Treatment Options

Hormone Replacement Therapy (HRT) - FDA approved manufactured products

Intermediate Value

This assessment does not address Bioidentical Hormone Replacement Therapy (BHRT) - compounded.It is addressed in a separate assessment.  This assessment does not address testosterone therapy. 

U. S. Food and Drug Administration (FDA) approved manufactured products for hormone replacement therapy (HRT) have traditionally been used to treat the symptoms of menopause.  Every woman experiences menopause differently.  Some may not experience any noticeable effects at all.  HRT is the replacement of estrogen or estrogen and progestin hormones. HRT consists of estrogen alone for women whose uterus has been removed or estrogen with progestin for women who still have their uterus.

Menopause is sometimes called “the change of life.”  Natural menopause occurs when the ovaries gradually produce lower levels of estrogen and progesterone and the woman has her last menstrual period.  It is considered complete when menstruation has stopped for one year. Surgical menopause occurs when both ovaries are surgically removed, and the production of estrogen stops immediately.  Menopause may include symptoms such as hot flashes, night sweats, sleeplessness and vaginal dryness.  Conditions such as weak bones and heart disease are more common in women postmenopause.  Postmenopause is the term for all the years beyond menopause – either natural or surgical.

In addition to treating the symptoms of menopause, some research seems to indicate that HRT prevents bone fractures and colorectal cancer.  Recent studies indicate that the risks of long-term estrogen with progestin outweigh the benefits for postmenopausal women.  Women should discuss the options, risks and benefits of HRT with their health care provider.

 

Things to Consider

  • This assessment does not address bioidentical hormone replacement therapy (BHRT) - compounded.  It is addressed in a separate assessment.  This assessment does not address testosterone therapy.
  • Women are advised to discuss their options, as well as the risks and benefits of HRT with their health care provider.  Short-term hormonal therapy may be prescribed by your health care provider for conditions other than menopause.
  • The American College of Obstetricians and Gynecologists (ACOG) in February of 2009 stated that “The decision of whether or not to take hormone therapy for menopausal symptoms is highly individualized based on a woman's health, risk factors, and personal wishes. There are a number of FDA-approved hormone therapy products available in a variety of formulations. ACOG advises women to talk with their doctor about both the benefits and risks of hormone therapy.”
  • Hormone replacement therapy, with estrogen or estrogen and progestin, has traditionally been prescribed for the management of menopausal symptoms.  Drugs for this use must be approved by the U. S. Food and Drug Administration (FDA).
  • According to the FDA, the major points arising from the WHI (Women’s Health Initiative) study and the WHIMS (Women’s Health Initiative Memory Study) released in 2002 and 2003 are:
    • “Postmenopausal women should not take estrogen and progestin to protect the heart
    • Estrogens and progestins may increase the risk of heart attack, stroke, blood clots and breast cancer
    • Although other doses of Prempro (the dose of Prempro used in the WHI study was 0.625mg) and other estrogens and progestins were not studied, it is important to warn postmenopausal women who take estrogens and progestins about the potential risks, which must be presumed to be the same
    • When these drugs are being prescribed only to prevent osteoporosis, health care providers are encouraged to consider other treatments before prescribing estrogen or estrogen with progestin
    • Estrogens and estrogen with progestin should be used at the lowest dose for the shortest duration
    • The estrogen with progestin combination studied in WHIMS does not prevent dementia or slow progress toward dementia over time”
    • Women treated with combination estrogen plus progestin have a greater risk of developing dementia
    • There is a higher incidence of mammography abnormalities requiring medical attention”

See also:

  • Bioidentical Hormone Replacement Therapy (BHRT) - compounded

 

Results

Intermediate Value

Will I live longer if I take hormone replacement therapy?

No. This treatment will not lengthen your life.  The risks involved with HRT need to be discussed with your health care provider to help you determine if the benefits outweigh the risks.    

Will hormone replacement therapy improve my quality of life?

For some women, HRT may improve quality of life by minimizing symptoms of menopause. However, risks of stroke, blood clots and heart attack are increased.

Will hormone replacement therapy make my symptoms better?

For some women, HRT will improve menopausal symptoms.  Talk with your health care provider to help you determine if the benefits outweigh the risks

 

Safety

Little Value

The American College of Obstetricians and Gynecologists (ACOG) in February of 2009 stated that “The decision of whether or not to take hormone therapy for menopausal symptoms is highly individualized based on a woman's health, risk factors, and personal wishes. There are a number of FDA-approved hormone therapy products available in a variety of formulations. ACOG advises women to talk with their doctor about both the benefits and risks of hormone therapy.”

According to the FDA:

  • “Estrogens and progestins should not be used to prevent memory loss, heart disease, heart attacks, or strokes.
  • Estrogens provide valuable therapy for many women, but carry serious risks, and therefore postmenopausal women who use or are considering using estrogen or estrogen with progestin treatments should discuss with their physicians whether the benefits outweigh the risks.
  • For hot flashes and significant symptoms of vulvar and vaginal atrophy, these products are the most effective approved therapies. These products are also options for women whose significant risk of osteoporosis outweighs the risks of treatment; other treatments for prevention of postmenopausal osteoporosis are available.”  There may be value in preventing osteoporosis and heart disease the first 5 years after menopause especially in younger women with premature menopause.
  • “Estrogens and progestins should be used at the lowest doses for the shortest duration to reach treatment goals, although it is not known at what dose there may be less risk of serious side effects.
  • Women are encouraged to talk to their health care provider regularly about whether treatment is still needed.
  • There is a higher incidence of abnormal mammograms which require medical attention.
  • Each woman’s individual medical situation needs to be carefully discussed with her health care provider to make the best decision for her”

Minor reported complications with estrogen and progestin therapy:

  • Nausea and vomiting, cramps or bloating in the abdomen
  • Hair loss or abnormal hairiness
  • Breast tenderness or enlargement, pain and discharge
  • Fibrocystic breast changes
  • Enlargement of benign uterine fibroids
  • Change in the amount of cervical secretion
  • Vaginal yeast infections
  • Stomach cramps
  • Fluid retention (edema)
  • Spotty darkening of the skin (particularly on the face), reddening of the skin, skin rashes, hives
  • Headaches, migraines, dizziness or changes in vision (including intolerance to contact lenses)
  • Involuntary muscle spasms
  • Increase or decrease in weight
  • Change in sex drive – may increase or decrease
  • Nervousness, mood disturbances and irritability
  • Reduced carbohydrate tolerance
  • Leg cramps

Major reported complications with estrogen and progestin therapy:

  • Increased risk of breast cancer, particularly when used for more than four years
  • Evidence of increase in coronary heart disease, heart attacks, stroke, venous thrombosis (clot) and pulmonary emboli (blood clots in the lungs or blocked arteries to the lungs), deep vein thrombosis (clots in deep veins) in postmenopausal women (50 to 79 years of age)
  • Increased incidence of gallbladder disease
  • Inflammation of the pancreas
  • High calcium in the blood of individuals with breast cancer and bone metastases
  • Abnormal vision
  • Dementia and possible memory loss in postmenopausal women 65 years of age or older. It’s not known if this is a problem in younger women.

Major reported complications with estrogen-alone therapy:

  • Risk of stroke
  • Risk of deep vein thrombosis (clots)
  • Increased risk of ovarian cancer when used for 10 or more years
  • Increased risk of endometrial (uterine) cancer, particularly when estrogens are used for five or more years with the persistence of risk for at least 8 to 15 years after estrogen therapy is discontinued

Contraindications for hormone replacement therapy:

  • Known or suspected pregnancy
  • Recent childbirth
  • Undiagnosed abnormal vaginal bleeding
  • Known or suspected cancer of the breast except in appropriately selected individuals being treated for cancer
  • Known or suspected cancer (such as breast, uterine, etc.)
  • Active blood clot in the leg or lung or a history of these conditions
  • Active or recent clotting disease of an artery (e.g., stroke, heart attack)
  • Abnormal sensitivity to the drug

 

Comparison

Intermediate Value

This assessment does not address bioidentical hormone replacement therapy (BHRT) - compounded.  It is addressed in a separate assessment.  This assessment does not address testosterone therapy. 

Conservative therapy:

  • Avoid hot rooms, hot drinks, spicy food, caffeine, alcohol and stress
  • Wear layered lightweight clothing
  • Exercise
  • Eat a healthy diet
  • Increase dietary calcium and/or dietary calcium supplementation and vitamin D
  • Maintain appropriate weight for height
  • Maintain normal blood pressure, cholesterol and blood sugar
  • Avoid tobacco use
  • Use yoga or other meditation techniques
  • Have massages

Prescription medications are available for the treatment of hot flashes and the prevention of osteoporosis and heart disease. Over the counter preparations are available to help vaginal dryness.

 

Cost

Intermediate Value

The cost of HRT depends on the type of therapy ordered by your physician.

The delivery of HRT can include oral tablets, patches, creams, injections or implantation pellets.  Cost can vary from under $100 to over $1,000 per year.

Women are advised to discuss their treatment options, as well as the risks and benefits, of HRT with their health care provider.

The cost may or may not be covered by your health benefits plan.

Sources

The following are off-site links off-site link :

American Congress of Obstetricians and Gynecologists. (2012, February). Committee opinion: Compounded bioidentical menopausal hormone therapy. Retrieved March 25, 2014 from http://www.acog.org/~/media/Committee%20Opinions/Committee%20on%20Gynecologic%20Practice/co532.pdf?dmc=1&ts=20121017T2155422363.

National Cancer Institute. National Institutes of Health. (2011, December). Menopausal hormone therapy and cancer. Retrieved March 25, 2014 from http://www.cancer.gov/cancertopics/factsheet/Risk/menopausal-hormones.

National Institute of Aging. National Institutes of Health. (2014, March). Hormones and menopause. Retrieved March 25, 2014 from http://www.nia.nih.gov/HealthInformation/Publications/hormones.htm.

U. S. Food and Drug Administration. (2009, April). Center for Devices and Radiological Health. Questions and answers for estrogen and estrogen with progestin therapies for postmenopausal women (updated). Retrieved March 25, 2014 from http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm135339.htm

Next Review Date

3/27/2015

This document has been classified as public information.

Table of Findings

results:  intermediate value

safety:  little value

comparison:  intermediate value

cost: intermediate value


total: intermediate value

legend

scale

Page modified:March 31, 2014