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HORMONE REPLACEMENT THERAPY (HRT) Evidence-based Guidelines

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VASOMOTOR HOT FLUSHES (includes night sweats) Grade B ... Women who have had a hysterectomy may take unopposed estrogen therapy ... – PowerPoint PPT presentation

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Title: HORMONE REPLACEMENT THERAPY (HRT) Evidence-based Guidelines


1
HORMONE REPLACEMENT THERAPY (HRT)
Evidence-based Guidelines
7th International Annual Congress Alexandria
12- 2002
Dr Mahdy El- Mazzahy Damietta general Hospital
2
Introduction
  • HRT does not suit everyone.
  • Each woman needs to be aware of the benefits and
    potential risks of HRT (pros and cons) so that
    she can make an informed decision.
  • Our duty as clinicians is to ensure that women
    are provided with consistent and up-to-date
    information

3
HRT and Menopausal Symptoms
4
VASOMOTOR HOT FLUSHES includes night sweats
  • Grade A
  • HRT is an effective treatment for hot flushes
  • Tibolone is effective for alleviating the
    severity and reducing the frequency of hot
    flushes


N.Z Guidelines May 2001
N.Z Guidelines May 2001
5
VASOMOTOR HOT FLUSHES (includes night sweats)
  • Grade B
  • Unopposed estrogen may be effective for reducing
    the waking episodes that are associated with
    sleep disruption.
  • There is no evidence that HRT is effective for
    vasomotor symptoms such as headaches and
    dizziness.

N.Z Guidelines May 2001
6
Vaginal atrophy
  • Grade A
  • Low dose topical estrogen is an effective
    treatment
  • E3 (estriol) therapy is also effective but
    requires either the addition of progestogen or
    close monitoring of the endometrium
  • Tibolone has been shown to be effective for
    vaginal atrophy


N.Z Guidelines May 2001
7
PSYCHOLOGICAL SYMPTOMS
  • These include depression, mood changes, anxiety,
    irritability, loss of libido, lack of energy and
    memory loss.

8
PSYCHOLOGICAL SYMPTOMS
  • Grade A
  • Estrogen is not an effective treatment in elderly
    women with established Alzheimer's disease
  • The addition of low doses of androgens to HRT
    provides relief in women with either a premature
    or surgical menopause who suffer from low libido
    ( for lt2 years).


N.Z Guidelines May 2001
9
PSYCHOLOGICAL SYMPTOMS
  • Grade A
  • Tibolone is effective in providing relief from
    low libido in postmenopausal women
  • Estrogen replacement therapy is not an effective
    treatment for loss of libido in postmenopausal
    women.

N.Z Guidelines May 2001
10
PSYCHOLOGICAL SYMPTOMS
  • There is insufficient or inconsistent evidence
    that HRT
  • Improves measures of cognition
  • 2-Prevents or delays the onset of Alzheimer's
    disease
  • 3-Elevates mood or relieves depression

11
HRT and risk of cancer
12
RISK OF BREAST CANCER
  • Continuous combined HRT was associated with an
    increased breast cancer risk if used for four
    years or more
  • However this increased risk dissipates quickly
    once use is discontinued.

(NICHD) study November 29,2002. (WHI) July 2002
13
RISK OF BREAST CANCER
  • Inspite of an increased risk of breast cancer
    diagnosis, the mortality from breast cancer is
    unchanged

. (WHI) July 2002
14
RISK OF ENDOMETRIAL CANCER
  • Grade A
  • Unopposed estrogen therapy should not be used in
    women with a uterus because of an increased risk
    of endometrial cancer.
  • Women who have had a hysterectomy may take
    unopposed estrogen therapy

15
RISK OF ENDOMETRIAL CANCER
  • A
  • Combined continuous regimens offer better
    protection of the endometrium than sequential
    regimens.

N.Z Guidelines May 2001
16
RISK OF OVARIAN CANCER
  • Grade A
  • There is no conclusive evidence that combined
    regimens HRT either increases or decreases the
    risk of developing ovarian cancer.

N.Z Guidelines May 2001
17
RISK OF OVARIAN CANCER
  • Researchers from the National Cancer Institute
    (NCI) have found that women in a large study more
    than 44000 women who used estrogen replacement
    therapy after menopause were at increased risk
    for ovarian cancer.

July 2002 JAMA
18
HRT and Osteoporosis
The silent killer
19
HRT and Osteoporosis
  • Grade A
  • HRT and Bisphosphonates has positive effects on
    bone density in postmenopausal women whether or
    not they have osteoporosis

N.Z Guidelines May 2001
20
HRT and Osteoporosis
  • Grade B
  • Maintaining HRT use decreases the risk of
    vertebral and non-vertebral fractures in women
    after surgical menopause ,early postmenopausal
    women and in women with established osteoporosis

21
HRT and Osteoporosis
  • Grade B
  • Selective Estrogen Receptor Modulators (SERMs)
    may be useful in the prevention of vertebral
    fractures in women who cannot use HRT
    or bisphosphonates.

N.Z Guidelines May 2001
22
ACOG issues New Recommendations On SERMS
  • ACOG recommends Raloxifene in the prevention of
    osteoporosis in women at risk for the disease,
    and in the prevention of bone fractures in
    women who already have osteoporosis
  • ACOG recommends that SERMS can not be used in
    women with a history of blood clots.
  • SERMS increase vaginal dryness and hot flashes.



ACOG. October,2002
23
  • HRT and cardiac risk

24
HRT and cardiac risk
  • Unlike earlier observational studies that
    suggested the possibility of some protection
    against heart disease, recent studies showed a
    small but significant increased risk of non-fatal
    heart attacks

25
HRT and cardiac risk
  • The Heart and Estrogen Replacement Study (HERS)
    is the first published randomized placebo
    controlled study of HRT in 2763 women with
    established coronary artery disease (HERS I
    1998)
  • (HERS II) is follow up study of HERS I the report
    was published in the July 2002 issue of The
    Journal of the American Medical Association
    (JAMA).

26
HRT and cardiac risk
  • HERS II trial results confirm the initial
    findings of HERS I
  • increased risk of coronary events in the early
    years of treatment
  • increase in thromboembolic events in the HRT
    group compared with placebo mainly seen in the
    first year of use

27
HRT and cardiac risk
  • Grade B
  • HRT is contraindicated for secondary prevention
    of further coronary disease because of lack of
    documented efficacy and a possible early excess
    mortality.

28
the Women's Health Initiative (WHI)study
  • This randomized controlled trial examined the
    risks and benefits of long-term combined HRT use
    in 16.608 asymptomatic postmenopausal women
    compared to the placebo group
  • The trial has been halted prematurely, after 5.
    years of an 8-year study, due to an increased
    risk of invasive breast cancer.
    .

July 2002 JAMA
29
The Women's Health Initiative (WHI) Study
  • The another WHI trial on estrogen use alone is
    continuing, because of no increased risk for
    breast cancer in this study.
  • The report was published in the July, 2002, issue
    of JAMA

30
The Women's Health Initiative (WHI) Study
  • The key findings after five years / 10,000
    women per year
  • Breast cancer increased from 30 to 38 cases ( did
    not appear in the first four years of use).
  • Coronary heart disease increased from 30 to 37
    cases (appeared in first year of use )
  • Stroke increased from 21 to 29 cases
  • (were greatest during the first 2 years )
  • Blood Clots increased from16 to 34 cases

July 2002 JAMA
31
The Women's Health Initiative (WHI) Study
  • The benefits were
  • A reduction in colorectal cancer from 16 to 10
    cases
  • The reduced risk of colorectal cancer emerged
    after 3 years
  • Hip fracture (reduced from 15 to 10)


July 2002 JAMA
32
New Study of the National Institute of Child
Health and Human Development (NICHD) November 29,
2002
  • Unlike the WHI, this study looked at pill and
    patch hormone users as well as several types of
    hormone regimens in 3,823 postmenopausal women

ACOG. November 29,2002
33
New Study of the National Institute of Child
Health and Human Development (NICHD)
  • Results were consistent with the recent Women's
    Health Initiative
  • Continuous combined HRT was associated with an
    increased breast cancer risk if used for five or
    more years.
  • no association between breast cancer risk and the
    regimens of either estrogen-alone or sequential
    HRT .
  • However, the study found this increased risk
    dissipates quickly once use is discontinued.

ACOG. November 29,2002
34
Conclusion
  • An Important Note Research Continues,
    Recommendations May Change
  • 1-HRT is not recommended for routine use in the
    menopause.
  • 2-HRT must be used for as short a time as
    possible with lowest effective dose .

ACOG. August,2002
35
Conclusion (cont.)
  • 3- The results of the WHI study confirm what is
    already known about the long-term risks of HRT,
    including breast cancer and venous
    thromboembolism.
  • 4-HRT has not been proven to be beneficial in
    primary and secondary prevention of coronary
    heart disease in fact may result in a small
    increased rate of CHD.

36
Conclusion (cont.)
  • 5-ACOG continues to recommend that decisions
    regarding HRT therapy must be made between the
    woman and her physician on an individual basis.
  • 6- HRT is the most effective treatment of
    menopausal symptoms .

ACOG. July, 2002
37
Conclusion (cont.)
  • 7-For patients with osteoporosis, other
    preventive therapies such as bisphosphonates and
    SERM are available. However, for women at risk of
    osteoporosis who also have vasomotor menopausal
    symptoms, HRT can be of benefit .
    .

ACOG. August,2002
38
  • Thank you
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