Premature Stoppage of Women's Health Initiative
Clinical medical practice changed with two parallel WHI studies of postmenopausal HRT. Prior studies were smaller, and many were of women who electively took hormonal therapy. The WHI studies were the first large, double-blind, placebo-controlled clinical trials of HRT in healthy, postmenopausal women.
The WHI estrogen-plus-progestin trial was stopped prematurely in 2002 because preliminary results suggested risks of combined conjugated equine estrogen and progestin exceeded their benefits. The estrogen-alone trial, performed on women who were post hysterectomy, due to the proliferative effect of the hormone on endometrial tissue, did not show such problems and was continued. However, in February 2004 it, too, was halted. While there was a 23% decreased incidence of breast cancer in estrogen only arm, risks of stroke and pulmonary embolism were increased, predominantly in patients who began HRT over the age of 60.
The first report on the halted WHI estrogen-plus-progestin study came out in July 2002. It followed over 16 000 women for an average of 5.2 years, half of whom took placebo, while the other half took a combination of progestin medroxyprogesterone acetate and conjugated equine estrogen.
The study reported statistically significant increases in rates of breast cancer, coronary heart disease, strokes and pulmonary emboli. The study also found statistically significant decreases in rates of hip fracture and colorectal cancer. "A year after the study was stopped in 2002, an article was published indicating that estrogen plus progestin also increases the risks of dementia." The conclusion of the study was that the HRT combination presented risks that outweighed its measured benefits. The results were almost universally reported as risks and problems associated with HRT in general, rather than with PremPro, the specific proprietary combination of conjugated equine estrogen and progestin studied.
After the increased clotting found in the first WHI results was reported in 2002, the number of Prempro prescriptions filled reduced by almost half. An unknown number of women started taking alternatives to Prempro, such as bioidentical hormones. A sharp drop in breast cancer rates was observed following these changes, and held steady in subsequent years.
Read more about this topic: Hormone Replacement Therapy (menopause)
Famous quotes containing the words premature, women, health and/or initiative:
“God screens us evermore from premature ideas. Our eyes are holden that we cannot see things that stare us in the face, until the hour arrives when the mind is ripened; then we behold them, and the time when we saw them not is like a dream.”
—Ralph Waldo Emerson (1803–1882)
“... business training in early life should not be regarded solely as insurance against destitution in the case of an emergency. For from business experience women can gain, too, knowledge of the world and of human beings, which should be of immeasurable value to their marriage careers. Self-discipline, co-operation, adaptability, efficiency, economic management,—if she learns these in her business life she is liable for many less heartbreaks and disappointments in her married life.”
—Hortense Odlum (1892–?)
“In health of mind and body, men should see with their own eyes, hear and speak without trumpets, walk on their feet, not on wheels, and work and war with their arms, not with engine-beams, nor rifles warranted to kill twenty men at a shot before you can see them.”
—John Ruskin (1819–1900)
“A shocking crime was committed on the unscrupulous initiative of few individuals, with the blessing of more, and amid the passive acquiescence of all.”
—Tacitus (c. 55–120)