Healthy Skepticism Library item: 12341

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Publication type: news

Cordileone E.
Is there a replacement for HRT? Bioidenticals promise to help. But do they? And are they safe?
The Star 2008 Jan 10
http://www.thestar.com/printArticle/292539

Full text:

Barbara Mintzes refuses to take hormone replacement therapy for menopausal symptoms – in any form.

It’s not that Mintzes, 52, is anti-pharmaceutical. With a Ph.D. in clinical epidemiology, she assesses drug effectiveness and safety based on clinical trials.

In her professional opinion, the benefits of HRT simply do not outweigh the potential harm.

“To me it’s a no-brainer,” Mintzes states, referring to the large-scale Women’s Health Initiative (WHI) study cut short in 2002.

Researchers determined the participants taking synthetic estrogen and progestin had higher risks of breast cancer and heart disease compared to the placebo group.

Mintzes, who is also an assistant professor in the University of British Columbia’s department of anesthesiology, pharmacology and therapeutics, says the WHI study provides the best available data about HRT and confirms similar findings in earlier studies, such as the 1998 Heart and Estrogen/Progestin Replacement Study (HERS).

With synthetic hormones now linked to increased risks, many menopausal women are turning to bioidentical alternatives.

Bioidentical hormones are synthesized from soya and yams and have molecular structures identical to those produced in the body.

But women should not take the word “bioidentical” to mean natural and therefore harmless, cautions Dr. Marla Shapiro, who is a Toronto menopause specialist, the North American Menopause Society consumer education chair and a University of Toronto associate professor.

“No data exists to prove or disprove their safety,” she says.

Pharmaceutical companies do manufacture some bioidenticals, such as Estrace and Prometrium, in predetermined dosages. Many doctors prescribe them.

Other bioidenticals are made by special compounding pharmacies, which custom-make patches, gels, cream or tablets on their premises, based on a doctor’s prescription.

These compounded formulas, however, require no Health Canada labelling or quality assurance testing. That’s because the pharmacists who make them come under provincial regulations, not federal jurisdiction.

“While the pharmacist is regulated, the actual compounded product is not,” Shapiro explains.

Burlington resident Anna Marie Teckert, 59, knew about the WHI results when menopause hit five years ago.

Desperate to stop the severe sweating that made nights unbearable and the 40 to 50 red-hot flashes that ruined her days, she turned to her long-time gynaecologist for help.

Fearful of taking synthetic drugs, she asked her doctor for bioidentical hormones.

“He pooh-poohed the concept,” she says. “He said there was no such thing.”

However, he did prescribe EstroGel, which he identified as a natural product, but is, in fact, a bioidentical estrogen, plus progesterone capsules.

Within a month after she started her prescription medicine, Teckert’s belly and breasts swelled uncomfortably, the migraines she’d once endured returned and she gained 10 pounds.

But, remembering the dreadful earlier symptoms, she stayed with the regimen until 2005.

Then Teckert, a cosmetologist and mother of two, quit the treatments cold turkey.

She did this after a benign uterine tumour the size of a golf ball appeared for the second time.

Withdrawal brought hot flashes “10 times worse” than before, she says.

She endured them until she met Dr. Alvin Pettle six months later. The Toronto gynaecologist prescribed her different bioidentical hormones.

He insists enough medical studies exist to support his contention that they are safer than synthetic hormones.

Pettle opened his North York clinic in 1994 after leaving his post as chief of obstetrics and gynecology at Etobicoke General Hospital.

His current practice focuses on alternative medicine for menopause and PMS.

His most recent book, Sexy Hormones (Fitzhenry & Whiteside 2007), co-authored with Lorna R. Vanderhaeghe, contends bioidenticals, when properly prescribed – the right type of hormone, the appropriate range of hormones and in the correct dosage for the individual – are safer and more effective than synthetic varieties.

Although he agrees more double-blind studies are required on the safety of bioidentical hormones, Pettle says there are enough scientific studies to convince him. His book contains 36 pages listing them.

Pettle tested her hormone levels and prescribed estriol, progesterone and testosterone creams.

“Within a week, I slept better and had less sweating,” Teckert says. “Within a month, I started to feel better.”