Can menopausal women safely take HRT drugs again to alleviate symptoms?

More than two decades ago, the alarming results of a study done by the Women’s Health Initiative (WHI) challenged the safety of women taking hormones for menopausal symptoms, saying the drugs put women at risk for cardiovascular disease, stroke, pulmonary embolism and breast cancer.

Overnight, millions of women and their doctors abandoned the drugs. That left a whole generation of women to suffer the vexing symptoms of menopause, like hot flashes and night sweats, with no real help.

This year, a long-term follow-up of the Women’s Health Initiative published in JAMA found that the original study was flawed, and the benefits actually outweigh the risks of hormone replacement in patients under the age of 60.

The original study was of more than 160,000 post-menopausal women between the ages of 50 and 79. In 2002, the study was abruptly stopped because data from the hormone replacement group showed an increased risk of the diseases mentioned above.

The new study eliminated all the women who should have been disqualified in the first place, said Joshua Lupton, DO, at Cape Cod Hospital Obstetrics & Gynecology in Hyannis.

“They took a lot of women who were more than 10 years from menopause and a lot of women had hypertension and diabetes,” he said. “Some of them were smokers, so a lot of that information you can’t correlate with women who are recently menopausal and overall healthy.”

After eliminating those patients, researchers went back and looked at all of that data to look at what are the risks for women who should have been the main focus of the original study, such as those who are recently menopausal, who have menopausal symptoms and who start hormone replacement therapy (HRT), he said. They found that while there are risks, they are very low.

According to Dr. Lupton, the symptoms of menopause that his patients find the most difficult are:

• Hot flashes
• Night sweats
• Anxiety
• Depression
• Tiredness
• Chronic sleep disruption
• Less muscle volume, even if exercising regularly
• More fat, especially around the mid-section
• Joint pain
• Trouble with concentration and focus at work
• Vaginal dryness and atrophy

“Some women seem not to be affected by menopause very much, but most women are affected to some degree and sometimes really terribly,” he said. “It affects their job performance. It affects their relationships. It affects their sex life. It is just very detrimental to their overall well-being.”

Holistic Approaches First

When a patient comes to Dr. Lupton for relief from menopausal symptoms, he first talks to them about a more holistic approach, though the studies and reviews of them are mixed, he said. He talks to them about importance of a healthy diet, the possibility of adding foods with phytoestrogens, regular exercise and good sleep. He also discusses herbal remedies like red clover and black cohosh.

“Then there are FDA-approved medications that we use off-label that are non-hormonal – things like clonidine, gabapentin and paroxetine, so I do talk to patients about those options,” he said. “But none of those are going to halt menopausal symptoms like estrogen, plain and simple.”

If a patient would like to go on hormone replacement therapy, the first thing Dr. Lupton does is make sure they are healthy enough for it to be safe. He always looks at their blood pressure, lipid panel and diabetes screening. He also consults the ASCVD Risk Estimator that shows a patient’s 10-year risk of having a heart attack.

Who Can Take HRT?

Even though there are relatively few absolute contraindications for taking hormone replacement therapy, there are several relative contraindications because they raise the risk of health complications, Dr. Lupton said. They include anyone who:

• Has been deemed high-risk on the ASCVD Risk Estimator
• Has a history of migraines with aura
• Is a smoker
• Has diabetes
• Has hypertension
• Is obese
• Has a history of blood clots
• Has a history of previous breast cancer.

Once a woman has been cleared of any of these conditions, Dr. Lupton asks them if they have a uterus, because the treatment is different if they do. Women with uteruses have to take progesterone as well as estrogen to prevent stimulating growth of the lining of the uterus, which increases the risk of endometrial cancer. Women who don’t have a uterus can just take estrogen.

Dr. Lupton then explains to patients that the risks are not zero, but they are incredibly low, and he goes over those risks.

“We know there is a small increased risk of breast cancer,” he said. “Although when you look at the WHI, and look at the estrogen-only arm, there’s actually a decreased incidence of breast cancer. In the arm (that includes) women taking estrogen with progesterone, because they have their uterus, there was an increased risk of breast cancer. Overall, there’s a few studies on HRT and we believe there is a very small increased risk of breast cancer, blood clots, stroke – those are the biggest things I talk to patients about.”

Starting HRT

The definition of menopause is 12 months with no menstrual cycle, according to Dr. Lupton, and he likes to start patients on HRT within five to 10 years of the onset of menopause. He starts with a low dose and titrates from there until the desired effect is reached. Most women take HRT for five to 10 years because that’s how long hot flashes are typically the worst. Hot flashes may continue for up to 20 years, but they are less frequent and less severe.

For women who have vaginal symptoms, only, a vaginal estrogen medication is available as a pill, ring or cream. The whole point of any hormone replacement therapy is to help women have a better quality of life, Dr. Lupton said.

Even with new research results that show the risks of HRT were overblown in the past, some doctors are hesitant to prescribe it because the old stigma still exists. Plus, even OB/GYNs whose focus is women’s health don’t get extensive training in menopause care during their residency program, Dr. Lupton said.

“Now people are starting to prescribe them more but there is also a lot of misinformation and misperception, even from healthcare providers,” he said. “I’ve heard so many patients say, ‘I’ve spoken to my PCP and they won’t give me estrogen and these hot flashes are awful. I’m only 40 years old and this is ruining my life.’ Dr. Lupton said he will happily go through their history and prescribe them HRT, if that’s what they want, and they have none of the risks associated with taking it.

“I’ve had women say (HRT) changed their life. They feel so much better on a daily basis,” he said.

In addition to any advice or prescriptions he may dispense, Dr. Lupton always directs women in perimenopause or menopause to the North American Menopause Society website. Which has a of lot good information and resources for women. He said he often prints handouts from the website to give to patients.