Hormone trial for disease prevention stopped earlyBMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7355.61 (Published 13 July 2002) Cite this as: BMJ 2002;325:61
A US randomised, placebo controlled, double blind trial to evaluate oestrogen and progestogen in postmenopausal women was stopped early by the Women's Health Initiative because health risks exceeded health benefits by a small margin.
It is the first trial to examine whether continuous oestrogen plus progestogen has a favourable or unfavourable effect on coronary heart disease and overall risks and benefits in healthy women.
JAMA has already posted the article on its website (http://www.jama.com/issues/v288/n3/abs/joc21036.html). The article will then be published in the 17 July issue together with an editorial that says, “do not use estrogen/progestin to prevent chronic disease” (JAMA 2002;288:321-33, 366-8).
Lead author Dr Jacques Rossouw, acting director of the study for the National Heart, Lung, and Blood Institute, cautioned, “This is not an urgent situation like a drug recall. The average risk to the individual woman is one tenth of 1% per year for breast cancer and similarly for heart attacks. There was no change in death rates.”
The trial was part of a 40 centre study investigating ways to reduce heart disease, breast and colorectal cancer, and fractures in postmenopausal women aged 50 to 79. The trial was planned to last for 8.5 years but was stopped after 5.2 years.
Of the 16608 women in the study, 8506 were randomised to receive oestrogen plus progestogen and 8102 to receive placebo. The oestrogen plus progestogen regimen was a daily pill containing 0.625 mg of conjugated equine oestrogens and 2.5 mg of medroxyprogesterone acetate.
The pill is marketed in the United States as Prempro by Wyeth-Ayerst and is prescribed to 77% of women receiving combination hormonal therapy.
In evaluating risk, a global index assigned additional weight to coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, and death from other causes.
Although the numbers were small, women receiving oestrogen plus progestogen had a higher rate of breast cancer and more adverse cardiovascular events than those receiving placebo. For every 10000 women receiving combined oestrogen plus progestogen, there would be [projected] no more than seven excess coronary heart disease events, eight more breast cancers, eight more strokes, and eight more pulmonary emboli but six fewer colorectal cancers and five fewer hip fractures.
“The regimen doesn't work to prevent heart disease. It makes it worse. It works to prevent fractures, but there are other options for that,” said Dr Rossouw.
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