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Why you (still) shouldn’t prescribe hormone therapy for disease prevention

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?1

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

References

1. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Final recommendation statement. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/recommendation/menopausal-hormone-therapy-preventive-medication

2. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Evidence summary. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary28/menopausal-hormone-therapy-preventive-medication

3. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310:1353-1368. doi: 10.1001/jama.2013.278040

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Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the CDC’s Advisory Committee on Immunization Practices.

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Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the CDC’s Advisory Committee on Immunization Practices.

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the CDC’s Advisory Committee on Immunization Practices.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?1

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?1

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

References

1. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Final recommendation statement. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/recommendation/menopausal-hormone-therapy-preventive-medication

2. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Evidence summary. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary28/menopausal-hormone-therapy-preventive-medication

3. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310:1353-1368. doi: 10.1001/jama.2013.278040

References

1. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Final recommendation statement. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/recommendation/menopausal-hormone-therapy-preventive-medication

2. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Evidence summary. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary28/menopausal-hormone-therapy-preventive-medication

3. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310:1353-1368. doi: 10.1001/jama.2013.278040

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