HT not useful for preventing chronic disease after menopause

Last Updated: 2017-12-12

By Will Boggs MD

NEW YORK (Reuters Health) - After reviewing recent evidence, the U.S. Preventive Services Task Force (USPSTF) has reiterated its 2012 recommendation against the use of menopausal hormone therapy (HT) for the primary prevention of chronic conditions in postmenopausal women.

"This recommendation applies to women who have gone through menopause and are considering hormone therapy to prevent chronic health problems, and most medical organizations agree with this approach," Dr. Maureen Phipps, Task Force member from Warren Alpert Medical School of Brown University, Providence, Rhode Island, told Reuters Health by email. "It is important to note that this recommendation is not focused on the use of hormone therapy to manage menopausal symptoms, such as hot flashes or night sweats."

The recommendations are supported by a systematic review of 18 trials, including 40,058 women, undertaken by Dr. Gerald Gartlehner from RTI International-University of North Carolina at Chapel Hill and colleagues. The findings, along with the USPSTF recommendation document, were published online December 12 in JAMA.

Compared with placebo, estrogen-only treatment was associated with slightly lower risks per 10,000 person-years for diabetes (19 fewer cases) and fractures (53 fewer) but significantly higher risks for gallbladder disease (30 more cases), stroke (11 more), venous thromboembolism (11 more), and urinary incontinence (1,261 more).

Combination estrogen-progestin therapy was associated with lower risks of colorectal cancer, diabetes, and fractures, but higher risks of invasive breast cancer, probable dementia, gallbladder disease, stroke, urinary incontinence, and venous thromboembolism.

"Over the past years, there was a lot of hype about the timing hypothesis and whether the initiation of hormone therapy during early postmenopause is beneficial," Dr. Gartlehner told Reuters Health by email. "I was surprised how thin the evidence on the timing hypothesis actually is. The evidence is insufficient to draw any clear conclusions - and definitely not strong enough to recommend early initiation of hormone therapy to women."

"Don't recommend hormone therapy for the primary prevention of chronic conditions," he concluded. "Our report was not about the treatment of symptoms. The use of hormone therapy for symptom relief is an entirely different decision than for the primary prevention of chronic diseases."

"The Task Force has several other recommendations on ways women can reduce their risk of chronic disease through preventive services," Dr. Phipps said.

The current recommendation statement mentions a healthy diet and physical activity for preventing cardiovascular disease; daily low-dose aspirin to reduce the risk of colon cancer and cardiovascular disease in certain women; and medications like tamoxifen and raloxifene to reduce the risk of breast cancer in high-risk women.

The recommendations are not without controversy. Dr. Cora E. Lewis from University of Alabama at Birmingham School of Medicine, who coauthored a related editorial, told Reuters Health by email, "The draft recommendation report was posted to the Task Force website over the summer, and already some reactions have been published. Two of them were discussed briefly in the editorial. Cano et al. said the recommendations were irrelevant and misleading since professional societies don't recommend hormones for prevention of chronic conditions and women who would be candidates are not seen in practice."

"On the hand, Langer et al. still argue for a role in primary prevention of chronic disease," she said. "The studies they cite conducted after WHI, those that are clinical trials, are too small and too short to really answer the question though. Observational studies do not answer the question either."

"We have other ways to prevent chronic disease like coronary heart disease and diabetes besides hormone therapy, and hormone therapy is not recommended for that indication," Dr. Lewis said. "For women in their 50s with sufficiently bothersome symptoms actually due to menopause, hormone therapy can be considered after a discussion of benefits and risks between the woman and her doctor or provider."

She added, ""At the time we were recruiting, WHI was controversial. Some in the medical community were so convinced that postmenopausal hormone therapy would be beneficial for many conditions, including prevention of cardiovascular disease, that it was unethical to perform a trial in which women could be randomized to placebo. We asked women to be part of the answer and participate, and thousands of them did. We are deeply grateful to them."

Dr. Nanette K. Wenger from Emory University School of Medicine, Atlanta, Georgia, who wrote a related editorial online December 12 JAMA Cardiology, told Reuters Healthby email, "Perhaps new both for physicians and for women is the WHI data showing that, based on 18 years of follow-up, all-cause mortality rates did not differ significantly for the hormone and placebo groups. Thus, menopausal hormone therapy, used in this trial for 5-7 years, was not associated with a risk of long-term all-cause, cardiovascular, or cancer mortality."

As for cardiovascular prevention, Dr. Wenger said, "the American Heart Association's 'Life's Simple 7,' addressing initially lifestyle and, if needed, medications to prevent cardiovascular risk, is the widely accepted preventive approach."

"Cardiovascular disease remains the leading cause of mortality for U.S. women," she added. "Thus, women and their physicians must address the control of conventional coronary risk factors, as well as the emerging cardiovascular risk factors that either predominate in women or are unique to women."

"The story of hormone therapy is one of an intervention that affects a large number of important clinical outcomes; it is both beneficial and harmful," writes Dr. Deborah Grady, deputy editor of JAMA Internal Medicine from University of California, San Francisco and San Francisco VA Medical Center in a related editorial online December 12 in JAMA Internal Medicine.

She concludes, "The Task Force updated recommendation on hormone therapy is a reminder of the importance for public health to have high-quality randomized clinical trial data before widespread adoption of preventive strategies."

SOURCES: http://bit.ly/2AxcOJt, http://bit.ly/2nRdZNP, http://bit.ly/2z435Yz, http://bit.ly/2Az4RDp and http://bit.ly/2AxjmrD

JAMA, JAMA Cardiol and JAMA Intern Med 2017.