Hot flashes, sleeplessness, irritability. Menopause throws many women’s bodies into hormonal chaos. Now there’s a natural alternative to synthetic hormones.
By Scott Weinberger, Milwaukee Magazine
October 2006
Linda, a 47-year-old Jefferson resident, was experiencing hot flashes, difficulty sleeping, irritability and crying jags. Years earlier, she’d had a hysterectomy, with removal of both ovaries, and was experiencing typical menopausal symptoms.
Linda, who asked that her last name not be used, was on “regular” hormone replacement therapy – substances like Premarin (estrogen) and Provera (progesterone), which are derived from animal or synthetic sources. They helped the symptoms, but the side effects were overwhelming.
“I felt like I was having a heart attack chest pain, shortness of breath, heart palpitations,” she recalls. “It was scary. It was worse than my symptoms.”
The cause? “My estrogen levels were too high,” she says. “I was on a very low dosage, but apparently it was too high for me.”
A nurse practitioner then prescribed “bioidentical” hormones, which are individually compounded at a special pharmacy. Most bioidentical, hormone ingredients are manufactured from plant sources, such as wild yam and soy, to yield a chemical structure biologically identical or equivalent to the hormones the body produces prior to menopause.
Two weeks after starting the new hormones, Linda’s menopausal symptoms were gone. Her hormone levels are tested yearly, and the bioidentical compounding dosage is changed as necessary to meet her needs.
“My husband tells me now he’ll never let me go off of them,” she laughs.
On the flip side, another patient, who preferred to remain anonymous, isn’t so sure bioidentical hormones work better for her than traditional hormone therapy. By email, the 50-year-old southwestern Milwaukee resident confided: “It’s really hard to tell exactly how much of a help or not they are. Some things are better, some are the same. It seems to help my depression. But my whole life experience has changed at the same time, so perhaps some of the physiological things also changed because of that. I don’t know how I feel about them yet. I may very well still continue to use the bioidentical hormones for a while. It took me almost a solid year to adjust to them.
Traditional Hormone Replacement
Traditional hormone replacement therapy with “synthetic” drugs has been used for decades to alleviate menopausal symptoms and until recently was prescribed for long-term use because it was believed to reduce risks for several, potentially fatal conditions.
Some women experience symptom relief from traditional HR, while others like Linda can’t tolerate the drugs’ side effects. Still others like the idea of using a more natural substance. Drugs such as Premarin, made from pregnant horses’ urine, also contain other substances that may affect the body.
The decision to use traditional hormone therapy became less clear-cut following the Women’s Health Initiative study that included tens of thousands of women and provided more questions than answers, particularly about long-term use. The statistical analysis of the data was complicated and open to interpretation.
After WHI, hormone replacement standards changed and now call for the “smallest possible dose for a limited period of time” says Dr. Marilyn M. Schapira, associate professor of internal medicine at the Medical College of Wisconsin. In menopausal women, HR is now primarily prescribed for symptoms that affect daily functioning, and the patient should be regularly re-evaluated with the idea that HR will only be used for a few years at most, she says.
“There were 300 studies before WHI that found that estrogen and hormone replacement were the next best thing to the fountain of youth,” says Advanced Healthcare’s Dr. Henry Kaminski, a fellow of the American College of Obstetricians and Gynecologists. These studies suggested that hormone replacement could help prevent osteoporosis, colon cancer, macular degeneration, Parkinson’s disease, even tooth decay.
Then the WHI study introduced the suggestion of an increased risk of stroke, blood clots, heart disease and breast cancer in some patients. But, says Kaminski, the increased risks were not “statistically significant” based on typical research standards. Another weakness with the WHI study was that most patients were well past age 51, the median age of menopause onset.
Someone who has a first child after age 30 or is obese has a greater chance of getting breast cancer than someone taking traditional hormone replacement, says Kaminski.
“Life is a series of risks. Some are worth taking. Some are not,” he states. “If you have such hot flashes that you can’t sleep at night, why not take [traditional] hormone replacement therapy? [And] if estrogen needs to be used, it should be used for the shortest time possible.”
Bioidentical Compounding
Bioidentical hormones are “identical to what the body naturally produces” says Marla Ahlgrimm, a registered pharmacist and founder and chairman of Madison’s Women’s Health Associates/Madison Pharmacy Associates, believed to be the nation’s first pharmacy focusing on women’s health. “Synthetic hormones are similar but not identical.”
But does research support the effectiveness and safety of using bioidentical hormones? Some small studies have shown various benefits, but there have been no large, random, double-blind, placebo-controlled clinic
“You can’t patent natural hormones, so we don’t have the backing of a large pharmaceutical company,” says Monica Zatarski. With a Doctor of Pharmacy degree, she is a registered pharmacist at MD Custom Rx a compounding- only pharmacy in Glendale.
According to Zatarski, there are three types of “natural” estrogens: estriol, estradiol and estrone. Bioidentical estrogen will typically include 80 percent estriol and 20 percent estradiol, a formulation known as Biest. “There are no contraindications or interactions because they are naturally found in the body” says Zatarski.
Unless a woman has had a hysterectomy, estrogen is not prescribed by itself but in conjunction with a progesterone. Left unopposed, estrogen therapy can lead to endometrial cancer. So a bioidentical progesterone may also be prescribed.
“We are not putting a foreign substance in the body, so we can bypass side effects of synthetic hormones” Zatarski claims. “We can restore hormonal balance and eliminate symptoms. It takes a good two months for the hormones to stabilize in the body, but you can start to see some benefits in about two weeks. Often it takes some tweaking to get the optimal dose. It’s very effective to work with a physician who’s an expert hormone balancer,” but it’s not something typically taught in medical schools, she says.
Some proponents of bioidentical hormones use saliva tests to check and monitor hormone levels and prescribe a custom dosage.
“Natural hormones are very easy to measure in saliva, and we know the normal range when a woman is 40 or 50 or what you have,” says Ahlgrimm. “It can be monitored so you can use the lowest effective dose. But timing of saliva collection is very important.”
Dr. Rose Kumar, board certified in internal medicine and clinic director of the Ommani Center for Integrative Medicine in Pewaukee, uses a different measure- blood serum testing. “Because hormones vary day by day,” she says, “serum is much more accurate.” Kumar was traditionally trained in Western medicine, which is more apt to opt for serum testing.
The disadvantage of serum testing, Zatarski says, is that most hormones are bound up in proteins and may not be available for the body’s use. “With saliva testing…we can see the hormones available at the cellular level.”
But “saliva testing is very complicated,” she continues. It’s not readily available because not many laboratories can perform it. She uses an outside lab for testing.
For dosage, Kumar starts low, with .375 mg of estrogen as a topical cream rather than a pill-because it bypasses the GI tract and liver-and increases it as needed. By comparison, the standard dose synthetic Premarin is 625 mg.
“I’m not working on [hormone] levels as much as a woman’s symptoms,” says Kumar “Sometimes the lab values may lag behind. If she’s not responding or a dose adjustment needs to be made, I retest her to make sure she’s not overshooting the dose.”
Compounding Pharmacies
Compounding pharmacies that provide bioidentical hormones differ from typical retail pharmacies in that they focus on customizing the concentration, form or ingredients of medications to suit the preferences of individual customers. Patients who have swallowing disorders, for example, may receive a medication as a liquid instead of a pill.
Compounding Pharmacies start with raw ingredients; the ability to alter dosages per customer is one of the advantages of bioidentical hormones, say supporters.
Synthetic hormones are one-size-fits- all designed, which is a ridiculous concept, says Ahlgrimm. The dosage required to balance hormones is “much lower than anyone expected” and should vary by individual.
Pharmacist Zatarski emphasizes that she doesn’t determine what is compounded. A physician or prescribing nurse must write every prescription.
Compounding pharmacies swear by their quality-control processes, but Wyeth, the pharmaceutical giant that makes Premarin petitioned the FDA to block bioidentical hormone compounding, claiming that quality-control standards at compounding pharmacies aren’t as high as in the pharmaceutical industry.
Zatarski’s response: Wyeth should concern itself with its own quality-control issues, she says, which have been noted by the FDA.
“There are federal regulations in place that do govern compounding,” says Zatarski. “There is an accredited training process for prescription compounding.” Prescription compounding pharmacies and pharmacies in general operate under state control and not under the rule of the FDA.
Physicians Perspectives
“Synthetic hormones tend to be over stimulating,” says Kumar. “Bioidentical hormones are gentler on the body. I prescribe them for short-term use – three to six months – if the woman is having really severe side effects and needs hormone replacement to transition through menopause. Without data, long-term use is not indicated.”
Meanwhile Kaminski uses the term “bioequivalent” hormones rather than bioidentical because the chemical structure of substances taken from plants is somewhat modified for human use.
“We don’t know if all estrogens behave the same way” says Kaminski. “If I say bioequivalent hormones are better for you, you can’t back it up with evidence from studies. I don’t know if it’s better. Natural doesn’t mean safe.”
Many menopausal women suffering severe symptoms would like to find out –by research reports or personal experience. One way or another.
Other Alternative Approaches
“Bioidentical” hormones are alternatives to traditional “synthetic” hormone replacement therapy to treat menopausal symptoms. But when possible, some doctors prefer to use other options and avoid hormone supplements altogether.
“My preference is to manage these women with complementary medicine and lifestyle changes,” says Dr. Rose Kumar, who is board certified in internal medicine and clinic director of the Ommani Center for Integrative Medicine in Pewaukee. Kumar was traditionally trained in Western medicine, including a stint at Stanford University.
“Diet is a biggie, so is stress reduction, and Chinese herbal medicine, like black cohosh, chasteberry, and hawthorn, works very well,” she says. “Getting a massage twice a month helps produce endorphins, gives a boost to neurotransmitters and helps balance cortisol and DHEA” (hormones produced by the body.) To manage symptoms, Kumar may also prescribe regular exercise, such as brisk walking three to four times a week; acupuncture; and dietary supplements.