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Kent MacLeod
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Women's Health Initiative (WHI) Study 1

Synthetic Hormone Replacement Therapy and the Women’s Health Initiative (WHI) Study 1 



This study, released in July 2002, was created to address the issue of whether post-menopausal women with their uteruses still intact require Hormone Replacement Therapy (HRT) to prevent the development of chronic disease. More than sixteen thousand women were given synthetic conjugated estrogen substances (Premarin) plus progestin (Provera). These women were monitored beginning in 1993. The study was intended to continue for 8.5 years; however, in May of 2002, after 5.2 years of follow-up, the regulatory and safety monitoring board recommended to stop the trial early.

The researchers found adverse outcomes of this study included coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death) and invasive breast cancer. A global index summarizing the balance of the risks and benefits included these two outcomes plus stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. As the risks of synthetic HRT outweighed the benefits, the study concluded that estrogen/progestin should not be started or continued for primary prevention of CHD.


References



3.Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from Women’s Health Initiative Randomized Controlled Trial. JAMA 2002:288 (3): 321-33
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