes it’s a safe drug she could probably have taken forever, but now, at 63, she feels there’s no reason to take a drug she no longer needs. She laughs at the notion of hormones as an anti-aging panacea: “That’s working with a kind of magical thinking.” While bioidentical hormones must be used with care, Dr. Prior says too many physicians are quick to dismiss them. “It’s a question of domain – my colleagues don’t like naturopathic and alternative medicine horning in on gynecologists’ and endocrinologists’ territory.”

So should midlife women be using bioidentical hormones? If you have symptoms that are affecting your quality of life, bioidentical hormones may be a worthwhile option to explore. We won’t have definitive answers about their safety and efficacy for several years since, when it comes to their long-term use, this is all new territory. But when it comes to competing interests fighting over profits from women who want to look and feel younger – well, we all know there’s nothing new about that.

This article originally appeared in the Spring 2007 issue of More