Women's Health

The US Department of Veterans Affairs (VA) provides health care to about 600,000 women veterans—half are of child-bearing age. Pregnancies in women veterans using VA care have increased by more than 80% since 2014, from 6950 in 2014 to 12,524 in 2022.

Until recently, VA maternity care coordinators would help women navigate health care from the beginning of pregnancy to 8 weeks postpartum. But “[e]vidence shows that new mothers often need support and care coordination long after 8 weeks postpartum, which is why VA is taking action to support veteran mothers for much longer after they give birth,” said Under Secretary for Health Shereef Elnahal, MD. As of October 1, 2023, the maternity support is now extended to 12 months postpartum.

The full range of maternity care services includes primary care, examinations, tests, ultrasounds, newborn care, and screening for social determinants of health, mental health risk factors, and relationship health and safety. Maternity care coordinators also connect veterans with care after delivery and ensure access to follow-up screenings.

The VA says expanding access to maternity care coordinators is part of the work it’s doing to implement the White House Blueprint for Addressing the Maternal Health Crisis, released last year. The US maternal mortality rate is the highest of any developed nation in the world and more than double the rate of peer countries, the report says. According to the Centers for Disease Control and Prevention (CDC), from 2018 to 2021, the maternal death rate in the US increased from 17.4 to 32.9 per 100,000 live births.

Moreover, “[t]housands of women experience unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to their health,” the White House report says, “such as heart issues, the need for blood transfusions, eclampsia, and blood infections.” Disturbingly, more than 80% of pregnancy-related deaths are preventable. Black and American Indian/Alaska Native women, regardless of income or education, are most likely to experience poor outcomes. Women who live in rural America—where there are many maternal care “deserts”—are about 60% more likely to die, the White House report says.

Quality care requires “care organized for and provided to all women in a manner that maintains their dignity, privacy, and confidentiality, ensures freedom from harm and mistreatment, and enables informed choice and con­tinuous support during labor and childbirth,” say CDC researchers who surveyed 2407 women about their maternity care experiences. One in 5 respondents reported instances of mistreatment. Roughly one-third of Black, Hispanic, and multiracial women reported, for instance, receiving no response to requests for help, being shouted at or scolded, not having their physical privacy protected, and being threatened with withholding treatment or made to accept unwanted treatment.

The White House Blueprint delineates several goals. One is to ”ensure those giving birth are heard and are decisionmakers in accountable systems of care…to improve quality of care, hold providers accountable, and prioritize patient needs and their experience before, during, and after pregnancy.”

The Blueprint advises, for instance, expanding the Hear Her campaign to include culturally relevant materials to raise awareness of urgent maternal warning signs and improve communication between patients and clinicians. It also urges addressing social determinants of maternal health, supporting projects to expand maternal mental health access, increasing access to digital tools, and expanding models that train maternal health care practitoners and students on how to address implicit bias and racism and screen for social determinants of health.

Answering its question of “how we get there,” the Blueprint says, “In working toward this vision, the Biden-Harris Administration has developed, for the first time, a national, whole-of-government strategy to address our maternal health crisis. This strategy starts with the recognition that a concerted national effort to solve the crisis must begin with clear leadership and action from across the federal government. Addressing the maternal health crisis is not limited to a single health care policy or federal agency but should include experts across the government, including: the US Departments of Health and Human Services, Agriculture, Defense, Housing and Urban Development, Labor, Justice, Environmental Protection Agency, Office of Personnel Management, as well as the VA.

“The Biden-Harris Administration believes that only through this whole-of-government approach—one that considers the entirety of a person’s health and experiences over the course of their full life—will we finally be able to make real progress in tackling this longstanding challenge.”

The US Department of Veterans Affairs (VA) provides health care to about 600,000 women veterans—half are of child-bearing age. Pregnancies in women veterans using VA care have increased by more than 80% since 2014, from 6950 in 2014 to 12,524 in 2022.

Until recently, VA maternity care coordinators would help women navigate health care from the beginning of pregnancy to 8 weeks postpartum. But “[e]vidence shows that new mothers often need support and care coordination long after 8 weeks postpartum, which is why VA is taking action to support veteran mothers for much longer after they give birth,” said Under Secretary for Health Shereef Elnahal, MD. As of October 1, 2023, the maternity support is now extended to 12 months postpartum.

The full range of maternity care services includes primary care, examinations, tests, ultrasounds, newborn care, and screening for social determinants of health, mental health risk factors, and relationship health and safety. Maternity care coordinators also connect veterans with care after delivery and ensure access to follow-up screenings.

The VA says expanding access to maternity care coordinators is part of the work it’s doing to implement the White House Blueprint for Addressing the Maternal Health Crisis, released last year. The US maternal mortality rate is the highest of any developed nation in the world and more than double the rate of peer countries, the report says. According to the Centers for Disease Control and Prevention (CDC), from 2018 to 2021, the maternal death rate in the US increased from 17.4 to 32.9 per 100,000 live births.

Moreover, “[t]housands of women experience unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to their health,” the White House report says, “such as heart issues, the need for blood transfusions, eclampsia, and blood infections.” Disturbingly, more than 80% of pregnancy-related deaths are preventable. Black and American Indian/Alaska Native women, regardless of income or education, are most likely to experience poor outcomes. Women who live in rural America—where there are many maternal care “deserts”—are about 60% more likely to die, the White House report says.

Quality care requires “care organized for and provided to all women in a manner that maintains their dignity, privacy, and confidentiality, ensures freedom from harm and mistreatment, and enables informed choice and con­tinuous support during labor and childbirth,” say CDC researchers who surveyed 2407 women about their maternity care experiences. One in 5 respondents reported instances of mistreatment. Roughly one-third of Black, Hispanic, and multiracial women reported, for instance, receiving no response to requests for help, being shouted at or scolded, not having their physical privacy protected, and being threatened with withholding treatment or made to accept unwanted treatment.

The White House Blueprint delineates several goals. One is to ”ensure those giving birth are heard and are decisionmakers in accountable systems of care…to improve quality of care, hold providers accountable, and prioritize patient needs and their experience before, during, and after pregnancy.”

The Blueprint advises, for instance, expanding the Hear Her campaign to include culturally relevant materials to raise awareness of urgent maternal warning signs and improve communication between patients and clinicians. It also urges addressing social determinants of maternal health, supporting projects to expand maternal mental health access, increasing access to digital tools, and expanding models that train maternal health care practitoners and students on how to address implicit bias and racism and screen for social determinants of health.

Answering its question of “how we get there,” the Blueprint says, “In working toward this vision, the Biden-Harris Administration has developed, for the first time, a national, whole-of-government strategy to address our maternal health crisis. This strategy starts with the recognition that a concerted national effort to solve the crisis must begin with clear leadership and action from across the federal government. Addressing the maternal health crisis is not limited to a single health care policy or federal agency but should include experts across the government, including: the US Departments of Health and Human Services, Agriculture, Defense, Housing and Urban Development, Labor, Justice, Environmental Protection Agency, Office of Personnel Management, as well as the VA.

“The Biden-Harris Administration believes that only through this whole-of-government approach—one that considers the entirety of a person’s health and experiences over the course of their full life—will we finally be able to make real progress in tackling this longstanding challenge.”

The US Department of Veterans Affairs (VA) provides health care to about 600,000 women veterans—half are of child-bearing age. Pregnancies in women veterans using VA care have increased by more than 80% since 2014, from 6950 in 2014 to 12,524 in 2022.

Until recently, VA maternity care coordinators would help women navigate health care from the beginning of pregnancy to 8 weeks postpartum. But “[e]vidence shows that new mothers often need support and care coordination long after 8 weeks postpartum, which is why VA is taking action to support veteran mothers for much longer after they give birth,” said Under Secretary for Health Shereef Elnahal, MD. As of October 1, 2023, the maternity support is now extended to 12 months postpartum.

The full range of maternity care services includes primary care, examinations, tests, ultrasounds, newborn care, and screening for social determinants of health, mental health risk factors, and relationship health and safety. Maternity care coordinators also connect veterans with care after delivery and ensure access to follow-up screenings.

The VA says expanding access to maternity care coordinators is part of the work it’s doing to implement the White House Blueprint for Addressing the Maternal Health Crisis, released last year. The US maternal mortality rate is the highest of any developed nation in the world and more than double the rate of peer countries, the report says. According to the Centers for Disease Control and Prevention (CDC), from 2018 to 2021, the maternal death rate in the US increased from 17.4 to 32.9 per 100,000 live births.

Moreover, “[t]housands of women experience unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to their health,” the White House report says, “such as heart issues, the need for blood transfusions, eclampsia, and blood infections.” Disturbingly, more than 80% of pregnancy-related deaths are preventable. Black and American Indian/Alaska Native women, regardless of income or education, are most likely to experience poor outcomes. Women who live in rural America—where there are many maternal care “deserts”—are about 60% more likely to die, the White House report says.

Quality care requires “care organized for and provided to all women in a manner that maintains their dignity, privacy, and confidentiality, ensures freedom from harm and mistreatment, and enables informed choice and con­tinuous support during labor and childbirth,” say CDC researchers who surveyed 2407 women about their maternity care experiences. One in 5 respondents reported instances of mistreatment. Roughly one-third of Black, Hispanic, and multiracial women reported, for instance, receiving no response to requests for help, being shouted at or scolded, not having their physical privacy protected, and being threatened with withholding treatment or made to accept unwanted treatment.

The White House Blueprint delineates several goals. One is to ”ensure those giving birth are heard and are decisionmakers in accountable systems of care…to improve quality of care, hold providers accountable, and prioritize patient needs and their experience before, during, and after pregnancy.”

The Blueprint advises, for instance, expanding the Hear Her campaign to include culturally relevant materials to raise awareness of urgent maternal warning signs and improve communication between patients and clinicians. It also urges addressing social determinants of maternal health, supporting projects to expand maternal mental health access, increasing access to digital tools, and expanding models that train maternal health care practitoners and students on how to address implicit bias and racism and screen for social determinants of health.

Answering its question of “how we get there,” the Blueprint says, “In working toward this vision, the Biden-Harris Administration has developed, for the first time, a national, whole-of-government strategy to address our maternal health crisis. This strategy starts with the recognition that a concerted national effort to solve the crisis must begin with clear leadership and action from across the federal government. Addressing the maternal health crisis is not limited to a single health care policy or federal agency but should include experts across the government, including: the US Departments of Health and Human Services, Agriculture, Defense, Housing and Urban Development, Labor, Justice, Environmental Protection Agency, Office of Personnel Management, as well as the VA.

“The Biden-Harris Administration believes that only through this whole-of-government approach—one that considers the entirety of a person’s health and experiences over the course of their full life—will we finally be able to make real progress in tackling this longstanding challenge.”

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

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

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

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

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

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

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

According to research results published in the American Journal of Obstetrics and Gynecology, consuming a primarily plant-based diet is associated with a lower risk of developing hypertensive disorders of pregnancy.
 

The prospective cohort study followed 11,459 women older than 18 years and evaluated their diet from the beginning using a validated questionnaire about the frequency and quality of plant-based foods. The participants had taken part in the Nurses’ Health Study II (1991-2009). From responses on the questionnaire, the investigators calculated the plant-based diet index (PDI) even among participants with an omnivorous diet. A higher score indicated greater adherence to the PDI.

“We wanted to know how one’s diet leading up to pregnancy influences the pregnancy, so we monitored women for virtually their entire reproductive life – almost 20 years – and gained an awareness of their typical diet before pregnancy,” study author Jorge E. Chavarro, MD, ScD, told this news organization. Dr. Chavarro is a professor of nutrition, epidemiology, and medicine at Harvard Medical School, Boston, and Harvard University’s School of Public Health in Cambridge, Mass. He researches how nutrition and lifestyle influence reproductive health and overall lifelong health in women.

Analysis of the data from the Nurses’ Health Study II revealed that as the proportion of animal products in diets decreased and the proportion of plant-based products increased, the risk of women experiencing hypertensive disorders of pregnancy decreased as well. Women in the highest PDI quintile had a significantly lower risk of hypertensive disorders of pregnancy, in comparison with those in the lowest quintile (relative risk, 0.76). This association was slightly stronger for pregnancy-related hypertension (RR, 0.77) than for preeclampsia (RR, 0.80).

Women in the highest PDI quintile had a 24% lower risk of hypertensive disorders of pregnancy than those in the lowest quintile; the risk of pregnancy-related hypertension decreased in a linear fashion as PDI increased, while the relationship of PDI to preeclampsia was restricted to women in the quintile with the highest adherence.

“It was clearer for pregnancy-related hypertension than for preeclampsia, but a diet made up primarily of plant-based foods seemed to be protective for both,” said Dr. Chavarro. He added that in addition to the problems these conditions cause during pregnancy, both increase the risk of subsequently developing other chronic diseases. “Could it be that modifiable lifestyle factors before and during pregnancy may not only help reduce problems during gestation but also prevent women’s health problems years later? That was the general motivation for this study.”

Mercedes Sotos-Prieto, PhD, a researcher at the Autonomous University of Madrid and an associate professor at Harvard University’s School of Public Health, told this news organization that the study’s methodology was very robust and that the investigators utilized appropriate statistical techniques for the analysis. She highlighted the fact that they used a validated food frequency questionnaire. She believes the study is also important because of the population group it focused on. “There has always been greater resistance when it comes to the diet of pregnant women, and the same is true for older adults. But we have seen that this type of diet, if it’s a quality diet, may be associated with health benefits.” She did not participate in the study.

Dr. Sotos-Prieto has a doctorate in nutritional epidemiology and public health. She works with large epidemiologic cohorts, such as the cohort of American nurses on which this study was based, and ENRICA, a cohort that is representative of the Spanish population and the population of older adults. She is the author of other studies that, like this one, found an association between a plant-based diet and a lower risk of frailty, both in the study involving American nurses and in a study involving a cohort of individuals aged 60 years or older in Spain (ENRICA-1).

Dr. Sotos-Prieto is also principal investigator on a project assessing the risk of cardiovascular disease based on modifiable lifestyles. For this project, the researchers created a tool, the healthy heart test, that can be used to evaluate diet quality “in 5 minutes, because we all know that doctors don’t have any time.” She thinks this test could be implemented in clinical practice to identify lifestyle behaviors that can be improved, such as by replacing refined cereals with whole grains or increasing legume consumption.
 

Tomatoes and French fries

The greatest benefit of a plant-based diet comes from the diet overall, not from any single food item. That said, these studies use a scoring system to reflect which items are healthy and which are not.

Diet was assessed every 4 years, starting in 1991, using a semiquantitative food frequency questionnaire that recorded the consumption of 131 foods and drinks during the previous year. The researchers determined the average frequency with which participants consumed each food. Eighteen food groups were sorted into three categories: healthy plant-based foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea, and coffee), unhealthy plant-based foods (fruit juices, refined grains, potatoes, sugary drinks, sweets, and desserts), and animal-based foods (dairy, eggs, fish or shellfish, meat, and various foods of animal origin).

Healthy plant-based foods were given positive scores, while less healthy plant-based foods and the animal-based food groups were given negative scores. The consumption of each food group was classified into PDI using quintiles.

Women in the highest PDI quintile had a significantly lower risk for hypertensive disorders of pregnancy, compared with women in the lowest quintile. There was a negative dose-response relationship between PDI and risk of the disease. “A vegetarian diet isn’t necessarily healthier than a nonvegetarian diet if it’s made up of superfluous foods like French fries and soft drinks,” said Dr. Sotos-Prieto. “The difference lies in the quality of the plant-based foods. That’s what makes the difference between a healthy and an unhealthy diet.”
 

Give up meat?

Dr. Chavarro said that removing meat from his dinner menu 22 years ago was one of the hardest things he ever did. “Now, it’s no problem,” he said. But he understands that there are people for whom changing the diet by replacing animal products with nonanimal products is difficult. But meat need not be entirely abandoned.

“The women in the highest quintile aren’t necessarily vegetarian or vegan, but they consume much fewer animal-based foods than the others,” he noted. He added that vegetarian or vegan diets are not incompatible with a healthy pregnancy. “All vegans know how to get vitamin B12 from supplements.”
 

Diet or weight loss?

Much of the benefit observed in the study appears to be related to better weight control. The body mass index between dietary assessment and pregnancy accounted for 39% of the relationship between PDI and hypertensive disorders of pregnancy and 48% of the relationship between PDI and pregnancy-related hypertension.

“Part of the association seems to be explained by better weight control over long periods,” explained Dr. Chavarro. Women who adopted diets with more plant-based foods gained weight more slowly than those who consumed more animal-based foods. “They are different in terms of their weight trajectory over many years. So, part of the association that we observe is related to better long-term weight control. But the other half of the association is attributable to the diet itself and not necessarily to weight.” The authors suggest mechanisms of action such as endothelial dysfunction, inflammation, or blood pressure before pregnancy to explain the association.

Dr. Sotos-Prieto believes that this point is “extremely relevant.” In her opinion, it reveals that controlling weight at the start of pregnancy is important for pregnant women. Weight control may also improve other factors, like gestational diabetes. “I think preventive measures should focus on that. These results show that interventions are needed to increase the likelihood of going into pregnancy with an appropriate weight. And this includes modifying diet.”
 

Generalizable results?

More than 90% of the participants in the Nurses’ Health Study were White, not Hispanic. Can the results be extrapolated to other populations? “The answer: The study needs to be repeated in other populations,” said Dr. Chavarro, “and that’s going to take time. But even without that information, I think we can use this study to inform other populations, regardless of ethnicity.”

Dr. Sotos-Prieto admitted that this hypothesis has not yet been tested in the Spanish population, but she is the author of a similar study that followed nearly 12,000 Spanish adults for a decade using the same PDI. In this study, every 10-point increase in PDI was associated with a 14% lower risk of mortality from any cause (hazard ratio, 0.86) and a 37% lower risk of death from cardiovascular disease (HR, 0.63). She also believes that the recommendations derived from the study could be generalized to other populations “as long as each country’s culture is taken into account, to see how it can be culturally adapted. If it’s a population that consumes a lot of refined cereals, for example, make small changes to whole grains.”
 

Weighing the evidence

The study has strengths and limitations, owing to its methodology, and Dr. Chavarro himself recognizes that “in terms of hypertensive disorders of pregnancy specifically, this won’t be the last word.” But there is a pressing need to find answers.

The American College of Obstetricians and Gynecologists and the World Health Organization encourage women to follow healthy diets before and during pregnancy. But they provide little guidance on what constitutes a healthy diet when it comes to minimizing the risks of adverse pregnancy outcomes. “They are quite ambiguous and vague,” said Dr. Chavarro.

These new findings suggest that plant-based diets may be one such strategy, particularly because some evidence was found that these diets may be beneficial for women older than 35 years, who are considered a high-risk group.

“There are certainly many ways to eat healthily, but if we think about these pregnancy complications that can have serious consequences for the mother and the fetus, we might consider this as a healthy diet option,” Dr. Chavarro noted.

But is the evidence robust enough to recommend that patients make changes? “Ideally, there will be more studies,” stated Dr. Chavarro. “There are two ways to understand the problem. One is not making recommendations until you have three controlled clinical trials, which, even with the willingness and funding to do so, will take 15-20 years. But if we have to provide the best available information to those who need it today, I think these are solid results for guiding behavior.

“It’s always better if we can make decisions based on solid, incontrovertible information. But it’s not always available, and you must learn to live in both worlds and make decisions with uncertainties,” he concluded.

Dr. Sotos-Prieto and Dr. Chavarro have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish Edition. A version of this article first appeared on Medscape.com.

According to research results published in the American Journal of Obstetrics and Gynecology, consuming a primarily plant-based diet is associated with a lower risk of developing hypertensive disorders of pregnancy.
 

The prospective cohort study followed 11,459 women older than 18 years and evaluated their diet from the beginning using a validated questionnaire about the frequency and quality of plant-based foods. The participants had taken part in the Nurses’ Health Study II (1991-2009). From responses on the questionnaire, the investigators calculated the plant-based diet index (PDI) even among participants with an omnivorous diet. A higher score indicated greater adherence to the PDI.

“We wanted to know how one’s diet leading up to pregnancy influences the pregnancy, so we monitored women for virtually their entire reproductive life – almost 20 years – and gained an awareness of their typical diet before pregnancy,” study author Jorge E. Chavarro, MD, ScD, told this news organization. Dr. Chavarro is a professor of nutrition, epidemiology, and medicine at Harvard Medical School, Boston, and Harvard University’s School of Public Health in Cambridge, Mass. He researches how nutrition and lifestyle influence reproductive health and overall lifelong health in women.

Analysis of the data from the Nurses’ Health Study II revealed that as the proportion of animal products in diets decreased and the proportion of plant-based products increased, the risk of women experiencing hypertensive disorders of pregnancy decreased as well. Women in the highest PDI quintile had a significantly lower risk of hypertensive disorders of pregnancy, in comparison with those in the lowest quintile (relative risk, 0.76). This association was slightly stronger for pregnancy-related hypertension (RR, 0.77) than for preeclampsia (RR, 0.80).

Women in the highest PDI quintile had a 24% lower risk of hypertensive disorders of pregnancy than those in the lowest quintile; the risk of pregnancy-related hypertension decreased in a linear fashion as PDI increased, while the relationship of PDI to preeclampsia was restricted to women in the quintile with the highest adherence.

“It was clearer for pregnancy-related hypertension than for preeclampsia, but a diet made up primarily of plant-based foods seemed to be protective for both,” said Dr. Chavarro. He added that in addition to the problems these conditions cause during pregnancy, both increase the risk of subsequently developing other chronic diseases. “Could it be that modifiable lifestyle factors before and during pregnancy may not only help reduce problems during gestation but also prevent women’s health problems years later? That was the general motivation for this study.”

Mercedes Sotos-Prieto, PhD, a researcher at the Autonomous University of Madrid and an associate professor at Harvard University’s School of Public Health, told this news organization that the study’s methodology was very robust and that the investigators utilized appropriate statistical techniques for the analysis. She highlighted the fact that they used a validated food frequency questionnaire. She believes the study is also important because of the population group it focused on. “There has always been greater resistance when it comes to the diet of pregnant women, and the same is true for older adults. But we have seen that this type of diet, if it’s a quality diet, may be associated with health benefits.” She did not participate in the study.

Dr. Sotos-Prieto has a doctorate in nutritional epidemiology and public health. She works with large epidemiologic cohorts, such as the cohort of American nurses on which this study was based, and ENRICA, a cohort that is representative of the Spanish population and the population of older adults. She is the author of other studies that, like this one, found an association between a plant-based diet and a lower risk of frailty, both in the study involving American nurses and in a study involving a cohort of individuals aged 60 years or older in Spain (ENRICA-1).

Dr. Sotos-Prieto is also principal investigator on a project assessing the risk of cardiovascular disease based on modifiable lifestyles. For this project, the researchers created a tool, the healthy heart test, that can be used to evaluate diet quality “in 5 minutes, because we all know that doctors don’t have any time.” She thinks this test could be implemented in clinical practice to identify lifestyle behaviors that can be improved, such as by replacing refined cereals with whole grains or increasing legume consumption.
 

Tomatoes and French fries

The greatest benefit of a plant-based diet comes from the diet overall, not from any single food item. That said, these studies use a scoring system to reflect which items are healthy and which are not.

Diet was assessed every 4 years, starting in 1991, using a semiquantitative food frequency questionnaire that recorded the consumption of 131 foods and drinks during the previous year. The researchers determined the average frequency with which participants consumed each food. Eighteen food groups were sorted into three categories: healthy plant-based foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea, and coffee), unhealthy plant-based foods (fruit juices, refined grains, potatoes, sugary drinks, sweets, and desserts), and animal-based foods (dairy, eggs, fish or shellfish, meat, and various foods of animal origin).

Healthy plant-based foods were given positive scores, while less healthy plant-based foods and the animal-based food groups were given negative scores. The consumption of each food group was classified into PDI using quintiles.

Women in the highest PDI quintile had a significantly lower risk for hypertensive disorders of pregnancy, compared with women in the lowest quintile. There was a negative dose-response relationship between PDI and risk of the disease. “A vegetarian diet isn’t necessarily healthier than a nonvegetarian diet if it’s made up of superfluous foods like French fries and soft drinks,” said Dr. Sotos-Prieto. “The difference lies in the quality of the plant-based foods. That’s what makes the difference between a healthy and an unhealthy diet.”
 

Give up meat?

Dr. Chavarro said that removing meat from his dinner menu 22 years ago was one of the hardest things he ever did. “Now, it’s no problem,” he said. But he understands that there are people for whom changing the diet by replacing animal products with nonanimal products is difficult. But meat need not be entirely abandoned.

“The women in the highest quintile aren’t necessarily vegetarian or vegan, but they consume much fewer animal-based foods than the others,” he noted. He added that vegetarian or vegan diets are not incompatible with a healthy pregnancy. “All vegans know how to get vitamin B12 from supplements.”
 

Diet or weight loss?

Much of the benefit observed in the study appears to be related to better weight control. The body mass index between dietary assessment and pregnancy accounted for 39% of the relationship between PDI and hypertensive disorders of pregnancy and 48% of the relationship between PDI and pregnancy-related hypertension.

“Part of the association seems to be explained by better weight control over long periods,” explained Dr. Chavarro. Women who adopted diets with more plant-based foods gained weight more slowly than those who consumed more animal-based foods. “They are different in terms of their weight trajectory over many years. So, part of the association that we observe is related to better long-term weight control. But the other half of the association is attributable to the diet itself and not necessarily to weight.” The authors suggest mechanisms of action such as endothelial dysfunction, inflammation, or blood pressure before pregnancy to explain the association.

Dr. Sotos-Prieto believes that this point is “extremely relevant.” In her opinion, it reveals that controlling weight at the start of pregnancy is important for pregnant women. Weight control may also improve other factors, like gestational diabetes. “I think preventive measures should focus on that. These results show that interventions are needed to increase the likelihood of going into pregnancy with an appropriate weight. And this includes modifying diet.”
 

Generalizable results?

More than 90% of the participants in the Nurses’ Health Study were White, not Hispanic. Can the results be extrapolated to other populations? “The answer: The study needs to be repeated in other populations,” said Dr. Chavarro, “and that’s going to take time. But even without that information, I think we can use this study to inform other populations, regardless of ethnicity.”

Dr. Sotos-Prieto admitted that this hypothesis has not yet been tested in the Spanish population, but she is the author of a similar study that followed nearly 12,000 Spanish adults for a decade using the same PDI. In this study, every 10-point increase in PDI was associated with a 14% lower risk of mortality from any cause (hazard ratio, 0.86) and a 37% lower risk of death from cardiovascular disease (HR, 0.63). She also believes that the recommendations derived from the study could be generalized to other populations “as long as each country’s culture is taken into account, to see how it can be culturally adapted. If it’s a population that consumes a lot of refined cereals, for example, make small changes to whole grains.”
 

Weighing the evidence

The study has strengths and limitations, owing to its methodology, and Dr. Chavarro himself recognizes that “in terms of hypertensive disorders of pregnancy specifically, this won’t be the last word.” But there is a pressing need to find answers.

The American College of Obstetricians and Gynecologists and the World Health Organization encourage women to follow healthy diets before and during pregnancy. But they provide little guidance on what constitutes a healthy diet when it comes to minimizing the risks of adverse pregnancy outcomes. “They are quite ambiguous and vague,” said Dr. Chavarro.

These new findings suggest that plant-based diets may be one such strategy, particularly because some evidence was found that these diets may be beneficial for women older than 35 years, who are considered a high-risk group.

“There are certainly many ways to eat healthily, but if we think about these pregnancy complications that can have serious consequences for the mother and the fetus, we might consider this as a healthy diet option,” Dr. Chavarro noted.

But is the evidence robust enough to recommend that patients make changes? “Ideally, there will be more studies,” stated Dr. Chavarro. “There are two ways to understand the problem. One is not making recommendations until you have three controlled clinical trials, which, even with the willingness and funding to do so, will take 15-20 years. But if we have to provide the best available information to those who need it today, I think these are solid results for guiding behavior.

“It’s always better if we can make decisions based on solid, incontrovertible information. But it’s not always available, and you must learn to live in both worlds and make decisions with uncertainties,” he concluded.

Dr. Sotos-Prieto and Dr. Chavarro have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish Edition. A version of this article first appeared on Medscape.com.

According to research results published in the American Journal of Obstetrics and Gynecology, consuming a primarily plant-based diet is associated with a lower risk of developing hypertensive disorders of pregnancy.
 

The prospective cohort study followed 11,459 women older than 18 years and evaluated their diet from the beginning using a validated questionnaire about the frequency and quality of plant-based foods. The participants had taken part in the Nurses’ Health Study II (1991-2009). From responses on the questionnaire, the investigators calculated the plant-based diet index (PDI) even among participants with an omnivorous diet. A higher score indicated greater adherence to the PDI.

“We wanted to know how one’s diet leading up to pregnancy influences the pregnancy, so we monitored women for virtually their entire reproductive life – almost 20 years – and gained an awareness of their typical diet before pregnancy,” study author Jorge E. Chavarro, MD, ScD, told this news organization. Dr. Chavarro is a professor of nutrition, epidemiology, and medicine at Harvard Medical School, Boston, and Harvard University’s School of Public Health in Cambridge, Mass. He researches how nutrition and lifestyle influence reproductive health and overall lifelong health in women.

Analysis of the data from the Nurses’ Health Study II revealed that as the proportion of animal products in diets decreased and the proportion of plant-based products increased, the risk of women experiencing hypertensive disorders of pregnancy decreased as well. Women in the highest PDI quintile had a significantly lower risk of hypertensive disorders of pregnancy, in comparison with those in the lowest quintile (relative risk, 0.76). This association was slightly stronger for pregnancy-related hypertension (RR, 0.77) than for preeclampsia (RR, 0.80).

Women in the highest PDI quintile had a 24% lower risk of hypertensive disorders of pregnancy than those in the lowest quintile; the risk of pregnancy-related hypertension decreased in a linear fashion as PDI increased, while the relationship of PDI to preeclampsia was restricted to women in the quintile with the highest adherence.

“It was clearer for pregnancy-related hypertension than for preeclampsia, but a diet made up primarily of plant-based foods seemed to be protective for both,” said Dr. Chavarro. He added that in addition to the problems these conditions cause during pregnancy, both increase the risk of subsequently developing other chronic diseases. “Could it be that modifiable lifestyle factors before and during pregnancy may not only help reduce problems during gestation but also prevent women’s health problems years later? That was the general motivation for this study.”

Mercedes Sotos-Prieto, PhD, a researcher at the Autonomous University of Madrid and an associate professor at Harvard University’s School of Public Health, told this news organization that the study’s methodology was very robust and that the investigators utilized appropriate statistical techniques for the analysis. She highlighted the fact that they used a validated food frequency questionnaire. She believes the study is also important because of the population group it focused on. “There has always been greater resistance when it comes to the diet of pregnant women, and the same is true for older adults. But we have seen that this type of diet, if it’s a quality diet, may be associated with health benefits.” She did not participate in the study.

Dr. Sotos-Prieto has a doctorate in nutritional epidemiology and public health. She works with large epidemiologic cohorts, such as the cohort of American nurses on which this study was based, and ENRICA, a cohort that is representative of the Spanish population and the population of older adults. She is the author of other studies that, like this one, found an association between a plant-based diet and a lower risk of frailty, both in the study involving American nurses and in a study involving a cohort of individuals aged 60 years or older in Spain (ENRICA-1).

Dr. Sotos-Prieto is also principal investigator on a project assessing the risk of cardiovascular disease based on modifiable lifestyles. For this project, the researchers created a tool, the healthy heart test, that can be used to evaluate diet quality “in 5 minutes, because we all know that doctors don’t have any time.” She thinks this test could be implemented in clinical practice to identify lifestyle behaviors that can be improved, such as by replacing refined cereals with whole grains or increasing legume consumption.
 

Tomatoes and French fries

The greatest benefit of a plant-based diet comes from the diet overall, not from any single food item. That said, these studies use a scoring system to reflect which items are healthy and which are not.

Diet was assessed every 4 years, starting in 1991, using a semiquantitative food frequency questionnaire that recorded the consumption of 131 foods and drinks during the previous year. The researchers determined the average frequency with which participants consumed each food. Eighteen food groups were sorted into three categories: healthy plant-based foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea, and coffee), unhealthy plant-based foods (fruit juices, refined grains, potatoes, sugary drinks, sweets, and desserts), and animal-based foods (dairy, eggs, fish or shellfish, meat, and various foods of animal origin).

Healthy plant-based foods were given positive scores, while less healthy plant-based foods and the animal-based food groups were given negative scores. The consumption of each food group was classified into PDI using quintiles.

Women in the highest PDI quintile had a significantly lower risk for hypertensive disorders of pregnancy, compared with women in the lowest quintile. There was a negative dose-response relationship between PDI and risk of the disease. “A vegetarian diet isn’t necessarily healthier than a nonvegetarian diet if it’s made up of superfluous foods like French fries and soft drinks,” said Dr. Sotos-Prieto. “The difference lies in the quality of the plant-based foods. That’s what makes the difference between a healthy and an unhealthy diet.”
 

Give up meat?

Dr. Chavarro said that removing meat from his dinner menu 22 years ago was one of the hardest things he ever did. “Now, it’s no problem,” he said. But he understands that there are people for whom changing the diet by replacing animal products with nonanimal products is difficult. But meat need not be entirely abandoned.

“The women in the highest quintile aren’t necessarily vegetarian or vegan, but they consume much fewer animal-based foods than the others,” he noted. He added that vegetarian or vegan diets are not incompatible with a healthy pregnancy. “All vegans know how to get vitamin B12 from supplements.”
 

Diet or weight loss?

Much of the benefit observed in the study appears to be related to better weight control. The body mass index between dietary assessment and pregnancy accounted for 39% of the relationship between PDI and hypertensive disorders of pregnancy and 48% of the relationship between PDI and pregnancy-related hypertension.

“Part of the association seems to be explained by better weight control over long periods,” explained Dr. Chavarro. Women who adopted diets with more plant-based foods gained weight more slowly than those who consumed more animal-based foods. “They are different in terms of their weight trajectory over many years. So, part of the association that we observe is related to better long-term weight control. But the other half of the association is attributable to the diet itself and not necessarily to weight.” The authors suggest mechanisms of action such as endothelial dysfunction, inflammation, or blood pressure before pregnancy to explain the association.

Dr. Sotos-Prieto believes that this point is “extremely relevant.” In her opinion, it reveals that controlling weight at the start of pregnancy is important for pregnant women. Weight control may also improve other factors, like gestational diabetes. “I think preventive measures should focus on that. These results show that interventions are needed to increase the likelihood of going into pregnancy with an appropriate weight. And this includes modifying diet.”
 

Generalizable results?

More than 90% of the participants in the Nurses’ Health Study were White, not Hispanic. Can the results be extrapolated to other populations? “The answer: The study needs to be repeated in other populations,” said Dr. Chavarro, “and that’s going to take time. But even without that information, I think we can use this study to inform other populations, regardless of ethnicity.”

Dr. Sotos-Prieto admitted that this hypothesis has not yet been tested in the Spanish population, but she is the author of a similar study that followed nearly 12,000 Spanish adults for a decade using the same PDI. In this study, every 10-point increase in PDI was associated with a 14% lower risk of mortality from any cause (hazard ratio, 0.86) and a 37% lower risk of death from cardiovascular disease (HR, 0.63). She also believes that the recommendations derived from the study could be generalized to other populations “as long as each country’s culture is taken into account, to see how it can be culturally adapted. If it’s a population that consumes a lot of refined cereals, for example, make small changes to whole grains.”
 

Weighing the evidence

The study has strengths and limitations, owing to its methodology, and Dr. Chavarro himself recognizes that “in terms of hypertensive disorders of pregnancy specifically, this won’t be the last word.” But there is a pressing need to find answers.

The American College of Obstetricians and Gynecologists and the World Health Organization encourage women to follow healthy diets before and during pregnancy. But they provide little guidance on what constitutes a healthy diet when it comes to minimizing the risks of adverse pregnancy outcomes. “They are quite ambiguous and vague,” said Dr. Chavarro.

These new findings suggest that plant-based diets may be one such strategy, particularly because some evidence was found that these diets may be beneficial for women older than 35 years, who are considered a high-risk group.

“There are certainly many ways to eat healthily, but if we think about these pregnancy complications that can have serious consequences for the mother and the fetus, we might consider this as a healthy diet option,” Dr. Chavarro noted.

But is the evidence robust enough to recommend that patients make changes? “Ideally, there will be more studies,” stated Dr. Chavarro. “There are two ways to understand the problem. One is not making recommendations until you have three controlled clinical trials, which, even with the willingness and funding to do so, will take 15-20 years. But if we have to provide the best available information to those who need it today, I think these are solid results for guiding behavior.

“It’s always better if we can make decisions based on solid, incontrovertible information. But it’s not always available, and you must learn to live in both worlds and make decisions with uncertainties,” he concluded.

Dr. Sotos-Prieto and Dr. Chavarro have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish Edition. A version of this article first appeared on Medscape.com.

PHILADELPHIA – About two in five perimenopausal or postmenopausal women have ever used cannabis in any form, but 10% have used it in the past month, according to cross-sectional survey results presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

Though most women reported using cannabis for recreational reasons, 13% used it only for medical reasons, most often for chronic pain, anxiety, sleep, and stress.

“These findings highlight the importance of recognizing and discussing cannabis use in the health care setting, and the need for additional research to evaluate the potential harms and/or benefits of use in this vulnerable population,” Carolyn J. Gibson, PhD, MPH, a staff psychologist in women’s health at the San Francisco VA Health Care System and an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, told attendees.

As cannabis has become more accessible, with its use legalized in 38 states and Washington, D.C., the proportion of U.S. adults using it has doubled over about a decade, from 6% in 2007 to 12% in 2019, Dr. Gibson said. Further, women aged 50 and older are among the fastest-growing groups of users of cannabis, and it’s being increasingly used – and marketed – for treating menopause-related and aging-related symptoms, including insomnia, anxiety, and chronic pain, she said.

“With these decisions to use cannabis, medically or for these other purposes, there’s this perception that it’s harmless,” Dr. Gibson said. Yet potential health risks associated with cannabis include the usual health effects associated with any kind of smoking as well as dependence in those who use it more frequently and/or develop a tolerance for it. She noted that average THC potency has increased over time, and acute risks for using cannabis with high levels of THC – at least 15% or at least 10 mg – can include anxiety/panic, confusion, disturbing/intrusive thoughts, psychosis, and effects on coordination and cognition. She also acknowledged, however, that most of the data available on risks come from studies of men and younger adults rather than older women.

Given the growing normalization of cannabis use, Dr. Gibson’s team sought to better understand prevalence of use as well as types of use and reasons for use in perimenopasual and postmenopausal women. They analyzed data from a cross-sectional survey of women and gender-diverse members, aged 45-64, of Ipsos KnowledgePanel, an online panel with more than 60,000 participating members in the United States.

All the respondents identified themselves as female at birth and had not used gender-affirming therapy or undergone gender-affirming surgery. The survey included questions on sociodemographics, menopause status, frequency of cannabis use, types of cannabis used, reasons for using cannabis, and use of cannabis in the previous 30 days. The 5,174 respondents were an average 55 years old and predominantly non-Hispanic white (63%), with 13% non-Hispanic Black and 16% Hispanic. Two-thirds of the women reported working full- or part-time (67%) and two-thirds were postmenopausal (68%), with 64% reporting experiencing menopause symptoms.

About two in five respondents (42%) had ever used cannabis in any form, most often smoking it (83%) or consuming edibles (51%). Among those who had ever used it, 30% reported having smoked it daily or nearly daily for at least a year at some point.

Ten percent of respondents had used cannabis in the past month, again primarily smoking (56%) or edibles (52%), though 39% said they used it in more than one form, including vaping, dabbing, or topical use. Nearly half (46%) of the respondents who smoked cannabis recently did not know the THC potency of what they consumed, and just over 20% of those consuming edibles didn’t know the THC potency of what they used. However, about a third of those taking edibles used cannabis with less than 10 mg of THC, and a little over a quarter used edibles with 10 mg of THC.

Within the 10% who had used cannabis in the past month, nearly a third (31%) of respondents – or around 3.1% of the total sample – reported smoking cannabis daily or almost daily, and 19% (or 1.9% of the overall sample) consumed cannabis edibles daily or almost daily.

Most of the respondents who used cannabis said it was for recreational use (62%), but a quarter (25%) reported using it for both recreational and medical reasons, and 13% used it only for medical reasons. The most common reason women used cannabis was to treat chronic pain (28%), followed by nearly as many women reporting cannabis use for anxiety (24%), sleep (22%), and stress (22%). Six percent of women used cannabis specifically for menopause-related sleep and mood problems.

Given the growing use of cannabis in this population and the dearth of data on its effects in older women, Dr. Gibson highlighted the need for research examining the potential benefits and harms of cannabis for menopausal women.
 

Not risk-free

Susan D. Reed, MD, MPH, MSCP, a professor emeritus of ob.gyn. at the University of Washington, Seattle, and president of the Menopause Society, found the study well-executed and was not surprised by how many respondents had ever used cannabis.

“What did surprise me was that nearly a third reported daily use for at least 1 year and that 38% were medical marijuana users, not just recreational,” Dr. Reed said in an interview. The proportions of women using cannabis for menopausal symptoms or using it daily are concerning, she added.

“These individuals are at risk for dependence and health risks related to marijuana use,” Dr. Reed said. “Providers should always ask patients about OTC products, herbals, supplements, cannabis use, and alternative management of menopausal symptoms to better understand patient preferences for menopausal symptom therapies, so that treatment plans can be discussed with individual patient preferences in mind. We need to start with where the patient is coming from.”

Data presented throughout the conference has shown how people are “disillusioned with the care they are receiving for menopause,” Dr. Reed added. “It is so difficult to distinguish truth from myths based on information gained through social media, family, and friends, and that often is where most people are getting their information.”

Physicians often have not received adequate training on how to provide people with accurate information about menopause and managing menopausal symptoms, so she advises patients and physicians to visit reliable sites such as the Menopause Society, the Swan Study, and My Menoplan.

The research was funded by the Tobacco-Related Disease Research Program and the Veterans Administration. Dr. Gibson has provided unpaid consultation to Astellas Pharmaceuticals. Dr. Reed has received research support from Bayer and receives royalties from UpToDate.

PHILADELPHIA – About two in five perimenopausal or postmenopausal women have ever used cannabis in any form, but 10% have used it in the past month, according to cross-sectional survey results presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

Though most women reported using cannabis for recreational reasons, 13% used it only for medical reasons, most often for chronic pain, anxiety, sleep, and stress.

“These findings highlight the importance of recognizing and discussing cannabis use in the health care setting, and the need for additional research to evaluate the potential harms and/or benefits of use in this vulnerable population,” Carolyn J. Gibson, PhD, MPH, a staff psychologist in women’s health at the San Francisco VA Health Care System and an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, told attendees.

As cannabis has become more accessible, with its use legalized in 38 states and Washington, D.C., the proportion of U.S. adults using it has doubled over about a decade, from 6% in 2007 to 12% in 2019, Dr. Gibson said. Further, women aged 50 and older are among the fastest-growing groups of users of cannabis, and it’s being increasingly used – and marketed – for treating menopause-related and aging-related symptoms, including insomnia, anxiety, and chronic pain, she said.

“With these decisions to use cannabis, medically or for these other purposes, there’s this perception that it’s harmless,” Dr. Gibson said. Yet potential health risks associated with cannabis include the usual health effects associated with any kind of smoking as well as dependence in those who use it more frequently and/or develop a tolerance for it. She noted that average THC potency has increased over time, and acute risks for using cannabis with high levels of THC – at least 15% or at least 10 mg – can include anxiety/panic, confusion, disturbing/intrusive thoughts, psychosis, and effects on coordination and cognition. She also acknowledged, however, that most of the data available on risks come from studies of men and younger adults rather than older women.

Given the growing normalization of cannabis use, Dr. Gibson’s team sought to better understand prevalence of use as well as types of use and reasons for use in perimenopasual and postmenopausal women. They analyzed data from a cross-sectional survey of women and gender-diverse members, aged 45-64, of Ipsos KnowledgePanel, an online panel with more than 60,000 participating members in the United States.

All the respondents identified themselves as female at birth and had not used gender-affirming therapy or undergone gender-affirming surgery. The survey included questions on sociodemographics, menopause status, frequency of cannabis use, types of cannabis used, reasons for using cannabis, and use of cannabis in the previous 30 days. The 5,174 respondents were an average 55 years old and predominantly non-Hispanic white (63%), with 13% non-Hispanic Black and 16% Hispanic. Two-thirds of the women reported working full- or part-time (67%) and two-thirds were postmenopausal (68%), with 64% reporting experiencing menopause symptoms.

About two in five respondents (42%) had ever used cannabis in any form, most often smoking it (83%) or consuming edibles (51%). Among those who had ever used it, 30% reported having smoked it daily or nearly daily for at least a year at some point.

Ten percent of respondents had used cannabis in the past month, again primarily smoking (56%) or edibles (52%), though 39% said they used it in more than one form, including vaping, dabbing, or topical use. Nearly half (46%) of the respondents who smoked cannabis recently did not know the THC potency of what they consumed, and just over 20% of those consuming edibles didn’t know the THC potency of what they used. However, about a third of those taking edibles used cannabis with less than 10 mg of THC, and a little over a quarter used edibles with 10 mg of THC.

Within the 10% who had used cannabis in the past month, nearly a third (31%) of respondents – or around 3.1% of the total sample – reported smoking cannabis daily or almost daily, and 19% (or 1.9% of the overall sample) consumed cannabis edibles daily or almost daily.

Most of the respondents who used cannabis said it was for recreational use (62%), but a quarter (25%) reported using it for both recreational and medical reasons, and 13% used it only for medical reasons. The most common reason women used cannabis was to treat chronic pain (28%), followed by nearly as many women reporting cannabis use for anxiety (24%), sleep (22%), and stress (22%). Six percent of women used cannabis specifically for menopause-related sleep and mood problems.

Given the growing use of cannabis in this population and the dearth of data on its effects in older women, Dr. Gibson highlighted the need for research examining the potential benefits and harms of cannabis for menopausal women.
 

Not risk-free

Susan D. Reed, MD, MPH, MSCP, a professor emeritus of ob.gyn. at the University of Washington, Seattle, and president of the Menopause Society, found the study well-executed and was not surprised by how many respondents had ever used cannabis.

“What did surprise me was that nearly a third reported daily use for at least 1 year and that 38% were medical marijuana users, not just recreational,” Dr. Reed said in an interview. The proportions of women using cannabis for menopausal symptoms or using it daily are concerning, she added.

“These individuals are at risk for dependence and health risks related to marijuana use,” Dr. Reed said. “Providers should always ask patients about OTC products, herbals, supplements, cannabis use, and alternative management of menopausal symptoms to better understand patient preferences for menopausal symptom therapies, so that treatment plans can be discussed with individual patient preferences in mind. We need to start with where the patient is coming from.”

Data presented throughout the conference has shown how people are “disillusioned with the care they are receiving for menopause,” Dr. Reed added. “It is so difficult to distinguish truth from myths based on information gained through social media, family, and friends, and that often is where most people are getting their information.”

Physicians often have not received adequate training on how to provide people with accurate information about menopause and managing menopausal symptoms, so she advises patients and physicians to visit reliable sites such as the Menopause Society, the Swan Study, and My Menoplan.

The research was funded by the Tobacco-Related Disease Research Program and the Veterans Administration. Dr. Gibson has provided unpaid consultation to Astellas Pharmaceuticals. Dr. Reed has received research support from Bayer and receives royalties from UpToDate.

PHILADELPHIA – About two in five perimenopausal or postmenopausal women have ever used cannabis in any form, but 10% have used it in the past month, according to cross-sectional survey results presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

Though most women reported using cannabis for recreational reasons, 13% used it only for medical reasons, most often for chronic pain, anxiety, sleep, and stress.

“These findings highlight the importance of recognizing and discussing cannabis use in the health care setting, and the need for additional research to evaluate the potential harms and/or benefits of use in this vulnerable population,” Carolyn J. Gibson, PhD, MPH, a staff psychologist in women’s health at the San Francisco VA Health Care System and an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, told attendees.

As cannabis has become more accessible, with its use legalized in 38 states and Washington, D.C., the proportion of U.S. adults using it has doubled over about a decade, from 6% in 2007 to 12% in 2019, Dr. Gibson said. Further, women aged 50 and older are among the fastest-growing groups of users of cannabis, and it’s being increasingly used – and marketed – for treating menopause-related and aging-related symptoms, including insomnia, anxiety, and chronic pain, she said.

“With these decisions to use cannabis, medically or for these other purposes, there’s this perception that it’s harmless,” Dr. Gibson said. Yet potential health risks associated with cannabis include the usual health effects associated with any kind of smoking as well as dependence in those who use it more frequently and/or develop a tolerance for it. She noted that average THC potency has increased over time, and acute risks for using cannabis with high levels of THC – at least 15% or at least 10 mg – can include anxiety/panic, confusion, disturbing/intrusive thoughts, psychosis, and effects on coordination and cognition. She also acknowledged, however, that most of the data available on risks come from studies of men and younger adults rather than older women.

Given the growing normalization of cannabis use, Dr. Gibson’s team sought to better understand prevalence of use as well as types of use and reasons for use in perimenopasual and postmenopausal women. They analyzed data from a cross-sectional survey of women and gender-diverse members, aged 45-64, of Ipsos KnowledgePanel, an online panel with more than 60,000 participating members in the United States.

All the respondents identified themselves as female at birth and had not used gender-affirming therapy or undergone gender-affirming surgery. The survey included questions on sociodemographics, menopause status, frequency of cannabis use, types of cannabis used, reasons for using cannabis, and use of cannabis in the previous 30 days. The 5,174 respondents were an average 55 years old and predominantly non-Hispanic white (63%), with 13% non-Hispanic Black and 16% Hispanic. Two-thirds of the women reported working full- or part-time (67%) and two-thirds were postmenopausal (68%), with 64% reporting experiencing menopause symptoms.

About two in five respondents (42%) had ever used cannabis in any form, most often smoking it (83%) or consuming edibles (51%). Among those who had ever used it, 30% reported having smoked it daily or nearly daily for at least a year at some point.

Ten percent of respondents had used cannabis in the past month, again primarily smoking (56%) or edibles (52%), though 39% said they used it in more than one form, including vaping, dabbing, or topical use. Nearly half (46%) of the respondents who smoked cannabis recently did not know the THC potency of what they consumed, and just over 20% of those consuming edibles didn’t know the THC potency of what they used. However, about a third of those taking edibles used cannabis with less than 10 mg of THC, and a little over a quarter used edibles with 10 mg of THC.

Within the 10% who had used cannabis in the past month, nearly a third (31%) of respondents – or around 3.1% of the total sample – reported smoking cannabis daily or almost daily, and 19% (or 1.9% of the overall sample) consumed cannabis edibles daily or almost daily.

Most of the respondents who used cannabis said it was for recreational use (62%), but a quarter (25%) reported using it for both recreational and medical reasons, and 13% used it only for medical reasons. The most common reason women used cannabis was to treat chronic pain (28%), followed by nearly as many women reporting cannabis use for anxiety (24%), sleep (22%), and stress (22%). Six percent of women used cannabis specifically for menopause-related sleep and mood problems.

Given the growing use of cannabis in this population and the dearth of data on its effects in older women, Dr. Gibson highlighted the need for research examining the potential benefits and harms of cannabis for menopausal women.
 

Not risk-free

Susan D. Reed, MD, MPH, MSCP, a professor emeritus of ob.gyn. at the University of Washington, Seattle, and president of the Menopause Society, found the study well-executed and was not surprised by how many respondents had ever used cannabis.

“What did surprise me was that nearly a third reported daily use for at least 1 year and that 38% were medical marijuana users, not just recreational,” Dr. Reed said in an interview. The proportions of women using cannabis for menopausal symptoms or using it daily are concerning, she added.

“These individuals are at risk for dependence and health risks related to marijuana use,” Dr. Reed said. “Providers should always ask patients about OTC products, herbals, supplements, cannabis use, and alternative management of menopausal symptoms to better understand patient preferences for menopausal symptom therapies, so that treatment plans can be discussed with individual patient preferences in mind. We need to start with where the patient is coming from.”

Data presented throughout the conference has shown how people are “disillusioned with the care they are receiving for menopause,” Dr. Reed added. “It is so difficult to distinguish truth from myths based on information gained through social media, family, and friends, and that often is where most people are getting their information.”

Physicians often have not received adequate training on how to provide people with accurate information about menopause and managing menopausal symptoms, so she advises patients and physicians to visit reliable sites such as the Menopause Society, the Swan Study, and My Menoplan.

The research was funded by the Tobacco-Related Disease Research Program and the Veterans Administration. Dr. Gibson has provided unpaid consultation to Astellas Pharmaceuticals. Dr. Reed has received research support from Bayer and receives royalties from UpToDate.

Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.

Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.

At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.

“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”

Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.

Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.

The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.

“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.

Conversely, unexpectedly degraded bone raises questions.

“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.

Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.

“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
 

10-year-old tech, recently covered

The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.

Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.

“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.

Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.

“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
 

Potential drawbacks

The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.

TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.

Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
 

‘Opportunistic screening’ with CT?

TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.

But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.

“In these images is information about the bone,” Dr. Walker said.

Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.

One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.

Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.

“By far, bone mass is the most important bone quality,” Dr. Walker said.

Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.

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

Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.

Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.

At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.

“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”

Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.

Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.

The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.

“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.

Conversely, unexpectedly degraded bone raises questions.

“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.

Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.

“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
 

10-year-old tech, recently covered

The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.

Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.

“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.

Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.

“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
 

Potential drawbacks

The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.

TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.

Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
 

‘Opportunistic screening’ with CT?

TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.

But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.

“In these images is information about the bone,” Dr. Walker said.

Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.

One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.

Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.

“By far, bone mass is the most important bone quality,” Dr. Walker said.

Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.

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

Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.

Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.

At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.

“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”

Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.

Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.

The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.

“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.

Conversely, unexpectedly degraded bone raises questions.

“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.

Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.

“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
 

10-year-old tech, recently covered

The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.

Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.

“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.

Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.

“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
 

Potential drawbacks

The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.

TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.

Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
 

‘Opportunistic screening’ with CT?

TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.

But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.

“In these images is information about the bone,” Dr. Walker said.

Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.

One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.

Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.

“By far, bone mass is the most important bone quality,” Dr. Walker said.

Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.

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

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

This transcript has been edited for clarity.

Vaginal dryness is killing women.

I mean it. It’s actually killing women.

What do you mean, Dr. Rubin? How is vaginal dryness killing women? We minimize the term vaginal dryness. When women come to our offices and complain of a little vaginal dryness – or they don’t even come to our office to complain of it because the doctor can’t be bothered with a little vaginal dryness — what they don’t understand is that this “little vaginal dryness” is really something called genitourinary syndrome of menopause (GSM). They don’t know that because they’ve never heard of it, and you may have never heard of it either. In 2014, we changed the terms vaginal dryness and vulvovaginal atrophy or atrophic vaginitis to GSM to make it short and simple.

GSM – what does it mean? It’s not just a little vaginal dryness. It turns out that all of the genital and urinary symptoms from menopause just get worse over time. The bladder, the urethra, and the vagina have lots of hormone receptors, including estrogen and testosterone. When the body no longer makes those hormones, the system doesn’t work very well, and genital and urinary symptoms occur that just get worse over time without treatment. Unlike hot flashes, which tend to go away, GSM does not.

What are the symptoms of GSM? Some are sexual: a little vaginal dryness, pain with sex, and worsening orgasm. But there are also genital and urinary symptoms that get worse: itching, burning irritation, rawness, an awareness of their genitals that the patient has never had before. And as a urologist, we see frequency, urgency, and leakage.

The thing that kills women is recurrent urinary tract infections (UTIs). Did you know that UTIs account for 7 million visits and hospitalizations annually and 25% of all infections in older people? In fact, apparently one-third of the total Medicare expenditure is around UTIs. Not preventing UTIs is costing our health care system an enormous amount of money and resources.

Did you know we’ve had safe and effective treatment options for GSM since the 1970s? Vaginal hormones have existed since the 1970s, but we’re using them only for pain with sex and not for GSM. In fact, data show that by using vaginal hormones, we can prevent UTIs by more than 50%. We can save lives using safe, effective, local, low-dose vaginal hormone strategies. And they are safe and effective for all of our patients in pre- and post menopause.

There are five different treatment options: vaginal estrogen inserts, vaginal estrogen creams, vaginal dehydroepiandrosterone (DHEA), low-dose vaginal estrogen rings, and an oral pill option called ospemifene (Osphena). All are used to treat GSM and will only work if your patient actually uses them and continues to use them.

These treatments are safe. They are effective. They do not increase the level of systemic hormones in the bloodstream. I have many patients with breast cancer who use these products as well. The only patients you may want to talk to your oncology colleagues about is women on active aromatase inhibitors.

We have to understand that UTIs kill people and having GSM is debilitating, often requiring pain medication because it can hurt to sit or to wear pads and our patients’ quality of life is severely affected. So please consider learning how to treat GSM. It turns out you don’t have to do exams. You don’t have to do follow-up. You can give these therapies, and women can use them for life.

Now, if your patient has vaginal bleeding, of course they need to see their gynecologist. But this is something every primary care doctor can and should do. As a urologist, we prescribe a lot of tamsulosin (Flomax) for our male patients to help with urination. Vaginal estrogen or DHEA is basically like Flomax for women, but it prevents UTIs and actually works like sildenafil (Viagra) because it can help orgasm and reduce pain with sex.

You have access to affordable, safe, effective treatment options to treat GSM. So check them out and hopefully change the world.

Dr. Rubin is an assistant clinical professor in the department of urology at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GlaxoSmithKline, and Endo.

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

This transcript has been edited for clarity.

Vaginal dryness is killing women.

I mean it. It’s actually killing women.

What do you mean, Dr. Rubin? How is vaginal dryness killing women? We minimize the term vaginal dryness. When women come to our offices and complain of a little vaginal dryness – or they don’t even come to our office to complain of it because the doctor can’t be bothered with a little vaginal dryness — what they don’t understand is that this “little vaginal dryness” is really something called genitourinary syndrome of menopause (GSM). They don’t know that because they’ve never heard of it, and you may have never heard of it either. In 2014, we changed the terms vaginal dryness and vulvovaginal atrophy or atrophic vaginitis to GSM to make it short and simple.

GSM – what does it mean? It’s not just a little vaginal dryness. It turns out that all of the genital and urinary symptoms from menopause just get worse over time. The bladder, the urethra, and the vagina have lots of hormone receptors, including estrogen and testosterone. When the body no longer makes those hormones, the system doesn’t work very well, and genital and urinary symptoms occur that just get worse over time without treatment. Unlike hot flashes, which tend to go away, GSM does not.

What are the symptoms of GSM? Some are sexual: a little vaginal dryness, pain with sex, and worsening orgasm. But there are also genital and urinary symptoms that get worse: itching, burning irritation, rawness, an awareness of their genitals that the patient has never had before. And as a urologist, we see frequency, urgency, and leakage.

The thing that kills women is recurrent urinary tract infections (UTIs). Did you know that UTIs account for 7 million visits and hospitalizations annually and 25% of all infections in older people? In fact, apparently one-third of the total Medicare expenditure is around UTIs. Not preventing UTIs is costing our health care system an enormous amount of money and resources.

Did you know we’ve had safe and effective treatment options for GSM since the 1970s? Vaginal hormones have existed since the 1970s, but we’re using them only for pain with sex and not for GSM. In fact, data show that by using vaginal hormones, we can prevent UTIs by more than 50%. We can save lives using safe, effective, local, low-dose vaginal hormone strategies. And they are safe and effective for all of our patients in pre- and post menopause.

There are five different treatment options: vaginal estrogen inserts, vaginal estrogen creams, vaginal dehydroepiandrosterone (DHEA), low-dose vaginal estrogen rings, and an oral pill option called ospemifene (Osphena). All are used to treat GSM and will only work if your patient actually uses them and continues to use them.

These treatments are safe. They are effective. They do not increase the level of systemic hormones in the bloodstream. I have many patients with breast cancer who use these products as well. The only patients you may want to talk to your oncology colleagues about is women on active aromatase inhibitors.

We have to understand that UTIs kill people and having GSM is debilitating, often requiring pain medication because it can hurt to sit or to wear pads and our patients’ quality of life is severely affected. So please consider learning how to treat GSM. It turns out you don’t have to do exams. You don’t have to do follow-up. You can give these therapies, and women can use them for life.

Now, if your patient has vaginal bleeding, of course they need to see their gynecologist. But this is something every primary care doctor can and should do. As a urologist, we prescribe a lot of tamsulosin (Flomax) for our male patients to help with urination. Vaginal estrogen or DHEA is basically like Flomax for women, but it prevents UTIs and actually works like sildenafil (Viagra) because it can help orgasm and reduce pain with sex.

You have access to affordable, safe, effective treatment options to treat GSM. So check them out and hopefully change the world.

Dr. Rubin is an assistant clinical professor in the department of urology at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GlaxoSmithKline, and Endo.

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

This transcript has been edited for clarity.

Vaginal dryness is killing women.

I mean it. It’s actually killing women.

What do you mean, Dr. Rubin? How is vaginal dryness killing women? We minimize the term vaginal dryness. When women come to our offices and complain of a little vaginal dryness – or they don’t even come to our office to complain of it because the doctor can’t be bothered with a little vaginal dryness — what they don’t understand is that this “little vaginal dryness” is really something called genitourinary syndrome of menopause (GSM). They don’t know that because they’ve never heard of it, and you may have never heard of it either. In 2014, we changed the terms vaginal dryness and vulvovaginal atrophy or atrophic vaginitis to GSM to make it short and simple.

GSM – what does it mean? It’s not just a little vaginal dryness. It turns out that all of the genital and urinary symptoms from menopause just get worse over time. The bladder, the urethra, and the vagina have lots of hormone receptors, including estrogen and testosterone. When the body no longer makes those hormones, the system doesn’t work very well, and genital and urinary symptoms occur that just get worse over time without treatment. Unlike hot flashes, which tend to go away, GSM does not.

What are the symptoms of GSM? Some are sexual: a little vaginal dryness, pain with sex, and worsening orgasm. But there are also genital and urinary symptoms that get worse: itching, burning irritation, rawness, an awareness of their genitals that the patient has never had before. And as a urologist, we see frequency, urgency, and leakage.

The thing that kills women is recurrent urinary tract infections (UTIs). Did you know that UTIs account for 7 million visits and hospitalizations annually and 25% of all infections in older people? In fact, apparently one-third of the total Medicare expenditure is around UTIs. Not preventing UTIs is costing our health care system an enormous amount of money and resources.

Did you know we’ve had safe and effective treatment options for GSM since the 1970s? Vaginal hormones have existed since the 1970s, but we’re using them only for pain with sex and not for GSM. In fact, data show that by using vaginal hormones, we can prevent UTIs by more than 50%. We can save lives using safe, effective, local, low-dose vaginal hormone strategies. And they are safe and effective for all of our patients in pre- and post menopause.

There are five different treatment options: vaginal estrogen inserts, vaginal estrogen creams, vaginal dehydroepiandrosterone (DHEA), low-dose vaginal estrogen rings, and an oral pill option called ospemifene (Osphena). All are used to treat GSM and will only work if your patient actually uses them and continues to use them.

These treatments are safe. They are effective. They do not increase the level of systemic hormones in the bloodstream. I have many patients with breast cancer who use these products as well. The only patients you may want to talk to your oncology colleagues about is women on active aromatase inhibitors.

We have to understand that UTIs kill people and having GSM is debilitating, often requiring pain medication because it can hurt to sit or to wear pads and our patients’ quality of life is severely affected. So please consider learning how to treat GSM. It turns out you don’t have to do exams. You don’t have to do follow-up. You can give these therapies, and women can use them for life.

Now, if your patient has vaginal bleeding, of course they need to see their gynecologist. But this is something every primary care doctor can and should do. As a urologist, we prescribe a lot of tamsulosin (Flomax) for our male patients to help with urination. Vaginal estrogen or DHEA is basically like Flomax for women, but it prevents UTIs and actually works like sildenafil (Viagra) because it can help orgasm and reduce pain with sex.

You have access to affordable, safe, effective treatment options to treat GSM. So check them out and hopefully change the world.

Dr. Rubin is an assistant clinical professor in the department of urology at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GlaxoSmithKline, and Endo.

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

The Food and Drug Administration approval of zuranolone for postpartum depression in August 2023 has raised many important questions (and opinions) about its future use in clinical practice.

At the UNC-Chapel Hill Center for Women’s Mood Disorders, we treat women and pregnant people throughout hormonal transitions, including pregnancy and the postpartum, and have been part of development, research, and now delivery of both brexanolone and zuranolone. While we are excited about new tools in the arsenal for alleviating maternal mental health, we also want to be clear that our work is far from complete and continued efforts to care for pregnant people and their families are imperative.

courtesy UNC-Chapel Hill

What is zuranolone?

Zuranolone (brand name Zurzuvae) is an oral medication developed by Sage Therapeutics and Biogen. It is a positive allosteric modulator of the GABA_A receptor, the brain’s major inhibitory system. As a positive allosteric modulator, it increases the sensitivity of the GABA_A receptor to GABA.

Zuranolone is very similar to brexanolone, a synthetic form of allopregnanolone, a neurosteroid byproduct of progesterone (see below). However, zuranolone is not an oral form of brexanolone – it was slightly modified to ensure good oral stability and bioavailability. It is metabolized by the hepatic enzyme CYP3A4 and has a half-life of 16-23 hours. Zurzuvae is currently produced in capsule form.
 

What does zuranolone treat?

Zuranolone is the first FDA-approved oral drug for postpartum depression (PPD). It follows brexanolone, an intravenous drug, which was the first FDA-approved medication for PPD. Though these are the first medications with specific approval for PDD, many other treatment options are currently available including therapy, SSRIs, serotonin norepinephrine reuptake inhibitors (SNRIs), and other treatments used in major depression.

How does zuranolone work?

courtesy UNC-Chapel Hill

Zuranolone is a neuroactive steroid, which means that it is a steroid that goes into and acts on the brain. Zuranolone binds to different GABA receptor subunits from those bound by other positive modulators, such as benzodiazepines (for example, lorazepam). As a synthetic form of allopregnanolone, a metabolite of progesterone which rises dramatically in pregnancy then drops during labor and delivery, zuranolone was originally thought to mitigate the response to this drop in patients that are vulnerable to it during the postpartum. An alternative proposed mechanism is that the increased GABAergic, inhibitory signaling with zuranolone may act directly to decrease depression irrespective of the exact mechanism by which the depression occurred.

How was it studied?

Zuranolone was studied in women with severe postpartum depression and had to meet criteria for major depressive disorder (MDD) no earlier than the third trimester of pregnancy (about 28 weeks’ gestation) and no later than 4 weeks post partum. Patients were excluded from these studies if they had a history of bipolar disorder, psychotic disorders, attempted suicide, or if they were at risk for suicide.

The two phase 3 clinical trials that led to FDA approval are ROBIN and SKYLARK. These studies measured the efficacy and safety of zuranolone at 30 mg and 50 mg, respectively, and met their end points of rapid improvement in depressive and anxiety symptoms in postpartum depression.
 

When will we be able to start using it?

It is anticipated that zuranolone will become commercially available in early 2024.

Who can prescribe it?

courtesy UNC-Chapel Hill

Those with medical licenses. Most people will likely receive treatment from their obstetric, family medicine, or psychiatric clinicians.

How much will it cost?

The manufacturers have not released this information as of August 2023.

What sort of doses and duration is recommended?

The current FDA recommended dose is 50 mg for 14 days, taken once per evening with a fatty meal. The dose can be reduced to 40 mg if there are central nervous system (CNS) depressant effects, and to 30 mg if the patient has severe hepatic or moderate-severe renal impairment. There are currently no studies on longer courses of treatment.

What happens if the patient relapses after a 14-day trial?

While there is no clear guidance, an open-label trial (The SHORELINE Study) demonstrated that a repeated 14-day administration can restore clinical response.

What are the side effects?

courtesy UNC-Chapel Hill

Common side effects include drowsiness, dizziness, lower energy, diarrhea, and symptoms similar to the common cold. Zuranolone can act like a CNS depressant and can lead to sedation and somnolence.

Are there any boxed warnings?

Because of the CNS depressant effects, zuranolone was given a boxed warning that patients should not drive or operate heavy machinery within 12 hours of taking the medication as it may lead to impairment. Similar to other antidepressants, there is also a warning that zuranolone may increase risk for suicidal thoughts in patients under 24 years old.

Can it be used with other medications?

Yes. In the original trials, women were allowed to remain on medications treating their depressive symptoms (such as SSRIs and SNRIs). According to the FDA, zuranolone can be used alone or with other antidepressants.

Are there any medicines to avoid?

We recommend caution with other medications which may increase sedation, such as benzodiazepines.

Can it be used with birth control?

Yes. In fact, because the outcomes on a fetus are not yet studied, it is recommended that patients be on concurrent birth control during treatment and for a week after cessation. This does not mean that zuranolone is known to cause issues with fetal development, but rather that we do not know at this time.

Can it be used in pregnancy?

As above, the outcomes on fetal development are not known at this time, nor are the effects of zuranolone on labor and delivery. More research will need to be done to understand if there is risk with taking zuranolone during pregnancy. It should be noted that allopregnanolone levels ordinarily reach quite high levels during pregnancy.
 

Long-term side effects?

Long-term side effects are unknown. The study duration of ROBIN and SKYLARK was 45 days.

Breastfeeding?

Use in lactation has not yet been studied. Continued research is needed.

Can it be used in mood changes related to other reproductive changes or diagnoses like premenstrual dysphoric disorder and perimenopause?

The mechanism by which zuranolone is thought to work – that is, during changes in reproductive hormones – is implicated in other reproductive transitions such as premenstrual dysphoric disorder and perimenopause when reproductive hormones are fluctuating, though at lower levels than in pregnancy. Research will be required to assess efficacy and safety; however, the mechanistic reasons is worth pursuing. Additionally, zuranolone has not been studied in postpartum psychosis.

Can zuranolone be used to treat other affective conditions besides postpartum depression? Bipolar disorder?

Zuranolone is currently only approved for the treatment of postpartum depression. It has not received FDA approval for major depression outside of the perinatal period at this time. Whether it may be beneficial for patients with a depressive episode that is part of an underlying bipolar disorder or other psychiatric illness is not yet known.

Anxiety?

Along with depressive symptoms, women who received zuranolone in the clinical trials also had improvements in anxiety symptoms. These findings provide some hope that zuranolone may eventually be beneficial in patients with anxiety.

However, to date zuranolone has not been directly studied as a treatment for anxiety disorders (such as generalized anxiety disorder, panic disorder, etc.), so its efficacy for these illnesses is currently unknown.
 

Insomnia?

In a study of 153 postpartum women, randomized to placebo or zuranolone, scale questions for insomnia were improved in the group receiving zuranolone. This provides some hope that, if zuranolone is appropriate, concurrent polypharmacy with a sleep aid can be avoided. Additionally, future evaluation of use in insomnia outside of PPD may be warranted.

How is it different from brexanolone?

The two are slightly different molecules. Brexanolone is synthetically identical to allopregnanolone and zuranolone has been altered to be active and orally bioavailable.

Brexanolone is a 60-hour infusion that requires hospital admission at an approved health care site. Zuranolone is an oral at-home once-daily dosing treatment for 14 days. Zuranolone does not require enrollment in a risk evaluation and mitigation strategy for risk of excessive sedation and sudden loss of consciousness.
 

When would you consider zuranolone vs. brexanolone vs. other antidepressants?

Zuranolone and brexanolone are rapid-acting antidepressants with a response within 14 days or 60 hours, respectively. Antidepressants such as SSRIs/SNRIs are still available, well studied, and work, although take longer to reach clinical efficacy and are accompanied by potentially troubling side effects (for example, weight gain, sexual dysfunction).

Time to treatment effect should be considered when assessing severity of symptoms and functional impairment of the mother and the overall family unit. Brexanolone requires continuous monitoring which may be beneficial for women who are severely impaired and may benefit from frequent clinical monitoring. Brexanolone does not require a dose reduction with hepatic impairment, however, should be avoided in end-stage renal disease because of the potential accumulation of the solubilizing agent.
 

Where can I find more information?

Many states have maternal mental health consultation lines (examples include NCMATTERS here in North Carolina and MCPAP for Moms in Massachusetts) for clinicians (mental health, primary care, and obstetricians) that can be utilized for questions about prescribing. Postpartum Support International also has a clinician line for those without state services.

We plan to update this entry upon market release and access to new information.

Dr. Riddle and Dr. Nathan are assistant professors in the department of psychiatry at the University of North Carolina at Chapel Hill. Dr. Richardson is a perinatal psychiatry fellow, department of psychiatry, UNC-Chapel Hill. Dr. Rubinow is Distinguished Professor in the department of psychiatry, UNC-Chapel Hill. Dr. Meltzer-Brody is Assad Meymandi Distinguished Professor and Chair, department of psychiatry, UNC-Chapel Hill.

References

Deligiannidis KM et al. J Clin Psychiatry. 2023 Jan 30;84(1):22m14475. doi: 10.4088/JCP.22m14475.

Deligiannidis KM et al. . Obstetrics & Gynecology. 2023 May;141(5S):64S-65S. doi: 10.1097/01.AOG.0000930588.16136.3f.

Deligiannidis KM et al. Am J Psychiatry. 2023 Sep 1;180(9):668-75. doi: 10.1176/appi.ajp.20220785.

Deligiannidis KM et al. JAMA Psychiatry. 2021 Sep 1;78(9):951-59. doi: 10.1001/jamapsychiatry.2021.1559.

FDA Approves First Oral Treatment for Postpartum Depression. 2023 Aug 4. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression

ZURZUVAE – HIGHLIGHTS OF PRESCRIBING INFORMATION. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217369s000lbl.pdf

The Food and Drug Administration approval of zuranolone for postpartum depression in August 2023 has raised many important questions (and opinions) about its future use in clinical practice.

At the UNC-Chapel Hill Center for Women’s Mood Disorders, we treat women and pregnant people throughout hormonal transitions, including pregnancy and the postpartum, and have been part of development, research, and now delivery of both brexanolone and zuranolone. While we are excited about new tools in the arsenal for alleviating maternal mental health, we also want to be clear that our work is far from complete and continued efforts to care for pregnant people and their families are imperative.

courtesy UNC-Chapel Hill

What is zuranolone?

Zuranolone (brand name Zurzuvae) is an oral medication developed by Sage Therapeutics and Biogen. It is a positive allosteric modulator of the GABA_A receptor, the brain’s major inhibitory system. As a positive allosteric modulator, it increases the sensitivity of the GABA_A receptor to GABA.

Zuranolone is very similar to brexanolone, a synthetic form of allopregnanolone, a neurosteroid byproduct of progesterone (see below). However, zuranolone is not an oral form of brexanolone – it was slightly modified to ensure good oral stability and bioavailability. It is metabolized by the hepatic enzyme CYP3A4 and has a half-life of 16-23 hours. Zurzuvae is currently produced in capsule form.
 

What does zuranolone treat?

Zuranolone is the first FDA-approved oral drug for postpartum depression (PPD). It follows brexanolone, an intravenous drug, which was the first FDA-approved medication for PPD. Though these are the first medications with specific approval for PDD, many other treatment options are currently available including therapy, SSRIs, serotonin norepinephrine reuptake inhibitors (SNRIs), and other treatments used in major depression.

How does zuranolone work?

courtesy UNC-Chapel Hill

Zuranolone is a neuroactive steroid, which means that it is a steroid that goes into and acts on the brain. Zuranolone binds to different GABA receptor subunits from those bound by other positive modulators, such as benzodiazepines (for example, lorazepam). As a synthetic form of allopregnanolone, a metabolite of progesterone which rises dramatically in pregnancy then drops during labor and delivery, zuranolone was originally thought to mitigate the response to this drop in patients that are vulnerable to it during the postpartum. An alternative proposed mechanism is that the increased GABAergic, inhibitory signaling with zuranolone may act directly to decrease depression irrespective of the exact mechanism by which the depression occurred.

How was it studied?

Zuranolone was studied in women with severe postpartum depression and had to meet criteria for major depressive disorder (MDD) no earlier than the third trimester of pregnancy (about 28 weeks’ gestation) and no later than 4 weeks post partum. Patients were excluded from these studies if they had a history of bipolar disorder, psychotic disorders, attempted suicide, or if they were at risk for suicide.

The two phase 3 clinical trials that led to FDA approval are ROBIN and SKYLARK. These studies measured the efficacy and safety of zuranolone at 30 mg and 50 mg, respectively, and met their end points of rapid improvement in depressive and anxiety symptoms in postpartum depression.
 

When will we be able to start using it?

It is anticipated that zuranolone will become commercially available in early 2024.

Who can prescribe it?

courtesy UNC-Chapel Hill

Those with medical licenses. Most people will likely receive treatment from their obstetric, family medicine, or psychiatric clinicians.

How much will it cost?

The manufacturers have not released this information as of August 2023.

What sort of doses and duration is recommended?

The current FDA recommended dose is 50 mg for 14 days, taken once per evening with a fatty meal. The dose can be reduced to 40 mg if there are central nervous system (CNS) depressant effects, and to 30 mg if the patient has severe hepatic or moderate-severe renal impairment. There are currently no studies on longer courses of treatment.

What happens if the patient relapses after a 14-day trial?

While there is no clear guidance, an open-label trial (The SHORELINE Study) demonstrated that a repeated 14-day administration can restore clinical response.

What are the side effects?

courtesy UNC-Chapel Hill

Common side effects include drowsiness, dizziness, lower energy, diarrhea, and symptoms similar to the common cold. Zuranolone can act like a CNS depressant and can lead to sedation and somnolence.

Are there any boxed warnings?

Because of the CNS depressant effects, zuranolone was given a boxed warning that patients should not drive or operate heavy machinery within 12 hours of taking the medication as it may lead to impairment. Similar to other antidepressants, there is also a warning that zuranolone may increase risk for suicidal thoughts in patients under 24 years old.

Can it be used with other medications?

Yes. In the original trials, women were allowed to remain on medications treating their depressive symptoms (such as SSRIs and SNRIs). According to the FDA, zuranolone can be used alone or with other antidepressants.

Are there any medicines to avoid?

We recommend caution with other medications which may increase sedation, such as benzodiazepines.

Can it be used with birth control?

Yes. In fact, because the outcomes on a fetus are not yet studied, it is recommended that patients be on concurrent birth control during treatment and for a week after cessation. This does not mean that zuranolone is known to cause issues with fetal development, but rather that we do not know at this time.

Can it be used in pregnancy?

As above, the outcomes on fetal development are not known at this time, nor are the effects of zuranolone on labor and delivery. More research will need to be done to understand if there is risk with taking zuranolone during pregnancy. It should be noted that allopregnanolone levels ordinarily reach quite high levels during pregnancy.
 

Long-term side effects?

Long-term side effects are unknown. The study duration of ROBIN and SKYLARK was 45 days.

Breastfeeding?

Use in lactation has not yet been studied. Continued research is needed.

Can it be used in mood changes related to other reproductive changes or diagnoses like premenstrual dysphoric disorder and perimenopause?

The mechanism by which zuranolone is thought to work – that is, during changes in reproductive hormones – is implicated in other reproductive transitions such as premenstrual dysphoric disorder and perimenopause when reproductive hormones are fluctuating, though at lower levels than in pregnancy. Research will be required to assess efficacy and safety; however, the mechanistic reasons is worth pursuing. Additionally, zuranolone has not been studied in postpartum psychosis.

Can zuranolone be used to treat other affective conditions besides postpartum depression? Bipolar disorder?

Zuranolone is currently only approved for the treatment of postpartum depression. It has not received FDA approval for major depression outside of the perinatal period at this time. Whether it may be beneficial for patients with a depressive episode that is part of an underlying bipolar disorder or other psychiatric illness is not yet known.

Anxiety?

Along with depressive symptoms, women who received zuranolone in the clinical trials also had improvements in anxiety symptoms. These findings provide some hope that zuranolone may eventually be beneficial in patients with anxiety.

However, to date zuranolone has not been directly studied as a treatment for anxiety disorders (such as generalized anxiety disorder, panic disorder, etc.), so its efficacy for these illnesses is currently unknown.
 

Insomnia?

In a study of 153 postpartum women, randomized to placebo or zuranolone, scale questions for insomnia were improved in the group receiving zuranolone. This provides some hope that, if zuranolone is appropriate, concurrent polypharmacy with a sleep aid can be avoided. Additionally, future evaluation of use in insomnia outside of PPD may be warranted.

How is it different from brexanolone?

The two are slightly different molecules. Brexanolone is synthetically identical to allopregnanolone and zuranolone has been altered to be active and orally bioavailable.

Brexanolone is a 60-hour infusion that requires hospital admission at an approved health care site. Zuranolone is an oral at-home once-daily dosing treatment for 14 days. Zuranolone does not require enrollment in a risk evaluation and mitigation strategy for risk of excessive sedation and sudden loss of consciousness.
 

When would you consider zuranolone vs. brexanolone vs. other antidepressants?

Zuranolone and brexanolone are rapid-acting antidepressants with a response within 14 days or 60 hours, respectively. Antidepressants such as SSRIs/SNRIs are still available, well studied, and work, although take longer to reach clinical efficacy and are accompanied by potentially troubling side effects (for example, weight gain, sexual dysfunction).

Time to treatment effect should be considered when assessing severity of symptoms and functional impairment of the mother and the overall family unit. Brexanolone requires continuous monitoring which may be beneficial for women who are severely impaired and may benefit from frequent clinical monitoring. Brexanolone does not require a dose reduction with hepatic impairment, however, should be avoided in end-stage renal disease because of the potential accumulation of the solubilizing agent.
 

Where can I find more information?

Many states have maternal mental health consultation lines (examples include NCMATTERS here in North Carolina and MCPAP for Moms in Massachusetts) for clinicians (mental health, primary care, and obstetricians) that can be utilized for questions about prescribing. Postpartum Support International also has a clinician line for those without state services.

We plan to update this entry upon market release and access to new information.

Dr. Riddle and Dr. Nathan are assistant professors in the department of psychiatry at the University of North Carolina at Chapel Hill. Dr. Richardson is a perinatal psychiatry fellow, department of psychiatry, UNC-Chapel Hill. Dr. Rubinow is Distinguished Professor in the department of psychiatry, UNC-Chapel Hill. Dr. Meltzer-Brody is Assad Meymandi Distinguished Professor and Chair, department of psychiatry, UNC-Chapel Hill.

References

Deligiannidis KM et al. J Clin Psychiatry. 2023 Jan 30;84(1):22m14475. doi: 10.4088/JCP.22m14475.

Deligiannidis KM et al. . Obstetrics & Gynecology. 2023 May;141(5S):64S-65S. doi: 10.1097/01.AOG.0000930588.16136.3f.

Deligiannidis KM et al. Am J Psychiatry. 2023 Sep 1;180(9):668-75. doi: 10.1176/appi.ajp.20220785.

Deligiannidis KM et al. JAMA Psychiatry. 2021 Sep 1;78(9):951-59. doi: 10.1001/jamapsychiatry.2021.1559.

FDA Approves First Oral Treatment for Postpartum Depression. 2023 Aug 4. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression

ZURZUVAE – HIGHLIGHTS OF PRESCRIBING INFORMATION. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217369s000lbl.pdf

The Food and Drug Administration approval of zuranolone for postpartum depression in August 2023 has raised many important questions (and opinions) about its future use in clinical practice.

At the UNC-Chapel Hill Center for Women’s Mood Disorders, we treat women and pregnant people throughout hormonal transitions, including pregnancy and the postpartum, and have been part of development, research, and now delivery of both brexanolone and zuranolone. While we are excited about new tools in the arsenal for alleviating maternal mental health, we also want to be clear that our work is far from complete and continued efforts to care for pregnant people and their families are imperative.

courtesy UNC-Chapel Hill

What is zuranolone?

Zuranolone (brand name Zurzuvae) is an oral medication developed by Sage Therapeutics and Biogen. It is a positive allosteric modulator of the GABA_A receptor, the brain’s major inhibitory system. As a positive allosteric modulator, it increases the sensitivity of the GABA_A receptor to GABA.

Zuranolone is very similar to brexanolone, a synthetic form of allopregnanolone, a neurosteroid byproduct of progesterone (see below). However, zuranolone is not an oral form of brexanolone – it was slightly modified to ensure good oral stability and bioavailability. It is metabolized by the hepatic enzyme CYP3A4 and has a half-life of 16-23 hours. Zurzuvae is currently produced in capsule form.
 

What does zuranolone treat?

Zuranolone is the first FDA-approved oral drug for postpartum depression (PPD). It follows brexanolone, an intravenous drug, which was the first FDA-approved medication for PPD. Though these are the first medications with specific approval for PDD, many other treatment options are currently available including therapy, SSRIs, serotonin norepinephrine reuptake inhibitors (SNRIs), and other treatments used in major depression.

How does zuranolone work?

courtesy UNC-Chapel Hill

Zuranolone is a neuroactive steroid, which means that it is a steroid that goes into and acts on the brain. Zuranolone binds to different GABA receptor subunits from those bound by other positive modulators, such as benzodiazepines (for example, lorazepam). As a synthetic form of allopregnanolone, a metabolite of progesterone which rises dramatically in pregnancy then drops during labor and delivery, zuranolone was originally thought to mitigate the response to this drop in patients that are vulnerable to it during the postpartum. An alternative proposed mechanism is that the increased GABAergic, inhibitory signaling with zuranolone may act directly to decrease depression irrespective of the exact mechanism by which the depression occurred.

How was it studied?

Zuranolone was studied in women with severe postpartum depression and had to meet criteria for major depressive disorder (MDD) no earlier than the third trimester of pregnancy (about 28 weeks’ gestation) and no later than 4 weeks post partum. Patients were excluded from these studies if they had a history of bipolar disorder, psychotic disorders, attempted suicide, or if they were at risk for suicide.

The two phase 3 clinical trials that led to FDA approval are ROBIN and SKYLARK. These studies measured the efficacy and safety of zuranolone at 30 mg and 50 mg, respectively, and met their end points of rapid improvement in depressive and anxiety symptoms in postpartum depression.
 

When will we be able to start using it?

It is anticipated that zuranolone will become commercially available in early 2024.

Who can prescribe it?

courtesy UNC-Chapel Hill

Those with medical licenses. Most people will likely receive treatment from their obstetric, family medicine, or psychiatric clinicians.

How much will it cost?

The manufacturers have not released this information as of August 2023.

What sort of doses and duration is recommended?

The current FDA recommended dose is 50 mg for 14 days, taken once per evening with a fatty meal. The dose can be reduced to 40 mg if there are central nervous system (CNS) depressant effects, and to 30 mg if the patient has severe hepatic or moderate-severe renal impairment. There are currently no studies on longer courses of treatment.

What happens if the patient relapses after a 14-day trial?

While there is no clear guidance, an open-label trial (The SHORELINE Study) demonstrated that a repeated 14-day administration can restore clinical response.

What are the side effects?

courtesy UNC-Chapel Hill

Common side effects include drowsiness, dizziness, lower energy, diarrhea, and symptoms similar to the common cold. Zuranolone can act like a CNS depressant and can lead to sedation and somnolence.

Are there any boxed warnings?

Because of the CNS depressant effects, zuranolone was given a boxed warning that patients should not drive or operate heavy machinery within 12 hours of taking the medication as it may lead to impairment. Similar to other antidepressants, there is also a warning that zuranolone may increase risk for suicidal thoughts in patients under 24 years old.

Can it be used with other medications?

Yes. In the original trials, women were allowed to remain on medications treating their depressive symptoms (such as SSRIs and SNRIs). According to the FDA, zuranolone can be used alone or with other antidepressants.

Are there any medicines to avoid?

We recommend caution with other medications which may increase sedation, such as benzodiazepines.

Can it be used with birth control?

Yes. In fact, because the outcomes on a fetus are not yet studied, it is recommended that patients be on concurrent birth control during treatment and for a week after cessation. This does not mean that zuranolone is known to cause issues with fetal development, but rather that we do not know at this time.

Can it be used in pregnancy?

As above, the outcomes on fetal development are not known at this time, nor are the effects of zuranolone on labor and delivery. More research will need to be done to understand if there is risk with taking zuranolone during pregnancy. It should be noted that allopregnanolone levels ordinarily reach quite high levels during pregnancy.
 

Long-term side effects?

Long-term side effects are unknown. The study duration of ROBIN and SKYLARK was 45 days.

Breastfeeding?

Use in lactation has not yet been studied. Continued research is needed.

Can it be used in mood changes related to other reproductive changes or diagnoses like premenstrual dysphoric disorder and perimenopause?

The mechanism by which zuranolone is thought to work – that is, during changes in reproductive hormones – is implicated in other reproductive transitions such as premenstrual dysphoric disorder and perimenopause when reproductive hormones are fluctuating, though at lower levels than in pregnancy. Research will be required to assess efficacy and safety; however, the mechanistic reasons is worth pursuing. Additionally, zuranolone has not been studied in postpartum psychosis.

Can zuranolone be used to treat other affective conditions besides postpartum depression? Bipolar disorder?

Zuranolone is currently only approved for the treatment of postpartum depression. It has not received FDA approval for major depression outside of the perinatal period at this time. Whether it may be beneficial for patients with a depressive episode that is part of an underlying bipolar disorder or other psychiatric illness is not yet known.

Anxiety?

Along with depressive symptoms, women who received zuranolone in the clinical trials also had improvements in anxiety symptoms. These findings provide some hope that zuranolone may eventually be beneficial in patients with anxiety.

However, to date zuranolone has not been directly studied as a treatment for anxiety disorders (such as generalized anxiety disorder, panic disorder, etc.), so its efficacy for these illnesses is currently unknown.
 

Insomnia?

In a study of 153 postpartum women, randomized to placebo or zuranolone, scale questions for insomnia were improved in the group receiving zuranolone. This provides some hope that, if zuranolone is appropriate, concurrent polypharmacy with a sleep aid can be avoided. Additionally, future evaluation of use in insomnia outside of PPD may be warranted.

How is it different from brexanolone?

The two are slightly different molecules. Brexanolone is synthetically identical to allopregnanolone and zuranolone has been altered to be active and orally bioavailable.

Brexanolone is a 60-hour infusion that requires hospital admission at an approved health care site. Zuranolone is an oral at-home once-daily dosing treatment for 14 days. Zuranolone does not require enrollment in a risk evaluation and mitigation strategy for risk of excessive sedation and sudden loss of consciousness.
 

When would you consider zuranolone vs. brexanolone vs. other antidepressants?

Zuranolone and brexanolone are rapid-acting antidepressants with a response within 14 days or 60 hours, respectively. Antidepressants such as SSRIs/SNRIs are still available, well studied, and work, although take longer to reach clinical efficacy and are accompanied by potentially troubling side effects (for example, weight gain, sexual dysfunction).

Time to treatment effect should be considered when assessing severity of symptoms and functional impairment of the mother and the overall family unit. Brexanolone requires continuous monitoring which may be beneficial for women who are severely impaired and may benefit from frequent clinical monitoring. Brexanolone does not require a dose reduction with hepatic impairment, however, should be avoided in end-stage renal disease because of the potential accumulation of the solubilizing agent.
 

Where can I find more information?

Many states have maternal mental health consultation lines (examples include NCMATTERS here in North Carolina and MCPAP for Moms in Massachusetts) for clinicians (mental health, primary care, and obstetricians) that can be utilized for questions about prescribing. Postpartum Support International also has a clinician line for those without state services.

We plan to update this entry upon market release and access to new information.

Dr. Riddle and Dr. Nathan are assistant professors in the department of psychiatry at the University of North Carolina at Chapel Hill. Dr. Richardson is a perinatal psychiatry fellow, department of psychiatry, UNC-Chapel Hill. Dr. Rubinow is Distinguished Professor in the department of psychiatry, UNC-Chapel Hill. Dr. Meltzer-Brody is Assad Meymandi Distinguished Professor and Chair, department of psychiatry, UNC-Chapel Hill.

References

Deligiannidis KM et al. J Clin Psychiatry. 2023 Jan 30;84(1):22m14475. doi: 10.4088/JCP.22m14475.

Deligiannidis KM et al. . Obstetrics & Gynecology. 2023 May;141(5S):64S-65S. doi: 10.1097/01.AOG.0000930588.16136.3f.

Deligiannidis KM et al. Am J Psychiatry. 2023 Sep 1;180(9):668-75. doi: 10.1176/appi.ajp.20220785.

Deligiannidis KM et al. JAMA Psychiatry. 2021 Sep 1;78(9):951-59. doi: 10.1001/jamapsychiatry.2021.1559.

FDA Approves First Oral Treatment for Postpartum Depression. 2023 Aug 4. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression

ZURZUVAE – HIGHLIGHTS OF PRESCRIBING INFORMATION. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217369s000lbl.pdf

TOPLINE:

Approximately one-third of women with rheumatic diseases develop anemia by the third trimester of pregnancy, and two-thirds are iron deficient, according to findings from a longitudinal cohort study.

METHODOLOGY:

• Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
• Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
• Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.

TAKEAWAY:

• The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
• The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
• There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
• Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).

IN PRACTICE:

“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.

SOURCE:

The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.

LIMITATIONS:

The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.

DISCLOSURES:

The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.

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

TOPLINE:

Approximately one-third of women with rheumatic diseases develop anemia by the third trimester of pregnancy, and two-thirds are iron deficient, according to findings from a longitudinal cohort study.

METHODOLOGY:

• Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
• Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
• Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.

TAKEAWAY:

• The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
• The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
• There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
• Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).

IN PRACTICE:

“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.

SOURCE:

The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.

LIMITATIONS:

The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.

DISCLOSURES:

The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.

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

TOPLINE:

Approximately one-third of women with rheumatic diseases develop anemia by the third trimester of pregnancy, and two-thirds are iron deficient, according to findings from a longitudinal cohort study.

METHODOLOGY:

• Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
• Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
• Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.

TAKEAWAY:

• The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
• The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
• There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
• Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).

IN PRACTICE:

“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.

SOURCE:

The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.

LIMITATIONS:

The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.

DISCLOSURES:

The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.

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

College-aged women ranked health care providers, the Internet, and school resources as their top resources for seeking information about direct-to-consumer screening for sexually transmitted infections, based on surveys from 92 individuals.

University of North Texas Health Science Center

Direct-to-consumer (DTC) sexually transmitted infection (STI) screening methods involve the use of self-collected samples outside of a clinical setting, and may help reach women who avoid screening or lack access to clinical care, wrote Stacey B. Griner, PhD, of the University of North Texas Health Science Center, Fort Worth, and colleagues.

However, data on the methods used to promote DTC to the young female population are limited, and the goal of the current study was to identify preferred sources and communication channels for DTC STI information in this population, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from 92 women aged 18-24 years at a single university who participated in an online survey. Of these, 24 also participated in in-depth interviews. The mean age of the participants was 20.0 years, and all reported being sexually active in the past year. Approximately two-thirds (68.5%) were White, 24% were Hispanic, 13% were Black or African American; 63.0% overall were heterosexual.

Participants received a description of DTC methods and were asked whether they were interested in receiving more information, and if so, what were their preferred sources for receiving the information. Potential sources included health care providers, friends, family members, partners, the Internet, college resources, classes, and other, and participants were asked to rank these choices in order of preference.

More than half of the participants identified health care providers as their preferred source of information (56.5%), followed by trusted websites (25%), and university-based resources or friends (6.5% for both).

Overall, participants who underwent STI screening in the past 12 months ranked college resources higher than those who had not undergone screening.

Race played a significant role in ranking partners and family members as resources. Compared with Black participants, White participants and those who were biracial/multiracial/another race ranked partners as a significantly more preferred source, but the differences between White and biracial/multiracial/another race were not significant. White participants and Black participants were similar in ranking family as a preferred information source, but White participants, compared with biracial/multiracial/other participants, ranked family as a significantly more preferred source.

Differences in rankings were similar across sexual orientations.

In-depth interviews were conducted on the college campus prior to the COVID-19 pandemic. The mean age of the interview participants was 19.5 years, and most were non-Hispanic White. Sexual orientation was varied, with 50% identifying as heterosexual and 50% identifying as a sexual minority.

In the interviews, health care providers were seen as influential for considering DTC methods, with gynecologists, other specialists, and more experienced physicians deemed the most trustworthy. Interviewees noted social media sites as a way to provide information and raise awareness of DTC methods, such as through the advertisements feature on Instagram. They also identified university orientation as a way to reach students and provide information about DTC options in the context of other health-related orientation topics such as sexual consent and alcohol use.

Many interviewees also mentioned friends as a resource for discussing sex, sexuality, and STI screening, and said they would be accepting of information, knowledge, and emotional support when learning about DTC from friends.

The findings were limited by several factors, including the cross-sectional design, use of data from a single campus setting, and the overrepresentation of White women, and more studies are needed to identify differences by region and campus type that might guide interventions, the researchers noted. The study also was limited by “the lack of specificity of what participants considered to be credible Internet information sources,” they said.

However, the results suggest that using health care providers, trusted websites, and established college resources as dissemination channels may help increase the awareness and use of DTC methods for STI screening in young women, they concluded.

The study was supported in part by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS/STD Prevention at Indiana University and by the University of South Florida College of Public Health. The researchers had no financial conflicts to disclose.

College-aged women ranked health care providers, the Internet, and school resources as their top resources for seeking information about direct-to-consumer screening for sexually transmitted infections, based on surveys from 92 individuals.

University of North Texas Health Science Center

Direct-to-consumer (DTC) sexually transmitted infection (STI) screening methods involve the use of self-collected samples outside of a clinical setting, and may help reach women who avoid screening or lack access to clinical care, wrote Stacey B. Griner, PhD, of the University of North Texas Health Science Center, Fort Worth, and colleagues.

However, data on the methods used to promote DTC to the young female population are limited, and the goal of the current study was to identify preferred sources and communication channels for DTC STI information in this population, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from 92 women aged 18-24 years at a single university who participated in an online survey. Of these, 24 also participated in in-depth interviews. The mean age of the participants was 20.0 years, and all reported being sexually active in the past year. Approximately two-thirds (68.5%) were White, 24% were Hispanic, 13% were Black or African American; 63.0% overall were heterosexual.

Participants received a description of DTC methods and were asked whether they were interested in receiving more information, and if so, what were their preferred sources for receiving the information. Potential sources included health care providers, friends, family members, partners, the Internet, college resources, classes, and other, and participants were asked to rank these choices in order of preference.

More than half of the participants identified health care providers as their preferred source of information (56.5%), followed by trusted websites (25%), and university-based resources or friends (6.5% for both).

Overall, participants who underwent STI screening in the past 12 months ranked college resources higher than those who had not undergone screening.

Race played a significant role in ranking partners and family members as resources. Compared with Black participants, White participants and those who were biracial/multiracial/another race ranked partners as a significantly more preferred source, but the differences between White and biracial/multiracial/another race were not significant. White participants and Black participants were similar in ranking family as a preferred information source, but White participants, compared with biracial/multiracial/other participants, ranked family as a significantly more preferred source.

Differences in rankings were similar across sexual orientations.

In-depth interviews were conducted on the college campus prior to the COVID-19 pandemic. The mean age of the interview participants was 19.5 years, and most were non-Hispanic White. Sexual orientation was varied, with 50% identifying as heterosexual and 50% identifying as a sexual minority.

In the interviews, health care providers were seen as influential for considering DTC methods, with gynecologists, other specialists, and more experienced physicians deemed the most trustworthy. Interviewees noted social media sites as a way to provide information and raise awareness of DTC methods, such as through the advertisements feature on Instagram. They also identified university orientation as a way to reach students and provide information about DTC options in the context of other health-related orientation topics such as sexual consent and alcohol use.

Many interviewees also mentioned friends as a resource for discussing sex, sexuality, and STI screening, and said they would be accepting of information, knowledge, and emotional support when learning about DTC from friends.

The findings were limited by several factors, including the cross-sectional design, use of data from a single campus setting, and the overrepresentation of White women, and more studies are needed to identify differences by region and campus type that might guide interventions, the researchers noted. The study also was limited by “the lack of specificity of what participants considered to be credible Internet information sources,” they said.

However, the results suggest that using health care providers, trusted websites, and established college resources as dissemination channels may help increase the awareness and use of DTC methods for STI screening in young women, they concluded.

The study was supported in part by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS/STD Prevention at Indiana University and by the University of South Florida College of Public Health. The researchers had no financial conflicts to disclose.

College-aged women ranked health care providers, the Internet, and school resources as their top resources for seeking information about direct-to-consumer screening for sexually transmitted infections, based on surveys from 92 individuals.

University of North Texas Health Science Center

Direct-to-consumer (DTC) sexually transmitted infection (STI) screening methods involve the use of self-collected samples outside of a clinical setting, and may help reach women who avoid screening or lack access to clinical care, wrote Stacey B. Griner, PhD, of the University of North Texas Health Science Center, Fort Worth, and colleagues.

However, data on the methods used to promote DTC to the young female population are limited, and the goal of the current study was to identify preferred sources and communication channels for DTC STI information in this population, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from 92 women aged 18-24 years at a single university who participated in an online survey. Of these, 24 also participated in in-depth interviews. The mean age of the participants was 20.0 years, and all reported being sexually active in the past year. Approximately two-thirds (68.5%) were White, 24% were Hispanic, 13% were Black or African American; 63.0% overall were heterosexual.

Participants received a description of DTC methods and were asked whether they were interested in receiving more information, and if so, what were their preferred sources for receiving the information. Potential sources included health care providers, friends, family members, partners, the Internet, college resources, classes, and other, and participants were asked to rank these choices in order of preference.

More than half of the participants identified health care providers as their preferred source of information (56.5%), followed by trusted websites (25%), and university-based resources or friends (6.5% for both).

Overall, participants who underwent STI screening in the past 12 months ranked college resources higher than those who had not undergone screening.

Race played a significant role in ranking partners and family members as resources. Compared with Black participants, White participants and those who were biracial/multiracial/another race ranked partners as a significantly more preferred source, but the differences between White and biracial/multiracial/another race were not significant. White participants and Black participants were similar in ranking family as a preferred information source, but White participants, compared with biracial/multiracial/other participants, ranked family as a significantly more preferred source.

Differences in rankings were similar across sexual orientations.

In-depth interviews were conducted on the college campus prior to the COVID-19 pandemic. The mean age of the interview participants was 19.5 years, and most were non-Hispanic White. Sexual orientation was varied, with 50% identifying as heterosexual and 50% identifying as a sexual minority.

In the interviews, health care providers were seen as influential for considering DTC methods, with gynecologists, other specialists, and more experienced physicians deemed the most trustworthy. Interviewees noted social media sites as a way to provide information and raise awareness of DTC methods, such as through the advertisements feature on Instagram. They also identified university orientation as a way to reach students and provide information about DTC options in the context of other health-related orientation topics such as sexual consent and alcohol use.

Many interviewees also mentioned friends as a resource for discussing sex, sexuality, and STI screening, and said they would be accepting of information, knowledge, and emotional support when learning about DTC from friends.

The findings were limited by several factors, including the cross-sectional design, use of data from a single campus setting, and the overrepresentation of White women, and more studies are needed to identify differences by region and campus type that might guide interventions, the researchers noted. The study also was limited by “the lack of specificity of what participants considered to be credible Internet information sources,” they said.

However, the results suggest that using health care providers, trusted websites, and established college resources as dissemination channels may help increase the awareness and use of DTC methods for STI screening in young women, they concluded.

The study was supported in part by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS/STD Prevention at Indiana University and by the University of South Florida College of Public Health. The researchers had no financial conflicts to disclose.