A natural therapy for menopause.

 

Some women are turning to hormones synthesized from plants. But they may not be safer than conventional therapies.


MANY women bade farewell to hormone therapy after a major study found risks from taking hormones after menopause - and far fewer benefits than once believed.

But not all.

Some women felt that, for them, the benefits outweighed the risks. Others turned to "bioidentical hormones," which are synthesized from soy and yams and are similar to the hormones the body produces. They're much more similar, for instance, than the hormones in pills such as Prempro and Premarin.

Some mainstream researchers are leery. Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital, called the research on bioidentical hormones "very, very sparse."

"We need to be cautious about not repeating the debacle that occurred with conventional hormone therapy," said Manson, a leader in the 2002 research on standard hormone replacement therapy.

In a newsletter last September, doctors from the Mayo Clinic similarly warned that "hormones aren't safer or better just because they're labeled natural or bioidentical."

Proponents argue that bioidentical hormones won't have the dangerous side effects of oral hormones, such as Prempro, which the 2002 study found to modestly increase the risk of breast cancer, heart disease and stroke from blood clots.

Key to the approach is not just the hormones used but the way they're delivered.

The only way to get a "bioidentical" substance into the system is non-orally, chiefly through the skin via patches, creams, lotions or gels. That's because medicines taken orally don't enter the bloodstream in the same form that you take them. They pass first through the liver, where their chemical structure is altered.

Medicines taken transdermally don't pass through the liver first en route to the bloodstream, and thus aren't altered.

For example, when a woman takes oral estradiol, the hormone that declines precipitously at menopause, it is converted in the liver to estrone, a weaker hormone, said Dr. Alan M. Altman, a menopause specialist in private practice in Brookline, Mass.

By contrast, when estradiol is absorbed transdermally, it gets right into the bloodstream - as estradiol.

Transdermally delivered estradiol appears not to increase certain cardiovascular risk factors, such as blood clotting proteins, triglycerides and C-reactive protein, as oral estradiol does, hormone specialists say.

And research suggests that oral estrogen reduces the amount of available testosterone and therefore sex drive, while transdermal does not.

For the moment, at least, "non-oral is the way to go," said Dr. Carolyn Shaak, medical director of WomanWell in Needham, Mass., and a longtime proponent of bioidentical hormones. "If you want to duplicate the function of the ovary, you want to use a non-oral delivery system."

Bioidentical hormones can either be made by drug companies, or - as proponents prefer - on a patient-by-patient basis by a "compounding" pharmacist, who follows a doctor's prescription to deliver a precise dose. The compounded versions are safer and more effective than standard hormones cooked up by drug companies, proponents say.

Dr. Steven F. Hotze, who owns a compounding pharmacy in Houston and has treated thousands of patients with bioidentical hormones, has no doubts about the superiority of these products. His patients, he said, "come in on Premarin and are sick. We put them on bioidentical hormones and they get well. Hello? Come talk to my patients!"

But there's no hard evidence that compounded hormones, which are not approved by the Food and Drug Administration, are safe or effective.

In late October, a review committee of the American College of Obstetricians and Gynecologists found that "there is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies."

The group cited a government analysis of 29 product samples (not all of them hormones) from 12 compounding pharmacies. It found that one-third of the products flunked quality tests, with many not containing a proper amount of the active ingredients.

You don't have to go to a compounding pharmacy to get bioidentical products. There have long been FDA-approved estradiol patches on the market. And one FDA-approved cream (Estrasorb) and an FDA-approved gel (EstroGel) have recently become available.

There are also FDA-approved vaginal rings that deliver estradiol: one called Estring, which only combats vaginal dryness; and another called Femring, which delivers estrogen to the whole body and therefore addresses more symptoms.

Things get trickier with the other menopausal hormones, testosterone and progesterone. A testosterone patch for women is in the works, but at the moment, the only way for women to get testosterone is to use small amounts of approved male products "off label" or to use a compounded testosterone cream. The latter option means doses may vary from application to application.

For progesterone, needed for women who still have a uterus to offset the raised risk of uterine cancer from estrogen, a good solution is micronized progesterone. It's sold as Prometrium, a pill that may carry less cardiovascular risk than the synthetic progesterone sold as Provera.

The growing popularity of non-oral approaches to hormone replacement is not lost on big drug companies, some of which are making patches and creams.

Wyeth Pharmaceuticals, which makes the pill Premarin, went so far as to file a citizens petition to the FDA in October to address what a company spokeswoman called "the growing and unlawful manufacture and marketing of so-called bioidentical hormone replacement therapy."

The reaction to that in the bioidentical world is no surprise. Says Hotze, the Houston compounding specialist, "They're putting pressure on the FDA to drive us little guys out of business. It's a big monopoly push."

One thing seems clear: Women will continue to explore new options as they deal with the symptoms of menopause and the knowledge that a therapy used for years has both risks and limitations. Hormone therapy - as we all know by now - is a moving target.

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