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HORMONE REPLACEMENT THERAPY:
A PATIENT EDUCATION WEB PAGE
Catherine A. Martin, RN, BSN
Submitted in Partial Fulfillment of the Requirements
for the Masters of Science in Nursing Degree
Edinboro University of Pennsylvania
Approved by:
Judith Schilling, CRNP, PhD
Committee Chairperson
fl
Michele P. Denial, CRNP, MSN
Committee Member
Saint Vincent Health System
Date
Date
c. >
Abstract
Hormone Replacement Therapy: A Patient Education Web Page
Hormone replacement therapy (HRT) is used by perimenopausal women to
manage the symptoms associated with menopause and for potential long-term health
benefits. These potential benefits include protection against osteoporosis, heart disease,
colon cancer, and possibly Alzheimer’s disease (Shaywitz et al., 1999). The decision to
start therapy must take into consideration the potential risks of breast and endometrial
cancer, and thromboembolic disorders (Cutson & Meuleman, 2000).
The purpose of this project is to provide information to perimenopausal and
postmenopausal women related to hormone replacement therapy. This information will
be made available via internet and world wide web at www.velocity.net/~rrmartin.The
web page was evaluated using the Model for Evaluating Printed Educational Materials by
Bernier and Yasko (1991). The content is based on a review of the literature and is
presented at the eighth grade level using the McLaughlin Smog Formula (McLaughlin,
1969). The topics covered include health risks, benefits, and alternative therapies. The
theoretical framework for this project is the Neuman Systems Model by Betty Neuman
(1995). Based on this theory, the nurse practitioner analyzes how sociocultural,
developmental, and psychological variables influence a patient’s health practices (Reed,
1993).
i
Table of Contents
Contents
Page
Chapter 1: Introduction...
1
Background of the Problem
1
History..
1
Physiology
2
Treatment Issues.
2
Discontinuation of Therapy
2
Statement of the Problem
2
Therorectical Framework
3
Statement of the Purpose
4
Assumptions
4
Limitations
4
Definition of Terms
5
Summary
5
7
Chapter 2: Review of the Literature
7
Physiology
Perimenopausal Years
7
Postmenopausal Years
8
8
Treatment Issues....
9
Osteoporosis
10
Heart Disease...
12
Colon Cancer..
ii
Alzheimer's Disease
13
Breast Cancer..
15
Summary..
17
Chapter 3: Methodology
18
Development of a Web Page
18
Factors Influencing the Adult Learner
18
Model for Evaluating Printed Education Materials
19
Predesign
19
Design
20
Pilot Test
20
I mp le mentation/D istribut ion
21
Evaluation
21
Summary
21
References
22
Appendix A: Web Page Overview
27
iii
Chapter 1
Introduction
This chapter provides a brief introduction to hormone replacement therapy
(HRT), also known as estrogen replacement therapy or hormone therapy. Information
includes the health risks and benefits of HRT, alternative therapies, and approximate cost
of treatment. The theoretical framework utilized for this project is the Neuman Systems
Model by Betty Neuman (Neuman, 1995). Assumptions, limitations, and definitions of
terms are also included.
Background of the Problem
Issues surrounding perimenopausal and postmenopausal use of HRT include
menopausal symptoms and physiology, pharmacological treatment, alternative therapies,
risks and benefits, and reasons for starting or discontinuing therapy. Information needs to
be available to women considering HRT so that they can make informed decisions.
Changes associated with the perimenopausal and postmenopausal years were described in
the medical literature as early as 200 years ago.
History. The effects of menopause were documented during the 18th century when
peasant women were thought to be unaffected by menopause while women of the upper
class suffered from the loss of estrogenic function as seen by changes within their bodies
and loss of social status (Lewis & Bernstein, 1996). At that time, the goal of treatment
was to promote the excretion of toxins that were believed to be retained when
menstruation became irregular or stopped. This treatment included the use of leeches and
phlebotomy and was thought to restore sexual attractiveness (Lewis & Bernstein).
2
g to Lewis and Bernstein (1996), the first study conducted on menopause
was published in 1933 and determined that the most frequent symptom (62.3%) was
flushing. Based on these findings, the first therapy was aimed at symptom relief.
Physiology. The perimenopausal years may be characterized by irregular
menstrual cycles and erratic estrogen production generally affecting women between 45
and 55 years of age (Winter & Bernard, 1998). Signs and symptoms include hot flashes
(vasomotor response); nighttime flushes, sweats, and sleep disturbances; genitourinary
complaints such as vaginal dryness; and a decrease in skin thinness, muscle strength, and
memory (Lewis & Bernstein, 1996). HRT may be used short term for symptom control
(Yanni & Klein, 2000). The postmenopausal period begins when menses have ceased for
12 months (Papaioannou & Parksinson, 1998).
Treatment Issues. At the center of HRT controversy is the debate concerning
perceived risks versus benefits. The possible benefits of HRT include protection against
osteoporosis, heart disease, colon cancer, and possibly Alzheimer’s disease (Gambrell,
1998). The risks associated with HRT are increased risk of breast and endometrial cancer,
and thromboembolic disorders (Cutson & Meuleman, 2000).
Discontinuation of Therapy. Women may decline or discontinue HRT for several
reasons: breast tenderness, breakthrough bleeding, and fear of cancer or thromboembolic
disorders (Cutson & Meuleman, 2000). Of these reasons, the fear of cancer and
breakthrough bleeding are the most common (“HRT 2000: Pause for thought,” 2000).
Statement of the Problem
The decision made by perimenopausal and postmenopausal women regarding
hormone replacement therapy will, in all probability, depend upon their perceptions of
3
potential health risks versus health benefits. For this reason, Mrmration related to side
effects, health hazards and benefits, and alternative therapies needs to be made available
from a reliable source.
Theoretical Framework
The decision whether to start ho:•rmone replacement therapy should be made on
the basis of promoting health and maintaining wellness. One of the roles of the nurse
practitioner is to educate the patient during this decision process by providing materials
that will allow her to make an informed decision.
The Neuman Systems Model (Neuman, 1995) demonstrates how sociocultural,
developmental, and psychological factors influence a patient’s health maintenance
decision. Sociocultural variables measure the relationship the patient has with family,
friends, significant others, and community members (Reed, 1993). For example, a
patient’s economic level may influence her health practices, beliefs, and lifestyle. In a
primary care environment, these factors must be taken into account when developing a
plan of treatment. Additionally, teaching plans must consider language, culture, and the
methods of learning that are appropriate for the patient. The developmental variable in
Neuman’s model measures cognitive abilities, education, and life experiences (Reed,
1993). The patient’s developmental age must be taken into consideration as well as her
ability to conceptualize and respond to changes in health status. The psychological
variable encompasses the mental and emotional aspects of the patient.
Since the Neuman Systems Model is multidimensional and recognizes the
variability and interactions that patients share with each other and the environment, it is
an attractive model for the nurse practitioner. The emphasis on wellness and levels of
4
prevention speak to the heart of primary care. Since its
R
been usgd
a
guide for nursmg education and practice (Fawcett et al, 1982). By addressing the
sociocultural, developmental, and psychological factors that influence a patient’s health
maintenance decision, the nurse practitioner can effectively provide information relating
to hormone replacement therapy and allow the patient to make an informed decision.
Statement of the Purpose
The purpose of this project is to provide information relating to hormone
replacement therapy to perimenopausal and postmenopausal women. This information
will be made available over the internet via the world wide web.
Assumptions
This project is motivated by the following assumptions:
1. There is a need for unbiased patient education material relating to HRT.
2. A significant number of perimenopausal and postmenopausal women have a
desire to learn about short and long-term HRT therapy.
3. A large number of patients have access to the world wide web and are capable
of reading and understanding the English language at the eighth grade level.
Limitations
The limitations of this project are identified as follows:
T The internet-user audience is not entirely representative of the target
population. Currently, the majority of internet users are Caucasians who are not in the
perimenopausal or postmenopausal age groups and have a household income of greater
than $75,000 anually (“Internet access in America,” 2000).
2. Those individuals who utilize the internet to research health related topics
independantly are more likely to have a
population.
higher educational attainment than the general
5
Definition of Terms
ormone replacement therapy (HRT) is a combination of estrogen plus
progestin that partially replaces the body’s depleting hormonal stores as a woman goes
through the perimenopausal and postmenopausal period (“Decision tree can guide
recommendations,” 2000).
2. Estrogen replacement therapy involves the use of a natural or synthetic form of
estrogen to replace, in part, the estrogen no longer produced by the ovaries (Ammer,
1995).
3. Perimenopause, the transition into menopause, includes a few years before and
one year after the permanent cessation of menses and is associated with a reduction in
estradiol and progesterone. Symptoms associated with the decrease in estrogen are hot
flashes, night sweats, fatigue, irritability, forgetfulness, and headache (Li & Holm, 2000).
4. Postmenopause is a period that begins when menses have been absent for 12
months (Papaioannou & Parksinson, 1998).
5. Estrogen is a hormone produced by the ovaries and is responsible for female
sexual characteristics and the cyclic changes within the vagina and uterus. Natural
estrogens include estradiol, estrone, and estriol (Thomas, 1989).
6. Progestin is a synthetic form of progesterone, a hormone that is responsible for
the cyclic changes in the uterus (Thomas, 1989).
Summary
Hormone replacement therapy can be benficial to the perimenopausal and
postmenopausal patient. The advantages include a reduction in bone loss and prevention
of osteoporosis (Cutson & Meuleman, 2000), heart disease, colon cancer, and possible
6
decrease in the prevalence, incidence, and severity of the dementia of the Alzheimer’s
type (Gambrell, 1998). In addition, HRT offers relief from the symptoms associated with
perimenopause such as hot flushes, night sweats, sleep disturbances, vaginal dryness, and
changes to the skin, muscles, and memory (Lewis & Bernstein, 1996).
When deciding to use HRT, the side effects and potential health risks must also be
considered. Breast tenderness, breakthrough bleeding, thromboembolic disorders, and
the fear of cancer are the most common reasons for decisions against using HRT (Cutson
& Meuleman, 2000).
This scholarly project will provide information for women who are attempting to
make an informed decision regarding the advantages and disadvantages of HRT. It
allows nurse practitioners to provide patient education material related to HRT. It utilizes
the Neuman System Model which stresses the sociocultural, developmental, and
psychological variables that influence a patient’s decisions relating to health care. The
project is justified by the assum]iptions that a desire and a need exist for unbiased
information, and that many affected women possess the ability to understand this material
and the capability to access it over the internet. The audience is narrowed to these
indiviuals.
7
Chapter 2
Review of the Literature
Hormone replacement therapy is used by both perimenopausal and
postmenopausal women. The topics surrounding HRT including relief of menopausal
symptoms, physiology, risks and benefits, pharmacological treatment, alternative
therapies, and reasons for discontinuation of therapy are discussed.
Physiology
The physiology of menopause is presented in terms of perimenopause and
postmenopause. Treatment options and goals are dependent upon whether the woman is
perimenopausal or postmenopausal.
Perimenopausal Years. The perimenopausal years are associated with a reduction
in estradiol and progesterone (Li & Holm, 2000). This period of time is also called the
climacteric (Lewis & Bernstein, 1996). Menopause is a period between reproductive and
postreproductive years (Ammer, 1995) generally covering ages 40 to 60 (Lewis, &
Bernstein). Perimenopause may include women between 45 to 55 years of age (Winter &
Bernard, 1998). It may precede menopause by 1 to 2 years and is confirmed by a follicle-
stimulating hormone (FSH) level greater than 20mIU/ml (Lewis & Bernstein). Signs and
symptoms during this period may include hot flashes (vasomotor response), night sweats,
sleep disturbances, genitourinary complaints such as vaginal dryness, changes to the skin,
decreased muscle strength, and memory problems (Lewis & Bernstein). Since these
complaints are related to estrogen withdrawal from target organs, they impact long-term
health status. HRT may be used during the perimenopausal period for symptom control
(“Hormone replacement therapy,” 2000). Estrogen has been shown to improve mood and
dysphoria by affecting serotonin in the central nervous system and also to decrease mood
swings, depression, and difficulty with concentration (Cutson & Meuleman, 2000). HRT
8
also decreases hot flushes, urethral irritation, vaginal thinning, and dyspareunia. An
alternative therapy for these symptoms include natural progesterone present in yam root,
known as disogenin, which is prepared into a topical cream and may be topically applied
for absorption or may be taken orally as Prometrium (Cutson & Meuleman). Alternatives
may also include natural phytoestrogens called isoflavones which are soy proteins that
may reduce hot flushes, bone loss, and total cholesterol and LDL cholesterol levels;
vitamin E which is believed to stabilize estrogen levels; black cohosh which may
suppress luteinizing hormones; chasteberry that may decreases prolactin; supplemental
calcium and vitamin D, and many others (Cutson & Meuleman).
Postmenopausal Years. The postmenopausal years begin when menses have been
absent for 12 months (Papaioannou & Parksinson, 1998). The use of HRT after
menopause is for long-term health benefits including protection against osteoporosis,
heart disease, colon cancer, and possibly Alzheimer’s disease (“Hormone replacement
therapy,” 2000).
Treatment Issues
The absolute contraindications for HRT often include estrogen-responsive breast
cancer, endometrial cancer, undiagnosed abnormal vaginal bleeding, active
thromboembolic disease, and a history of malignant melanoma (Cutson & Meuleman,
2000). The relative contraindications for the use of HRT include chronic liver disease,
severe hypertriglyceridemia, endometriosis, previous thromboembolic disease, and
gallbladder disease (Cutson & Meuleman). The side effects of HRT are attributed to the
estrogen component and may include headache, nausea, breast tenderness, bloating, leg
cramps, irregular vaginal bleeding, and increased vaginal mucus (Ammer, 1995).
9
P
1_ Estrogen loss is the primary cause of osteoporosis and is associated
with an increased risk of fracture morbidity and mortality including hip and vertebral
fractures. Long-term HRT results in a 30% to 50% reduction in all osteoporotic fractures
(Cutson & Meuleman, 2000). The alternatives to HRT for bone protection include the
use of bisphosphonate medications such as alendronate (Fosamax), risedronate (Actonel),
and etidronate (Didronel) to maintain or increase bone mineral density and reduce
fractures. Intranasal calcitonin (Miacalcin) inhibits osteoclast activity. In addition,
raloxifen (Evista) is a selective estrogen receptor modulator that does not stimulate
endometrial or breast tissue and does reduce fractures. Other nonhormonal and alternative
therapies include the use of calcium and vitamin D supplements, weight bearing and
strengthening exercises, smoking cessation, and decreasing alcohol intake (Cutson &
Meuleman).
The Rancho Bernardo Study was a cross sectional study of 740 women aged 60 to
98 years concerning osteoporosis (Schneider, Barrett-Connor, & Morton, 1997). The
objective of the study was to determine the effect of initiation and duration of
postmenopausal estrogen therapy on bone mineral density (BMD). The women were
divided into groups based on HRT usage and length of treatment. The study concluded
that estrogen initiated in the ear.ly menopausal years and continued into later life was
associated with the highest BMD while estrogen started after age 60 years and continued
into later life provided near.ly equal osteoporosis protection. It was demonstrated that
BMD levels among current continuous users were 20% higher at the ultradistal radius.
12% higher at the midshait radius, 8% higher at the hip, and 13% higher at the lumbar
spine when compmed to women who had never used HRT. Current late users had similar
10
findings when compared to women who had never used HRT with a 19% increase in
bone density at the ultradistal radius, 10% at the midshaft radius, 7% at the hip, and 10%
at the lumbar spine.
Heart Disease. In American women, heart disease is the primary cause of death
claiming 223,000 lives annually, and affecting one out of two women (Cutson &
Meuleman, 2000). Estrogen has been shown to reduce the risk of heart disease 40% to
50% and reduce the relative risk of heart disease in one-third of the women who had ever
used it. However, according to Cutson and Meuleman, HRT does not have any benefit for
secondary prevention of cardiovascular events and may be only beneficial as primary
prevention in otherwise healthy women. Other nonhormonal approaches for the
prevention of cardiovascular disease include the prescription “statin” drugs such as
atrovastatin (Lipitor) or simvastatin (Zocor) for women with dyslipidemia, as well as the
use of aspirin to act as an anti-thromboembolic agent (“Hormone replacement therapy,”
2000). Alternative and nonpharmacological prevention measures include a diet high in
fiber, low in fat, and rich in antioxidants; cardiovascular/weight bearing exercises;
smoking cessation; and the use of relaxation techniques (Cutson & Meuleman).
The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial (PEPI Trial
Group, 1995) was a 3 year, multicenter, randomized, double-blinded, placebo-controlled
trial of 875 healthy postmenopausal women aged 45 to 64 years with no known
contraindication for HRT. The PEPI Trial subjects used estrogen without progestin or
estrogen/progestin combinations. Estrogen with or without progestin improved
lipoproteins. Estrogen alone resulted in a 5.6 tng/dL increase in high-density lipoprotein
cholesterol (HDL). However, the increased risk of endometrial cancer restricts the use of
11
unopposed estrogen in a woman with a uterus. Estrogen/progestin combinations also
showed a beneficial effect on HDL with an increase of 4.1 mg/dL. Mean low-density
lipoproteins decreased 14.5 to 17.7 mg/dL with either estrogen or estrogen/progestin
combmations. HRT was also noted to increase mean triglyceride levels 11.4 to 13.7
mg/dL.
A randomized, blinded, placebo-controlled secondary prevention trail was
conducted with 2763 women who had known coronary disease (Hulley et al., 1998).
Their mean age was 66.7 years and all had an intact uterus. The objective of the Heart
and Estrogen Replacement Study (HERS) was to determine, over a 4 year period, if HRT
altered the risk for coronary heart disease events in postmenopausal women with known
coronary artery disease. The results showed no significant difference between the
placebo and HRT groups (relative hazard [RH], 0.99; 95% confidence interval [CI], 0.801.22). The study concluded that HRT did not reduce the overall rate of cardiovascular
events but did increase the rate of thromboembolic events (RH 2.89; 95% CI, 1.50-5.58)
and gallbladder disease (RH 1.38; 95% CI, 1.00-1.92). Therefore, HRT was not
recommended as a means of secondary prevention in postmenopausal women with
known coronary artery disease.
A study by Parish et al. (1996) examined the effects of estrogen alone and in
combination with progestin on lipoprotein risk markers for coronary heart disease.
Eighty postmenopausal women were randomly assigned to received either estrogen with .
or without progestin for 12 months while monitoring lipoprotein levels. Estrogen alone
resulted in a slight rise in triglycerides and a decrease in low density lipoprotein (LDL)
cholesterol significant at 6 months (^<0.05). There was a 16% increase in HDL (p<0.01),
12
while lipoprotein(a) showed
no significant change. The combination of estrogen and
progestin caused a 31 % decrease in triglycerides (p
cholesterol (p<0.001), a 42% decrease in very low density lipoproteins (VLDL) (p<0.01),
9% decrease m LDL (p<0.05), and 11% decrease in HDL (p<0.001). Lipoprotein(a) was
reduced 39 /o (p<0.05). Since at the end of 1 year the combination of estrogen and
progestin had favorable effects on triglycerides, VLDL, LDL, and lipoprotein(a), these
may balance the adverse effect on HDL.
Colon Cancer. After age 50, there is a one in 19 chance of developing colon
cancer with a one in 40 chance of fatality (Daminitz, McCormick, & Rex, 1996).
Postmenopausal women using HRT are at a decreased risk since bile acids promote the
development of colon cancer and estrogen and progestins reduce the production of those
acids (Daminitz et al.). Alternative therapy for the prevention of colon cancer would
include an aspirin every other day (Daminitz et al.), previous use of oral contraceptives,
cessation of smoking, weight control, limited intake of red meat, and intake of folate
(Grodstein et al., 1998).
The Cancer Prevention Study II (CPS-II), which began in 1982 and ended
December 31, 1989, followed 422,373 postmenopausal women who were cancer-free
(Calle, Miracle-McMahill, Thun, & Heath, 1995). CPS-II demonstrated that any use of
HRT was associated with a decreased risk of colon cancer with the greatest reduction in
risk was among cunent user (RR, 0.55; 95% CI, 0.40 to 0.76) and with 11 or more years
of use (RR, 0.54; 95% CI, 0.39 to 0.76).
The Nurses’ Health Study was a prospective cohort and nested case-control study
comprised of 59,002 postmenopausa! registered nurses ta. 11 U.S. states (Grodstein et
13
al., 1998). This study used biennial questionnaires from 1980 to 1994 and found that 470
women developed colorectal cancer and 838 developed distal adenomas. The current use
of HRT was associated with a decreased risk of colon cancer (RR, 0.65; 95% CI, 0.50 to
0.83). This association declined with past use of HRT and was absent 5 years after HRT
was discontinued (RR, 0.92; 95% CI, 0.70 to 1.21). The Nurses’ Health Study
concluded that HRT decreased the risk of colon cancer, but this protection ceased when
therapy stopped.
A Wisconsin study identified women aged 30 to 74 years with a diagnosis of
colon or rectal cancer through a statewide tumor registry (Newcomb & Storer, 1995).
The study consisted of 694 case subjects and 1622 control subjects. Information on
postmenopausal hormone replacement use as well as medical history was obtained via
telephone interviews. Premenopausal women were excluded from the study. The
researchers concluded that HRT provided a statistically significant reduced risk of colon
cancer (RR, 0.54; 95% CI, 0.36 to 0.81), but had no effect on rectal cancer (RR, 0.91;
95% CI, 0.54 to 1.55).
Alzheimer’s Disease. Alzheimer’s disease is the most common form of dementia
and is a significant women’s health care concern since women live long enough to
develop more severe cognitive impairment than men (Benson, 1999). Dementia of the
Alzheimer’s type (DAT) affects three women for every one man. With the aging of the
American population it is becoming a medical expense in excess of $1 billion dollars
per year (Benson). The loss of estrogen is one contributing factor for DAT and, although
HRT is not yet approved for the treatment of DAT, research has shown that HRT
increases cerebral blood flow and may reduce the prevalence, incidence, and severity of
14
DAT as evidenced by improved memory, cognition, and Mini-Mental Status Exam
scores when compared to women not taking HRT.
A meta-analysis of ten studies of postmenopausal estrogen use and the risk of
dementia was conducted to detei;rmine if estrogen therapy improved cognition, prevented
the development of dementia, or improved the severity of dementia (Yaffe, Sawaya,
Lieberburg, & Grady, 1998). The study results demonstrated a 29% decreased risk of
developing dementia with estrogen use. However, studies of estrogen therapy in women
with Alzheimer’s disease have had small samples, have been of short duration, and were
generally uncontrolled. These studies indicated that estrogen might lead to improved
cognition, reduced risk for dementia, or improvement in the severity of dementia, but
further, long-term studies are needed before estrogen can be recommended for the
prevention or treatment of Alzheimer’s disease or other dementias (Yaffe et al., 1998).
The Baltimore Longitudinal Study of Aging also investigated the relationship
between estrogen use and the risk of developing Alzheimer s disease (Kawas et al.,
1997). This was a prospective multidisciplinary study of normal aging conducted by the
National Institute on Aging and included 472 postmenopausal or perimenopausal
women followed for up to 16 years. Estrogen use was documented, via either the oral or
transdermal routes, and the Cox proportional hazards model with time-dependent
covariates was utilized to determine the risk of developing Alzheimer’s disease. Forty-
five percent of the women in the study were using estrogen replacement therapy. Thirtyfour cases of Alzheimer’s disease were diagnosed; nine of these women were using
estrogen replacement therapy The study results demonstrated a reduced risk of
15
Alzheimer’s disease for women who
use estrogen replacement (RR,0.46; 95% CI, 0.209
to 0.997). This study also recommended randomized clinical trails for further study.
er. The fear of cancer is one of the most common reasons women
refuse or discontinue HRT (“HRT 2000,” 2000). Many women believe that breast cancer
is the leading cause of death in women when, iin fact, the chance of getting breast cancer
is one in 17 by age 65 as opposed to one in three by age 65 for heart disease. Unopposed
estrogen replacement therapy (ERT) should be taken only by women who have
undergone a hysterectomy since unopposed estrogen use carries a five to eight times
increased risk of endometrial adenocarcinoma (Cutson & Meuleman, 2000). HRT, a
combination of estrogen and progestin, is prescribed for women with an intact uterus. In
one study, combination HRT with estrogen and progestin was found to have a 24%
increased risk of breast cancer for every 5 years of use, which correlates to an increased
risk of 51% after ten years (Ross, Paganini-Hill, Wan, & Pike, 2000).
The Nurses’ Health Study examined the relationship between current and past
HRT use and the risk of breast cancer (Colditz, Stampfer, Willett, Hennekens, Rosner, &
Speizer, 1990). This was a prospective study of 121,700 female nurses 30 to 55 years of
age that were followed over a 6 year period. The Nurses’ Health Study showed that the
risk of breast cancer was highest among current HRT users (RR, 1.36; 95% CI, 1.11 to
1.67). This study also demonstrated that no elevated risk was associated with past use
and that a definitive answer relating to breast cancer has yet to be determined.
A cohort study of follow-up data for 1980 to 1995 from the Breast Cancer
Detection Demonstration Project was conducted to determine whether there is an
increased risk of breast cancer with estregen-progestin combination compared to estrogen
16
alone (Schairer, Lubin, Troisi, St„rge()n, Brinton- &
comprised of46,355 postmenopausal women, with
ag
e of 58 years, who were
located at 29 screening centers throughout the United States. During thel5 year follow
up, 2,082 cases of breast cancer were identified. The study concluded that there is a
slightly greater risk of breast cancer with estrogen-progestin (RR, 1.4; 95% CI, 1.1 to 1.8)
as opposed to estrogen alone (RR, 1.2; 95% CI, 1.0 to 1.4).
The Iowa Women s Health Study in 1986 was a prospective cohort study of
37,105 postmenopausal women aged 55 to 69 years (Gapstur, Morrow, & Sellers, 1999).
The study was conducted to determine associations between HRT use and breast cancer
with favorable histology. These women were followed over 11 years with a total of 1520
cases of breast cancer. For HRT use of 5 years or less there was an increase in invasive
carcinoma with favorable histology (RR, 1.81; 95% CI, 1.07 to 3.07) as opposed to HRT
use of greater than 5 years (RR, 2.65; 95% CI, 1.34 to 5.23). There was no association
between HRT use and the incidence of ductal carcinoma in situ or invasive ductal or
lobular carcinoma which have a less favorable histology. The study concluded that HRT
use was most strongly associated with an increased risk of breast cancer with favorable
histology and prognosis.
A population-based case-control study was conducted in King County in
Washington State to determine the risk of breast cancer in relation to the use of HRT
(Stanford et al., 1995). The participants were 50 to 64 years of age consisting of 537
patients with primary breast
cancer and 492 randomly selected control women without a
history of breast cancer. Menopausal hormones hod been used by 57.6% of the breast
cancer patients and 61.0% of the control gt»»p. In this study, the women taking HRT
17
(21.5% of the breast cancer patients and 21.3% of the control group) were not at an
increased risk of breast cancer (relative odds [RO], 0.9; 95% CI, 0.7 to 1.3). When
compared with nonusers of HRT, those women who used HRT for 8 years or longer had
a reduced risk of breast cancer (RO, 0.4; 95% CI, 0.2 to 1.0). The study concluded that in
middle-aged women, the use of HRT does not appear to be associated with an increased
risk of breast cancer, but further long-term studies need to be conducted.
Summary
Short term HRT therapy is indicated for the treatment of symptoms during the
perimenopausal period (Cutson & Meuleman, 2000). The many benefits of long-term
HRT use, primarily a decreased incidence of osteoporosis, improved lipid profiles,
decrease incidence of colon cancer, and possible reduced risk of dementia of the
Alzheimer’s type, must be weighed against potential health risks such as breast cancer.
Alternative therapies for nonhormonal treatment are available but have not been studied
for their long-term effectiveness or safety.
18
Chapter 3
Methodology
The purpose of this scholarly project was to construct a web page designed for
patient education related to hormone replacement therapy (HRT). The purpose of the
web page was to assist perimenopausal and postmenopausal women in making an
educated and informed decision as to the potential health benefits and perceived risks of
HRT. This chapter discusses the development of the web page using Dreamweaver 3.0
software by Icon Logic, factors influencing patient education, and the Evaluating Printed
Education Materials (EPEM) model by Bernier and Yasko (1991).
Development of a Web Page
To develop a web page, appropriate software must be utilized. For this project,
Dreamweaver 3.0 by Icon Logic was used beginning with a site folder (Siegel, 2000).
Once information, graphics, and links were entered into the site folder, it was submitted
to an Internet Service Provider where the site is stored on their network for internet
access. The codes for searching the web include ERT, HRT, hormones, hormone
replacement therapy, menopause, perimenopause, hot flashes, estrogen, and progesterone.
The font will be Tahoma with the majority of print at twelve point. The color scheme is
predominately grayscale with color graphics.
Factors Influencing the Adult Learner
Several factors influence adults’ participation in the educational process: attitudes
toward learning, life transitions, the importance of goals and their expectations for
meeting goals, information related to learning opportunities, and perceived barriers
toward learning opportunities (Whitman, Graham, Gleit, & Duncan Boyd, 1992),
Perimenopausal and postmenopausal women are affected by these factors when deciding
to use HRT. For example, negative attitudes toward learning will prohibit effective
education reiating to HRT, However, during this life transition, individuals often express
19
the desire to increase their knowhdge (Whitmi„ M
fa.e
goal attainment might also fecihtate learning. The opportunity to educate patients is
enhanced by educational material, including pamphlets and the internet. By increasing
the ease of obtammg information, the patient may be more willing to participate in
learning.
The Neuman Systems Model (Neuman, 1995) demonstrates how sociocultural,
developmental, and psychological factors influence a patient’s health maintenance
decision. Sociocultural variables measure the relationship the patient has with family,
friends, significant others, and community members (Reed, 1993). For example, a
patient’s economic level may influence her health practices, beliefs, and lifestyle. These
factors must be taken into account when developing a plan of treatment. Additionally,
teaching plans must consider language, culture, and the methods of learning that are
appropriate for the patient. The developmental variable in Neuman’s model measures
cognitive abilities, education, and life experiences. The patient’s developmental age must
be taken into consideration as well as the ability to conceptualize and respond to changes
in health status (Reed). The psychological variable encompasses the mental and
emotional aspects of the patient.
Model for Evaluating Printed Education Materials
To develop the web page, Bernier and Yasko's (1991) EPEM mode! was applied.
The model consists of five phases: predesign, design, pilot test, implementation, and
evaluation.
Pmdesion. The predesign phase included the assessment of the need for
information by perimenopausa! and postmenopausal women regarding hormone
replacement therapy. The decision to start HRT wUl. in a.l probability, depend upon their
20
perceptions of potential health risks
versus health benefits, information related to side
effects, and alternative therapies. This needs to be made available from a reliable source.
The purpose of the web page is to provide this information.
Design. The design phase involved the review of literature to determine the
information to be placed on the web page. This information was then combined with
graphics and presented so that patients, capable of reading and understanding the English
level at the eighth grade level, would comprehend the material. Links to other sites allow
the patient to research related topics and to find information at a higher learning level.
The McLaughlin Smog Formula (McLaughlin, 1969) was used to determine that
the web page reads at an eighth grade. The formula is based on counting 10 consecutive
sentences from the beginning of the web page, 10 consecutive sentences from the middle,
and 10 consecutive sentences from the end. From these 30 sentences, the words
containing three or more syllables are counted and the nearest perfect square root is
determined. To this number, a constant of 3 is added to determine the grade level. For
the eighth grade level, the word count will be 21 to 30, with the nearest perfect square
root being 5.
Pilot Test. The pilot test phase was completed by having the web page viewed by
two health care professionals and three postmenopausal women. The web page was
analyzed for clarity. content, and helpfulness of information and provided Mm. Changes
were made to graphics (floral design) on the HRT home page, explmtadons of test
questions were simplified, and ciarification concerning the indications for Evista was
added.
21
Implementation/Distnbution. This informational site was made available via the
world wide web and can be viewed by anyone with internet access. Information can be
downloaded and/or printed and supplied to any perimenopausal or postmenopausal
women requesting information on HRT.
Evaluation. The evaluation of the completed web page can be done by asking
anyone viewing the web page to respond to the web master via e-mail relating to the
effectiveness of the information provided. Changes to the site can be made based on their
responses and on new research findings concerning HRT.
Summary
In summary, the purpose of this scholarly project was to create a web page to be
utilized by perimenopausal and postmenopausal women as a means of patient education
on hormone replacement therapy. The web page address is www.velocitY.net/~rnnartm.
The site was developed using Dreamweaver 3.0 software by Icon Logic. Development
and evaluation of the site was done using the EPEM model by Bernier and Yasko (1991)
and the McLaughlin Smog Formula (1969).
22
References
c- <1995>-
(3rd ei).
New York: Facts
On File, Inc.
(1999). Hormone replacement therapy and Alzheimer's disease: An
update on the issues. HealthCare_for Women International. 20. 619-639.
Bernier, M. J., & Yasko, J. (1991). Designing and evaluating printed education
materials. Model and instrument development. Patient Education and Counseling, 18,
253-263.
Calle, E. E., Miracle-McMahill, H. L., Thun, M. J., & Heath, Jr., C. W. (1995).
Estrogen replacement therapy and risk of fatal colon cancer in a prospective cohort of
postmenopausal women. Journal of the National Cancer Institute, 87, 517-523.
Colditz, G., Stampfer, M., Willett, W., Hennekens, C., Rosner, B., & Speizer, F.
(1990). Prospective study of estrogen replacement therapy and risk of breast cancer in
postmenopausal women. Journal of the American Medical Association, 264a 2648-2653.
Cutson, T. M., & Meuleman, E. (2000). Managing menopause. American Family
Physician, 61, 1391-1400,1405-1406.
Daminitz, J. A. McCormick, L. H„ & Rex, D. K. (1996). Latest approaches to
prevention and screening. PatientCareJO, 124-128, 133, 137-138, 140-142,145.
Decision tree can guide recommendations for ERT or HRT in postmenopausal
women: Consensus opinion of the North American Menopause Society (2000).
Geriatrics, 55(6), 72-74.
23
parish, E., Spowart, K., Barnes, J., Fletcher, C., Calder, A., Brawn, A., & Hart, D.
(1996). Effects of postmenopausal hormone replacement therapy on lipoprateins
including lipoprotein (a) and LDL subtractions. Atheroralerosis. 126, 77-84.
Fawcett, J., Carpemto, L. J., Efinger, J., Goldblum-Graff, D., Groesbeck, M. J. V.,
Lowry, L. W., McCreary, C. S., & Wolf, Z. R. (1982). A framework for analysis and
evaluation of conceptual models of nursing with an analysis and evaluation of the
Neuman Systems Model. In B. Neuman (Ed.), The Neuman systems model: Application
to nursing education and practice (pp. 30-43). Norwalk, CT: Appleton-Century-Crofts.
Gambrell, R. (1998). Overcoming the side efects of hormone replacement
therapy: How to recognize; how to manage. Women’s Health in Primary Care, 1, 160-
163.
Gapstur, S., Morrow, M., & Sellers, T. (1999). Hormone replacement therapy and
risk of breast cancer with a favorable histology. Journal of the American Medical
Association, 281, 2091-2097.
Grodstein, F„ Martinez, M„ Platz, E„ Giovannucci, E„ Colditz, G„ Kautzky, M„
Fuchs, C„ & Stampfer, M. (1998). Postmenopausal hormone use and risk for colorectal
cancer and adenoma.
705’71k
Hormone replacement therapy. More risk than benefit? (2000). H^dMh
Letter, 25 (8), 4-5.
HRT 2000: Pause for thought. (2000). HggymdW®^^
Hulley, S„ Grady, D„ Bush, T., Furburg, C„ Hetrington, D„ Riggs, B, &
Vittinghoff, E. (1998). Randomized trial of estrogen plus progestin for secondary
24
prevention of coron^y heart disease in poslmenopausa!women. lom., „f ,te American
Medical Association, 280. 605-612
Internet access in America: Who's got it, who needs it? CyberAtlas (2000, Oct.).
[On-Line serial]. Available:
http ://cyberatlas. internet. com. bigjicture/demographics/article/O,1323,5911 47429 l,00.h
tml
Kawas, C., Resnick, S., Morrison, A., Brookmeyer, R., Corrada, M., Zonderman,
A., Bacal, C., Lingle, D., & Metter, E. (1997). A prosective study of estrogen
replacement therapy and the risk of developing Alzeheimer’s disease: The Baltimore
longitudinal study of aging. American Academy of Neurology, 48, 1517-1521.
Lewis, J. A., & Bernstein, J. (1996). Women's health: A relational perspective
across the life cycle. London: Jones and Barlett Publishers International.
Li, S., & Holm, K. (2000). Perimenopause and the quality of life. Clinical Nursing
Research, 9, 6-27.
McLaughlin, G. H. (1969). SMOG-grading: A new readability formula. Joumalof
Reading, 12, 639-645.
Neuman, B. (Ed.) (1995). TheNeuman systems model (3rd ed.). Norwalk:
Appleton & Lange.
Newcomb, P., & Storer, B. (1995). Postmenopausal hormone use and risk of large
bowel cancer. Jgunlsblflll^aAliiindLCAnserJigtitute^ST, 1067-1071.
Papaioannou, A., & Parksinsou, W. (1998). Women's decisions about hormone
replacement therapy after education and bone densitometry, ganadian Medic.) Journal.
159, 1253-1258.
25
PEPI Trial Group (!995). Effects of
heart disease risk factors in postmenopausal women The postmenopausal
estrogen/progestin interventions (PEPI) trial. Journal of the American Medical
Association, 273, 199-208.
Reed, K. S. (1993). Betty Neuman: The Neuman systems model. Newbury Park,
CA: Sage Publications, Inc.
Ross, R. K., Paganini-Hill, A., Wan, P. C., & Pike, M. C. (2000). Effects of
hormone replacement therapy on breast cancer risk: Estrogen versus estrogen plus
progestin. Journal of the National Cancer Institute, 92, 328-332.
Schairer, C., Lubin, J., Troisi, R., Sturgeon, S., Brinton, L., & Hoover, R. (2000).
Menopausal estrogen and estrogen-progestin replacement therapy and breast cancer risk.
Journal of the American Medical Association, 283, 485-491.
Schneider, D., Barrett-Connor, E., & Morton, D. (1997). Timing of
postmenopausal estrogen for optimal bone mineral density. Journal of the American
Medical Association, 277, 543-547.
Shaywitz, S., Shaywitz, B. Pugh, K„ Fulbright, R., Skudlarski, P„ Mencl, W„
Constable, R„ Naftolin, F„ Palter, S„ Marehione, K„ Katz, L„ Shankweiler, D„ Fletcher,
J„ Lacadie, C„ & Gore, J. (1999). Effects of estrogen on brain activation patterns in
postmenopausal women during
working memory tasks. JoumaLpfthe American Medical
Association, 281, 1197-1202.
Siegel, K. A. (2000).
Riva, MD: Icon Logic.
‘‘n<1 Jrills lraini°g-
26
Stanford, J., Weiss, N., Voigt, L., Daling, J., Habel, L., & Rossing, M. (1995).
Combined estrogen and progestin honnone „placemeM
tp
pf
breast cancer tn middle-aged women. Journal of the American Medical Association. 274.
137-142.
Thomas, C. L. (Ed.) (1989). Taber's cyclopedic medical dictionary (16th ed.).
Philadelphia: F. A. Davis Company.
Whitman, N. I., Graham, B„ A., Gleit, C. J., & Duncan Boyd, M. (1992).
Teaching in nursing practice: A professional model (2nd ed.). Norwalk, CT: Appleton &
Lange.
Winter, J. T., & Bernard, M. E. (1998). Oral contraceptive use during the
perimenopausal years. American Family Physician, 58, 1373-1380.
Yaffe, K., Sawaya, G., Lieberburg, I., & Grady, D. (1998). Estrogen therapy in
postmenopausal women: Effects of cognitive function and dementia. Journal of the
American Medical Association, 279, 688-695.
Yanni, L., & Klein, W. (2000). Alternatives to traditional hormone replacement
therapy. Women's Health mPrimaryCarg^477-489.
27
Appendix A
Web Page Overview
28
Overview
The opening screen -the site’s hoi
me Page- allows one to select from the
following menu and submenu:
Home-Page
Test Your Knowledge
As Women Age
HRT Issues (this page provides a menu of its own)
Osteoporosis
Heart Disease
Colon Cancer
Breast Cancer
Alzheimer’s Disease
Home Page
Alternative Therapies
Terminology
This paper illustrates the text on the various pages of the site. Underlined text
corresponds to references documented in the research paper or links to related
sites on the web. To observe corresponding images at this site, go to
www.velocity.net/~rrmartin. This site is posted on the velocity net server and is
available through searches to the public.
29
Home Page
When the site is contacted, the Home Page appears and dispiays the text
below. When one is navigating the site, a clicking on the "Home Page"
button will bring the viewer back to this page.
Hormone Replacement Therapy (HRT) is a process by which estrogen, and
possibly progestin, are administered to women to manage the symptoms
associated with menopause and to obtain potential long-term health benefits.
This site examines the potential benefits and possible risks associated with
HRT. The focus has been on providing an understandable presentation that
provides a thorough coverage of the HRT issues. Begin with "Test Your
Knowledge" and then continue through the various topics. For your convenience,
definitions of medical terms used at this site are only a click away. The author
welcomes e-mail comments and suggestions regarding this site.
Catherine A. Martin, RN, BSN, created this site in partial fulfillment of the requirements for the Master of
Science in Nursing Degree at Edinboro University of Pennsylvania. No pharmaceutical company sponsors
this site. Copyright © 2001.
30
Test Your Knowledge
From the main menu, clicking on "Test Your Knowledge- produces a page
which
introductory to the quiz and contains the message:
Enjoy a ten-question quiz that is informative and introduces a more detailed
discussion of hormone replacement therapy. You may exit at any time by
selecting from the menu on the left side of the page. Click the button below to
begin the quiz.
Clicking the “Start” button produces the quiz designed to stimulate
interest in the remainder of the site.
1
The leading cause of death in older women is
a. breast cancer
b. heart disease
One in eight women develop breast cancer over the course of their lives;
one in 25 will die because of it. One in three women will die of coronary
heart disease. Heart disease is, by far, the leading killer of women 55 and
older.
2
In the female body, estrogen is responsible for the development of female
breasts.
a. true
b. false
At the onset of puberty, estrogen stimulates the development of
characteristics such as rounded hips and breasts. Estrogen also plays an
essentia, pad in menstruation, being response for the month,,Ranges
in the lining of the womb. As a woman grows older, her ovanes
smaller amounts of estrogen as "change of life" begms.
31
3
Menopausal symptoms, such as hot flashes and night sweats, last for the
rest of a woman's life.
a. true
b. false
For most women, the symptoms of menopause last for a relatively short
time. However, a woman's level of estrogen always remains low after
menopause. This can affect many parts of the body including the sexual
and urinary organs, the heart, and the bones.
4
Memory can be affected by menopause.
a. true
b. false
Many menopausal women have problems with short-term memory because
of low estrogen levels. It is not unusual to forget things like appointments or
losing the end of a thought when speaking.
5
Hormone replacement therapy (HRT) relieves many of the symptoms
associated with menopause.
a. true
b. false
One immediate benefit of hormone replacement therapy is the relief of
uncomfortable symptoms that may occur with menopause; things such as
"hot flashes" (a wave of heat and sweating), night sweats, and painful
intercourse. Hormones also help alleviate other menopausal symptoms,
such as changes in urination, irritability, and depression.
6
HRT is risk free.
a. true
b. false
There are some risks associated with the long-term use of HRT. These
risks depend on the type of treatment prescribed, whether the woman has a
uterus, and how long the hormones are taken. There are almost no risks
32
associated with a short-term therapy of less than five years.
7
Every woman experiencing menopause may use HRT.
a. true
b. false
Not every woman is a candidate for HRT. Women with a family history of
breast cancer as well as women who have had breast cancer, abnormal
vaginal bleeding, liver disease, or blood clots should be carefully evaluated
before hormone replacement therapy begins.
8
HRT is used by postmenopausal women.
a. true
b. false
For healthy women, long-term use of HRT is often recommended to slow
bone loss, decrease the risk of bone fractures, prevent heart disease, and
reduce the risk of colon cancer.
9
For most women, the benefits associated with HRT outweigh the risks.
a. true
b. false
There is almost no short-term risk. Long-term risks that accompany HRT
include a small increased tendency toward blood clots in the veins and a
small increase in the risk of breast cancer. However, studies indicate that
the breast malignancies associated with HRT may be of a less aggressive
type than those discovered in postmenopausal women not using HRT.
10
HRT usage is rare.
a. true
b. false
HRT usage is not rare. About 12 million women in the United States take
estrogen alone while another 8.6 million women are on the combined
estrogen and progestin regimen, according to drug company estimates.
33
As Women Age
From the main menu, clicking on “As Women Age” produces a web
page that contains the text below:
As women age they eventually experience menopause, commonly referred
to as "change of life." It is characterized by irregular menstrual periods and
decreases in the amount of estrogen produced by the body. This condition
generally affects women between the ages of 40 and 60 years. This time
period may be characterized by hot flashes, night sweats, sleep
disturbances, vaginal dryness, changes to the skin, fatigue, irritability,
forgetfulness, and headache. Perimenopause symptoms may precede the
end of menstruation by one or two years.
What is happening within the body?
The natural estrogen produced in the ovaries of a woman not only allows
her to have children, but also helps keep her bones strong. As will be seen,
there is evidence that estrogen also protects against heart disease and
stroke. During the perimenopausal phase, the estrogen level gradually
decreases which causes the risk of heart and blood vessel disease to
slowly rise. By the time menstrual periods finally end, estrogen levels will
have been reduced significantly.
What if 1 had a hysterectomy?
According to the American Heart Association, if the menstrual periods are
brought to an abrupt stop through the surgical removal of the uterus, the
chance of heart and blood vessel disease sharply increases.
Can anything be done to control the symptoms associated with
menopause?
Cutson and Meuleman report that replenishing estrogen levels may
alleviate depression and the constant feeling of illness or discontent.
Estrogen also improves concentration and decreases the sensation of hot
flashes, urethral irritation, vaginal thinning, and painful intercourse.
34
Heart disease is the number one killer among women. What effect
does HRT have on heart disease?
The American Heart Association states that over the years, millions of
women have been given estrogen to relieve the symptoms associated with
perimenopause and to lessen the risk of heart and blood vessel disease.
For women who have not had a hysterectomy, the estrogen is combined
with another hormone called progestin. For women that have had a
hysterectomy, the progestin is unnecessary and they are given estrogen
alone.
May HRT be continued beyond the time when I no longer have
periods?
Yes. According to Gambrell, taking estrogen continues to offer protection
against osteoporosis, heart disease, colon cancer, and possibly
Alzheimer's disease long after menopause and even into very old age.
What risks are associated with hormone replacement therapy?
At the center of the HRT controversy is the debate concerning perceived
risks versus benefits. For women who take HRT for less than five years,
there is almost no risk involved. For long-term users, there seems to be a
slight increase in risk of breast and uterine cancers in some individuals,
and there may be a slight tendency to form blood clots. Some women have
discontinued HRT because of breast tenderness, vaginal bleeding, and the
fear of developing cancer or blood clots. To see a more complete
discussion of the benefits and risks associated with HRT, click on the "HRT
Issues" button at the left.
How do I decide whether HRT is right for me?
Begin by becoming well-informed. Read as much as you possibly can
about HRT and estrogen replacement therapy. This web is a good starting
point. Once you are knowledgeable, discuss the possibility of using
hormone therapy with your health care provider who will assess your
history and current health. On this basis, you and your health care provider
can determine if the potential benefits associated with HRT outweigh any
risks.
35
HRT Issues
From the main menu, clicking on “HRT Issues” produces a page that
serves as an introduction to the various HRT issues to be discussed.
Hormone Replacement Therapy is used to effectively manage the symptoms
associated with menopause. Used long-term, it also offers significant protection
against osteoporosis and heart disease in women, decreases the risk of colon
cancer, and may even offer some protection against Alzheimer's disease.
Medical science has identified estrogen loss as the cause of "change of life"
symptoms. Today, replenishing this lost estrogen is a simple and effective
process with a variety of prescription medications available - - much more
attractive than the use of leeches, a method used 200 years ago!
The decision to use HRT should be made on the basis of maintaining wellness
and promoting long-term health. In the face of this decision, a woman should
understand the risks as well as the benefits associated with this therapy.
This page introduces a new menu. A “Home Page” button may be clicked
to return to the original menu.
36
Osteoporosis
Clicking on “Osteoporosis” from the “HRT Issues” submenu produces this
Page.
The word osteoporosis means "porous bones." The bones become brittle
as this disease progresses. Women are particularly susceptible to
osteoporosis. It may begin even before menopause, but the effects of the
disease increase dramatically as a woman's estrogen level declines.
Postmenopausal women are at great risk from osteoporosis. The
skeletal system fractures easily when osteoporosis is in an advanced
stage.
The top image at the right shows bone that is becoming diseased. The dark
areas represent no bone growth. At the left is an image of a more
advanced form of osteoporosis in the same region. Notice the obvious
decrease in bone. A region with this type of bone loss is very susceptible to
fractures. Such fractures typically occur in the areas of the hip, wrist, and
vertebrae. The lower image to the right shows a vertebral fracture.
Cutson & Meuleman have demonstrated that HRT, when used long-term,
results in at least a 50% reduction of osteoporotic bone fractures.
May a woman obtain significant osteoporotic benefits if HRT is started later
in life? The Ranco Bernardo Study involved 740 women aged 60 to 98
years. The study concluded that estrogen initiated in the early menopausal
years and continued into later life resulted in the greatest bone strength.
But, the study also found that women who started HRT after age 60
obtained nearly the same amount of protection against osteoporosis.
37
Heart Disease
Clicking on “Heart Disease” from the “HRT Issues” submenu produces this
page.
The following statement may come as a bit of a shock: recent findings show
that twice as many women die from heart disease than from all forms of
cancer combined! Furthermore, an important part of this heart disease is the
diminishing supply of estrogen as women age.
Elevated levels of cholesterol in the blood can cause heart disease. There
are different types of cholesterol within the body. High levels of LDL
cholesterol (Low Density Lipoproteins - the "bad cholesterol") are responsible
for the formation of fatty deposits along the inside walls of the arteries. This
causes blockages in the arteries that often lead to serious heart disease. On
the other hand, HDL cholesterol (High Density Lipoproteins - the "good
cholesterol") transports excess blood cholesterol to the liver where it is
recycled or eliminated. As a result, increasing the HDL level protects against
coronary heart disease.
Several studies have shown the important role that estrogen replacement
plays in lowering the risk of heart disease. The Postmenopausal
Estrogen/Progestin Interventions Trial (PEPI Trial) was an extensive threeyear study involving women between the ages of 45 and 64 years. The study
found that the use of estrogen significantly lowered LDL levels and
significantly elevated HDL levels. In all, HRT was demonstrated to be
effective in lowering the risk of heart disease in healthy women even though
HRT does elevate triglycerides to some extent. Cutson and Meuleman claim
that HRT may reduce the risk of heart disease by 40% to 50%.
The Heart and Estrogen Replacement Study (HERS) was a four year study
that concluded that HRT provided no protective effect in women who already
had heart disease.
38
Colon Cancer
Clicking on “Colon Cancer” from the “HRT Issues” submenu produces this
Page.
The colon or large intestine (pictured in purple) has five parts: from the lower
right side of the body, the Ascending Colon extends upward to the Transverse
Colon which extends across the abdomen to the left side; the Descending Colon
extends downward to a lower S-shaped piece of large intestine called the
Sigmoid Colon which empties into the Rectum, a container that is vertical and
approximately seven inches in length. The Anus is the opening to the outside.
Colon cancers typically begin as benign polyps in the large intestine. They can
be detected and removed before they become cancerous. Through colonoscopy
or sigmoidoscopy, flexible scopes equipped with a light and tiny camera are
used to examine the colon. Adults should have such an exam every five years to
prevent colon cancer.
Acids formed in the liver (bile acids) promote the development of colon cancers.
A study done by Daminitz, McCormick, and Rex, determined that
postmenopausal women using HRT are at a decreased risk for colon cancer
since estrogen and progestin reduce the production of these bile acids. The
eight year Cancer Prevention Study II (CPS-II) demonstrated that any use of
HRT was associated with a decreased risk of colon cancer. These results were
also confirmed by the Wisconsin Study.
Even though these results indicate a significantly reduced risk of colon cancer,
the use of HRT seems to have no effect on the frequency of rectal cancer.
39
Breast Cancer
Clicking on “Breast Cancer” from the “HRT Issues” submenu
produces this page.
The relationship between the risk of breast cancer and HRT remains a concern.
Many women believe that breast cancer is the leading cause of death in women
when, in fact, the chance of getting heart disease by age 65 is six times greater.
Periodic mammograms are recommended for early detection of breast cancer.
There have been many studies, some that show HRT increases the risk of
breast cancer and others showing that HRT does not increase this risk. A 1995
study conducted in King County in Washington State concluded that middleaged women taking HRT were not at an increased risk for breast cancer.
The Breast Cancer Detection Demonstration Project (BCDDP), a national breast
cancer screening program that involved 46,355 postmenopausal women, found
an increased risk of one percent each year for women taking estrogen only; they
found an eight percent increase in breast cancer risk each year for women using
the estrogen-progestin combination. For someone taking the combination
estrogen-progestin over ten years, there may be an increase in the risk of
developing breast cancer.
As a result of the BCDDP, the National Cancer Institute advises women with no
uterus to avoid long-term combination therapy; however, the Institute also states
that the combination therapy poses no additional breast cancer risk for any
woman if used for only a few years to alleviate the symptoms associated with
menopause .
Because of the conflicting data regarding the risk of breast cancer and long-term
use of HRT, the National Cancer Institute is continuing this research and is soon
to gather and study new data.
40
Alzheimer’s Disease
Clicking on “Alzheimer’s” from the “HRT Issues” submenu produces this
page.
Alzheimer's disease is the most common form of dementia and is a significant
health concern for women since women live long enough to develop it more
often than men. According to Benson, dementia of the Alzheimer's type affects
three women for every one man. Very little is known about the cause and
currently there is no cure. In fact, the disease can be identified with absolute
certainty only by autopsy after death.
Scientists are currently exploring the effect of estrogen in the prevention of
Alzheimer's disease. It seems that estrogen may slow the formation of the
plaque produced by the disease, and improves blood flowthrough the brain.
In an analysis often studies by Yaffe, it was determined that postmenopausal
estrogen use decreased the risk of Alzheimer's disease by 29%. However, the
studies involved small groups of women for short periods of time. Therefore, the
results are not completely reliable.
The Baltimore Longitudinal Study of Aging (BLSA), conducted by the National
Institute on Aging, included 472 older women that were followed for 16 years.
This well-controlled study demonstrated a significantly reduced risk of
Alzheimer's disease for women who use HRT.
41
Alternative Therapies
From the main menu, clicking on “Alternative Therapies” produces a
web page that contains the text below:
The alternative approaches to HRT usually focus on dietary, nutritional, and
lifestyle changes. They may include prescription drugs or nonprescription
drugs other than estrogen/progestin. Many of these alternatives to HRT
involve a risk of their own since very few have been studied for either their
long-term effect or their safety. The motivation for using these therapies is
usually to avoid the risks associated with HRT therapy. Sometimes this
approach is very effective; in any case, it requires both great discipline and
patience. A generally healthy lifestyle is advocated which stresses good
nutrition and exercise, the elimination of smoking, and a decrease in
alcoholic consumption. Of course, this should be everyone's lifestyle.
The General Relief of Menopausal Symptoms
The Association of Reproductive Health Professionals heard testimony stating
that the natural progesterone present in yam root, taken orally as Prometrium
and used to provide relief of various menopausal symptoms, is no more effective
than a sugar pill. However, some alternative therapies are recognized as being
somewhat effective. Specific dietary and nutritional changes with nutritional and
herbal supplements have been shown to alleviate some menopausal
discomforts. For example, soy protein may reduce hot flashes, bone loss, and
LDL-cholesterol levels.
Osteoporosis
As a non-hormonal therapy, calcium is typically recommended to prevent bone
loss in women. With increased doses, and combined with vitamin D, calcium
does seem to provide some protection. Numerous studies have shown that
42
calcium alone does not build bone, but only slows bone loss.
Fosamax is another drug prescribed to improve bone density. The manner in
which Fosamax and other drugs of its type (biophosphates) slow the progression
of osteoporosis is not completely understood. Most endocrinologists prefer the
use of estrogen to biophosphates.
Calcitonin, a hormone naturally produced in the thyroid and prescribed for
patients with osteoporosis, is a prescription drug that produces modest
increases in bone mass. This drug is sprayed into the nose for quick absorption
into the blood stream. It is less effective than estrogen. Combining calcitonin and
estrogen, with enough calcium (1,200 mg a day), offers an even greater benefit
than using either separately.
Evista is another prescription drug that is used to prevent bone loss. It has no
effect on uterus or breast tissue and it does reduce osteoporotic fractures.
However, it cannot be taken by everyone. If you can become pregnant, are
nursing, have severe liver problems, or have had blood clots that required a
doctor's treatment, you cannot take Evista. Also, Evista cannot be started while a
woman is still experiencing hot flashes or the symptoms will worsen.
Heart Disease
Vitamin E is frequently taken to reduce the risk of heart disease. Researchers
from the National Heart, Lung and Blood Institute concluded in January, 2000
that estrogen provides more effective heart protection than vitamin E . Currently,
other studies are in progress to better determine the role of both estrogen and
vitamin E in preventing heart disease in postmenopausal women.
Typical measures taken to prevent heart disease include exercise, daily aspirin,
and a diet that is low in fat, high in fiber content, and rich in antioxidants. For
women with high cholesterol, prescription drugs such as Lipitor and Zocor are
often used. When these drugs are taken, periodic blood tests are required to
43
check liver function. Other prescription medications such as Baycof and
Pravachol are also available to combat cholesterol problems.
Colon Cancer
According to the Harvard Center for Cancer Prevention, men and women are at
equal risk for developing colon cancer. To lower colon cancer risk, eat less red
meat, exercise regularly, take multivitamins that contain folic acid, aspirin 325mg
every other day, vitamin E and get screened regularly after the age of 50. The
risk of dying from colon cancer is reduced about approximately 50% with
periodic screening.
In Conclusion...
There is a wide variety of alternatives to HRT. These alternatives range from
acupuncture to herbs and include prescription as well as nonprescription drugs.
The above discussion refers to some of the more popular alternative therapies.
Keep in mind that very little testing has been done to determine the actual
effectiveness of most of these non-pharmacological (or prescription drug)
alternatives. Of course, HRT is also not completely risk free.
The benefits of HRT are many. In addition to relieving the symptoms associated
with menopause, there are two proven major benefits with long-term usage: it
helps prevent osteoporosis and protects against heart disease. The decision to
begin HRT should be determined by you and your health care provider. Your
health care provider’s opinion will take into consideration your current health as
well as your family's health history.
44
Terminology
From the main page, clicking on “Terminology” produces a web page that
contains the text below:
endocrinologist
a doctor that specializes in the study of the
endocrine glands which produce the body's
hormones
estrogen
a hormone produced by the ovaries and
responsible for female sexual characteristics
and the cyclic changes with the vagina and the
uterus; the synthetic form is also called estrogen
estrogen replacement
the administering of estrogen to replenish
therapy (ERT)
diminishing estrogen levels in the female body
HDL (high density
this is the "good cholesterol" which helps
lipoproteins)
to protect the arteries from clogging
hormone replacement
therapy (HRT)
the administering of estrogen and possibly
progestin to replace hormones that become
depleated during and after menopause
hysterectomy
surgery to remove the uterus
LDL (low density
this is the "bad cholesterol" and is
lipoproteins)
responsible for the clogging of arteries in the
body
45
menopause
in medical use, this term refers to the precise
date of a woman’s last period; typically, it
means the transition period between
reproductive and postreproductive years
menses
menstruation; the discharge of a bloody fluid
from the vagina
osteoporosis
brittleness and softness of the bone tissue that
promotes a tendency for the bones to fracture;
porous bones
ovaries
the female sex glands that produce the eggs to
be fertilized by male sperm; this is where
estrogen and progesterone are produced;
these hormones are responsible for the
development of the female body
perimenopause
the time period including a few years before
and one year after the permanent cessation of
menses; this time period is characterized by
irregular menstrual cycles and is associated
with a reduction in hormone levels; symptoms
may include hot flashes, night sweats, fatigue,
irritability, forgetfulness, and headache
postmenopause
the time period that begins one year after
menses have ceased; that is, one year after
the date of your last period
46
progestin
a synthetic form of progesterone, a hormone
that is responsible for cyclic changes in the
uterus
progesterone
the natural hormone produced by the body; the
synthetic form is called progestin
uterus
the hollow pear-shaped organ that holds the
baby during pregnancy; also called the "womb"
(also see vagina)
vagina
the canal leading from the outside of the body
to the uterus; the region where sexual
intercourse takes place
womb
see uterus
A PATIENT EDUCATION WEB PAGE
Catherine A. Martin, RN, BSN
Submitted in Partial Fulfillment of the Requirements
for the Masters of Science in Nursing Degree
Edinboro University of Pennsylvania
Approved by:
Judith Schilling, CRNP, PhD
Committee Chairperson
fl
Michele P. Denial, CRNP, MSN
Committee Member
Saint Vincent Health System
Date
Date
c. >
Abstract
Hormone Replacement Therapy: A Patient Education Web Page
Hormone replacement therapy (HRT) is used by perimenopausal women to
manage the symptoms associated with menopause and for potential long-term health
benefits. These potential benefits include protection against osteoporosis, heart disease,
colon cancer, and possibly Alzheimer’s disease (Shaywitz et al., 1999). The decision to
start therapy must take into consideration the potential risks of breast and endometrial
cancer, and thromboembolic disorders (Cutson & Meuleman, 2000).
The purpose of this project is to provide information to perimenopausal and
postmenopausal women related to hormone replacement therapy. This information will
be made available via internet and world wide web at www.velocity.net/~rrmartin.The
web page was evaluated using the Model for Evaluating Printed Educational Materials by
Bernier and Yasko (1991). The content is based on a review of the literature and is
presented at the eighth grade level using the McLaughlin Smog Formula (McLaughlin,
1969). The topics covered include health risks, benefits, and alternative therapies. The
theoretical framework for this project is the Neuman Systems Model by Betty Neuman
(1995). Based on this theory, the nurse practitioner analyzes how sociocultural,
developmental, and psychological variables influence a patient’s health practices (Reed,
1993).
i
Table of Contents
Contents
Page
Chapter 1: Introduction...
1
Background of the Problem
1
History..
1
Physiology
2
Treatment Issues.
2
Discontinuation of Therapy
2
Statement of the Problem
2
Therorectical Framework
3
Statement of the Purpose
4
Assumptions
4
Limitations
4
Definition of Terms
5
Summary
5
7
Chapter 2: Review of the Literature
7
Physiology
Perimenopausal Years
7
Postmenopausal Years
8
8
Treatment Issues....
9
Osteoporosis
10
Heart Disease...
12
Colon Cancer..
ii
Alzheimer's Disease
13
Breast Cancer..
15
Summary..
17
Chapter 3: Methodology
18
Development of a Web Page
18
Factors Influencing the Adult Learner
18
Model for Evaluating Printed Education Materials
19
Predesign
19
Design
20
Pilot Test
20
I mp le mentation/D istribut ion
21
Evaluation
21
Summary
21
References
22
Appendix A: Web Page Overview
27
iii
Chapter 1
Introduction
This chapter provides a brief introduction to hormone replacement therapy
(HRT), also known as estrogen replacement therapy or hormone therapy. Information
includes the health risks and benefits of HRT, alternative therapies, and approximate cost
of treatment. The theoretical framework utilized for this project is the Neuman Systems
Model by Betty Neuman (Neuman, 1995). Assumptions, limitations, and definitions of
terms are also included.
Background of the Problem
Issues surrounding perimenopausal and postmenopausal use of HRT include
menopausal symptoms and physiology, pharmacological treatment, alternative therapies,
risks and benefits, and reasons for starting or discontinuing therapy. Information needs to
be available to women considering HRT so that they can make informed decisions.
Changes associated with the perimenopausal and postmenopausal years were described in
the medical literature as early as 200 years ago.
History. The effects of menopause were documented during the 18th century when
peasant women were thought to be unaffected by menopause while women of the upper
class suffered from the loss of estrogenic function as seen by changes within their bodies
and loss of social status (Lewis & Bernstein, 1996). At that time, the goal of treatment
was to promote the excretion of toxins that were believed to be retained when
menstruation became irregular or stopped. This treatment included the use of leeches and
phlebotomy and was thought to restore sexual attractiveness (Lewis & Bernstein).
2
g to Lewis and Bernstein (1996), the first study conducted on menopause
was published in 1933 and determined that the most frequent symptom (62.3%) was
flushing. Based on these findings, the first therapy was aimed at symptom relief.
Physiology. The perimenopausal years may be characterized by irregular
menstrual cycles and erratic estrogen production generally affecting women between 45
and 55 years of age (Winter & Bernard, 1998). Signs and symptoms include hot flashes
(vasomotor response); nighttime flushes, sweats, and sleep disturbances; genitourinary
complaints such as vaginal dryness; and a decrease in skin thinness, muscle strength, and
memory (Lewis & Bernstein, 1996). HRT may be used short term for symptom control
(Yanni & Klein, 2000). The postmenopausal period begins when menses have ceased for
12 months (Papaioannou & Parksinson, 1998).
Treatment Issues. At the center of HRT controversy is the debate concerning
perceived risks versus benefits. The possible benefits of HRT include protection against
osteoporosis, heart disease, colon cancer, and possibly Alzheimer’s disease (Gambrell,
1998). The risks associated with HRT are increased risk of breast and endometrial cancer,
and thromboembolic disorders (Cutson & Meuleman, 2000).
Discontinuation of Therapy. Women may decline or discontinue HRT for several
reasons: breast tenderness, breakthrough bleeding, and fear of cancer or thromboembolic
disorders (Cutson & Meuleman, 2000). Of these reasons, the fear of cancer and
breakthrough bleeding are the most common (“HRT 2000: Pause for thought,” 2000).
Statement of the Problem
The decision made by perimenopausal and postmenopausal women regarding
hormone replacement therapy will, in all probability, depend upon their perceptions of
3
potential health risks versus health benefits. For this reason, Mrmration related to side
effects, health hazards and benefits, and alternative therapies needs to be made available
from a reliable source.
Theoretical Framework
The decision whether to start ho:•rmone replacement therapy should be made on
the basis of promoting health and maintaining wellness. One of the roles of the nurse
practitioner is to educate the patient during this decision process by providing materials
that will allow her to make an informed decision.
The Neuman Systems Model (Neuman, 1995) demonstrates how sociocultural,
developmental, and psychological factors influence a patient’s health maintenance
decision. Sociocultural variables measure the relationship the patient has with family,
friends, significant others, and community members (Reed, 1993). For example, a
patient’s economic level may influence her health practices, beliefs, and lifestyle. In a
primary care environment, these factors must be taken into account when developing a
plan of treatment. Additionally, teaching plans must consider language, culture, and the
methods of learning that are appropriate for the patient. The developmental variable in
Neuman’s model measures cognitive abilities, education, and life experiences (Reed,
1993). The patient’s developmental age must be taken into consideration as well as her
ability to conceptualize and respond to changes in health status. The psychological
variable encompasses the mental and emotional aspects of the patient.
Since the Neuman Systems Model is multidimensional and recognizes the
variability and interactions that patients share with each other and the environment, it is
an attractive model for the nurse practitioner. The emphasis on wellness and levels of
4
prevention speak to the heart of primary care. Since its
R
been usgd
a
guide for nursmg education and practice (Fawcett et al, 1982). By addressing the
sociocultural, developmental, and psychological factors that influence a patient’s health
maintenance decision, the nurse practitioner can effectively provide information relating
to hormone replacement therapy and allow the patient to make an informed decision.
Statement of the Purpose
The purpose of this project is to provide information relating to hormone
replacement therapy to perimenopausal and postmenopausal women. This information
will be made available over the internet via the world wide web.
Assumptions
This project is motivated by the following assumptions:
1. There is a need for unbiased patient education material relating to HRT.
2. A significant number of perimenopausal and postmenopausal women have a
desire to learn about short and long-term HRT therapy.
3. A large number of patients have access to the world wide web and are capable
of reading and understanding the English language at the eighth grade level.
Limitations
The limitations of this project are identified as follows:
T The internet-user audience is not entirely representative of the target
population. Currently, the majority of internet users are Caucasians who are not in the
perimenopausal or postmenopausal age groups and have a household income of greater
than $75,000 anually (“Internet access in America,” 2000).
2. Those individuals who utilize the internet to research health related topics
independantly are more likely to have a
population.
higher educational attainment than the general
5
Definition of Terms
ormone replacement therapy (HRT) is a combination of estrogen plus
progestin that partially replaces the body’s depleting hormonal stores as a woman goes
through the perimenopausal and postmenopausal period (“Decision tree can guide
recommendations,” 2000).
2. Estrogen replacement therapy involves the use of a natural or synthetic form of
estrogen to replace, in part, the estrogen no longer produced by the ovaries (Ammer,
1995).
3. Perimenopause, the transition into menopause, includes a few years before and
one year after the permanent cessation of menses and is associated with a reduction in
estradiol and progesterone. Symptoms associated with the decrease in estrogen are hot
flashes, night sweats, fatigue, irritability, forgetfulness, and headache (Li & Holm, 2000).
4. Postmenopause is a period that begins when menses have been absent for 12
months (Papaioannou & Parksinson, 1998).
5. Estrogen is a hormone produced by the ovaries and is responsible for female
sexual characteristics and the cyclic changes within the vagina and uterus. Natural
estrogens include estradiol, estrone, and estriol (Thomas, 1989).
6. Progestin is a synthetic form of progesterone, a hormone that is responsible for
the cyclic changes in the uterus (Thomas, 1989).
Summary
Hormone replacement therapy can be benficial to the perimenopausal and
postmenopausal patient. The advantages include a reduction in bone loss and prevention
of osteoporosis (Cutson & Meuleman, 2000), heart disease, colon cancer, and possible
6
decrease in the prevalence, incidence, and severity of the dementia of the Alzheimer’s
type (Gambrell, 1998). In addition, HRT offers relief from the symptoms associated with
perimenopause such as hot flushes, night sweats, sleep disturbances, vaginal dryness, and
changes to the skin, muscles, and memory (Lewis & Bernstein, 1996).
When deciding to use HRT, the side effects and potential health risks must also be
considered. Breast tenderness, breakthrough bleeding, thromboembolic disorders, and
the fear of cancer are the most common reasons for decisions against using HRT (Cutson
& Meuleman, 2000).
This scholarly project will provide information for women who are attempting to
make an informed decision regarding the advantages and disadvantages of HRT. It
allows nurse practitioners to provide patient education material related to HRT. It utilizes
the Neuman System Model which stresses the sociocultural, developmental, and
psychological variables that influence a patient’s decisions relating to health care. The
project is justified by the assum]iptions that a desire and a need exist for unbiased
information, and that many affected women possess the ability to understand this material
and the capability to access it over the internet. The audience is narrowed to these
indiviuals.
7
Chapter 2
Review of the Literature
Hormone replacement therapy is used by both perimenopausal and
postmenopausal women. The topics surrounding HRT including relief of menopausal
symptoms, physiology, risks and benefits, pharmacological treatment, alternative
therapies, and reasons for discontinuation of therapy are discussed.
Physiology
The physiology of menopause is presented in terms of perimenopause and
postmenopause. Treatment options and goals are dependent upon whether the woman is
perimenopausal or postmenopausal.
Perimenopausal Years. The perimenopausal years are associated with a reduction
in estradiol and progesterone (Li & Holm, 2000). This period of time is also called the
climacteric (Lewis & Bernstein, 1996). Menopause is a period between reproductive and
postreproductive years (Ammer, 1995) generally covering ages 40 to 60 (Lewis, &
Bernstein). Perimenopause may include women between 45 to 55 years of age (Winter &
Bernard, 1998). It may precede menopause by 1 to 2 years and is confirmed by a follicle-
stimulating hormone (FSH) level greater than 20mIU/ml (Lewis & Bernstein). Signs and
symptoms during this period may include hot flashes (vasomotor response), night sweats,
sleep disturbances, genitourinary complaints such as vaginal dryness, changes to the skin,
decreased muscle strength, and memory problems (Lewis & Bernstein). Since these
complaints are related to estrogen withdrawal from target organs, they impact long-term
health status. HRT may be used during the perimenopausal period for symptom control
(“Hormone replacement therapy,” 2000). Estrogen has been shown to improve mood and
dysphoria by affecting serotonin in the central nervous system and also to decrease mood
swings, depression, and difficulty with concentration (Cutson & Meuleman, 2000). HRT
8
also decreases hot flushes, urethral irritation, vaginal thinning, and dyspareunia. An
alternative therapy for these symptoms include natural progesterone present in yam root,
known as disogenin, which is prepared into a topical cream and may be topically applied
for absorption or may be taken orally as Prometrium (Cutson & Meuleman). Alternatives
may also include natural phytoestrogens called isoflavones which are soy proteins that
may reduce hot flushes, bone loss, and total cholesterol and LDL cholesterol levels;
vitamin E which is believed to stabilize estrogen levels; black cohosh which may
suppress luteinizing hormones; chasteberry that may decreases prolactin; supplemental
calcium and vitamin D, and many others (Cutson & Meuleman).
Postmenopausal Years. The postmenopausal years begin when menses have been
absent for 12 months (Papaioannou & Parksinson, 1998). The use of HRT after
menopause is for long-term health benefits including protection against osteoporosis,
heart disease, colon cancer, and possibly Alzheimer’s disease (“Hormone replacement
therapy,” 2000).
Treatment Issues
The absolute contraindications for HRT often include estrogen-responsive breast
cancer, endometrial cancer, undiagnosed abnormal vaginal bleeding, active
thromboembolic disease, and a history of malignant melanoma (Cutson & Meuleman,
2000). The relative contraindications for the use of HRT include chronic liver disease,
severe hypertriglyceridemia, endometriosis, previous thromboembolic disease, and
gallbladder disease (Cutson & Meuleman). The side effects of HRT are attributed to the
estrogen component and may include headache, nausea, breast tenderness, bloating, leg
cramps, irregular vaginal bleeding, and increased vaginal mucus (Ammer, 1995).
9
P
1_ Estrogen loss is the primary cause of osteoporosis and is associated
with an increased risk of fracture morbidity and mortality including hip and vertebral
fractures. Long-term HRT results in a 30% to 50% reduction in all osteoporotic fractures
(Cutson & Meuleman, 2000). The alternatives to HRT for bone protection include the
use of bisphosphonate medications such as alendronate (Fosamax), risedronate (Actonel),
and etidronate (Didronel) to maintain or increase bone mineral density and reduce
fractures. Intranasal calcitonin (Miacalcin) inhibits osteoclast activity. In addition,
raloxifen (Evista) is a selective estrogen receptor modulator that does not stimulate
endometrial or breast tissue and does reduce fractures. Other nonhormonal and alternative
therapies include the use of calcium and vitamin D supplements, weight bearing and
strengthening exercises, smoking cessation, and decreasing alcohol intake (Cutson &
Meuleman).
The Rancho Bernardo Study was a cross sectional study of 740 women aged 60 to
98 years concerning osteoporosis (Schneider, Barrett-Connor, & Morton, 1997). The
objective of the study was to determine the effect of initiation and duration of
postmenopausal estrogen therapy on bone mineral density (BMD). The women were
divided into groups based on HRT usage and length of treatment. The study concluded
that estrogen initiated in the ear.ly menopausal years and continued into later life was
associated with the highest BMD while estrogen started after age 60 years and continued
into later life provided near.ly equal osteoporosis protection. It was demonstrated that
BMD levels among current continuous users were 20% higher at the ultradistal radius.
12% higher at the midshait radius, 8% higher at the hip, and 13% higher at the lumbar
spine when compmed to women who had never used HRT. Current late users had similar
10
findings when compared to women who had never used HRT with a 19% increase in
bone density at the ultradistal radius, 10% at the midshaft radius, 7% at the hip, and 10%
at the lumbar spine.
Heart Disease. In American women, heart disease is the primary cause of death
claiming 223,000 lives annually, and affecting one out of two women (Cutson &
Meuleman, 2000). Estrogen has been shown to reduce the risk of heart disease 40% to
50% and reduce the relative risk of heart disease in one-third of the women who had ever
used it. However, according to Cutson and Meuleman, HRT does not have any benefit for
secondary prevention of cardiovascular events and may be only beneficial as primary
prevention in otherwise healthy women. Other nonhormonal approaches for the
prevention of cardiovascular disease include the prescription “statin” drugs such as
atrovastatin (Lipitor) or simvastatin (Zocor) for women with dyslipidemia, as well as the
use of aspirin to act as an anti-thromboembolic agent (“Hormone replacement therapy,”
2000). Alternative and nonpharmacological prevention measures include a diet high in
fiber, low in fat, and rich in antioxidants; cardiovascular/weight bearing exercises;
smoking cessation; and the use of relaxation techniques (Cutson & Meuleman).
The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial (PEPI Trial
Group, 1995) was a 3 year, multicenter, randomized, double-blinded, placebo-controlled
trial of 875 healthy postmenopausal women aged 45 to 64 years with no known
contraindication for HRT. The PEPI Trial subjects used estrogen without progestin or
estrogen/progestin combinations. Estrogen with or without progestin improved
lipoproteins. Estrogen alone resulted in a 5.6 tng/dL increase in high-density lipoprotein
cholesterol (HDL). However, the increased risk of endometrial cancer restricts the use of
11
unopposed estrogen in a woman with a uterus. Estrogen/progestin combinations also
showed a beneficial effect on HDL with an increase of 4.1 mg/dL. Mean low-density
lipoproteins decreased 14.5 to 17.7 mg/dL with either estrogen or estrogen/progestin
combmations. HRT was also noted to increase mean triglyceride levels 11.4 to 13.7
mg/dL.
A randomized, blinded, placebo-controlled secondary prevention trail was
conducted with 2763 women who had known coronary disease (Hulley et al., 1998).
Their mean age was 66.7 years and all had an intact uterus. The objective of the Heart
and Estrogen Replacement Study (HERS) was to determine, over a 4 year period, if HRT
altered the risk for coronary heart disease events in postmenopausal women with known
coronary artery disease. The results showed no significant difference between the
placebo and HRT groups (relative hazard [RH], 0.99; 95% confidence interval [CI], 0.801.22). The study concluded that HRT did not reduce the overall rate of cardiovascular
events but did increase the rate of thromboembolic events (RH 2.89; 95% CI, 1.50-5.58)
and gallbladder disease (RH 1.38; 95% CI, 1.00-1.92). Therefore, HRT was not
recommended as a means of secondary prevention in postmenopausal women with
known coronary artery disease.
A study by Parish et al. (1996) examined the effects of estrogen alone and in
combination with progestin on lipoprotein risk markers for coronary heart disease.
Eighty postmenopausal women were randomly assigned to received either estrogen with .
or without progestin for 12 months while monitoring lipoprotein levels. Estrogen alone
resulted in a slight rise in triglycerides and a decrease in low density lipoprotein (LDL)
cholesterol significant at 6 months (^<0.05). There was a 16% increase in HDL (p<0.01),
12
while lipoprotein(a) showed
no significant change. The combination of estrogen and
progestin caused a 31 % decrease in triglycerides (p
cholesterol (p<0.001), a 42% decrease in very low density lipoproteins (VLDL) (p<0.01),
9% decrease m LDL (p<0.05), and 11% decrease in HDL (p<0.001). Lipoprotein(a) was
reduced 39 /o (p<0.05). Since at the end of 1 year the combination of estrogen and
progestin had favorable effects on triglycerides, VLDL, LDL, and lipoprotein(a), these
may balance the adverse effect on HDL.
Colon Cancer. After age 50, there is a one in 19 chance of developing colon
cancer with a one in 40 chance of fatality (Daminitz, McCormick, & Rex, 1996).
Postmenopausal women using HRT are at a decreased risk since bile acids promote the
development of colon cancer and estrogen and progestins reduce the production of those
acids (Daminitz et al.). Alternative therapy for the prevention of colon cancer would
include an aspirin every other day (Daminitz et al.), previous use of oral contraceptives,
cessation of smoking, weight control, limited intake of red meat, and intake of folate
(Grodstein et al., 1998).
The Cancer Prevention Study II (CPS-II), which began in 1982 and ended
December 31, 1989, followed 422,373 postmenopausal women who were cancer-free
(Calle, Miracle-McMahill, Thun, & Heath, 1995). CPS-II demonstrated that any use of
HRT was associated with a decreased risk of colon cancer with the greatest reduction in
risk was among cunent user (RR, 0.55; 95% CI, 0.40 to 0.76) and with 11 or more years
of use (RR, 0.54; 95% CI, 0.39 to 0.76).
The Nurses’ Health Study was a prospective cohort and nested case-control study
comprised of 59,002 postmenopausa! registered nurses ta. 11 U.S. states (Grodstein et
13
al., 1998). This study used biennial questionnaires from 1980 to 1994 and found that 470
women developed colorectal cancer and 838 developed distal adenomas. The current use
of HRT was associated with a decreased risk of colon cancer (RR, 0.65; 95% CI, 0.50 to
0.83). This association declined with past use of HRT and was absent 5 years after HRT
was discontinued (RR, 0.92; 95% CI, 0.70 to 1.21). The Nurses’ Health Study
concluded that HRT decreased the risk of colon cancer, but this protection ceased when
therapy stopped.
A Wisconsin study identified women aged 30 to 74 years with a diagnosis of
colon or rectal cancer through a statewide tumor registry (Newcomb & Storer, 1995).
The study consisted of 694 case subjects and 1622 control subjects. Information on
postmenopausal hormone replacement use as well as medical history was obtained via
telephone interviews. Premenopausal women were excluded from the study. The
researchers concluded that HRT provided a statistically significant reduced risk of colon
cancer (RR, 0.54; 95% CI, 0.36 to 0.81), but had no effect on rectal cancer (RR, 0.91;
95% CI, 0.54 to 1.55).
Alzheimer’s Disease. Alzheimer’s disease is the most common form of dementia
and is a significant women’s health care concern since women live long enough to
develop more severe cognitive impairment than men (Benson, 1999). Dementia of the
Alzheimer’s type (DAT) affects three women for every one man. With the aging of the
American population it is becoming a medical expense in excess of $1 billion dollars
per year (Benson). The loss of estrogen is one contributing factor for DAT and, although
HRT is not yet approved for the treatment of DAT, research has shown that HRT
increases cerebral blood flow and may reduce the prevalence, incidence, and severity of
14
DAT as evidenced by improved memory, cognition, and Mini-Mental Status Exam
scores when compared to women not taking HRT.
A meta-analysis of ten studies of postmenopausal estrogen use and the risk of
dementia was conducted to detei;rmine if estrogen therapy improved cognition, prevented
the development of dementia, or improved the severity of dementia (Yaffe, Sawaya,
Lieberburg, & Grady, 1998). The study results demonstrated a 29% decreased risk of
developing dementia with estrogen use. However, studies of estrogen therapy in women
with Alzheimer’s disease have had small samples, have been of short duration, and were
generally uncontrolled. These studies indicated that estrogen might lead to improved
cognition, reduced risk for dementia, or improvement in the severity of dementia, but
further, long-term studies are needed before estrogen can be recommended for the
prevention or treatment of Alzheimer’s disease or other dementias (Yaffe et al., 1998).
The Baltimore Longitudinal Study of Aging also investigated the relationship
between estrogen use and the risk of developing Alzheimer s disease (Kawas et al.,
1997). This was a prospective multidisciplinary study of normal aging conducted by the
National Institute on Aging and included 472 postmenopausal or perimenopausal
women followed for up to 16 years. Estrogen use was documented, via either the oral or
transdermal routes, and the Cox proportional hazards model with time-dependent
covariates was utilized to determine the risk of developing Alzheimer’s disease. Forty-
five percent of the women in the study were using estrogen replacement therapy. Thirtyfour cases of Alzheimer’s disease were diagnosed; nine of these women were using
estrogen replacement therapy The study results demonstrated a reduced risk of
15
Alzheimer’s disease for women who
use estrogen replacement (RR,0.46; 95% CI, 0.209
to 0.997). This study also recommended randomized clinical trails for further study.
er. The fear of cancer is one of the most common reasons women
refuse or discontinue HRT (“HRT 2000,” 2000). Many women believe that breast cancer
is the leading cause of death in women when, iin fact, the chance of getting breast cancer
is one in 17 by age 65 as opposed to one in three by age 65 for heart disease. Unopposed
estrogen replacement therapy (ERT) should be taken only by women who have
undergone a hysterectomy since unopposed estrogen use carries a five to eight times
increased risk of endometrial adenocarcinoma (Cutson & Meuleman, 2000). HRT, a
combination of estrogen and progestin, is prescribed for women with an intact uterus. In
one study, combination HRT with estrogen and progestin was found to have a 24%
increased risk of breast cancer for every 5 years of use, which correlates to an increased
risk of 51% after ten years (Ross, Paganini-Hill, Wan, & Pike, 2000).
The Nurses’ Health Study examined the relationship between current and past
HRT use and the risk of breast cancer (Colditz, Stampfer, Willett, Hennekens, Rosner, &
Speizer, 1990). This was a prospective study of 121,700 female nurses 30 to 55 years of
age that were followed over a 6 year period. The Nurses’ Health Study showed that the
risk of breast cancer was highest among current HRT users (RR, 1.36; 95% CI, 1.11 to
1.67). This study also demonstrated that no elevated risk was associated with past use
and that a definitive answer relating to breast cancer has yet to be determined.
A cohort study of follow-up data for 1980 to 1995 from the Breast Cancer
Detection Demonstration Project was conducted to determine whether there is an
increased risk of breast cancer with estregen-progestin combination compared to estrogen
16
alone (Schairer, Lubin, Troisi, St„rge()n, Brinton- &
comprised of46,355 postmenopausal women, with
ag
e of 58 years, who were
located at 29 screening centers throughout the United States. During thel5 year follow
up, 2,082 cases of breast cancer were identified. The study concluded that there is a
slightly greater risk of breast cancer with estrogen-progestin (RR, 1.4; 95% CI, 1.1 to 1.8)
as opposed to estrogen alone (RR, 1.2; 95% CI, 1.0 to 1.4).
The Iowa Women s Health Study in 1986 was a prospective cohort study of
37,105 postmenopausal women aged 55 to 69 years (Gapstur, Morrow, & Sellers, 1999).
The study was conducted to determine associations between HRT use and breast cancer
with favorable histology. These women were followed over 11 years with a total of 1520
cases of breast cancer. For HRT use of 5 years or less there was an increase in invasive
carcinoma with favorable histology (RR, 1.81; 95% CI, 1.07 to 3.07) as opposed to HRT
use of greater than 5 years (RR, 2.65; 95% CI, 1.34 to 5.23). There was no association
between HRT use and the incidence of ductal carcinoma in situ or invasive ductal or
lobular carcinoma which have a less favorable histology. The study concluded that HRT
use was most strongly associated with an increased risk of breast cancer with favorable
histology and prognosis.
A population-based case-control study was conducted in King County in
Washington State to determine the risk of breast cancer in relation to the use of HRT
(Stanford et al., 1995). The participants were 50 to 64 years of age consisting of 537
patients with primary breast
cancer and 492 randomly selected control women without a
history of breast cancer. Menopausal hormones hod been used by 57.6% of the breast
cancer patients and 61.0% of the control gt»»p. In this study, the women taking HRT
17
(21.5% of the breast cancer patients and 21.3% of the control group) were not at an
increased risk of breast cancer (relative odds [RO], 0.9; 95% CI, 0.7 to 1.3). When
compared with nonusers of HRT, those women who used HRT for 8 years or longer had
a reduced risk of breast cancer (RO, 0.4; 95% CI, 0.2 to 1.0). The study concluded that in
middle-aged women, the use of HRT does not appear to be associated with an increased
risk of breast cancer, but further long-term studies need to be conducted.
Summary
Short term HRT therapy is indicated for the treatment of symptoms during the
perimenopausal period (Cutson & Meuleman, 2000). The many benefits of long-term
HRT use, primarily a decreased incidence of osteoporosis, improved lipid profiles,
decrease incidence of colon cancer, and possible reduced risk of dementia of the
Alzheimer’s type, must be weighed against potential health risks such as breast cancer.
Alternative therapies for nonhormonal treatment are available but have not been studied
for their long-term effectiveness or safety.
18
Chapter 3
Methodology
The purpose of this scholarly project was to construct a web page designed for
patient education related to hormone replacement therapy (HRT). The purpose of the
web page was to assist perimenopausal and postmenopausal women in making an
educated and informed decision as to the potential health benefits and perceived risks of
HRT. This chapter discusses the development of the web page using Dreamweaver 3.0
software by Icon Logic, factors influencing patient education, and the Evaluating Printed
Education Materials (EPEM) model by Bernier and Yasko (1991).
Development of a Web Page
To develop a web page, appropriate software must be utilized. For this project,
Dreamweaver 3.0 by Icon Logic was used beginning with a site folder (Siegel, 2000).
Once information, graphics, and links were entered into the site folder, it was submitted
to an Internet Service Provider where the site is stored on their network for internet
access. The codes for searching the web include ERT, HRT, hormones, hormone
replacement therapy, menopause, perimenopause, hot flashes, estrogen, and progesterone.
The font will be Tahoma with the majority of print at twelve point. The color scheme is
predominately grayscale with color graphics.
Factors Influencing the Adult Learner
Several factors influence adults’ participation in the educational process: attitudes
toward learning, life transitions, the importance of goals and their expectations for
meeting goals, information related to learning opportunities, and perceived barriers
toward learning opportunities (Whitman, Graham, Gleit, & Duncan Boyd, 1992),
Perimenopausal and postmenopausal women are affected by these factors when deciding
to use HRT. For example, negative attitudes toward learning will prohibit effective
education reiating to HRT, However, during this life transition, individuals often express
19
the desire to increase their knowhdge (Whitmi„ M
fa.e
goal attainment might also fecihtate learning. The opportunity to educate patients is
enhanced by educational material, including pamphlets and the internet. By increasing
the ease of obtammg information, the patient may be more willing to participate in
learning.
The Neuman Systems Model (Neuman, 1995) demonstrates how sociocultural,
developmental, and psychological factors influence a patient’s health maintenance
decision. Sociocultural variables measure the relationship the patient has with family,
friends, significant others, and community members (Reed, 1993). For example, a
patient’s economic level may influence her health practices, beliefs, and lifestyle. These
factors must be taken into account when developing a plan of treatment. Additionally,
teaching plans must consider language, culture, and the methods of learning that are
appropriate for the patient. The developmental variable in Neuman’s model measures
cognitive abilities, education, and life experiences. The patient’s developmental age must
be taken into consideration as well as the ability to conceptualize and respond to changes
in health status (Reed). The psychological variable encompasses the mental and
emotional aspects of the patient.
Model for Evaluating Printed Education Materials
To develop the web page, Bernier and Yasko's (1991) EPEM mode! was applied.
The model consists of five phases: predesign, design, pilot test, implementation, and
evaluation.
Pmdesion. The predesign phase included the assessment of the need for
information by perimenopausa! and postmenopausal women regarding hormone
replacement therapy. The decision to start HRT wUl. in a.l probability, depend upon their
20
perceptions of potential health risks
versus health benefits, information related to side
effects, and alternative therapies. This needs to be made available from a reliable source.
The purpose of the web page is to provide this information.
Design. The design phase involved the review of literature to determine the
information to be placed on the web page. This information was then combined with
graphics and presented so that patients, capable of reading and understanding the English
level at the eighth grade level, would comprehend the material. Links to other sites allow
the patient to research related topics and to find information at a higher learning level.
The McLaughlin Smog Formula (McLaughlin, 1969) was used to determine that
the web page reads at an eighth grade. The formula is based on counting 10 consecutive
sentences from the beginning of the web page, 10 consecutive sentences from the middle,
and 10 consecutive sentences from the end. From these 30 sentences, the words
containing three or more syllables are counted and the nearest perfect square root is
determined. To this number, a constant of 3 is added to determine the grade level. For
the eighth grade level, the word count will be 21 to 30, with the nearest perfect square
root being 5.
Pilot Test. The pilot test phase was completed by having the web page viewed by
two health care professionals and three postmenopausal women. The web page was
analyzed for clarity. content, and helpfulness of information and provided Mm. Changes
were made to graphics (floral design) on the HRT home page, explmtadons of test
questions were simplified, and ciarification concerning the indications for Evista was
added.
21
Implementation/Distnbution. This informational site was made available via the
world wide web and can be viewed by anyone with internet access. Information can be
downloaded and/or printed and supplied to any perimenopausal or postmenopausal
women requesting information on HRT.
Evaluation. The evaluation of the completed web page can be done by asking
anyone viewing the web page to respond to the web master via e-mail relating to the
effectiveness of the information provided. Changes to the site can be made based on their
responses and on new research findings concerning HRT.
Summary
In summary, the purpose of this scholarly project was to create a web page to be
utilized by perimenopausal and postmenopausal women as a means of patient education
on hormone replacement therapy. The web page address is www.velocitY.net/~rnnartm.
The site was developed using Dreamweaver 3.0 software by Icon Logic. Development
and evaluation of the site was done using the EPEM model by Bernier and Yasko (1991)
and the McLaughlin Smog Formula (1969).
22
References
c- <1995>-
(3rd ei).
New York: Facts
On File, Inc.
(1999). Hormone replacement therapy and Alzheimer's disease: An
update on the issues. HealthCare_for Women International. 20. 619-639.
Bernier, M. J., & Yasko, J. (1991). Designing and evaluating printed education
materials. Model and instrument development. Patient Education and Counseling, 18,
253-263.
Calle, E. E., Miracle-McMahill, H. L., Thun, M. J., & Heath, Jr., C. W. (1995).
Estrogen replacement therapy and risk of fatal colon cancer in a prospective cohort of
postmenopausal women. Journal of the National Cancer Institute, 87, 517-523.
Colditz, G., Stampfer, M., Willett, W., Hennekens, C., Rosner, B., & Speizer, F.
(1990). Prospective study of estrogen replacement therapy and risk of breast cancer in
postmenopausal women. Journal of the American Medical Association, 264a 2648-2653.
Cutson, T. M., & Meuleman, E. (2000). Managing menopause. American Family
Physician, 61, 1391-1400,1405-1406.
Daminitz, J. A. McCormick, L. H„ & Rex, D. K. (1996). Latest approaches to
prevention and screening. PatientCareJO, 124-128, 133, 137-138, 140-142,145.
Decision tree can guide recommendations for ERT or HRT in postmenopausal
women: Consensus opinion of the North American Menopause Society (2000).
Geriatrics, 55(6), 72-74.
23
parish, E., Spowart, K., Barnes, J., Fletcher, C., Calder, A., Brawn, A., & Hart, D.
(1996). Effects of postmenopausal hormone replacement therapy on lipoprateins
including lipoprotein (a) and LDL subtractions. Atheroralerosis. 126, 77-84.
Fawcett, J., Carpemto, L. J., Efinger, J., Goldblum-Graff, D., Groesbeck, M. J. V.,
Lowry, L. W., McCreary, C. S., & Wolf, Z. R. (1982). A framework for analysis and
evaluation of conceptual models of nursing with an analysis and evaluation of the
Neuman Systems Model. In B. Neuman (Ed.), The Neuman systems model: Application
to nursing education and practice (pp. 30-43). Norwalk, CT: Appleton-Century-Crofts.
Gambrell, R. (1998). Overcoming the side efects of hormone replacement
therapy: How to recognize; how to manage. Women’s Health in Primary Care, 1, 160-
163.
Gapstur, S., Morrow, M., & Sellers, T. (1999). Hormone replacement therapy and
risk of breast cancer with a favorable histology. Journal of the American Medical
Association, 281, 2091-2097.
Grodstein, F„ Martinez, M„ Platz, E„ Giovannucci, E„ Colditz, G„ Kautzky, M„
Fuchs, C„ & Stampfer, M. (1998). Postmenopausal hormone use and risk for colorectal
cancer and adenoma.
705’71k
Hormone replacement therapy. More risk than benefit? (2000). H^dMh
Letter, 25 (8), 4-5.
HRT 2000: Pause for thought. (2000). HggymdW®^^
Hulley, S„ Grady, D„ Bush, T., Furburg, C„ Hetrington, D„ Riggs, B, &
Vittinghoff, E. (1998). Randomized trial of estrogen plus progestin for secondary
24
prevention of coron^y heart disease in poslmenopausa!women. lom., „f ,te American
Medical Association, 280. 605-612
Internet access in America: Who's got it, who needs it? CyberAtlas (2000, Oct.).
[On-Line serial]. Available:
http ://cyberatlas. internet. com. bigjicture/demographics/article/O,1323,5911 47429 l,00.h
tml
Kawas, C., Resnick, S., Morrison, A., Brookmeyer, R., Corrada, M., Zonderman,
A., Bacal, C., Lingle, D., & Metter, E. (1997). A prosective study of estrogen
replacement therapy and the risk of developing Alzeheimer’s disease: The Baltimore
longitudinal study of aging. American Academy of Neurology, 48, 1517-1521.
Lewis, J. A., & Bernstein, J. (1996). Women's health: A relational perspective
across the life cycle. London: Jones and Barlett Publishers International.
Li, S., & Holm, K. (2000). Perimenopause and the quality of life. Clinical Nursing
Research, 9, 6-27.
McLaughlin, G. H. (1969). SMOG-grading: A new readability formula. Joumalof
Reading, 12, 639-645.
Neuman, B. (Ed.) (1995). TheNeuman systems model (3rd ed.). Norwalk:
Appleton & Lange.
Newcomb, P., & Storer, B. (1995). Postmenopausal hormone use and risk of large
bowel cancer. Jgunlsblflll^aAliiindLCAnserJigtitute^ST, 1067-1071.
Papaioannou, A., & Parksinsou, W. (1998). Women's decisions about hormone
replacement therapy after education and bone densitometry, ganadian Medic.) Journal.
159, 1253-1258.
25
PEPI Trial Group (!995). Effects of
heart disease risk factors in postmenopausal women The postmenopausal
estrogen/progestin interventions (PEPI) trial. Journal of the American Medical
Association, 273, 199-208.
Reed, K. S. (1993). Betty Neuman: The Neuman systems model. Newbury Park,
CA: Sage Publications, Inc.
Ross, R. K., Paganini-Hill, A., Wan, P. C., & Pike, M. C. (2000). Effects of
hormone replacement therapy on breast cancer risk: Estrogen versus estrogen plus
progestin. Journal of the National Cancer Institute, 92, 328-332.
Schairer, C., Lubin, J., Troisi, R., Sturgeon, S., Brinton, L., & Hoover, R. (2000).
Menopausal estrogen and estrogen-progestin replacement therapy and breast cancer risk.
Journal of the American Medical Association, 283, 485-491.
Schneider, D., Barrett-Connor, E., & Morton, D. (1997). Timing of
postmenopausal estrogen for optimal bone mineral density. Journal of the American
Medical Association, 277, 543-547.
Shaywitz, S., Shaywitz, B. Pugh, K„ Fulbright, R., Skudlarski, P„ Mencl, W„
Constable, R„ Naftolin, F„ Palter, S„ Marehione, K„ Katz, L„ Shankweiler, D„ Fletcher,
J„ Lacadie, C„ & Gore, J. (1999). Effects of estrogen on brain activation patterns in
postmenopausal women during
working memory tasks. JoumaLpfthe American Medical
Association, 281, 1197-1202.
Siegel, K. A. (2000).
Riva, MD: Icon Logic.
‘‘n<1 Jrills lraini°g-
26
Stanford, J., Weiss, N., Voigt, L., Daling, J., Habel, L., & Rossing, M. (1995).
Combined estrogen and progestin honnone „placemeM
tp
pf
breast cancer tn middle-aged women. Journal of the American Medical Association. 274.
137-142.
Thomas, C. L. (Ed.) (1989). Taber's cyclopedic medical dictionary (16th ed.).
Philadelphia: F. A. Davis Company.
Whitman, N. I., Graham, B„ A., Gleit, C. J., & Duncan Boyd, M. (1992).
Teaching in nursing practice: A professional model (2nd ed.). Norwalk, CT: Appleton &
Lange.
Winter, J. T., & Bernard, M. E. (1998). Oral contraceptive use during the
perimenopausal years. American Family Physician, 58, 1373-1380.
Yaffe, K., Sawaya, G., Lieberburg, I., & Grady, D. (1998). Estrogen therapy in
postmenopausal women: Effects of cognitive function and dementia. Journal of the
American Medical Association, 279, 688-695.
Yanni, L., & Klein, W. (2000). Alternatives to traditional hormone replacement
therapy. Women's Health mPrimaryCarg^477-489.
27
Appendix A
Web Page Overview
28
Overview
The opening screen -the site’s hoi
me Page- allows one to select from the
following menu and submenu:
Home-Page
Test Your Knowledge
As Women Age
HRT Issues (this page provides a menu of its own)
Osteoporosis
Heart Disease
Colon Cancer
Breast Cancer
Alzheimer’s Disease
Home Page
Alternative Therapies
Terminology
This paper illustrates the text on the various pages of the site. Underlined text
corresponds to references documented in the research paper or links to related
sites on the web. To observe corresponding images at this site, go to
www.velocity.net/~rrmartin. This site is posted on the velocity net server and is
available through searches to the public.
29
Home Page
When the site is contacted, the Home Page appears and dispiays the text
below. When one is navigating the site, a clicking on the "Home Page"
button will bring the viewer back to this page.
Hormone Replacement Therapy (HRT) is a process by which estrogen, and
possibly progestin, are administered to women to manage the symptoms
associated with menopause and to obtain potential long-term health benefits.
This site examines the potential benefits and possible risks associated with
HRT. The focus has been on providing an understandable presentation that
provides a thorough coverage of the HRT issues. Begin with "Test Your
Knowledge" and then continue through the various topics. For your convenience,
definitions of medical terms used at this site are only a click away. The author
welcomes e-mail comments and suggestions regarding this site.
Catherine A. Martin, RN, BSN, created this site in partial fulfillment of the requirements for the Master of
Science in Nursing Degree at Edinboro University of Pennsylvania. No pharmaceutical company sponsors
this site. Copyright © 2001.
30
Test Your Knowledge
From the main menu, clicking on "Test Your Knowledge- produces a page
which
introductory to the quiz and contains the message:
Enjoy a ten-question quiz that is informative and introduces a more detailed
discussion of hormone replacement therapy. You may exit at any time by
selecting from the menu on the left side of the page. Click the button below to
begin the quiz.
Clicking the “Start” button produces the quiz designed to stimulate
interest in the remainder of the site.
1
The leading cause of death in older women is
a. breast cancer
b. heart disease
One in eight women develop breast cancer over the course of their lives;
one in 25 will die because of it. One in three women will die of coronary
heart disease. Heart disease is, by far, the leading killer of women 55 and
older.
2
In the female body, estrogen is responsible for the development of female
breasts.
a. true
b. false
At the onset of puberty, estrogen stimulates the development of
characteristics such as rounded hips and breasts. Estrogen also plays an
essentia, pad in menstruation, being response for the month,,Ranges
in the lining of the womb. As a woman grows older, her ovanes
smaller amounts of estrogen as "change of life" begms.
31
3
Menopausal symptoms, such as hot flashes and night sweats, last for the
rest of a woman's life.
a. true
b. false
For most women, the symptoms of menopause last for a relatively short
time. However, a woman's level of estrogen always remains low after
menopause. This can affect many parts of the body including the sexual
and urinary organs, the heart, and the bones.
4
Memory can be affected by menopause.
a. true
b. false
Many menopausal women have problems with short-term memory because
of low estrogen levels. It is not unusual to forget things like appointments or
losing the end of a thought when speaking.
5
Hormone replacement therapy (HRT) relieves many of the symptoms
associated with menopause.
a. true
b. false
One immediate benefit of hormone replacement therapy is the relief of
uncomfortable symptoms that may occur with menopause; things such as
"hot flashes" (a wave of heat and sweating), night sweats, and painful
intercourse. Hormones also help alleviate other menopausal symptoms,
such as changes in urination, irritability, and depression.
6
HRT is risk free.
a. true
b. false
There are some risks associated with the long-term use of HRT. These
risks depend on the type of treatment prescribed, whether the woman has a
uterus, and how long the hormones are taken. There are almost no risks
32
associated with a short-term therapy of less than five years.
7
Every woman experiencing menopause may use HRT.
a. true
b. false
Not every woman is a candidate for HRT. Women with a family history of
breast cancer as well as women who have had breast cancer, abnormal
vaginal bleeding, liver disease, or blood clots should be carefully evaluated
before hormone replacement therapy begins.
8
HRT is used by postmenopausal women.
a. true
b. false
For healthy women, long-term use of HRT is often recommended to slow
bone loss, decrease the risk of bone fractures, prevent heart disease, and
reduce the risk of colon cancer.
9
For most women, the benefits associated with HRT outweigh the risks.
a. true
b. false
There is almost no short-term risk. Long-term risks that accompany HRT
include a small increased tendency toward blood clots in the veins and a
small increase in the risk of breast cancer. However, studies indicate that
the breast malignancies associated with HRT may be of a less aggressive
type than those discovered in postmenopausal women not using HRT.
10
HRT usage is rare.
a. true
b. false
HRT usage is not rare. About 12 million women in the United States take
estrogen alone while another 8.6 million women are on the combined
estrogen and progestin regimen, according to drug company estimates.
33
As Women Age
From the main menu, clicking on “As Women Age” produces a web
page that contains the text below:
As women age they eventually experience menopause, commonly referred
to as "change of life." It is characterized by irregular menstrual periods and
decreases in the amount of estrogen produced by the body. This condition
generally affects women between the ages of 40 and 60 years. This time
period may be characterized by hot flashes, night sweats, sleep
disturbances, vaginal dryness, changes to the skin, fatigue, irritability,
forgetfulness, and headache. Perimenopause symptoms may precede the
end of menstruation by one or two years.
What is happening within the body?
The natural estrogen produced in the ovaries of a woman not only allows
her to have children, but also helps keep her bones strong. As will be seen,
there is evidence that estrogen also protects against heart disease and
stroke. During the perimenopausal phase, the estrogen level gradually
decreases which causes the risk of heart and blood vessel disease to
slowly rise. By the time menstrual periods finally end, estrogen levels will
have been reduced significantly.
What if 1 had a hysterectomy?
According to the American Heart Association, if the menstrual periods are
brought to an abrupt stop through the surgical removal of the uterus, the
chance of heart and blood vessel disease sharply increases.
Can anything be done to control the symptoms associated with
menopause?
Cutson and Meuleman report that replenishing estrogen levels may
alleviate depression and the constant feeling of illness or discontent.
Estrogen also improves concentration and decreases the sensation of hot
flashes, urethral irritation, vaginal thinning, and painful intercourse.
34
Heart disease is the number one killer among women. What effect
does HRT have on heart disease?
The American Heart Association states that over the years, millions of
women have been given estrogen to relieve the symptoms associated with
perimenopause and to lessen the risk of heart and blood vessel disease.
For women who have not had a hysterectomy, the estrogen is combined
with another hormone called progestin. For women that have had a
hysterectomy, the progestin is unnecessary and they are given estrogen
alone.
May HRT be continued beyond the time when I no longer have
periods?
Yes. According to Gambrell, taking estrogen continues to offer protection
against osteoporosis, heart disease, colon cancer, and possibly
Alzheimer's disease long after menopause and even into very old age.
What risks are associated with hormone replacement therapy?
At the center of the HRT controversy is the debate concerning perceived
risks versus benefits. For women who take HRT for less than five years,
there is almost no risk involved. For long-term users, there seems to be a
slight increase in risk of breast and uterine cancers in some individuals,
and there may be a slight tendency to form blood clots. Some women have
discontinued HRT because of breast tenderness, vaginal bleeding, and the
fear of developing cancer or blood clots. To see a more complete
discussion of the benefits and risks associated with HRT, click on the "HRT
Issues" button at the left.
How do I decide whether HRT is right for me?
Begin by becoming well-informed. Read as much as you possibly can
about HRT and estrogen replacement therapy. This web is a good starting
point. Once you are knowledgeable, discuss the possibility of using
hormone therapy with your health care provider who will assess your
history and current health. On this basis, you and your health care provider
can determine if the potential benefits associated with HRT outweigh any
risks.
35
HRT Issues
From the main menu, clicking on “HRT Issues” produces a page that
serves as an introduction to the various HRT issues to be discussed.
Hormone Replacement Therapy is used to effectively manage the symptoms
associated with menopause. Used long-term, it also offers significant protection
against osteoporosis and heart disease in women, decreases the risk of colon
cancer, and may even offer some protection against Alzheimer's disease.
Medical science has identified estrogen loss as the cause of "change of life"
symptoms. Today, replenishing this lost estrogen is a simple and effective
process with a variety of prescription medications available - - much more
attractive than the use of leeches, a method used 200 years ago!
The decision to use HRT should be made on the basis of maintaining wellness
and promoting long-term health. In the face of this decision, a woman should
understand the risks as well as the benefits associated with this therapy.
This page introduces a new menu. A “Home Page” button may be clicked
to return to the original menu.
36
Osteoporosis
Clicking on “Osteoporosis” from the “HRT Issues” submenu produces this
Page.
The word osteoporosis means "porous bones." The bones become brittle
as this disease progresses. Women are particularly susceptible to
osteoporosis. It may begin even before menopause, but the effects of the
disease increase dramatically as a woman's estrogen level declines.
Postmenopausal women are at great risk from osteoporosis. The
skeletal system fractures easily when osteoporosis is in an advanced
stage.
The top image at the right shows bone that is becoming diseased. The dark
areas represent no bone growth. At the left is an image of a more
advanced form of osteoporosis in the same region. Notice the obvious
decrease in bone. A region with this type of bone loss is very susceptible to
fractures. Such fractures typically occur in the areas of the hip, wrist, and
vertebrae. The lower image to the right shows a vertebral fracture.
Cutson & Meuleman have demonstrated that HRT, when used long-term,
results in at least a 50% reduction of osteoporotic bone fractures.
May a woman obtain significant osteoporotic benefits if HRT is started later
in life? The Ranco Bernardo Study involved 740 women aged 60 to 98
years. The study concluded that estrogen initiated in the early menopausal
years and continued into later life resulted in the greatest bone strength.
But, the study also found that women who started HRT after age 60
obtained nearly the same amount of protection against osteoporosis.
37
Heart Disease
Clicking on “Heart Disease” from the “HRT Issues” submenu produces this
page.
The following statement may come as a bit of a shock: recent findings show
that twice as many women die from heart disease than from all forms of
cancer combined! Furthermore, an important part of this heart disease is the
diminishing supply of estrogen as women age.
Elevated levels of cholesterol in the blood can cause heart disease. There
are different types of cholesterol within the body. High levels of LDL
cholesterol (Low Density Lipoproteins - the "bad cholesterol") are responsible
for the formation of fatty deposits along the inside walls of the arteries. This
causes blockages in the arteries that often lead to serious heart disease. On
the other hand, HDL cholesterol (High Density Lipoproteins - the "good
cholesterol") transports excess blood cholesterol to the liver where it is
recycled or eliminated. As a result, increasing the HDL level protects against
coronary heart disease.
Several studies have shown the important role that estrogen replacement
plays in lowering the risk of heart disease. The Postmenopausal
Estrogen/Progestin Interventions Trial (PEPI Trial) was an extensive threeyear study involving women between the ages of 45 and 64 years. The study
found that the use of estrogen significantly lowered LDL levels and
significantly elevated HDL levels. In all, HRT was demonstrated to be
effective in lowering the risk of heart disease in healthy women even though
HRT does elevate triglycerides to some extent. Cutson and Meuleman claim
that HRT may reduce the risk of heart disease by 40% to 50%.
The Heart and Estrogen Replacement Study (HERS) was a four year study
that concluded that HRT provided no protective effect in women who already
had heart disease.
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Colon Cancer
Clicking on “Colon Cancer” from the “HRT Issues” submenu produces this
Page.
The colon or large intestine (pictured in purple) has five parts: from the lower
right side of the body, the Ascending Colon extends upward to the Transverse
Colon which extends across the abdomen to the left side; the Descending Colon
extends downward to a lower S-shaped piece of large intestine called the
Sigmoid Colon which empties into the Rectum, a container that is vertical and
approximately seven inches in length. The Anus is the opening to the outside.
Colon cancers typically begin as benign polyps in the large intestine. They can
be detected and removed before they become cancerous. Through colonoscopy
or sigmoidoscopy, flexible scopes equipped with a light and tiny camera are
used to examine the colon. Adults should have such an exam every five years to
prevent colon cancer.
Acids formed in the liver (bile acids) promote the development of colon cancers.
A study done by Daminitz, McCormick, and Rex, determined that
postmenopausal women using HRT are at a decreased risk for colon cancer
since estrogen and progestin reduce the production of these bile acids. The
eight year Cancer Prevention Study II (CPS-II) demonstrated that any use of
HRT was associated with a decreased risk of colon cancer. These results were
also confirmed by the Wisconsin Study.
Even though these results indicate a significantly reduced risk of colon cancer,
the use of HRT seems to have no effect on the frequency of rectal cancer.
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Breast Cancer
Clicking on “Breast Cancer” from the “HRT Issues” submenu
produces this page.
The relationship between the risk of breast cancer and HRT remains a concern.
Many women believe that breast cancer is the leading cause of death in women
when, in fact, the chance of getting heart disease by age 65 is six times greater.
Periodic mammograms are recommended for early detection of breast cancer.
There have been many studies, some that show HRT increases the risk of
breast cancer and others showing that HRT does not increase this risk. A 1995
study conducted in King County in Washington State concluded that middleaged women taking HRT were not at an increased risk for breast cancer.
The Breast Cancer Detection Demonstration Project (BCDDP), a national breast
cancer screening program that involved 46,355 postmenopausal women, found
an increased risk of one percent each year for women taking estrogen only; they
found an eight percent increase in breast cancer risk each year for women using
the estrogen-progestin combination. For someone taking the combination
estrogen-progestin over ten years, there may be an increase in the risk of
developing breast cancer.
As a result of the BCDDP, the National Cancer Institute advises women with no
uterus to avoid long-term combination therapy; however, the Institute also states
that the combination therapy poses no additional breast cancer risk for any
woman if used for only a few years to alleviate the symptoms associated with
menopause .
Because of the conflicting data regarding the risk of breast cancer and long-term
use of HRT, the National Cancer Institute is continuing this research and is soon
to gather and study new data.
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Alzheimer’s Disease
Clicking on “Alzheimer’s” from the “HRT Issues” submenu produces this
page.
Alzheimer's disease is the most common form of dementia and is a significant
health concern for women since women live long enough to develop it more
often than men. According to Benson, dementia of the Alzheimer's type affects
three women for every one man. Very little is known about the cause and
currently there is no cure. In fact, the disease can be identified with absolute
certainty only by autopsy after death.
Scientists are currently exploring the effect of estrogen in the prevention of
Alzheimer's disease. It seems that estrogen may slow the formation of the
plaque produced by the disease, and improves blood flowthrough the brain.
In an analysis often studies by Yaffe, it was determined that postmenopausal
estrogen use decreased the risk of Alzheimer's disease by 29%. However, the
studies involved small groups of women for short periods of time. Therefore, the
results are not completely reliable.
The Baltimore Longitudinal Study of Aging (BLSA), conducted by the National
Institute on Aging, included 472 older women that were followed for 16 years.
This well-controlled study demonstrated a significantly reduced risk of
Alzheimer's disease for women who use HRT.
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Alternative Therapies
From the main menu, clicking on “Alternative Therapies” produces a
web page that contains the text below:
The alternative approaches to HRT usually focus on dietary, nutritional, and
lifestyle changes. They may include prescription drugs or nonprescription
drugs other than estrogen/progestin. Many of these alternatives to HRT
involve a risk of their own since very few have been studied for either their
long-term effect or their safety. The motivation for using these therapies is
usually to avoid the risks associated with HRT therapy. Sometimes this
approach is very effective; in any case, it requires both great discipline and
patience. A generally healthy lifestyle is advocated which stresses good
nutrition and exercise, the elimination of smoking, and a decrease in
alcoholic consumption. Of course, this should be everyone's lifestyle.
The General Relief of Menopausal Symptoms
The Association of Reproductive Health Professionals heard testimony stating
that the natural progesterone present in yam root, taken orally as Prometrium
and used to provide relief of various menopausal symptoms, is no more effective
than a sugar pill. However, some alternative therapies are recognized as being
somewhat effective. Specific dietary and nutritional changes with nutritional and
herbal supplements have been shown to alleviate some menopausal
discomforts. For example, soy protein may reduce hot flashes, bone loss, and
LDL-cholesterol levels.
Osteoporosis
As a non-hormonal therapy, calcium is typically recommended to prevent bone
loss in women. With increased doses, and combined with vitamin D, calcium
does seem to provide some protection. Numerous studies have shown that
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calcium alone does not build bone, but only slows bone loss.
Fosamax is another drug prescribed to improve bone density. The manner in
which Fosamax and other drugs of its type (biophosphates) slow the progression
of osteoporosis is not completely understood. Most endocrinologists prefer the
use of estrogen to biophosphates.
Calcitonin, a hormone naturally produced in the thyroid and prescribed for
patients with osteoporosis, is a prescription drug that produces modest
increases in bone mass. This drug is sprayed into the nose for quick absorption
into the blood stream. It is less effective than estrogen. Combining calcitonin and
estrogen, with enough calcium (1,200 mg a day), offers an even greater benefit
than using either separately.
Evista is another prescription drug that is used to prevent bone loss. It has no
effect on uterus or breast tissue and it does reduce osteoporotic fractures.
However, it cannot be taken by everyone. If you can become pregnant, are
nursing, have severe liver problems, or have had blood clots that required a
doctor's treatment, you cannot take Evista. Also, Evista cannot be started while a
woman is still experiencing hot flashes or the symptoms will worsen.
Heart Disease
Vitamin E is frequently taken to reduce the risk of heart disease. Researchers
from the National Heart, Lung and Blood Institute concluded in January, 2000
that estrogen provides more effective heart protection than vitamin E . Currently,
other studies are in progress to better determine the role of both estrogen and
vitamin E in preventing heart disease in postmenopausal women.
Typical measures taken to prevent heart disease include exercise, daily aspirin,
and a diet that is low in fat, high in fiber content, and rich in antioxidants. For
women with high cholesterol, prescription drugs such as Lipitor and Zocor are
often used. When these drugs are taken, periodic blood tests are required to
43
check liver function. Other prescription medications such as Baycof and
Pravachol are also available to combat cholesterol problems.
Colon Cancer
According to the Harvard Center for Cancer Prevention, men and women are at
equal risk for developing colon cancer. To lower colon cancer risk, eat less red
meat, exercise regularly, take multivitamins that contain folic acid, aspirin 325mg
every other day, vitamin E and get screened regularly after the age of 50. The
risk of dying from colon cancer is reduced about approximately 50% with
periodic screening.
In Conclusion...
There is a wide variety of alternatives to HRT. These alternatives range from
acupuncture to herbs and include prescription as well as nonprescription drugs.
The above discussion refers to some of the more popular alternative therapies.
Keep in mind that very little testing has been done to determine the actual
effectiveness of most of these non-pharmacological (or prescription drug)
alternatives. Of course, HRT is also not completely risk free.
The benefits of HRT are many. In addition to relieving the symptoms associated
with menopause, there are two proven major benefits with long-term usage: it
helps prevent osteoporosis and protects against heart disease. The decision to
begin HRT should be determined by you and your health care provider. Your
health care provider’s opinion will take into consideration your current health as
well as your family's health history.
44
Terminology
From the main page, clicking on “Terminology” produces a web page that
contains the text below:
endocrinologist
a doctor that specializes in the study of the
endocrine glands which produce the body's
hormones
estrogen
a hormone produced by the ovaries and
responsible for female sexual characteristics
and the cyclic changes with the vagina and the
uterus; the synthetic form is also called estrogen
estrogen replacement
the administering of estrogen to replenish
therapy (ERT)
diminishing estrogen levels in the female body
HDL (high density
this is the "good cholesterol" which helps
lipoproteins)
to protect the arteries from clogging
hormone replacement
therapy (HRT)
the administering of estrogen and possibly
progestin to replace hormones that become
depleated during and after menopause
hysterectomy
surgery to remove the uterus
LDL (low density
this is the "bad cholesterol" and is
lipoproteins)
responsible for the clogging of arteries in the
body
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menopause
in medical use, this term refers to the precise
date of a woman’s last period; typically, it
means the transition period between
reproductive and postreproductive years
menses
menstruation; the discharge of a bloody fluid
from the vagina
osteoporosis
brittleness and softness of the bone tissue that
promotes a tendency for the bones to fracture;
porous bones
ovaries
the female sex glands that produce the eggs to
be fertilized by male sperm; this is where
estrogen and progesterone are produced;
these hormones are responsible for the
development of the female body
perimenopause
the time period including a few years before
and one year after the permanent cessation of
menses; this time period is characterized by
irregular menstrual cycles and is associated
with a reduction in hormone levels; symptoms
may include hot flashes, night sweats, fatigue,
irritability, forgetfulness, and headache
postmenopause
the time period that begins one year after
menses have ceased; that is, one year after
the date of your last period
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progestin
a synthetic form of progesterone, a hormone
that is responsible for cyclic changes in the
uterus
progesterone
the natural hormone produced by the body; the
synthetic form is called progestin
uterus
the hollow pear-shaped organ that holds the
baby during pregnancy; also called the "womb"
(also see vagina)
vagina
the canal leading from the outside of the body
to the uterus; the region where sexual
intercourse takes place
womb
see uterus
Media of