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Fresh Criticism of the Women’s Health Initiative Study: Hormone Replacement Therapy and Breast Cancer Risk

Updated: Aug 2





A new critical review of the Women’s Health Initiative (WHI) study, which linked hormone therapy (HRT) with the risk of breast cancer, was published in the Menopause journal in 2023. This fresh analysis, led by US medical oncologist Dr. Avrum Bluming and colleagues, challenges the findings of the WHI study. Dr. Bluming and his team argue that if the WHI had been transparent about their findings on breast cancer, there would have been ‘minimal controversy, no confusion, and women’s health would not have suffered so dramatically over the ensuing decades.’


Background: The Controversial WHI Study

In 1993, the WHI began a clinical trial to investigate the health effects of women taking either estrogen-only or combined HRT compared to a placebo. In 2002, researchers halted the part of the study examining women taking both estrogen and progesterone early due to concerns over small increased risks of breast cancer, heart disease, strokes, and blood clots. This led to widespread confusion and concern among doctors and women worldwide. Worldwide, the number of women taking HRT fell sharply.


However, subsequent reviews and statements from the WHI researchers have acknowledged that HRT is the most effective treatment for managing menopausal symptoms like hot flashes. They also noted that taking estrogen alone reduces the risk of breast cancer by 23% and death by breast cancer by 40%.

Despite these acknowledgments, those involved with the WHI study have continued to insist on a small increased risk of breast cancer for women taking combined estrogen and progesterone.


Key Findings of Dr. Bluming and Colleagues


In their article in the Menopause journal, Dr. Bluming and his colleagues present a compelling argument against the findings of the WHI study:


  1. No Increased Breast Cancer Risk with Combined HRT: The review argues that combined HRT, when started for women who had not previously taken it, did not increase the risk of breast cancer, even in those with a family history of the condition.

  2. Minimal Additional Risk: Even if the WHI's risk estimates were accepted, they would imply only one additional case of non-fatal breast cancer for every 1,000 women taking HRT. The review stresses that there is no statistically significant risk between combined HRT and breast cancer when the data is adequately interpreted using the rules set out by the study.

  3. Impact on Women’s Health: The article highlights the significant negative impact on women's health due to the misinterpretation and subsequent widespread fear of HRT. It states, ‘A generation of women has been deprived of HRT largely as a result of this widely publicized misinterpretation of the data.’




The new review by Dr. Bluming and colleagues highlights the need to reexamine the findings of the WHI study and their impact on the perception and use of HRT. By addressing the misconceptions and providing a clearer understanding of the risks and benefits, this review aims to restore confidence in the use of HRT for managing menopausal symptoms and improving women’s health outcomes.

For more detailed insights, you can explore the paper: Bluming, Hodis, & Langer, 2023.


Dr Purity Carr GP & Menopause Doctor

Harvey, WA

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