Is HRT safe? Controversies and facts

Is HRT safe? Controversies and facts

As a provider specializing in female hormone replacement therapy (HRT), I frequently encounter questions about the risks vs. potential benefits of hormones. 15 years ago I went on a quest to learn all I could on this topic led me to pursue a fellowship in this area of medicine. Many studies have been published since, with the trend towards corroborating the safe use of natural hormones on women’s health.

Over the years, HRT has been a subject of debate and controversy, but recent research sheds light on its positive impacts, particularly for women experiencing symptoms of menopause. Let's explore the potential benefits of hormone replacement therapy and how it can improve the quality of life for many women.

Relief from Menopausal Symptoms

Menopause marks the end of a woman's reproductive years and is often accompanied by a range of bothersome symptoms such as hot flashes, night sweats, vaginal dryness, and mood swings. HRT can effectively alleviate these symptoms by replenishing declining hormone levels, primarily estrogen and progesterone and secondarily DHEA and testosterone.

Bone Health

Estrogen plays a crucial role in maintaining bone density. As women age and estrogen levels decline, the risk of osteoporosis increases. Hormone replacement therapy (estradiol) can help prevent bone loss and reduce the risk of fractures, thus promoting better bone health and reducing the incidence of osteoporosis-related complications.

Heart Health

Estrogen has cardio-protective effects, which means it helps maintain healthy blood vessels and may reduce the risk of heart disease. Some studies suggest that hormone replacement therapy, especially when initiated early in menopause, may lower the risk of cardiovascular events in women.

Improvement in Mood and Cognitive Function

Fluctuating hormone levels during menopause can contribute to mood swings, irritability, and difficulty concentrating. Hormone replacement therapy can stabilize hormone levels, leading to improved mood and cognitive function in some women.

Relief from Genitourinary Symptoms

Vaginal dryness, itching, and painful intercourse are common genitourinary symptoms experienced by women during menopause due to declining estrogen levels. HRT can help restore vaginal lubrication and improve overall vaginal health, enhancing comfort and sexual satisfaction. Common intravaginal formulations include estradiol/estriol/DHEA and testosterone

Sleep Disturbances

Many women experience disruptions in sleep patterns during menopause, including insomnia and frequent awakenings due to night sweats. Hormone replacement therapy, particularly estrogen and progesterone can help regulate sleep by reducing the frequency and severity of nocturnal symptoms.

Improved Sexual function Muscle mass and Well being

Testosterone therapy, a largely neglected hormone in female HRT in the US, has an impeccable 60 year safety and efficacy record and for many women is a game-changing addition to their HRT regimen. We have fallen way behind Europe in addressing testosterone deficiency in women. Furthermore, testosterone may have a place in the prophylactic prevention of recurrent breast cancer among breast cancer survivors who are otherwise denied HRT. 


The bulk of the controversy surround the use of HRT and prescribing trends as well as what guides clinical conversations with patients stem from the results of the Women’s Health Initiative study (WHI) 22 years ago. This study led to a change in HRT guidelines that has essentially not changed in 22 years despite a plethora of contradictory studies since then. 

Primary issues with the WHI study

The hormone formulations used in the WHI study consisted of conjugated equine estrogen and medroxyprogesterone acetate, which are synthetic hormones. There's evidence to suggest that different types of estrogen and progestin may have varying effects on health outcomes, and the WHI findings may not be directly applicable to other hormone formulations or routes of administration.

Additionally, the study population skewed old and unhealthy and adherence was difficult to gauge in the study participants. 

The results were framed as a 25% increase risk of cancer among HRT users, but in absolute terms, breast cancer cases went from the expected 4/1000 women per year to 5 cases in 1000 women per year. An absolute increase in 0.1% per year. Furthermore, and in hindsight, it appears that this slight increase was due solely to the synthetic progesterone (medroxyprogesterone acetate). 


Since our guidelines are woefully out of date and do not square with the guidelines in other developed countries, and because doctors are both untrained in HRT and also rely heavily on medical guidelines, women have been given outdated (sometimes harmful) information that does not square with modern science. Some estimate that this has led to nearly 100,000 hip fractures for example. Menopausal symptoms are often brushed off by clinicians, women are fear mongered away from HRT and the kick-in-the-pants comes when they are given anti-depressants instead of HRT. 

Given that the hormones used primarily nowadays are progesterone (bioidentical), estradiol (bioidentical) and the aggregate of data suggests safety with those forms; one can draw the conclusion that we have been categorically denying women life saving and quality of life enhancing treatments for 22 years. A mar on the the healthcare systems care of women for two generations to be sure. 

Beyond the use of Estradiol and Progesterone, clinicians need to gain comfort with the use of DHEA and testosterone as is more common and widely studied in Europe.  DHEA has a nearly 100 year safety profile and testosterone continues to garner press for its ability to restore libido, aid muscle mass, help mood and self confidence in women as well as potentially retard the growth of breast cancer. 

There is a sea change occurring in how menopause is managed in the US. We believe we are on the right side of history and are excited that more women will gain access to HRT moving forward.