|
The Women’s Health Initiative
|
The University of Cincinnati was one of 40 institutions selected to be a part
of the Women's Health Initiative (WHI). This landmark study, sponsored by the
National Heart Lung and Blood Institute of the National Institutes of Health (NIH),
enrolled 161,859 women ages 50-79 to study the effects of various interventions
on the prevention of chronic conditions of aging. The original study was to be
conducted from 1993 to 2005. In 2005, UC and 38 other WHI sites were awarded grants
to extend the study until 2010. Margery Gass, M.D., Professor of Clinical Obstetrics
and Gynecology, is the WHI Principal Investigator at the University of Cincinnati.
The WHI has two major components, a Clinical Trial (CT) and an Observation
Study (OS). At UC, more than 3500 women from the greater Cincinnati, Dayton,
Northern Kentucky and Southeast Indiana enrolled in the study between 1995 and
1998, with over 1400 women in the CT and 2100 in the OS. Primary endpoints were
coronary heart disease, breast and colorectal cancer, and hip fractures. Secondary
outcomes included other cardiovascular diseases, endometrial and ovarian cancer,
other fractures, venous thrombosis and diabetes mellitus.
Clinical Trial: The clinical trial was composed of three distinct studies.
A participant could enroll in one, two, or three of these studies:
• Hormone Trial: The Hormone Therapy (HT) Trial was
designed to study the effects of hormone therapy on prevention of cardiovascular
disease and osteoporotic fractures. Women in the HT arm of the CT were randomized
to conjugated equine estrogens 0.625 mg/day plus medroxyprogesterone acetate
2.5 mg/day (EPT) or a placebo. Women without a uterus were randomized to conjugated
equine estrogens 0.625 mg/day (ET) or placebo.
In July 2002, the WHI Data Safety Monitoring Board recommended that women
in the estrogen plus progestin (EPT) arm of the clinical trial discontinue
their study drugs because interim analyses indicated that the risks of taking
EPT outweighed the benefits. In March 2004, the NIH decided to stop the Estrogen
Trial as well because of an increased risk of stroke and an absence of the
expected cardiac benefit.
• Dietary Modification: Participants in the Dietary
arm of the CT were randomized into two groups. One group was instructed to
eat a low fat diet, high in fruits, vegetables and grains. This group attended
regular nutrition sessions led by trained dieticians. The second group was
asked to continue their usual eating pattern. Both groups regularly completed
questionnaires on the foods they were consuming.
• Calcium/Vitamin D: At their first and second annual visits,
participants were invited to enroll in the Calcium/Vitamin D arm of the trial.
Those enrolled were randomized to either 1000 mg calcium with 400 IU of vitamin
D daily or placebo.
Observational Study: This arm tracked the health of those
women who were not enrolled in the CT. After measurement of baseline characteristics,
these women were contacted periodically by mail and phone to ascertain clinical
events. Physical measurements were repeated in the participants' third year
with the study.
During the WHI Extension study, those participants who re-enrolled will be
asked annually to complete health-related questionnaires by mail and telephone.
The WHI will continue to collect medical records of all reported events so
that physicians and other scientists may continue to study the results of
CT interventions and the endpoints listed above.
WHI Ancillary Studies
The Cincinnati WHI is also participating in several ancillary studies of the
WHI. These include:
The WHI Memory Study (WHIMS)
The WHIMS was designed to ascertain the effects of hormone therapy on cognition
and dementia.
The Benign Breast Disease Study (BBD)
The BBD was designed to study the effects of dietary fat reduction, CaD
supplementation and hormone replacement therapy on risks of proliferative
benign breast disease.
The Breast Mammographic Density and Breast Cancer Study (MDBC)
The MBCD seeks to estimate the relative risk for breast cancer associated
with a change in mammographic density from the EPT arm of the Hormone Trial.
The Coronary Artery Calcium Study (CACS)
The CACS is designed to answer some questions raised in WHI concerning the
age at which hormone therapy is initiated and the effect of timing of HT
on cardiovascular risks and benefits.
The WHI is being coordinated at the Fred Hutchinson Cancer Research Center
in Seattle, which collates and performs statistical analyses of the data.
The WHI Clinical Center at UC is located on the 4th floor of the Holmes Hospital
Building on the East Campus of UC, across the street from the Medical Sciences
Building of the College of Medicine.
For more information, visit websites at www.whi.org or www.nhlbi.nih.org/whi/index.html
or call the UC WHI Clinical Center at (513) 584-6061 or toll free at (888)
558-6062.
Anyone interested in using the database for research may contact
UC WHI staff can be contacted by email at:
Program Director/Field Center Manager Susie Sheridan: ssherida@whi.org
Research Coordinator/Outcomes Manager Chris Barczak: cbarczak@whi.org
Principal Investigator
|
