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Is Hormone Replacement Therapy – HRT – Safe for You?

For years, women were told to avoid hormone replacement therapy. Now, doctors are again recommending it for some women. What changed?
Is Hormone Replacement Therapy – HRT – Safe for You?
Last updated:
12/3/2024
Written by:
Medically Reviewed by:

The Big Picture

Hormone replacement therapy (HRT) is a treatment for alleviating menopause symptoms such as hot flashes, night sweats, and mood swings. Initially celebrated in the mid-20th century for its potential to address these symptoms and prevent conditions like osteoporosis and heart disease, HRT saw widespread adoption. However, its reputation took a dramatic turn after the 2002 Women’s Health Initiative (WHI) study reported increased risks of breast cancer, heart disease, and stroke among HRT users. This triggered a steep decline in HRT usage and a wave of fear, with many women abandoning treatment and physicians hesitating to prescribe it. Over time, a more nuanced understanding of the WHI findings emerged, revealing that the risks varied based on factors such as age, time since menopause, and the type and dosage of hormones used. Subsequent research, including the landmark 2024 WHI follow-up study, highlighted that for women under 60 or within 10 years of menopause, the benefits of HRT often outweigh its risks, especially when using modern, lower-dose formulations delivered via safer methods like transdermal patches.

The 2024 WHI study marked a turning point, providing clarity and emphasizing the importance of individualized treatment plans tailored to each woman’s health profile and goals. Improved formulations and bioidentical hormones have further enhanced the safety and appeal of HRT, reducing associated risks. The study also underscored that HRT should not be used for preventing chronic conditions like heart disease or dementia but remains highly effective for managing menopausal symptoms and preserving bone health. Meanwhile, cultural shifts, education campaigns, and greater attention to quality of life have worked to rebuild trust in HRT, advocating for informed, shared decision-making between women and healthcare providers. Despite barriers like access disparities and lingering misconceptions, HRT is positioned as a viable and evolving option for many women. The article concludes that the question of HRT’s safety is best addressed through personalized healthcare, empowering women with accurate information and access to treatments that align with their unique health needs.

In this article:

Hormone replacement therapy (HRT) is a treatment meant to alleviate symptoms of menopause by replenishing estrogen and sometimes progesterone levels in the body. These hormonal fluctuations before and during menopause can lead to symptoms such as hot flashes, night sweats, mood swings, and vaginal dryness, among others. Despite its benefits, the safety of HRT has been a topic of debate for many years. This article explores the safety of HRT and examines its history, benefits, risks, and the latest guidelines.

The rise and fall of HRT

In the mid-20th century, HRT emerged as a promising solution for menopausal symptoms. Doctors and patients alike embraced the therapy, believing it could not only alleviate hot flashes, night sweats and other symptoms, but could prevent osteoporosis and heart disease as well. This optimism led to widespread adoption, and millions of women were prescribed HRT.

The landscape of HRT changed dramatically in 2002 with the publication of the Women’s Health Initiative (WHI) study. This large-scale clinical trial reported increased breast cancer risks, as well as increased potential for heart disease, stroke, and blood clots among women using HRT. The media amplified these findings. As a result, a wave of fear and skepticism swept over both patients and healthcare providers

The impact was immediate and profound. HRT prescriptions plummeted, with usage declining by 46% in the US and 28% in Canada. Women abandoned their treatments, often without consulting their doctors, fearing that the perceived risks of HRT outweighed any potential benefits.

The WHI study’s fallout extended beyond individual health decisions. It eroded women’s trust in medical recommendations and fueled a growing interest in “natural” or alternative therapies for menopausal symptoms. Doctors, wary of potential liability, became hesitant to prescribe HRT, even in cases where it might have been beneficial.

As time passed, it became clear that the WHI study’s findings had been oversimplified and, in some cases, misinterpreted, to the detriment of millions of women. The study had limitations, including the age of participants (most were over 60), the dosages used, and the types of hormones administered. These nuances were largely not covered in the media.

Additional research began to paint a clearer picture of HRT. Later studies suggested that for some women, particularly those younger than 60 or within 10 years of the onset of menopause, the benefits of HRT might outweigh the risks.

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2024 Women’s Health Initiative (WHI)

The Women’s Health Initiative (WHI) study, reported on in May of 2024, was a sea change for HRT treatment. The WHI was a major study involving over 160,000 postmenopausal women in the United States, with about 68,000 participating in clinical trials. The findings, based on two decades of follow-up data from the original WHI study, marked a turning point in the HRT narrative, and provided a more nuanced understanding of hormone therapy’s risks and benefits over time.

  • HRT in early menopause: The study found that women under 60 years old or in early menopause have a more favorable benefit-to-risk profile when using hormone therapy compared to older women. For women under age 60 without health risks, HRT can effectively treat moderate to severe menopausal symptoms. HRT can safely ease menopausal symptoms like hot flashes and night sweats without significantly increasing health risks.
  • HRT for disease prevention:  HRT is not recommended for preventing heart disease, dementia, or other chronic conditions in postmenopausal women.
  • Personalized approach: The WHI study also emphasized the importance of individualized and personalized healthcare and shared decision-making about HRT treatment options for each woman based on her individual health needs and risks.

Other important HRT developments

Along with the WHI’s specific findings, it highlights other notable issues that have implications for HRT treatment going forward.

Improved HRT formulations

The WHI 2024 researchers noted that women now have more options for hormone therapy. Lower dosages and improved delivery methods such as transdermal patches and gels – versus oral formulations – reduce risks associated with HRT. The use of bioidentical hormones, which have a molecular structure identical to those produced by the body, also gained in popularity due to their potentially lower risk and side effect profile.

Renewed focus on quality of life

The 2024 research also sparked a renewed emphasis on treating perimenopausal and menopausal symptoms holistically. Medical professionals began advocating more strongly for empowering women to make informed decisions about their health. This shift recognized that quality of life during menopause was a crucial factor often overlooked in previous risk-benefit analyses.

Media and public education campaigns

In response to the new findings, media outlets and healthcare organizations have launched campaigns to correct misconceptions stemming from the WHI era. Social media has been playing a significant role in disseminating updated information, with influential voices in women’s health leading the charge in reshaping the public’s perception of HRT.

Benefits and risks of hormone replacement therapy

As of 2024, here’s what we know about the benefits and risks of HRT.

  • Symptom relief: HRT is highly effective in managing vasomotor symptoms such as hot flashes and night sweats. It also helps with sleep disturbances, mood swings, and joint pain.
  • Bone health: HRT has been shown to prevent bone loss and reduce the risk of fractures in postmenopausal women.
  • Cardiovascular health: Some studies suggest that HRT may lower the risk of heart disease when started within ten years of menopause.
  • Metabolic benefits: There is evidence that HRT may be able to reduce the risk of diabetes.

There are some concerns and risks associated with HRT:

  • Breast cancer: The Women’s Health Initiative (WHI) study found an increased risk of breast cancer with combined estrogen-progestin therapy (EPT). However, this risk diminishes after discontinuing the treatment.
  • Blood clots: There is a heightened risk of blood clots, especially in women who begin HRT more than ten years after menopause or are older than 60. Transdermal delivery methods like patches present a lower risk compared to oral pills.
  • Endometrial cancer: For women who have not had a hysterectomy, using estrogen alone without progesterone – known as unopposed estrogen treatment – increases the risk of endometrial cancer.
  • Other risks: Other potential risks include stroke and gallbladder disease. The risks are generally higher in older women or those with pre-existing health conditions.

Is HRT safe for you?

The safety of HRT largely depends on your specific circumstances. While earlier studies raised concerns about increased risks of breast cancer and cardiovascular events, more recent research indicates that these risks are minimal for many women when HRT is used appropriately. If you’re considering HRT, you should engage in thorough discussions with your healthcare providers to weigh the potential benefits against the risks based on your personal health history and preferences. As research continues to evolve, so too will guidelines for the safe use of HRT in managing menopausal symptoms.

There are some women who should avoid hormone replacement therapy for perimenopause and menopause symptoms, due to certain health risks and contraindications. Women with a history of breast, endometrial, or other hormone-dependent cancers should avoid HRT, as the therapy can exacerbate these conditions. Additionally, those with undiagnosed vaginal bleeding or untreated endometrial hyperplasia are advised against using HRT due to the potential for worsening these issues. The presence of active or recent arterial thromboembolic disease, such as angina or myocardial infarction, also contraindicates the use of HRT, given the increased risk of cardiovascular events associated with hormone therapy.

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Women with liver disease or known hypersensitivity to hormone therapy components should not use HRT due to potential adverse effects. Women with a history of venous thromboembolism (VTE) – blood clots, including deep vein thrombosis or pulmonary embolism – are generally advised against HRT because estrogen therapy has been linked to an increased risk of VTE. Although transdermal estrogen may pose a lower risk, it is crucial for women with a predisposition to VTE to consult their healthcare provider before considering any form of hormone therapy.

Age and timing relative to menopause onset are also critical factors in determining HRT suitability. Women who begin HRT more than ten years after menopause or after age 60 face increased risks of heart disease and stroke. The risks associated with HRT are generally lower for healthy women under 60 or within ten years of menopause onset; however, those with untreated hypertension or high triglycerides should be cautious as these conditions can heighten the risks associated with hormone therapy. Therefore, a thorough assessment of individual health status and risk factors is essential before initiating HRT.

Moving forward with HRT

The medical community has made concerted efforts to address lingering fears about HRT. Positive patient testimonials and case studies have helped illustrate the potential benefits of hormone therapy when prescribed appropriately. However, rebuilding trust has been a gradual process, requiring ongoing education and open dialogue between healthcare providers and patients.

Despite the shifting landscape, barriers to HRT use persist. Cost and insurance coverage disparities continue to limit access for some women.  Other obstacles to care include a shortage of healthcare providers who are well-versed in the latest HRT research and prescribing practices, particularly in certain geographic areas.

Cultural stigmas surrounding menopause and aging also play a role in HRT acceptance. Many women don’t understand that “menopause symptoms” can occur during perimenopause -- the months and years prior to the onset of menopause. (Menopause is defined as the point at which menstrual periods have stopped for a full year.)  Some women still view menopause as a natural process that shouldn’t be “medicalized. “Others fear the perceived risks associated with hormone therapy.

Meanwhile, new studies are exploring the long-term health outcomes of hormone therapy, including its potential impact on cognitive function, cardiovascular health, and bone density. Researchers are also investigating the intersection of HRT with other therapies, such as lifestyle modifications and dietary supplements, to optimize overall health outcomes for menopausal women.

The 2024 findings have prompted calls for updated guidelines on HRT use. Professional medical organizations are reassessing their recommendations, with a trend toward more nuanced, individualized approaches to prescribing hormone therapy. Governments and healthcare organizations are being urged to improve access to HRT and ensure that healthcare providers receive up-to-date training on its benefits and risks.

As our understanding of HRT continues to evolve, the importance of clear, unbiased information for women cannot be overstated. Healthcare providers are focusing on empowering women to make informed decisions about their health, taking into account their individual risk factors, symptoms, and preferences. This approach recognizes that women’s needs change throughout different life stages and that HRT decisions should be revisited periodically.

A note from Paloma

The story of hormone replacement therapy is one of scientific progress, public perception, and the complex interplay between medical research and patient care. The WHI study’s lasting legacy serves as a reminder of the importance of nuanced interpretation of medical research and clear communication of findings to the public.

The shift in understanding brought about by the 2024 research offers renewed hope for improving women’s health through HRT. However, it also underscores the need for continued research, better education, and personalized care. As we move forward, the focus must remain on empowering women with accurate information and access to appropriate treatments, ensuring that decisions about HRT are made based on the best available evidence and individual health needs.

There’s no longer a simple yes or no answer to the question, “Is HRT safe?” Instead, it requires a discussion between you and your healthcare provider, weighing individual risks and benefits. As research continues and our understanding deepens, HRT stands poised to play a significant role in enhancing the health and quality of life for many women navigating the challenges of perimenopause and menopause.

As a Paloma Health member, you’ll gain a comprehensive understanding of the pros and cons of hormone replacement therapy (HRT) tailored to your unique health needs. Our expert practitioners specialize in hormonal health and take a personalized approach to guide you through your options, addressing any concerns along the way. Whether you’re managing hormonal imbalances like perimenopause, menopause, or hypothyroidism, Paloma Health ensures that you’re supported with evidence-based recommendations and a plan designed to optimize your hormonal health and overall wellness.

Key points

  • Early optimism about HRT’s benefits was overshadowed by the 2002 WHI study, which highlighted risks like breast cancer and heart disease, leading to significant declines in usage and trust.
  • The updated WHI 2024 findings present a more nuanced view, emphasizing benefits for some women and individualized decision-making.
  • Women under 60 or within 10 years of menopause onset benefit more from HRT, experiencing symptom relief and fewer risks compared to older users.
  • HRT is not generally recommended for prevention of osteoporosis and heart disease.
  • Improved formulations, including lower doses, transdermal methods, and bioidentical hormones, offer women safer and more effective HRT options.
  • Tailoring HRT decisions to individual health needs and risks is important. Shared decision-making between patients and providers is essential.
  • Menopausal symptoms should be treated holistically, valuing women’s quality of life as a critical factor in HRT considerations.
  • Challenges such as cost, provider shortages, and cultural stigmas persist, but ongoing research, education, and updated guidelines aim to improve access and understanding of HRT.

References:

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New study supports hormone replacement therapy in early menopause | SIU School of Medicine. Siumed.edu. Published July 16, 2024. Accessed November 24, 2024. https://www.siumed.edu/blog/new-study-supports-hormone-replacement-therapy-early-menopause  

The Women’s Health Initiative (WHI) reports key findings and clinical messages from long-term follow-up. EurekAlert! Published May 2024. Accessed November 24, 2024. https://www.eurekalert.org/news-releases/1042736

Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971-2980. doi: 10.2147/PPA.S430203. PMID: 38027078; PMCID: PMC10657761.
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Manson JE, Crandall CJ, Rossouw JE, et al. The Women’s Health Initiative Randomized Trials and Clinical Practice. JAMA. Published online May 1, 2024. doi:https://doi.org/10.1001/jama.2024.6542
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Barrett-Connor E, Stuenkel CA. Hormone replacement therapy (HRT)— risks and benefits. International Journal of Epidemiology. 2001;30(3):423-426. doi:https://doi.org/10.1093/ije/30.3.423
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Cagnacci A, Venier M. The Controversial History of Hormone Replacement Therapy. Medicina (Kaunas). 2019 Sep 18;55(9):602. doi: 10.3390/medicina55090602. PMID: 31540401; PMCID: PMC6780820
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Manson JE. The Women’s Health Initiative Trials: Clinical Messages. Medscape. Published May 6, 2024. https://www.medscape.com/viewarticle/womens-health-initiative-trials-clinical-messages-2024a10008aa

Stute P, Marsden J, Salih N, Cagnacci A. Reappraising 21 years of the WHI study: Putting the findings in context for clinical practice. Maturitas. 2023;174:8-13. doi:https://doi.org/10.1016/j.maturitas.2023.04.27
https://www.sciencedirect.com/science/article/pii/S0378512223003584 

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Mary Shomon

Patient Advocate

Mary Shomon is an internationally-recognized writer, award-winning patient advocate, health coach, and activist, and the New York Times bestselling author of 15 books on health and wellness, including the Thyroid Diet Revolution and Living Well With Hypothyroidism. On social media, Mary empowers and informs a community of more than a quarter million patients who have thyroid and hormonal health challenges.

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