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HORMONE
REPLACEMENT
THERAPY (HRT)
Evidence-based
Guidelines
7th International Annual Congress “Alexandria” 12- 2002
Dr Mahdy El- Mazzahy
Damietta general Hospital
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
HRT and Menopausal Symptoms
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
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
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
PSYCHOLOGICAL SYMPTOMS
• These include
depression, mood
changes, anxiety,
irritability, loss of
libido, lack of energy
and memory loss.
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 <2 years).
N.Z Guidelines May 2001
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
PSYCHOLOGICAL SYMPTOMS
There is insufficient or inconsistent
evidence that HRT
1. Improves measures of cognition
2-Prevents or delays the onset of
Alzheimer's disease
3-Elevates mood or relieves depression
HRT and risk
of cancer
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
RISK OF BREAST CANCER
• Inspite of an increased
risk of breast cancer
diagnosis, the mortality
from breast cancer is
unchanged
. (WHI) July 2002
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
RISK OF ENDOMETRIAL
CANCER
A
• Combined continuous
regimens offer better
protection of the
endometrium than
sequential regimens.
•
N.Z Guidelines May 2001
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
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
HRT and
Osteoporosis
The silent killer
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
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
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
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
•HRT
and
cardiac
risk
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
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).
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
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.
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
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
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
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
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
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
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
Conclusion (cont.)
3- The results of the WHI study confirm
what is already known about the longterm 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.
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
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