Women's Health

TOPLINE:

Universal testing identified germline pathogenic variants in 7.3% of women with breast cancer, suggesting that traditional risk-based criteria may miss more than a third of BRCA1, BRCA2, or PALB2 carriers.

METHODOLOGY:

• Traditional risk-based criteria, including family history and ancestry, are used to guide genetic testing decisions in women with breast cancer. However, these criteria may overlook patients with actionable genetic variants, particularly those outside the typical risk profile.
• To assess the efficacy of universal genetic testing, researchers conducted a cross-sectional study that included 729 women (median age at diagnosis, 53 years; 65.4% White women) newly diagnosed with invasive breast cancer between September 2019 and April 2022 at three Canadian institutions.
• All patients received genetic counseling followed by testing for the presence of germline pathogenic variants in 17 breast cancer susceptibility genes. The primary gene panel included screening for BRCA1, BRCA2, and PALB2, and the optional secondary panel included 14 additional breast cancer susceptibility genes.
• Of the participants, 659 (90.4%) were tested for both primary and secondary gene panels, whereas 70 (9.6%) underwent testing for only the primary panel. The majority of the cohort (66.8) were diagnosed with estrogen receptor–positive breast cancer, while 15.4% had triple-negative breast cancer.

TAKEAWAY:

• The prevalence of germline pathogenic variants was 7.3% (53 patients) — 5.3% for the primary gene panel and 2.1% for the secondary panel.
• Younger age (< 40 years; odds ratio [OR], 6.83), family history of ovarian cancer (OR, 9.75), high-grade disease (OR, 1.68), and triple-negative breast cancer (OR, 3.19) were independently associated with the presence of pathogenic genetic variants in BRCA1, BRCA2, or PALB2.
• Overall, 34.3% of patients with germline pathogenic variants in BRCA1, BRCA2, or PALB2, and 85.7% of carriers of secondary panel variants would not have qualified for traditional genetic testing according to the current risk factors.
• A total of 13 patients with BRCA1, BRCA2, or PALB2 variants had confirmed pathogenic mutations and were eligible for poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitors.

IN PRACTICE:

These findings have “informed our clinical practice, and we now offer mainstream, oncology-led genetic testing to all women diagnosed with incident invasive breast cancer younger than 50 years of age, those with triple-negative breast cancer and/or bilateral breast cancer, those potentially eligible for PARP inhibitors,” as well as to men with breast cancer, the authors wrote.

SOURCE:

The study was led by Zoulikha Rezoug, MSc, Lady Davis Institute of the Jewish General Hospital, McGill University in Montreal, Québec, Canada. It was published online on September 3, 2024, in JAMA Network Open.

LIMITATIONS:

The COVID-19 pandemic resulted in a 6-month recruitment pause. Adjustments in recruitment criteria, focus on younger patients and those with triple-negative breast cancer could have overestimated prevalence of genetic pathogenic variants among women aged ≥ 70 years.

DISCLOSURES:

The study was supported by grants from the Jewish General Hospital Foundation and the Québec Breast Cancer Foundation, as well as an award from the Fonds de Recherche du Québec - Santé. Two authors reported receiving grants or personal fees from various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Universal testing identified germline pathogenic variants in 7.3% of women with breast cancer, suggesting that traditional risk-based criteria may miss more than a third of BRCA1, BRCA2, or PALB2 carriers.

METHODOLOGY:

• Traditional risk-based criteria, including family history and ancestry, are used to guide genetic testing decisions in women with breast cancer. However, these criteria may overlook patients with actionable genetic variants, particularly those outside the typical risk profile.
• To assess the efficacy of universal genetic testing, researchers conducted a cross-sectional study that included 729 women (median age at diagnosis, 53 years; 65.4% White women) newly diagnosed with invasive breast cancer between September 2019 and April 2022 at three Canadian institutions.
• All patients received genetic counseling followed by testing for the presence of germline pathogenic variants in 17 breast cancer susceptibility genes. The primary gene panel included screening for BRCA1, BRCA2, and PALB2, and the optional secondary panel included 14 additional breast cancer susceptibility genes.
• Of the participants, 659 (90.4%) were tested for both primary and secondary gene panels, whereas 70 (9.6%) underwent testing for only the primary panel. The majority of the cohort (66.8) were diagnosed with estrogen receptor–positive breast cancer, while 15.4% had triple-negative breast cancer.

TAKEAWAY:

• The prevalence of germline pathogenic variants was 7.3% (53 patients) — 5.3% for the primary gene panel and 2.1% for the secondary panel.
• Younger age (< 40 years; odds ratio [OR], 6.83), family history of ovarian cancer (OR, 9.75), high-grade disease (OR, 1.68), and triple-negative breast cancer (OR, 3.19) were independently associated with the presence of pathogenic genetic variants in BRCA1, BRCA2, or PALB2.
• Overall, 34.3% of patients with germline pathogenic variants in BRCA1, BRCA2, or PALB2, and 85.7% of carriers of secondary panel variants would not have qualified for traditional genetic testing according to the current risk factors.
• A total of 13 patients with BRCA1, BRCA2, or PALB2 variants had confirmed pathogenic mutations and were eligible for poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitors.

IN PRACTICE:

These findings have “informed our clinical practice, and we now offer mainstream, oncology-led genetic testing to all women diagnosed with incident invasive breast cancer younger than 50 years of age, those with triple-negative breast cancer and/or bilateral breast cancer, those potentially eligible for PARP inhibitors,” as well as to men with breast cancer, the authors wrote.

SOURCE:

The study was led by Zoulikha Rezoug, MSc, Lady Davis Institute of the Jewish General Hospital, McGill University in Montreal, Québec, Canada. It was published online on September 3, 2024, in JAMA Network Open.

LIMITATIONS:

The COVID-19 pandemic resulted in a 6-month recruitment pause. Adjustments in recruitment criteria, focus on younger patients and those with triple-negative breast cancer could have overestimated prevalence of genetic pathogenic variants among women aged ≥ 70 years.

DISCLOSURES:

The study was supported by grants from the Jewish General Hospital Foundation and the Québec Breast Cancer Foundation, as well as an award from the Fonds de Recherche du Québec - Santé. Two authors reported receiving grants or personal fees from various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Universal testing identified germline pathogenic variants in 7.3% of women with breast cancer, suggesting that traditional risk-based criteria may miss more than a third of BRCA1, BRCA2, or PALB2 carriers.

METHODOLOGY:

• Traditional risk-based criteria, including family history and ancestry, are used to guide genetic testing decisions in women with breast cancer. However, these criteria may overlook patients with actionable genetic variants, particularly those outside the typical risk profile.
• To assess the efficacy of universal genetic testing, researchers conducted a cross-sectional study that included 729 women (median age at diagnosis, 53 years; 65.4% White women) newly diagnosed with invasive breast cancer between September 2019 and April 2022 at three Canadian institutions.
• All patients received genetic counseling followed by testing for the presence of germline pathogenic variants in 17 breast cancer susceptibility genes. The primary gene panel included screening for BRCA1, BRCA2, and PALB2, and the optional secondary panel included 14 additional breast cancer susceptibility genes.
• Of the participants, 659 (90.4%) were tested for both primary and secondary gene panels, whereas 70 (9.6%) underwent testing for only the primary panel. The majority of the cohort (66.8) were diagnosed with estrogen receptor–positive breast cancer, while 15.4% had triple-negative breast cancer.

TAKEAWAY:

• The prevalence of germline pathogenic variants was 7.3% (53 patients) — 5.3% for the primary gene panel and 2.1% for the secondary panel.
• Younger age (< 40 years; odds ratio [OR], 6.83), family history of ovarian cancer (OR, 9.75), high-grade disease (OR, 1.68), and triple-negative breast cancer (OR, 3.19) were independently associated with the presence of pathogenic genetic variants in BRCA1, BRCA2, or PALB2.
• Overall, 34.3% of patients with germline pathogenic variants in BRCA1, BRCA2, or PALB2, and 85.7% of carriers of secondary panel variants would not have qualified for traditional genetic testing according to the current risk factors.
• A total of 13 patients with BRCA1, BRCA2, or PALB2 variants had confirmed pathogenic mutations and were eligible for poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitors.

IN PRACTICE:

These findings have “informed our clinical practice, and we now offer mainstream, oncology-led genetic testing to all women diagnosed with incident invasive breast cancer younger than 50 years of age, those with triple-negative breast cancer and/or bilateral breast cancer, those potentially eligible for PARP inhibitors,” as well as to men with breast cancer, the authors wrote.

SOURCE:

The study was led by Zoulikha Rezoug, MSc, Lady Davis Institute of the Jewish General Hospital, McGill University in Montreal, Québec, Canada. It was published online on September 3, 2024, in JAMA Network Open.

LIMITATIONS:

The COVID-19 pandemic resulted in a 6-month recruitment pause. Adjustments in recruitment criteria, focus on younger patients and those with triple-negative breast cancer could have overestimated prevalence of genetic pathogenic variants among women aged ≥ 70 years.

DISCLOSURES:

The study was supported by grants from the Jewish General Hospital Foundation and the Québec Breast Cancer Foundation, as well as an award from the Fonds de Recherche du Québec - Santé. Two authors reported receiving grants or personal fees from various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr Matthew Frank Watto, here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. 

Paul, we’re going to talk about our primary hyperparathyroidism podcast with Dr. Lindsay Kuo. It’s a topic that I feel much more clear on now.

Now, Paul, in primary care, you see a lot of calcium that is just slightly high. Can we just blame that on thiazide diuretics?

Paul N. Williams, MD: It’s a place to start. As you’re starting to think about the possible etiologies, primary hyperparathyroidism and malignancy are the two that roll right off the tongue, but it is worth going back to the patient’s medication list and making sure you’re not missing something.

Thiazides famously cause hypercalcemia, but in some of the reading I did for this episode, they may just uncover it a little bit early. Patients who are on thiazides who become hypercalcemic seem to go on to develop primary hyperthyroidism anyway. So I don’t think you can solely blame the thiazide.

Another medication that can be causative is lithium. So a good place to look first after you’ve repeated the labs and confirmed hypercalcemia is the patient’s medication list. 

Dr. Watto: We’ve talked before about the basic workup for hypercalcemia, and determining whether it’s PTH dependent or PTH independent. On the podcast, we talk more about the full workup, but I wanted to talk about the classic symptoms. Our expert made the point that we don’t see them as much anymore, although we do see kidney stones. People used to present very late in the disease because they weren’t having labs done routinely.

The classic symptoms include osteoporosis and bone tumors. People can get nephrocalcinosis and kidney stones. I hadn’t really thought of it this way because we’re used to diagnosing it early now. Do you feel the same? 

Dr. Williams: As labs have started routinely reporting calcium levels, this is more and more often how it’s picked up. The other aspect is that as we are screening for and finding osteoporosis, part of the workup almost always involves getting a parathyroid hormone and a calcium level. We’re seeing these lab abnormalities before we’re seeing symptoms, which is good.

But it also makes things more diagnostically thorny.

Dr. Watto: Dr. Lindsay Kuo made the point that when she sees patients before and after surgery, she’s aware of these nonclassic symptoms — the stones, bones, groans, and the psychiatric overtones that can be anything from fatigue or irritability to dysphoria.

Some people have a generalized weakness that’s very nonspecific. Dr. Kuo said that sometimes these symptoms will disappear after surgery. The patients may just have gotten used to them, or they thought these symptoms were caused by something else, but after surgery they went away.

There are these nonclassic symptoms that are harder to pin down. I was surprised by that.

Dr. Williams: She mentioned polydipsia and polyuria, which have been reported in other studies. It seems like it can be anything. You have to take a good history, but none of those things in and of themselves is an indication for operating unless the patient has the classic renal or bone manifestations. 

Dr. Watto: The other thing we talked about is a normal calcium level in a patient with primary hyperparathyroidism, or the finding of a PTH level in the normal range but with a high calcium level that is inappropriate. Can you talk a little bit about those two situations? 

Dr. Williams: They’re hard to say but kind of easy to manage because you treat them the same way as someone who has elevated calcium and PTH levels. 

The normocalcemic patient is something we might stumble across with osteoporosis screening. Initially the calcium level is elevated, so you repeat it and it’s normal but with an elevated PTH level. You’re like, shoot. Now what?

It turns out that most endocrine surgeons say that the indications for surgery for the classic form of primary hyperparathyroidism apply to these patients as well, and it probably helps with the bone outcomes, which is one of the things they follow most closely. If you have hypercalcemia, you should have a suppressed PTH level, the so-called normohormonal hyperparathyroidism, which is not normal at all. So even if the PTH is in the normal range, it’s still relatively elevated compared with what it should be. That situation is treated in the same way as the classic elevated PTH and elevated calcium levels.

Dr. Watto: If the calcium is abnormal and the PTH is not quite what you’d expect it to be, you can always ask your friendly neighborhood endocrinologist to help you figure out whether the patient really has one of these conditions. You have to make sure that they don’t have a simple secondary cause like a low vitamin D level. In that case, you fix the vitamin D and then recheck the numbers to see if they’ve normalized. But I have found a bunch of these edge cases in which it has been helpful to confer with an endocrinologist, especially before you send someone to a surgeon to take out their parathyroid gland. 

This was a really fantastic conversation. If you want to hear the full podcast episode, click here.
 

Dr. Watto, Clinical Assistant Professor, Department of Medicine, Perelman School of Medicine at University of Pennsylvania; Internist, Department of Medicine, Hospital Medicine Section, Pennsylvania Hospital, Philadelphia, Pennsylvania, has disclosed no relevant financial relationships. Dr. Williams, Associate Professor of Clinical Medicine, Department of General Internal Medicine, Lewis Katz School of Medicine; Staff Physician, Department of General Internal Medicine, Temple Internal Medicine Associates, Philadelphia, Pennsylvania, served as a director, officer, partner, employee, adviser, consultant, or trustee for The Curbsiders, and has received income in an amount equal to or greater than $250 from The Curbsiders.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr Matthew Frank Watto, here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. 

Paul, we’re going to talk about our primary hyperparathyroidism podcast with Dr. Lindsay Kuo. It’s a topic that I feel much more clear on now.

Now, Paul, in primary care, you see a lot of calcium that is just slightly high. Can we just blame that on thiazide diuretics?

Paul N. Williams, MD: It’s a place to start. As you’re starting to think about the possible etiologies, primary hyperparathyroidism and malignancy are the two that roll right off the tongue, but it is worth going back to the patient’s medication list and making sure you’re not missing something.

Thiazides famously cause hypercalcemia, but in some of the reading I did for this episode, they may just uncover it a little bit early. Patients who are on thiazides who become hypercalcemic seem to go on to develop primary hyperthyroidism anyway. So I don’t think you can solely blame the thiazide.

Another medication that can be causative is lithium. So a good place to look first after you’ve repeated the labs and confirmed hypercalcemia is the patient’s medication list. 

Dr. Watto: We’ve talked before about the basic workup for hypercalcemia, and determining whether it’s PTH dependent or PTH independent. On the podcast, we talk more about the full workup, but I wanted to talk about the classic symptoms. Our expert made the point that we don’t see them as much anymore, although we do see kidney stones. People used to present very late in the disease because they weren’t having labs done routinely.

The classic symptoms include osteoporosis and bone tumors. People can get nephrocalcinosis and kidney stones. I hadn’t really thought of it this way because we’re used to diagnosing it early now. Do you feel the same? 

Dr. Williams: As labs have started routinely reporting calcium levels, this is more and more often how it’s picked up. The other aspect is that as we are screening for and finding osteoporosis, part of the workup almost always involves getting a parathyroid hormone and a calcium level. We’re seeing these lab abnormalities before we’re seeing symptoms, which is good.

But it also makes things more diagnostically thorny.

Dr. Watto: Dr. Lindsay Kuo made the point that when she sees patients before and after surgery, she’s aware of these nonclassic symptoms — the stones, bones, groans, and the psychiatric overtones that can be anything from fatigue or irritability to dysphoria.

Some people have a generalized weakness that’s very nonspecific. Dr. Kuo said that sometimes these symptoms will disappear after surgery. The patients may just have gotten used to them, or they thought these symptoms were caused by something else, but after surgery they went away.

There are these nonclassic symptoms that are harder to pin down. I was surprised by that.

Dr. Williams: She mentioned polydipsia and polyuria, which have been reported in other studies. It seems like it can be anything. You have to take a good history, but none of those things in and of themselves is an indication for operating unless the patient has the classic renal or bone manifestations. 

Dr. Watto: The other thing we talked about is a normal calcium level in a patient with primary hyperparathyroidism, or the finding of a PTH level in the normal range but with a high calcium level that is inappropriate. Can you talk a little bit about those two situations? 

Dr. Williams: They’re hard to say but kind of easy to manage because you treat them the same way as someone who has elevated calcium and PTH levels. 

The normocalcemic patient is something we might stumble across with osteoporosis screening. Initially the calcium level is elevated, so you repeat it and it’s normal but with an elevated PTH level. You’re like, shoot. Now what?

It turns out that most endocrine surgeons say that the indications for surgery for the classic form of primary hyperparathyroidism apply to these patients as well, and it probably helps with the bone outcomes, which is one of the things they follow most closely. If you have hypercalcemia, you should have a suppressed PTH level, the so-called normohormonal hyperparathyroidism, which is not normal at all. So even if the PTH is in the normal range, it’s still relatively elevated compared with what it should be. That situation is treated in the same way as the classic elevated PTH and elevated calcium levels.

Dr. Watto: If the calcium is abnormal and the PTH is not quite what you’d expect it to be, you can always ask your friendly neighborhood endocrinologist to help you figure out whether the patient really has one of these conditions. You have to make sure that they don’t have a simple secondary cause like a low vitamin D level. In that case, you fix the vitamin D and then recheck the numbers to see if they’ve normalized. But I have found a bunch of these edge cases in which it has been helpful to confer with an endocrinologist, especially before you send someone to a surgeon to take out their parathyroid gland. 

This was a really fantastic conversation. If you want to hear the full podcast episode, click here.
 

Dr. Watto, Clinical Assistant Professor, Department of Medicine, Perelman School of Medicine at University of Pennsylvania; Internist, Department of Medicine, Hospital Medicine Section, Pennsylvania Hospital, Philadelphia, Pennsylvania, has disclosed no relevant financial relationships. Dr. Williams, Associate Professor of Clinical Medicine, Department of General Internal Medicine, Lewis Katz School of Medicine; Staff Physician, Department of General Internal Medicine, Temple Internal Medicine Associates, Philadelphia, Pennsylvania, served as a director, officer, partner, employee, adviser, consultant, or trustee for The Curbsiders, and has received income in an amount equal to or greater than $250 from The Curbsiders.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr Matthew Frank Watto, here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. 

Paul, we’re going to talk about our primary hyperparathyroidism podcast with Dr. Lindsay Kuo. It’s a topic that I feel much more clear on now.

Now, Paul, in primary care, you see a lot of calcium that is just slightly high. Can we just blame that on thiazide diuretics?

Paul N. Williams, MD: It’s a place to start. As you’re starting to think about the possible etiologies, primary hyperparathyroidism and malignancy are the two that roll right off the tongue, but it is worth going back to the patient’s medication list and making sure you’re not missing something.

Thiazides famously cause hypercalcemia, but in some of the reading I did for this episode, they may just uncover it a little bit early. Patients who are on thiazides who become hypercalcemic seem to go on to develop primary hyperthyroidism anyway. So I don’t think you can solely blame the thiazide.

Another medication that can be causative is lithium. So a good place to look first after you’ve repeated the labs and confirmed hypercalcemia is the patient’s medication list. 

Dr. Watto: We’ve talked before about the basic workup for hypercalcemia, and determining whether it’s PTH dependent or PTH independent. On the podcast, we talk more about the full workup, but I wanted to talk about the classic symptoms. Our expert made the point that we don’t see them as much anymore, although we do see kidney stones. People used to present very late in the disease because they weren’t having labs done routinely.

The classic symptoms include osteoporosis and bone tumors. People can get nephrocalcinosis and kidney stones. I hadn’t really thought of it this way because we’re used to diagnosing it early now. Do you feel the same? 

Dr. Williams: As labs have started routinely reporting calcium levels, this is more and more often how it’s picked up. The other aspect is that as we are screening for and finding osteoporosis, part of the workup almost always involves getting a parathyroid hormone and a calcium level. We’re seeing these lab abnormalities before we’re seeing symptoms, which is good.

But it also makes things more diagnostically thorny.

Dr. Watto: Dr. Lindsay Kuo made the point that when she sees patients before and after surgery, she’s aware of these nonclassic symptoms — the stones, bones, groans, and the psychiatric overtones that can be anything from fatigue or irritability to dysphoria.

Some people have a generalized weakness that’s very nonspecific. Dr. Kuo said that sometimes these symptoms will disappear after surgery. The patients may just have gotten used to them, or they thought these symptoms were caused by something else, but after surgery they went away.

There are these nonclassic symptoms that are harder to pin down. I was surprised by that.

Dr. Williams: She mentioned polydipsia and polyuria, which have been reported in other studies. It seems like it can be anything. You have to take a good history, but none of those things in and of themselves is an indication for operating unless the patient has the classic renal or bone manifestations. 

Dr. Watto: The other thing we talked about is a normal calcium level in a patient with primary hyperparathyroidism, or the finding of a PTH level in the normal range but with a high calcium level that is inappropriate. Can you talk a little bit about those two situations? 

Dr. Williams: They’re hard to say but kind of easy to manage because you treat them the same way as someone who has elevated calcium and PTH levels. 

The normocalcemic patient is something we might stumble across with osteoporosis screening. Initially the calcium level is elevated, so you repeat it and it’s normal but with an elevated PTH level. You’re like, shoot. Now what?

It turns out that most endocrine surgeons say that the indications for surgery for the classic form of primary hyperparathyroidism apply to these patients as well, and it probably helps with the bone outcomes, which is one of the things they follow most closely. If you have hypercalcemia, you should have a suppressed PTH level, the so-called normohormonal hyperparathyroidism, which is not normal at all. So even if the PTH is in the normal range, it’s still relatively elevated compared with what it should be. That situation is treated in the same way as the classic elevated PTH and elevated calcium levels.

Dr. Watto: If the calcium is abnormal and the PTH is not quite what you’d expect it to be, you can always ask your friendly neighborhood endocrinologist to help you figure out whether the patient really has one of these conditions. You have to make sure that they don’t have a simple secondary cause like a low vitamin D level. In that case, you fix the vitamin D and then recheck the numbers to see if they’ve normalized. But I have found a bunch of these edge cases in which it has been helpful to confer with an endocrinologist, especially before you send someone to a surgeon to take out their parathyroid gland. 

This was a really fantastic conversation. If you want to hear the full podcast episode, click here.
 

Dr. Watto, Clinical Assistant Professor, Department of Medicine, Perelman School of Medicine at University of Pennsylvania; Internist, Department of Medicine, Hospital Medicine Section, Pennsylvania Hospital, Philadelphia, Pennsylvania, has disclosed no relevant financial relationships. Dr. Williams, Associate Professor of Clinical Medicine, Department of General Internal Medicine, Lewis Katz School of Medicine; Staff Physician, Department of General Internal Medicine, Temple Internal Medicine Associates, Philadelphia, Pennsylvania, served as a director, officer, partner, employee, adviser, consultant, or trustee for The Curbsiders, and has received income in an amount equal to or greater than $250 from The Curbsiders.

A version of this article first appeared on Medscape.com.

Research on pain management during placement of intrauterine devices (IUD) is lacking, but most studies so far indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) are not effective, according to a poster presented at Pain Week 2024 in Las Vegas.

Roughly 79% of the 14 studies included in the systematic review found NSAIDs — one of the most common drugs clinicians advise patients to take before placement — did not diminish discomfort.

“We’re challenging the current practice of using just NSAIDs as a first-line of treatment,” said Kevin Rowland, PhD, professor and chair of biomedical sciences at Tilman J. Fertitta Family College of Medicine in Houston, who helped conduct the meta-analysis. “We need additional measures.”

Some studies found the drugs offered virtually no improvement for patients, while the biggest drop in pain shown in one study was about 40%. The range of pain levels women reported while using NSAIDs was between 1.8 and 7.3 on the visual analog scale (VAS), with an average score of 4.25.

The review included 10 types of NSAIDs and dosages administered to patients before the procedure. One intramuscular NSAID was included while the remaining were oral. All studies were peer-reviewed, used the VAS pain scale, and were not limited to any specific population.

The findings highlight a longstanding but unresolved problem in reproductive health: An overall lack of effective pain management strategies for gynecologic procedures.

“We went into this having a pretty good idea of what we were going to find because [the lack of NSAID efficacy] has been shown before, it’s been talked about before, and we’re just not listening as a medical community,” said Isabella D. Martingano, an MD candidate at Tilman J. Fertitta Family College of Medicine, who led the review.

The research also points to a lack of robust studies on pain during IUD placement, said Emma Lakey, a coauthor and medical student at Tilman J. Fertitta Family College of Medicine.

“We were only able to review 14 studies, which was enough to go off of, but considering we were looking for trials about pain control for a procedure that helps prevent pregnancy, that’s just not enough research,” Ms. Lakey said.

Discomfort associated with IUD placement ranges from mild to severe, can last for over a week, and includes cramping, bleeding, lightheadedness, nausea, and fainting. Some research suggests that providers may underestimate the level of pain the procedures cause.

“Unfortunately, the pain associated with IUD insertion and removal has been underplayed for a long time and many practitioners in the field likely haven’t counseled patients fully on what the procedure will feel like,” said Jennifer Chin, MD, an ob.gyn. and assistant professor of obstetrics and gynecology at the University of Washington in Seattle.

NSAIDs are not mentioned in the recently expanded guidelines on IUD placement from the US Centers for Disease Control and Prevention (CDC). The CDC recommends lidocaine paracervical blocks, gels, sprays, and creams, plus counseling women about pain ahead of the procedures.

IUDs are one of the most effective forms of birth control, with a failure rate below 1%.

Yet hearing about painful placement keeps many women from seeking out an IUD or replacing an existing device, Dr. Rowland said. The review adds to the body of evidence that current strategies are not working and that more research is needed, he said.

According to Dr. Chin, making IUDs more accessible means taking a more personalized approach to pain management while understanding that what may be a painless procedure for one patient may be excruciating for another.

Dr. Chin offers a range of options for her patients, including NSAIDs, lorazepam for anxiety, paracervical blocks, lidocaine jelly and spray, intravenous sedation, and general anesthesia. She also talks to her patients through the procedure and provides guided imagery and meditation.

“We should always make sure we’re prioritizing the patients and providing evidence-based, compassionate, and individualized care,” said Dr. Chin. “Each patient comes to us in a particular context and with a specific set of experiences and history that will make a difference in how we’re best able to take care of them.”

The authors reported no disclosures and no sources of funding. Dr. Chin reported no disclosures.
 

A version of this article first appeared on Medscape.com.

Research on pain management during placement of intrauterine devices (IUD) is lacking, but most studies so far indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) are not effective, according to a poster presented at Pain Week 2024 in Las Vegas.

Roughly 79% of the 14 studies included in the systematic review found NSAIDs — one of the most common drugs clinicians advise patients to take before placement — did not diminish discomfort.

“We’re challenging the current practice of using just NSAIDs as a first-line of treatment,” said Kevin Rowland, PhD, professor and chair of biomedical sciences at Tilman J. Fertitta Family College of Medicine in Houston, who helped conduct the meta-analysis. “We need additional measures.”

Some studies found the drugs offered virtually no improvement for patients, while the biggest drop in pain shown in one study was about 40%. The range of pain levels women reported while using NSAIDs was between 1.8 and 7.3 on the visual analog scale (VAS), with an average score of 4.25.

The review included 10 types of NSAIDs and dosages administered to patients before the procedure. One intramuscular NSAID was included while the remaining were oral. All studies were peer-reviewed, used the VAS pain scale, and were not limited to any specific population.

The findings highlight a longstanding but unresolved problem in reproductive health: An overall lack of effective pain management strategies for gynecologic procedures.

“We went into this having a pretty good idea of what we were going to find because [the lack of NSAID efficacy] has been shown before, it’s been talked about before, and we’re just not listening as a medical community,” said Isabella D. Martingano, an MD candidate at Tilman J. Fertitta Family College of Medicine, who led the review.

The research also points to a lack of robust studies on pain during IUD placement, said Emma Lakey, a coauthor and medical student at Tilman J. Fertitta Family College of Medicine.

“We were only able to review 14 studies, which was enough to go off of, but considering we were looking for trials about pain control for a procedure that helps prevent pregnancy, that’s just not enough research,” Ms. Lakey said.

Discomfort associated with IUD placement ranges from mild to severe, can last for over a week, and includes cramping, bleeding, lightheadedness, nausea, and fainting. Some research suggests that providers may underestimate the level of pain the procedures cause.

“Unfortunately, the pain associated with IUD insertion and removal has been underplayed for a long time and many practitioners in the field likely haven’t counseled patients fully on what the procedure will feel like,” said Jennifer Chin, MD, an ob.gyn. and assistant professor of obstetrics and gynecology at the University of Washington in Seattle.

NSAIDs are not mentioned in the recently expanded guidelines on IUD placement from the US Centers for Disease Control and Prevention (CDC). The CDC recommends lidocaine paracervical blocks, gels, sprays, and creams, plus counseling women about pain ahead of the procedures.

IUDs are one of the most effective forms of birth control, with a failure rate below 1%.

Yet hearing about painful placement keeps many women from seeking out an IUD or replacing an existing device, Dr. Rowland said. The review adds to the body of evidence that current strategies are not working and that more research is needed, he said.

According to Dr. Chin, making IUDs more accessible means taking a more personalized approach to pain management while understanding that what may be a painless procedure for one patient may be excruciating for another.

Dr. Chin offers a range of options for her patients, including NSAIDs, lorazepam for anxiety, paracervical blocks, lidocaine jelly and spray, intravenous sedation, and general anesthesia. She also talks to her patients through the procedure and provides guided imagery and meditation.

“We should always make sure we’re prioritizing the patients and providing evidence-based, compassionate, and individualized care,” said Dr. Chin. “Each patient comes to us in a particular context and with a specific set of experiences and history that will make a difference in how we’re best able to take care of them.”

The authors reported no disclosures and no sources of funding. Dr. Chin reported no disclosures.
 

A version of this article first appeared on Medscape.com.

Research on pain management during placement of intrauterine devices (IUD) is lacking, but most studies so far indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) are not effective, according to a poster presented at Pain Week 2024 in Las Vegas.

Roughly 79% of the 14 studies included in the systematic review found NSAIDs — one of the most common drugs clinicians advise patients to take before placement — did not diminish discomfort.

“We’re challenging the current practice of using just NSAIDs as a first-line of treatment,” said Kevin Rowland, PhD, professor and chair of biomedical sciences at Tilman J. Fertitta Family College of Medicine in Houston, who helped conduct the meta-analysis. “We need additional measures.”

Some studies found the drugs offered virtually no improvement for patients, while the biggest drop in pain shown in one study was about 40%. The range of pain levels women reported while using NSAIDs was between 1.8 and 7.3 on the visual analog scale (VAS), with an average score of 4.25.

The review included 10 types of NSAIDs and dosages administered to patients before the procedure. One intramuscular NSAID was included while the remaining were oral. All studies were peer-reviewed, used the VAS pain scale, and were not limited to any specific population.

The findings highlight a longstanding but unresolved problem in reproductive health: An overall lack of effective pain management strategies for gynecologic procedures.

“We went into this having a pretty good idea of what we were going to find because [the lack of NSAID efficacy] has been shown before, it’s been talked about before, and we’re just not listening as a medical community,” said Isabella D. Martingano, an MD candidate at Tilman J. Fertitta Family College of Medicine, who led the review.

The research also points to a lack of robust studies on pain during IUD placement, said Emma Lakey, a coauthor and medical student at Tilman J. Fertitta Family College of Medicine.

“We were only able to review 14 studies, which was enough to go off of, but considering we were looking for trials about pain control for a procedure that helps prevent pregnancy, that’s just not enough research,” Ms. Lakey said.

Discomfort associated with IUD placement ranges from mild to severe, can last for over a week, and includes cramping, bleeding, lightheadedness, nausea, and fainting. Some research suggests that providers may underestimate the level of pain the procedures cause.

“Unfortunately, the pain associated with IUD insertion and removal has been underplayed for a long time and many practitioners in the field likely haven’t counseled patients fully on what the procedure will feel like,” said Jennifer Chin, MD, an ob.gyn. and assistant professor of obstetrics and gynecology at the University of Washington in Seattle.

NSAIDs are not mentioned in the recently expanded guidelines on IUD placement from the US Centers for Disease Control and Prevention (CDC). The CDC recommends lidocaine paracervical blocks, gels, sprays, and creams, plus counseling women about pain ahead of the procedures.

IUDs are one of the most effective forms of birth control, with a failure rate below 1%.

Yet hearing about painful placement keeps many women from seeking out an IUD or replacing an existing device, Dr. Rowland said. The review adds to the body of evidence that current strategies are not working and that more research is needed, he said.

According to Dr. Chin, making IUDs more accessible means taking a more personalized approach to pain management while understanding that what may be a painless procedure for one patient may be excruciating for another.

Dr. Chin offers a range of options for her patients, including NSAIDs, lorazepam for anxiety, paracervical blocks, lidocaine jelly and spray, intravenous sedation, and general anesthesia. She also talks to her patients through the procedure and provides guided imagery and meditation.

“We should always make sure we’re prioritizing the patients and providing evidence-based, compassionate, and individualized care,” said Dr. Chin. “Each patient comes to us in a particular context and with a specific set of experiences and history that will make a difference in how we’re best able to take care of them.”

The authors reported no disclosures and no sources of funding. Dr. Chin reported no disclosures.
 

A version of this article first appeared on Medscape.com.

TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM_2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

• This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM_2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
• Residential exposure to road traffic noise (most exposed facade of the home) and PM_2.5 was estimated using validated models and linked to data from national registers.
• Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

• Each 2.9 µg/m³ increase in the 5-year average exposure to PM_2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
• No significant association was found between exposure to PM_2.5 and infertility in women.
• Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
• Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM_2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM_2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

• This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM_2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
• Residential exposure to road traffic noise (most exposed facade of the home) and PM_2.5 was estimated using validated models and linked to data from national registers.
• Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

• Each 2.9 µg/m³ increase in the 5-year average exposure to PM_2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
• No significant association was found between exposure to PM_2.5 and infertility in women.
• Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
• Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM_2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM_2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

• This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM_2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
• Residential exposure to road traffic noise (most exposed facade of the home) and PM_2.5 was estimated using validated models and linked to data from national registers.
• Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

• Each 2.9 µg/m³ increase in the 5-year average exposure to PM_2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
• No significant association was found between exposure to PM_2.5 and infertility in women.
• Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
• Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM_2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.

The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.

“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”

There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.

The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.

The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.

There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.

The FDA plans a more expansive set of analyses than the earlier study, the agency announced.

“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”

The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.

Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.

The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.

The FDA announcement did not specify a timeframe for the completion of its investigation.

A version of this article first appeared on WebMD.

The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.

The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.

“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”

There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.

The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.

The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.

There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.

The FDA plans a more expansive set of analyses than the earlier study, the agency announced.

“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”

The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.

Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.

The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.

The FDA announcement did not specify a timeframe for the completion of its investigation.

A version of this article first appeared on WebMD.

The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.

The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.

“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”

There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.

The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.

The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.

There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.

The FDA plans a more expansive set of analyses than the earlier study, the agency announced.

“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”

The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.

Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.

The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.

The FDA announcement did not specify a timeframe for the completion of its investigation.

A version of this article first appeared on WebMD.

TOPLINE: 

Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.

METHODOLOGY:

• Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
• Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
• The primary outcome was the identification of LVSD confirmed by echocardiography.
• Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.

TAKEAWAY:

• AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
• The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
• No serious adverse events related to study participation were reported.
• The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.

IN PRACTICE:

“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
 

SOURCE:

This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.

LIMITATIONS:

The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.

DISCLOSURES:

Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.

METHODOLOGY:

• Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
• Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
• The primary outcome was the identification of LVSD confirmed by echocardiography.
• Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.

TAKEAWAY:

• AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
• The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
• No serious adverse events related to study participation were reported.
• The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.

IN PRACTICE:

“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
 

SOURCE:

This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.

LIMITATIONS:

The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.

DISCLOSURES:

Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.

METHODOLOGY:

• Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
• Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
• The primary outcome was the identification of LVSD confirmed by echocardiography.
• Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.

TAKEAWAY:

• AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
• The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
• No serious adverse events related to study participation were reported.
• The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.

IN PRACTICE:

“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
 

SOURCE:

This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.

LIMITATIONS:

The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.

DISCLOSURES:

Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Elinzanetant, the selective antagonist of neurokinin 1 and 3 receptors, led to rapid improvement in the frequency of vasomotor symptoms and significant improvements in the severity of symptoms, sleep disturbances, and menopause-related quality of life in two phase 3 studies. Researchers led by JoAnn V. Pinkerton, MD, from the University of Virginia Health in Charlottesville, reported their findings, which resulted from the randomized OASIS 1 and 2 studies, in JAMA.

“Women experience a variety of symptoms during their menopausal transition, including vasomotor symptoms ... and sleep disturbances, reported by up to 80% and 60%, respectively,” wrote the researchers. “Menopausal symptoms can negatively impact quality of life, reducing the capacity for daily activities and work productivity, and may be associated with long-term negative health outcomes such as cardiovascular events, depressive symptoms, cognitive decline, and other adverse brain outcomes.” The researchers also noted that some therapeutic options are available, including hormone replacement therapy and, in some countries, paroxetine, a selective serotonin reuptake inhibitor.

The Italian Ministry of Health’s menopause website points out that the transition generally occurs between ages 45 and 55 years. This huge hormonal change has consequences for women’s health. Ministry experts explain that diet and hormone replacement therapy (which should be taken under medical supervision) can prevent or counteract these consequences.

“Many women have contraindications, have tolerability issues leading to discontinuation, or prefer not to take these treatments,” wrote Dr. Pinkerton and colleagues, who evaluated the efficacy and tolerability of elinzanetant, a nonhormonal alternative treatment in development. The two double-blind, randomized, phase 3 studies (OASIS 1 and 2) included postmenopausal participants between ages 40 and 65 years with moderate to severe vasomotor symptoms who were treated with elinzanetant (OASIS 1, n = 199; OASIS 2, n = 200) or placebo (OASIS 1, n = 197; OASIS 2, n = 200).

After 4 weeks of treatment, 62.8% of participants in the OASIS 1 study and 62.2% in the OASIS 2 study reported at least a 50% reduction in the frequency of vasomotor symptoms (29.2% and 32.3% in the respective placebo groups). Improvements increased by week 12, with 71.4% and 74.7% of women in the elinzanetant group achieving this reduction (42.0% and 48.3% in the respective placebo groups). Women who took the medication also reported a reduction in the severity of vasomotor symptoms and improvements in sleep and menopause-related quality of life, with no significant tolerability and safety issues. “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate to severe vasomotor symptoms,” the authors concluded.

“With the discovery of nonhormonal treatment options targeting the neurons responsible for vasomotor symptoms, menopause care should advance on this solid scientific footing to benefit affected individuals,” wrote Stephanie S. Faubion, MD, and Chrisandra L. Shufelt, MD, who are affiliated with the Mayo Clinic in Rochester, Minnesota, and Jacksonville, Florida, in an accompanying editorial.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Elinzanetant, the selective antagonist of neurokinin 1 and 3 receptors, led to rapid improvement in the frequency of vasomotor symptoms and significant improvements in the severity of symptoms, sleep disturbances, and menopause-related quality of life in two phase 3 studies. Researchers led by JoAnn V. Pinkerton, MD, from the University of Virginia Health in Charlottesville, reported their findings, which resulted from the randomized OASIS 1 and 2 studies, in JAMA.

“Women experience a variety of symptoms during their menopausal transition, including vasomotor symptoms ... and sleep disturbances, reported by up to 80% and 60%, respectively,” wrote the researchers. “Menopausal symptoms can negatively impact quality of life, reducing the capacity for daily activities and work productivity, and may be associated with long-term negative health outcomes such as cardiovascular events, depressive symptoms, cognitive decline, and other adverse brain outcomes.” The researchers also noted that some therapeutic options are available, including hormone replacement therapy and, in some countries, paroxetine, a selective serotonin reuptake inhibitor.

The Italian Ministry of Health’s menopause website points out that the transition generally occurs between ages 45 and 55 years. This huge hormonal change has consequences for women’s health. Ministry experts explain that diet and hormone replacement therapy (which should be taken under medical supervision) can prevent or counteract these consequences.

“Many women have contraindications, have tolerability issues leading to discontinuation, or prefer not to take these treatments,” wrote Dr. Pinkerton and colleagues, who evaluated the efficacy and tolerability of elinzanetant, a nonhormonal alternative treatment in development. The two double-blind, randomized, phase 3 studies (OASIS 1 and 2) included postmenopausal participants between ages 40 and 65 years with moderate to severe vasomotor symptoms who were treated with elinzanetant (OASIS 1, n = 199; OASIS 2, n = 200) or placebo (OASIS 1, n = 197; OASIS 2, n = 200).

After 4 weeks of treatment, 62.8% of participants in the OASIS 1 study and 62.2% in the OASIS 2 study reported at least a 50% reduction in the frequency of vasomotor symptoms (29.2% and 32.3% in the respective placebo groups). Improvements increased by week 12, with 71.4% and 74.7% of women in the elinzanetant group achieving this reduction (42.0% and 48.3% in the respective placebo groups). Women who took the medication also reported a reduction in the severity of vasomotor symptoms and improvements in sleep and menopause-related quality of life, with no significant tolerability and safety issues. “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate to severe vasomotor symptoms,” the authors concluded.

“With the discovery of nonhormonal treatment options targeting the neurons responsible for vasomotor symptoms, menopause care should advance on this solid scientific footing to benefit affected individuals,” wrote Stephanie S. Faubion, MD, and Chrisandra L. Shufelt, MD, who are affiliated with the Mayo Clinic in Rochester, Minnesota, and Jacksonville, Florida, in an accompanying editorial.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Elinzanetant, the selective antagonist of neurokinin 1 and 3 receptors, led to rapid improvement in the frequency of vasomotor symptoms and significant improvements in the severity of symptoms, sleep disturbances, and menopause-related quality of life in two phase 3 studies. Researchers led by JoAnn V. Pinkerton, MD, from the University of Virginia Health in Charlottesville, reported their findings, which resulted from the randomized OASIS 1 and 2 studies, in JAMA.

“Women experience a variety of symptoms during their menopausal transition, including vasomotor symptoms ... and sleep disturbances, reported by up to 80% and 60%, respectively,” wrote the researchers. “Menopausal symptoms can negatively impact quality of life, reducing the capacity for daily activities and work productivity, and may be associated with long-term negative health outcomes such as cardiovascular events, depressive symptoms, cognitive decline, and other adverse brain outcomes.” The researchers also noted that some therapeutic options are available, including hormone replacement therapy and, in some countries, paroxetine, a selective serotonin reuptake inhibitor.

The Italian Ministry of Health’s menopause website points out that the transition generally occurs between ages 45 and 55 years. This huge hormonal change has consequences for women’s health. Ministry experts explain that diet and hormone replacement therapy (which should be taken under medical supervision) can prevent or counteract these consequences.

“Many women have contraindications, have tolerability issues leading to discontinuation, or prefer not to take these treatments,” wrote Dr. Pinkerton and colleagues, who evaluated the efficacy and tolerability of elinzanetant, a nonhormonal alternative treatment in development. The two double-blind, randomized, phase 3 studies (OASIS 1 and 2) included postmenopausal participants between ages 40 and 65 years with moderate to severe vasomotor symptoms who were treated with elinzanetant (OASIS 1, n = 199; OASIS 2, n = 200) or placebo (OASIS 1, n = 197; OASIS 2, n = 200).

After 4 weeks of treatment, 62.8% of participants in the OASIS 1 study and 62.2% in the OASIS 2 study reported at least a 50% reduction in the frequency of vasomotor symptoms (29.2% and 32.3% in the respective placebo groups). Improvements increased by week 12, with 71.4% and 74.7% of women in the elinzanetant group achieving this reduction (42.0% and 48.3% in the respective placebo groups). Women who took the medication also reported a reduction in the severity of vasomotor symptoms and improvements in sleep and menopause-related quality of life, with no significant tolerability and safety issues. “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate to severe vasomotor symptoms,” the authors concluded.

“With the discovery of nonhormonal treatment options targeting the neurons responsible for vasomotor symptoms, menopause care should advance on this solid scientific footing to benefit affected individuals,” wrote Stephanie S. Faubion, MD, and Chrisandra L. Shufelt, MD, who are affiliated with the Mayo Clinic in Rochester, Minnesota, and Jacksonville, Florida, in an accompanying editorial.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.