Issues in postmenopausal hormone therapy: Depression, endometrial health, and discontinuation

http://www.srm-ejournal.com/pages.asp?id=8042 

The American Society for Reproductive Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The American Society for Reproductive Medicine designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Expiration Date: October 1, 2010

Needs assessment
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 flashes, 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 an 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.

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