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Complete Summary

GUIDELINE TITLE

Estrogen and progestogen therapy in postmenopausal women.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Estrogen and progestogen therapy

GUIDELINE CATEGORY

Management
Prevention

CLINICAL SPECIALTY

Family Practice
Internal Medicine
Obstetrics and Gynecology

INTENDED USERS

Physicians

GUIDELINE OBJECTIVE(S)

To present recommendations for the use of hormone therapy to treat or prevent problems associated with the decline of estrogen production by the ovaries after menopause

TARGET POPULATION

Postmenopausal women

INTERVENTIONS AND PRACTICES CONSIDERED

  1. Estrogen alone therapy (EP)
  2. Estrogen combined with progesterone therapy (E/PT)

MAJOR OUTCOMES CONSIDERED

  • Cessation of symptoms associated with estrogen depletion
  • Adverse effects associated with hormone therapy

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

METHODS USED TO ANALYZE THE EVIDENCE

Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The Practice Committee of the American Society for Reproductive Medicine and the Board of Directors of the American Society for Reproductive Medicine approved this report.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • Hot flushes occur in over 50% of women entering the menopause and the frequency declines to 30% after three years. Symptoms may persist, however, in up to 16% of women at 67 years of age.
  • The usual reason for prescribing hormone therapy (HT) is the treatment of vasomotor symptoms. The average patient is a woman aged 45 to 60 years, and the most common duration of use is less than three years.
  • Estrogen with or without progestogen is an effective treatment for urogenital atrophy, but may worsen urinary incontinence.
  • Estrogen and progestogen reduce risk of osteoporotic fractures of the hip, vertebrae, and other sites, but the effect on hip fracture is small, and HT treatment is not warranted solely for fracture prevention.
  • Although estrogen was associated with a 34% reduction in the risk of senile dementia in epidemiological studies, the Women's Health Initiative Memory Study (WHIMS) failed to corroborate these observations.
  • HT is not indicated for the primary or secondary prevention of coronary artery disease events. Alternative health strategies and pharmaceutical agents with established value should be used for primary prevention of coronary heart disease.
  • Risk of venous thromboembolism is increased among women using estrogen/progestogen therapy (E/PT) and declines during continuing use. Route of administration may affect the magnitude of risk.
  • E/PT treatment has a small but significant effect on breast cancer risk equivalent to eight new cases per annum per 10,000 women. The increased risk is seen after five years of current use and disappears several years after discontinuing therapy.
  • Epidemiological studies suggest that there is a small but significant increased risk of epithelial ovarian cancer with unopposed estrogen use that is not observed when estrogen is combined with progestin. The effect is significant in women who take ET for 10 or more years.
  • ET and E/PT are associated with side effects that include breast tenderness, vaginal discharge, and uterine bleeding.
  • The current indications for ET and E/PT include the treatment of moderate to severe vasomotor symptoms, the treatment of vulvar and vaginal atrophy, and the prevention of osteoporosis.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each recommendation.

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

  • Reduce symptoms resulting from estrogen depletion, including hot flushes, sleeplessness, lethargy, depressed mood, and vaginal dryness
  • Treat urogenital atrophy
  • Prevent osteoporosis

POTENTIAL HARMS

  • Estrogen therapy (ET) and estrogen/progestogen therapy (E/PT) are associated with side effects that include breast tenderness, vaginal discharge, and uterine bleeding.
  • Risk of venous thromboembolism is increased among women using estrogen/progestogen therapy (E/PT) and declines during continuing use. Route of administration may affect the magnitude of risk.
  • E/PT treatment has a small but significant effect on breast cancer risk equivalent to eight new cases per annum per 10,000 women. The increased risk is seen after five years of current use and disappears several years after discontinuing therapy.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

While this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better
Staying Healthy

IOM DOMAIN

Effectiveness
Patient-centeredness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 Jan

GUIDELINE DEVELOPER(S)

American Society for Reproductive Medicine - Private Nonprofit Organization

SOURCE(S) OF FUNDING

American Society for Reproductive Medicine

GUIDELINE COMMITTEE

The Practice Committee of the American Society for Reproductive Medicine

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the American Society for Reproductive Medicine Web site.

Print copies: Available from American Society for Reproductive Medicine, 1209 Montgomery Highway, Birmingham, Alabama 35216-2809; Phone: (205) 978-5000; Fax: (205) 978-5005; E-mail: asrm@asrm.org; Web site: www.asrm.org.

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on August 23, 2004.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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