In a gluten challenge trial, latiglutenase (IMGX003) reduced symptom severity and mucosal deterioration in patients with celiac disease, according to a new study published in Gastroenterology.

Latiglutenase led to 95% gluten degradation in the stomach, as indicated by measurements of gluten-immunogenic peptides in urine, wrote Joseph A. Murray, MD, a gastroenterologist at the Mayo Clinic, Rochester, Minn., and Jack A. Syage, PhD, CEO and cofounder of ImmunogenX Inc., Newport Beach, Calif., and colleagues on behalf of the CeliacShield Study Group.

For patients with celiac disease, the only available treatment is a life-long gluten-free diet (GFD). Low levels of gluten exposure can lead to ongoing inflammation and the risk of complications, and about half of patients continue to experience moderate to severe symptoms.

“Although a GFD can reduce symptoms and intestinal damage, the diet is neither easy nor readily achievable by many patients and, furthermore, can be lacking in essential nutrients,” the authors wrote.

In a randomized, double-blind, placebo-controlled gluten challenge study, the research team assessed the efficacy and safety of a 1,200-mg dose of IMGX003, formerly known as ALV003. The dual-enzyme supplementation therapy was “designed to mitigate the impact of gluten exposure in patients who are attempting to adhere to a GFD.”

The phase 2 trial was conducted at the Mayo Clinic with adult patients (aged 18-80 years) who had physician-diagnosed and biopsy-confirmed celiac disease, followed a GFD for more than 1 year, and had histologically well-controlled disease. During the study, they were exposed to 2 g of gluten per day for 6 weeks.

The primary endpoint focused on the change in the ratio of villus height to crypt depth. The “secondary endpoints included density of intraepithelial lymphocytes and symptom severity. Additional endpoints included serology and gluten-immunogenic peptides in urine.”

Among the 50 patients randomized, 43 completed the study, with 21 assigned to the IMGX003 group. About 74% of the participants were women; the mean age of all participants was 43.8 years.

Overall, the mean change in the ratio of villus height to crypt depth was –0.04 for IMGX003, compared with –0.35 for placebo. In addition, the mean change in the density of intraepithelial lymphocytes for IMGX003 was 9.8, compared with 24.8 for placebo. Based on the ratio of the means for both groups, the researchers estimated an 88% reduction of change in villus height to crypt depth and a 60% reduction of change in intraepithelial lymphocytes.

The mean changes, or worsening from baseline, in symptom severity for IMGX003 vs. placebo were 0.22 vs. 1.63 for abdominal pain, 0.96 vs. 3.29 for bloating, 0.02 vs. 3.2 for tiredness, and 0.64 vs. 2.27 for nonstool composite. The calculated symptom reduction values were 93% for abdominal pain, 53% for bloating, 99% for tiredness, and 70% for nonstool composite.

The mean change from baseline for symptom severity was evaluated over three 2-week periods, and the percent changes showed consistent reduction of symptom worsening during that time. Based on the effect size and trend significance, the P values were .014 for abdominal pain, .030 for bloating, .002 for tiredness, and < . 001 for nonstool composite.

The mean change in gluten-immunogenic peptides in urine (GIP) relative to baseline was 0.59 for IMGX003, compared with 11.53 for placebo. The researchers estimated an efficacy of gluten degradation in vivo of 95%.

“Measurement of GIP in urine demonstrated the purported mechanism of action of IMGX003, namely, degradation of gluten in the stomach, thereby preventing the triggering of the immunogenic autoimmune response,” the authors wrote. “Targeting gluten by degrading the immunogenic peptides before absorption minimizes or abrogates the cascading innate and adaptive immune responses that characterize the inflammatory response to gluten in CeD [celiac disease].”

The study was sponsored by ImmunogenX Inc., and partially funded by a grant from the National Center for Complementary and Integrative Health. The project was further supported by grants from the National Center for Advancing Translational Sciences and the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants from numerous funders, including ImmunogenX, and some reported being a cofounder, stockholder, or board director of the company.

In a gluten challenge trial, latiglutenase (IMGX003) reduced symptom severity and mucosal deterioration in patients with celiac disease, according to a new study published in Gastroenterology.

Latiglutenase led to 95% gluten degradation in the stomach, as indicated by measurements of gluten-immunogenic peptides in urine, wrote Joseph A. Murray, MD, a gastroenterologist at the Mayo Clinic, Rochester, Minn., and Jack A. Syage, PhD, CEO and cofounder of ImmunogenX Inc., Newport Beach, Calif., and colleagues on behalf of the CeliacShield Study Group.

For patients with celiac disease, the only available treatment is a life-long gluten-free diet (GFD). Low levels of gluten exposure can lead to ongoing inflammation and the risk of complications, and about half of patients continue to experience moderate to severe symptoms.

“Although a GFD can reduce symptoms and intestinal damage, the diet is neither easy nor readily achievable by many patients and, furthermore, can be lacking in essential nutrients,” the authors wrote.

In a randomized, double-blind, placebo-controlled gluten challenge study, the research team assessed the efficacy and safety of a 1,200-mg dose of IMGX003, formerly known as ALV003. The dual-enzyme supplementation therapy was “designed to mitigate the impact of gluten exposure in patients who are attempting to adhere to a GFD.”

The phase 2 trial was conducted at the Mayo Clinic with adult patients (aged 18-80 years) who had physician-diagnosed and biopsy-confirmed celiac disease, followed a GFD for more than 1 year, and had histologically well-controlled disease. During the study, they were exposed to 2 g of gluten per day for 6 weeks.

The primary endpoint focused on the change in the ratio of villus height to crypt depth. The “secondary endpoints included density of intraepithelial lymphocytes and symptom severity. Additional endpoints included serology and gluten-immunogenic peptides in urine.”

Among the 50 patients randomized, 43 completed the study, with 21 assigned to the IMGX003 group. About 74% of the participants were women; the mean age of all participants was 43.8 years.

Overall, the mean change in the ratio of villus height to crypt depth was –0.04 for IMGX003, compared with –0.35 for placebo. In addition, the mean change in the density of intraepithelial lymphocytes for IMGX003 was 9.8, compared with 24.8 for placebo. Based on the ratio of the means for both groups, the researchers estimated an 88% reduction of change in villus height to crypt depth and a 60% reduction of change in intraepithelial lymphocytes.

The mean changes, or worsening from baseline, in symptom severity for IMGX003 vs. placebo were 0.22 vs. 1.63 for abdominal pain, 0.96 vs. 3.29 for bloating, 0.02 vs. 3.2 for tiredness, and 0.64 vs. 2.27 for nonstool composite. The calculated symptom reduction values were 93% for abdominal pain, 53% for bloating, 99% for tiredness, and 70% for nonstool composite.

The mean change from baseline for symptom severity was evaluated over three 2-week periods, and the percent changes showed consistent reduction of symptom worsening during that time. Based on the effect size and trend significance, the P values were .014 for abdominal pain, .030 for bloating, .002 for tiredness, and < . 001 for nonstool composite.

The mean change in gluten-immunogenic peptides in urine (GIP) relative to baseline was 0.59 for IMGX003, compared with 11.53 for placebo. The researchers estimated an efficacy of gluten degradation in vivo of 95%.

“Measurement of GIP in urine demonstrated the purported mechanism of action of IMGX003, namely, degradation of gluten in the stomach, thereby preventing the triggering of the immunogenic autoimmune response,” the authors wrote. “Targeting gluten by degrading the immunogenic peptides before absorption minimizes or abrogates the cascading innate and adaptive immune responses that characterize the inflammatory response to gluten in CeD [celiac disease].”

The study was sponsored by ImmunogenX Inc., and partially funded by a grant from the National Center for Complementary and Integrative Health. The project was further supported by grants from the National Center for Advancing Translational Sciences and the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants from numerous funders, including ImmunogenX, and some reported being a cofounder, stockholder, or board director of the company.

In a gluten challenge trial, latiglutenase (IMGX003) reduced symptom severity and mucosal deterioration in patients with celiac disease, according to a new study published in Gastroenterology.

Latiglutenase led to 95% gluten degradation in the stomach, as indicated by measurements of gluten-immunogenic peptides in urine, wrote Joseph A. Murray, MD, a gastroenterologist at the Mayo Clinic, Rochester, Minn., and Jack A. Syage, PhD, CEO and cofounder of ImmunogenX Inc., Newport Beach, Calif., and colleagues on behalf of the CeliacShield Study Group.

For patients with celiac disease, the only available treatment is a life-long gluten-free diet (GFD). Low levels of gluten exposure can lead to ongoing inflammation and the risk of complications, and about half of patients continue to experience moderate to severe symptoms.

“Although a GFD can reduce symptoms and intestinal damage, the diet is neither easy nor readily achievable by many patients and, furthermore, can be lacking in essential nutrients,” the authors wrote.

In a randomized, double-blind, placebo-controlled gluten challenge study, the research team assessed the efficacy and safety of a 1,200-mg dose of IMGX003, formerly known as ALV003. The dual-enzyme supplementation therapy was “designed to mitigate the impact of gluten exposure in patients who are attempting to adhere to a GFD.”

The phase 2 trial was conducted at the Mayo Clinic with adult patients (aged 18-80 years) who had physician-diagnosed and biopsy-confirmed celiac disease, followed a GFD for more than 1 year, and had histologically well-controlled disease. During the study, they were exposed to 2 g of gluten per day for 6 weeks.

The primary endpoint focused on the change in the ratio of villus height to crypt depth. The “secondary endpoints included density of intraepithelial lymphocytes and symptom severity. Additional endpoints included serology and gluten-immunogenic peptides in urine.”

Among the 50 patients randomized, 43 completed the study, with 21 assigned to the IMGX003 group. About 74% of the participants were women; the mean age of all participants was 43.8 years.

Overall, the mean change in the ratio of villus height to crypt depth was –0.04 for IMGX003, compared with –0.35 for placebo. In addition, the mean change in the density of intraepithelial lymphocytes for IMGX003 was 9.8, compared with 24.8 for placebo. Based on the ratio of the means for both groups, the researchers estimated an 88% reduction of change in villus height to crypt depth and a 60% reduction of change in intraepithelial lymphocytes.

The mean changes, or worsening from baseline, in symptom severity for IMGX003 vs. placebo were 0.22 vs. 1.63 for abdominal pain, 0.96 vs. 3.29 for bloating, 0.02 vs. 3.2 for tiredness, and 0.64 vs. 2.27 for nonstool composite. The calculated symptom reduction values were 93% for abdominal pain, 53% for bloating, 99% for tiredness, and 70% for nonstool composite.

The mean change from baseline for symptom severity was evaluated over three 2-week periods, and the percent changes showed consistent reduction of symptom worsening during that time. Based on the effect size and trend significance, the P values were .014 for abdominal pain, .030 for bloating, .002 for tiredness, and < . 001 for nonstool composite.

The mean change in gluten-immunogenic peptides in urine (GIP) relative to baseline was 0.59 for IMGX003, compared with 11.53 for placebo. The researchers estimated an efficacy of gluten degradation in vivo of 95%.

“Measurement of GIP in urine demonstrated the purported mechanism of action of IMGX003, namely, degradation of gluten in the stomach, thereby preventing the triggering of the immunogenic autoimmune response,” the authors wrote. “Targeting gluten by degrading the immunogenic peptides before absorption minimizes or abrogates the cascading innate and adaptive immune responses that characterize the inflammatory response to gluten in CeD [celiac disease].”

The study was sponsored by ImmunogenX Inc., and partially funded by a grant from the National Center for Complementary and Integrative Health. The project was further supported by grants from the National Center for Advancing Translational Sciences and the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants from numerous funders, including ImmunogenX, and some reported being a cofounder, stockholder, or board director of the company.

As an undergraduate student at Northeastern University in Boston, Meghan Chin spent her summers working for a day program in Rhode Island. Her charges were adults with various forms of intellectual and developmental disabilities (IDD).

“I was very much a caretaker,” Ms. Chin, now 29, said. “It was everything from helping them get dressed in the morning to getting them to medical appointments.”

During one such visit Ms. Chin got a lesson about how health care looks from the viewpoint of someone with an IDD.

The patient was a woman in her 60s and she was having gastrointestinal issues; symptoms she could have articulated, if asked. “She was perfectly capable of telling a clinician where it hurt, how long she had experienced the problem, and what she had done or not done to alleviate it,” Ms. Chin said.

And of comprehending a response. But she was not given the opportunity.

“She would explain what was going on to the clinician,” Ms. Chin recalled. “And the clinician would turn to me and answer. It was this weird three-way conversation – as if she wasn’t even there in the room with us.”

Ms. Chin was incensed at the rude and disrespectful way the patient had been treated. But her charge didn’t seem upset or surprised. Just resigned. “Sadly, she had become used to this,” Ms. Chin said. 

For the young aide, however, the experience was searing. “It didn’t seem right to me,” Ms. Chin said. “That’s why, when I went to medical school, I knew I wanted to do better for this population.”

Serendipity led her to Georgetown University, Washington, where she met Kim Bullock, MD, one of the country’s leading advocates for improved health care delivery to those with IDDs.

Dr. Bullock, an associate professor of family medicine, seeks to create better training and educational opportunities for medical students who will likely encounter patients with these disabilities in their practices.

When Dr. Bullock heard Ms. Chin’s story about the patient being ignored, she was not surprised.

“This is not an unusual or unique situation,” said Dr. Bullock, who is also director of Georgetown’s community health division and a faculty member of the university’s Center for Excellence for Developmental Disabilities. “In fact, it’s quite common and is part of what spurred my own interest in educating pre-med and medical students about effective communication techniques, particularly when addressing neurodiverse patients.”

More than 13% of Americans, or roughly 44 million people, have some form of disability, according to the National Institute on Disability at the University of New Hampshire, a figure that does not include those who are institutionalized. The Centers for Disease Control and Prevention estimates that 17% of children aged 3-17 years have a developmental disability.

Even so, many physicians feel ill-prepared to care for disabled patients. A survey of physicians, published in the journal Health Affairs, found that some lacked the resources and training to properly care for patients with disabilities, or that they struggled to coordinate care for such individuals. Some said they did not know which types of accessible equipment, like adjustable tables and chair scales, were needed or how to use them. And some said they actively try to avoid treating patients with disabilities.
 

Don’t assume

The first step at correcting the problem, Dr. Bullock said, is to not assume that all IDD patients are incapable of communicating. By talking not to the patient but to their caregiver or spouse or child, as the clinician did with Ms. Chin years ago, “we are taking away their agency, their autonomy to speak for and about themselves.”

Change involves altering physicians’ attitudes and assumptions toward this population, through education. But how?

“The medical school curriculum is tight as it is,” Dr. Bullock acknowledged. “There’s a lot of things students have to learn. People wonder: where we will add this?”

Her suggestion: Incorporate IDD all along the way, through programs or experiences that will enable medical students to see such patients “not as something separate, but as people that have special needs just as other populations have.”

Case in point: Operation House Call, a program in Massachusetts designed to support young health care professionals, by building “confidence, interest, and sensitivity” toward individuals with IDD.

Eight medical and allied health schools, including those at Harvard Medical School and Yale School of Nursing, participate in the program, the centerpiece of which is time spent by teams of medical students in the homes of families with neurodiverse members. “It’s transformational,” said Susan Feeney, DNP, NP-C, director of adult gerontology and family nurse practitioner programs at the graduate school of nursing at the University of Massachusetts, Worcester. “They spend a few hours at the homes of these families, have this interaction with them, and journal about their experiences.”

Dr. Feeney described as “transformational” the experience of the students after getting to know these families. “They all come back profoundly changed,” she told this news organization. “As a medical or health care professional, you meet people in an artificial environment of the clinic and hospital. Here, they become human, like you. It takes the stigma away.”

One area of medicine in which this is an exception is pediatrics, where interaction with children with IDD and their families is common – and close. “They’re going to be much more attuned to this,” Dr. Feeney said. “The problem is primary care or internal medicine. Once these children get into their mid and later 20s, and they need a practitioner to talk to about adult concerns.”

And with adulthood come other medical needs, as the physical demands of age fall no less heavily on individuals with IDDs than those without. For example: “Neurodiverse people get pregnant,” Dr. Bullock said. They also can get heart disease as they age; or require the care of a rheumatologist, a neurologist, an orthopedic surgeon, or any other medical specialty.

Generation gap

Fortunately, the next generation of physicians may be more open to this more inclusionary approach toward a widely misunderstood population.

Like Ms. Chin, Sarah Bdeir had experience with this population prior to beginning her training in medicine. She had volunteered at a school for people with IDD.

“It was one of the best experiences I’ve ever had,” Ms. Bdeir, now 23 and a first-year medical student at Wayne State University, Detroit, said. She found that the neurodiverse individuals she worked with had as many abilities as disabilities. “They are capable of learning, but they do it differently,” she said. “You have to adjust to the way they learn. And you have to step out of your own box.”

Ms. Bdeir also heard about Dr. Bullock’s work and is assisting her in a research project on how to better improve nutritional education for people with IDDs. And although she said it may take time for curriculum boards at medical schools to integrate this kind of training into their programs, she believes they will, in part because the rising cohort of medical students today have an eagerness to engage with and learn more about IDD patients.

As does Ms. Chin.

“When I talk to my peers about this, they’re very receptive,” Ms. Chin said. “They want to learn how to better support the IDD population. And they will learn. I believe in my generation of future doctors.”

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

As an undergraduate student at Northeastern University in Boston, Meghan Chin spent her summers working for a day program in Rhode Island. Her charges were adults with various forms of intellectual and developmental disabilities (IDD).

“I was very much a caretaker,” Ms. Chin, now 29, said. “It was everything from helping them get dressed in the morning to getting them to medical appointments.”

During one such visit Ms. Chin got a lesson about how health care looks from the viewpoint of someone with an IDD.

The patient was a woman in her 60s and she was having gastrointestinal issues; symptoms she could have articulated, if asked. “She was perfectly capable of telling a clinician where it hurt, how long she had experienced the problem, and what she had done or not done to alleviate it,” Ms. Chin said.

And of comprehending a response. But she was not given the opportunity.

“She would explain what was going on to the clinician,” Ms. Chin recalled. “And the clinician would turn to me and answer. It was this weird three-way conversation – as if she wasn’t even there in the room with us.”

Ms. Chin was incensed at the rude and disrespectful way the patient had been treated. But her charge didn’t seem upset or surprised. Just resigned. “Sadly, she had become used to this,” Ms. Chin said. 

For the young aide, however, the experience was searing. “It didn’t seem right to me,” Ms. Chin said. “That’s why, when I went to medical school, I knew I wanted to do better for this population.”

Serendipity led her to Georgetown University, Washington, where she met Kim Bullock, MD, one of the country’s leading advocates for improved health care delivery to those with IDDs.

Dr. Bullock, an associate professor of family medicine, seeks to create better training and educational opportunities for medical students who will likely encounter patients with these disabilities in their practices.

When Dr. Bullock heard Ms. Chin’s story about the patient being ignored, she was not surprised.

“This is not an unusual or unique situation,” said Dr. Bullock, who is also director of Georgetown’s community health division and a faculty member of the university’s Center for Excellence for Developmental Disabilities. “In fact, it’s quite common and is part of what spurred my own interest in educating pre-med and medical students about effective communication techniques, particularly when addressing neurodiverse patients.”

More than 13% of Americans, or roughly 44 million people, have some form of disability, according to the National Institute on Disability at the University of New Hampshire, a figure that does not include those who are institutionalized. The Centers for Disease Control and Prevention estimates that 17% of children aged 3-17 years have a developmental disability.

Even so, many physicians feel ill-prepared to care for disabled patients. A survey of physicians, published in the journal Health Affairs, found that some lacked the resources and training to properly care for patients with disabilities, or that they struggled to coordinate care for such individuals. Some said they did not know which types of accessible equipment, like adjustable tables and chair scales, were needed or how to use them. And some said they actively try to avoid treating patients with disabilities.
 

Don’t assume

The first step at correcting the problem, Dr. Bullock said, is to not assume that all IDD patients are incapable of communicating. By talking not to the patient but to their caregiver or spouse or child, as the clinician did with Ms. Chin years ago, “we are taking away their agency, their autonomy to speak for and about themselves.”

Change involves altering physicians’ attitudes and assumptions toward this population, through education. But how?

“The medical school curriculum is tight as it is,” Dr. Bullock acknowledged. “There’s a lot of things students have to learn. People wonder: where we will add this?”

Her suggestion: Incorporate IDD all along the way, through programs or experiences that will enable medical students to see such patients “not as something separate, but as people that have special needs just as other populations have.”

Case in point: Operation House Call, a program in Massachusetts designed to support young health care professionals, by building “confidence, interest, and sensitivity” toward individuals with IDD.

Eight medical and allied health schools, including those at Harvard Medical School and Yale School of Nursing, participate in the program, the centerpiece of which is time spent by teams of medical students in the homes of families with neurodiverse members. “It’s transformational,” said Susan Feeney, DNP, NP-C, director of adult gerontology and family nurse practitioner programs at the graduate school of nursing at the University of Massachusetts, Worcester. “They spend a few hours at the homes of these families, have this interaction with them, and journal about their experiences.”

Dr. Feeney described as “transformational” the experience of the students after getting to know these families. “They all come back profoundly changed,” she told this news organization. “As a medical or health care professional, you meet people in an artificial environment of the clinic and hospital. Here, they become human, like you. It takes the stigma away.”

One area of medicine in which this is an exception is pediatrics, where interaction with children with IDD and their families is common – and close. “They’re going to be much more attuned to this,” Dr. Feeney said. “The problem is primary care or internal medicine. Once these children get into their mid and later 20s, and they need a practitioner to talk to about adult concerns.”

And with adulthood come other medical needs, as the physical demands of age fall no less heavily on individuals with IDDs than those without. For example: “Neurodiverse people get pregnant,” Dr. Bullock said. They also can get heart disease as they age; or require the care of a rheumatologist, a neurologist, an orthopedic surgeon, or any other medical specialty.

Generation gap

Fortunately, the next generation of physicians may be more open to this more inclusionary approach toward a widely misunderstood population.

Like Ms. Chin, Sarah Bdeir had experience with this population prior to beginning her training in medicine. She had volunteered at a school for people with IDD.

“It was one of the best experiences I’ve ever had,” Ms. Bdeir, now 23 and a first-year medical student at Wayne State University, Detroit, said. She found that the neurodiverse individuals she worked with had as many abilities as disabilities. “They are capable of learning, but they do it differently,” she said. “You have to adjust to the way they learn. And you have to step out of your own box.”

Ms. Bdeir also heard about Dr. Bullock’s work and is assisting her in a research project on how to better improve nutritional education for people with IDDs. And although she said it may take time for curriculum boards at medical schools to integrate this kind of training into their programs, she believes they will, in part because the rising cohort of medical students today have an eagerness to engage with and learn more about IDD patients.

As does Ms. Chin.

“When I talk to my peers about this, they’re very receptive,” Ms. Chin said. “They want to learn how to better support the IDD population. And they will learn. I believe in my generation of future doctors.”

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

As an undergraduate student at Northeastern University in Boston, Meghan Chin spent her summers working for a day program in Rhode Island. Her charges were adults with various forms of intellectual and developmental disabilities (IDD).

“I was very much a caretaker,” Ms. Chin, now 29, said. “It was everything from helping them get dressed in the morning to getting them to medical appointments.”

During one such visit Ms. Chin got a lesson about how health care looks from the viewpoint of someone with an IDD.

The patient was a woman in her 60s and she was having gastrointestinal issues; symptoms she could have articulated, if asked. “She was perfectly capable of telling a clinician where it hurt, how long she had experienced the problem, and what she had done or not done to alleviate it,” Ms. Chin said.

And of comprehending a response. But she was not given the opportunity.

“She would explain what was going on to the clinician,” Ms. Chin recalled. “And the clinician would turn to me and answer. It was this weird three-way conversation – as if she wasn’t even there in the room with us.”

Ms. Chin was incensed at the rude and disrespectful way the patient had been treated. But her charge didn’t seem upset or surprised. Just resigned. “Sadly, she had become used to this,” Ms. Chin said. 

For the young aide, however, the experience was searing. “It didn’t seem right to me,” Ms. Chin said. “That’s why, when I went to medical school, I knew I wanted to do better for this population.”

Serendipity led her to Georgetown University, Washington, where she met Kim Bullock, MD, one of the country’s leading advocates for improved health care delivery to those with IDDs.

Dr. Bullock, an associate professor of family medicine, seeks to create better training and educational opportunities for medical students who will likely encounter patients with these disabilities in their practices.

When Dr. Bullock heard Ms. Chin’s story about the patient being ignored, she was not surprised.

“This is not an unusual or unique situation,” said Dr. Bullock, who is also director of Georgetown’s community health division and a faculty member of the university’s Center for Excellence for Developmental Disabilities. “In fact, it’s quite common and is part of what spurred my own interest in educating pre-med and medical students about effective communication techniques, particularly when addressing neurodiverse patients.”

More than 13% of Americans, or roughly 44 million people, have some form of disability, according to the National Institute on Disability at the University of New Hampshire, a figure that does not include those who are institutionalized. The Centers for Disease Control and Prevention estimates that 17% of children aged 3-17 years have a developmental disability.

Even so, many physicians feel ill-prepared to care for disabled patients. A survey of physicians, published in the journal Health Affairs, found that some lacked the resources and training to properly care for patients with disabilities, or that they struggled to coordinate care for such individuals. Some said they did not know which types of accessible equipment, like adjustable tables and chair scales, were needed or how to use them. And some said they actively try to avoid treating patients with disabilities.
 

Don’t assume

The first step at correcting the problem, Dr. Bullock said, is to not assume that all IDD patients are incapable of communicating. By talking not to the patient but to their caregiver or spouse or child, as the clinician did with Ms. Chin years ago, “we are taking away their agency, their autonomy to speak for and about themselves.”

Change involves altering physicians’ attitudes and assumptions toward this population, through education. But how?

“The medical school curriculum is tight as it is,” Dr. Bullock acknowledged. “There’s a lot of things students have to learn. People wonder: where we will add this?”

Her suggestion: Incorporate IDD all along the way, through programs or experiences that will enable medical students to see such patients “not as something separate, but as people that have special needs just as other populations have.”

Case in point: Operation House Call, a program in Massachusetts designed to support young health care professionals, by building “confidence, interest, and sensitivity” toward individuals with IDD.

Eight medical and allied health schools, including those at Harvard Medical School and Yale School of Nursing, participate in the program, the centerpiece of which is time spent by teams of medical students in the homes of families with neurodiverse members. “It’s transformational,” said Susan Feeney, DNP, NP-C, director of adult gerontology and family nurse practitioner programs at the graduate school of nursing at the University of Massachusetts, Worcester. “They spend a few hours at the homes of these families, have this interaction with them, and journal about their experiences.”

Dr. Feeney described as “transformational” the experience of the students after getting to know these families. “They all come back profoundly changed,” she told this news organization. “As a medical or health care professional, you meet people in an artificial environment of the clinic and hospital. Here, they become human, like you. It takes the stigma away.”

One area of medicine in which this is an exception is pediatrics, where interaction with children with IDD and their families is common – and close. “They’re going to be much more attuned to this,” Dr. Feeney said. “The problem is primary care or internal medicine. Once these children get into their mid and later 20s, and they need a practitioner to talk to about adult concerns.”

And with adulthood come other medical needs, as the physical demands of age fall no less heavily on individuals with IDDs than those without. For example: “Neurodiverse people get pregnant,” Dr. Bullock said. They also can get heart disease as they age; or require the care of a rheumatologist, a neurologist, an orthopedic surgeon, or any other medical specialty.

Generation gap

Fortunately, the next generation of physicians may be more open to this more inclusionary approach toward a widely misunderstood population.

Like Ms. Chin, Sarah Bdeir had experience with this population prior to beginning her training in medicine. She had volunteered at a school for people with IDD.

“It was one of the best experiences I’ve ever had,” Ms. Bdeir, now 23 and a first-year medical student at Wayne State University, Detroit, said. She found that the neurodiverse individuals she worked with had as many abilities as disabilities. “They are capable of learning, but they do it differently,” she said. “You have to adjust to the way they learn. And you have to step out of your own box.”

Ms. Bdeir also heard about Dr. Bullock’s work and is assisting her in a research project on how to better improve nutritional education for people with IDDs. And although she said it may take time for curriculum boards at medical schools to integrate this kind of training into their programs, she believes they will, in part because the rising cohort of medical students today have an eagerness to engage with and learn more about IDD patients.

As does Ms. Chin.

“When I talk to my peers about this, they’re very receptive,” Ms. Chin said. “They want to learn how to better support the IDD population. And they will learn. I believe in my generation of future doctors.”

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

Don’t just sit there. Post something.

To combat misinformation about colonoscopy, health care providers (HCPs) should engage more with social media platforms and create accurate, engaging educational videos, according to investigators.

An assessment of top-ranking YouTube videos about colonoscopy by both lay people and HCPs revealed numerous inaccuracies, which have potentially contributed to public hesitancy to undergo appropriate screening, reported lead author Austin L. Chiang, MD, MPH, of Thomas Jefferson University Hospitals, Philadelphia, and colleagues.

“The prevalence and predictors of misinformation among contents on social media platforms such as YouTube with regard to colonoscopy remain unknown,” the investigators wrote in Gastro Hep Advances. They noted that previous research characterized YouTube as a “suboptimal” resource for information about colonoscopy, although those studies did not use validated instruments.

For the present cohort study, Dr. Chiang and colleagues performed a YouTube search for “colonoscopy” on Nov. 21, 2020. Results with more than 250,000 views were included in the analysis, netting 69 videos. Of these, 39 were posted by lay people, while the remaining 30 were posted by HCPs.

Three board-certified gastroenterologists measured video quality with two validated instruments for evaluating consumer health information: DISCERN and the Patient Education Material Assessment Tool (PEMAT) understandability score. Any video with a DISCERN score less than 2 or a PEMAT score less than 50% was deemed “inaccurate or of low scientific quality per established standards.” The investigators also scored likelihood of recommending a video to a patient on a 5-point Likert scale.

More than half of the videos were low quality based on DISCERN (52.2%) and PEMAT (59.4%) criteria. Videos that featured an HCP scored significantly higher on both scales, while videos created by HCPs were more likely to meet minimum-quality criteria and be recommended to patients.

Specifically, only 20.5% of videos created by laypeople made the grade, compared with 66.7% (PMAT) and 83.3% (DISCERN) of videos made by HCPs, depending on the quality instrument. It therefore follows that an HCP creator was the greatest predictive factor for a high-quality video, according to the area under the receiving operating characteristic curve.

“Our analysis demonstrates a disturbing proportion of inaccuracies and poor scientific quality information among the most viewed YouTube videos around colonoscopy using validated instruments for consumer information,” the investigators wrote.

Types of misinformation varied. Some of the videos contradicted current recommendations and intentionally overstated colonoscopy risk, while others called for screening every year.

“Although it is disheartening to imagine the influence of these inaccurate videos on millions of people, it may be helpful to learn from them and dissect why they have succeeded in attracting viewers,” the investigators wrote.

So which videos had the most views? To put it bluntly, it was the funny, “gross” stuff. The top-ranking colonoscopy videos featured comedians talking about their colonoscopies or had shocking footage, like worms wiggling during an endoscopic exam of a patient with a parasitic infection.
 

How to create better content

While these acts may be hard to follow for the average gastroenterologist-YouTuber, Dr. Chiang and colleagues did detect one video characteristic that should be avoided: complexity. Multivariate analysis showed that endoscopic footage was a negative effect modifier for clarity and understandability.

“The main challenge of any video content is striking a balance between brevity and accuracy/comprehensiveness,” the investigators wrote. “When describing endoscopic videos to lay audiences, gastroenterologists must be careful to provide appropriate clinical context and use wording that is concise and easily comprehended.”

More broadly, the investigators called for a three-pronged approach to combat misinformation by creating better content.

First, they advised HCPs to increase participation on social media channels, with a focus on promoting health equity among at-risk and non–English-speaking audiences. Second, they asked professional societies such as the American Gastroenterological Association to assist HCPs with the fundamentals of content creation, including techniques in storytelling and videography. Finally, they proposed HCPs partner with lay creators, following a common strategy in traditional media in which celebrities share scientifically grounded medical information.

“Although the prevalence of inaccurate colonoscopy videos is concerning, an understanding of existing health misinformation and a proactive approach to cultivate professional content creation may help provide patients with high-quality information to help achieve colorectal cancer screening targets and improve health outcomes,” the investigators concluded.

The study was partially funded by the National Institutes of Health. Dr. Chiang is an employee of Medtronic and holds a seat on the YouTube Health Advisory Board. The other investigators disclosed no competing interests.

Don’t just sit there. Post something.

To combat misinformation about colonoscopy, health care providers (HCPs) should engage more with social media platforms and create accurate, engaging educational videos, according to investigators.

An assessment of top-ranking YouTube videos about colonoscopy by both lay people and HCPs revealed numerous inaccuracies, which have potentially contributed to public hesitancy to undergo appropriate screening, reported lead author Austin L. Chiang, MD, MPH, of Thomas Jefferson University Hospitals, Philadelphia, and colleagues.

“The prevalence and predictors of misinformation among contents on social media platforms such as YouTube with regard to colonoscopy remain unknown,” the investigators wrote in Gastro Hep Advances. They noted that previous research characterized YouTube as a “suboptimal” resource for information about colonoscopy, although those studies did not use validated instruments.

For the present cohort study, Dr. Chiang and colleagues performed a YouTube search for “colonoscopy” on Nov. 21, 2020. Results with more than 250,000 views were included in the analysis, netting 69 videos. Of these, 39 were posted by lay people, while the remaining 30 were posted by HCPs.

Three board-certified gastroenterologists measured video quality with two validated instruments for evaluating consumer health information: DISCERN and the Patient Education Material Assessment Tool (PEMAT) understandability score. Any video with a DISCERN score less than 2 or a PEMAT score less than 50% was deemed “inaccurate or of low scientific quality per established standards.” The investigators also scored likelihood of recommending a video to a patient on a 5-point Likert scale.

More than half of the videos were low quality based on DISCERN (52.2%) and PEMAT (59.4%) criteria. Videos that featured an HCP scored significantly higher on both scales, while videos created by HCPs were more likely to meet minimum-quality criteria and be recommended to patients.

Specifically, only 20.5% of videos created by laypeople made the grade, compared with 66.7% (PMAT) and 83.3% (DISCERN) of videos made by HCPs, depending on the quality instrument. It therefore follows that an HCP creator was the greatest predictive factor for a high-quality video, according to the area under the receiving operating characteristic curve.

“Our analysis demonstrates a disturbing proportion of inaccuracies and poor scientific quality information among the most viewed YouTube videos around colonoscopy using validated instruments for consumer information,” the investigators wrote.

Types of misinformation varied. Some of the videos contradicted current recommendations and intentionally overstated colonoscopy risk, while others called for screening every year.

“Although it is disheartening to imagine the influence of these inaccurate videos on millions of people, it may be helpful to learn from them and dissect why they have succeeded in attracting viewers,” the investigators wrote.

So which videos had the most views? To put it bluntly, it was the funny, “gross” stuff. The top-ranking colonoscopy videos featured comedians talking about their colonoscopies or had shocking footage, like worms wiggling during an endoscopic exam of a patient with a parasitic infection.
 

How to create better content

While these acts may be hard to follow for the average gastroenterologist-YouTuber, Dr. Chiang and colleagues did detect one video characteristic that should be avoided: complexity. Multivariate analysis showed that endoscopic footage was a negative effect modifier for clarity and understandability.

“The main challenge of any video content is striking a balance between brevity and accuracy/comprehensiveness,” the investigators wrote. “When describing endoscopic videos to lay audiences, gastroenterologists must be careful to provide appropriate clinical context and use wording that is concise and easily comprehended.”

More broadly, the investigators called for a three-pronged approach to combat misinformation by creating better content.

First, they advised HCPs to increase participation on social media channels, with a focus on promoting health equity among at-risk and non–English-speaking audiences. Second, they asked professional societies such as the American Gastroenterological Association to assist HCPs with the fundamentals of content creation, including techniques in storytelling and videography. Finally, they proposed HCPs partner with lay creators, following a common strategy in traditional media in which celebrities share scientifically grounded medical information.

“Although the prevalence of inaccurate colonoscopy videos is concerning, an understanding of existing health misinformation and a proactive approach to cultivate professional content creation may help provide patients with high-quality information to help achieve colorectal cancer screening targets and improve health outcomes,” the investigators concluded.

The study was partially funded by the National Institutes of Health. Dr. Chiang is an employee of Medtronic and holds a seat on the YouTube Health Advisory Board. The other investigators disclosed no competing interests.

Don’t just sit there. Post something.

To combat misinformation about colonoscopy, health care providers (HCPs) should engage more with social media platforms and create accurate, engaging educational videos, according to investigators.

An assessment of top-ranking YouTube videos about colonoscopy by both lay people and HCPs revealed numerous inaccuracies, which have potentially contributed to public hesitancy to undergo appropriate screening, reported lead author Austin L. Chiang, MD, MPH, of Thomas Jefferson University Hospitals, Philadelphia, and colleagues.

“The prevalence and predictors of misinformation among contents on social media platforms such as YouTube with regard to colonoscopy remain unknown,” the investigators wrote in Gastro Hep Advances. They noted that previous research characterized YouTube as a “suboptimal” resource for information about colonoscopy, although those studies did not use validated instruments.

For the present cohort study, Dr. Chiang and colleagues performed a YouTube search for “colonoscopy” on Nov. 21, 2020. Results with more than 250,000 views were included in the analysis, netting 69 videos. Of these, 39 were posted by lay people, while the remaining 30 were posted by HCPs.

Three board-certified gastroenterologists measured video quality with two validated instruments for evaluating consumer health information: DISCERN and the Patient Education Material Assessment Tool (PEMAT) understandability score. Any video with a DISCERN score less than 2 or a PEMAT score less than 50% was deemed “inaccurate or of low scientific quality per established standards.” The investigators also scored likelihood of recommending a video to a patient on a 5-point Likert scale.

More than half of the videos were low quality based on DISCERN (52.2%) and PEMAT (59.4%) criteria. Videos that featured an HCP scored significantly higher on both scales, while videos created by HCPs were more likely to meet minimum-quality criteria and be recommended to patients.

Specifically, only 20.5% of videos created by laypeople made the grade, compared with 66.7% (PMAT) and 83.3% (DISCERN) of videos made by HCPs, depending on the quality instrument. It therefore follows that an HCP creator was the greatest predictive factor for a high-quality video, according to the area under the receiving operating characteristic curve.

“Our analysis demonstrates a disturbing proportion of inaccuracies and poor scientific quality information among the most viewed YouTube videos around colonoscopy using validated instruments for consumer information,” the investigators wrote.

Types of misinformation varied. Some of the videos contradicted current recommendations and intentionally overstated colonoscopy risk, while others called for screening every year.

“Although it is disheartening to imagine the influence of these inaccurate videos on millions of people, it may be helpful to learn from them and dissect why they have succeeded in attracting viewers,” the investigators wrote.

So which videos had the most views? To put it bluntly, it was the funny, “gross” stuff. The top-ranking colonoscopy videos featured comedians talking about their colonoscopies or had shocking footage, like worms wiggling during an endoscopic exam of a patient with a parasitic infection.
 

How to create better content

While these acts may be hard to follow for the average gastroenterologist-YouTuber, Dr. Chiang and colleagues did detect one video characteristic that should be avoided: complexity. Multivariate analysis showed that endoscopic footage was a negative effect modifier for clarity and understandability.

“The main challenge of any video content is striking a balance between brevity and accuracy/comprehensiveness,” the investigators wrote. “When describing endoscopic videos to lay audiences, gastroenterologists must be careful to provide appropriate clinical context and use wording that is concise and easily comprehended.”

More broadly, the investigators called for a three-pronged approach to combat misinformation by creating better content.

First, they advised HCPs to increase participation on social media channels, with a focus on promoting health equity among at-risk and non–English-speaking audiences. Second, they asked professional societies such as the American Gastroenterological Association to assist HCPs with the fundamentals of content creation, including techniques in storytelling and videography. Finally, they proposed HCPs partner with lay creators, following a common strategy in traditional media in which celebrities share scientifically grounded medical information.

“Although the prevalence of inaccurate colonoscopy videos is concerning, an understanding of existing health misinformation and a proactive approach to cultivate professional content creation may help provide patients with high-quality information to help achieve colorectal cancer screening targets and improve health outcomes,” the investigators concluded.

The study was partially funded by the National Institutes of Health. Dr. Chiang is an employee of Medtronic and holds a seat on the YouTube Health Advisory Board. The other investigators disclosed no competing interests.

The probability of spontaneous conversion to sinus rhythm (SCV) was increased with the intravenous administration of magnesium and potassium in patients with nonpermanent atrial fibrillation presenting to the ER, a registry study shows.

Compared with no treatment, potassium and magnesium administration was associated with a 10% higher rate of SVC.

The finding suggests that giving intravenous potassium and magnesium might lessen the need for antiarrhythmic therapy and the associated potential adverse effects in patients with nonpermanent atrial fibrillation (AFib), the study authors say.

Still, they add, “The results of our study have no direct implications for clinical practice in the management of care for patients with AF [atrial fibrillation] or AFL [atrial flutter] in the ED. The findings are purely exploratory and hypothesis-generating but could potentially provide a rationale for an appropriate prospective trial.”

The study was published online in JAMA Network Open.

“Atrial fibrillation is becoming an increasing burden for health care systems worldwide owing to population aging,” write Filippo Cacioppo, MD, and colleagues from Medical University of Vienna (Austria).

“Pharmacologic and electrical conversion are common therapies in emergency departments, especially for highly symptomatic patients. Each intervention has specific risks, and neither is considered cost-effective owing to frequent recurrence of AF. In addition, AF often terminates spontaneously,” Dr. Cacioppo and colleagues write.

They add that evidence suggests hypokalemia and hypomagnesemia contribute to AFib development, and so the administration of potassium and magnesium could be a reasonable strategy to improve SCV rates.

To test their hypothesis, Dr. Cacioppo and associates conducted a registry-based cohort study in all patients with AFib or AFL presenting to their center’s ED between Feb. 6, 2009, and Feb. 16, 2020.

During this time, they observed a total of 2,546 episodes of nonpermanent AFib. The median patient age was 68 years (interquartile range, 58-75 years). Most were men (n = 1,411 patients, 55.4%).

In addition, there were 573 episodes of nonpermanent AFL. The median patient age was 68 years (IQR, 58-75 years), and 332 patients (57.9%) were men.

Intravenous potassium and magnesium were administered in just over half (n = 1,763; 56.5%) of the episodes.

The median amount of potassium and magnesium was delivered via one 250-mL infusion bag, which consisted of 24 mEq potassium and 145.8 mg magnesium combined with 500 mL of balanced crystalloid fluid containing 2.5 mEq potassium and 18.2 mg magnesium, administered for 90 minutes, the authors write.

If patients experienced pain at the injection site, the infusion rate was reduced until the pain subsided.

Conversion to sinus rhythm was considered spontaneous if no attempt at pharmacologic rhythm control was made until conversion occurred; if SCV occurred after an unsuccessful attempt at electrical cardioversion; or following rate control with beta-blockers, nondihydropyridine calcium channel blockers, or digitalis glycosides, the authors state.
 

IV treatment increased odds of SCV

The median duration of stay in the ED was 6.4 hours (IQR, 3.9-11.6 hours) for patients with AFib and 6.1 hours (IQR, 3.9-11.8 hours) for patients with AFL.

During the stay in the ED, SCV occurred in 15.4% (n = 393) of AFib episodes and 12.7% (n = 73) of AFL episodes.

Intravenous potassium and magnesium increased the possibility of SCV compared with no IV potassium and magnesium in AFib, but not in AFL.

In episodes of AFib, administration of intravenous potassium and magnesium was associated with 19.2% increased odds of SCV, compared with 10.4% with no administration (odds ratio, 1.98; 95% CI, 1.53-2.57).

In contrast, for AFL, no association was observed for the probability of SCV with potassium and magnesium administration when compared with no administration (13.0% vs. 12.5%; OR, 1.05; 95% CI, 0.65-1.69).
 

Not in the guidelines

“To date, it is unclear whether potassium and magnesium administration might be reasonable in the acute treatment of AF and AFL, and although this intervention may be common practice in some EDs, it is not part of the treatment recommendations in current guidelines,” Dr. Cacioppo and colleagues write.

“Our findings suggest that intravenous potassium and magnesium administration may increase the chance of SCV in patients with AF with either hypokalemia or with plasma potassium levels in the range of 3.50 to 3.99 mEq/L. In patients with AFL, however, potassium and magnesium administration may not be associated with SCV probability,” they write.

Dr. Cacioppo and associates add that in their study IV administration of potassium and magnesium was associated with SCV only in patients with symptom onset of less than 48 hours, suggesting a time-dependent outcome. However, they caution, “because only a limited number of patients with SCV had symptom onset greater than or equal to 48 hours, this finding warrants further investigation.”
 

A Band-Aid approach

“I’m a little skeptical about this study,” Georgios Syros, MD, director of arrhythmia services at Mount Sinai Queens and Mount Sinai Brooklyn, New York, said in an interview.

“Atrial fibrillation is a chronic disease. The natural history of this disease is that it is paroxysmal in the beginning, and at some point the episodes become more frequent and longer in duration. For some people, at some point, it becomes permanent,” Dr. Syros said.

“Suppose I cut my finger while slicing bread. I put a Band-Aid on the cut. That doesn’t mean I have fixed it, it means I’ve helped it temporarily. Atrial fibrillation in this paper is very analogous,” he said. “The patient may have episodes, goes to the emergency room, you give them medication, and temporarily alleviate the situation so that the patient does not have to be admitted. It’s simple, inexpensive, you make the heart rate go back to normal, not permanently, with few side effects, except perhaps for some pain at the injection site, but that doesn’t mean you have fixed the AFib permanently. But for someone who has had a first incidence, or doesn’t want to stay in the hospital because it’s the weekend, yes, you can use this as a Band-Aid,” he said.

Intravenous potassium and magnesium, as proposed in the current study, is similar to a medication currently in use in Europe, called vernakalant, Dr. Syros said.

“Vernakalant is not FDA approved in the U.S. It is not meant to treat atrial fibrillation permanently, so we have to inform the public about the limitations of what we are doing,” he said. “Vernakalant is similar to IV potassium and magnesium, as given in this study, but it is more expensive. It temporarily allows people to go back to sinus rhythm, but it’s not going to be there forever and you may go back to permanent AFib, so this is not magic, unfortunately.”

Dr. Syros emphasized that the current study results apply only to cases of paroxysmal atrial fibrillation of less than 48 hours duration. “This is a very important distinction,” he said.

“For example, a patient who drank a lot and the day after is in AFib, with what we call holiday heart, would be a good candidate for the treatment in this study. He’s young, without any heart damage, no diabetes, no hypertension, no prior stroke, so sure, help him out with potassium and magnesium, provided that he can prove to us that this started within 48 hours,” Dr. Syros said.

Dr. Cacioppo and colleagues and Dr. Syros report no relevant financial relationships. Study corresponding author Jan Niederdoeckl, MD, PhD, obtained funding for the study.

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

The probability of spontaneous conversion to sinus rhythm (SCV) was increased with the intravenous administration of magnesium and potassium in patients with nonpermanent atrial fibrillation presenting to the ER, a registry study shows.

Compared with no treatment, potassium and magnesium administration was associated with a 10% higher rate of SVC.

The finding suggests that giving intravenous potassium and magnesium might lessen the need for antiarrhythmic therapy and the associated potential adverse effects in patients with nonpermanent atrial fibrillation (AFib), the study authors say.

Still, they add, “The results of our study have no direct implications for clinical practice in the management of care for patients with AF [atrial fibrillation] or AFL [atrial flutter] in the ED. The findings are purely exploratory and hypothesis-generating but could potentially provide a rationale for an appropriate prospective trial.”

The study was published online in JAMA Network Open.

“Atrial fibrillation is becoming an increasing burden for health care systems worldwide owing to population aging,” write Filippo Cacioppo, MD, and colleagues from Medical University of Vienna (Austria).

“Pharmacologic and electrical conversion are common therapies in emergency departments, especially for highly symptomatic patients. Each intervention has specific risks, and neither is considered cost-effective owing to frequent recurrence of AF. In addition, AF often terminates spontaneously,” Dr. Cacioppo and colleagues write.

They add that evidence suggests hypokalemia and hypomagnesemia contribute to AFib development, and so the administration of potassium and magnesium could be a reasonable strategy to improve SCV rates.

To test their hypothesis, Dr. Cacioppo and associates conducted a registry-based cohort study in all patients with AFib or AFL presenting to their center’s ED between Feb. 6, 2009, and Feb. 16, 2020.

During this time, they observed a total of 2,546 episodes of nonpermanent AFib. The median patient age was 68 years (interquartile range, 58-75 years). Most were men (n = 1,411 patients, 55.4%).

In addition, there were 573 episodes of nonpermanent AFL. The median patient age was 68 years (IQR, 58-75 years), and 332 patients (57.9%) were men.

Intravenous potassium and magnesium were administered in just over half (n = 1,763; 56.5%) of the episodes.

The median amount of potassium and magnesium was delivered via one 250-mL infusion bag, which consisted of 24 mEq potassium and 145.8 mg magnesium combined with 500 mL of balanced crystalloid fluid containing 2.5 mEq potassium and 18.2 mg magnesium, administered for 90 minutes, the authors write.

If patients experienced pain at the injection site, the infusion rate was reduced until the pain subsided.

Conversion to sinus rhythm was considered spontaneous if no attempt at pharmacologic rhythm control was made until conversion occurred; if SCV occurred after an unsuccessful attempt at electrical cardioversion; or following rate control with beta-blockers, nondihydropyridine calcium channel blockers, or digitalis glycosides, the authors state.
 

IV treatment increased odds of SCV

The median duration of stay in the ED was 6.4 hours (IQR, 3.9-11.6 hours) for patients with AFib and 6.1 hours (IQR, 3.9-11.8 hours) for patients with AFL.

During the stay in the ED, SCV occurred in 15.4% (n = 393) of AFib episodes and 12.7% (n = 73) of AFL episodes.

Intravenous potassium and magnesium increased the possibility of SCV compared with no IV potassium and magnesium in AFib, but not in AFL.

In episodes of AFib, administration of intravenous potassium and magnesium was associated with 19.2% increased odds of SCV, compared with 10.4% with no administration (odds ratio, 1.98; 95% CI, 1.53-2.57).

In contrast, for AFL, no association was observed for the probability of SCV with potassium and magnesium administration when compared with no administration (13.0% vs. 12.5%; OR, 1.05; 95% CI, 0.65-1.69).
 

Not in the guidelines

“To date, it is unclear whether potassium and magnesium administration might be reasonable in the acute treatment of AF and AFL, and although this intervention may be common practice in some EDs, it is not part of the treatment recommendations in current guidelines,” Dr. Cacioppo and colleagues write.

“Our findings suggest that intravenous potassium and magnesium administration may increase the chance of SCV in patients with AF with either hypokalemia or with plasma potassium levels in the range of 3.50 to 3.99 mEq/L. In patients with AFL, however, potassium and magnesium administration may not be associated with SCV probability,” they write.

Dr. Cacioppo and associates add that in their study IV administration of potassium and magnesium was associated with SCV only in patients with symptom onset of less than 48 hours, suggesting a time-dependent outcome. However, they caution, “because only a limited number of patients with SCV had symptom onset greater than or equal to 48 hours, this finding warrants further investigation.”
 

A Band-Aid approach

“I’m a little skeptical about this study,” Georgios Syros, MD, director of arrhythmia services at Mount Sinai Queens and Mount Sinai Brooklyn, New York, said in an interview.

“Atrial fibrillation is a chronic disease. The natural history of this disease is that it is paroxysmal in the beginning, and at some point the episodes become more frequent and longer in duration. For some people, at some point, it becomes permanent,” Dr. Syros said.

“Suppose I cut my finger while slicing bread. I put a Band-Aid on the cut. That doesn’t mean I have fixed it, it means I’ve helped it temporarily. Atrial fibrillation in this paper is very analogous,” he said. “The patient may have episodes, goes to the emergency room, you give them medication, and temporarily alleviate the situation so that the patient does not have to be admitted. It’s simple, inexpensive, you make the heart rate go back to normal, not permanently, with few side effects, except perhaps for some pain at the injection site, but that doesn’t mean you have fixed the AFib permanently. But for someone who has had a first incidence, or doesn’t want to stay in the hospital because it’s the weekend, yes, you can use this as a Band-Aid,” he said.

Intravenous potassium and magnesium, as proposed in the current study, is similar to a medication currently in use in Europe, called vernakalant, Dr. Syros said.

“Vernakalant is not FDA approved in the U.S. It is not meant to treat atrial fibrillation permanently, so we have to inform the public about the limitations of what we are doing,” he said. “Vernakalant is similar to IV potassium and magnesium, as given in this study, but it is more expensive. It temporarily allows people to go back to sinus rhythm, but it’s not going to be there forever and you may go back to permanent AFib, so this is not magic, unfortunately.”

Dr. Syros emphasized that the current study results apply only to cases of paroxysmal atrial fibrillation of less than 48 hours duration. “This is a very important distinction,” he said.

“For example, a patient who drank a lot and the day after is in AFib, with what we call holiday heart, would be a good candidate for the treatment in this study. He’s young, without any heart damage, no diabetes, no hypertension, no prior stroke, so sure, help him out with potassium and magnesium, provided that he can prove to us that this started within 48 hours,” Dr. Syros said.

Dr. Cacioppo and colleagues and Dr. Syros report no relevant financial relationships. Study corresponding author Jan Niederdoeckl, MD, PhD, obtained funding for the study.

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

The probability of spontaneous conversion to sinus rhythm (SCV) was increased with the intravenous administration of magnesium and potassium in patients with nonpermanent atrial fibrillation presenting to the ER, a registry study shows.

Compared with no treatment, potassium and magnesium administration was associated with a 10% higher rate of SVC.

The finding suggests that giving intravenous potassium and magnesium might lessen the need for antiarrhythmic therapy and the associated potential adverse effects in patients with nonpermanent atrial fibrillation (AFib), the study authors say.

Still, they add, “The results of our study have no direct implications for clinical practice in the management of care for patients with AF [atrial fibrillation] or AFL [atrial flutter] in the ED. The findings are purely exploratory and hypothesis-generating but could potentially provide a rationale for an appropriate prospective trial.”

The study was published online in JAMA Network Open.

“Atrial fibrillation is becoming an increasing burden for health care systems worldwide owing to population aging,” write Filippo Cacioppo, MD, and colleagues from Medical University of Vienna (Austria).

“Pharmacologic and electrical conversion are common therapies in emergency departments, especially for highly symptomatic patients. Each intervention has specific risks, and neither is considered cost-effective owing to frequent recurrence of AF. In addition, AF often terminates spontaneously,” Dr. Cacioppo and colleagues write.

They add that evidence suggests hypokalemia and hypomagnesemia contribute to AFib development, and so the administration of potassium and magnesium could be a reasonable strategy to improve SCV rates.

To test their hypothesis, Dr. Cacioppo and associates conducted a registry-based cohort study in all patients with AFib or AFL presenting to their center’s ED between Feb. 6, 2009, and Feb. 16, 2020.

During this time, they observed a total of 2,546 episodes of nonpermanent AFib. The median patient age was 68 years (interquartile range, 58-75 years). Most were men (n = 1,411 patients, 55.4%).

In addition, there were 573 episodes of nonpermanent AFL. The median patient age was 68 years (IQR, 58-75 years), and 332 patients (57.9%) were men.

Intravenous potassium and magnesium were administered in just over half (n = 1,763; 56.5%) of the episodes.

The median amount of potassium and magnesium was delivered via one 250-mL infusion bag, which consisted of 24 mEq potassium and 145.8 mg magnesium combined with 500 mL of balanced crystalloid fluid containing 2.5 mEq potassium and 18.2 mg magnesium, administered for 90 minutes, the authors write.

If patients experienced pain at the injection site, the infusion rate was reduced until the pain subsided.

Conversion to sinus rhythm was considered spontaneous if no attempt at pharmacologic rhythm control was made until conversion occurred; if SCV occurred after an unsuccessful attempt at electrical cardioversion; or following rate control with beta-blockers, nondihydropyridine calcium channel blockers, or digitalis glycosides, the authors state.
 

IV treatment increased odds of SCV

The median duration of stay in the ED was 6.4 hours (IQR, 3.9-11.6 hours) for patients with AFib and 6.1 hours (IQR, 3.9-11.8 hours) for patients with AFL.

During the stay in the ED, SCV occurred in 15.4% (n = 393) of AFib episodes and 12.7% (n = 73) of AFL episodes.

Intravenous potassium and magnesium increased the possibility of SCV compared with no IV potassium and magnesium in AFib, but not in AFL.

In episodes of AFib, administration of intravenous potassium and magnesium was associated with 19.2% increased odds of SCV, compared with 10.4% with no administration (odds ratio, 1.98; 95% CI, 1.53-2.57).

In contrast, for AFL, no association was observed for the probability of SCV with potassium and magnesium administration when compared with no administration (13.0% vs. 12.5%; OR, 1.05; 95% CI, 0.65-1.69).
 

Not in the guidelines

“To date, it is unclear whether potassium and magnesium administration might be reasonable in the acute treatment of AF and AFL, and although this intervention may be common practice in some EDs, it is not part of the treatment recommendations in current guidelines,” Dr. Cacioppo and colleagues write.

“Our findings suggest that intravenous potassium and magnesium administration may increase the chance of SCV in patients with AF with either hypokalemia or with plasma potassium levels in the range of 3.50 to 3.99 mEq/L. In patients with AFL, however, potassium and magnesium administration may not be associated with SCV probability,” they write.

Dr. Cacioppo and associates add that in their study IV administration of potassium and magnesium was associated with SCV only in patients with symptom onset of less than 48 hours, suggesting a time-dependent outcome. However, they caution, “because only a limited number of patients with SCV had symptom onset greater than or equal to 48 hours, this finding warrants further investigation.”
 

A Band-Aid approach

“I’m a little skeptical about this study,” Georgios Syros, MD, director of arrhythmia services at Mount Sinai Queens and Mount Sinai Brooklyn, New York, said in an interview.

“Atrial fibrillation is a chronic disease. The natural history of this disease is that it is paroxysmal in the beginning, and at some point the episodes become more frequent and longer in duration. For some people, at some point, it becomes permanent,” Dr. Syros said.

“Suppose I cut my finger while slicing bread. I put a Band-Aid on the cut. That doesn’t mean I have fixed it, it means I’ve helped it temporarily. Atrial fibrillation in this paper is very analogous,” he said. “The patient may have episodes, goes to the emergency room, you give them medication, and temporarily alleviate the situation so that the patient does not have to be admitted. It’s simple, inexpensive, you make the heart rate go back to normal, not permanently, with few side effects, except perhaps for some pain at the injection site, but that doesn’t mean you have fixed the AFib permanently. But for someone who has had a first incidence, or doesn’t want to stay in the hospital because it’s the weekend, yes, you can use this as a Band-Aid,” he said.

Intravenous potassium and magnesium, as proposed in the current study, is similar to a medication currently in use in Europe, called vernakalant, Dr. Syros said.

“Vernakalant is not FDA approved in the U.S. It is not meant to treat atrial fibrillation permanently, so we have to inform the public about the limitations of what we are doing,” he said. “Vernakalant is similar to IV potassium and magnesium, as given in this study, but it is more expensive. It temporarily allows people to go back to sinus rhythm, but it’s not going to be there forever and you may go back to permanent AFib, so this is not magic, unfortunately.”

Dr. Syros emphasized that the current study results apply only to cases of paroxysmal atrial fibrillation of less than 48 hours duration. “This is a very important distinction,” he said.

“For example, a patient who drank a lot and the day after is in AFib, with what we call holiday heart, would be a good candidate for the treatment in this study. He’s young, without any heart damage, no diabetes, no hypertension, no prior stroke, so sure, help him out with potassium and magnesium, provided that he can prove to us that this started within 48 hours,” Dr. Syros said.

Dr. Cacioppo and colleagues and Dr. Syros report no relevant financial relationships. Study corresponding author Jan Niederdoeckl, MD, PhD, obtained funding for the study.

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

Rates of subarachnoid hemorrhage (SAH) are increasing, particularly in Black people, new research suggests.

Results of a new study based on hospital discharge data show Black people have disproportionately high rates of SAH versus other racial groups. Compared with White and Hispanic people, who had an average of 10 cases per 100,000, or Asian people, with 8 per 100,000 people, Black people had an average of 15 cases per 100,000 population.

Whereas case rates held steady for other racial groups in the study over a 10-year period, Black people were the only racial group for whom SAH incidence increased over time, at a rate of 1.8% per year.

“Root causes of the higher SAH incidence in Black [people] are complex and likely extend beyond simple differences in risk factor characteristics to other socioeconomic factors including level of education, poverty level, lack of insurance, access to quality care, and structural racism,” study investigator Fadar Oliver Otite, MD, assistant professor of neurology at SUNY Upstate Medical University, Syracuse, said in an interview.

“Addressing this racial disparity will require multidisciplinary factors targeted not just at subarachnoid hemorrhage risk factors but also at socioeconomic equity,” he added.

The study was published online in Neurology.
 

Uncontrolled hypertension

The average incidence of SAH for all participants was 11 cases per 100,000 people. Men had an average rate of 10 cases and women an average rate of 13 cases per 100,000.

As expected, incidence increased with age: For middle-aged men, the average was four cases per 100,000 people whereas for men 65 and older, the average was 22 cases.

Dr. Otite and his team combined U.S. Census data with two state hospitalization databases in New York and Florida and found that there were nearly 40,000 people hospitalized for SAH between 2007 and 2017. To find annual incidences of SAH per 100,000 population, they calculated the number of SAH cases and the total adult population for the year.

“Smoking and hypertension are two of the strongest risk factors for subarachnoid hemorrhage,” Dr. Otite said. “Hypertension is more prevalent in Black people in the United States, and Black patients with hypertension are more likely to have it uncontrolled.”
 

Racism, toxic stress

Anjail Sharieff, MD, associate professor of neurology at UT Health, Houston, said aside from a high rate of common SAH risk factors such as hypertension, Black Americans also face a barrage of inequities to health education and quality health care that contributes to higher SAH rates.

“The impact of toxic stress related to racism and discrimination experiences, and chronic stress related to poverty, can contribute to hypertension in Black people,” Dr. Sharieff said, adding that these factors contribute to stroke risk and are not usually accounted for in studies.

Dr. Sharieff said many of her first-time patients end up in her office due to a heart attack or stroke because they were previously uninsured and did not have access to primary care. “We need to begin leveraging trust with people in communities – meeting people where they are,” to educate them about hypertension and other health issues, she said.

A shining example of community engagement to reduce hypertension in Black communities was the Cedars-Sinai Barbershop Study, where 52 barbershops in Los Angeles implemented blood pressure checks and interventions among customers. A year later, the project was still working.

“Once we can identify the health problems in Black communities,” said Dr. Sharieff, “we can treat them.”

Dr. Otite and Dr. Sharieff report no relevant financial relationships.

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

Rates of subarachnoid hemorrhage (SAH) are increasing, particularly in Black people, new research suggests.

Results of a new study based on hospital discharge data show Black people have disproportionately high rates of SAH versus other racial groups. Compared with White and Hispanic people, who had an average of 10 cases per 100,000, or Asian people, with 8 per 100,000 people, Black people had an average of 15 cases per 100,000 population.

Whereas case rates held steady for other racial groups in the study over a 10-year period, Black people were the only racial group for whom SAH incidence increased over time, at a rate of 1.8% per year.

“Root causes of the higher SAH incidence in Black [people] are complex and likely extend beyond simple differences in risk factor characteristics to other socioeconomic factors including level of education, poverty level, lack of insurance, access to quality care, and structural racism,” study investigator Fadar Oliver Otite, MD, assistant professor of neurology at SUNY Upstate Medical University, Syracuse, said in an interview.

“Addressing this racial disparity will require multidisciplinary factors targeted not just at subarachnoid hemorrhage risk factors but also at socioeconomic equity,” he added.

The study was published online in Neurology.
 

Uncontrolled hypertension

The average incidence of SAH for all participants was 11 cases per 100,000 people. Men had an average rate of 10 cases and women an average rate of 13 cases per 100,000.

As expected, incidence increased with age: For middle-aged men, the average was four cases per 100,000 people whereas for men 65 and older, the average was 22 cases.

Dr. Otite and his team combined U.S. Census data with two state hospitalization databases in New York and Florida and found that there were nearly 40,000 people hospitalized for SAH between 2007 and 2017. To find annual incidences of SAH per 100,000 population, they calculated the number of SAH cases and the total adult population for the year.

“Smoking and hypertension are two of the strongest risk factors for subarachnoid hemorrhage,” Dr. Otite said. “Hypertension is more prevalent in Black people in the United States, and Black patients with hypertension are more likely to have it uncontrolled.”
 

Racism, toxic stress

Anjail Sharieff, MD, associate professor of neurology at UT Health, Houston, said aside from a high rate of common SAH risk factors such as hypertension, Black Americans also face a barrage of inequities to health education and quality health care that contributes to higher SAH rates.

“The impact of toxic stress related to racism and discrimination experiences, and chronic stress related to poverty, can contribute to hypertension in Black people,” Dr. Sharieff said, adding that these factors contribute to stroke risk and are not usually accounted for in studies.

Dr. Sharieff said many of her first-time patients end up in her office due to a heart attack or stroke because they were previously uninsured and did not have access to primary care. “We need to begin leveraging trust with people in communities – meeting people where they are,” to educate them about hypertension and other health issues, she said.

A shining example of community engagement to reduce hypertension in Black communities was the Cedars-Sinai Barbershop Study, where 52 barbershops in Los Angeles implemented blood pressure checks and interventions among customers. A year later, the project was still working.

“Once we can identify the health problems in Black communities,” said Dr. Sharieff, “we can treat them.”

Dr. Otite and Dr. Sharieff report no relevant financial relationships.

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

Rates of subarachnoid hemorrhage (SAH) are increasing, particularly in Black people, new research suggests.

Results of a new study based on hospital discharge data show Black people have disproportionately high rates of SAH versus other racial groups. Compared with White and Hispanic people, who had an average of 10 cases per 100,000, or Asian people, with 8 per 100,000 people, Black people had an average of 15 cases per 100,000 population.

Whereas case rates held steady for other racial groups in the study over a 10-year period, Black people were the only racial group for whom SAH incidence increased over time, at a rate of 1.8% per year.

“Root causes of the higher SAH incidence in Black [people] are complex and likely extend beyond simple differences in risk factor characteristics to other socioeconomic factors including level of education, poverty level, lack of insurance, access to quality care, and structural racism,” study investigator Fadar Oliver Otite, MD, assistant professor of neurology at SUNY Upstate Medical University, Syracuse, said in an interview.

“Addressing this racial disparity will require multidisciplinary factors targeted not just at subarachnoid hemorrhage risk factors but also at socioeconomic equity,” he added.

The study was published online in Neurology.
 

Uncontrolled hypertension

The average incidence of SAH for all participants was 11 cases per 100,000 people. Men had an average rate of 10 cases and women an average rate of 13 cases per 100,000.

As expected, incidence increased with age: For middle-aged men, the average was four cases per 100,000 people whereas for men 65 and older, the average was 22 cases.

Dr. Otite and his team combined U.S. Census data with two state hospitalization databases in New York and Florida and found that there were nearly 40,000 people hospitalized for SAH between 2007 and 2017. To find annual incidences of SAH per 100,000 population, they calculated the number of SAH cases and the total adult population for the year.

“Smoking and hypertension are two of the strongest risk factors for subarachnoid hemorrhage,” Dr. Otite said. “Hypertension is more prevalent in Black people in the United States, and Black patients with hypertension are more likely to have it uncontrolled.”
 

Racism, toxic stress

Anjail Sharieff, MD, associate professor of neurology at UT Health, Houston, said aside from a high rate of common SAH risk factors such as hypertension, Black Americans also face a barrage of inequities to health education and quality health care that contributes to higher SAH rates.

“The impact of toxic stress related to racism and discrimination experiences, and chronic stress related to poverty, can contribute to hypertension in Black people,” Dr. Sharieff said, adding that these factors contribute to stroke risk and are not usually accounted for in studies.

Dr. Sharieff said many of her first-time patients end up in her office due to a heart attack or stroke because they were previously uninsured and did not have access to primary care. “We need to begin leveraging trust with people in communities – meeting people where they are,” to educate them about hypertension and other health issues, she said.

A shining example of community engagement to reduce hypertension in Black communities was the Cedars-Sinai Barbershop Study, where 52 barbershops in Los Angeles implemented blood pressure checks and interventions among customers. A year later, the project was still working.

“Once we can identify the health problems in Black communities,” said Dr. Sharieff, “we can treat them.”

Dr. Otite and Dr. Sharieff report no relevant financial relationships.

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

Falls are common in patients with multiple sclerosis (MS) and a new study suggests impairment in a specific aspect of neuromuscular function can identify those at highest risk. Compared with patients with MS who didn’t fall, those who did fall had worse neuromuscular function as evidenced by a reduced rate of force development.

“Our study suggests that instead of looking at reduced maximum muscle strength, perhaps we should start looking at reduced rate of force development when trying to identify potential fallers,” said Laurits Taul-Madsen, PhD student, Aarhus University, Denmark.

The study was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Explosive strength

In contrast to maximal muscle strength, the rate of force development is a measure of explosive strength, or simply the amount of force that an individual can produce over a given time period. When a patient is about to fall, what’s most important is not how strong the person is, but how quickly they can produce enough force to counteract the balance perturbation, thus avoid falling, said Dr. Taul-Madsen.

“If a person is very slow to produce this force, [that person] will have fallen before he or she has produced enough force to counteract the balance perturbation that the person is experiencing,” he added.

Research has shown a reduced rate of force development (RFD) in patients with MS, compared with healthy controls. However, little is known about the impact of RFD on falls in those with MS.

To investigate, researchers studied 53 adults with MS: Twenty-four had no fall history in the prior year, 16 had one to two prior falls, and 13 had three or more falls. The two groups of fallers were both slightly older and had a slightly higher Expanded Disability Status Scale (EDSS) scores, “which may not be so surprising,” Dr. Taul-Madsen said.

Knee extensor neuromuscular function, including maximum muscle strength and RFD at 50 and 200 milliseconds, was assessed via isokinetic dynamometry.

A high RFD is “good and the non-fallers had the highest RFD at 50 ms.” On this measure, “we saw quite a big difference between the non-fallers and the two groups of fallers,” Dr. Taul-Madsen reported.

At 200 ms, the RFD was again highest in the group of non-fallers but the difference was somewhat smaller. Non-fallers also had greater maximum muscle strength than that of the fallers.

There was “good” correlation between these neuromuscular measurements and falls, Dr. Taul-Madsen said.

He noted that RFD, which can be improved with resistance training, “seems like a specialized and difficult measurement, but it doesn’t have to be. It can be measured with just a linear encoder and a chair to perform the sit-to-stand test, so in clinical practice, it’s quite easily measured.”
 

‘Highly promising’ approach

“There are some data on predictors of falls in persons with MS, but not yet on neuromuscular function, as has been done in other populations,” said Brian Sandroff, PhD, senior research scientist, Kessler Foundation, West Orange, N.J.

This study is “interesting in that recurrent fallers were distinguished based on having worse neuromuscular function,” said Dr. Sandroff, who was not part of the research team.

“Although this relationship is somewhat intuitive,” RFD provides a “potentially sensitive measure that can be addressed via specific resistance exercise programs as a highly promising approach for reducing fall risk and falls themselves in persons with MS,” Dr. Sandroff said.

More generally, he said this study provides “more evidence on the multisystemic benefits of exercise training and having better physical fitness in persons with MS.

“The evidence seems to be converging more and more on this, as research groups across countries and continents are reporting on similar themes,” said Dr. Sandroff.

The study had no specific funding. Dr. Taul-Madsen and Dr. Sandroff report no relevant financial relationships.

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

Falls are common in patients with multiple sclerosis (MS) and a new study suggests impairment in a specific aspect of neuromuscular function can identify those at highest risk. Compared with patients with MS who didn’t fall, those who did fall had worse neuromuscular function as evidenced by a reduced rate of force development.

“Our study suggests that instead of looking at reduced maximum muscle strength, perhaps we should start looking at reduced rate of force development when trying to identify potential fallers,” said Laurits Taul-Madsen, PhD student, Aarhus University, Denmark.

The study was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Explosive strength

In contrast to maximal muscle strength, the rate of force development is a measure of explosive strength, or simply the amount of force that an individual can produce over a given time period. When a patient is about to fall, what’s most important is not how strong the person is, but how quickly they can produce enough force to counteract the balance perturbation, thus avoid falling, said Dr. Taul-Madsen.

“If a person is very slow to produce this force, [that person] will have fallen before he or she has produced enough force to counteract the balance perturbation that the person is experiencing,” he added.

Research has shown a reduced rate of force development (RFD) in patients with MS, compared with healthy controls. However, little is known about the impact of RFD on falls in those with MS.

To investigate, researchers studied 53 adults with MS: Twenty-four had no fall history in the prior year, 16 had one to two prior falls, and 13 had three or more falls. The two groups of fallers were both slightly older and had a slightly higher Expanded Disability Status Scale (EDSS) scores, “which may not be so surprising,” Dr. Taul-Madsen said.

Knee extensor neuromuscular function, including maximum muscle strength and RFD at 50 and 200 milliseconds, was assessed via isokinetic dynamometry.

A high RFD is “good and the non-fallers had the highest RFD at 50 ms.” On this measure, “we saw quite a big difference between the non-fallers and the two groups of fallers,” Dr. Taul-Madsen reported.

At 200 ms, the RFD was again highest in the group of non-fallers but the difference was somewhat smaller. Non-fallers also had greater maximum muscle strength than that of the fallers.

There was “good” correlation between these neuromuscular measurements and falls, Dr. Taul-Madsen said.

He noted that RFD, which can be improved with resistance training, “seems like a specialized and difficult measurement, but it doesn’t have to be. It can be measured with just a linear encoder and a chair to perform the sit-to-stand test, so in clinical practice, it’s quite easily measured.”
 

‘Highly promising’ approach

“There are some data on predictors of falls in persons with MS, but not yet on neuromuscular function, as has been done in other populations,” said Brian Sandroff, PhD, senior research scientist, Kessler Foundation, West Orange, N.J.

This study is “interesting in that recurrent fallers were distinguished based on having worse neuromuscular function,” said Dr. Sandroff, who was not part of the research team.

“Although this relationship is somewhat intuitive,” RFD provides a “potentially sensitive measure that can be addressed via specific resistance exercise programs as a highly promising approach for reducing fall risk and falls themselves in persons with MS,” Dr. Sandroff said.

More generally, he said this study provides “more evidence on the multisystemic benefits of exercise training and having better physical fitness in persons with MS.

“The evidence seems to be converging more and more on this, as research groups across countries and continents are reporting on similar themes,” said Dr. Sandroff.

The study had no specific funding. Dr. Taul-Madsen and Dr. Sandroff report no relevant financial relationships.

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

Falls are common in patients with multiple sclerosis (MS) and a new study suggests impairment in a specific aspect of neuromuscular function can identify those at highest risk. Compared with patients with MS who didn’t fall, those who did fall had worse neuromuscular function as evidenced by a reduced rate of force development.

“Our study suggests that instead of looking at reduced maximum muscle strength, perhaps we should start looking at reduced rate of force development when trying to identify potential fallers,” said Laurits Taul-Madsen, PhD student, Aarhus University, Denmark.

The study was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Explosive strength

In contrast to maximal muscle strength, the rate of force development is a measure of explosive strength, or simply the amount of force that an individual can produce over a given time period. When a patient is about to fall, what’s most important is not how strong the person is, but how quickly they can produce enough force to counteract the balance perturbation, thus avoid falling, said Dr. Taul-Madsen.

“If a person is very slow to produce this force, [that person] will have fallen before he or she has produced enough force to counteract the balance perturbation that the person is experiencing,” he added.

Research has shown a reduced rate of force development (RFD) in patients with MS, compared with healthy controls. However, little is known about the impact of RFD on falls in those with MS.

To investigate, researchers studied 53 adults with MS: Twenty-four had no fall history in the prior year, 16 had one to two prior falls, and 13 had three or more falls. The two groups of fallers were both slightly older and had a slightly higher Expanded Disability Status Scale (EDSS) scores, “which may not be so surprising,” Dr. Taul-Madsen said.

Knee extensor neuromuscular function, including maximum muscle strength and RFD at 50 and 200 milliseconds, was assessed via isokinetic dynamometry.

A high RFD is “good and the non-fallers had the highest RFD at 50 ms.” On this measure, “we saw quite a big difference between the non-fallers and the two groups of fallers,” Dr. Taul-Madsen reported.

At 200 ms, the RFD was again highest in the group of non-fallers but the difference was somewhat smaller. Non-fallers also had greater maximum muscle strength than that of the fallers.

There was “good” correlation between these neuromuscular measurements and falls, Dr. Taul-Madsen said.

He noted that RFD, which can be improved with resistance training, “seems like a specialized and difficult measurement, but it doesn’t have to be. It can be measured with just a linear encoder and a chair to perform the sit-to-stand test, so in clinical practice, it’s quite easily measured.”
 

‘Highly promising’ approach

“There are some data on predictors of falls in persons with MS, but not yet on neuromuscular function, as has been done in other populations,” said Brian Sandroff, PhD, senior research scientist, Kessler Foundation, West Orange, N.J.

This study is “interesting in that recurrent fallers were distinguished based on having worse neuromuscular function,” said Dr. Sandroff, who was not part of the research team.

“Although this relationship is somewhat intuitive,” RFD provides a “potentially sensitive measure that can be addressed via specific resistance exercise programs as a highly promising approach for reducing fall risk and falls themselves in persons with MS,” Dr. Sandroff said.

More generally, he said this study provides “more evidence on the multisystemic benefits of exercise training and having better physical fitness in persons with MS.

“The evidence seems to be converging more and more on this, as research groups across countries and continents are reporting on similar themes,” said Dr. Sandroff.

The study had no specific funding. Dr. Taul-Madsen and Dr. Sandroff report no relevant financial relationships.

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

Continuing treatment with two common multiple sclerosis (MS) medications during pregnancy is associated with significantly lower relapse rates and few pregnancy-related complications, new research shows. Results of two studies show that preterm birth, spontaneous abortions, and major congenital anomalies were rare with anti-CD20 drugs ocrelizumab or natalizumab, even when continued well into the third trimester. However, hematologic abnormalities were common in newborns who were exposed to MS therapies during pregnancy.

The research comes at a time when the incidence of MS is on the rise worldwide and pregnancy in MS patients is becoming more common (Neurology. 2018 Oct 23;91[17]:e1559-69). “The results of our study should lead to a distinct risk-benefit discussion between neurologists and pregnant natalizumab-treated women to maintain treatment up to the 30th or even the 34th week of gestation, in combination with an early restart during the first 4 weeks after delivery,” Sandra Thiel, PhD, an investigator in one of the studies, told delegates attending the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Thiel is in the department of neurology at St. Josef Hospital and Ruhr University Bochum (Germany).
 

Rising number of pregnancies

In a second study, researchers from Spain presented results from the largest dataset of pregnancy outcomes for an anti-CD20 therapy in MS. The trial included 2,020 pregnancies, most of which were followed prospectively. The study included data on pregnancies since 2008. The largest single-year increase among participants was in the past year, in which there was a 65% rise in the number of pregnancies.

“The number of women with MS exposed to ocrelizumab before, during, and after the pregnancy is increasing and increasing,” Celia Oreja-Guevara, MD, PhD, vice-chair of neurology and head of the Multiple Sclerosis Center of the University Hospital San Carlos, Madrid, told conference attendees. “We have more evidence, we have more knowledge, patients and physicians trust ocrelizumab more. They know that it’s a safe treatment, and more patients are becoming pregnant.”

Dr. Oreja-Guevara highlighted a decrease in the number of elective abortions, which dropped from 50% in 2021 to 11% in the past year. The number was higher for patients with known exposure to ocrelizumab (11.5% vs. 3.7%).

Among the prospective cases, ectopic pregnancies occurred in 1.8% of those who were not exposed to ocrelizumab versus 1.4% of those exposed to the medication. The overall rate of spontaneous abortion was 11.8%, which, Dr. Oreja-Guevara said, is lower than the rate among the general population in Spain.

In the total cohort, 79.0% of pregnancies resulted in live births. Rates were similar regardless of ocrelizumab exposure. About 57% of births were full term, and 10.0% were preterm. Gestational age was unknown in 32.9% of the cases.

Overall, 0.9% of infants had a major congenital anomaly, which Dr. Oreja-Guevara said is lower than the rate of 2%-3% in all children born in Europe.
 

A look at natalizumab

To examine outcomes following use of natalizumab during pregnancy, researchers examined data from the German Multiple Sclerosis and Pregnancy Registry, which was created in 2006 and follows people during pregnancy and up to 6 years post partum. Of the 350 pregnant people included in the study, 171 continued natalizumab therapy beyond the first trimester. Discontinuation occurred at a median of 30.9 gestational weeks.

Most patients did not experience MS relapse during pregnancy, but the number was higher for patients who continued taking natalizumab later into pregnancy compared with those who stopped taking the drug in the first trimester (94.8% vs. 67.6%).

In the group analysis, women who continued treatment after the first trimester had significantly fewer relapses during pregnancy (5.9% vs. 32.4%; P < .001) and in the postpartum period (22.8% vs. 49.7%, P < .001). Resuming treatment with natalizumab within 4 weeks after birth significantly reduced relapse risk post partum (odds ratio, 0.32; P < .001).

The researchers also examined relapse risk with respect to treatment duration after the first trimester. Significantly more women who discontinued natalizumab before the 30th gestational week experienced postpartum relapses, compared with those whose treatment extended beyond that point (38.5% vs. 16.0%; P = .008), especially during the first postpartum trimester (26.9% vs. 8.00%; P = .009).

There were no significant differences in preterm births or major congenital abnormalities between groups. However, about half of the infants exposed to natalizumab beyond the first trimester were born with anemia or other hematologic abnormalities.

Another unexpected finding was the number of infants who were small for their gestational age (SGA). About 19% of infants born to women who continued treatment later in pregnancy were SGA. Among those in the group that discontinued therapy in the first trimester, the figure was just under 17%.

“Pregnancy outcomes were within the expected range, but a potential increased risk for small for gestational age newborns justified further investigation,” Dr. Thiel said.
 

Reassuring data

Angie Child Jelin, MD, director of the first trimester screening program and associate professor of gynecology and obstetrics at Johns Hopkins University, Baltimore, said that the increase in the number of pregnant patients with MS seen in their clinic could be caused in part by the growing body of work on MS treatment during pregnancy.

“It’s very reassuring that these data have come out and showed how safe they are generally in pregnancy,” Dr. Jalin said.

Although hematologic abnormalities in newborns are thought to be acute, Dr. Jalin said long-term study is needed to better understand any potential lasting effects from those abnormalities, as well as any effects in SGA newborns.

“Long-term outcomes are very hard to acquire, but ideally you’d want long-term outcomes on all of these measures,” Dr. Jalin said.

Funding for the natalizumab study was not disclosed. The ocrelizumab study was funded by F. Hoffmann–La Roche. Dr. Oreja-Guevara received honoraria for consulting and serving on advisory boards from Biogen Idec, F. Hoffmann–La Roche, Genzyme, Merck, Novartis, and Teva. Dr. Thiel has received speaker honoraria from Bayer Healthcare. Dr. Jalin reported no relevant financial relationships.

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

Continuing treatment with two common multiple sclerosis (MS) medications during pregnancy is associated with significantly lower relapse rates and few pregnancy-related complications, new research shows. Results of two studies show that preterm birth, spontaneous abortions, and major congenital anomalies were rare with anti-CD20 drugs ocrelizumab or natalizumab, even when continued well into the third trimester. However, hematologic abnormalities were common in newborns who were exposed to MS therapies during pregnancy.

The research comes at a time when the incidence of MS is on the rise worldwide and pregnancy in MS patients is becoming more common (Neurology. 2018 Oct 23;91[17]:e1559-69). “The results of our study should lead to a distinct risk-benefit discussion between neurologists and pregnant natalizumab-treated women to maintain treatment up to the 30th or even the 34th week of gestation, in combination with an early restart during the first 4 weeks after delivery,” Sandra Thiel, PhD, an investigator in one of the studies, told delegates attending the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Thiel is in the department of neurology at St. Josef Hospital and Ruhr University Bochum (Germany).
 

Rising number of pregnancies

In a second study, researchers from Spain presented results from the largest dataset of pregnancy outcomes for an anti-CD20 therapy in MS. The trial included 2,020 pregnancies, most of which were followed prospectively. The study included data on pregnancies since 2008. The largest single-year increase among participants was in the past year, in which there was a 65% rise in the number of pregnancies.

“The number of women with MS exposed to ocrelizumab before, during, and after the pregnancy is increasing and increasing,” Celia Oreja-Guevara, MD, PhD, vice-chair of neurology and head of the Multiple Sclerosis Center of the University Hospital San Carlos, Madrid, told conference attendees. “We have more evidence, we have more knowledge, patients and physicians trust ocrelizumab more. They know that it’s a safe treatment, and more patients are becoming pregnant.”

Dr. Oreja-Guevara highlighted a decrease in the number of elective abortions, which dropped from 50% in 2021 to 11% in the past year. The number was higher for patients with known exposure to ocrelizumab (11.5% vs. 3.7%).

Among the prospective cases, ectopic pregnancies occurred in 1.8% of those who were not exposed to ocrelizumab versus 1.4% of those exposed to the medication. The overall rate of spontaneous abortion was 11.8%, which, Dr. Oreja-Guevara said, is lower than the rate among the general population in Spain.

In the total cohort, 79.0% of pregnancies resulted in live births. Rates were similar regardless of ocrelizumab exposure. About 57% of births were full term, and 10.0% were preterm. Gestational age was unknown in 32.9% of the cases.

Overall, 0.9% of infants had a major congenital anomaly, which Dr. Oreja-Guevara said is lower than the rate of 2%-3% in all children born in Europe.
 

A look at natalizumab

To examine outcomes following use of natalizumab during pregnancy, researchers examined data from the German Multiple Sclerosis and Pregnancy Registry, which was created in 2006 and follows people during pregnancy and up to 6 years post partum. Of the 350 pregnant people included in the study, 171 continued natalizumab therapy beyond the first trimester. Discontinuation occurred at a median of 30.9 gestational weeks.

Most patients did not experience MS relapse during pregnancy, but the number was higher for patients who continued taking natalizumab later into pregnancy compared with those who stopped taking the drug in the first trimester (94.8% vs. 67.6%).

In the group analysis, women who continued treatment after the first trimester had significantly fewer relapses during pregnancy (5.9% vs. 32.4%; P < .001) and in the postpartum period (22.8% vs. 49.7%, P < .001). Resuming treatment with natalizumab within 4 weeks after birth significantly reduced relapse risk post partum (odds ratio, 0.32; P < .001).

The researchers also examined relapse risk with respect to treatment duration after the first trimester. Significantly more women who discontinued natalizumab before the 30th gestational week experienced postpartum relapses, compared with those whose treatment extended beyond that point (38.5% vs. 16.0%; P = .008), especially during the first postpartum trimester (26.9% vs. 8.00%; P = .009).

There were no significant differences in preterm births or major congenital abnormalities between groups. However, about half of the infants exposed to natalizumab beyond the first trimester were born with anemia or other hematologic abnormalities.

Another unexpected finding was the number of infants who were small for their gestational age (SGA). About 19% of infants born to women who continued treatment later in pregnancy were SGA. Among those in the group that discontinued therapy in the first trimester, the figure was just under 17%.

“Pregnancy outcomes were within the expected range, but a potential increased risk for small for gestational age newborns justified further investigation,” Dr. Thiel said.
 

Reassuring data

Angie Child Jelin, MD, director of the first trimester screening program and associate professor of gynecology and obstetrics at Johns Hopkins University, Baltimore, said that the increase in the number of pregnant patients with MS seen in their clinic could be caused in part by the growing body of work on MS treatment during pregnancy.

“It’s very reassuring that these data have come out and showed how safe they are generally in pregnancy,” Dr. Jalin said.

Although hematologic abnormalities in newborns are thought to be acute, Dr. Jalin said long-term study is needed to better understand any potential lasting effects from those abnormalities, as well as any effects in SGA newborns.

“Long-term outcomes are very hard to acquire, but ideally you’d want long-term outcomes on all of these measures,” Dr. Jalin said.

Funding for the natalizumab study was not disclosed. The ocrelizumab study was funded by F. Hoffmann–La Roche. Dr. Oreja-Guevara received honoraria for consulting and serving on advisory boards from Biogen Idec, F. Hoffmann–La Roche, Genzyme, Merck, Novartis, and Teva. Dr. Thiel has received speaker honoraria from Bayer Healthcare. Dr. Jalin reported no relevant financial relationships.

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

Continuing treatment with two common multiple sclerosis (MS) medications during pregnancy is associated with significantly lower relapse rates and few pregnancy-related complications, new research shows. Results of two studies show that preterm birth, spontaneous abortions, and major congenital anomalies were rare with anti-CD20 drugs ocrelizumab or natalizumab, even when continued well into the third trimester. However, hematologic abnormalities were common in newborns who were exposed to MS therapies during pregnancy.

The research comes at a time when the incidence of MS is on the rise worldwide and pregnancy in MS patients is becoming more common (Neurology. 2018 Oct 23;91[17]:e1559-69). “The results of our study should lead to a distinct risk-benefit discussion between neurologists and pregnant natalizumab-treated women to maintain treatment up to the 30th or even the 34th week of gestation, in combination with an early restart during the first 4 weeks after delivery,” Sandra Thiel, PhD, an investigator in one of the studies, told delegates attending the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Thiel is in the department of neurology at St. Josef Hospital and Ruhr University Bochum (Germany).
 

Rising number of pregnancies

In a second study, researchers from Spain presented results from the largest dataset of pregnancy outcomes for an anti-CD20 therapy in MS. The trial included 2,020 pregnancies, most of which were followed prospectively. The study included data on pregnancies since 2008. The largest single-year increase among participants was in the past year, in which there was a 65% rise in the number of pregnancies.

“The number of women with MS exposed to ocrelizumab before, during, and after the pregnancy is increasing and increasing,” Celia Oreja-Guevara, MD, PhD, vice-chair of neurology and head of the Multiple Sclerosis Center of the University Hospital San Carlos, Madrid, told conference attendees. “We have more evidence, we have more knowledge, patients and physicians trust ocrelizumab more. They know that it’s a safe treatment, and more patients are becoming pregnant.”

Dr. Oreja-Guevara highlighted a decrease in the number of elective abortions, which dropped from 50% in 2021 to 11% in the past year. The number was higher for patients with known exposure to ocrelizumab (11.5% vs. 3.7%).

Among the prospective cases, ectopic pregnancies occurred in 1.8% of those who were not exposed to ocrelizumab versus 1.4% of those exposed to the medication. The overall rate of spontaneous abortion was 11.8%, which, Dr. Oreja-Guevara said, is lower than the rate among the general population in Spain.

In the total cohort, 79.0% of pregnancies resulted in live births. Rates were similar regardless of ocrelizumab exposure. About 57% of births were full term, and 10.0% were preterm. Gestational age was unknown in 32.9% of the cases.

Overall, 0.9% of infants had a major congenital anomaly, which Dr. Oreja-Guevara said is lower than the rate of 2%-3% in all children born in Europe.
 

A look at natalizumab

To examine outcomes following use of natalizumab during pregnancy, researchers examined data from the German Multiple Sclerosis and Pregnancy Registry, which was created in 2006 and follows people during pregnancy and up to 6 years post partum. Of the 350 pregnant people included in the study, 171 continued natalizumab therapy beyond the first trimester. Discontinuation occurred at a median of 30.9 gestational weeks.

Most patients did not experience MS relapse during pregnancy, but the number was higher for patients who continued taking natalizumab later into pregnancy compared with those who stopped taking the drug in the first trimester (94.8% vs. 67.6%).

In the group analysis, women who continued treatment after the first trimester had significantly fewer relapses during pregnancy (5.9% vs. 32.4%; P < .001) and in the postpartum period (22.8% vs. 49.7%, P < .001). Resuming treatment with natalizumab within 4 weeks after birth significantly reduced relapse risk post partum (odds ratio, 0.32; P < .001).

The researchers also examined relapse risk with respect to treatment duration after the first trimester. Significantly more women who discontinued natalizumab before the 30th gestational week experienced postpartum relapses, compared with those whose treatment extended beyond that point (38.5% vs. 16.0%; P = .008), especially during the first postpartum trimester (26.9% vs. 8.00%; P = .009).

There were no significant differences in preterm births or major congenital abnormalities between groups. However, about half of the infants exposed to natalizumab beyond the first trimester were born with anemia or other hematologic abnormalities.

Another unexpected finding was the number of infants who were small for their gestational age (SGA). About 19% of infants born to women who continued treatment later in pregnancy were SGA. Among those in the group that discontinued therapy in the first trimester, the figure was just under 17%.

“Pregnancy outcomes were within the expected range, but a potential increased risk for small for gestational age newborns justified further investigation,” Dr. Thiel said.
 

Reassuring data

Angie Child Jelin, MD, director of the first trimester screening program and associate professor of gynecology and obstetrics at Johns Hopkins University, Baltimore, said that the increase in the number of pregnant patients with MS seen in their clinic could be caused in part by the growing body of work on MS treatment during pregnancy.

“It’s very reassuring that these data have come out and showed how safe they are generally in pregnancy,” Dr. Jalin said.

Although hematologic abnormalities in newborns are thought to be acute, Dr. Jalin said long-term study is needed to better understand any potential lasting effects from those abnormalities, as well as any effects in SGA newborns.

“Long-term outcomes are very hard to acquire, but ideally you’d want long-term outcomes on all of these measures,” Dr. Jalin said.

Funding for the natalizumab study was not disclosed. The ocrelizumab study was funded by F. Hoffmann–La Roche. Dr. Oreja-Guevara received honoraria for consulting and serving on advisory boards from Biogen Idec, F. Hoffmann–La Roche, Genzyme, Merck, Novartis, and Teva. Dr. Thiel has received speaker honoraria from Bayer Healthcare. Dr. Jalin reported no relevant financial relationships.

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

INDIANAPOLIS – The way Maria C. Garzon, MD, sees it, capillary malformations are often misunderstood. She views them not as a single diagnosis but rather as a variety of conditions that fall under the term capillary malformation.

“The challenge is, we also use that term to describe a diagnosis,” Dr. Garzon, professor of dermatology and pediatrics at Columbia University, New York, said at the annual meeting of the Society for Pediatric Dermatology. “We have imperfect terminology. We use many different terms like capillary nevi and vascular stain. Instead of port wine stain, we now use the term port wine birthmark, and old terms like nevus flammeus are still used. This leads to diagnostic confusion, and it’s a barrier to developing care guidelines.”

Some capillary malformations, she noted, are benign and fade away while others can cause disfigurement or herald significant medical issues.

Histologically, she continued, not all capillary malformations are composed of capillaries. “Some are composed of postcapillary venules,” she said. “There are also mixed type capillary malformations that include lymphatic tissue, and the capillary malformation of capillary malformation-arteriovenous malformation (CM-AVM) syndrome shares histologic features of evolving AVMs as opposed to classic port wine birthmarks.”

The most recent International Society for the Study of Vascular Anomalies Classification of Vascular Anomalies was published in 2018 and is currently being updated. Other proposed clinical classifications have been published, including one that is diagnosis-specific and includes 20 different types of capillary malformations (J Eur Acad Dermatol Venereol. 2015 29[12]:2295-305, Pediatr Dermatol. 2016;33[6]:570-84).

“There are also syndromic classifications. Another question relates to the role of genomics: Are we ready for a classification that’s based purely on genetic variants, or do we need to incorporate it into existing classifications?” Dr. Garzon said. “Novel testing technologies using cell-free DNA and digital droplet PCR may be used in the future to establish diagnoses.” Genetic variants are found within capillary malformations, and they tend to be associated with three major pathways: the RAS-MAPK/ERK pathway, the PI3K/Akt/mTOR pathway, and the G protein pathway.

The type of capillary malformation that dermatologists and pediatricians most commonly see is nevus simplex, which occurs in 20%-82% of neonates. Other terms used include angel’s kiss, stork bite, salmon patch, nevus flammeus simplex, fading vascular stain, medial telangiectatic nevus, and butterfly mark. “It’s important to differentiate this from a port wine birthmark,” Dr. Garzon said. “This can be challenging when the birthmark is a darker red color. I have cared for patients who were initially thought to have nevus simplex and later found to have Sturge-Weber syndrome.”

Typical locations of nevus simplex include the central forehead/glabella, eyelids, the nape of the neck, scalp (parietal and occipital), nose, lip area (including philtrum), and the back (lumbosacral area and upper back). Most lesions fade/disappear without treatment (J Am Acad Dermatol. 2020;63[5]:805-14). Rare genetic syndromes associated with exaggerated nevus simplex complex include macrocephaly-capillary malformation syndrome and Beckwith-Wiedemann syndrome, “which tells us that this is a heterogeneous group of patients,” she said.

Dr. Garzon added that it’s “incredibly common” to see an eczema flare occurring within a nevus simplex on the nape of the neck. These patients will have a patch of atopic dermatitis that doesn’t get better. “Beneath it is their nevus simplex,” she said. “Remind parents that even after treating the eczema, the pink patch is not going to go away” (Pediatr Rep. 2021;13[1]:131-4).

Meanwhile, the classic port wine birthmark is usually congenital, uniform, and darker red in color. It darkens with maturity and the pattern will correlate with embryonic vasculature. “I am very wary of acquired port wine lesions,” she added. “It’s been described with trauma-related lesions, but early morphea can also mimic a port wine birthmark. You will see this if you’re practicing pediatric dermatology.”

Nearly a decade ago researchers established a link between port wine birthmarks and genetic variants in the GNAQ gene. “We see this in GNA11 as well,” Dr. Garzon said. “These changes are found in isolated port wine stains, and in Sturge-Weber syndrome. We now know that GNAQ drives the formation of large blood vessels through angiopoietin-2,” she noted (Arterioscler Throm Vasc Biol. 2022;42[1]:e27-43).

In general, studies that have examined genotype-phenotype correlations have demonstrated that the classic port wine birthmark is associated with GNAQ while GNA11 variants can be associated with a more reticulated pattern. “But this is not as clearcut as it seems,” she said. Investigators of a recent study showed an association between hypertension and renal anomalies in patients with skin capillary malformations and mosaic GNAQ or GNA11 variants. “This is a new finding,” she said. “Investigators are working to understand this association.”

Port wine birthmarks with the highest risk of Sturge-Weber syndrome include those that involve the forehead, upper eyelid, the midline frontonasal area, the hemifacial area, and median sites. “Patients who have this should be evaluated at birth,” Dr. Garzon said. “You should not delay for 2 months. They should be evaluated by ophthalmology and neurology early.”

The other morphologies commonly seen are “geographic” well-demarcated capillary malformations, which are dark in color. These lesions can be seen in conditions that are associated with genetic variants in PIK3CA (PROS) and include classic Klippel-Trenaunay syndrome, CLOVES (congenital lipomatous overgrowth, vascular malformations, epidermal nevi, scoliosis/skeletal and spinal) syndrome, and CLAPO (capillary malformation of the lower lip, lymphatic malformation of the face and neck, asymmetry of the face and limbs, and partial or generalized overgrowth) syndrome.

“Reticulated stains are much more heterogeneous,” Dr. Garzon said. “They can be localized or widespread. When you see a patient with a widespread reticulated capillary malformation, think about diffuse capillary malformation with overgrowth (DCMO). This condition is clinically and genetically heterogenous with the affected tissue of some patients showing variants in GNA11 while others have variants in PIK3CA. Therefore, a thorough examination at presentation and long-term follow-up is very important.”

Dr. Garzon disclosed that she is a member of the executive board for the International Society for the Study of Vascular Anomalies.

INDIANAPOLIS – The way Maria C. Garzon, MD, sees it, capillary malformations are often misunderstood. She views them not as a single diagnosis but rather as a variety of conditions that fall under the term capillary malformation.

“The challenge is, we also use that term to describe a diagnosis,” Dr. Garzon, professor of dermatology and pediatrics at Columbia University, New York, said at the annual meeting of the Society for Pediatric Dermatology. “We have imperfect terminology. We use many different terms like capillary nevi and vascular stain. Instead of port wine stain, we now use the term port wine birthmark, and old terms like nevus flammeus are still used. This leads to diagnostic confusion, and it’s a barrier to developing care guidelines.”

Some capillary malformations, she noted, are benign and fade away while others can cause disfigurement or herald significant medical issues.

Histologically, she continued, not all capillary malformations are composed of capillaries. “Some are composed of postcapillary venules,” she said. “There are also mixed type capillary malformations that include lymphatic tissue, and the capillary malformation of capillary malformation-arteriovenous malformation (CM-AVM) syndrome shares histologic features of evolving AVMs as opposed to classic port wine birthmarks.”

The most recent International Society for the Study of Vascular Anomalies Classification of Vascular Anomalies was published in 2018 and is currently being updated. Other proposed clinical classifications have been published, including one that is diagnosis-specific and includes 20 different types of capillary malformations (J Eur Acad Dermatol Venereol. 2015 29[12]:2295-305, Pediatr Dermatol. 2016;33[6]:570-84).

“There are also syndromic classifications. Another question relates to the role of genomics: Are we ready for a classification that’s based purely on genetic variants, or do we need to incorporate it into existing classifications?” Dr. Garzon said. “Novel testing technologies using cell-free DNA and digital droplet PCR may be used in the future to establish diagnoses.” Genetic variants are found within capillary malformations, and they tend to be associated with three major pathways: the RAS-MAPK/ERK pathway, the PI3K/Akt/mTOR pathway, and the G protein pathway.

The type of capillary malformation that dermatologists and pediatricians most commonly see is nevus simplex, which occurs in 20%-82% of neonates. Other terms used include angel’s kiss, stork bite, salmon patch, nevus flammeus simplex, fading vascular stain, medial telangiectatic nevus, and butterfly mark. “It’s important to differentiate this from a port wine birthmark,” Dr. Garzon said. “This can be challenging when the birthmark is a darker red color. I have cared for patients who were initially thought to have nevus simplex and later found to have Sturge-Weber syndrome.”

Typical locations of nevus simplex include the central forehead/glabella, eyelids, the nape of the neck, scalp (parietal and occipital), nose, lip area (including philtrum), and the back (lumbosacral area and upper back). Most lesions fade/disappear without treatment (J Am Acad Dermatol. 2020;63[5]:805-14). Rare genetic syndromes associated with exaggerated nevus simplex complex include macrocephaly-capillary malformation syndrome and Beckwith-Wiedemann syndrome, “which tells us that this is a heterogeneous group of patients,” she said.

Dr. Garzon added that it’s “incredibly common” to see an eczema flare occurring within a nevus simplex on the nape of the neck. These patients will have a patch of atopic dermatitis that doesn’t get better. “Beneath it is their nevus simplex,” she said. “Remind parents that even after treating the eczema, the pink patch is not going to go away” (Pediatr Rep. 2021;13[1]:131-4).

Meanwhile, the classic port wine birthmark is usually congenital, uniform, and darker red in color. It darkens with maturity and the pattern will correlate with embryonic vasculature. “I am very wary of acquired port wine lesions,” she added. “It’s been described with trauma-related lesions, but early morphea can also mimic a port wine birthmark. You will see this if you’re practicing pediatric dermatology.”

Nearly a decade ago researchers established a link between port wine birthmarks and genetic variants in the GNAQ gene. “We see this in GNA11 as well,” Dr. Garzon said. “These changes are found in isolated port wine stains, and in Sturge-Weber syndrome. We now know that GNAQ drives the formation of large blood vessels through angiopoietin-2,” she noted (Arterioscler Throm Vasc Biol. 2022;42[1]:e27-43).

In general, studies that have examined genotype-phenotype correlations have demonstrated that the classic port wine birthmark is associated with GNAQ while GNA11 variants can be associated with a more reticulated pattern. “But this is not as clearcut as it seems,” she said. Investigators of a recent study showed an association between hypertension and renal anomalies in patients with skin capillary malformations and mosaic GNAQ or GNA11 variants. “This is a new finding,” she said. “Investigators are working to understand this association.”

Port wine birthmarks with the highest risk of Sturge-Weber syndrome include those that involve the forehead, upper eyelid, the midline frontonasal area, the hemifacial area, and median sites. “Patients who have this should be evaluated at birth,” Dr. Garzon said. “You should not delay for 2 months. They should be evaluated by ophthalmology and neurology early.”

The other morphologies commonly seen are “geographic” well-demarcated capillary malformations, which are dark in color. These lesions can be seen in conditions that are associated with genetic variants in PIK3CA (PROS) and include classic Klippel-Trenaunay syndrome, CLOVES (congenital lipomatous overgrowth, vascular malformations, epidermal nevi, scoliosis/skeletal and spinal) syndrome, and CLAPO (capillary malformation of the lower lip, lymphatic malformation of the face and neck, asymmetry of the face and limbs, and partial or generalized overgrowth) syndrome.

“Reticulated stains are much more heterogeneous,” Dr. Garzon said. “They can be localized or widespread. When you see a patient with a widespread reticulated capillary malformation, think about diffuse capillary malformation with overgrowth (DCMO). This condition is clinically and genetically heterogenous with the affected tissue of some patients showing variants in GNA11 while others have variants in PIK3CA. Therefore, a thorough examination at presentation and long-term follow-up is very important.”

Dr. Garzon disclosed that she is a member of the executive board for the International Society for the Study of Vascular Anomalies.

INDIANAPOLIS – The way Maria C. Garzon, MD, sees it, capillary malformations are often misunderstood. She views them not as a single diagnosis but rather as a variety of conditions that fall under the term capillary malformation.

“The challenge is, we also use that term to describe a diagnosis,” Dr. Garzon, professor of dermatology and pediatrics at Columbia University, New York, said at the annual meeting of the Society for Pediatric Dermatology. “We have imperfect terminology. We use many different terms like capillary nevi and vascular stain. Instead of port wine stain, we now use the term port wine birthmark, and old terms like nevus flammeus are still used. This leads to diagnostic confusion, and it’s a barrier to developing care guidelines.”

Some capillary malformations, she noted, are benign and fade away while others can cause disfigurement or herald significant medical issues.

Histologically, she continued, not all capillary malformations are composed of capillaries. “Some are composed of postcapillary venules,” she said. “There are also mixed type capillary malformations that include lymphatic tissue, and the capillary malformation of capillary malformation-arteriovenous malformation (CM-AVM) syndrome shares histologic features of evolving AVMs as opposed to classic port wine birthmarks.”

The most recent International Society for the Study of Vascular Anomalies Classification of Vascular Anomalies was published in 2018 and is currently being updated. Other proposed clinical classifications have been published, including one that is diagnosis-specific and includes 20 different types of capillary malformations (J Eur Acad Dermatol Venereol. 2015 29[12]:2295-305, Pediatr Dermatol. 2016;33[6]:570-84).

“There are also syndromic classifications. Another question relates to the role of genomics: Are we ready for a classification that’s based purely on genetic variants, or do we need to incorporate it into existing classifications?” Dr. Garzon said. “Novel testing technologies using cell-free DNA and digital droplet PCR may be used in the future to establish diagnoses.” Genetic variants are found within capillary malformations, and they tend to be associated with three major pathways: the RAS-MAPK/ERK pathway, the PI3K/Akt/mTOR pathway, and the G protein pathway.

The type of capillary malformation that dermatologists and pediatricians most commonly see is nevus simplex, which occurs in 20%-82% of neonates. Other terms used include angel’s kiss, stork bite, salmon patch, nevus flammeus simplex, fading vascular stain, medial telangiectatic nevus, and butterfly mark. “It’s important to differentiate this from a port wine birthmark,” Dr. Garzon said. “This can be challenging when the birthmark is a darker red color. I have cared for patients who were initially thought to have nevus simplex and later found to have Sturge-Weber syndrome.”

Typical locations of nevus simplex include the central forehead/glabella, eyelids, the nape of the neck, scalp (parietal and occipital), nose, lip area (including philtrum), and the back (lumbosacral area and upper back). Most lesions fade/disappear without treatment (J Am Acad Dermatol. 2020;63[5]:805-14). Rare genetic syndromes associated with exaggerated nevus simplex complex include macrocephaly-capillary malformation syndrome and Beckwith-Wiedemann syndrome, “which tells us that this is a heterogeneous group of patients,” she said.

Dr. Garzon added that it’s “incredibly common” to see an eczema flare occurring within a nevus simplex on the nape of the neck. These patients will have a patch of atopic dermatitis that doesn’t get better. “Beneath it is their nevus simplex,” she said. “Remind parents that even after treating the eczema, the pink patch is not going to go away” (Pediatr Rep. 2021;13[1]:131-4).

Meanwhile, the classic port wine birthmark is usually congenital, uniform, and darker red in color. It darkens with maturity and the pattern will correlate with embryonic vasculature. “I am very wary of acquired port wine lesions,” she added. “It’s been described with trauma-related lesions, but early morphea can also mimic a port wine birthmark. You will see this if you’re practicing pediatric dermatology.”

Nearly a decade ago researchers established a link between port wine birthmarks and genetic variants in the GNAQ gene. “We see this in GNA11 as well,” Dr. Garzon said. “These changes are found in isolated port wine stains, and in Sturge-Weber syndrome. We now know that GNAQ drives the formation of large blood vessels through angiopoietin-2,” she noted (Arterioscler Throm Vasc Biol. 2022;42[1]:e27-43).

In general, studies that have examined genotype-phenotype correlations have demonstrated that the classic port wine birthmark is associated with GNAQ while GNA11 variants can be associated with a more reticulated pattern. “But this is not as clearcut as it seems,” she said. Investigators of a recent study showed an association between hypertension and renal anomalies in patients with skin capillary malformations and mosaic GNAQ or GNA11 variants. “This is a new finding,” she said. “Investigators are working to understand this association.”

Port wine birthmarks with the highest risk of Sturge-Weber syndrome include those that involve the forehead, upper eyelid, the midline frontonasal area, the hemifacial area, and median sites. “Patients who have this should be evaluated at birth,” Dr. Garzon said. “You should not delay for 2 months. They should be evaluated by ophthalmology and neurology early.”

The other morphologies commonly seen are “geographic” well-demarcated capillary malformations, which are dark in color. These lesions can be seen in conditions that are associated with genetic variants in PIK3CA (PROS) and include classic Klippel-Trenaunay syndrome, CLOVES (congenital lipomatous overgrowth, vascular malformations, epidermal nevi, scoliosis/skeletal and spinal) syndrome, and CLAPO (capillary malformation of the lower lip, lymphatic malformation of the face and neck, asymmetry of the face and limbs, and partial or generalized overgrowth) syndrome.

“Reticulated stains are much more heterogeneous,” Dr. Garzon said. “They can be localized or widespread. When you see a patient with a widespread reticulated capillary malformation, think about diffuse capillary malformation with overgrowth (DCMO). This condition is clinically and genetically heterogenous with the affected tissue of some patients showing variants in GNA11 while others have variants in PIK3CA. Therefore, a thorough examination at presentation and long-term follow-up is very important.”

Dr. Garzon disclosed that she is a member of the executive board for the International Society for the Study of Vascular Anomalies.

Drugs commonly used to treat erectile dysfunction (ED) are not associated with a decreased risk of Alzheimer’s disease and related dementias (ADRD), new research shows.

The findings contradict results from a previous study that suggested that individuals who take sildenafil (Viagra) were significantly less likely to develop Alzheimer’s.

The new research, part of a larger effort to identify existing medications that could be repurposed to treat ADRD, employed a study design that reduced the risk for potential bias that may have influenced the earlier findings, the investigators note.

“That study came out last fall and was widely covered in the media, and we thought there were some methodological shortcomings that might have explained the results,” lead investigator Rishi Desai, PhD, assistant professor of medicine at Harvard Medical School and an associate epidemiologist at Brigham and Women’s Hospital, both in Boston, said in an interview.

The new study was published online in Brain Communications.


 

Not the final word?

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, a drug class that includes the ED drugs sildenafil and tadalafil (Cialis), improve memory and cognitive function and reduce amyloid burden. But studies in humans have yielded conflicting results.*

Although the new research and the work published last year both drew on Medicare data, they examined different patient populations.

The first study compared those who took sildenafil for any reason to those who did not take it. That design likely resulted in an analysis of a comparison of individuals with ED – the most common indication for sildenafil – to generally older individuals with diabetes or hypertension, Dr. Desai said.

In contrast, the current study included only those with pulmonary arterial hypertension (PAH), which is also an indication for PDE5 inhibitors. The researchers compared ADRD incidence in those who took PDE5 inhibitors with the incidence among those who took a different medication to treat their PAH. They used propensity matching to create two groups with similar characteristics and examined the data using four analytic strategies.

The investigators found no significant difference between groups in the incidence of ADRD, regardless of the strategy they used. Cell culture studies also revealed no protective effect from PDE5 inhibitors.

“No study of this kind should claim the final word,” Dr. Desai said. “It is extremely difficult to nail down causality from these types of data sources.”
 

Impressive study design

Commenting on the findings, David Knopman, MD, professor of neurology at Mayo Clinic, Rochester, Minn., described the study design as “impressive” for its efforts to minimize bias, a key limitation in the previous study.

“It was always the case that the claims about sildenafil needed further developmental work prior to testing the drug in randomized controlled trials,” Dr. Knopman said. “The evidence for the use of the drug was never sufficient for clinicians to use it in their patients.”

The study was funded by National Institute on Aging. Dr. Desai is an investigator who receives research grants from Bayer, Vertex, and Novartis that were given to the Brigham and Women’s Hospital for unrelated projects. Dr. Knopman has disclosed no relevant financial relationships.

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

Correction, 11/3/22: An earlier version of this article misstated the abbreviation for phosphodiesterase-5. It is PDE-5.

Drugs commonly used to treat erectile dysfunction (ED) are not associated with a decreased risk of Alzheimer’s disease and related dementias (ADRD), new research shows.

The findings contradict results from a previous study that suggested that individuals who take sildenafil (Viagra) were significantly less likely to develop Alzheimer’s.

The new research, part of a larger effort to identify existing medications that could be repurposed to treat ADRD, employed a study design that reduced the risk for potential bias that may have influenced the earlier findings, the investigators note.

“That study came out last fall and was widely covered in the media, and we thought there were some methodological shortcomings that might have explained the results,” lead investigator Rishi Desai, PhD, assistant professor of medicine at Harvard Medical School and an associate epidemiologist at Brigham and Women’s Hospital, both in Boston, said in an interview.

The new study was published online in Brain Communications.


 

Not the final word?

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, a drug class that includes the ED drugs sildenafil and tadalafil (Cialis), improve memory and cognitive function and reduce amyloid burden. But studies in humans have yielded conflicting results.*

Although the new research and the work published last year both drew on Medicare data, they examined different patient populations.

The first study compared those who took sildenafil for any reason to those who did not take it. That design likely resulted in an analysis of a comparison of individuals with ED – the most common indication for sildenafil – to generally older individuals with diabetes or hypertension, Dr. Desai said.

In contrast, the current study included only those with pulmonary arterial hypertension (PAH), which is also an indication for PDE5 inhibitors. The researchers compared ADRD incidence in those who took PDE5 inhibitors with the incidence among those who took a different medication to treat their PAH. They used propensity matching to create two groups with similar characteristics and examined the data using four analytic strategies.

The investigators found no significant difference between groups in the incidence of ADRD, regardless of the strategy they used. Cell culture studies also revealed no protective effect from PDE5 inhibitors.

“No study of this kind should claim the final word,” Dr. Desai said. “It is extremely difficult to nail down causality from these types of data sources.”
 

Impressive study design

Commenting on the findings, David Knopman, MD, professor of neurology at Mayo Clinic, Rochester, Minn., described the study design as “impressive” for its efforts to minimize bias, a key limitation in the previous study.

“It was always the case that the claims about sildenafil needed further developmental work prior to testing the drug in randomized controlled trials,” Dr. Knopman said. “The evidence for the use of the drug was never sufficient for clinicians to use it in their patients.”

The study was funded by National Institute on Aging. Dr. Desai is an investigator who receives research grants from Bayer, Vertex, and Novartis that were given to the Brigham and Women’s Hospital for unrelated projects. Dr. Knopman has disclosed no relevant financial relationships.

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

Correction, 11/3/22: An earlier version of this article misstated the abbreviation for phosphodiesterase-5. It is PDE-5.

Drugs commonly used to treat erectile dysfunction (ED) are not associated with a decreased risk of Alzheimer’s disease and related dementias (ADRD), new research shows.

The findings contradict results from a previous study that suggested that individuals who take sildenafil (Viagra) were significantly less likely to develop Alzheimer’s.

The new research, part of a larger effort to identify existing medications that could be repurposed to treat ADRD, employed a study design that reduced the risk for potential bias that may have influenced the earlier findings, the investigators note.

“That study came out last fall and was widely covered in the media, and we thought there were some methodological shortcomings that might have explained the results,” lead investigator Rishi Desai, PhD, assistant professor of medicine at Harvard Medical School and an associate epidemiologist at Brigham and Women’s Hospital, both in Boston, said in an interview.

The new study was published online in Brain Communications.


 

Not the final word?

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, a drug class that includes the ED drugs sildenafil and tadalafil (Cialis), improve memory and cognitive function and reduce amyloid burden. But studies in humans have yielded conflicting results.*

Although the new research and the work published last year both drew on Medicare data, they examined different patient populations.

The first study compared those who took sildenafil for any reason to those who did not take it. That design likely resulted in an analysis of a comparison of individuals with ED – the most common indication for sildenafil – to generally older individuals with diabetes or hypertension, Dr. Desai said.

In contrast, the current study included only those with pulmonary arterial hypertension (PAH), which is also an indication for PDE5 inhibitors. The researchers compared ADRD incidence in those who took PDE5 inhibitors with the incidence among those who took a different medication to treat their PAH. They used propensity matching to create two groups with similar characteristics and examined the data using four analytic strategies.

The investigators found no significant difference between groups in the incidence of ADRD, regardless of the strategy they used. Cell culture studies also revealed no protective effect from PDE5 inhibitors.

“No study of this kind should claim the final word,” Dr. Desai said. “It is extremely difficult to nail down causality from these types of data sources.”
 

Impressive study design

Commenting on the findings, David Knopman, MD, professor of neurology at Mayo Clinic, Rochester, Minn., described the study design as “impressive” for its efforts to minimize bias, a key limitation in the previous study.

“It was always the case that the claims about sildenafil needed further developmental work prior to testing the drug in randomized controlled trials,” Dr. Knopman said. “The evidence for the use of the drug was never sufficient for clinicians to use it in their patients.”

The study was funded by National Institute on Aging. Dr. Desai is an investigator who receives research grants from Bayer, Vertex, and Novartis that were given to the Brigham and Women’s Hospital for unrelated projects. Dr. Knopman has disclosed no relevant financial relationships.

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

Correction, 11/3/22: An earlier version of this article misstated the abbreviation for phosphodiesterase-5. It is PDE-5.

Listening to birdsong appears to have a positive and significant impact on mental health and mood, new research suggests.

Investigators found that people who listened to recordings of birds singing experienced a significant reduction in anxiety and paranoia. In contrast, the researchers also found that recordings of traffic noises, including car engines, sirens, and construction, increased depressive states.

“The results suggest that it may be worthwhile to investigate the targeted use of natural sounds such as birdsong in a clinical setting – for example, in hospital waiting rooms or in psychiatric settings,” study investigator Emil Stobbe, MSc, a predoctoral fellow at the Max Planck Institute for Human Development, Berlin, said in an interview.

“If someone is seeking an easily accessible intervention to lower distress, listening to an audio clip of birds singing might be a great option,” he added.

The study was published online in Scientific Reports.
 

Nature’s calming effect

The aim of the research was “to investigate how the physical environment impact brain and mental health,” Mr. Stobbe said.

Mr. Stobbe said that there is significantly more research examining visual properties of the physical environment but that the auditory domain is not as well researched, although, he added, that the beneficial effects of interactions with nature are “well studied.”

He noted that anxiety and paranoia can be experienced by many individuals even though they may be unaware that they are experiencing these states.

“We wanted to investigate if the beneficial effects of nature can also exert their impact on these states. In theory, birds can be representational for natural and vital environment, which, in turn, transfer the positive effects of nature on birdsong listeners,” he said.

A previous study compared nature versus city soundscape conditions and showed that the nature soundscape improved participants’ cognitive performance but did not improve mood. The present study added diversity to the soundscapes and focused not only on cognition and general mood but also on state paranoia, “which can be measured in a change-sensitive manner” and “has been shown to increase in response to traffic noise.”

The researchers hypothesized that birdsong would have a greater beneficial effect on mood and paranoia and on cognitive performance compared with traffic noise. They also investigated whether greater versus lower diversity of bird species or noise sources within the soundscapes “would be a relevant factor modulating the effects.”

The researchers recruited participants (n = 295) from a crowdsourcing platform. Participants’ mean age was late 20s (standard deviations ranged from 6.30 to 7.72), with a greater proportion of male versus female participants.

To be included, participants were required to have no history of mental illness, hearing difficulties, substance/drug intake, or suicidal thoughts/tendencies.

The outcomes of interest (mood, paranoia, cognitive performance) were measured before and after soundscape exposure and each soundscape had a low- versus high-diversity version. This resulted in several analyses that compared two types of sounds (birdsongs vs. traffic noise) x two levels of diversity (low vs. high diversity) and two time points (pre- vs. post exposure).

The exposure to sounds lasted for 6 minutes, after which they were asked to report (on a 0-100 visual scale) how diverse/monotone, beautiful, and pleasant they perceived the soundscape to be.
 

Reduction in depressive symptoms

Participants were divided into four groups: low-diversity traffic noise soundscape (n = 83), high-diversity traffic noise soundscape (n = 60), low-diversity birdsong soundscape (n = 63), and high-diversity birdsong soundscape (n = 80)

In addition to listening to the sounds, participants completed questionnaires measuring mood (depression and anxiety) and paranoia as well as a test of digit span cognitive performance (both the forward and the backward versions).

The type, diversity, and type x diversity all revealed significant effect sizes (F[3, 276] = 78.6; P < .001; eta-squared = 0.461; F[3, 276] = 3.16; P = .025; eta-squared = 0.033; and F[3, 276] = 2.66; P = .028, respectively), “suggesting that all of these factors, as well as their interaction, had a significant impact on the perception of soundscapes (that is, ratings on monotony/diversity, beauty, and pleasantness).”

A post hoc examination showed that depressive symptoms significantly increased within the low- and high-diversity urban soundscapes but decreased significantly in the high-diversity birdsong soundscapes (T[1, 60] = –2.57; P = .012; d = –0.29).

For anxiety, the post hoc within-group analyses found no effects within low- and high-diversity traffic noise conditions (T[1, 82] = –1.37; P = .174; d = –0.15 and T[1, 68] = 0.49; P = .629; d = 0.06, respectively). By contrast, there were significant declines in both birdsong conditions (low diversity: T[1, 62] = –6.13; P < .001; d = –0.77; high diversity: T[1, 60] = –6.32; P < .001; d =  –0.70).

Similarly, there were no changes in participants with paranoia when they listened to either low- or high-diversity traffic noises (T[1, 82] = –0.55; P = .583; d = –0.06 and T[1, 68] = 0.67; P = .507; d = 0.08, respectively). On the other hand, both birdsong conditions yielded reductions in paranoia (low diversity: T[1, 62] = –5.90; P < .001; d = –0.74; high diversity: T[1, 60] =  –4.11; P < .001; d = –0.46).

None of the soundscapes had any effect on cognition.

“In theory, birds can be representational for natural and vital environments which, in turn, transfer the positive effects of nature on birdsong listeners,” said Mr. Stobbe.

“Taken together, the findings of the current study provide another facet of why interactions with nature can be beneficial for our mental health, and it is highly important to preserve nature,” he added.

Mr. Stobbe said that future research should focus on investigating mixed soundscapes including examining whether the presence of natural sounds in urban settings lower stressors such as traffic noise.
 

An understudied area

Commenting for this article, Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness called the study “interesting but limited.”

Dr. Duckworth, who was not involved in the research said that the “benefits of nature are understudied” and agreed with the investigators that it is potentially important to study the use of birdsongs in psychiatric facilities. “Future studies could also correlate the role of birdsong with the mental health benefits/aspects of ‘being in nature,’ which has been found to have some effect.”

Open Access funding was enabled and organized by Projekt DEAL. The authors and Dr. Duckworth declared no competing interests.

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

Listening to birdsong appears to have a positive and significant impact on mental health and mood, new research suggests.

Investigators found that people who listened to recordings of birds singing experienced a significant reduction in anxiety and paranoia. In contrast, the researchers also found that recordings of traffic noises, including car engines, sirens, and construction, increased depressive states.

“The results suggest that it may be worthwhile to investigate the targeted use of natural sounds such as birdsong in a clinical setting – for example, in hospital waiting rooms or in psychiatric settings,” study investigator Emil Stobbe, MSc, a predoctoral fellow at the Max Planck Institute for Human Development, Berlin, said in an interview.

“If someone is seeking an easily accessible intervention to lower distress, listening to an audio clip of birds singing might be a great option,” he added.

The study was published online in Scientific Reports.
 

Nature’s calming effect

The aim of the research was “to investigate how the physical environment impact brain and mental health,” Mr. Stobbe said.

Mr. Stobbe said that there is significantly more research examining visual properties of the physical environment but that the auditory domain is not as well researched, although, he added, that the beneficial effects of interactions with nature are “well studied.”

He noted that anxiety and paranoia can be experienced by many individuals even though they may be unaware that they are experiencing these states.

“We wanted to investigate if the beneficial effects of nature can also exert their impact on these states. In theory, birds can be representational for natural and vital environment, which, in turn, transfer the positive effects of nature on birdsong listeners,” he said.

A previous study compared nature versus city soundscape conditions and showed that the nature soundscape improved participants’ cognitive performance but did not improve mood. The present study added diversity to the soundscapes and focused not only on cognition and general mood but also on state paranoia, “which can be measured in a change-sensitive manner” and “has been shown to increase in response to traffic noise.”

The researchers hypothesized that birdsong would have a greater beneficial effect on mood and paranoia and on cognitive performance compared with traffic noise. They also investigated whether greater versus lower diversity of bird species or noise sources within the soundscapes “would be a relevant factor modulating the effects.”

The researchers recruited participants (n = 295) from a crowdsourcing platform. Participants’ mean age was late 20s (standard deviations ranged from 6.30 to 7.72), with a greater proportion of male versus female participants.

To be included, participants were required to have no history of mental illness, hearing difficulties, substance/drug intake, or suicidal thoughts/tendencies.

The outcomes of interest (mood, paranoia, cognitive performance) were measured before and after soundscape exposure and each soundscape had a low- versus high-diversity version. This resulted in several analyses that compared two types of sounds (birdsongs vs. traffic noise) x two levels of diversity (low vs. high diversity) and two time points (pre- vs. post exposure).

The exposure to sounds lasted for 6 minutes, after which they were asked to report (on a 0-100 visual scale) how diverse/monotone, beautiful, and pleasant they perceived the soundscape to be.
 

Reduction in depressive symptoms

Participants were divided into four groups: low-diversity traffic noise soundscape (n = 83), high-diversity traffic noise soundscape (n = 60), low-diversity birdsong soundscape (n = 63), and high-diversity birdsong soundscape (n = 80)

In addition to listening to the sounds, participants completed questionnaires measuring mood (depression and anxiety) and paranoia as well as a test of digit span cognitive performance (both the forward and the backward versions).

The type, diversity, and type x diversity all revealed significant effect sizes (F[3, 276] = 78.6; P < .001; eta-squared = 0.461; F[3, 276] = 3.16; P = .025; eta-squared = 0.033; and F[3, 276] = 2.66; P = .028, respectively), “suggesting that all of these factors, as well as their interaction, had a significant impact on the perception of soundscapes (that is, ratings on monotony/diversity, beauty, and pleasantness).”

A post hoc examination showed that depressive symptoms significantly increased within the low- and high-diversity urban soundscapes but decreased significantly in the high-diversity birdsong soundscapes (T[1, 60] = –2.57; P = .012; d = –0.29).

For anxiety, the post hoc within-group analyses found no effects within low- and high-diversity traffic noise conditions (T[1, 82] = –1.37; P = .174; d = –0.15 and T[1, 68] = 0.49; P = .629; d = 0.06, respectively). By contrast, there were significant declines in both birdsong conditions (low diversity: T[1, 62] = –6.13; P < .001; d = –0.77; high diversity: T[1, 60] = –6.32; P < .001; d =  –0.70).

Similarly, there were no changes in participants with paranoia when they listened to either low- or high-diversity traffic noises (T[1, 82] = –0.55; P = .583; d = –0.06 and T[1, 68] = 0.67; P = .507; d = 0.08, respectively). On the other hand, both birdsong conditions yielded reductions in paranoia (low diversity: T[1, 62] = –5.90; P < .001; d = –0.74; high diversity: T[1, 60] =  –4.11; P < .001; d = –0.46).

None of the soundscapes had any effect on cognition.

“In theory, birds can be representational for natural and vital environments which, in turn, transfer the positive effects of nature on birdsong listeners,” said Mr. Stobbe.

“Taken together, the findings of the current study provide another facet of why interactions with nature can be beneficial for our mental health, and it is highly important to preserve nature,” he added.

Mr. Stobbe said that future research should focus on investigating mixed soundscapes including examining whether the presence of natural sounds in urban settings lower stressors such as traffic noise.
 

An understudied area

Commenting for this article, Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness called the study “interesting but limited.”

Dr. Duckworth, who was not involved in the research said that the “benefits of nature are understudied” and agreed with the investigators that it is potentially important to study the use of birdsongs in psychiatric facilities. “Future studies could also correlate the role of birdsong with the mental health benefits/aspects of ‘being in nature,’ which has been found to have some effect.”

Open Access funding was enabled and organized by Projekt DEAL. The authors and Dr. Duckworth declared no competing interests.

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

Listening to birdsong appears to have a positive and significant impact on mental health and mood, new research suggests.

Investigators found that people who listened to recordings of birds singing experienced a significant reduction in anxiety and paranoia. In contrast, the researchers also found that recordings of traffic noises, including car engines, sirens, and construction, increased depressive states.

“The results suggest that it may be worthwhile to investigate the targeted use of natural sounds such as birdsong in a clinical setting – for example, in hospital waiting rooms or in psychiatric settings,” study investigator Emil Stobbe, MSc, a predoctoral fellow at the Max Planck Institute for Human Development, Berlin, said in an interview.

“If someone is seeking an easily accessible intervention to lower distress, listening to an audio clip of birds singing might be a great option,” he added.

The study was published online in Scientific Reports.
 

Nature’s calming effect

The aim of the research was “to investigate how the physical environment impact brain and mental health,” Mr. Stobbe said.

Mr. Stobbe said that there is significantly more research examining visual properties of the physical environment but that the auditory domain is not as well researched, although, he added, that the beneficial effects of interactions with nature are “well studied.”

He noted that anxiety and paranoia can be experienced by many individuals even though they may be unaware that they are experiencing these states.

“We wanted to investigate if the beneficial effects of nature can also exert their impact on these states. In theory, birds can be representational for natural and vital environment, which, in turn, transfer the positive effects of nature on birdsong listeners,” he said.

A previous study compared nature versus city soundscape conditions and showed that the nature soundscape improved participants’ cognitive performance but did not improve mood. The present study added diversity to the soundscapes and focused not only on cognition and general mood but also on state paranoia, “which can be measured in a change-sensitive manner” and “has been shown to increase in response to traffic noise.”

The researchers hypothesized that birdsong would have a greater beneficial effect on mood and paranoia and on cognitive performance compared with traffic noise. They also investigated whether greater versus lower diversity of bird species or noise sources within the soundscapes “would be a relevant factor modulating the effects.”

The researchers recruited participants (n = 295) from a crowdsourcing platform. Participants’ mean age was late 20s (standard deviations ranged from 6.30 to 7.72), with a greater proportion of male versus female participants.

To be included, participants were required to have no history of mental illness, hearing difficulties, substance/drug intake, or suicidal thoughts/tendencies.

The outcomes of interest (mood, paranoia, cognitive performance) were measured before and after soundscape exposure and each soundscape had a low- versus high-diversity version. This resulted in several analyses that compared two types of sounds (birdsongs vs. traffic noise) x two levels of diversity (low vs. high diversity) and two time points (pre- vs. post exposure).

The exposure to sounds lasted for 6 minutes, after which they were asked to report (on a 0-100 visual scale) how diverse/monotone, beautiful, and pleasant they perceived the soundscape to be.
 

Reduction in depressive symptoms

Participants were divided into four groups: low-diversity traffic noise soundscape (n = 83), high-diversity traffic noise soundscape (n = 60), low-diversity birdsong soundscape (n = 63), and high-diversity birdsong soundscape (n = 80)

In addition to listening to the sounds, participants completed questionnaires measuring mood (depression and anxiety) and paranoia as well as a test of digit span cognitive performance (both the forward and the backward versions).

The type, diversity, and type x diversity all revealed significant effect sizes (F[3, 276] = 78.6; P < .001; eta-squared = 0.461; F[3, 276] = 3.16; P = .025; eta-squared = 0.033; and F[3, 276] = 2.66; P = .028, respectively), “suggesting that all of these factors, as well as their interaction, had a significant impact on the perception of soundscapes (that is, ratings on monotony/diversity, beauty, and pleasantness).”

A post hoc examination showed that depressive symptoms significantly increased within the low- and high-diversity urban soundscapes but decreased significantly in the high-diversity birdsong soundscapes (T[1, 60] = –2.57; P = .012; d = –0.29).

For anxiety, the post hoc within-group analyses found no effects within low- and high-diversity traffic noise conditions (T[1, 82] = –1.37; P = .174; d = –0.15 and T[1, 68] = 0.49; P = .629; d = 0.06, respectively). By contrast, there were significant declines in both birdsong conditions (low diversity: T[1, 62] = –6.13; P < .001; d = –0.77; high diversity: T[1, 60] = –6.32; P < .001; d =  –0.70).

Similarly, there were no changes in participants with paranoia when they listened to either low- or high-diversity traffic noises (T[1, 82] = –0.55; P = .583; d = –0.06 and T[1, 68] = 0.67; P = .507; d = 0.08, respectively). On the other hand, both birdsong conditions yielded reductions in paranoia (low diversity: T[1, 62] = –5.90; P < .001; d = –0.74; high diversity: T[1, 60] =  –4.11; P < .001; d = –0.46).

None of the soundscapes had any effect on cognition.

“In theory, birds can be representational for natural and vital environments which, in turn, transfer the positive effects of nature on birdsong listeners,” said Mr. Stobbe.

“Taken together, the findings of the current study provide another facet of why interactions with nature can be beneficial for our mental health, and it is highly important to preserve nature,” he added.

Mr. Stobbe said that future research should focus on investigating mixed soundscapes including examining whether the presence of natural sounds in urban settings lower stressors such as traffic noise.
 

An understudied area

Commenting for this article, Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness called the study “interesting but limited.”

Dr. Duckworth, who was not involved in the research said that the “benefits of nature are understudied” and agreed with the investigators that it is potentially important to study the use of birdsongs in psychiatric facilities. “Future studies could also correlate the role of birdsong with the mental health benefits/aspects of ‘being in nature,’ which has been found to have some effect.”

Open Access funding was enabled and organized by Projekt DEAL. The authors and Dr. Duckworth declared no competing interests.

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