Today the medical community is changing its thinking about Hormone Replacement Therapy (HRT) following the findings of a major study which showed that long-term HRT can cause heart attacks, stroke, blood clots and breast cancer in women. All of which do not bestow health or beauty to ageing women.
The study, part of a large US government-funded research programme known as the Women's Health Initiative (WHI), was the first and only large one to compare the effects of HRT with placebos (dummy pills) in healthy women.
The study looked at the effects of one commonly used form of HRT drug; estrogen plus progestin (known as combined HRT) on 16,000 healthy menopausal women whose condition was monitored for about 5 years.
The study was supposed to prove, once and for all, that HRT was beneficial. Instead, HRT turned out to do more harm than good. There was a 29% increase in coronary heart disease, a 26% increase in breast cancer, and a 41% increase in stroke. All of which overpowered a decrease in the incidence of hip fractures and colon cancer.
Due to the serious harm involved, on 9th July 2002 the National Heart, Lung and Blood Institute (NHLBI) of the US National Institutes of Health announced that they had stopped the initially planned 15-year study early, after an average of 5.2 years, to protect the test subjects from the serious side effects.
Letters were immediately sent out to all the study's participants, telling them to stop taking their medications.
Doctors know there are benefits and risks associated with postmenopausal hormone use. However, many doctors have always felt that the benefits outweighed the risks.
Findings from the WHI study, however, proved otherwise. The study concluded that the combined hormone medication used in the trial posed more risks than benefits.
New Prominent Warning label for HRT Drugs
Following the study, on 8th January 2003, the US Food and Drug Administration approved new patient information leaflets for Prempro (the drug used in the WHI study), Premphase (containing estrogens with a progestin) and Premarin (containing estrogens); as well as new physician prescribing information.
The new, boxed warning; the highest level of warning information in labelling highlights the increased risks for heart disease, heart attacks, strokes and breast cancer.
The warning also emphasis that the products are not approved for heart disease prevention.
The approved indications for the 3 drugs have also been modified to clarify that these drugs should only be used when the benefits clearly outweigh the risks. Of the 3 indications, 3 have been revised to include consideration of other therapies.
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