Misreporting and Poorly Presented Results Shrouded Benefits of HRT

In a highly critical re-analysis of the Women’s Health Initiative (WHI) study of 2002,¹ the results of which prompted safety fears about hormone replacement therapy (HRT) significantly increasing the risk of breast cancer, it was concluded that the weight of evidence supports benefits over risks for use of HRT in women with severe symptoms of menopause or other conditions.²

The main criticism of the WHI study is how the findings were misrepresented by the media, with little effort made by those affiliated with the study to correct the misinformation. The media focused their reporting on relative risk, citing that women who use HRT have a 26% increased risk of breast cancer developing. The actual risk should have been reported in terms of absolute risk, with a modest increase in risk of 4 additional cases of breast cancer per 1000 women taking HRT over 5 years.² In addition, of the 16,608 women involved in the WHI study, 11,086 (67%) women were between the ages of 60 and 79 years, generally long past the age at which most women experience menopause. However, the results of the WHI study were generalized to all women. This misreporting changed how many physicians prescribed HRT.

Since 2002, the rates of use of HRT have decreased between 40% and 80%. The effects of this decline in use have not been studied, but the International Menopause Society, as quoted in the re-analysis, believes that the decline in HRT use “has disadvantaged nearly a decade of women who may have unnecessarily suffered severe menopausal symptoms and who may have missed the potential therapeutic window to reduce their future cardiovascular, fracture, and dementia risk.”²

A downside of HRT is a modestly increased risk of stroke, venous thromboembolism, and breast cancer. To maximize the benefits of HRT, treatment should be started within a few years of the onset of menopause in women with symptoms. The re-analysis emphasizes that HRT should not be considered safe for most women, but there are cases in which use of HRT is justified. Before prescribing HRT, physicians should consider the severity of a woman’s symptoms and whether there is any history of breast cancer.

Pertinent Points:

-A re-analysis of the Women’s Health Initiative of 2002 has concluded that HRT is associated with the following benefits:

- Improved quality of life in menopausal women
- Reduced risk of coronary heart disease and death (if taken before age 60 years or within 10 years of menopause)
- Reduced risk of colorectal cancer
- Reduced risk of dementia for women beginning HRT early (later use may increase risk)
- Decreased risk of fracture (modest)

References:

References
1. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333.
2. Special edition on Women’s Health Initiative and HRT. Climacteric. 2012;15(3):205-293.