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New Insights, New Standards: How 2023 Changed Care for Internists
The past year brought major changes in preventive standards for anxiety, HIV, and RSV along with new guidelines for the treatment of atrial fibrillation. For insight into the effect on internal medicine, we turned to Sarah Candler, MD, MPH, a Houston internist who specializes in the care of high-risk older adults.
Q: Which new prevention guidelines had the most impact on you over the past year?
A: I’m a primary care doctor, and most of the internal medicine updates that are interesting to me focus on how we can keep people from getting sick in the first place. That’s especially important in light of the fact that we had a decrease in life expectancy of 2 years [it finally rose slightly in 2022] and widening of the gender gap in life expectancy for men and women.
I’m excited to see new recommendations from the U.S. Preventive Services Task Force, including a new one about using PREP [pre-exposure prophylaxis] to preventively treat anyone who’s at risk for getting HIV. That’s a big one because it’s one of the first times that we’ve identified at-risk groups for screening based on social risk factors, not gender, age, or genetics.
The new recommendation is PREP for anyone who’s at risk for getting HIV because they have a partner with HIV, had an sexually transmitted infection in the last 6 months, or a history of inconsistent or no condom use with partners with unknown HIV status.
PREP therapy is something that most primary care physicians can either do or learn how to do pretty easily. But the treatment does require maintenance and monitoring.
Q: How firm is this recommendation?
A: The task force gives different grades for their recommendations based on how strong the evidence is. For the guidelines about PREP, they give a grade of A. That means this is top of the class: You should definitely do this.
Q: What are the best strategies to ask patients personal questions about their sex lives in order to evaluate their risk?
A: A lot of internal medicine physicians are getting pretty good at this. We see it as part of our job just the same way as we asked things like, “How often are you walking?” and “Have you been feeling down?”
There’s no one right way to have a conversation like that. But it’s key to say, as I do to my patients, that “I’m not here to judge anything. I am truly here to gather information and make recommendations to you as a partner in your care.”
Q: What other guidelines made an impact in 2023?
A: The U.S. Preventive Services Task Force made a recommendation to screen adults aged 18-64 for anxiety, and this guidance got a B grade. [The task force said there’s not enough evidence to support routine anxiety screening in adults 65 and older.]
The new recommendations is a sign that we’re doing a better job at making treatment of those diseases more acceptable. This is also another example of the medical community recognizing that internal medicine physicians are pretty good at identifying and treating mental health.
Q: How do you figure out whether to treat depression/anxiety yourself or refer patients to specialists?
A: As a primary care physician, I feel comfortable diagnosing and managing some mental health disease in my own practice. There are FDA-approved medications for both anxiety and depression that are easily managed by a primary care physician.
And there’s something to the therapeutic relationship, to naming and identifying these conditions with your patients. Some patients feel a bit of relief just knowing that they have a diagnosis.
Q: What should internists know about the new CDC guidelines that promote discussing RSV vaccines with patients who are over 60?
A: The vaccines are recommended for folks who have underlying conditions like lung disease or heart disease. Those are the ones who end up getting really, really sick. There are two adult vaccines that are available, and there’s not a preference for one over the other.
The vaccines are both protein-based, like the old-school versions of vaccines, not the mRNA vaccines that we’ve all been hearing more about through COVID. Anybody who’s reluctant to take an mRNA vaccine can rest assured that the RSV is not protein-based. And they are single-dose vaccines, which is helpful.
Q: What else should internists know about that was new in 2023?
A: I’m super excited about how cardiologists are thinking about atrial fibrillation. In 2023, the American College of Cardiology and the American Heart Association came up with a giant overhaul of how they look at atrial fibrillation. They classify it in stages and allows us to think about stopping it before it starts.
They’re talking about something they’re calling preclinical or subclinical atrial fibrillation, which you may detect on wearables like somebody’s watch or another tool used to monitor heart rate or exercise. It might be the first harbinger that there’s something wrong with the heart rate, and they may not even have symptoms of it. [A 2023 study in The New England Journal of Medicine linked the anticoagulant apixaban, or Eliquis, to a 37% lower risk of stroke and systemic embolism rates in older patients with subclinical atrial fibrillation but an 80% higher risk of major bleeding vs. aspirin therapy.]
And they’re now recommending early rhythm control.
Q: What does early rhythm control mean for patients and physicians?
A: For the longest time, we have thought about atrial fibrillation treatment in terms of rate control and not worrying too much about the rhythm. But now we recognize that it’s actually really important that we get the rhythm under control because physical changes to the heart can lead to permanent damage.
So now they’re recommending catheter ablation as first-line therapy in some patients as a class 1 recommendation because heart function is already decreased. Improving the ability of the heart to beat with a regular rhythm can lead to improvement of function. This was unheard of even 5 years ago.
Q: Should internists be more willing to refer patients with atrial fibrillation to cardiologists?
A: Yes, I think so. One of the biggest changes for me is that I am going to refer new diagnoses of atrial fibrillation to a cardiologist. And I’m going to ask patients if they have wearable devices because sometimes those things might tell me about something like subclinical atrial fibrillation.
Q: There’s also detailed data about atrial fibrillation risk factors, which include older age, smoking, sedentary lifestyle, alcohol use, diabetes, height, obesity, diabetes, and others. Is this information useful?
A: It’s a really great tool to have in the arsenal because it helps me have shared decision-making conversations with my patients in a way that’s much more convincing. A patient might say, “Why do you care if I drink so much? My liver levels are fine.” And I can say, “It’s going to be a risk factor for having problems with your heart.”
For better or worse, people really take the heart very seriously, I am an internal medicine physician, so I love all the organs equally. But man, people get pretty scared when you tell them something can affect their heart. So when I talk to patients about their risk factors, it’s going to really be helpful that I can remind them of the impact that some of these lifestyle behaviors can have on their heart health.
Dr. Candler has no disclosures.
The past year brought major changes in preventive standards for anxiety, HIV, and RSV along with new guidelines for the treatment of atrial fibrillation. For insight into the effect on internal medicine, we turned to Sarah Candler, MD, MPH, a Houston internist who specializes in the care of high-risk older adults.
Q: Which new prevention guidelines had the most impact on you over the past year?
A: I’m a primary care doctor, and most of the internal medicine updates that are interesting to me focus on how we can keep people from getting sick in the first place. That’s especially important in light of the fact that we had a decrease in life expectancy of 2 years [it finally rose slightly in 2022] and widening of the gender gap in life expectancy for men and women.
I’m excited to see new recommendations from the U.S. Preventive Services Task Force, including a new one about using PREP [pre-exposure prophylaxis] to preventively treat anyone who’s at risk for getting HIV. That’s a big one because it’s one of the first times that we’ve identified at-risk groups for screening based on social risk factors, not gender, age, or genetics.
The new recommendation is PREP for anyone who’s at risk for getting HIV because they have a partner with HIV, had an sexually transmitted infection in the last 6 months, or a history of inconsistent or no condom use with partners with unknown HIV status.
PREP therapy is something that most primary care physicians can either do or learn how to do pretty easily. But the treatment does require maintenance and monitoring.
Q: How firm is this recommendation?
A: The task force gives different grades for their recommendations based on how strong the evidence is. For the guidelines about PREP, they give a grade of A. That means this is top of the class: You should definitely do this.
Q: What are the best strategies to ask patients personal questions about their sex lives in order to evaluate their risk?
A: A lot of internal medicine physicians are getting pretty good at this. We see it as part of our job just the same way as we asked things like, “How often are you walking?” and “Have you been feeling down?”
There’s no one right way to have a conversation like that. But it’s key to say, as I do to my patients, that “I’m not here to judge anything. I am truly here to gather information and make recommendations to you as a partner in your care.”
Q: What other guidelines made an impact in 2023?
A: The U.S. Preventive Services Task Force made a recommendation to screen adults aged 18-64 for anxiety, and this guidance got a B grade. [The task force said there’s not enough evidence to support routine anxiety screening in adults 65 and older.]
The new recommendations is a sign that we’re doing a better job at making treatment of those diseases more acceptable. This is also another example of the medical community recognizing that internal medicine physicians are pretty good at identifying and treating mental health.
Q: How do you figure out whether to treat depression/anxiety yourself or refer patients to specialists?
A: As a primary care physician, I feel comfortable diagnosing and managing some mental health disease in my own practice. There are FDA-approved medications for both anxiety and depression that are easily managed by a primary care physician.
And there’s something to the therapeutic relationship, to naming and identifying these conditions with your patients. Some patients feel a bit of relief just knowing that they have a diagnosis.
Q: What should internists know about the new CDC guidelines that promote discussing RSV vaccines with patients who are over 60?
A: The vaccines are recommended for folks who have underlying conditions like lung disease or heart disease. Those are the ones who end up getting really, really sick. There are two adult vaccines that are available, and there’s not a preference for one over the other.
The vaccines are both protein-based, like the old-school versions of vaccines, not the mRNA vaccines that we’ve all been hearing more about through COVID. Anybody who’s reluctant to take an mRNA vaccine can rest assured that the RSV is not protein-based. And they are single-dose vaccines, which is helpful.
Q: What else should internists know about that was new in 2023?
A: I’m super excited about how cardiologists are thinking about atrial fibrillation. In 2023, the American College of Cardiology and the American Heart Association came up with a giant overhaul of how they look at atrial fibrillation. They classify it in stages and allows us to think about stopping it before it starts.
They’re talking about something they’re calling preclinical or subclinical atrial fibrillation, which you may detect on wearables like somebody’s watch or another tool used to monitor heart rate or exercise. It might be the first harbinger that there’s something wrong with the heart rate, and they may not even have symptoms of it. [A 2023 study in The New England Journal of Medicine linked the anticoagulant apixaban, or Eliquis, to a 37% lower risk of stroke and systemic embolism rates in older patients with subclinical atrial fibrillation but an 80% higher risk of major bleeding vs. aspirin therapy.]
And they’re now recommending early rhythm control.
Q: What does early rhythm control mean for patients and physicians?
A: For the longest time, we have thought about atrial fibrillation treatment in terms of rate control and not worrying too much about the rhythm. But now we recognize that it’s actually really important that we get the rhythm under control because physical changes to the heart can lead to permanent damage.
So now they’re recommending catheter ablation as first-line therapy in some patients as a class 1 recommendation because heart function is already decreased. Improving the ability of the heart to beat with a regular rhythm can lead to improvement of function. This was unheard of even 5 years ago.
Q: Should internists be more willing to refer patients with atrial fibrillation to cardiologists?
A: Yes, I think so. One of the biggest changes for me is that I am going to refer new diagnoses of atrial fibrillation to a cardiologist. And I’m going to ask patients if they have wearable devices because sometimes those things might tell me about something like subclinical atrial fibrillation.
Q: There’s also detailed data about atrial fibrillation risk factors, which include older age, smoking, sedentary lifestyle, alcohol use, diabetes, height, obesity, diabetes, and others. Is this information useful?
A: It’s a really great tool to have in the arsenal because it helps me have shared decision-making conversations with my patients in a way that’s much more convincing. A patient might say, “Why do you care if I drink so much? My liver levels are fine.” And I can say, “It’s going to be a risk factor for having problems with your heart.”
For better or worse, people really take the heart very seriously, I am an internal medicine physician, so I love all the organs equally. But man, people get pretty scared when you tell them something can affect their heart. So when I talk to patients about their risk factors, it’s going to really be helpful that I can remind them of the impact that some of these lifestyle behaviors can have on their heart health.
Dr. Candler has no disclosures.
The past year brought major changes in preventive standards for anxiety, HIV, and RSV along with new guidelines for the treatment of atrial fibrillation. For insight into the effect on internal medicine, we turned to Sarah Candler, MD, MPH, a Houston internist who specializes in the care of high-risk older adults.
Q: Which new prevention guidelines had the most impact on you over the past year?
A: I’m a primary care doctor, and most of the internal medicine updates that are interesting to me focus on how we can keep people from getting sick in the first place. That’s especially important in light of the fact that we had a decrease in life expectancy of 2 years [it finally rose slightly in 2022] and widening of the gender gap in life expectancy for men and women.
I’m excited to see new recommendations from the U.S. Preventive Services Task Force, including a new one about using PREP [pre-exposure prophylaxis] to preventively treat anyone who’s at risk for getting HIV. That’s a big one because it’s one of the first times that we’ve identified at-risk groups for screening based on social risk factors, not gender, age, or genetics.
The new recommendation is PREP for anyone who’s at risk for getting HIV because they have a partner with HIV, had an sexually transmitted infection in the last 6 months, or a history of inconsistent or no condom use with partners with unknown HIV status.
PREP therapy is something that most primary care physicians can either do or learn how to do pretty easily. But the treatment does require maintenance and monitoring.
Q: How firm is this recommendation?
A: The task force gives different grades for their recommendations based on how strong the evidence is. For the guidelines about PREP, they give a grade of A. That means this is top of the class: You should definitely do this.
Q: What are the best strategies to ask patients personal questions about their sex lives in order to evaluate their risk?
A: A lot of internal medicine physicians are getting pretty good at this. We see it as part of our job just the same way as we asked things like, “How often are you walking?” and “Have you been feeling down?”
There’s no one right way to have a conversation like that. But it’s key to say, as I do to my patients, that “I’m not here to judge anything. I am truly here to gather information and make recommendations to you as a partner in your care.”
Q: What other guidelines made an impact in 2023?
A: The U.S. Preventive Services Task Force made a recommendation to screen adults aged 18-64 for anxiety, and this guidance got a B grade. [The task force said there’s not enough evidence to support routine anxiety screening in adults 65 and older.]
The new recommendations is a sign that we’re doing a better job at making treatment of those diseases more acceptable. This is also another example of the medical community recognizing that internal medicine physicians are pretty good at identifying and treating mental health.
Q: How do you figure out whether to treat depression/anxiety yourself or refer patients to specialists?
A: As a primary care physician, I feel comfortable diagnosing and managing some mental health disease in my own practice. There are FDA-approved medications for both anxiety and depression that are easily managed by a primary care physician.
And there’s something to the therapeutic relationship, to naming and identifying these conditions with your patients. Some patients feel a bit of relief just knowing that they have a diagnosis.
Q: What should internists know about the new CDC guidelines that promote discussing RSV vaccines with patients who are over 60?
A: The vaccines are recommended for folks who have underlying conditions like lung disease or heart disease. Those are the ones who end up getting really, really sick. There are two adult vaccines that are available, and there’s not a preference for one over the other.
The vaccines are both protein-based, like the old-school versions of vaccines, not the mRNA vaccines that we’ve all been hearing more about through COVID. Anybody who’s reluctant to take an mRNA vaccine can rest assured that the RSV is not protein-based. And they are single-dose vaccines, which is helpful.
Q: What else should internists know about that was new in 2023?
A: I’m super excited about how cardiologists are thinking about atrial fibrillation. In 2023, the American College of Cardiology and the American Heart Association came up with a giant overhaul of how they look at atrial fibrillation. They classify it in stages and allows us to think about stopping it before it starts.
They’re talking about something they’re calling preclinical or subclinical atrial fibrillation, which you may detect on wearables like somebody’s watch or another tool used to monitor heart rate or exercise. It might be the first harbinger that there’s something wrong with the heart rate, and they may not even have symptoms of it. [A 2023 study in The New England Journal of Medicine linked the anticoagulant apixaban, or Eliquis, to a 37% lower risk of stroke and systemic embolism rates in older patients with subclinical atrial fibrillation but an 80% higher risk of major bleeding vs. aspirin therapy.]
And they’re now recommending early rhythm control.
Q: What does early rhythm control mean for patients and physicians?
A: For the longest time, we have thought about atrial fibrillation treatment in terms of rate control and not worrying too much about the rhythm. But now we recognize that it’s actually really important that we get the rhythm under control because physical changes to the heart can lead to permanent damage.
So now they’re recommending catheter ablation as first-line therapy in some patients as a class 1 recommendation because heart function is already decreased. Improving the ability of the heart to beat with a regular rhythm can lead to improvement of function. This was unheard of even 5 years ago.
Q: Should internists be more willing to refer patients with atrial fibrillation to cardiologists?
A: Yes, I think so. One of the biggest changes for me is that I am going to refer new diagnoses of atrial fibrillation to a cardiologist. And I’m going to ask patients if they have wearable devices because sometimes those things might tell me about something like subclinical atrial fibrillation.
Q: There’s also detailed data about atrial fibrillation risk factors, which include older age, smoking, sedentary lifestyle, alcohol use, diabetes, height, obesity, diabetes, and others. Is this information useful?
A: It’s a really great tool to have in the arsenal because it helps me have shared decision-making conversations with my patients in a way that’s much more convincing. A patient might say, “Why do you care if I drink so much? My liver levels are fine.” And I can say, “It’s going to be a risk factor for having problems with your heart.”
For better or worse, people really take the heart very seriously, I am an internal medicine physician, so I love all the organs equally. But man, people get pretty scared when you tell them something can affect their heart. So when I talk to patients about their risk factors, it’s going to really be helpful that I can remind them of the impact that some of these lifestyle behaviors can have on their heart health.
Dr. Candler has no disclosures.
How an Obesity Drug Could Help Alcohol Use Disorder
The glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide has made headlines as a US Food and Drug Administration (FDA)–approved treatment for type 2 diabetes (Ozempic) and obesity (Wegovy).
Recently,
“There is some really interesting preclinical research in rodents and monkeys that shows that GLP-1 agonist molecules, like semaglutide, have the effect of reducing the consumption of not just food, but also alcohol, nicotine, cocaine and amphetamines,” Kyle Simmons, PhD, professor of pharmacology and physiology at Oklahoma State University Center for Health Sciences in Tulsa, said in an interview.
Some of that early research was conducted by Elisabet Jerlhag Holm, PhD, and colleagues at University of Gothenburg, Sweden.
“We have worked on GLP-1 and alcohol since 2012, and observe promising effects,” Holm told this news organization.
Her team published two studies earlier this year — one in one in Frontiers in Pharmacology and the other in eBioMedicine — demonstrating that semaglutide, in low doses, reduces alcohol intake in male and female rats.
“We have shown that semaglutide binds to the nucleus accumbens — an area of the brain associated with reward. We have also shown that semaglutide alters the dopamine metabolism when alcohol is on board. This provides a tentative mechanism,” Dr. Holm said.
First Human Data
The preclinical data fueled interest in testing the value of the GLP-1 agonist in patient populations with addiction.
Dr. Simmons and colleagues have now published what is believed to be the first evidence in humans that semaglutide specifically reduces the symptoms of alcohol use disorder (AUD).
In a report published online on November 27 in The Journal of Clinical Psychiatry, they describe six patients (of whom five are female; mean age, 43 years) who received semaglutide treatment in the course of pharmacotherapy for weight loss.
All six screened positive for AUD on the Alcohol Use Disorders Identification Test (AUDIT), and all six showed significant improvement in their alcohol-related symptoms after starting semaglutide.
An AUDIT score > 8 is considered positive. The mean AUDIT score at baseline was 14. It fell to 4.5 on average after semaglutide treatment. The mean 9.5-point decrease in AUDIT scores with semaglutide was statistically significant (P < .001).
The patients were followed up from a few weeks to almost 9 months, and all of them had a reduction in AUD symptoms. At the various follow-up time points, all six patients had AUDIT scores consistent with “low-risk” drinking.
Strong Response at Low Doses
“There was a very strong response, even at a very low dose,” lead author Jesse Richards, DO, director of obesity medicine and assistant professor of medicine University of Oklahoma School of Community Medicine, Tulsa, said in an interview.
Three patients were treated with 0.5 mg of semaglutide weekly, two with 0.25 mg weekly, and one with 1 mg weekly. These doses are lower than those currently approved for treatment of type 2 diabetes and obesity.
Dr. Holm is not surprised by the results in these six patients. “Based on our preclinical data, this outcome is expected. The data are promising and bigger studies needed,” she said.
Simmons is currently leading a randomized placebo-controlled trial to further test the impact of semaglutide on AUD.
The STAR (Semaglutide Therapy for Alcohol Reduction) study is funded by the Hardesty Family Foundation and Oklahoma State University Center for Health Sciences.
A sister study is also currently underway in Baltimore, funded by the National Institute on Drug Abuse.
Hopefully, these studies will be able to “definitively tell us whether semaglutide is safe and effective for treatment” for AUD, Dr. Simmons said in a statement.
Despite being a major cause of preventable death worldwide, AUD currently has only three FDA-approved pharmacotherapies. However, there has been limited uptake of these drugs.
“There remains a significant treatment gap and need for new and novel or perhaps better tolerated or different mechanism treatment options for patients,” Dr. Richards said.
The preclinical and early clinical data provide a “signal” of a treatment effect for semaglutide in AUD, Dr. Richards said. The randomized controlled trials now underway should be concluding in the next 1-2 years, “at which point we’ll have a much better sense of the safety and efficacy of this drug for AUD,” he said.
The case series had no specific funding. Dr. Richards is on speakers bureaus for Rhythm Pharmaceuticals and Novo Nordisk and is on an advisory board for Rhythm Pharmaceuticals. Simmons is the recipient of a grant from the Hardesty Family Foundation to support an ongoing clinical trial of semaglutide in the treatment of AUD. Dr. Holm has no relevant disclosures.
A version of this article appeared on Medscape.com.
The glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide has made headlines as a US Food and Drug Administration (FDA)–approved treatment for type 2 diabetes (Ozempic) and obesity (Wegovy).
Recently,
“There is some really interesting preclinical research in rodents and monkeys that shows that GLP-1 agonist molecules, like semaglutide, have the effect of reducing the consumption of not just food, but also alcohol, nicotine, cocaine and amphetamines,” Kyle Simmons, PhD, professor of pharmacology and physiology at Oklahoma State University Center for Health Sciences in Tulsa, said in an interview.
Some of that early research was conducted by Elisabet Jerlhag Holm, PhD, and colleagues at University of Gothenburg, Sweden.
“We have worked on GLP-1 and alcohol since 2012, and observe promising effects,” Holm told this news organization.
Her team published two studies earlier this year — one in one in Frontiers in Pharmacology and the other in eBioMedicine — demonstrating that semaglutide, in low doses, reduces alcohol intake in male and female rats.
“We have shown that semaglutide binds to the nucleus accumbens — an area of the brain associated with reward. We have also shown that semaglutide alters the dopamine metabolism when alcohol is on board. This provides a tentative mechanism,” Dr. Holm said.
First Human Data
The preclinical data fueled interest in testing the value of the GLP-1 agonist in patient populations with addiction.
Dr. Simmons and colleagues have now published what is believed to be the first evidence in humans that semaglutide specifically reduces the symptoms of alcohol use disorder (AUD).
In a report published online on November 27 in The Journal of Clinical Psychiatry, they describe six patients (of whom five are female; mean age, 43 years) who received semaglutide treatment in the course of pharmacotherapy for weight loss.
All six screened positive for AUD on the Alcohol Use Disorders Identification Test (AUDIT), and all six showed significant improvement in their alcohol-related symptoms after starting semaglutide.
An AUDIT score > 8 is considered positive. The mean AUDIT score at baseline was 14. It fell to 4.5 on average after semaglutide treatment. The mean 9.5-point decrease in AUDIT scores with semaglutide was statistically significant (P < .001).
The patients were followed up from a few weeks to almost 9 months, and all of them had a reduction in AUD symptoms. At the various follow-up time points, all six patients had AUDIT scores consistent with “low-risk” drinking.
Strong Response at Low Doses
“There was a very strong response, even at a very low dose,” lead author Jesse Richards, DO, director of obesity medicine and assistant professor of medicine University of Oklahoma School of Community Medicine, Tulsa, said in an interview.
Three patients were treated with 0.5 mg of semaglutide weekly, two with 0.25 mg weekly, and one with 1 mg weekly. These doses are lower than those currently approved for treatment of type 2 diabetes and obesity.
Dr. Holm is not surprised by the results in these six patients. “Based on our preclinical data, this outcome is expected. The data are promising and bigger studies needed,” she said.
Simmons is currently leading a randomized placebo-controlled trial to further test the impact of semaglutide on AUD.
The STAR (Semaglutide Therapy for Alcohol Reduction) study is funded by the Hardesty Family Foundation and Oklahoma State University Center for Health Sciences.
A sister study is also currently underway in Baltimore, funded by the National Institute on Drug Abuse.
Hopefully, these studies will be able to “definitively tell us whether semaglutide is safe and effective for treatment” for AUD, Dr. Simmons said in a statement.
Despite being a major cause of preventable death worldwide, AUD currently has only three FDA-approved pharmacotherapies. However, there has been limited uptake of these drugs.
“There remains a significant treatment gap and need for new and novel or perhaps better tolerated or different mechanism treatment options for patients,” Dr. Richards said.
The preclinical and early clinical data provide a “signal” of a treatment effect for semaglutide in AUD, Dr. Richards said. The randomized controlled trials now underway should be concluding in the next 1-2 years, “at which point we’ll have a much better sense of the safety and efficacy of this drug for AUD,” he said.
The case series had no specific funding. Dr. Richards is on speakers bureaus for Rhythm Pharmaceuticals and Novo Nordisk and is on an advisory board for Rhythm Pharmaceuticals. Simmons is the recipient of a grant from the Hardesty Family Foundation to support an ongoing clinical trial of semaglutide in the treatment of AUD. Dr. Holm has no relevant disclosures.
A version of this article appeared on Medscape.com.
The glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide has made headlines as a US Food and Drug Administration (FDA)–approved treatment for type 2 diabetes (Ozempic) and obesity (Wegovy).
Recently,
“There is some really interesting preclinical research in rodents and monkeys that shows that GLP-1 agonist molecules, like semaglutide, have the effect of reducing the consumption of not just food, but also alcohol, nicotine, cocaine and amphetamines,” Kyle Simmons, PhD, professor of pharmacology and physiology at Oklahoma State University Center for Health Sciences in Tulsa, said in an interview.
Some of that early research was conducted by Elisabet Jerlhag Holm, PhD, and colleagues at University of Gothenburg, Sweden.
“We have worked on GLP-1 and alcohol since 2012, and observe promising effects,” Holm told this news organization.
Her team published two studies earlier this year — one in one in Frontiers in Pharmacology and the other in eBioMedicine — demonstrating that semaglutide, in low doses, reduces alcohol intake in male and female rats.
“We have shown that semaglutide binds to the nucleus accumbens — an area of the brain associated with reward. We have also shown that semaglutide alters the dopamine metabolism when alcohol is on board. This provides a tentative mechanism,” Dr. Holm said.
First Human Data
The preclinical data fueled interest in testing the value of the GLP-1 agonist in patient populations with addiction.
Dr. Simmons and colleagues have now published what is believed to be the first evidence in humans that semaglutide specifically reduces the symptoms of alcohol use disorder (AUD).
In a report published online on November 27 in The Journal of Clinical Psychiatry, they describe six patients (of whom five are female; mean age, 43 years) who received semaglutide treatment in the course of pharmacotherapy for weight loss.
All six screened positive for AUD on the Alcohol Use Disorders Identification Test (AUDIT), and all six showed significant improvement in their alcohol-related symptoms after starting semaglutide.
An AUDIT score > 8 is considered positive. The mean AUDIT score at baseline was 14. It fell to 4.5 on average after semaglutide treatment. The mean 9.5-point decrease in AUDIT scores with semaglutide was statistically significant (P < .001).
The patients were followed up from a few weeks to almost 9 months, and all of them had a reduction in AUD symptoms. At the various follow-up time points, all six patients had AUDIT scores consistent with “low-risk” drinking.
Strong Response at Low Doses
“There was a very strong response, even at a very low dose,” lead author Jesse Richards, DO, director of obesity medicine and assistant professor of medicine University of Oklahoma School of Community Medicine, Tulsa, said in an interview.
Three patients were treated with 0.5 mg of semaglutide weekly, two with 0.25 mg weekly, and one with 1 mg weekly. These doses are lower than those currently approved for treatment of type 2 diabetes and obesity.
Dr. Holm is not surprised by the results in these six patients. “Based on our preclinical data, this outcome is expected. The data are promising and bigger studies needed,” she said.
Simmons is currently leading a randomized placebo-controlled trial to further test the impact of semaglutide on AUD.
The STAR (Semaglutide Therapy for Alcohol Reduction) study is funded by the Hardesty Family Foundation and Oklahoma State University Center for Health Sciences.
A sister study is also currently underway in Baltimore, funded by the National Institute on Drug Abuse.
Hopefully, these studies will be able to “definitively tell us whether semaglutide is safe and effective for treatment” for AUD, Dr. Simmons said in a statement.
Despite being a major cause of preventable death worldwide, AUD currently has only three FDA-approved pharmacotherapies. However, there has been limited uptake of these drugs.
“There remains a significant treatment gap and need for new and novel or perhaps better tolerated or different mechanism treatment options for patients,” Dr. Richards said.
The preclinical and early clinical data provide a “signal” of a treatment effect for semaglutide in AUD, Dr. Richards said. The randomized controlled trials now underway should be concluding in the next 1-2 years, “at which point we’ll have a much better sense of the safety and efficacy of this drug for AUD,” he said.
The case series had no specific funding. Dr. Richards is on speakers bureaus for Rhythm Pharmaceuticals and Novo Nordisk and is on an advisory board for Rhythm Pharmaceuticals. Simmons is the recipient of a grant from the Hardesty Family Foundation to support an ongoing clinical trial of semaglutide in the treatment of AUD. Dr. Holm has no relevant disclosures.
A version of this article appeared on Medscape.com.
What Makes Patients Vulnerable to Delusions of Parasitosis?
, reported researchers in a small retrospective case-control study.
Delusions of parasitosis (DOP) affects mostly middle-aged women and has associations with renal failure and some medications, wrote corresponding author Colleen Reisz, MD, a dermatologist with the department of internal medicine at the University of Missouri–Kansas City School of Medicine, and her coauthors. The study was published online December 15, 2023, in the Journal of the American Academy of Dermatology.
“We hypothesize that vulnerability to DOP emerges when multiple factors combine, such as age, sex, medications, and changes in [drug] clearance capacity,” Dr. Reisz and her coauthors wrote. “Changes in health care, such as the dramatic increase in stimulant prescriptions and alternatives to opioids in pain management, may be contributing to off target drug effects on the brain.”
To test their hypothesis, the researchers conducted a case-control study of biometric and pharmaceutical data from 34 patients with DOP which they compared to an age-matched control group of 53 women presenting with a dermatitis above the clavicle from a general dermatology practice between 2012 and 2020. They de-identified the data and performed statistical analysis on variables that included biometric data and intake of pharmaceuticals and nutraceuticals. Polypharmacy was defined as five or more drugs.
Of the 34 patients with DOP, 27 were women with a mean age of 58 years and 7 were men with a mean age of 60 years. Dr. Reisz and her colleagues observed statistical significance between cases and controls in terms of polypharmacy (P = .011), attention-deficit/hyperactivity disorder medications (P < .001), selective serotonin reuptake inhibitors (P = .005), opioids (P = .003), and gabapentin (P = .003).
In other findings, half of DOP cases presented with samples of perceived parasitic material, and four associated the perceived infestation with a single emotion-laden event. This prompted the researchers “to consider that DOP may share mechanisms with fear conditioning and extinction,” they wrote. “Fear conditioning refers to the process of memory acquisition and extinction. This process is essential for survival and has been studied in posttraumatic stress disorder.”
They acknowledged certain limitations of the study, including its retrospective single-center design and the lack of control for factors such as socioeconomic background and level of education.
“Patients with DOP should undergo detailed drug histories and examination of clearance profiles, especially renal function,” the researchers concluded.
Evan A. Rieder, MD, a New York City–based dermatologist and psychiatrist who was asked to comment on the study, said that delusional infestation is one of the most difficult medical conditions to treat and study.
“Though the numbers of cases in this research letter are small, they are instructive in demonstrating a high burden of polypharmacy including psychostimulants, opioids, and SSRIs in such patients,” he told this news organization. “Dermatologists should be performing detailed drug histories, obtaining comprehensive lab work, and considering the effects of medications — both illicit and prescribed — on clinical presentations. While in many cases, delusional patients refuse to consent to psychopharmacologic medications (or treatment in general), the elimination or decrease in dose of certain problematic medications may be helpful in and of themselves.”
The researchers reported having no financial disclosures. Dr. Rieder disclosed that he is a consultant for AbbVie, L’Oréal, Pierre Fabre, Procter & Gamble, and Unilever.
, reported researchers in a small retrospective case-control study.
Delusions of parasitosis (DOP) affects mostly middle-aged women and has associations with renal failure and some medications, wrote corresponding author Colleen Reisz, MD, a dermatologist with the department of internal medicine at the University of Missouri–Kansas City School of Medicine, and her coauthors. The study was published online December 15, 2023, in the Journal of the American Academy of Dermatology.
“We hypothesize that vulnerability to DOP emerges when multiple factors combine, such as age, sex, medications, and changes in [drug] clearance capacity,” Dr. Reisz and her coauthors wrote. “Changes in health care, such as the dramatic increase in stimulant prescriptions and alternatives to opioids in pain management, may be contributing to off target drug effects on the brain.”
To test their hypothesis, the researchers conducted a case-control study of biometric and pharmaceutical data from 34 patients with DOP which they compared to an age-matched control group of 53 women presenting with a dermatitis above the clavicle from a general dermatology practice between 2012 and 2020. They de-identified the data and performed statistical analysis on variables that included biometric data and intake of pharmaceuticals and nutraceuticals. Polypharmacy was defined as five or more drugs.
Of the 34 patients with DOP, 27 were women with a mean age of 58 years and 7 were men with a mean age of 60 years. Dr. Reisz and her colleagues observed statistical significance between cases and controls in terms of polypharmacy (P = .011), attention-deficit/hyperactivity disorder medications (P < .001), selective serotonin reuptake inhibitors (P = .005), opioids (P = .003), and gabapentin (P = .003).
In other findings, half of DOP cases presented with samples of perceived parasitic material, and four associated the perceived infestation with a single emotion-laden event. This prompted the researchers “to consider that DOP may share mechanisms with fear conditioning and extinction,” they wrote. “Fear conditioning refers to the process of memory acquisition and extinction. This process is essential for survival and has been studied in posttraumatic stress disorder.”
They acknowledged certain limitations of the study, including its retrospective single-center design and the lack of control for factors such as socioeconomic background and level of education.
“Patients with DOP should undergo detailed drug histories and examination of clearance profiles, especially renal function,” the researchers concluded.
Evan A. Rieder, MD, a New York City–based dermatologist and psychiatrist who was asked to comment on the study, said that delusional infestation is one of the most difficult medical conditions to treat and study.
“Though the numbers of cases in this research letter are small, they are instructive in demonstrating a high burden of polypharmacy including psychostimulants, opioids, and SSRIs in such patients,” he told this news organization. “Dermatologists should be performing detailed drug histories, obtaining comprehensive lab work, and considering the effects of medications — both illicit and prescribed — on clinical presentations. While in many cases, delusional patients refuse to consent to psychopharmacologic medications (or treatment in general), the elimination or decrease in dose of certain problematic medications may be helpful in and of themselves.”
The researchers reported having no financial disclosures. Dr. Rieder disclosed that he is a consultant for AbbVie, L’Oréal, Pierre Fabre, Procter & Gamble, and Unilever.
, reported researchers in a small retrospective case-control study.
Delusions of parasitosis (DOP) affects mostly middle-aged women and has associations with renal failure and some medications, wrote corresponding author Colleen Reisz, MD, a dermatologist with the department of internal medicine at the University of Missouri–Kansas City School of Medicine, and her coauthors. The study was published online December 15, 2023, in the Journal of the American Academy of Dermatology.
“We hypothesize that vulnerability to DOP emerges when multiple factors combine, such as age, sex, medications, and changes in [drug] clearance capacity,” Dr. Reisz and her coauthors wrote. “Changes in health care, such as the dramatic increase in stimulant prescriptions and alternatives to opioids in pain management, may be contributing to off target drug effects on the brain.”
To test their hypothesis, the researchers conducted a case-control study of biometric and pharmaceutical data from 34 patients with DOP which they compared to an age-matched control group of 53 women presenting with a dermatitis above the clavicle from a general dermatology practice between 2012 and 2020. They de-identified the data and performed statistical analysis on variables that included biometric data and intake of pharmaceuticals and nutraceuticals. Polypharmacy was defined as five or more drugs.
Of the 34 patients with DOP, 27 were women with a mean age of 58 years and 7 were men with a mean age of 60 years. Dr. Reisz and her colleagues observed statistical significance between cases and controls in terms of polypharmacy (P = .011), attention-deficit/hyperactivity disorder medications (P < .001), selective serotonin reuptake inhibitors (P = .005), opioids (P = .003), and gabapentin (P = .003).
In other findings, half of DOP cases presented with samples of perceived parasitic material, and four associated the perceived infestation with a single emotion-laden event. This prompted the researchers “to consider that DOP may share mechanisms with fear conditioning and extinction,” they wrote. “Fear conditioning refers to the process of memory acquisition and extinction. This process is essential for survival and has been studied in posttraumatic stress disorder.”
They acknowledged certain limitations of the study, including its retrospective single-center design and the lack of control for factors such as socioeconomic background and level of education.
“Patients with DOP should undergo detailed drug histories and examination of clearance profiles, especially renal function,” the researchers concluded.
Evan A. Rieder, MD, a New York City–based dermatologist and psychiatrist who was asked to comment on the study, said that delusional infestation is one of the most difficult medical conditions to treat and study.
“Though the numbers of cases in this research letter are small, they are instructive in demonstrating a high burden of polypharmacy including psychostimulants, opioids, and SSRIs in such patients,” he told this news organization. “Dermatologists should be performing detailed drug histories, obtaining comprehensive lab work, and considering the effects of medications — both illicit and prescribed — on clinical presentations. While in many cases, delusional patients refuse to consent to psychopharmacologic medications (or treatment in general), the elimination or decrease in dose of certain problematic medications may be helpful in and of themselves.”
The researchers reported having no financial disclosures. Dr. Rieder disclosed that he is a consultant for AbbVie, L’Oréal, Pierre Fabre, Procter & Gamble, and Unilever.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Light therapy a beacon of hope for Alzheimer’s?
TOPLINE:
Light therapy leads to significant improvement in several sleep measures and helps alleviate depression and agitation in patients with Alzheimer’s disease (AD), a meta-analysis of 15 high-quality trials shows.
METHODOLOGY:
- This meta-analysis included 15 randomized controlled trials involving 598 patients with mild to moderate AD.
- The included trials were written in English, published between 2005 and 2022, and performed in seven countries. A fixed-effects model was used for data analysis.
TAKEAWAY:
- Light therapy significantly improved sleep efficiency (mean difference [MD], −2.42; P < .00001), increased interdaily stability (MD, −0.04; P < .00001), and reduced intradaily variability (MD, −0.04; P < .00001), indicating better sleep quality.
- Light therapy reduced agitation (MD, −3.97; P < .00001), depression (MD, −2.55; P < .00001), and caregiver burden (MD, −3.57; P < .00001).
- Light therapy also had a significant advantage over usual care in reducing the severity of psychobehavioral symptoms as assessed by the Neuropsychiatric Inventory (MD, −3.07; P < .00001).
- Light therapy had no statistically significant effect on improving cognitive function as measured by the Mini-Mental State Examination.
IN PRACTICE:
“These findings, combined with its low side-effects, suggest the role of light therapy as a promising treatment for AD. Although light therapy has fewer side effects than pharmacological treatment, adverse behavioral outcomes in patients due to bright light exposure should be considered,” the authors wrote.
SOURCE:
The study by Lili Zang and colleagues from Weifang Medical University School of Nursing, Shandong Province, China, was published online on December 6, 2023, in PLOS One.
LIMITATIONS:
The types and degrees of dementia in the included studies were inconsistent, potentially affecting the outcome indicators. Some articles did not clearly describe their randomization and allocation concealment methods, indicating possible bias in these studies.
DISCLOSURES:
The study was supported by the Natural Science Foundation of Shandong Province, China. The authors declared no competing interests.
Megan Brooks has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Light therapy leads to significant improvement in several sleep measures and helps alleviate depression and agitation in patients with Alzheimer’s disease (AD), a meta-analysis of 15 high-quality trials shows.
METHODOLOGY:
- This meta-analysis included 15 randomized controlled trials involving 598 patients with mild to moderate AD.
- The included trials were written in English, published between 2005 and 2022, and performed in seven countries. A fixed-effects model was used for data analysis.
TAKEAWAY:
- Light therapy significantly improved sleep efficiency (mean difference [MD], −2.42; P < .00001), increased interdaily stability (MD, −0.04; P < .00001), and reduced intradaily variability (MD, −0.04; P < .00001), indicating better sleep quality.
- Light therapy reduced agitation (MD, −3.97; P < .00001), depression (MD, −2.55; P < .00001), and caregiver burden (MD, −3.57; P < .00001).
- Light therapy also had a significant advantage over usual care in reducing the severity of psychobehavioral symptoms as assessed by the Neuropsychiatric Inventory (MD, −3.07; P < .00001).
- Light therapy had no statistically significant effect on improving cognitive function as measured by the Mini-Mental State Examination.
IN PRACTICE:
“These findings, combined with its low side-effects, suggest the role of light therapy as a promising treatment for AD. Although light therapy has fewer side effects than pharmacological treatment, adverse behavioral outcomes in patients due to bright light exposure should be considered,” the authors wrote.
SOURCE:
The study by Lili Zang and colleagues from Weifang Medical University School of Nursing, Shandong Province, China, was published online on December 6, 2023, in PLOS One.
LIMITATIONS:
The types and degrees of dementia in the included studies were inconsistent, potentially affecting the outcome indicators. Some articles did not clearly describe their randomization and allocation concealment methods, indicating possible bias in these studies.
DISCLOSURES:
The study was supported by the Natural Science Foundation of Shandong Province, China. The authors declared no competing interests.
Megan Brooks has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Light therapy leads to significant improvement in several sleep measures and helps alleviate depression and agitation in patients with Alzheimer’s disease (AD), a meta-analysis of 15 high-quality trials shows.
METHODOLOGY:
- This meta-analysis included 15 randomized controlled trials involving 598 patients with mild to moderate AD.
- The included trials were written in English, published between 2005 and 2022, and performed in seven countries. A fixed-effects model was used for data analysis.
TAKEAWAY:
- Light therapy significantly improved sleep efficiency (mean difference [MD], −2.42; P < .00001), increased interdaily stability (MD, −0.04; P < .00001), and reduced intradaily variability (MD, −0.04; P < .00001), indicating better sleep quality.
- Light therapy reduced agitation (MD, −3.97; P < .00001), depression (MD, −2.55; P < .00001), and caregiver burden (MD, −3.57; P < .00001).
- Light therapy also had a significant advantage over usual care in reducing the severity of psychobehavioral symptoms as assessed by the Neuropsychiatric Inventory (MD, −3.07; P < .00001).
- Light therapy had no statistically significant effect on improving cognitive function as measured by the Mini-Mental State Examination.
IN PRACTICE:
“These findings, combined with its low side-effects, suggest the role of light therapy as a promising treatment for AD. Although light therapy has fewer side effects than pharmacological treatment, adverse behavioral outcomes in patients due to bright light exposure should be considered,” the authors wrote.
SOURCE:
The study by Lili Zang and colleagues from Weifang Medical University School of Nursing, Shandong Province, China, was published online on December 6, 2023, in PLOS One.
LIMITATIONS:
The types and degrees of dementia in the included studies were inconsistent, potentially affecting the outcome indicators. Some articles did not clearly describe their randomization and allocation concealment methods, indicating possible bias in these studies.
DISCLOSURES:
The study was supported by the Natural Science Foundation of Shandong Province, China. The authors declared no competing interests.
Megan Brooks has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Depression, constipation, UTIs early signs of MS?
However, these prodromal symptoms are also more likely to occur in people with two other autoimmune diseases — lupus and Crohn’s disease — and therefore, will not help earlier diagnosis, study investigator, Céline Louapre, professor of neurology, Sorbonne University and Paris Brain Institute, Paris, France, said in an interview.
“On the other hand, in certain patients who may be at particular risk of developing MS, such as in certain familial forms or in patients with incidental inflammatory lesions discovered on MRI, the presence of these symptoms could suggest an already active process, prior to the first typical symptoms of the disease,” she noted.
Retracing MS Origins
The case-control study, published online in Neurology, included 20,174 people with newly diagnosed MS who were matched to 54,790 without MS, as well as 30,477 with Crohn’s disease and 7337 with lupus.
Using International Classification of Diseases, 10th revision (ICD-10) codes in electronic health records, the researchers assessed the associations between 113 diseases and symptoms in the 5 years before and after an MS diagnosis.
Twelve ICD-10 codes were significantly positively associated with the risk for MS compared with controls without MS.
After considering ICD-10 codes suggestive of neurologic symptoms as the first diagnosis of MS, the following five ICD-10 codes remained significantly associated with MS:
- Depression (odds ratio [OR], 1.22; 95% CI, 1.11-1.34)
- Sexual dysfunction (OR, 1.47; 95% CI, 1.11-1.95)
- Constipation (OR, 1.5; 95% CI, 1.27-1.78)
- Cystitis (OR, 1.21; 95% CI, 1.05-1.39)
- UTIs of unspecified site (OR, 1.38; 95% CI, 1.18-1.61)
However, none of these conditions was selectively associated with MS in comparison with both lupus and Crohn’s disease. All five ICD-10 codes identified were still associated with MS during the 5 years after diagnosis.
“The importance of investigating prodromal signs in MS is that it allows us to retrace the origins of the disease,” said Dr. Louapre.
“The main contribution of the data on prodromes in MS is to clarify that the disease and its mechanisms are frequently underway well before the first typical neurological symptoms, and that the causes of MS are probably present many years before diagnosis,” she added.
A limitation of the study was that data were not available for other factors that could influence people’s risk of developing MS, such as education level, ethnicity, body mass index, socioeconomic status, or genetic information.
It also remains unclear whether the conditions linked to MS are risk factors for the disease or nonspecific early MS symptoms.
Preventing Disease Evolution
In a linked editorial, Ruth Ann Marrie, MD, PhD, with the University of Manitoba, Manitoba, Canada, and Raffaele Palladino, MD, PhD, with the University of Naples Federico II, Naples, Italy, note these findings highlight the challenges of accurately identifying the prodromal stage of a specific disease.
“Commonalities of prodromal features are recognized across neurodegenerative diseases; this is also true for immune-mediated diseases, and it is not surprising, given shared etiologic factors and pathobiological mechanisms,” they point out.
“This suggests that we should be trying to link prodromal features to specific underlying pathobiological changes rather than specific diseases. This approach would require use of different study designs, including broad, deeply phenotyped cohorts, but would allow us to develop and test interventions targeted at those mechanisms, and could ultimately achieve the goal of preventing disease evolution,” they add.
The study was supported by the French National Research Agency. Dr. Louapre has received consulting or travel fees from Biogen, Novartis, Roche, Sanofi, Teva, and Merck Serono, unrelated to this study. Dr. Marrie is a coinvestigator on studies receiving funding from Biogen Idec and Roche Canada; receives research funding from CIHR, Research Manitoba, Multiple Sclerosis Society of Canada, Multiple Sclerosis Scientific Foundation, Crohn’s and Colitis Canada, National Multiple Sclerosis Society, CMSC, the Arthritis Society and the US Department of Defense; and serves on the editorial board of Neurology. Dr. Palladino has taken part in advisory boards/consultancy for MSD and Sanofi and has received support from the UK MS Society.
A version of this article appeared on Medscape.com.
However, these prodromal symptoms are also more likely to occur in people with two other autoimmune diseases — lupus and Crohn’s disease — and therefore, will not help earlier diagnosis, study investigator, Céline Louapre, professor of neurology, Sorbonne University and Paris Brain Institute, Paris, France, said in an interview.
“On the other hand, in certain patients who may be at particular risk of developing MS, such as in certain familial forms or in patients with incidental inflammatory lesions discovered on MRI, the presence of these symptoms could suggest an already active process, prior to the first typical symptoms of the disease,” she noted.
Retracing MS Origins
The case-control study, published online in Neurology, included 20,174 people with newly diagnosed MS who were matched to 54,790 without MS, as well as 30,477 with Crohn’s disease and 7337 with lupus.
Using International Classification of Diseases, 10th revision (ICD-10) codes in electronic health records, the researchers assessed the associations between 113 diseases and symptoms in the 5 years before and after an MS diagnosis.
Twelve ICD-10 codes were significantly positively associated with the risk for MS compared with controls without MS.
After considering ICD-10 codes suggestive of neurologic symptoms as the first diagnosis of MS, the following five ICD-10 codes remained significantly associated with MS:
- Depression (odds ratio [OR], 1.22; 95% CI, 1.11-1.34)
- Sexual dysfunction (OR, 1.47; 95% CI, 1.11-1.95)
- Constipation (OR, 1.5; 95% CI, 1.27-1.78)
- Cystitis (OR, 1.21; 95% CI, 1.05-1.39)
- UTIs of unspecified site (OR, 1.38; 95% CI, 1.18-1.61)
However, none of these conditions was selectively associated with MS in comparison with both lupus and Crohn’s disease. All five ICD-10 codes identified were still associated with MS during the 5 years after diagnosis.
“The importance of investigating prodromal signs in MS is that it allows us to retrace the origins of the disease,” said Dr. Louapre.
“The main contribution of the data on prodromes in MS is to clarify that the disease and its mechanisms are frequently underway well before the first typical neurological symptoms, and that the causes of MS are probably present many years before diagnosis,” she added.
A limitation of the study was that data were not available for other factors that could influence people’s risk of developing MS, such as education level, ethnicity, body mass index, socioeconomic status, or genetic information.
It also remains unclear whether the conditions linked to MS are risk factors for the disease or nonspecific early MS symptoms.
Preventing Disease Evolution
In a linked editorial, Ruth Ann Marrie, MD, PhD, with the University of Manitoba, Manitoba, Canada, and Raffaele Palladino, MD, PhD, with the University of Naples Federico II, Naples, Italy, note these findings highlight the challenges of accurately identifying the prodromal stage of a specific disease.
“Commonalities of prodromal features are recognized across neurodegenerative diseases; this is also true for immune-mediated diseases, and it is not surprising, given shared etiologic factors and pathobiological mechanisms,” they point out.
“This suggests that we should be trying to link prodromal features to specific underlying pathobiological changes rather than specific diseases. This approach would require use of different study designs, including broad, deeply phenotyped cohorts, but would allow us to develop and test interventions targeted at those mechanisms, and could ultimately achieve the goal of preventing disease evolution,” they add.
The study was supported by the French National Research Agency. Dr. Louapre has received consulting or travel fees from Biogen, Novartis, Roche, Sanofi, Teva, and Merck Serono, unrelated to this study. Dr. Marrie is a coinvestigator on studies receiving funding from Biogen Idec and Roche Canada; receives research funding from CIHR, Research Manitoba, Multiple Sclerosis Society of Canada, Multiple Sclerosis Scientific Foundation, Crohn’s and Colitis Canada, National Multiple Sclerosis Society, CMSC, the Arthritis Society and the US Department of Defense; and serves on the editorial board of Neurology. Dr. Palladino has taken part in advisory boards/consultancy for MSD and Sanofi and has received support from the UK MS Society.
A version of this article appeared on Medscape.com.
However, these prodromal symptoms are also more likely to occur in people with two other autoimmune diseases — lupus and Crohn’s disease — and therefore, will not help earlier diagnosis, study investigator, Céline Louapre, professor of neurology, Sorbonne University and Paris Brain Institute, Paris, France, said in an interview.
“On the other hand, in certain patients who may be at particular risk of developing MS, such as in certain familial forms or in patients with incidental inflammatory lesions discovered on MRI, the presence of these symptoms could suggest an already active process, prior to the first typical symptoms of the disease,” she noted.
Retracing MS Origins
The case-control study, published online in Neurology, included 20,174 people with newly diagnosed MS who were matched to 54,790 without MS, as well as 30,477 with Crohn’s disease and 7337 with lupus.
Using International Classification of Diseases, 10th revision (ICD-10) codes in electronic health records, the researchers assessed the associations between 113 diseases and symptoms in the 5 years before and after an MS diagnosis.
Twelve ICD-10 codes were significantly positively associated with the risk for MS compared with controls without MS.
After considering ICD-10 codes suggestive of neurologic symptoms as the first diagnosis of MS, the following five ICD-10 codes remained significantly associated with MS:
- Depression (odds ratio [OR], 1.22; 95% CI, 1.11-1.34)
- Sexual dysfunction (OR, 1.47; 95% CI, 1.11-1.95)
- Constipation (OR, 1.5; 95% CI, 1.27-1.78)
- Cystitis (OR, 1.21; 95% CI, 1.05-1.39)
- UTIs of unspecified site (OR, 1.38; 95% CI, 1.18-1.61)
However, none of these conditions was selectively associated with MS in comparison with both lupus and Crohn’s disease. All five ICD-10 codes identified were still associated with MS during the 5 years after diagnosis.
“The importance of investigating prodromal signs in MS is that it allows us to retrace the origins of the disease,” said Dr. Louapre.
“The main contribution of the data on prodromes in MS is to clarify that the disease and its mechanisms are frequently underway well before the first typical neurological symptoms, and that the causes of MS are probably present many years before diagnosis,” she added.
A limitation of the study was that data were not available for other factors that could influence people’s risk of developing MS, such as education level, ethnicity, body mass index, socioeconomic status, or genetic information.
It also remains unclear whether the conditions linked to MS are risk factors for the disease or nonspecific early MS symptoms.
Preventing Disease Evolution
In a linked editorial, Ruth Ann Marrie, MD, PhD, with the University of Manitoba, Manitoba, Canada, and Raffaele Palladino, MD, PhD, with the University of Naples Federico II, Naples, Italy, note these findings highlight the challenges of accurately identifying the prodromal stage of a specific disease.
“Commonalities of prodromal features are recognized across neurodegenerative diseases; this is also true for immune-mediated diseases, and it is not surprising, given shared etiologic factors and pathobiological mechanisms,” they point out.
“This suggests that we should be trying to link prodromal features to specific underlying pathobiological changes rather than specific diseases. This approach would require use of different study designs, including broad, deeply phenotyped cohorts, but would allow us to develop and test interventions targeted at those mechanisms, and could ultimately achieve the goal of preventing disease evolution,” they add.
The study was supported by the French National Research Agency. Dr. Louapre has received consulting or travel fees from Biogen, Novartis, Roche, Sanofi, Teva, and Merck Serono, unrelated to this study. Dr. Marrie is a coinvestigator on studies receiving funding from Biogen Idec and Roche Canada; receives research funding from CIHR, Research Manitoba, Multiple Sclerosis Society of Canada, Multiple Sclerosis Scientific Foundation, Crohn’s and Colitis Canada, National Multiple Sclerosis Society, CMSC, the Arthritis Society and the US Department of Defense; and serves on the editorial board of Neurology. Dr. Palladino has taken part in advisory boards/consultancy for MSD and Sanofi and has received support from the UK MS Society.
A version of this article appeared on Medscape.com.
FROM NEUROLOGY
Toward a better framework for postmarketing reproductive safety surveillance of medications
For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.
With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.
When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.
It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.
Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.
FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.
Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.
The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.
Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
Looking ahead
While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.
In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.
To come out on the “other side” of the PLLR, , which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.
With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.
When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.
It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.
Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.
FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.
Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.
The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.
Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
Looking ahead
While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.
In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.
To come out on the “other side” of the PLLR, , which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.
With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.
When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.
It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.
Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.
FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.
Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.
The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.
Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
Looking ahead
While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.
In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.
To come out on the “other side” of the PLLR, , which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
1 in 3 women have lasting health problems after giving birth: Study
Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).
Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis.
The study says most women see a doctor 6 to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.
“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”
The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.
“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.
“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
A version of this article appeared on WebMD.com.
Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).
Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis.
The study says most women see a doctor 6 to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.
“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”
The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.
“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.
“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
A version of this article appeared on WebMD.com.
Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).
Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis.
The study says most women see a doctor 6 to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.
“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”
The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.
“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.
“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
A version of this article appeared on WebMD.com.
FROM THE LANCET GLOBAL HEALTH
Adverse events in childhood alter brain function
In a meta-analysis of 83 functional magnetic resonance imaging (fMRI) studies that included more than 5000 patients, exposure to adversity was associated with higher amygdala reactivity and lower prefrontal cortical reactivity across a range of task domains.
The altered responses were only observed in studies including adult participants and were clearest in participants who had been exposed to severe threat and trauma. Children and adolescents did not show significant adversity-related differences in brain function.
“By integrating the results from 83 previous brain imaging studies, we were able to provide what is arguably the clearest evidence to date that adults who have been exposed to early life trauma have different brain responses to psychological challenges,” senior author Marco Leyton, PhD, professor of psychiatry and director of the Temperament Adversity Biology Lab at McGill University in Montreal, Quebec, Canada, said in a press release. “This includes exaggerated responses in a region that processes emotionally intense information (the amygdala) and reduced responses in a region that helps people regulate emotions and associated behaviors (the frontal cortex).”
The findings were published in JAMA Network Open.
Changes in Reactivity
“One big issue we have in psychology, and especially in neuroscience, is that single-study results are often not reproducible,” lead author Niki Hosseini-Kamkar, PhD, neuroimaging research associate at Atlas Institute for Veterans and Families at Royal Ottawa Hospital, said in an interview.
“It was very important to me to use a meta-analysis to get an overall picture of what brain regions are consistently reported across all these different studies. That is what we did here,” she added. Dr. Hosseini-Kamkar conducted this analysis while she was a postdoctoral research fellow at McGill University in Montreal.
She and her group examined adversity exposure and brain function in the following four domains of task-based fMRI: emotion processing, memory processing, inhibitory control, and reward processing. Their study included 5242 participants. The researchers used multilevel kernel density analyses (MKDA) to analyze the data more accurately.
Adversity exposure was associated with higher amygdala reactivity (P < .001) and lower prefrontal cortical reactivity (P < .001), compared with controls with no adversity exposure.
Threat types of adversity were associated with greater blood-oxygen-level-dependent (BOLD) responses in the superior temporal gyrus and lower prefrontal cortex activity in participants exposed to threat, compared with controls.
Analysis of studies of inhibitory control tasks found greater activity in the claustrum, anterior cingulate cortex, and insula in the adversity-exposed participants, compared with controls.
In addition, studies that administered emotion processing tasks showed greater amygdala reactivity and lower prefrontal cortex (superior frontal gyrus) reactivity in the adversity exposure group, compared with controls.
“The main takeaway is that there’s an exaggerated activity in the amygdala, and diminished prefrontal cortex activity, and together, this might point to a mechanism for how a history of adversity diminishes the ability to cope with later stressors and can therefore heighten susceptibility to mental illness,” said Dr. Hosseini-Kamkar.
‘Important Next Step’
“Overall, the meta-analysis by Dr. Hosseini-Kamkar and colleagues represents an important next step in understanding associations of adversity exposure with brain function while highlighting the importance of considering the role of development,” wrote Dylan G. Gee, PhD, associate professor of psychology at Yale University in New Haven, Connecticut, and Alexis Brieant, PhD, assistant professor of research or creative works at the University of Vermont in Burlington, in an accompanying commentary.
They also applauded the authors for their use of MKDA. They noted that the technique “allows inferences about the consistency and specificity of brain activation across studies and is thought to be more robust to small sample sizes than activation likelihood estimation (ALE) meta-analysis.”
Dr. Gee and Dr. Brieant also observed that a recent ALE meta-analysis failed to find a link between adversity and brain function. “Although it is important to note that the file drawer problem — by which researchers are less likely to publish null results — presents challenges to the inferences that can be drawn in the current work, the current study may provide complementary information to prior ALE meta-analyses.”
Epigenetic Changes?
Commenting on the findings for this article, Victor Fornari, MD, director of child and adolescent psychiatry at Northwell Health in Glen Oaks, New York, said, “Historically, when someone went through a traumatic event, they were told to just get over it, because somehow trauma doesn’t have a lasting impact on the brain.” Dr. Fornari was not involved in the research.
“We have certainly learned so much more over the past decade about early adversity and that it does have a profound impact on the brain and probably even epigenetic changes in our genes,” Dr. Fornari said.
“This is a very important avenue of investigation. People are really trying to understand if there are biological markers that we can actually measure in the brain that will offer us a window to better understand the consequence of adversity, as well as possible avenues of treatment.”
No funding source for this study was reported. Dr. Leyton, Dr. Hosseini-Kamkar, and Dr. Fornari report no relevant financial relationships. Gee reports receiving grants from the National Science Foundation and National Institutes of Health outside the submitted work. Dr. Brieant reports receiving grants from the National Institute of Mental Health outside the submitted work.
A version of this article appeared on Medscape.com.
In a meta-analysis of 83 functional magnetic resonance imaging (fMRI) studies that included more than 5000 patients, exposure to adversity was associated with higher amygdala reactivity and lower prefrontal cortical reactivity across a range of task domains.
The altered responses were only observed in studies including adult participants and were clearest in participants who had been exposed to severe threat and trauma. Children and adolescents did not show significant adversity-related differences in brain function.
“By integrating the results from 83 previous brain imaging studies, we were able to provide what is arguably the clearest evidence to date that adults who have been exposed to early life trauma have different brain responses to psychological challenges,” senior author Marco Leyton, PhD, professor of psychiatry and director of the Temperament Adversity Biology Lab at McGill University in Montreal, Quebec, Canada, said in a press release. “This includes exaggerated responses in a region that processes emotionally intense information (the amygdala) and reduced responses in a region that helps people regulate emotions and associated behaviors (the frontal cortex).”
The findings were published in JAMA Network Open.
Changes in Reactivity
“One big issue we have in psychology, and especially in neuroscience, is that single-study results are often not reproducible,” lead author Niki Hosseini-Kamkar, PhD, neuroimaging research associate at Atlas Institute for Veterans and Families at Royal Ottawa Hospital, said in an interview.
“It was very important to me to use a meta-analysis to get an overall picture of what brain regions are consistently reported across all these different studies. That is what we did here,” she added. Dr. Hosseini-Kamkar conducted this analysis while she was a postdoctoral research fellow at McGill University in Montreal.
She and her group examined adversity exposure and brain function in the following four domains of task-based fMRI: emotion processing, memory processing, inhibitory control, and reward processing. Their study included 5242 participants. The researchers used multilevel kernel density analyses (MKDA) to analyze the data more accurately.
Adversity exposure was associated with higher amygdala reactivity (P < .001) and lower prefrontal cortical reactivity (P < .001), compared with controls with no adversity exposure.
Threat types of adversity were associated with greater blood-oxygen-level-dependent (BOLD) responses in the superior temporal gyrus and lower prefrontal cortex activity in participants exposed to threat, compared with controls.
Analysis of studies of inhibitory control tasks found greater activity in the claustrum, anterior cingulate cortex, and insula in the adversity-exposed participants, compared with controls.
In addition, studies that administered emotion processing tasks showed greater amygdala reactivity and lower prefrontal cortex (superior frontal gyrus) reactivity in the adversity exposure group, compared with controls.
“The main takeaway is that there’s an exaggerated activity in the amygdala, and diminished prefrontal cortex activity, and together, this might point to a mechanism for how a history of adversity diminishes the ability to cope with later stressors and can therefore heighten susceptibility to mental illness,” said Dr. Hosseini-Kamkar.
‘Important Next Step’
“Overall, the meta-analysis by Dr. Hosseini-Kamkar and colleagues represents an important next step in understanding associations of adversity exposure with brain function while highlighting the importance of considering the role of development,” wrote Dylan G. Gee, PhD, associate professor of psychology at Yale University in New Haven, Connecticut, and Alexis Brieant, PhD, assistant professor of research or creative works at the University of Vermont in Burlington, in an accompanying commentary.
They also applauded the authors for their use of MKDA. They noted that the technique “allows inferences about the consistency and specificity of brain activation across studies and is thought to be more robust to small sample sizes than activation likelihood estimation (ALE) meta-analysis.”
Dr. Gee and Dr. Brieant also observed that a recent ALE meta-analysis failed to find a link between adversity and brain function. “Although it is important to note that the file drawer problem — by which researchers are less likely to publish null results — presents challenges to the inferences that can be drawn in the current work, the current study may provide complementary information to prior ALE meta-analyses.”
Epigenetic Changes?
Commenting on the findings for this article, Victor Fornari, MD, director of child and adolescent psychiatry at Northwell Health in Glen Oaks, New York, said, “Historically, when someone went through a traumatic event, they were told to just get over it, because somehow trauma doesn’t have a lasting impact on the brain.” Dr. Fornari was not involved in the research.
“We have certainly learned so much more over the past decade about early adversity and that it does have a profound impact on the brain and probably even epigenetic changes in our genes,” Dr. Fornari said.
“This is a very important avenue of investigation. People are really trying to understand if there are biological markers that we can actually measure in the brain that will offer us a window to better understand the consequence of adversity, as well as possible avenues of treatment.”
No funding source for this study was reported. Dr. Leyton, Dr. Hosseini-Kamkar, and Dr. Fornari report no relevant financial relationships. Gee reports receiving grants from the National Science Foundation and National Institutes of Health outside the submitted work. Dr. Brieant reports receiving grants from the National Institute of Mental Health outside the submitted work.
A version of this article appeared on Medscape.com.
In a meta-analysis of 83 functional magnetic resonance imaging (fMRI) studies that included more than 5000 patients, exposure to adversity was associated with higher amygdala reactivity and lower prefrontal cortical reactivity across a range of task domains.
The altered responses were only observed in studies including adult participants and were clearest in participants who had been exposed to severe threat and trauma. Children and adolescents did not show significant adversity-related differences in brain function.
“By integrating the results from 83 previous brain imaging studies, we were able to provide what is arguably the clearest evidence to date that adults who have been exposed to early life trauma have different brain responses to psychological challenges,” senior author Marco Leyton, PhD, professor of psychiatry and director of the Temperament Adversity Biology Lab at McGill University in Montreal, Quebec, Canada, said in a press release. “This includes exaggerated responses in a region that processes emotionally intense information (the amygdala) and reduced responses in a region that helps people regulate emotions and associated behaviors (the frontal cortex).”
The findings were published in JAMA Network Open.
Changes in Reactivity
“One big issue we have in psychology, and especially in neuroscience, is that single-study results are often not reproducible,” lead author Niki Hosseini-Kamkar, PhD, neuroimaging research associate at Atlas Institute for Veterans and Families at Royal Ottawa Hospital, said in an interview.
“It was very important to me to use a meta-analysis to get an overall picture of what brain regions are consistently reported across all these different studies. That is what we did here,” she added. Dr. Hosseini-Kamkar conducted this analysis while she was a postdoctoral research fellow at McGill University in Montreal.
She and her group examined adversity exposure and brain function in the following four domains of task-based fMRI: emotion processing, memory processing, inhibitory control, and reward processing. Their study included 5242 participants. The researchers used multilevel kernel density analyses (MKDA) to analyze the data more accurately.
Adversity exposure was associated with higher amygdala reactivity (P < .001) and lower prefrontal cortical reactivity (P < .001), compared with controls with no adversity exposure.
Threat types of adversity were associated with greater blood-oxygen-level-dependent (BOLD) responses in the superior temporal gyrus and lower prefrontal cortex activity in participants exposed to threat, compared with controls.
Analysis of studies of inhibitory control tasks found greater activity in the claustrum, anterior cingulate cortex, and insula in the adversity-exposed participants, compared with controls.
In addition, studies that administered emotion processing tasks showed greater amygdala reactivity and lower prefrontal cortex (superior frontal gyrus) reactivity in the adversity exposure group, compared with controls.
“The main takeaway is that there’s an exaggerated activity in the amygdala, and diminished prefrontal cortex activity, and together, this might point to a mechanism for how a history of adversity diminishes the ability to cope with later stressors and can therefore heighten susceptibility to mental illness,” said Dr. Hosseini-Kamkar.
‘Important Next Step’
“Overall, the meta-analysis by Dr. Hosseini-Kamkar and colleagues represents an important next step in understanding associations of adversity exposure with brain function while highlighting the importance of considering the role of development,” wrote Dylan G. Gee, PhD, associate professor of psychology at Yale University in New Haven, Connecticut, and Alexis Brieant, PhD, assistant professor of research or creative works at the University of Vermont in Burlington, in an accompanying commentary.
They also applauded the authors for their use of MKDA. They noted that the technique “allows inferences about the consistency and specificity of brain activation across studies and is thought to be more robust to small sample sizes than activation likelihood estimation (ALE) meta-analysis.”
Dr. Gee and Dr. Brieant also observed that a recent ALE meta-analysis failed to find a link between adversity and brain function. “Although it is important to note that the file drawer problem — by which researchers are less likely to publish null results — presents challenges to the inferences that can be drawn in the current work, the current study may provide complementary information to prior ALE meta-analyses.”
Epigenetic Changes?
Commenting on the findings for this article, Victor Fornari, MD, director of child and adolescent psychiatry at Northwell Health in Glen Oaks, New York, said, “Historically, when someone went through a traumatic event, they were told to just get over it, because somehow trauma doesn’t have a lasting impact on the brain.” Dr. Fornari was not involved in the research.
“We have certainly learned so much more over the past decade about early adversity and that it does have a profound impact on the brain and probably even epigenetic changes in our genes,” Dr. Fornari said.
“This is a very important avenue of investigation. People are really trying to understand if there are biological markers that we can actually measure in the brain that will offer us a window to better understand the consequence of adversity, as well as possible avenues of treatment.”
No funding source for this study was reported. Dr. Leyton, Dr. Hosseini-Kamkar, and Dr. Fornari report no relevant financial relationships. Gee reports receiving grants from the National Science Foundation and National Institutes of Health outside the submitted work. Dr. Brieant reports receiving grants from the National Institute of Mental Health outside the submitted work.
A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN
VA’s Annual Report on Suicide: Reasons for Despair—and Hope
When COVID-19 hit, the number of suicides among veterans had been going down. Before 2021, veteran suicide declined 2 years in a row—from 6718 in 2018 to 6278 in 2020. But in 2021, the trend began to reverse: 6392 veterans died by suicide, according to the US Department of Veterans Affairs (VA) recently released National Veteran Suicide Prevention Annual Report, which includes the first full year of information since March 2020.
The pandemic took a toll in uncountable ways: increasing social and financial insecurity, anxiety, depression, and barriers to health care—all factors associated with a higher risk of suicide. Nonveteran suicides also increased, to 40,020 deaths in 2021, 2000 more than in 2020. But the age- and sex-adjusted suicide rate among veterans increased by 11.6%, compared with an increase of 4.5% among nonveteran adults.
In 2021, the unadjusted suicide rate was highest among American Indian or Alaska Natives (46.3 per 100,000), followed by 36.3 per 100,000 for White veterans; 31.6 per 100,000 for Asian, Native Hawaiian or Pacific Islander veterans; 19.7 per 100,000 for veterans with Hispanic ethnicity; 17.4 per 100,000 for Black or African American veterans; and 6.7 per 100,000 for veterans of multiple races.
The report demonstrates a deep dive into the data but the findings on risk factors may come as no surprise. A documented factor in the rise in suicide among veterans was distress, which increased from fall 2019 to fall and winter 2020, with evidence of the highest increases in distress among veterans aged 18 to 44 years and among women veterans. The rise in distress was associated with increasing socioeconomic concerns, greater problematic alcohol use, and less community integration. Moreover, during the pandemic, veterans were found to experience more mental health concerns than nonveterans.
A review of 23 studies found a greater prevalence of alcohol use, anxiety, depression, posttraumatic stress disorder, stress, loneliness, and suicidal ideation. Key risk factors included pandemic-related stress, family relationship strain, lack of social support, financial concerns, and preexisting mental health disorders.
VA Behavioral Health Autopsy Program data indicated that the most frequently identified risk factors for suicide deaths in 2019 to 2021 were pain (55.9%), sleep problems (51.7%), increased health problems (40.7%), relationship problems (33.7%), recent declines in physical ability (33.0%), hopelessness (30.6%) and unsecured firearms in the home (28.8%).
Meanwhile, more people were buying guns: A study published in the Annals of Internal Medicine found that, as of April 2021, approximately 10% of gun owners in the US had become new gun owners over the previous 28 months. Firearm availability is known to increase the risk of suicide and the risk of dying during a suicide attempt. According to 2021 VA data, nearly 7 of every 10 veteran deaths by suicide are the result of firearm injuries.
Among US adults who died from suicide in 2021, firearms were more commonly involved among veteran deaths (72.2%) than among nonveteran deaths (52.2%). In each year studied, firearm suicide mortality rates were greater for men than for women; however, the firearm suicide rate among veteran women was 281.1% higher than that of nonveteran women, while the firearm suicide rate among veteran men was 62.4% higher than for nonveteran men.
But there were some bright spots. “Hope is essential to life,” the report says, “and hope serves an important role within suicide prevention efforts.” It points to areas where things improved, even amid the pandemic. Suicide rates fell by 8.1% for veteran men aged 75 years and older. Among recent VA users between ages 55 and 74 years, the suicide rate fell by 2.2% overall (-0.6% for men, -24.9% for women). Among male recent VA users, suicide rates fell by 1.9% for those aged 18 to 34 years. From 2001 to 2021, the suicide rate among recent VA users with mental health or substance use disorder diagnoses fell from 77.8 per 100,000 to 58.2 per 100,000.
Nonetheless, the data show veterans “remain at elevated risk for suicide.” “We will do everything in our power to learn from this report and use its findings to help us save lives,” said VA Under Secretary for Health Shereef Elnahal, MD. “It will take all of us—working together—to end veteran suicide, and we will not rest until that goal becomes a reality.”
“Suicide is a complex problem,” Dr. Carolyn Clancy, Executive in Charge, Office of the Under Secretary for Health, writes in the VA publication National Strategy for Preventing Veteran Suicide, 2018–2028. “[I]t requires coordinated, evidence-based solutions that reach beyond the traditional medical model of prevention.” She notes that the VA has “embraced a comprehensive public health approach to reduce veteran suicide rates, one that looks beyond the individual to involve peers, family members, and the community.”
“Yet we know we cannot do it alone, as roughly half of all veterans in the US do not receive services or benefits from VA. This means we must collaborate with partners and communities nationwide to use the best available information and practices to support all veterans, whether or not they’re engaging with VA.”
The VA calls ending veteran suicide its top clinical priority and supports the Biden Administration’s goal of reducing the annual suicide rate in the US by 20% by 2025. Since 2021, the VA has bolstered and broadened resources for at-risk veterans, such as no-cost health care at VA or non-VA facilities for those in crisis; the 988 (then press 1) Veterans Crisis Line; partnerships with community-based suicide prevention organizations; and expanded firearm suicide prevention efforts.
The VA says these efforts, plus a national veteran suicide prevention awareness campaign, have led to more than 33,000 veterans getting free emergency health care, a 12.1% increase in use of the Veterans Crisis Line, and more than 3.5 million visits to the VA’s support website. Moving forward, the VA says, it will continue to work “urgently” alongside the Biden-Harris Administration to end veteran suicide through a public health approach that combines both community-based and clinically based strategies to save lives.
“There is nothing more important to VA than preventing veteran suicide —nothing,” said Secretary of VA Denis McDonough. “One veteran suicide will always be too many, and we at VA will use every tool to our disposal to prevent these tragedies and save veterans’ lives.”
If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line: www.veteranscrisisline.net.
Related resources:
- The National Suicide Prevention Lifeline is a hotline for individuals in crisis or for those looking to help someone else. To speak with a certified listener, call 1-800-273-8255.
- Crisis Text Line is a texting service for emotional crisis support. To speak with a trained listener, text HELLO to 741741. It is free, available 24/7, and confidential.
- American Foundation for Suicide Prevention. https://afsp.org/
When COVID-19 hit, the number of suicides among veterans had been going down. Before 2021, veteran suicide declined 2 years in a row—from 6718 in 2018 to 6278 in 2020. But in 2021, the trend began to reverse: 6392 veterans died by suicide, according to the US Department of Veterans Affairs (VA) recently released National Veteran Suicide Prevention Annual Report, which includes the first full year of information since March 2020.
The pandemic took a toll in uncountable ways: increasing social and financial insecurity, anxiety, depression, and barriers to health care—all factors associated with a higher risk of suicide. Nonveteran suicides also increased, to 40,020 deaths in 2021, 2000 more than in 2020. But the age- and sex-adjusted suicide rate among veterans increased by 11.6%, compared with an increase of 4.5% among nonveteran adults.
In 2021, the unadjusted suicide rate was highest among American Indian or Alaska Natives (46.3 per 100,000), followed by 36.3 per 100,000 for White veterans; 31.6 per 100,000 for Asian, Native Hawaiian or Pacific Islander veterans; 19.7 per 100,000 for veterans with Hispanic ethnicity; 17.4 per 100,000 for Black or African American veterans; and 6.7 per 100,000 for veterans of multiple races.
The report demonstrates a deep dive into the data but the findings on risk factors may come as no surprise. A documented factor in the rise in suicide among veterans was distress, which increased from fall 2019 to fall and winter 2020, with evidence of the highest increases in distress among veterans aged 18 to 44 years and among women veterans. The rise in distress was associated with increasing socioeconomic concerns, greater problematic alcohol use, and less community integration. Moreover, during the pandemic, veterans were found to experience more mental health concerns than nonveterans.
A review of 23 studies found a greater prevalence of alcohol use, anxiety, depression, posttraumatic stress disorder, stress, loneliness, and suicidal ideation. Key risk factors included pandemic-related stress, family relationship strain, lack of social support, financial concerns, and preexisting mental health disorders.
VA Behavioral Health Autopsy Program data indicated that the most frequently identified risk factors for suicide deaths in 2019 to 2021 were pain (55.9%), sleep problems (51.7%), increased health problems (40.7%), relationship problems (33.7%), recent declines in physical ability (33.0%), hopelessness (30.6%) and unsecured firearms in the home (28.8%).
Meanwhile, more people were buying guns: A study published in the Annals of Internal Medicine found that, as of April 2021, approximately 10% of gun owners in the US had become new gun owners over the previous 28 months. Firearm availability is known to increase the risk of suicide and the risk of dying during a suicide attempt. According to 2021 VA data, nearly 7 of every 10 veteran deaths by suicide are the result of firearm injuries.
Among US adults who died from suicide in 2021, firearms were more commonly involved among veteran deaths (72.2%) than among nonveteran deaths (52.2%). In each year studied, firearm suicide mortality rates were greater for men than for women; however, the firearm suicide rate among veteran women was 281.1% higher than that of nonveteran women, while the firearm suicide rate among veteran men was 62.4% higher than for nonveteran men.
But there were some bright spots. “Hope is essential to life,” the report says, “and hope serves an important role within suicide prevention efforts.” It points to areas where things improved, even amid the pandemic. Suicide rates fell by 8.1% for veteran men aged 75 years and older. Among recent VA users between ages 55 and 74 years, the suicide rate fell by 2.2% overall (-0.6% for men, -24.9% for women). Among male recent VA users, suicide rates fell by 1.9% for those aged 18 to 34 years. From 2001 to 2021, the suicide rate among recent VA users with mental health or substance use disorder diagnoses fell from 77.8 per 100,000 to 58.2 per 100,000.
Nonetheless, the data show veterans “remain at elevated risk for suicide.” “We will do everything in our power to learn from this report and use its findings to help us save lives,” said VA Under Secretary for Health Shereef Elnahal, MD. “It will take all of us—working together—to end veteran suicide, and we will not rest until that goal becomes a reality.”
“Suicide is a complex problem,” Dr. Carolyn Clancy, Executive in Charge, Office of the Under Secretary for Health, writes in the VA publication National Strategy for Preventing Veteran Suicide, 2018–2028. “[I]t requires coordinated, evidence-based solutions that reach beyond the traditional medical model of prevention.” She notes that the VA has “embraced a comprehensive public health approach to reduce veteran suicide rates, one that looks beyond the individual to involve peers, family members, and the community.”
“Yet we know we cannot do it alone, as roughly half of all veterans in the US do not receive services or benefits from VA. This means we must collaborate with partners and communities nationwide to use the best available information and practices to support all veterans, whether or not they’re engaging with VA.”
The VA calls ending veteran suicide its top clinical priority and supports the Biden Administration’s goal of reducing the annual suicide rate in the US by 20% by 2025. Since 2021, the VA has bolstered and broadened resources for at-risk veterans, such as no-cost health care at VA or non-VA facilities for those in crisis; the 988 (then press 1) Veterans Crisis Line; partnerships with community-based suicide prevention organizations; and expanded firearm suicide prevention efforts.
The VA says these efforts, plus a national veteran suicide prevention awareness campaign, have led to more than 33,000 veterans getting free emergency health care, a 12.1% increase in use of the Veterans Crisis Line, and more than 3.5 million visits to the VA’s support website. Moving forward, the VA says, it will continue to work “urgently” alongside the Biden-Harris Administration to end veteran suicide through a public health approach that combines both community-based and clinically based strategies to save lives.
“There is nothing more important to VA than preventing veteran suicide —nothing,” said Secretary of VA Denis McDonough. “One veteran suicide will always be too many, and we at VA will use every tool to our disposal to prevent these tragedies and save veterans’ lives.”
If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line: www.veteranscrisisline.net.
Related resources:
- The National Suicide Prevention Lifeline is a hotline for individuals in crisis or for those looking to help someone else. To speak with a certified listener, call 1-800-273-8255.
- Crisis Text Line is a texting service for emotional crisis support. To speak with a trained listener, text HELLO to 741741. It is free, available 24/7, and confidential.
- American Foundation for Suicide Prevention. https://afsp.org/
When COVID-19 hit, the number of suicides among veterans had been going down. Before 2021, veteran suicide declined 2 years in a row—from 6718 in 2018 to 6278 in 2020. But in 2021, the trend began to reverse: 6392 veterans died by suicide, according to the US Department of Veterans Affairs (VA) recently released National Veteran Suicide Prevention Annual Report, which includes the first full year of information since March 2020.
The pandemic took a toll in uncountable ways: increasing social and financial insecurity, anxiety, depression, and barriers to health care—all factors associated with a higher risk of suicide. Nonveteran suicides also increased, to 40,020 deaths in 2021, 2000 more than in 2020. But the age- and sex-adjusted suicide rate among veterans increased by 11.6%, compared with an increase of 4.5% among nonveteran adults.
In 2021, the unadjusted suicide rate was highest among American Indian or Alaska Natives (46.3 per 100,000), followed by 36.3 per 100,000 for White veterans; 31.6 per 100,000 for Asian, Native Hawaiian or Pacific Islander veterans; 19.7 per 100,000 for veterans with Hispanic ethnicity; 17.4 per 100,000 for Black or African American veterans; and 6.7 per 100,000 for veterans of multiple races.
The report demonstrates a deep dive into the data but the findings on risk factors may come as no surprise. A documented factor in the rise in suicide among veterans was distress, which increased from fall 2019 to fall and winter 2020, with evidence of the highest increases in distress among veterans aged 18 to 44 years and among women veterans. The rise in distress was associated with increasing socioeconomic concerns, greater problematic alcohol use, and less community integration. Moreover, during the pandemic, veterans were found to experience more mental health concerns than nonveterans.
A review of 23 studies found a greater prevalence of alcohol use, anxiety, depression, posttraumatic stress disorder, stress, loneliness, and suicidal ideation. Key risk factors included pandemic-related stress, family relationship strain, lack of social support, financial concerns, and preexisting mental health disorders.
VA Behavioral Health Autopsy Program data indicated that the most frequently identified risk factors for suicide deaths in 2019 to 2021 were pain (55.9%), sleep problems (51.7%), increased health problems (40.7%), relationship problems (33.7%), recent declines in physical ability (33.0%), hopelessness (30.6%) and unsecured firearms in the home (28.8%).
Meanwhile, more people were buying guns: A study published in the Annals of Internal Medicine found that, as of April 2021, approximately 10% of gun owners in the US had become new gun owners over the previous 28 months. Firearm availability is known to increase the risk of suicide and the risk of dying during a suicide attempt. According to 2021 VA data, nearly 7 of every 10 veteran deaths by suicide are the result of firearm injuries.
Among US adults who died from suicide in 2021, firearms were more commonly involved among veteran deaths (72.2%) than among nonveteran deaths (52.2%). In each year studied, firearm suicide mortality rates were greater for men than for women; however, the firearm suicide rate among veteran women was 281.1% higher than that of nonveteran women, while the firearm suicide rate among veteran men was 62.4% higher than for nonveteran men.
But there were some bright spots. “Hope is essential to life,” the report says, “and hope serves an important role within suicide prevention efforts.” It points to areas where things improved, even amid the pandemic. Suicide rates fell by 8.1% for veteran men aged 75 years and older. Among recent VA users between ages 55 and 74 years, the suicide rate fell by 2.2% overall (-0.6% for men, -24.9% for women). Among male recent VA users, suicide rates fell by 1.9% for those aged 18 to 34 years. From 2001 to 2021, the suicide rate among recent VA users with mental health or substance use disorder diagnoses fell from 77.8 per 100,000 to 58.2 per 100,000.
Nonetheless, the data show veterans “remain at elevated risk for suicide.” “We will do everything in our power to learn from this report and use its findings to help us save lives,” said VA Under Secretary for Health Shereef Elnahal, MD. “It will take all of us—working together—to end veteran suicide, and we will not rest until that goal becomes a reality.”
“Suicide is a complex problem,” Dr. Carolyn Clancy, Executive in Charge, Office of the Under Secretary for Health, writes in the VA publication National Strategy for Preventing Veteran Suicide, 2018–2028. “[I]t requires coordinated, evidence-based solutions that reach beyond the traditional medical model of prevention.” She notes that the VA has “embraced a comprehensive public health approach to reduce veteran suicide rates, one that looks beyond the individual to involve peers, family members, and the community.”
“Yet we know we cannot do it alone, as roughly half of all veterans in the US do not receive services or benefits from VA. This means we must collaborate with partners and communities nationwide to use the best available information and practices to support all veterans, whether or not they’re engaging with VA.”
The VA calls ending veteran suicide its top clinical priority and supports the Biden Administration’s goal of reducing the annual suicide rate in the US by 20% by 2025. Since 2021, the VA has bolstered and broadened resources for at-risk veterans, such as no-cost health care at VA or non-VA facilities for those in crisis; the 988 (then press 1) Veterans Crisis Line; partnerships with community-based suicide prevention organizations; and expanded firearm suicide prevention efforts.
The VA says these efforts, plus a national veteran suicide prevention awareness campaign, have led to more than 33,000 veterans getting free emergency health care, a 12.1% increase in use of the Veterans Crisis Line, and more than 3.5 million visits to the VA’s support website. Moving forward, the VA says, it will continue to work “urgently” alongside the Biden-Harris Administration to end veteran suicide through a public health approach that combines both community-based and clinically based strategies to save lives.
“There is nothing more important to VA than preventing veteran suicide —nothing,” said Secretary of VA Denis McDonough. “One veteran suicide will always be too many, and we at VA will use every tool to our disposal to prevent these tragedies and save veterans’ lives.”
If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line: www.veteranscrisisline.net.
Related resources:
- The National Suicide Prevention Lifeline is a hotline for individuals in crisis or for those looking to help someone else. To speak with a certified listener, call 1-800-273-8255.
- Crisis Text Line is a texting service for emotional crisis support. To speak with a trained listener, text HELLO to 741741. It is free, available 24/7, and confidential.
- American Foundation for Suicide Prevention. https://afsp.org/
Higher blood levels of oleic acid tied to depression
TOPLINE:
National survey data reveal an association between higher serum oleic acid levels and depression in adults, new research shows.
METHODOLOGY:
Oleic acid is the most abundant fatty acid in plasma and has been associated with multiple neurologic diseases. However, the relationship between oleic acid and depression is unclear.
This cross-sectional analyzed data on 4459 adults from the 2011-2014 National Health and Nutrition Examination Survey (NHANES).
Multivariable logistic regression models adjusting for demographics, health and lifestyle factors quantified the association between oleic acid levels and depression. Depression was assessed using the Patient Health Questionnaire-9 (PHQ-9) with depression defined as a score ≥ 10.
TAKEAWAY:
Serum oleic acid levels were positively associated with depression before and after multivariable adjustment.
After adjusting for all covariates, for every 1 mmol/L increase in serum oleic acid levels, the prevalence of depression increased by 40% (adjusted odds ratio [aOR], 1.40; 95% CI, 1.03-1.90).
Adults in the top quartile of oleic acid (≥ 2.51 mmol/L) had a greater than twofold higher likelihood of depression (aOR, 2.22; 95% CI, 1.04-4.73) compared with peers in the lowest quartile (≤ 1.54 mmol/L).
IN PRACTICE:
“A better understanding of the role of oleic acid in depression may lead to new preventive and therapeutic methods. Thus, carefully designed prospective studies are necessary to explore the positive effects of changing serum oleic acid levels through diet, medicine, or other measures on depression,” the authors write.
SOURCE:
The study, with first author Jiahui Yin of Shandong University of Traditional Chinese Medicine in Jinan, China, was published online on November 16, 2023 in BMC Psychiatry .
LIMITATIONS:
The cross-sectional study can’t prove causality. The findings may not apply to clinically diagnosed major depressive disorder.
DISCLOSURES:
The study had no specific funding. The authors report no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
National survey data reveal an association between higher serum oleic acid levels and depression in adults, new research shows.
METHODOLOGY:
Oleic acid is the most abundant fatty acid in plasma and has been associated with multiple neurologic diseases. However, the relationship between oleic acid and depression is unclear.
This cross-sectional analyzed data on 4459 adults from the 2011-2014 National Health and Nutrition Examination Survey (NHANES).
Multivariable logistic regression models adjusting for demographics, health and lifestyle factors quantified the association between oleic acid levels and depression. Depression was assessed using the Patient Health Questionnaire-9 (PHQ-9) with depression defined as a score ≥ 10.
TAKEAWAY:
Serum oleic acid levels were positively associated with depression before and after multivariable adjustment.
After adjusting for all covariates, for every 1 mmol/L increase in serum oleic acid levels, the prevalence of depression increased by 40% (adjusted odds ratio [aOR], 1.40; 95% CI, 1.03-1.90).
Adults in the top quartile of oleic acid (≥ 2.51 mmol/L) had a greater than twofold higher likelihood of depression (aOR, 2.22; 95% CI, 1.04-4.73) compared with peers in the lowest quartile (≤ 1.54 mmol/L).
IN PRACTICE:
“A better understanding of the role of oleic acid in depression may lead to new preventive and therapeutic methods. Thus, carefully designed prospective studies are necessary to explore the positive effects of changing serum oleic acid levels through diet, medicine, or other measures on depression,” the authors write.
SOURCE:
The study, with first author Jiahui Yin of Shandong University of Traditional Chinese Medicine in Jinan, China, was published online on November 16, 2023 in BMC Psychiatry .
LIMITATIONS:
The cross-sectional study can’t prove causality. The findings may not apply to clinically diagnosed major depressive disorder.
DISCLOSURES:
The study had no specific funding. The authors report no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
National survey data reveal an association between higher serum oleic acid levels and depression in adults, new research shows.
METHODOLOGY:
Oleic acid is the most abundant fatty acid in plasma and has been associated with multiple neurologic diseases. However, the relationship between oleic acid and depression is unclear.
This cross-sectional analyzed data on 4459 adults from the 2011-2014 National Health and Nutrition Examination Survey (NHANES).
Multivariable logistic regression models adjusting for demographics, health and lifestyle factors quantified the association between oleic acid levels and depression. Depression was assessed using the Patient Health Questionnaire-9 (PHQ-9) with depression defined as a score ≥ 10.
TAKEAWAY:
Serum oleic acid levels were positively associated with depression before and after multivariable adjustment.
After adjusting for all covariates, for every 1 mmol/L increase in serum oleic acid levels, the prevalence of depression increased by 40% (adjusted odds ratio [aOR], 1.40; 95% CI, 1.03-1.90).
Adults in the top quartile of oleic acid (≥ 2.51 mmol/L) had a greater than twofold higher likelihood of depression (aOR, 2.22; 95% CI, 1.04-4.73) compared with peers in the lowest quartile (≤ 1.54 mmol/L).
IN PRACTICE:
“A better understanding of the role of oleic acid in depression may lead to new preventive and therapeutic methods. Thus, carefully designed prospective studies are necessary to explore the positive effects of changing serum oleic acid levels through diet, medicine, or other measures on depression,” the authors write.
SOURCE:
The study, with first author Jiahui Yin of Shandong University of Traditional Chinese Medicine in Jinan, China, was published online on November 16, 2023 in BMC Psychiatry .
LIMITATIONS:
The cross-sectional study can’t prove causality. The findings may not apply to clinically diagnosed major depressive disorder.
DISCLOSURES:
The study had no specific funding. The authors report no conflicts of interest.
A version of this article first appeared on Medscape.com.