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This listing
provides a quick reference of some of the major research studies
that have helped to advance what we know about women's health and
health differences between men and women. There are a number of
other studies, not listed on this page, that are also contributing
to this knowledge. For a list of websites offering information on
current research studies, click
here.
Women's Health
Initiative
The National Institutes of Health (NIH) established the Women's Health
Initiative (WHI) in 1991 to address the most common causes of death, disability
and impaired quality of life in postmenopausal women. The WHI is a long-term
national health study that focuses on strategies for preventing heart
disease, breast and colorectal cancer and osteoporosis in postmenopausal
women. These diseases are the major causes of death and disability in
older women of all races and socioeconomic backgrounds.
This 15-year project,
sponsored by the National Institutes of Health (NIH), National Heart,
Lung, and Blood Institute (NHLBI), involves over 161,000 women aged 50-79.
The WHI will attempt to address many of the inequities in women's health
research and provide practical information to women and their physicians
about hormone replacement therapy, dietary patterns and calcium/vitamin
D supplements, and their effects on the prevention of heart disease, cancer
and osteoporosis.
View the Women's Health
Initiative Homepage.
Postmenopausal
Estrogen/Progestin Interventions (PEPI)
The National Heart, Lung and Blood Institute (NHLBI), along with other
units of the National Institutes of Health (NIH) launched the Postmenopausal
Estrogen/Progestin Interventions (PEPI) Trial in 1987. PEPI was conducted
at seven research centers across the United States and followed 875 women
for 3 years. At the start of the trial, the women were ages 45-64.
PEPI's main goal was
to see what effects different types of hormone replacement therapy (the
use of synthetic hormones estrogen and/or progestin) would have on increased
cholesterol and high blood pressure, which are key risk factors for heart
disease. The study looked at different forms of hormone replacement therapy
including the use of estrogen alone and estrogen in combination with progestin
or a placebo (sugar pill). PEPI also examined hormone replacement therapy's
effects on bone mass (an indicator of osteoporosis risk) and quality of
life.
Women's Ischemia
Syndrome Evaluation (WISE)
Each year in the US 250,000 women die of ischemic heart disease,
a condition characterized by decreased blood supply to the heart.
Ischemia can be caused by atherosclerosis, a thickening and hardening
of the walls of the blood vessels that supply the heart. Despite
the fact that ischemic heart disease is the leading killer of women,
it is diagnosed less often in women than men, and when it is diagnosed,
it is usually at a later stage than men's and is treated less aggressively.
The Women's Ischemia
Syndrome Evaluation (WISE) study, sponsored by the National Heart, Lung
and Blood Institute, is a four-center study designed to address ischemia
in women. Over 900 women will be enrolled in the study.
The WISE study is
attempting to understand the best way to evaluate symptoms of ischemic
heart disease in women and to optimize testing for the disease. The researchers
will also try to understand why women have different symptoms then men
and will look at the role of reproductive hormones (such as estrogen and
progesterone) on symptoms and testing of the disease.
Nurses Health
Study
In 1976, researchers at Harvard Medical School and Brigham and Women's
Hospital mailed a two-page questionnaire to 175,000 registered nurses
between the ages of 30 and 55. More than 120,000 were returned. This began
the Nurses Health Study, one of the longest-running and largest studies
of the risk factors for chronic diseases, such as cancer and diabetes,
in women.
The researchers have
resurveyed the group at 2-year intervals, each time asking new questions
about the women's lifestyles and states of health. The answers have provided
information on
- the role of diet
and exercise in preventing disease
- the risks and benefits
of hormone replacement therapy
- lifestyle behaviors
(such as smoking and physical activity) that may put women at risk,
or offer protection from adult-onset diabetes, heart disease, cancer
and osteoporosis.
By now, the original
members of the study are 55-75 years old. Researchers have recently recruited
a second group of younger nurses to form the Nurses Health Study II to
continue to study health questions that women face during their reproductive
years.
HIV Viral Load
Studies
A number of researchers have begun to study sex differences in HIV (Human
Immunodeficiency Virus) and AIDS (Acquired Immune Deficiency Syndrome).
HIV, the virus that causes AIDS, can exist in different amounts in the
blood. The amount of the HIV in the blood is called the viral load. The
level of the viral load is often used to determine when treatment should
begin.
Recent studies have
produced remarkable information on gender differences in the levels of
HIV-1 (human immunodeficiency virus type 1) in infected individuals. One
of the earliest and most important studies was from a team at Johns Hopkins
University, School of Hygiene and Public Health. The study, released in
1998, showed differences in men and women in the HIV-1 viral load throughout
the course of the disease. Although the length of time it took to progress
from HIV to AIDS was similar for both men and women in the study, the
women had lower HIV-1 viral loads throughout the course of progression.
Although the cause
of this difference remains unclear, the information is important for the
treatment of HIV. The guidelines for certain HIV treatments are set to
begin when an infected individual reaches a certain viral load. Currently,
the guidelines are the same for men and women. The results of this study
suggest that women may need different treatment guidelines than men.
Prostate, Lung,
Colorectal, and Ovarian Cancer Screening Trial
The Prostate, Lung,
Colorectal, and Ovarian Screening Trial is a large-scale study focusing
on whether tests, that may detect cancers before symptoms develop, will
reduce the number of deaths from these cancers. The study will involve
148,000 women and men aged 55 through 74 years at 11 medical facilities
throughout the United States. The study includes the following tests for
these diseases:
Ovarian Cancer
- physical examination
of the ovaries
- blood tests for
the tumor marker CA-125 ( a protein that is increased in the blood of
many women with ovarian cancer
- transvaginal ultrasounds
(an ultrasound test performed with a small instrument placed in the
vagina)
Colorectal Cancer
- sigmoidoscopy (examination
of the rectum and colon using a flexible lighted tube)
Lung Cancer
Prostate Cancer
Visit the PLCO
homepage for more in-depth information about the study.
Study of Tamoxifen
and Raloxifene (STAR)
The Study of Tamoxifen and Raloxifene (STAR) is a clinical trial designed
to see how the drug raloxifene (Evista®) compares with the drug tamoxifen
(Nolvadex®) in reducing the rates of breast cancer in women who are
at an increased risk of developing the disease. The study is primarily
funded by the National Cancer Institute (NCI). The STAR trial is the first
trial to compare a drug proven to reduce the chance of developing breast
cancer with another drug that has the potential to reduce breast cancer
risk. The study may help to give women more options for lowering their
risk of breast cancer.
Researchers with the
National Surgical Adjuvant Breast and Bowel Project (NSABP) are conducting
the study at more than 400 centers across the United States, Puerto Rico,
and Canada. The NSABP has a 40-year history of designing and conducting
clinical trials. The results of their research has changed the way breast
cancer is treated and, now, prevented.
Check out the
National Cancer Institute's CancerTrials
website for more information about the STAR trial.
Gender Differences
in Response to Pain Relievers
Research supported by the National Institute of Dental and Craniofacial
Research (NIDR) has revealed important differences in the way that men
and women response to certain analgesics (pain relievers). The NIDR studies
looked at men and women's responses to analgesics following wisdom tooth
extractions. Investigators reported that kappa-opiods, a type of analgesic,
produced significant pain relief following surgery in female patients
but not in male patients.
Prior to these studies
kappa-opiods were studied primarily in men. Because they provided little
pain relief for men, they were thought to be ineffective at relieving
pain. After women were included in studies on the drugs, researchers realized
that the kappa-opiods did provide pain relief for women. The inclusion
of women in these studies resulted in new pain relief options for women
and highlighted the important role of gender in the body's response to
certain medications.
The National
Institute of Dental and Craniofacial Research website contains
information on gender differences in pain and other conditions.
Fracture Intervention
Trial (FIT)
Eight million American women have osteoporosis, a disease in which bones
become fragile and more likely to break. In addition, 18 million Americans
have low bone density, a risk factor for the disease. For this reason,
studies on the prevention of osteoporosis and the related health problems
are very important to our public's health. One such study, the Fracture
Intervention Trial (FIT) is studying the effects of alendronate, a type
of medication called an amino-bishphosphonate. Alendronate has been shown,
in past studies, to increase bone density. This study examined alendronate's
effect on the risk of fractures in women with low bone density.
Over 6000 women between
the ages of 55-80 years participated in the Fracture Intervention Trial
(FIT). All women in the study were diagnosed as having low bone density.
The study found that the treatment increased bone density and reduced
the risk of fractures. The study, sponsored by Merck Research Laboratories,
is one of the largest intervention trials on osteoporosis. In conjunction
with the FIT trial, additional studies are being conducted which will
address a number of women's health issues.

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