The Women’s Health Initiative Randomized Trials and Clinical Practice

Alex Haga — Mon, 13 May 2024 21:25:57 +0000

Date Added:

May 13, 2024

Journal/Publication:

JAMA

Publisher:

JAMA

Publication Date:

May 1, 2024

URL:

The Women’s Health Initiative Randomized Trials and Clinical Practice

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2024.6542

Keywords

PMID (1):

38691368

A summary review of the results of the Womens Health Initiative Study pertaining to HRT, Vit D/calcium supplementation, and low-fat diet in menopausal women. James W. Mold, MD, MPH

Free full text

View

Importance: Approximately 55 million people in the US and approximately 1.1 billion people worldwide are postmenopausal women. To inform clinical practice about the health effects of menopausal hormone therapy, calcium plus vitamin D supplementation, and a low-fat dietary pattern, the Women's Health Initiative (WHI) enrolled 161 808 postmenopausal US women (N = 68 132 in the clinical trials) aged 50 to 79 years at baseline from 1993 to 1998, and followed them up for up to 20 years.

Observations: The WHI clinical trial results do not support hormone therapy with oral conjugated equine estrogens plus medroxyprogesterone acetate for postmenopausal women or conjugated equine estrogens alone for those with prior hysterectomy to prevent cardiovascular disease, dementia, or other chronic diseases. However, hormone therapy is effective for treating moderate to severe vasomotor and other menopausal symptoms. These benefits of hormone therapy in early menopause, combined with lower rates of adverse effects of hormone therapy in early compared with later menopause, support initiation of hormone therapy before age 60 years for women without contraindications to hormone therapy who have bothersome menopausal symptoms. The WHI results do not support routinely recommending calcium plus vitamin D supplementation for fracture prevention in all postmenopausal women. However, calcium and vitamin D are appropriate for women who do not meet national guidelines for recommended intakes of these nutrients through diet. A low-fat dietary pattern with increased fruit, vegetable, and grain consumption did not prevent the primary outcomes of breast or colorectal cancer but was associated with lower rates of the secondary outcome of breast cancer mortality during long-term follow-up.

Conclusions and relevance: For postmenopausal women, the WHI randomized clinical trials do not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases. Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause, without contraindications, who are interested in taking hormone therapy. The WHI evidence does not support routine supplementation with calcium plus vitamin D for menopausal women to prevent fractures or a low-fat diet with increased fruits, vegetables, and grains to prevent breast or colorectal cancer. A potential role of a low-fat dietary pattern in reducing breast cancer mortality, a secondary outcome, warrants further study.

Author/s:

Manson, J.E., Crandall, C.J., Rossouw, J.E.

Compounded Bioidentical Hormone Therapy The National Academies Weigh In

Devin Evans — Mon, 21 Dec 2020 06:00:00 +0000

Date Added:

December 21, 2020

Journal/Publication:

Journal of the American Medical Association Internal Medicine

Publication Date:

December 14, 2020

URL:

Compounded Bioidentical Hormone Therapy The National Academies Weigh In

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jamainternmed.2020.7232

Keywords

menopause

hormone therapy

Menopausal women

PMID (1):

33315055

MeSH

menopause

Data Collection

Endocrinologists

A concise summary of the findings of the National Academy of Medicine regarding the safety and effectiveness of compounded bio-identical hormones for management of menopausal women. James W. Mold, MD, MPH

Free full text

View

After 21 months of data collection and analysis, the NASEM committee’s overarching conclusion was, “Given the paucity of data on the safety and effectiveness of cBHT…there is insufficient evidence to support the overall clinical utility of cBHT as treatment for menopause.”1(p9) Specific concerns included inadequate labeling requirements of cBHT preparations, paucity of reliable pharmacokinetic and bioavailability data, technical challenges with difficult-to-compound steroid hormones (particularly pellet therapies), and insufficient high-quality evidence to establish whether cBHT preparations are safe and effective. The committee further concluded that most marketing claims about safety and effectiveness are not supported by evidence from welldesigned, properly controlled studies. Incomplete adverse event reporting contributes to safety concerns. The committee acknowledged that in the absence of safety and effectiveness data for cBHT, patient preference should not be the sole driver for use.

Author/s:

Stuenkel, Cynthia A., Manson, JoAnn E.