Are "Natural" Hormones Safer?

Bioidentical compounded hormones sound so appealing: derived from botanical products, seemingly free of risks, and created just for your menopause symptoms. But check the facts before you make any decisions.

By Susan Ince

It’s not just estrogen that’s a troublemaker: In June 2006, researchers at the Harvard School of Public Health reported that, after accounting for other common risk factors, postmenopausal women not taking hormones who ranked in the top 20 percent in testosterone levels were at least three times more likely to become diabetic than those naturally low in testosterone. "The research does raise some concerns that testosterone therapy [which is prescribed to boost libido] may possibly increase the risk of diabetes in women," says JoAnn E. Manson, MD, chief of the division of preventive medicine at the Brigham and Women’s Hospital, in Boston.

The Bottom Line: It’s a fallacy that if hormones don’t come from a pharmaceutical company, then there’s no cancer, stroke, or other disease risk associated with them.

The Pitch: "Compounded bioidenticals are the only way to get a very low dose of hormones."

The WHI study, whose results scared so many women away from hormone therapy, looked at just one drug, Prempro, a specific combination of oral estrogen and synthetic progestin. Over the past 15 years, information has accumulated establishing the lowest effective doses for treating menopausal symptoms, and many low-dose products and topical formulas (patches, gels, creams) are now on the market.

"We’ve gone through the same process with menopausal hormones as we did with oral contraceptives," says Wulf Utian, MD, of the North American Menopause Society. "The first birth control pills could have killed an elephant. But the hormones in second-, third- and fourth-generation pills became progressively lower, so now you get only a small fraction of what was in the pills in the early 1960s."

The Bottom Line: Ask your physician for the lowest possible dose, but also check how you feel. No matter how low the dose, if you’re still having unbearable symptoms, that level isn’t working for you. And no matter what the dose, use hormones for the shortest time possible to relieve symptoms.

The Catch with Compounding

Compounding has long been a traditional part of pharmacy practice. It meets the needs of people who are allergic to a commercial product or who must have the active ingredient in an alternative form. However, compounders vary greatly in their training, equipment, and experience. There is no regulatory body overseeing compounders to keep them honest or compliant. In a 2004 study, compounded vaginal suppositories containing progesterone were gathered from 10 randomly chosen compounding pharmacies and tested. Only one pharmacy created suppositories that were as close to the labeled dose as commercial products are required to be. Nine of the 10 were either under or over in the amount of the active ingredient. And while the progesterone was bioidentical, the product as a whole was not: The average pH of the compounded products was well above the normal, healthy level for the vagina and that found in commercial suppositories. One pharmacy’s product was even contaminated by bacteria! The State of Missouri, stunned by the case of a compounding pharmacist who scammed cancer patients by deliberately diluting chemotherapy medications, has recently taken the lead in establishing a quality control system. Earlier this year, the Missouri Board of Pharmacy published the results of its testing since the law went into effect. From 2003 to early 2006, the amount of the prescribed active ingredient was incorrect by more than 10 percent in 81 of 410 products tested; a few samples had no active ingredient, and one had more than five times the prescribed amount. Twenty-eight of the below-potency prescriptions were hormones. "The failure rate of 19.8 percent is high and of obvious concern," says registered pharmacist Kevin Kinkade, retired executive director of the Missouri Board of Pharmacy. The FDA also conducted quality surveys (finding 10 of 29 products failed to meet standards), but when it tried to step up inspections, compounders sued, saying that state boards, not the federal government, had control over their practices. For best results, find a pharmacy that specializes in compounding.

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