These are confusing times for women in their years preceding or at menopause, whose total population is currently estimated at 54 million. Last year, studies indicate, they spent $2.75 billion on hormone replacement therapy drugs (HRT); for reference, that's comparable to peak Prozac sales. HRT drugs are dominated by Ayerst-Wyeth Labs' Premarin (estrogen), Provera (progestin) and Prempro (combination) brands, which have a combined 80 percent market share. But that market is being challenged now that the National Institutes of Health (NIH) terminated the Prempro portion of its Women's Health Initiative (WHI) HRT study three years early. As reported throughout the media, the combination hormone therapy research yielded small but statistically significant increases in cardiovascular disease and breast cancer, outweighing the decreased risk benefits of hip fractures and colon cancer. The estrogen-only (Premarin) portion of the study will continue among women with hysterectomies, who are not vulnerable to the risk of uterine cancer posed by unopposed estrogen, with findings due out in 2005. Some doctors contend that the overall increased absolute risks associated with Prempro are slight and warn patients of possible over-reaction to the findings. But the resulting doubts regarding HRT have left people questioning their position and searching for safer alternative therapies. Local pharmaceutical companies and doctors report increasing inquiries for information on natural therapies, which people assume carry less risk. The term ‘natural’ is broad at best, and can be confusing. It is applied to a wide variety of products, many of which are not subject to FDA study and approval, including vitamins, herbs (which are regulated in England), and natural hormones. Dr. Corinne deCholnoky of Stamford, CT, ob/gyn and frequent lecturer on menopause and natural therapies, points out that, "Premarin is natural in that it comes from a pregnant mare's urine; it's just not an appetizing source. Scorpion poison is natural, too.” When it comes to estrogen, she continues, “You have to know exactly what you're talking about when you use the term natural. When I talk about natural, I always talk about plant sources as opposed to other sources.” She stresses that these treatments should not be considered in a vacuum, but rather in the context of one's diet, exercise routines and stress levels.
Weeding through the options While it makes sense to begin with one's doctor, alternative therapies are not typically in the domain of traditional physicians, and may require some self-education to better one's understanding of menopause, symptoms of hormonal imbalance and treatments options. To this end, some hospitals, such as Stamford Health Center, are offering women's health seminars, as are some alternative pharmaceutical companies, such as At Last Naturals in Valhalla. There are important decisions to be made when we feel our hormones are thrown out of balance, says Dr. Erika Schwartz, author of The Hormone Solution and founder of the Natural Hormone Pharmacy in Valhalla. Do we replace them? Supplement them? Do nothing? Dr. Schwartz describes natural hormones as the "safe universal answer to symptoms of hormone imbalance." But how do we know they're safe without the benefit of clinical trials and FDA approval? Natural hormones are products derived from plants deemed fit for human consumption, i.e., soy beans and yams. They are classified as bioidentical, which means they are identical in structure to our own bodies' sex hormones. Dr. Schwartz explains that these bioidentical products are recognized by our estrogen and progesterone cell receptors as their own. They are therefore regarded as safer than synthetics; in the absence of synthetic molecules, they are believed to supplement without competing with our own hormones. Natural hormones have been available for approximately 20 years, but have not all been formally studied under clinical trial. Nor have they been patented, except for those with unique delivery systems, (i.e., patches), because their production does not typically involve a prerequisite for drug patents, that is, altered molecular structure. They can be obtained over-the-counter in cream form as well as by prescription in pill, cream or patch form. According to Christiane Northrup, M.D., best-selling author of The Wisdom of Menopause, a decline in progesterone is the first hormonal change to cause symptoms in women approaching menopause, symptoms that can be felt years before they suspect the nearing change. Dr. John R. Lee, author of What Your Doctor May Not Tell You About Menopause, fathered the concept of natural progesterone replacement for hormone balance, and OTC creams at 2 percent strength have been available for over 20 years. Dr. Northrup describes cream as a preferable delivery system because it enters the bloodstream quickly and easily without causing gastrointestinal disturbance or liver function stress. One such progesterone cream is the Equigest brand from At Last Naturals. Zane Last, pharmacist, senior vice president, and director of research and development for this company, says it is important for women to understand and take a role in their own care, and urges them “to find and work with doctors (or nutritionists or naturopaths) who are amenable to the natural approach." He recommends hormone level assessment at the outset of treatment to determine proper dosage, preferring saliva testing to the more traditional blood testing. If a woman works within the normal guideline of 20mg/day of progesterone cream for two weeks prior to menses and adjusts accordingly, Last reports no known side effects. When asked what possible negative effects could be felt, he allows that with moderate to higher doses, there can be a calming effect, "almost drunken-like when too high," versus estrogen which is excitatory. Dr. deCholnoky concurs that some women get sleepy or dizzy from natural progesterone. She emphasizes the importance of treating each patient on a individual basis, taking into account her lifestyle, symptoms, body build and estrogen production. She is less concerned with hormone level testing, stating, "The most important thing is to find out the patient's clinical symptoms at the time of treatment, as opposed to hormone levels which can change over time." Dr. Schwartz champions natural combination hormone replacement for hormone balance. At her pharmacy, she has bioidentical hormones compounded into a cream whose dosage is meted out in daily individual portions via syringe (versus a standard tube). The components are estradiol (already available in measureable cream amounts in France) and micronized progesterone (Estrace and Prometrium), which are both FDA-approved drugs but not so in combination. She describes the cream as bioavailable, meaning it can be effectively processed and transformed into the needed hormones. She maintains that this is not the case with the OTC natural hormone products; not only are they typically not bioavailable, she says, but they are offered separately rather than in combination, and at inadequate doses. She never prescribes estrogen without progesterone, emphasizing that "it is the balance between estrogen and progesterone that saved the day... the balance keeps us healthy at any age so what is needed at all times is the right balance of both." When asked what negative side effects of her lowest dose prescription could be, she mentions breast tenderness and bloating, but adds that she monitors her patients with follow-up appointments and phone consultations. Her belief in the safety of natural hormones is founded in her understanding of the difference between synthetic and natural hormones, and her own research and experience with patients and prescriptions without any observed harmful side effects. Dr. deCholnoky suggests that such treatments are still somewhat intuitive; since these drugs have not been studied in the same way as Premarin/Provera, one can't prove that they are better or safer in the long run. In fact, she cautions, "Any time you use estrogen, you have all the same concerns no matter what formulation of estrogen, even if plant-based. They all have the same effect and that's the bottom line." Dr. Schwartz hopes to be able to one day prove the safety of natural hormones. She has been in contact with the NIH, which is currently studying some herbal treatments, such as black cohosh for night sweats (Remifemin, already approved in Germany), to start a non-profit research institute for natural hormone research. Dr. Isaac Schiff, chief of obstetrics/gynecology at Massachusetts General Hospital and head of The American College of Obstetrics and Gynecology task force on HRT guidelines, has expressed his support. Additionally, there is already ongoing research at Columbia on phytoestrogens (plant-based estrogens). The NIH termination of its Prempro arm of the WHI study has heightened levels of doubt and confusion about safe and effective hormone therapy. But it has also brought the dialogue about menopause and its treatment more out into the open, engendering perhaps a greater open-mindedness among patients and their doctors towards possible alternative therapies.
RESOURCES Organizations • National Women's Health Network, "The Truth About Hormone Replacement Therapy”, www.womenshealthnetwork.org, (202) 628-7814 • Natural Woman Institute, www.naturalwoman.org • World Health Organization, www.who.int
Books and Author Websites • Herbal Health for Women, by Rosemary McIntyre • The Hormone Solution, by Erika Schwartz, M.D., www.HormoneSolution.com • Super Nutrition for Menopause, by Anne Louise Gettelman • What Your Doctor May Not Tell You About Menopause, by John R. Lee, M.D., www.johnleemd.com • The Wisdom of Menopause, by Christiane Northrup, M.D. , www.drnorthrup.com (videotape and newsletter as well) • Women's Herbs, Women's Health, by Christopher Hobbs and Kathi Keville