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Long-Term Follow-Up reports key findings and clinical messages from the largest study of women’s health in the US




Long-Term Follow-Up reports key findings and clinical messages from the largest study of women's health in the US

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Researchers from Brigham and colleagues report on the long-term follow-up of the largest study of women’s health in the US, shedding light on the role of menopausal hormone therapy, calcium and vitamin D supplementation, and a low-fat diet among women . postmenopausal women

More than 1.1 billion women worldwide are postmenopausal. A review article from authors at Brigham and Women’s Hospital and other leading experts from across the country helps answer some of the most pressing questions in postmenopausal women’s health and fill important knowledge gaps to improve postmenopausal health improve menopause.

Using data from The Women’s Health Initiative (WHI), the authors present guidelines on menopausal hormone therapy (HT), calcium and vitamin D supplementation, and a low-fat diet. The review paper is published in JAMA.

Based on long-term WHI follow-up (up to 20 years), the researchers report that younger women (younger than 60 years) had fewer side effects and a more favorable benefit-risk ratio of HT than late menopausal women. . Although HT should not be used to prevent heart disease, stroke, dementia or other chronic diseases, WHI’s findings support its use in early menopause for the treatment of moderate to severe hot flashes, night sweats and other menopausal symptoms. an FDA-approved indication.

“The WHI findings should never be used as a reason to refuse hormone therapy to women in early menopause with bothersome menopausal symptoms. Many women are good candidates for treatment and, in shared decision-making with their doctors, should be able to receive appropriate and personalized treatments. health care for their needs,” said JoAnn Manson, MD, chief of Preventive Medicine at Brigham and Women’s Hospital and first author of the new report in JAMA.

Manson added: “Women also now have more treatment options, including estrogen in lower doses and administered through the skin as a patch or gel, which can further reduce risks; non-hormonal treatments are also available.”

Regarding calcium and vitamin D supplements, the WHI results do not support routine recommendation of these supplements for fracture prevention in all postmenopausal women. However, calcium and vitamin D supplements are appropriate to fill nutritional gaps for women who do not meet national guidelines for dietary intake of these nutrients.

Finally, a low-fat diet with increased intake of fruits, vegetables and grains did not reduce the risk of breast or colorectal cancer, but was associated with a lower risk of breast cancer mortality more than ten years after the end of the trial.

“A diet low in fat and high in fruits, vegetables and grains showed benefits in reducing deaths from breast cancer at long-term follow-up, providing an option for women who want to reduce these risks,” Manson said.

The Brigham’s Division of Preventive Medicine was one of the vanguard centers for the WHI, which included multicenter randomized trials initiated by the National Institutes of Health. The WHI, the largest study of women’s health in the U.S., involves more than 160,000 postmenopausal women ages 50 to 79 in studies to prevent heart disease, cancer (primarily breast and colorectal cancer), and hip fracture.

More than 68,000 women participated in randomized clinical trials to test the health effects of menopausal HT, calcium and vitamin D supplementation, and low-fat diet modifications. The WHI observational study addressed a wide range of questions related to healthy aging and the prevention of chronic diseases.

When the WHI began recruitment in 1993, observational studies had reported that postmenopausal women who used HT had a lower risk of heart disease, stroke, dementia, other chronic diseases, and all-cause mortality than women who did not use HT.

“In the early 1990s, nearly 15 million American women received HT prescriptions each year, and HT was often (and increasingly) prescribed to prevent cardiovascular disease and other chronic diseases in women in both early and late menopause, whether or not the patient had had hot flashes or other menopausal symptoms,” Manson said.

“However, no randomized trials had been done in postmenopausal women to evaluate the benefits and risks of HT for the prevention of chronic disease. Ironically, the only randomized trial of estrogen had been conducted in men.”

The WHI tested the most commonly used formulations of HT at the time. The study was not intended to evaluate HT for the treatment of hot flashes or other menopausal symptoms, because those benefits of HT were already well established; and this was an FDA-approved indication for use.

Calcium and vitamin D supplements were studied in the WHI because they had previously been tested primarily in populations with osteoporosis or low bone mineral density, and no prior clinical trial had evaluated their benefits and risks in postmenopausal women at typical fracture risk.

A low-fat diet was tested because observational studies suggested that people with higher dietary fat intake and fewer fruits and vegetables had higher rates of breast and colorectal cancer.

“This new WHI report provides, for the first time, clinical messages for healthcare providers and for the general public from the long-term follow-up of all studies,” Manson said.

More information:
JoAnn Manson et al, The Women’s Health Initiative Randomized Trials and Clinical Practice: An Overview. JAMA (2024). DOI: 10.1001/jama.2024.6542.

Provided by Brigham and Women’s Hospital

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