Natural May Not Mean Safe

Dental hygienists have a variety of interrelated roles—including clinician, educator, researcher, administrator/ manager, and advocate. In order to fulfill these roles, hygienists must be well versed in the most current medical, pharmacological, and clinical research findings. Pharmacology is particularly challenging because it is constantly changing, but understanding drug interactions and possible adverse reactions are paramount to providing safe and efficacious treatment planning. The use of bio-identical hormone replacement therapy is common among women during and after menopause and its use may have significant health implications.

Menopause is a normal transition that occurs in all women. The term menopause literally means “without estrogen” and occurs when menstruation has ceased for 12 months.^1,2 Perimeno pause—the time before the onset of menopause—may last several years and is characterized by irregular menstrual cycles. Many but not all perimenopausal and postmenopausal women report a variety of symptoms including hot flashes, flushing of the face, interrupted sleep, mood swings, memory loss, irritability, not feeling well, and depression. These symptoms are likely related to the natural decline of estrogen levels.^2,3

To treat these symptoms, women have been using hormone replacement therapy (estrogen and progesterone) for more than 50 years. The number of annual hormone therapy prescriptions increased from 58 million in 1995 to 90 million in 1999; the highest level—91 million—was reached during the 2000 to 2001 time period.⁴ In 2002, research was published that noted possible harmful effects from the use of conventional hormone therapy, thus prescriptions for popular hormone replacement drugs declined dramatically from January through June of 2003.⁴

The 2002 research included results from the 1993-1998 Women’s Health Initiative Study (WHI). The objective of WHI was to assess the risks and benefits of combined estrogen and progestin (a synthetic form of the hormone progesterone) therapy on cardiovascular disease, cancer, and osteoporosis in postmenopausal women.⁵ The study was originally designed to last 81/2 years but after 5 years, the safety monitoring board recommended that the study be discontinued because of the increased risk of coronary heart disease and breast cancer in women taking estrogen and progestin. It was concluded that the overall health risks exceeded the benefits of using the combined estrogen plus progestin. The WHI results indicated that hormone replacement therapy should not be initiated or continued for the primary prevention of cardiovascular disease or osteoporosis.⁶

Because of the risk incurred from conventional hormone replacement therapy, approximately 30% of menopausal women now seek complementary and alternative therapies to treat menopausal symptoms, which may include “natural” hormones.⁷

THE NATURAL APPROACH

When updating the medical histories of female patients, dental hygienists should ask about the possible use of hormone replacement therapy, including bio-identical hormone replacement therapy (BHRT). BHRT includes drugs that address menopause symptoms and are marketed as “natural.” These drugs are available commercially or they are compounded by pharmacies into different doses and for different routes of administration. In general, compounded BHRT may include estriol, estrone, estradiol, testosterone, micronized progesterone, and occasionally, dehydroepiandrosterone (DHEA).⁷ Bio-identical hormones are not approved by the Food and Drug Administration (FDA) and no credible scientific evidence exists to support claims on the safety and effectiveness of compounded BHRT drugs.⁸

The term “bio-identical” has no defined meaning in any medical or conventional dictionary and is often used in conjunction with the term “natural.”⁹ Bio-identical hormones are advertised as natural pharmacy-compounded hormones that are synthesized from chemical substances found in various plants (most commonly soybeans and wild yams). BHRT may be used by women to alleviate distressing symptoms associated with menopause. Proponents of BHRT speculate that these hormones produce fewer side effects than synthetic hormones because they bind to receptor sites exactly, while artificial and nonbio-identical versions do not match as closely.¹⁰ Although BHRT products are plant-derived, they must be chemically altered so that they replicate the endogenous human hormones.¹¹

Many women believe that these hormones have fewer or no side effects or risks compared to traditional hormone replacement therapy. A survey conducted by Adams et al¹² explored women’s beliefs about “natural” hormones and the risks and side effects compared to traditional hormone replacement therapy. Of the women surveyed, 90% reported that they had heard about natural hormones. Of those, about half believed natural meant plant-derived, not synthesized or made without chemicals. Most believed that natural hormones had fewer or no risks (71.4%), had fewer or no side effects (69.0%), and were equally or more effective for managing menopause symptoms (61.8%).¹²

PHARMACY COMPOUNDING

Pharmacy compounding is the preparation of an individualized prescription drug product by a pharmacy to fill a medical prescription for a patient. For example, a child may not be able to swallow a medication in a pill form, so the pharmacy may compound the prescribed medication into a liquid version. The FDA does not directly regulate this practice.¹¹

Traditional compounding fills an essential need for some patients who have prescription drug needs that can’t be met by commercial pharmaceutical companies. The FDA is working on distinguishing between traditional pharmacy compounding and nontraditional pharmacy compounding.¹¹ The concern comes from the nontraditional pharmacy practice of compounding bio-identical hormones using questionable methods to meet a patient’s individualized requirements. These compounded prescription drugs are available via the Internet and can also be found in magazine advertisements where they are marketed as wholesale replacements for commercial prescription drugs.¹¹

DENTAL IMPLICATIONS

Traditional hormone supplements (including birth control) may cause adverse oral and physical effects, including exacerbation of gingivitis and bleeding, dizziness, headache, migraines, and depression.⁹ Changes in hormone levels that occur during puberty, pregnancy, menstruation, and menopause, as well as those that happen with the use of hormone supplements are related to the development of gingivitis.¹ Hormone replacement drugs may interact with medications for seizure disorders, depression, or other mental disorders. They are contraindicated for people who have hypertension, blood vessel disease, breast cancer, ovarian cancer, heart attack, stroke, and blood clotting disorders.¹³

Many bio-identical hormones are similar to the hormones used in some commercial pharmaceutical preparations. For example, Estradiol, a bio-identical hormone is available commercially (including Estrace®, Gynodiol ®, and generics).¹⁴ Until reliable clinical research proves otherwise, enough evidence suggests that BHRT carries the same adverse effects as conventional meno pausal hormone regimens.^13,14

Traditional hormone replacement therapies have long lists of side effects and warnings. Many women believe that “natural” hormones have fewer side effects or no risks. Due to the lack of randomized, controlled clinical research studies conducted on BHRT, there is no way to positively determine adverse effects or oral implications associated with its use.^7,8,11,15 Female patients should be encouraged to discuss BHRT with their medical providers. BHRT may cause adverse oral effects, including gingivitis, and may contain ingredients that interact with prescription drugs. Dental hygienists serve as patient advocates and this information can help them fulfill their role in promoting oral and systemic health.

REFERENCES

1. Krejci CB, Bissada NF. Women’s health issues and their relationship to periodontitis. J Am Dent Assoc. 2002;133:323-329.
2. Farquhar C, Marjoribanks J, Lethaby A, Suckling JA, Lamberts Q. Long term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2009;2:CD004143.
3. Menopause Resources. The Hormone Foundation. Available at www.hormone.org/menopause. Accesed August 14, 2009.
4. Hersh AL, Stefanick ML, Stafford RS. National use of postmenopausal hormone therapy annual trends and response to recent evidence. JAMA. 2004;291:47-53.
5. National Heart Lung and Blood Institute. The Women’s Health Initiative: Clinical Trials. Available at: www.nhlbi.nih.gov/resources/deca/descriptions/whict.htm. Accessed August 14, 2009.
6. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of esrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288:321-33.
7. Cirigliano M. Bioidentical hormone therapy: a review of the evidence. J Womens Health. 2007;16:600-631.
8. Bio-identical Hormones: Sorting Myths From Facts. Food and Drug Administration. Available at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm. Accessed August 14, 2009.
9. Gage TW, Pickett FA, eds. Mosby’s Dental Drug Reference. 7th ed. St. Louis: Elsevier-Mosby; 2005:299-303.
10. Watt PJ, Hughes RB, Rettew LB, Adams R. A holistic programmatic approach to natural hormone replacement. Fam Community Health. 2003;26:53-63.
11. Patsner B. Pharmacy compounding of bioidentical hormone replacement therapy (BHRT): a proposed new approach to justify FDA regulation of these prescription drugs. Food Drug Law J. 2008;63:459-491.
12. Adams C, Cannell S. Women’s beliefs about “natural” hormones and natural hormone replacement therapy. Menopause. 2001;8:433-440.
13. Drug Facts and Comparisons Pocket Version. 13th ed. St. Louis: Wolters Kluwer Health; 2009:113-159.
14. Fugh-Berman A, Bythrow J. Bioidentical hormones for menopausal hormone therapy: variation on a theme. J Gen Intern Med. 2007;22:1030-1034.
15. Boothby LA, Doering P. Bioidentical hormone therapy: a panacea that lacks supportive evidence. Curr Opin Obstet Gynecol. 2008;20:400-407.

From Dimensions of Dental Hygiene. September 2009; 7(9): 32-35.