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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
SUMMARIES FOR PATIENTS
Postmenopausal Hormone Replacement and the Risk for Blood Clots
2 May 2000 | Volume 132 Issue 9 | Page 689
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians-American Society of Internal Medicine.
The summary below is from the full report titled "Postmenopausal Hormone Therapy Increases Risk for Venous Thromboembolic Disease. The Heart and Estrogen/progestin Replacement Study.". It is in the 2 May 2000 issue of Annals of Internal Medicine (volume 132, pages 689-696). The authors are D. Grady, N.K. Wenger, D. Herrington, S. Khan, C. Furberg, D. Hunninghake, E. Vittinghoff, and S. Hulley, for the Heart and Estrogen/progestin Replacement Study Research Group.
What is the problem and what is known about it so far?
Two hormones, estrogen and progestin, are often prescribed to women after menopause to prevent thinning of bones. When these hormones are used in oral contraceptive pills, blood clots are a known side effect of treatment. The blood clots usually develop in the deep veins of the leg, a condition called deep venous thrombosis. Parts of these clots can break off and travel through the bloodstream to the lungs, a condition called pulmonary embolism. Although they are usually treatable with blood thinners, deep venous thrombosis and pulmonary embolism can be disabling or even deadly. Despite these concerns, little is known about the risk for blood clots in women who take both estrogen and progestin as postmenopausal hormone replacement therapy.
Why did the researchers do this particular study?
To find out whether women who take postmenopausal hormone replacement therapy are at a greater risk of developing blood clots than women who do not.
Who was studied?
The researchers studied 2763 women who were known to have heart disease and were past menopause but were younger than 80 years old, had not had a hysterectomy, and had never had a blood clot. These women were participating in a larger study of hormone replacement therapy to prevent heart attacks.
How was the study done?
The researchers assigned women to receive either hormone replacement therapy with estrogen and progestin or a placebo tablet. The placebo tablet looked identical to the hormone tablet, but it contained no active ingredients. They then followed women over time to see who developed deep venous thrombosis or pulmonary embolism.
What did the researchers find?
After 4 years of follow up, 34 of 1380 women taking the hormone pill had experienced a blood clot compared to 13 out of 1383 women taking the placebo pills. This means that about 1 out of every 263 women treated with hormone replacement therapy will experience a blood clot each year because of the hormonal treatment. Women with leg fractures, cancer, or hospitalization for surgery were more likely to develop a blood clot than were women without these conditions. Women taking aspirin and those taking certain cholesterol-lowering medications were less likely to develop clots than were women not taking these medications.
What were the limitations of the study?
All of the women in this study had heart disease. The study results might not apply to women without heart disease.
What are the implications of the study?
Women and their doctors should consider the potential side effect of blood clots when considering the risks and benefits of hormone replacement therapy after menopause.
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