June 8, 2009
Hormone Replacement Therapy
Dr. Naomi Paschall Dr. Tracy Nims
In this increasingly informed world, women tend to make more decisions and take control of their lives. But women need to think twice about what they may know when it comes to hormone replacement therapy.
Traditional menopausal hormone replacement therapy came under fire several years ago when a Women's Health Initiative study looked at the effects of hormone replacement therapy on thousands of women. The study was stopped before its completion because of an increased risk of heart attack, stroke, breast cancer and blood clots.
After news reports of the study focused on the associated risks, research found that 70 percent of women who were taking hormone therapy discontinued it, and 26 percent of women lost confidence in medical recommendations in general.
"Women have been scared by the WHI study, but further analysis has revealed its flaws," says obstetrician/gynecologist Naomi Paschall, M.D. "While some risks are associated with hormone therapy, each woman is different and her individual risk should be evaluated by a gynecologist she trusts."
The effects of estrogen are complex and dependent on a variety of factors individual to each woman, including age, weight and health conditions. The flaw in the wide-scale WHI study is that the results didn't take into account the age of women (they ranged from 50-79), the dosage they may need or the method of delivery. All women were exposed to the same high dosage of hormones orally, regardless of any other risk factors they may have had.
Analysis of the WHI data indicates age is a determining factor in whether hormone replacement therapy is the right choice for women. Risks of heart disease, breast cancer, stroke and blood clot were low in patients 50-59 years old, but increased with age. On the flip side, women age 70-79 were no longer responsive to the benefits of hormone replacement therapy and experienced greater risks.
Paschall, who practices at Franklin Healthcare for Women, says method of hormone delivery also is a significant factor in how women are affected, and newer, safer products are available.
"Newer studies show women who receive transdermal (though the skin) estrogen bypass many of the effects seen in the WHI study," she says. "One study shows a significantly lower risk of heart attack in women who choose transdermal estrogen as opposed to taking it orally."
Although options have increased for women when it comes to hormone replacement therapy, Paschall says some fallout still remains from the WHI study. Women routinely ask her about bioidentical hormones, which many falsely think are natural and safer than traditional hormone replacement therapy.
Paschall says the main concern with what most people consider bioidentical hormones is that they are not regulated by the Food and Drug Administration, and the effects on the body are unknown. The FDA approves prescription medications that include bioidentical hormones, but the term "bioidentical" often is used to refer to custom-compounded hormones, which are not tested for purity, potency and safety by the FDA.
Although made from soy products or wild yam, bioidentical hormones are not natural, as Paschall says many women believe. They are converted to hormones in a laboratory, much the same way FDA-approved hormones are created. However, no tests or studies have been undertaken to determine the risks associated with compounded bioidentical hormones.
"A lot of misinformation exists regarding bioidentical hormones," Paschall says. "Some of what we hear in the mainstream media is partially correct, but partially incorrect, and there's a false belief among some women that bioidentical therapy is better than traditional hormone therapy."
The FDA did at one point analyze bioidentical hormones, and 34 percent failed one or more standard quality tests. In comparison, FDA-approved drugs fail at a rate of less than 2 percent.
The American College of Obstetricians and Gynecologists, North American Menopause Society and The Endocrine Society all have issued statements noting the lack of safety data on compounded bioidentical hormones. Industry standards say if the risk is unknown, the risks and benefits should be assumed to be the same as FDA-approved hormone therapies, although the American College of Obstetricians and Gynecologists says bioidentical hormones may have additional risks because of compounding.
The testing avenue of hormone levels in patients seeking bioidentical hormone therapy is another source of concern, Paschall says. Bioidentical hormone therapy often is prescribed based on salivary hormone testing, but salivary testing as a way to determine hormone dosage is questioned by the medical community.
"Current studies are reviewing the validity of saliva testing, but we don't know the results of those yet," Paschall says.
In the meantime, both the Endocrine Society and the American College of Obstetricians and Gynecologists have issued statements advising against salivary testing.
"It's known versus the unknown," Paschall says. "Women will ask for compounded bioidentical hormone therapy when we don't know the associated risks, but yet we have large-scale studies to help us understand traditional hormone replacement, which women may shy away from.
"The bottom line is to find a gynecologist with whom you feel comfortable, and together you can determine the right path for you, taking into consideration any risk factors you may have."
Resources: "Bioidentical Hormones," OBG Management, January 2009
Contemporary OB/GYN, January 2009