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We have been hearing about the hormone replacement study that was
halted.........will here is the study .......straight from The
Journal of the American Medical Association. If after reading this
article , you would like a natural estrogen replacement
choice.........send me an email.
JAMA-EXPRESS
Risks and Benefits of Estrogen Plus Progestin in Healthy
Postmenopausal Women
Principal Results From the Women's Health Initiative Randomized
Controlled Trial
Writing Group for the Women's Health Initiative Investigators
JAMA. 2002;288:321-333.
Context Despite decades of accumulated observational evidence, the
balance of risks and benefits for hormone use in healthy
postmenopausal women remains uncertain.
Objective To assess the major health benefits and risks of the most
commonly used combined hormone preparation in the United States.
Design Estrogen plus progestin component of the Women's Health
Initiative, a randomized controlled primary prevention trial (planned
duration, 8.5 years) in which 16608 postmenopausal women aged 50-79
years with an intact uterus at baseline were recruited by 40 US
clinical centers in 1993-1998.
Interventions Participants received conjugated equine estrogens,
0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet
(n = 8506) or placebo (n = 8102).
Main Outcomes Measures The primary outcome was coronary heart
disease (CHD) (nonfatal myocardial infarction and CHD death), with
invasive breast cancer as the primary adverse outcome. A global index
summarizing the balance of risks and benefits included the 2 primary
outcomes plus stroke, pulmonary embolism (PE), endometrial cancer,
colorectal cancer, hip fracture, and death due to other causes.
Results On May 31, 2002, after a mean of 5.2 years of follow-up, the
data and safety monitoring board recommended stopping the trial of
estrogen plus progestin vs placebo because the test statistic for
invasive breast cancer exceeded the stopping boundary for this
adverse effect and the global index statistic supported risks
exceeding benefits. This report includes data on the major clinical
outcomes through April 30, 2002. Estimated hazard ratios (HRs)
(nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29
(1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290
cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25)
with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases;
endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture,
0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92
(0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for
composite outcomes were 1.22 (1.09-1.36) for total cardiovascular
disease (arterial and venous disease), 1.03 (0.90-1.17) for total
cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for
total mortality, and 1.15 (1.03-1.28) for the global index. Absolute
excess risks per 10 000 person-years attributable to estrogen plus
progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8
more invasive breast cancers, while absolute risk reductions per 10
000 person-years were 6 fewer colorectal cancers and 5 fewer hip
fractures. The absolute excess risk of events included in the global
index was 19 per 10 000 person-years.
Conclusions Overall health risks exceeded benefits from use of
combined estrogen plus progestin for an average 5.2-year follow-up
among healthy postmenopausal US women. All-cause mortality was not
affected during the trial. The risk-benefit profile found in this
trial is not consistent with the requirements for a viable
intervention for primary prevention of chronic diseases, and the
results indicate that this regimen should not be initiated or
continued for primary prevention of CHD.
Writing Group for the Women's Health Initiative Investigators:
Jacques E. Rossouw, MBChB, MD, National Heart, Lung, and Blood
Institute, Bethesda, Md; Garnet L. Anderson, PhD, Ross L. Prentice,
PhD, Andrea Z. LaCroix, PhD, and Charles Kooperberg, PhD, Fred
Hutchinson Cancer Research Center, Seattle, Wash; Marcia L.
Stefanick, PhD, Stanford University Clinical Center, Stanford, Calif;
Rebecca D. Jackson, MD, Ohio State University Clinical Center,
Columbus; Shirley A. A. Beresford, PhD, Fred Hutchinson Cancer
Research Center, Seattle, Wash; Barbara V. Howard, PhD, MedStar
Research Institute, Washington, DC; Karen C. Johnson, MD, MPH,
University of Tennessee, Memphis; Jane Morley Kotchen, MD, Medical
College of Wisconsin, Milwaukee; Judith Ockene, PhD, University of
Massachusetts Medical School, Worcester.