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Published on April 06, 2021

Is hormone replacement therapy safe?

Hormone Therapy

There is a lot of contradictory advice about hormone replacement therapy for women going through menopause, which makes it hard to know what to believe. Even doctors don’t all agree on the topic.

“It’s controversial,” said Obstetrician/Gynecologist Tara Chute, MD, at Cape Cod Hospital OB/GYN. “If you go to different providers, you will get different answers. Every provider is individualized in what they do.”

Dr. Chute’s approach is based on the information from the Women’s Health Initiative, which is a long-term national health study focused on preventing health complications in postmenopausal women. The study was launched in 1993 and enrolled 161,808 women ages 50 to 79. Dr. Chute also follows the American College of Obstetricians and Gynecologists (ACOG) guidelines since they are the governing board for her profession.

“Some providers will obviously look at newer studies and potentially amend or adjust what they do, but the approach I take is, first of all, I tell women this is not for prevention of any chronic condition,” Dr. Chute said. “It’s solely, in my opinion, for improvement of quality of life during menopause.”

The biggest benefit of hormone replacement therapy is that it reduces vasomotor symptoms, commonly referred to as hot flashes, although for most women it also increases their energy and makes their skin look younger.

The way Dr. Chute approaches hormone replacement therapy is to judge how significant the patient’s symptoms are. Since menopausal symptoms are a diagnosis of exclusion, the first thing that she needs to do is rule out other possible underlying medical conditions that may be causing vasomotor symptoms. Those include undiagnosed hypertension, side effects from medications and thyroid disease.

“We always want to make sure that we are not increasing risk and missing an actual medical diagnosis,” she said.

Once other medical conditions have been ruled out, Dr. Chute talks to patients about the benefits versus risks of hormone replacement therapy. Women who have a history of breast cancer, hypertension, blood clots or strokes are never a candidate for estrogen, no matter how bad their vasomotor symptoms are.

Women without those histories who take systematic estrogen either orally or with a patch face an increased risk of cardiovascular disease, stroke, blood clots and possibly breast cancer.

“The biggest issue is that you are treating a quality of life issue with a potential significant risk,” Dr. Chute said. “You need to understand the risk you are taking, so symptoms have to be significant enough that you are willing to take the risk.”

Risks Vs. Benefits

Some women have such intense hot flashes it truly has a negative impact on their life. They have trouble focusing at work, and they wake up 15 to 20 times per night in a cold sweat.

“For those women, the risks to them may be worth it, but not indefinitely,” she said. “The goal I always set with patients is five years or less. In all the studies it seems like the risk increases significantly after five years.”

In addition to systematic estrogen, women who have intact uteruses also have to take a low dose of progesterone because estrogen alone can increase the risk of uterine cancer. Women who have had hysterectomies do not need to take progesterone.

Just to add to the confusion, there is also local estrogen, which has a very different set of recommendations. Local estrogen is available in either a pill, a cream or a ring that is inserted vaginally. Since it is only locally absorbed, progesterone is not needed and this form of estrogen does not pose the same risks as systemic estrogen, and is generally safe to use.

“I use local estrogen typically for what’s called genital-urinary symptoms, which are basically vaginal dryness, recurrent urinary tract infections and painful intercourse,” Dr. Chute said. “I have no problem prescribing that forever. Women ask me how long they should stay on it and I say as long as you want to remain comfortable. I have women in their 90s on it for various issues.”

The other controversial topic that complicates discussions about hormone replacement therapy is bio-identical hormone treatment. That topic comes up frequently in Dr. Chute’s office because there is a misperception that because the hormones are plant derived, they are potentially safer. Women who choose this option go to a provider who does hormone tests, usually with saliva, which are not accurate, according to Dr. Chute. Then the patients go to compounding pharmacies to fill the prescription.

Dr. Chute has a lot of concerns about bio-identical hormones.

“The issue at hand is, first of all, our governing body, ACOG, does not recommend them, and the other issue is that just like vitamins are not regulated, bio-identical hormones are not regulated.”

Dr. Chute has read studies that show that you could go to 20 different pharmacies and get 17 different prescriptions of bio-identical hormones with various estrogen and progesterone levels.

“You can imagine that that could get potentially unsafe,” she said.

Another issue is that because they are not regulated by the FDA, some of the science behind bio-identical hormones is not true. One study showed a product with yams as the source of progesterone. The human body can’t process that form of progesterone so the women who took it were on unopposed estrogen (estrogen without progesterone) and didn’t realize it.

“It’s not regulated, so I tell patients that I don’t personally feel comfortable prescribing that because I do have medications that I know exactly what you are getting that is regulated by the FDA,” Dr. Chute said. “The other thing that I bring up is that there are a couple of other medications that are generally safer that can treat hot flashes, such as Paxil. It is more known as an antidepressant but it’s actually FDA approved for vasomotor symptoms because of how it works. And Gabapentin is another medication that can be helpful. It’s a medication that helps with nerve pain, but it can also help with hot flashes.”

Dr. Chute prefers to be very conservative, particularly because hormone replacement therapy is not treating a disease, but ultimately it is a decision that has to be made in conjunction with the patient. Some patients decide the risks aren’t worth it and others are willing to take the chance.

“I would say the whole process is extremely individualized, from the provider standpoint and from the patient standpoint,” she said. “There’s a lot of factors: age, medical comorbidities and severity of symptoms. There’s a lot that goes into it.”