Should Symptomatic Menopausal Women Be Offered Hormone Therapy?

Rogerio A. Lobo, MD; Serge Bélisle, MD, MSc; William T. Creasman, MD; Nancy R. Frankel, BS, MBA; Neil F. Goodman, MD, FACE; Janet E. Hall, MD; Susan Lee Ivey, MD, MHSA, FAAFP; Sheryl Kingsberg, PhD; Robert Langer, MD, MPH; Rebecca Lehman, MPAS, PA-C; Donna Behler McArthur, PhD, APRN, BC, FAANP; Valerie Montgomery-Rice, MD; Morris Notelovitz, MD, PhD, MB, BCh, FRCOG, FACOG; Gary S. Packin, DO, FACOOG; Robert W. Rebar, MD; MaryEllen Rousseau, CNM; Robert S. Schenken, MD; Diane L. Schneider, MD, MSc; Katherine Sherif, MD; Susan Wysocki, NP

In This Article

Abstract and Background

Many physicians remain uncertain about prescribing hormone therapy for symptomatic women at the onset of menopause. The American Society for Reproductive Medicine (ASRM) convened a multidisciplinary group of healthcare providers to discuss the efficacy and risks of hormone therapy for symptomatic women, and to determine whether it would be appropriate to treat women at the onset of menopause who were complaining of menopausal symptoms.
Major Findings: Numerous controlled clinical trials consistently demonstrate that hormone therapy, administered via oral, transdermal, or vaginal routes, is the most effective treatment for vasomotor symptoms. Topical vaginal formulations of hormone therapy should be preferred when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy. Data from the Women's Health Initiative indicate that the overall attributable risk of invasive breast cancer in women receiving estrogen plus progestin was 8 more cases per 10,000 women-years. No increased risk for invasive breast cancer was detected for women who never used hormone therapy in the past or for those receiving estrogen only. Hormone therapy is not effective for the treatment of cardiovascular disease and that the risk of cardiovascular disease with hormone therapy is principally in older women who are considerably postmenopause.
Conclusions: Healthy symptomatic women should be offered the option of hormone therapy for menopausal symptoms. Symptom relief with hormone therapy for many younger women (at the onset of menopause) with menopausal symptoms outweighs the risks and may provide an overall improvement in quality of life. Hormone therapy should be individualized for symptomatic women. This involves tailoring the regimen and dose to individual needs.

The use of hormone therapy in menopausal patients underwent a dramatic shift following the published results of the Heart and Estrogen/Progestin Replacement Study (HERS) and the Women's Health Initiative (WHI). Hersh and colleagues[1] evaluated national trends in hormone therapy use between January 1995 and July 2003 using the National Prescription Audit and the National Disease and Therapeutic Index databases. Prior to the release of the HERS and WHI results, approximately 42% of women aged 50-74 years were taking hormone therapy. Following the publication of HERS and WHI results in 2002, hormone therapy exposure declined to 28% of women in this age group. Further, annual prescriptions fell 38%, from 91.0 million in 2001 to 56.9 million in 2003. The greatest decline in hormone use was among the oral estrogen and oral estrogen/progestin preparations, contrasting that of transdermal and vaginal formulations which remained stable.

HERS showed that in women with preexisting coronary heart disease (CHD), hormone therapy (conjugated equine estrogens [CEE] 0.625 mg and medroxyprogesterone acetate [MPA] 2.5 mg) was not effective as a means of preventing cardiovascular events and was associated with an increased risk for myocardial infarction in the first year in some women.[2] Similarly, the attributable risk (per 10,000 person-years) as reported by the WHI was 7 more CHD events, 8 more strokes, and 8 more invasive breast cancers, as well as 5 fewer hip fractures and 6 fewer colorectal cancers.[3] However, selective reporting from the popular media and some scientific sources have clouded the overall results from WHI by emphasizing results in terms of relative risks. For example, the 29% increase in CHD, 41% increase in stroke, 26% increase in breast cancer, 37% reduction in colorectal cancer, and 34% reduction in hip fractures were presented as a meaningful increase in risk rather than risks which were all less than 1.5 times the placebo rate. In the case of CHD, the final data analysis found that the relative risk decreased from 29% to 24%, and the overall risk of CHD did not achieve statistical significance.[4]

A number of position papers by major organizations have attempted to clarify the risks and benefits with hormone therapy in the aftermath of the recent clinical trials. However, despite such efforts, the popular media failed to correctly communicate the clinical implications of the results for everyday practice of providing healthcare to the individual patient. The influence of the media on this matter was underscored by a postal survey of 1700 current users of hormone therapy in Sweden. Hoffmann and colleagues[5] found that women (53-54 years of age) perceived hormone therapy as more risky and less beneficial in 2003 (post HERS II and WHI) compared with 1999. The major sources of information that women relied on were from print media (43.8%) and television/radio (31.7%). Only 18.3% of women received information about hormone therapy from their healthcare providers. Use of hormone therapy decreased from 40.5% to 25.3%, and this decline was significantly correlated with the changes in attitudes towards hormone therapy (P < .001).

Many physicians also remain uncertain about prescribing hormone therapy for symptomatic women at the onset of menopause. For example, Williams and colleagues[6] conducted a postal survey in March 2004 of all primary care physicians in Florida about their understanding of the risks and benefits of hormone therapy. The respondents comprised 600 primary care specialists, including 203 ob/gyns, 145 internists, 219 family practitioners, and 33 "other." They found that respondents overestimated the magnitude of risks and benefits with hormone therapy 67% of the time. The study authors postulated that the lack of understanding regarding attributable risk and relative risk may have contributed to the overestimation of risk (and benefit). These concepts will be discussed later in this article.

The data from Williams and colleagues, as well as others, underscore the need to educate physicians to address perceptions of hormone therapy based on WHI findings and clarify the appropriate use of hormone therapy in symptomatic menopausal women. In October 2004, the American Society for Reproductive Medicine (ASRM) reported the results of an online survey of 556 reproductive health professionals at its annual meeting. Nearly 100% of the reproductive health professionals surveyed agreed that their patients are confused about menopausal treatments, and 73% said that they spend a considerable amount of time counseling their menopausal patients about the best treatment. On the basis of the survey results and many informal conversations, ASRM concluded that additional guidance and educational tools were needed to assist general gynecologists and primary care practitioners in appropriate decision-making for the treatment of symptomatic menopausal women.

In November 2005, ASRM supported a workshop that convened a multidisciplinary group of healthcare providers to discuss whether it would be appropriate to treat healthy women at the onset of menopause who were complaining of menopausal symptoms. This was not a consensus meeting and there was no intent to duplicate or modify position papers of major organizations such as the American College of Obstetrics and Gynecologists, American Society for Reproductive Medicine, the North American Menopause Society, etc. Eighteen national societies whose members provide primary care for women were invited to send representatives to the workshop. It was predetermined, however, that these member representatives were representing themselves and not the official positions of the societies. Presentations focused on hormone therapy as a therapeutic option for the major symptoms (ie, vasomotor symptoms, vulvovaginal problems, mood/depression, and changes in sleep and sexual function) associated with the onset of menopause. This publication is not a position statement, nor does it represent the official positions of the societies who sent representatives. Rather, this document is a condensed summary of the presentations, discussions, and clinical experience of the group in addressing this important clinical scenario of the symptomatic menopausal woman seeking treatment.


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