hrtrecommendation

The following is the recommendation from the

Response to Women's Health Initiative Study Results

by The American College of Obstetricians and Gynecologists

August 9, 2002

Recommendations For Hormone Replacement Therapy Use

It is important to reemphasize that this trial from the WHI studied only one formulation of

hormone replacement therapy (0.625 mg/d conjugated equine estrogen and 2.5 mg/d

medroxyprogesterone acetate), and results are applicable only to this regimen. The ability to

extrapolate results to other formulations is limited. The following recommendations are based

on an ACOG expert panel review of the best currently available data.

The decision about use of HRT requires evaluation of the risks and benefits for each individual

woman. For women currently using HRT, it is important to assess their reasons for use and to

evaluate potential risks, benefits and alternatives.

In the past, short-term use has generally been defined as use of HRT for five years or less, most

often prescribed to treat acute menopausal symptoms. There are no data from this study to

establish clearly what constitutes safe short-term use. An increase in the diagnosis of invasive

breast cancer appears after four years of use, but the influence of continuous estrogen and

progestin therapy on breast cancer is unclear after even one year of use due to the biology of

breast cancer.

Women who take HRT for the management of vasomotor symptoms should be encouraged to

take it for as short a time as possible and to use the lowest effective dose. Long-term use of

continuous combined estrogen and progestin therapy should be discontinued in asymptomatic

patients. Patients interested in HRT for long-term use should be counseled about the risks and

benefits of use, and about available alternatives. After counseling, women who want to continue

taking HRT for general improvement in well-being may do so provided they understand the

potential risks. In addition, for a postmenopausal woman with a uterus, switching from an

estrogen and progestin combination to unopposed estrogen is not recommended, due to the

increased risk of endometrial cancer (3). Women who choose to continue HRT for quality-of-life

benefits should reevaluate the need for HRT periodically. If they decide to continue, they should

be encouraged to use the lowest possible dose.

HRT has been shown to be the most effective treatment for symptomatic relief of vasomotor

symptoms including hot flashes (4). For patients who decide not to use HRT, nonhormonal

alternatives such as selective serotonin reuptake inhibitors, clonidine, or Bellergal-S may be

helpful for this indication (5). Other agents such as black cohosh have been proposed; however

there are conflicting data on effectiveness, and safety profiles are not established.

Based on the WHI data, combined continuous estrogen and progestin therapy is no longer

recommended for the prevention of cardiovascular disease, and if previously prescribed for that

purpose should be discontinued. In fact, the risk of stroke and pulmonary embolism appear to

increase within the first two years of the study. Alternatives for improved cardiovascular health,

including lifestyle modifications such as exercise smoking cessation and weight loss should be

encouraged for all women. The use of cholesterol-lowering medications such as statins and the

need for treatment of hypertension should be evaluated for each individual patient.

For patients with osteoporosis, other preventive therapies such as bisphosphonates and selective

estrogen receptor modulators are available. However, for women at risk of osteoporosis who

also have vasomotor menopausal symptoms, HRT can be of benefit.

For genitourinary symptoms associated with menopause, estrogen and progestin have been

shown to be beneficial. Alternatives to oral delivery of estrogen, such as vaginal creams, tablets

or rings, are usually effective. Although these delivery methods do not increase systemic

estrogen levels appreciably, there are little data to assess the long-term safety of these

alternatives.

For women with a family history of colorectal cancer, the risk-benefit ratio for use of combined

estrogen and progestin remains unclear. While there appears to be a benefit with hormone use,

the study results do not appear sufficiently robust to recommend its use solely for the prevention

of colorectal cancer. In addition, routine periodic screening such as by fecal occult blood testing,

flexible sigmoidoscopy, or colonoscopy will help to prevent colorectal cancer by identifying

polyps that can be removed before they become cancerous.

The WHI study did not address possible cognitive indications for HRT such as the prevention of

Alzheimer's disease, or mood disturbances. Other studies on these indications are inconclusive.

A determination of appropriate follow-up for patients who choose HRT is also important.

Periodic reassessment of the need for HRT is recommended at least at every annual visit or more

frequently if indicated.

Patients should use the lowest dose of HRT that provides relief of symptoms. Some limited data

suggest that the adverse effects of HRT may be dose related (6). In addition, patients may find

fewer adverse effects with discontinuation of use on a lower dose.

For women planning to discontinue use of hormone therapy, there are no definitive data to guide

this process. Whether stopping abruptly or discontinuing use incrementally, some patients will

develop vasomotor symptoms and will have to restart medication. Physicians should be aware

that when discontinuing HRT, women may also experience vaginal bleeding, which may at times

be heavy. If symptoms recur, more gradual withdrawal should be considered.

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