Issues in postmenopausal hormone therapy: A 3-part CME newsletter series
Counseling patients about bioidentical hormone preparations (Part 1 of 3)
Nanette F. Santoro
Professor and Director, Division of Reproductive Endocrinology, Department of Ob/Gyn and Women’s Health, Albert Einstein College of Medicine, Bronx, New York
Deciding how to manage menopausal symptoms is a balance between the desire to provide the most effective therapy and an individual’s risks. However, patients’ perceptions of the risks and benefits of hormone therapy can add additional complexity when selecting an agent. In this 3-part, case-based CME series, James H. Liu, MD, Nanette F. Santoro, MD, and Veronica A. Ravnikar, MD, FACOG, deftly navigate challenges in patient management, offering creative solutions to common problems.
In Case 1, Nanette F. Santoro, MD, discusses approaches to counseling patients about bioidentical hormone preparations. In Case 2, Veronica A. Ravnikar, MD, FACOG, addresses the risk for venous thromboembolism associated with hormone use in postmenopausal women. In Case 3, James H. Liu, MD, discusses alternatives to hormone therapy.
ACCREDITATION STATEMENT The American Society for Reproductive Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT The American Society for Reproductive Medicine designates this educational activity for a maximum of 0.25 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Release Date: October 6, 2009 Expiration Date: October 6, 2010 Estimated Time to Complete Activity: 0.25 hour
It is the policy of the ASRM to ensure balance, independence, objectivity, and scientific rigor in all its educational activities. All faculty/authors participating in this activity are expected to disclose any relationships they may have with companies whose products or services may be mentioned so that participants may evaluate the objectivity of the presentations. The content and views presented in this activity are those of the faculty/authors and do not necessarily reflect those of the ASRM or Solvay Pharmaceuticals, Inc. Any discussion of off-label, experimental, or investigational use of drugs or devices will also be disclosed. The disclosure statements were reviewed by the Subcommittee for Standards of Commercial Support of the CME Committee of ASRM and any perceived conflicts of interest were resolved in accordance with the policies of the ACCME.
NEEDS ASSESSMENT Background American women on average spend one-third of their lifetimes in the postmenopausal period, characterized by diminution of ovarian function with consequent changes in metabolism and body composition. Physical and physiologic changes associated with the postmenopausal state range from annoying to life-threatening. These include hot flushes, night sweats, sleep difficulties, depression, incontinence, sexual dysfunction, osteopenia and osteoporosis, and cardiovascular disease. However, it has been difficult to distinguish changes in bodily composition and metabolism due to normal aging from those due to ovarian senescence. Problems appear to be most common during the menopausal transition, or perimenopause, although the prevalence varies with race, ethnicity, smoking, alcohol consumption, exercise, weight, and general physical condition. As the population of the United States as a whole has aged, with increasing numbers of women in the postmenopausal state, medical researchers have sought remedies for postmenopausal symptoms. For almost 50 years, physicians have recognized that administration of estrogen alleviates hot flushes in some women, although in some women administration of placebo appears also to mitigate the frequency and severity of these thermogenic vasomotor episodes.Therapy for postmenopausal symptoms has focused on either (1) treating the underlying cause, ie, diminished production of ovarian hormones, or (2) treating the symptoms, ie, difficulty sleeping, bone loss, etc. Selection of hormonal versus nonhormonal treatments must be tailored to a woman’s specific circumstances, such as presence of an intact uterus, family history of breast cancer or osteoporosis, individual history of cardiovascular problems, etc. In addition, standard medical practice requires that therapy be based on sound scientific evidence and not place women at undue risk of adverse events. The publications emanating from the Heart and Estrogen/Progestin Replacement Study (HERS) and the Women’s Health Initiative (WHI) study led to a one-third decline in the use of hormone therapy by postmenopausal women ages 50 to 74 due to apparent slight, but statistically significant, increases in certain metabolic diseases. Stratification and reanalysis of the data now suggest that in fact hormone therapy does not increase the incidence of either breast cancer or coronary heart disease. The lingering uncertainty regarding the safety of hormone therapy has driven many patients and physicians to consider nonhormonal alternatives that have not proven effective in randomized controlled trials. These include soy, isoflavones, black cohosh, vitamin E, dong quai, evening primrose oil, ginseng, licorice, and acupuncture. Some women with mild hot flushes gain relief with simple modifications of lifestyle.A substantial proportion of women have resorted to “bioidentical” hormone preparations under the mistaken notion that a bioidentical hormone is better than a US Food and Drug Administration (FDA)–tested and approved preparation. Technically, a bioidentical hormone is one that is structurally identical to a naturally occurring hormone. The term bioidentical has come to be used to refer to mixtures of naturally occurring hormones prepared individually for patients by compounding pharmacists. These preparations vary with the person preparing the mixture. In January 2008, the FDA officially warned 7 pharmacy operations that their claims about the safety and efficacy of their so-called “bioidentical hormone replacement therapy” preparations were misleading and unsupported by medical evidence because the mixtures are not tested for purity, potency, efficacy, or safety.
Identification of the Practice Gap Patients and physicians are confused by conflicting reports of the efficacy and safety of hormone therapy, both FDA-approved and non–FDA-approved bioidentical, as evidenced by the decline in women using hormone therapy despite their desire to continue therapy.
A large percentage of postmenopausal women report being worried by news reports that the 2002 WHI report showed that hormone therapy is dangerous.
Physicians report that the ambiguous and inconclusive results of the WHI reports sent mixed messages to physicians and patients that compromised physicians’ ability to discuss hormone therapy with their postmenopausal patients.
Regardless of the type of preparation used, use of hormone therapy must consider the varying formulations available, pharmacodynamics, and individual patient factors.References
TARGET AUDIENCE This activity has been designed to meet the educational needs of health professionals who care for women from adolescence to postmenopause.
ACGME Competencies Patient Care; Interpersonal and Communication Skills
EDUCATIONAL OBJECTIVES At the conclusion of the educational activity, participants should be able to: Assess the composition, purity, potency, efficacy and safety of bioidentical hormone preparations.Describe the regulatory process related to bioidentical hormone preparations.Translate reports on efficacy and safety of various hormone therapies into appropriate prescriptive decisions.Discuss the issues of concern to patients and approaches to counseling patients about bioidentical hormone preparations.
Nanette F. Santoro, MD, reports that she serves as a consultant to QuatRx Pharmaceuticals.
There may be discussion of off-label or otherwise nonapproved uses of products and/or devices.
ACKNOWLEDGEMENT This CME activity is sponsored by the American Society for Reproductive Medicine.
STATEMENT OF SUPPORT This CME activity is supported by an educational grant from Solvay Pharmaceuticals, Inc.
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