- Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
- What is the comparative effectiveness of different hormone therapy preparations when used by postmenopausal women or women in the menopausal transition stage for reducing symptoms of menopause: hot flashes/flushes, sleep disturbances/night sweats, mood changes (depression), urogenital atrophy, sexual function, and quality-of-life measures? Are there differences between estrogen replacement products and low-dose estrogen oral contraceptives?
- What is the comparative effectiveness of different hormone therapy preparations when used by postmenopausal women or women in the menopausal transition stage for preventing low bone density and fractures? Are there differences between estrogen replacement products and low-dose estrogen oral contraceptives?
- What are the comparative harms of different hormone therapy preparations for short-term use (<5 years)? Are there differences between estrogen replacement products and low-dose estrogen oral contraceptives?
- What are the comparative harms of different hormone therapy preparations for long-term use (5 or more years)? Are there differences between estrogen replacement products and low-dose estrogen oral contraceptives?
- Are there subgroups of patients based on demographics, other medications, comorbidities, length of use, or initiation of use relative to onset of menopause, for which one medication, preparation, or estrogen dose is more effective or associated with fewer adverse effects?
- Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)
yes
- If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:
Interventions include oral, transdermal and vaginal estrogen monotherapy or estrogen plus progestin/progesterone preparations or low-dose estrogen containing oral contraceptives.
1)17-beta estradiol (E2): oral, transdermal, vaginal cream
2)Estradiol valerate (E2V): oral
3)Conjugated equine estrogen (CEE): oral, vaginal cream
4)Synthetic conjugated estrogen: oral
5)Esterified estrogen (EE): oral
6)Estropipate: oral
- What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)
- Study participants include women recruited from any health care setting or a population based sample experiencing menopause. When possible, data are considered separately for women with natural versus surgical menopause (oophorectomy) and for postmenopausal women versus women in the menopausal transition stage.
- Women in the menopausal transition stage are those transitioning through natural menopause who have had irregular menstrual periods within the last 12 months.
- Postmenopausal women are those with surgical or natural menopause and amenorrhea for more than 12 months.
- Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
Minority women
- Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
- Hot flashes or flushes defined as any otherwise unexplained sensation of flushing/sweating experienced by the woman being studied. Studies will be included if they measured frequency, severity, presence versus absence, or a combination measure of frequency and severity as either primary or secondary outcomes at baseline, 3 months, and/or end of study.
- Other symptoms such as sleep disturbances/night sweats, mood changes (depression), sexual function, urogenital atrophy, and quality-of-life measures.
- Prevention of osteoporosis measured by improvement in bone density and fracture outcomes after at least 1 year of use.
- Describe any health-related risks, side effects, or harms that you are concerned about.
Harms outcomes
- Withdrawals
- Withdrawals due to adverse effects
- Withdrawals due to specific adverse effects For short-term use
- Atypical bleeding; endometrial hypertrophy
- Nausea and vomiting
- Breast tenderness
- Headaches
- Weight changes
- Dizziness
- Thrombosis (including relationship to estradiol levels)
- Cardiovascular events
- Rash and pruritis
- Cholecystitis
- Effects on the liver For long-term use
- Cardiovascular events
- Breast cancer
- Thrombosis
- Cholecystitis
- Ovarian cancer/endometrial cancer
Appropriateness for EHC Program
- Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?
yes
- Which priority area(s) and population(s) does this topic apply to? (check all that apply)
-
- EHC Priority Conditions (updated in 2008)
- Depression and other mental health disorders
- Functional limitations and disability
- AHRQ Priority Populations
- Minority groups
- Women
- Federal Health Care Program
- Medicaid
- Medicare
Importance
- Describe why this topic is important.
See DERP preliminary scan report.
- What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)
See DERP preliminary scan report.
- Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)
yes
- If yes, please explain:
See DERP preliminary scan report.
Potential Impact
- How will an answer to your research question be used or help inform decisions for you or your group?
Evidence will be used to determine DERP policy on HRT therapy for menopausal women.
- Describe the timeframe in which an answer to your question is needed.
6-12 months
- Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.
Nominator Information
- Other Information About You: (optional)
-
- Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)
Evidence will be used to determine DERP policy on HRT therapy for menopausal women.
- Are you making a suggestion as an individual or on behalf of an organization?
Organization
- Please tell us how you heard about the Effective Health Care Program
