Customized hormones for treating menopause: Converts, concerns

Customized hormones for treating menopause: Converts, concerns

Debbie Sans remembers it well – the way she'd go to bed at night exhausted but couldn't sleep.

The awful headaches she had, the irritability, the hot flashes that plagued her 35 times a day.

"I thought, 'What in the world is wrong with me?'" she said.

As it turns out, it was nothing Mother Nature didn't plan for women reaching the end of their child-bearing years.

To relieve her menopause miseries, Sans, 57, of Paxton, started traditional hormone therapy several years ago.

It helped, but she worried about the risks, among them a link between hormone therapy and breast cancer, that have surfaced in recent years. The worry drove her to stop taking hormones, but her symptoms came roaring back.

About a year and a half ago, Sans was intrigued when she read about a different kind of treatment called bioidentical hormone therapy, which uses plant-derived hormones designed to be biochemically identical to those in the human body.

And she wouldn't have to go far to find it: A pharmacist in her own community was working with doctors to test women for their own hormone imbalances and custom-mixing individual bioidentical hormone remedies.

Sans said she liked the idea of taking something customized just for her, and decided to give it a try. Now, she's feeling so much better, she wants to tell every older woman she meets about bioidentical hormones.

"I think these work better because they're matched to me," she said.

Interest in bioidentical hormone therapy has surged after TV host Oprah Winfrey devoted two programs to it last month and disclosed she has been using it successfully to treat her own menopause symptoms.

But finding a practitioner to prescribe what Oprah's using can be a challenge.

Bioidential hormone therapy isn't available through Carle Clinic or Christie Clinic, and both clinics declined requests for interviews about it.

Some patients wind up driving out of town. Dr. Tom Rohde, a Decatur family medicine physician, said bioidentical hormone therapy is a growing part of his practice as more women find him from outside the Decatur area.

Rohde speculates many doctors don't offer bioidentical hormones out of liability concerns. (Bioidentical hormones mixed for individual patients, like all treatments made by compounding pharmacists, aren't FDA-approved.)

So why doesn't he worry about potential lawsuits related to bioidentical hormones? Rohde said he spends plenty of time with his patients, and he's convinced most malpractice suits are filed by patients who feel shortchanged by their doctors.

When patients come to see him about bioidentical hormones, the first consultation lasts an hour. There's testing and follow-up involved.

"It's nontraditional, and it takes time," he said. "And unfortunately, in our medical profession today, you don't get paid to take time."

The bioidentical debate

Hot flashes, mood swings, weight gain, forgetfulness, hair loss, insomnia, headaches, diminished libido. ... Is it any wonder many older women who once looked forward to the end of their monthly menstrual periods find menopause worse than the curse?

Women suffering from menopause symptoms enough to seek treatment should begin with an understanding that their discomfort is all about hormone imbalance, said Lisa Oakley, a nurse practitioner who has been prescribing bioidentical hormone therapy for about eight years through Center for Health Renewal and Longevity, her private practice in Champaign.

Even before perimenopause – the transition time preceding menopause – women in their 30s begin experiencing a decline in a sex hormone precursor called dehydroepiandrosterone, or DHEA, which is made in the adrenal glands, Oakley said. Women in their 40s and 50s begin experiencing hot flashes and other menopause symptoms as their estrogen, progesterone and testosterone levels decline.

Until recent years, menopause symptoms were commonly treated with manufactured hormone products such as Premarin (a conjugated estrogen product derived from horse urine) and Prempro, a mix of conjugated estrogen plus progestin, a progesterone-like substance that has some similar properties to progesterone.

But in 2002, a Women's Health Initiative study linked Prempro with increased risk of breast cancer, heart disease, blood clots and stroke, causing many women to back away from hormone therapy entirely.

Bioidentical hormones don't come without risks, either, Oakley said.

Nor is it correct to call bioidentical hormones "natural," said Doug Higgins, who makes bioidentical hormone products at his Paxton business, Doug's Compounding Pharmacy.

So what's the bioidentical advantage?

By taking something just like your body makes, the hope is there will be fewer problems, Oakley said.

Bioidentical hormones "are synthesized to be identical to the hormones your body makes," Higgins said. "When you put something in that is like your body makes, your body knows how to metabolize it."

Another plus for Oakley and Rodhe: Hormone therapy is best taken in the least amount needed to be effective, and with proper testing and the right bioidentical compound, patients aren't getting levels of hormones they don't need.

Some practitioners remain unconvinced.

The American College of Obstetricians and Gynecologists holds compounded bioidenticals have the same safety issues as those approved by the FDA – and may even have additional risks due to the compounding process.

"There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progresterone regimens prepared by compounding pharmacies," the organization said in an Oct. 31, 2005, opinion that was reaffirmed in 2007 and remains unchanged today.

Most compounded products haven't undergone rigorous clinical testing, and concerns remain about the purity, potency and quality of compounded products and the fact that they lack the black box warnings about the risks that come with FDA-approved products, the organization said.

In January 2008, the FDA sent warning letters to seven pharmacy operations stating their claims about the safety and effectiveness of bioidentical hormone therapy products are unsupported by medical evidence and are considered false and misleading by the agency.

"The pharmacy operations also make unsupported claims that their drugs are better than FDA-approved menopausal hormone therapy drugs, and can be used to prevent and treat serious diseases such as Alzheimer's disease, stroke and various forms of cancer," the FDA said.

Higgins said the ingredients compounding pharmacies use are FDA-approved, and the FDA regulates manufacturers, not pharmacies.

Patients with safety concerns should ask their compounding pharmacists how long they've been compounding, whether they compound as a sideline or full time, whether they can provide references, and whether they've ever sought independent analysis of their products, he advises.

Dr. Suzanne Trupin, a Champaign gynecologist, shares concerns raised by the American College of Obstetricians and Gynecologists and prescribes mostly FDA-approved hormone treatments. She said she occasionally prescribes bioidentical hormones for patients, but only if she's convinced they fully understand they're getting an off-label product.

"Most of us feel the FDA process provides a level of safety that compounding does not," she said.

Another concern for Trupin: Many patients wind up footing the bill for bioidentical hormones out of pocket, when a hormone treatment covered by insurance may work just as well, she said.

Rohde, originally an obstetrician who turned to alternative medicine about 12 years ago, said drug companies routinely tell him prescribing their non-bioidentical hormone products would save him time and get patients out his door faster.

But prescribing hormones without testing the patient first is incomprehensible to him. Doctors don't treat other conditions that way, he said. They don't just guess your cholesterol or your blood pressure, so why try and guess a woman's hormone levels?

"I can measure your estrogen, DHEA, progesterone and testosterone, compare it to norms and say, this is where you should be at for your age," Rohde said.

Who's a good candidate for bioidentical hormones? Any aging person who's motivated to look and feel the best they can – and that doesn't just include women, Rohde said. Men also suffer their own version of menopause symptoms as they age, adds the 51-year-old doctor who acknowledges that he takes bioidentical hormones himself to stave off some of the ill effects of aging.

"I want to feel the best I can. I plan to be a cantankerous 95-year-old man flying to Florida," he said.

Made to order

Higgins said he began compounding bioidentical hormones about a decade ago. The market for them has grown so much, it's now 30 to 40 percent of his business.

Finding the right hormone balance starts with a test to measure hormone levels in the patient's saliva, Higgins said. Then he works with doctors to choose among hundreds of strengths of the various hormones to find the right prescription and compounds hormone mixtures in mostly creams and lozenges.

The saliva test itself is controversial. Trupin calls it "a lot of money out of pocket to give you results that are probably inaccurate."

But Higgins argues many doctors just aren't familiar with how saliva testing works, and when skeptics claim it's inaccurate he counters by asking them how much training they've had in saliva testing. He's had lots, he said, and he's convinced it's the most effective way to measure hormone levels..

The cost for all this: Higgins said the saliva test can run up to about $200, and the hormone treatments average $35 to $60 a month.

Health insurers treat his pharmacy as out of network, Higgins said, but getting coverage isn't impossible.

Even all out of pocket, the cost might be worth it to women like Sans.

"To me, it's $60 a month to feel good," she said.

To treat or not to treat

Practitioners say the decision to begin hormone treatment is ultimately an individual choice based on how good or bad you feel and the quality of life you want.

Trupin said she begins educating her patients about taking charge of their health long before menopause, and for her, a do-nothing approach to menopause isn't the best option for women who want to stay mentally and physically fit and sexually active.

There are low-dose creams and patches that can offer relief for menopausal symptoms, she said. There are diet and exercise changes menopausal women can make, and screenings such as bone density tests they should be getting on a regular basis.

"You really do want to be proactive," she said.

Oakley says she sees a lot of needless suffering from menopause symptoms, and relief doesn't always need to come in the form of a hormone prescription. Some women get along fine with the right diet, exercise and some vitamin supplements.

For those interested in bioidentical hormone therapy, she advises working with an experienced specialist who can fully explain the risks and benefits and who treats menopause symptoms as part of a woman's overall health.

Sans said women suffering from severe menopause symptoms need to know they're not going crazy and help is out there. Just ask her.

"I have my life back," she said.

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