Neurology

Peripheral neuropathy is common in U.S. adults and is associated with an increased risk of death, even in the absence of diabetes, researchers reported  in Annals of Internal Medicine.

©mheim3011/thinkstockphotos.com

The findings do not necessarily mean that doctors should implement broader screening for peripheral neuropathy at this time, however, the investigators said.

“Doctors don’t typically screen for peripheral neuropathy in persons without diabetes,” senior author Elizabeth Selvin, PhD, MPH, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

“Our study shows that peripheral neuropathy – as assessed by decreased sensation in the feet – is common, even in people without diabetes,” Dr. Selvin explained. “It is not yet clear whether we should be screening people without diabetes since we don’t have clear treatments, but our study does suggest that this condition is an underrecognized condition that is associated with poor outcomes.”

Patients with diabetes typically undergo annual foot examinations that include screening for peripheral neuropathy, but that’s not the case for most adults in the absence of diabetes.

“I don’t know if we can make the jump that we should be screening people without diabetes,” said first author Caitlin W. Hicks, MD, assistant professor of surgery, division of vascular surgery and endovascular therapy, Johns Hopkins University, Baltimore. “Right now, we do not exactly know what it means in the people without diabetes, and we definitely do not know how to treat it. So, screening for it will tell us that this person has this and is at higher risk of mortality than someone who doesn’t, but we do not know what to do with that information yet.”

Nevertheless, the study raises the question of whether physicians should pay more attention to peripheral neuropathy in people without diabetes, said Dr. Hicks, director of research at the university’s diabetic foot and wound service.
 

Heightened risk

To examine associations between peripheral neuropathy and all-cause and cardiovascular mortality in U.S. adults, Dr. Hicks and colleagues analyzed data from 7,116 adults aged 40 years or older who participated in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004.

The study included participants who underwent monofilament testing for peripheral neuropathy. During testing, technicians used a standard 5.07 Semmes-Weinstein nylon monofilament to apply slight pressure to the bottom of each foot at three sites. If participants could not correctly identify where pressure was applied, the test was repeated. After participants gave two incorrect or undeterminable responses for a site, the site was defined as insensate. The researchers defined peripheral neuropathy as at least one insensate site on either foot.

The researchers determined deaths and causes of death using death certificate records from the National Death Index through 2015.

In all, 13.5% of the participants had peripheral neuropathy, including 27% of adults with diabetes and 11.6% of adults without diabetes. Those with peripheral neuropathy were older, were more likely to be male, and had lower levels of education, compared with participants without peripheral neuropathy. They also had higher body mass index, were more often former or current smokers, and had a higher prevalence of hypertension, hypercholesterolemia, and cardiovascular disease.

During a median follow-up of 13 years, 2,128 participants died, including 488 who died of cardiovascular causes.

The incidence rate of all-cause mortality per 1,000 person-years was 57.6 in adults with diabetes and peripheral neuropathy, 34.3 in adults with peripheral neuropathy but no diabetes, 27.1 in adults with diabetes but no peripheral neuropathy, and 13.0 in adults without diabetes or peripheral neuropathy.

Among participants with diabetes, the leading cause of death was cardiovascular disease (31% of deaths), whereas among participants without diabetes, the leading cause of death was malignant neoplasms (27% of deaths).

After adjustment for age, sex, race, or ethnicity, and risk factors such as cardiovascular disease, peripheral neuropathy was significantly associated with all-cause mortality (hazard ratio [HR], 1.49) and cardiovascular mortality (HR, 1.66) in participants with diabetes. In participants without diabetes, peripheral neuropathy was significantly associated with all-cause mortality (HR, 1.31), but its association with cardiovascular mortality was not statistically significant.

The association between peripheral neuropathy and all-cause mortality persisted in a sensitivity analysis that focused on adults with normoglycemia.
 

Related conditions

The study confirms findings from prior studies that examined the prevalence of loss of peripheral sensation in populations of older adults with and without diabetes, said Elsa S. Strotmeyer, PhD, MPH, associate professor of epidemiology at the University of Pittsburgh. “The clinical significance of the loss of peripheral sensation in older adults without diabetes is not fully appreciated,” she said.

A limitation of the study is that peripheral neuropathy was not a clinical diagnosis. “Monofilament testing at the foot is a quick clinical screen for decreased lower-extremity sensation that likely is a result of sensory peripheral nerve decline,” Dr. Strotmeyer said.

Another limitation is that death certificates are less accurate than medical records for determining cause of death.

“Past studies have indicated that peripheral nerve decline is related to common conditions in aging such as the metabolic syndrome and cardiovascular disease, cancer treatment, and physical function loss,” Dr. Strotmeyer said. “Therefore it is not surprising that is related to mortality as these conditions in aging are associated with increased mortality. Loss of peripheral sensation at the foot may also be related to fall injuries, and mortality from fall injuries has increased dramatically in older adults over the past several decades.”

Prior research has suggested that monofilament testing may play a role in screening for fall risk in older adults without diabetes, Dr. Strotmeyer added.

“For older adults both with and without diabetes, past studies have recommended monofilament testing be incorporated in geriatric screening for fall risk. Therefore, this article expands implications of clinical importance to understanding the pathology and consequences of loss of sensation at the foot in older patients,” she said.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. Dr. Hicks, Dr. Selvin, and a coauthor, Kunihiro Matsushita, MD, PhD, disclosed NIH grants. In addition, Dr. Selvin disclosed personal fees from Novo Nordisk and grants from the Foundation for the National Institutes of Health outside the submitted work, and Dr. Matsushita disclosed grants and personal fees from Fukuda Denshi outside the submitted work. Dr. Strotmeyer receives funding from the National Institute on Aging and the National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chair of the health sciences section of the Gerontological Society of America.

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

Peripheral neuropathy is common in U.S. adults and is associated with an increased risk of death, even in the absence of diabetes, researchers reported  in Annals of Internal Medicine.

©mheim3011/thinkstockphotos.com

The findings do not necessarily mean that doctors should implement broader screening for peripheral neuropathy at this time, however, the investigators said.

“Doctors don’t typically screen for peripheral neuropathy in persons without diabetes,” senior author Elizabeth Selvin, PhD, MPH, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

“Our study shows that peripheral neuropathy – as assessed by decreased sensation in the feet – is common, even in people without diabetes,” Dr. Selvin explained. “It is not yet clear whether we should be screening people without diabetes since we don’t have clear treatments, but our study does suggest that this condition is an underrecognized condition that is associated with poor outcomes.”

Patients with diabetes typically undergo annual foot examinations that include screening for peripheral neuropathy, but that’s not the case for most adults in the absence of diabetes.

“I don’t know if we can make the jump that we should be screening people without diabetes,” said first author Caitlin W. Hicks, MD, assistant professor of surgery, division of vascular surgery and endovascular therapy, Johns Hopkins University, Baltimore. “Right now, we do not exactly know what it means in the people without diabetes, and we definitely do not know how to treat it. So, screening for it will tell us that this person has this and is at higher risk of mortality than someone who doesn’t, but we do not know what to do with that information yet.”

Nevertheless, the study raises the question of whether physicians should pay more attention to peripheral neuropathy in people without diabetes, said Dr. Hicks, director of research at the university’s diabetic foot and wound service.
 

Heightened risk

To examine associations between peripheral neuropathy and all-cause and cardiovascular mortality in U.S. adults, Dr. Hicks and colleagues analyzed data from 7,116 adults aged 40 years or older who participated in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004.

The study included participants who underwent monofilament testing for peripheral neuropathy. During testing, technicians used a standard 5.07 Semmes-Weinstein nylon monofilament to apply slight pressure to the bottom of each foot at three sites. If participants could not correctly identify where pressure was applied, the test was repeated. After participants gave two incorrect or undeterminable responses for a site, the site was defined as insensate. The researchers defined peripheral neuropathy as at least one insensate site on either foot.

The researchers determined deaths and causes of death using death certificate records from the National Death Index through 2015.

In all, 13.5% of the participants had peripheral neuropathy, including 27% of adults with diabetes and 11.6% of adults without diabetes. Those with peripheral neuropathy were older, were more likely to be male, and had lower levels of education, compared with participants without peripheral neuropathy. They also had higher body mass index, were more often former or current smokers, and had a higher prevalence of hypertension, hypercholesterolemia, and cardiovascular disease.

During a median follow-up of 13 years, 2,128 participants died, including 488 who died of cardiovascular causes.

The incidence rate of all-cause mortality per 1,000 person-years was 57.6 in adults with diabetes and peripheral neuropathy, 34.3 in adults with peripheral neuropathy but no diabetes, 27.1 in adults with diabetes but no peripheral neuropathy, and 13.0 in adults without diabetes or peripheral neuropathy.

Among participants with diabetes, the leading cause of death was cardiovascular disease (31% of deaths), whereas among participants without diabetes, the leading cause of death was malignant neoplasms (27% of deaths).

After adjustment for age, sex, race, or ethnicity, and risk factors such as cardiovascular disease, peripheral neuropathy was significantly associated with all-cause mortality (hazard ratio [HR], 1.49) and cardiovascular mortality (HR, 1.66) in participants with diabetes. In participants without diabetes, peripheral neuropathy was significantly associated with all-cause mortality (HR, 1.31), but its association with cardiovascular mortality was not statistically significant.

The association between peripheral neuropathy and all-cause mortality persisted in a sensitivity analysis that focused on adults with normoglycemia.
 

Related conditions

The study confirms findings from prior studies that examined the prevalence of loss of peripheral sensation in populations of older adults with and without diabetes, said Elsa S. Strotmeyer, PhD, MPH, associate professor of epidemiology at the University of Pittsburgh. “The clinical significance of the loss of peripheral sensation in older adults without diabetes is not fully appreciated,” she said.

A limitation of the study is that peripheral neuropathy was not a clinical diagnosis. “Monofilament testing at the foot is a quick clinical screen for decreased lower-extremity sensation that likely is a result of sensory peripheral nerve decline,” Dr. Strotmeyer said.

Another limitation is that death certificates are less accurate than medical records for determining cause of death.

“Past studies have indicated that peripheral nerve decline is related to common conditions in aging such as the metabolic syndrome and cardiovascular disease, cancer treatment, and physical function loss,” Dr. Strotmeyer said. “Therefore it is not surprising that is related to mortality as these conditions in aging are associated with increased mortality. Loss of peripheral sensation at the foot may also be related to fall injuries, and mortality from fall injuries has increased dramatically in older adults over the past several decades.”

Prior research has suggested that monofilament testing may play a role in screening for fall risk in older adults without diabetes, Dr. Strotmeyer added.

“For older adults both with and without diabetes, past studies have recommended monofilament testing be incorporated in geriatric screening for fall risk. Therefore, this article expands implications of clinical importance to understanding the pathology and consequences of loss of sensation at the foot in older patients,” she said.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. Dr. Hicks, Dr. Selvin, and a coauthor, Kunihiro Matsushita, MD, PhD, disclosed NIH grants. In addition, Dr. Selvin disclosed personal fees from Novo Nordisk and grants from the Foundation for the National Institutes of Health outside the submitted work, and Dr. Matsushita disclosed grants and personal fees from Fukuda Denshi outside the submitted work. Dr. Strotmeyer receives funding from the National Institute on Aging and the National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chair of the health sciences section of the Gerontological Society of America.

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

Peripheral neuropathy is common in U.S. adults and is associated with an increased risk of death, even in the absence of diabetes, researchers reported  in Annals of Internal Medicine.

©mheim3011/thinkstockphotos.com

The findings do not necessarily mean that doctors should implement broader screening for peripheral neuropathy at this time, however, the investigators said.

“Doctors don’t typically screen for peripheral neuropathy in persons without diabetes,” senior author Elizabeth Selvin, PhD, MPH, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

“Our study shows that peripheral neuropathy – as assessed by decreased sensation in the feet – is common, even in people without diabetes,” Dr. Selvin explained. “It is not yet clear whether we should be screening people without diabetes since we don’t have clear treatments, but our study does suggest that this condition is an underrecognized condition that is associated with poor outcomes.”

Patients with diabetes typically undergo annual foot examinations that include screening for peripheral neuropathy, but that’s not the case for most adults in the absence of diabetes.

“I don’t know if we can make the jump that we should be screening people without diabetes,” said first author Caitlin W. Hicks, MD, assistant professor of surgery, division of vascular surgery and endovascular therapy, Johns Hopkins University, Baltimore. “Right now, we do not exactly know what it means in the people without diabetes, and we definitely do not know how to treat it. So, screening for it will tell us that this person has this and is at higher risk of mortality than someone who doesn’t, but we do not know what to do with that information yet.”

Nevertheless, the study raises the question of whether physicians should pay more attention to peripheral neuropathy in people without diabetes, said Dr. Hicks, director of research at the university’s diabetic foot and wound service.
 

Heightened risk

To examine associations between peripheral neuropathy and all-cause and cardiovascular mortality in U.S. adults, Dr. Hicks and colleagues analyzed data from 7,116 adults aged 40 years or older who participated in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004.

The study included participants who underwent monofilament testing for peripheral neuropathy. During testing, technicians used a standard 5.07 Semmes-Weinstein nylon monofilament to apply slight pressure to the bottom of each foot at three sites. If participants could not correctly identify where pressure was applied, the test was repeated. After participants gave two incorrect or undeterminable responses for a site, the site was defined as insensate. The researchers defined peripheral neuropathy as at least one insensate site on either foot.

The researchers determined deaths and causes of death using death certificate records from the National Death Index through 2015.

In all, 13.5% of the participants had peripheral neuropathy, including 27% of adults with diabetes and 11.6% of adults without diabetes. Those with peripheral neuropathy were older, were more likely to be male, and had lower levels of education, compared with participants without peripheral neuropathy. They also had higher body mass index, were more often former or current smokers, and had a higher prevalence of hypertension, hypercholesterolemia, and cardiovascular disease.

During a median follow-up of 13 years, 2,128 participants died, including 488 who died of cardiovascular causes.

The incidence rate of all-cause mortality per 1,000 person-years was 57.6 in adults with diabetes and peripheral neuropathy, 34.3 in adults with peripheral neuropathy but no diabetes, 27.1 in adults with diabetes but no peripheral neuropathy, and 13.0 in adults without diabetes or peripheral neuropathy.

Among participants with diabetes, the leading cause of death was cardiovascular disease (31% of deaths), whereas among participants without diabetes, the leading cause of death was malignant neoplasms (27% of deaths).

After adjustment for age, sex, race, or ethnicity, and risk factors such as cardiovascular disease, peripheral neuropathy was significantly associated with all-cause mortality (hazard ratio [HR], 1.49) and cardiovascular mortality (HR, 1.66) in participants with diabetes. In participants without diabetes, peripheral neuropathy was significantly associated with all-cause mortality (HR, 1.31), but its association with cardiovascular mortality was not statistically significant.

The association between peripheral neuropathy and all-cause mortality persisted in a sensitivity analysis that focused on adults with normoglycemia.
 

Related conditions

The study confirms findings from prior studies that examined the prevalence of loss of peripheral sensation in populations of older adults with and without diabetes, said Elsa S. Strotmeyer, PhD, MPH, associate professor of epidemiology at the University of Pittsburgh. “The clinical significance of the loss of peripheral sensation in older adults without diabetes is not fully appreciated,” she said.

A limitation of the study is that peripheral neuropathy was not a clinical diagnosis. “Monofilament testing at the foot is a quick clinical screen for decreased lower-extremity sensation that likely is a result of sensory peripheral nerve decline,” Dr. Strotmeyer said.

Another limitation is that death certificates are less accurate than medical records for determining cause of death.

“Past studies have indicated that peripheral nerve decline is related to common conditions in aging such as the metabolic syndrome and cardiovascular disease, cancer treatment, and physical function loss,” Dr. Strotmeyer said. “Therefore it is not surprising that is related to mortality as these conditions in aging are associated with increased mortality. Loss of peripheral sensation at the foot may also be related to fall injuries, and mortality from fall injuries has increased dramatically in older adults over the past several decades.”

Prior research has suggested that monofilament testing may play a role in screening for fall risk in older adults without diabetes, Dr. Strotmeyer added.

“For older adults both with and without diabetes, past studies have recommended monofilament testing be incorporated in geriatric screening for fall risk. Therefore, this article expands implications of clinical importance to understanding the pathology and consequences of loss of sensation at the foot in older patients,” she said.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. Dr. Hicks, Dr. Selvin, and a coauthor, Kunihiro Matsushita, MD, PhD, disclosed NIH grants. In addition, Dr. Selvin disclosed personal fees from Novo Nordisk and grants from the Foundation for the National Institutes of Health outside the submitted work, and Dr. Matsushita disclosed grants and personal fees from Fukuda Denshi outside the submitted work. Dr. Strotmeyer receives funding from the National Institute on Aging and the National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chair of the health sciences section of the Gerontological Society of America.

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

A new type of laser therapy is safe and effective for children with drug-resistant epilepsy, new research suggests. In a study of nearly 150 children, more than half of those who received MRI-guided laser interstitial thermal therapy (MRgLITT) were seizure free at 1 year.

Results show that this “is a new and promising therapy” for children for whom drug therapy has failed, said study investigator Elysa Widjaja, MD, a pediatric neuroradiologist at the Hospital for Sick Children and professor in the department of medical imaging, University of Toronto.

In addition, the procedure is less invasive and requires a shorter hospital stay than does open epilepsy surgery, Dr. Widjaja said.

The findings were presented at the annual meeting of the American Epilepsy Society, which was held online this year because of the COVID-19 pandemic.
 

Registry study

To date, most published studies on the laser procedure have had a small number of participants from only a few centers, Dr. Widjaja noted. “The aim of our registry is to collect data from multiple centers in both Canada and the U.S. to try to get a better understanding of the outcomes following laser therapy and the complications associated with this treatment,” she said.

In the procedure, a surgeon drills a tiny hole through the skull and, guided by MRI, inserts a very thin laser fiber into the center of the lesion. Heat then ablates the affected brain region.

From the dedicated registry, researchers recruited 182 children who were treated with MRgLITT at seven pediatric centers in the United States and two centers in Canada. The youngest patient was aged 14 months, and the oldest was aged 21 years (mean age, 11.2 years). Some pediatric hospitals treat patients up to age 21, Dr. Widjaja noted.

All of the study participants had focal epilepsy, “so the seizures are coming from a defined area of the brain,” she added. In addition, study participants’ conditions were drug-resistant, defined as conditions in which two antiseizure medications had previously failed.

The mean age at seizure onset was 5.4 years, and the mean number of antiepileptic drugs that were taken was 2.3.

Before receiving the therapy, children typically undergo extensive analyses, including MRI and video electroencephalography, to pinpoint where in the brain the seizures originate. Dr. Widjaja noted that the specific area of the brain that is affected varies widely from child to child.

The investigators collected baseline clinical characteristic and procedural data, including ablation site, type of lesion, length of stay, complications, number of MRgLITT procedures, and seizure outcome. To gather this information, they used a secure electronic platform designed to collect and store research data.
 

Seizure freedom

Among 137 patients for whom 1-year seizure outcomes were available, seizure freedom was reported for 74 patients (54%). In a recent meta-analysis conducted by the investigators, the rate of seizure-free outcomes following epilepsy surgery was about 65%. Although this rate is higher than with the laser therapy, Dr. Widjaja pointed out that the laser intervention is less invasive and the hospital stay of a mean of 3.3 days is shorter than the week or so needed after surgery. This, she said, makes the procedure cost-effective.

Unlike surgery, laser therapy is also “particularly good” at reaching lesions deep in the brain without damaging surrounding tissue, Dr. Widjaja said.

Although the researchers have not evaluated seizure outcomes with respect to age, Dr. Widjaja believes age is not a major factor in outcomes. “I suspect it’s the type of lesion and how big the lesion is that mainly influences the outcome, rather than actual age,” she said.

Complications related to the laser therapy, including infections and bleeding, occurred in 15% of patients. Neurologic deficits affected about 8% of patients; however, these tended to be transient, Dr. Widjaja noted. There were two cases (1%) of permanent neurologic deficits, both of which involved weakness of arms or legs. This, said Dr. Widjaja, is less than the 5% rate of permanent neurologic deficits that occur following surgery, as reported in the literature.

There were no cases of major intracranial hemorrhage among the participants. At 30 days, there was one reported death.

Laser therapy is limited to relatively small lesions of no more than about 2 cm on average, Dr. Widjaja said. “We normally can’t treat huge lesions using laser therapy; they would need surgery.” However, it is possible to treat the same area twice. In the current study, 20 patients (11%) underwent laser therapy on one region on two occasions. Of these participants, 12 (60%) achieved freedom from seizures.

Dr. Widjaja noted that two additional epilepsy centers will soon be providing laser therapy and will expand the registry. In addition, the investigators are building a surgery registry that will enable them to compare outcomes of laser treatment with surgery.

Currently, laser therapy is available only at specialized epilepsy centers that perform surgery.
 

‘Very important’ research

Commenting on the study, Daniel Goldenholz, MD, PhD, division of epilepsy, department of neurology, Beth Israel Deaconess Medical Center, Boston, called this is “a very important study.”

Laser therapy “offers the opportunity for very rapid recovery from a minimally invasive, targeted technique while simultaneously offering promising outcomes,” said Dr. Goldenholz, who was not involved with the research.

He noted the importance of the investigators’ choosing freedom from seizures as the outcome of interest. In addition, the 54% seizure-freedom rate in the study is “substantially better” than rates from other interventions, he said.

“To put the results into perspective, other work has found that these same patients would have a less than 10% chance of seizure freedom if many different drug combinations were tried,” said Dr. Goldenholz.

He noted that the 1-year outcomes “are a good first time point” but that it is very important to assess longer-term outcomes. “Often, postsurgical outcomes are worse when looking at 2 or 5 years postoperatively,” he added. These longer-term data will be important “to fully inform our patients about long-term prognosis,” Dr. Goldenholz said.

Still, given the overall favorable results so far, “I think more centers will be likely to explore this newer technology,” he said.

The study was funded by the Pediatric Epilepsy Research Foundation. The study authors and Dr. Goldenholz report no relevant financial relationships.

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

A new type of laser therapy is safe and effective for children with drug-resistant epilepsy, new research suggests. In a study of nearly 150 children, more than half of those who received MRI-guided laser interstitial thermal therapy (MRgLITT) were seizure free at 1 year.

Results show that this “is a new and promising therapy” for children for whom drug therapy has failed, said study investigator Elysa Widjaja, MD, a pediatric neuroradiologist at the Hospital for Sick Children and professor in the department of medical imaging, University of Toronto.

In addition, the procedure is less invasive and requires a shorter hospital stay than does open epilepsy surgery, Dr. Widjaja said.

The findings were presented at the annual meeting of the American Epilepsy Society, which was held online this year because of the COVID-19 pandemic.
 

Registry study

To date, most published studies on the laser procedure have had a small number of participants from only a few centers, Dr. Widjaja noted. “The aim of our registry is to collect data from multiple centers in both Canada and the U.S. to try to get a better understanding of the outcomes following laser therapy and the complications associated with this treatment,” she said.

In the procedure, a surgeon drills a tiny hole through the skull and, guided by MRI, inserts a very thin laser fiber into the center of the lesion. Heat then ablates the affected brain region.

From the dedicated registry, researchers recruited 182 children who were treated with MRgLITT at seven pediatric centers in the United States and two centers in Canada. The youngest patient was aged 14 months, and the oldest was aged 21 years (mean age, 11.2 years). Some pediatric hospitals treat patients up to age 21, Dr. Widjaja noted.

All of the study participants had focal epilepsy, “so the seizures are coming from a defined area of the brain,” she added. In addition, study participants’ conditions were drug-resistant, defined as conditions in which two antiseizure medications had previously failed.

The mean age at seizure onset was 5.4 years, and the mean number of antiepileptic drugs that were taken was 2.3.

Before receiving the therapy, children typically undergo extensive analyses, including MRI and video electroencephalography, to pinpoint where in the brain the seizures originate. Dr. Widjaja noted that the specific area of the brain that is affected varies widely from child to child.

The investigators collected baseline clinical characteristic and procedural data, including ablation site, type of lesion, length of stay, complications, number of MRgLITT procedures, and seizure outcome. To gather this information, they used a secure electronic platform designed to collect and store research data.
 

Seizure freedom

Among 137 patients for whom 1-year seizure outcomes were available, seizure freedom was reported for 74 patients (54%). In a recent meta-analysis conducted by the investigators, the rate of seizure-free outcomes following epilepsy surgery was about 65%. Although this rate is higher than with the laser therapy, Dr. Widjaja pointed out that the laser intervention is less invasive and the hospital stay of a mean of 3.3 days is shorter than the week or so needed after surgery. This, she said, makes the procedure cost-effective.

Unlike surgery, laser therapy is also “particularly good” at reaching lesions deep in the brain without damaging surrounding tissue, Dr. Widjaja said.

Although the researchers have not evaluated seizure outcomes with respect to age, Dr. Widjaja believes age is not a major factor in outcomes. “I suspect it’s the type of lesion and how big the lesion is that mainly influences the outcome, rather than actual age,” she said.

Complications related to the laser therapy, including infections and bleeding, occurred in 15% of patients. Neurologic deficits affected about 8% of patients; however, these tended to be transient, Dr. Widjaja noted. There were two cases (1%) of permanent neurologic deficits, both of which involved weakness of arms or legs. This, said Dr. Widjaja, is less than the 5% rate of permanent neurologic deficits that occur following surgery, as reported in the literature.

There were no cases of major intracranial hemorrhage among the participants. At 30 days, there was one reported death.

Laser therapy is limited to relatively small lesions of no more than about 2 cm on average, Dr. Widjaja said. “We normally can’t treat huge lesions using laser therapy; they would need surgery.” However, it is possible to treat the same area twice. In the current study, 20 patients (11%) underwent laser therapy on one region on two occasions. Of these participants, 12 (60%) achieved freedom from seizures.

Dr. Widjaja noted that two additional epilepsy centers will soon be providing laser therapy and will expand the registry. In addition, the investigators are building a surgery registry that will enable them to compare outcomes of laser treatment with surgery.

Currently, laser therapy is available only at specialized epilepsy centers that perform surgery.
 

‘Very important’ research

Commenting on the study, Daniel Goldenholz, MD, PhD, division of epilepsy, department of neurology, Beth Israel Deaconess Medical Center, Boston, called this is “a very important study.”

Laser therapy “offers the opportunity for very rapid recovery from a minimally invasive, targeted technique while simultaneously offering promising outcomes,” said Dr. Goldenholz, who was not involved with the research.

He noted the importance of the investigators’ choosing freedom from seizures as the outcome of interest. In addition, the 54% seizure-freedom rate in the study is “substantially better” than rates from other interventions, he said.

“To put the results into perspective, other work has found that these same patients would have a less than 10% chance of seizure freedom if many different drug combinations were tried,” said Dr. Goldenholz.

He noted that the 1-year outcomes “are a good first time point” but that it is very important to assess longer-term outcomes. “Often, postsurgical outcomes are worse when looking at 2 or 5 years postoperatively,” he added. These longer-term data will be important “to fully inform our patients about long-term prognosis,” Dr. Goldenholz said.

Still, given the overall favorable results so far, “I think more centers will be likely to explore this newer technology,” he said.

The study was funded by the Pediatric Epilepsy Research Foundation. The study authors and Dr. Goldenholz report no relevant financial relationships.

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

A new type of laser therapy is safe and effective for children with drug-resistant epilepsy, new research suggests. In a study of nearly 150 children, more than half of those who received MRI-guided laser interstitial thermal therapy (MRgLITT) were seizure free at 1 year.

Results show that this “is a new and promising therapy” for children for whom drug therapy has failed, said study investigator Elysa Widjaja, MD, a pediatric neuroradiologist at the Hospital for Sick Children and professor in the department of medical imaging, University of Toronto.

In addition, the procedure is less invasive and requires a shorter hospital stay than does open epilepsy surgery, Dr. Widjaja said.

The findings were presented at the annual meeting of the American Epilepsy Society, which was held online this year because of the COVID-19 pandemic.
 

Registry study

To date, most published studies on the laser procedure have had a small number of participants from only a few centers, Dr. Widjaja noted. “The aim of our registry is to collect data from multiple centers in both Canada and the U.S. to try to get a better understanding of the outcomes following laser therapy and the complications associated with this treatment,” she said.

In the procedure, a surgeon drills a tiny hole through the skull and, guided by MRI, inserts a very thin laser fiber into the center of the lesion. Heat then ablates the affected brain region.

From the dedicated registry, researchers recruited 182 children who were treated with MRgLITT at seven pediatric centers in the United States and two centers in Canada. The youngest patient was aged 14 months, and the oldest was aged 21 years (mean age, 11.2 years). Some pediatric hospitals treat patients up to age 21, Dr. Widjaja noted.

All of the study participants had focal epilepsy, “so the seizures are coming from a defined area of the brain,” she added. In addition, study participants’ conditions were drug-resistant, defined as conditions in which two antiseizure medications had previously failed.

The mean age at seizure onset was 5.4 years, and the mean number of antiepileptic drugs that were taken was 2.3.

Before receiving the therapy, children typically undergo extensive analyses, including MRI and video electroencephalography, to pinpoint where in the brain the seizures originate. Dr. Widjaja noted that the specific area of the brain that is affected varies widely from child to child.

The investigators collected baseline clinical characteristic and procedural data, including ablation site, type of lesion, length of stay, complications, number of MRgLITT procedures, and seizure outcome. To gather this information, they used a secure electronic platform designed to collect and store research data.
 

Seizure freedom

Among 137 patients for whom 1-year seizure outcomes were available, seizure freedom was reported for 74 patients (54%). In a recent meta-analysis conducted by the investigators, the rate of seizure-free outcomes following epilepsy surgery was about 65%. Although this rate is higher than with the laser therapy, Dr. Widjaja pointed out that the laser intervention is less invasive and the hospital stay of a mean of 3.3 days is shorter than the week or so needed after surgery. This, she said, makes the procedure cost-effective.

Unlike surgery, laser therapy is also “particularly good” at reaching lesions deep in the brain without damaging surrounding tissue, Dr. Widjaja said.

Although the researchers have not evaluated seizure outcomes with respect to age, Dr. Widjaja believes age is not a major factor in outcomes. “I suspect it’s the type of lesion and how big the lesion is that mainly influences the outcome, rather than actual age,” she said.

Complications related to the laser therapy, including infections and bleeding, occurred in 15% of patients. Neurologic deficits affected about 8% of patients; however, these tended to be transient, Dr. Widjaja noted. There were two cases (1%) of permanent neurologic deficits, both of which involved weakness of arms or legs. This, said Dr. Widjaja, is less than the 5% rate of permanent neurologic deficits that occur following surgery, as reported in the literature.

There were no cases of major intracranial hemorrhage among the participants. At 30 days, there was one reported death.

Laser therapy is limited to relatively small lesions of no more than about 2 cm on average, Dr. Widjaja said. “We normally can’t treat huge lesions using laser therapy; they would need surgery.” However, it is possible to treat the same area twice. In the current study, 20 patients (11%) underwent laser therapy on one region on two occasions. Of these participants, 12 (60%) achieved freedom from seizures.

Dr. Widjaja noted that two additional epilepsy centers will soon be providing laser therapy and will expand the registry. In addition, the investigators are building a surgery registry that will enable them to compare outcomes of laser treatment with surgery.

Currently, laser therapy is available only at specialized epilepsy centers that perform surgery.
 

‘Very important’ research

Commenting on the study, Daniel Goldenholz, MD, PhD, division of epilepsy, department of neurology, Beth Israel Deaconess Medical Center, Boston, called this is “a very important study.”

Laser therapy “offers the opportunity for very rapid recovery from a minimally invasive, targeted technique while simultaneously offering promising outcomes,” said Dr. Goldenholz, who was not involved with the research.

He noted the importance of the investigators’ choosing freedom from seizures as the outcome of interest. In addition, the 54% seizure-freedom rate in the study is “substantially better” than rates from other interventions, he said.

“To put the results into perspective, other work has found that these same patients would have a less than 10% chance of seizure freedom if many different drug combinations were tried,” said Dr. Goldenholz.

He noted that the 1-year outcomes “are a good first time point” but that it is very important to assess longer-term outcomes. “Often, postsurgical outcomes are worse when looking at 2 or 5 years postoperatively,” he added. These longer-term data will be important “to fully inform our patients about long-term prognosis,” Dr. Goldenholz said.

Still, given the overall favorable results so far, “I think more centers will be likely to explore this newer technology,” he said.

The study was funded by the Pediatric Epilepsy Research Foundation. The study authors and Dr. Goldenholz report no relevant financial relationships.

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

Sudden unexpected death in epilepsy (SUDEP) may explain 3% of all sudden deaths in children – a prevalence rate that is at least three times greater than previously reported estimates – new research shows.

Just a few years ago, the message regarding SUDEP was that “it’s very rare in children so you don’t need to worry about it,” said study investigator Vicky Whittemore, PhD, program director at the National Institute of Neurological Disorders and Stroke.

These new study results should refocus the message that “the condition is rare, but not as rare as we thought it was,” she said.

The findings were presented at the American Epilepsy Society’s 74th Annual Meeting, which was held online this year because of the COVID-19 pandemic.
 

Population-based study

Most of the research examining the pediatric SUDEP rate in the United States is based on convenience samples, with few population-based studies.

The investigators used data from the National Institutes of Health/Centers for Disease Control and Prevention Sudden Death in the Young Case Registry. The CDC set up the registry several years ago to record cases of sudden infant death syndrome and sudden deaths in children resulting from violence, trauma, and abuse. Its mandate has since expanded, and the registry now includes data on sudden cardiac death and SUDEP in children.

The current study included children with SUDEP or cardiac/SUDEP who were aged 0-17 years from several states or jurisdictions from 2015 to 2017. Cases were deemed to be SUDEP if the patient had a history of epilepsy, with or without evidence of seizure at the time of death, but excluding status epilepticus.

Criteria for cardiac/SUDEP cases included having a family history of a heritable cardiac condition or sudden death before age 50 years, a personal history of cardiac disease, or a clinical history suggestive of a cardiac disorder, such as death during exertion.

This second category, said Dr. Whittemore, might capture children with Dravet syndrome, a type of epilepsy caused by a genetic mutation that affects both the heart and the brain. “In these cases, it’s sometimes difficult to tell if the child died due to a heart complication or due to epilepsy,” she said.

The analysis included 1,776 cases. Of these, 3% were categorized as SUDEP, and 1% were categorized as cardiac/SUDEP.

The relatively high prevalence of SUDEP was somewhat unexpected, inasmuch as previous reports estimated the rate to be 0.5%-1%, said Dr. Whittemore.

She noted that the current study is population based and included all cases of child death, whereas past reports relied on death certificates. “That probably missed a lot of deaths because they weren’t recorded accurately on the death certificate or weren’t reported in a way that anyone could ascertain that it was a death in someone that had epilepsy.”
 

Racial differences

Autopsy rates were lower for SUDEP (70%), compared with other categories of death in the registry (81%-100%).

In most jurisdictions, parents must give consent for an autopsy to be performed for a child, and many parents who have suffered such a sudden loss don’t want further investigation, said Dr. Whittemore. “If you know your child had epilepsy, doing an autopsy really isn’t going to tell you very much. You already know they had epilepsy; you may not know the cause of the epilepsy, but an autopsy isn’t going to reveal as much as it would in children with sudden cardiac death.”

SUDEP was equally common in boys and girls. However, the SUDEP mortality rate was higher in Black children (0.32/100,000) than in White children (0.22/100,000). It’s unclear from this study why this is so, but another study that examined SUDEP rates by ZIP code suggested that the higher rate may be caused by socioeconomic factors, said Dr. Whittemore. “Black children from a lower-income family who don’t have access to care may not be getting as good treatment and so have more uncontrolled seizures, which may lead to higher incidence of SUDEP.”

SUDEP occurred at all ages, but mortality rates were highest among patients aged 0-1 year (0.53/100,000) and in those aged 14-17 years (0.31/100,000). Dr. Whittemore speculated that SUDEP rates were higher among the youngest patients because their seizures have just started, and it may be more difficult to bring them under control. In the past, some of these cases may have been classified as sudden infant death syndrome but are now recognized as SUDEP.

As for the older group, research shows that puberty can result in poorer seizure control, which may put teens at elevated risk for SUDEP, said Dr. Whittemore. She added that, as teens continue to age, SUDEP risk may continue to increase. Dr. Whittemore suggested that young adults who head off to college may stop taking their antiseizure medications or consume alcohol while taking these drugs.
 

Failure of arousal

The study results revealed that most SUDEP cases occurred during sleep without a witness. Dr. Whittemore believes that sleeping with one’s face in a pillow may prevent the reflex required to turn the head to breathe. “It’s sort of a failure of arousal that is potentially the underlying mechanism.”

In some cases, there are signs children had a seizure just prior to death, said Dr. Whittemore.

The researchers have now collected information for 2018 and 2019 and plan to add these data to the current 3-year results. “We will now expand our analysis to include these new numbers to make sure the trends we saw in those 3 years are continuing,” said Dr. Whittemore. The new results should help raise awareness that SUDEP is not as rare as previously believed.

Parents of children with epilepsy can take steps to help reduce the risk for SUDEP, she added. For example, they can use night monitors, and for the children at highest risk (e.g., those with Dravet syndrome), they can use an “alarm blanket” that alerts them when the child moves.
 

Much is still unknown

Commenting on the study, Daniel Goldenholz, MD, PhD, division of epilepsy, department of neurology, Beth Israel Deaconess Medical Center, New York, who has participated in SUDEP research, said it “raises important questions about SUDEP in children and about racial disparities in SUDEP.”

The understanding of SUDEP so far “leaves much to be desired,” said Dr. Goldenholz. “We don’t yet know why it happens, and we don’t yet know how to prevent it.” The current study “brings a couple of new data points to the table which need further validation, confirmation, and explanation.”

The Sudden Death in Young Case Registry is supported by the National Heart, Lung, and Blood Institute; the National Institute of Neurological Disorders and Stroke; and the CDC. The investigators and Dr. Goldenholz disclosed no relevant financial relationships.

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

Sudden unexpected death in epilepsy (SUDEP) may explain 3% of all sudden deaths in children – a prevalence rate that is at least three times greater than previously reported estimates – new research shows.

Just a few years ago, the message regarding SUDEP was that “it’s very rare in children so you don’t need to worry about it,” said study investigator Vicky Whittemore, PhD, program director at the National Institute of Neurological Disorders and Stroke.

These new study results should refocus the message that “the condition is rare, but not as rare as we thought it was,” she said.

The findings were presented at the American Epilepsy Society’s 74th Annual Meeting, which was held online this year because of the COVID-19 pandemic.
 

Population-based study

Most of the research examining the pediatric SUDEP rate in the United States is based on convenience samples, with few population-based studies.

The investigators used data from the National Institutes of Health/Centers for Disease Control and Prevention Sudden Death in the Young Case Registry. The CDC set up the registry several years ago to record cases of sudden infant death syndrome and sudden deaths in children resulting from violence, trauma, and abuse. Its mandate has since expanded, and the registry now includes data on sudden cardiac death and SUDEP in children.

The current study included children with SUDEP or cardiac/SUDEP who were aged 0-17 years from several states or jurisdictions from 2015 to 2017. Cases were deemed to be SUDEP if the patient had a history of epilepsy, with or without evidence of seizure at the time of death, but excluding status epilepticus.

Criteria for cardiac/SUDEP cases included having a family history of a heritable cardiac condition or sudden death before age 50 years, a personal history of cardiac disease, or a clinical history suggestive of a cardiac disorder, such as death during exertion.

This second category, said Dr. Whittemore, might capture children with Dravet syndrome, a type of epilepsy caused by a genetic mutation that affects both the heart and the brain. “In these cases, it’s sometimes difficult to tell if the child died due to a heart complication or due to epilepsy,” she said.

The analysis included 1,776 cases. Of these, 3% were categorized as SUDEP, and 1% were categorized as cardiac/SUDEP.

The relatively high prevalence of SUDEP was somewhat unexpected, inasmuch as previous reports estimated the rate to be 0.5%-1%, said Dr. Whittemore.

She noted that the current study is population based and included all cases of child death, whereas past reports relied on death certificates. “That probably missed a lot of deaths because they weren’t recorded accurately on the death certificate or weren’t reported in a way that anyone could ascertain that it was a death in someone that had epilepsy.”
 

Racial differences

Autopsy rates were lower for SUDEP (70%), compared with other categories of death in the registry (81%-100%).

In most jurisdictions, parents must give consent for an autopsy to be performed for a child, and many parents who have suffered such a sudden loss don’t want further investigation, said Dr. Whittemore. “If you know your child had epilepsy, doing an autopsy really isn’t going to tell you very much. You already know they had epilepsy; you may not know the cause of the epilepsy, but an autopsy isn’t going to reveal as much as it would in children with sudden cardiac death.”

SUDEP was equally common in boys and girls. However, the SUDEP mortality rate was higher in Black children (0.32/100,000) than in White children (0.22/100,000). It’s unclear from this study why this is so, but another study that examined SUDEP rates by ZIP code suggested that the higher rate may be caused by socioeconomic factors, said Dr. Whittemore. “Black children from a lower-income family who don’t have access to care may not be getting as good treatment and so have more uncontrolled seizures, which may lead to higher incidence of SUDEP.”

SUDEP occurred at all ages, but mortality rates were highest among patients aged 0-1 year (0.53/100,000) and in those aged 14-17 years (0.31/100,000). Dr. Whittemore speculated that SUDEP rates were higher among the youngest patients because their seizures have just started, and it may be more difficult to bring them under control. In the past, some of these cases may have been classified as sudden infant death syndrome but are now recognized as SUDEP.

As for the older group, research shows that puberty can result in poorer seizure control, which may put teens at elevated risk for SUDEP, said Dr. Whittemore. She added that, as teens continue to age, SUDEP risk may continue to increase. Dr. Whittemore suggested that young adults who head off to college may stop taking their antiseizure medications or consume alcohol while taking these drugs.
 

Failure of arousal

The study results revealed that most SUDEP cases occurred during sleep without a witness. Dr. Whittemore believes that sleeping with one’s face in a pillow may prevent the reflex required to turn the head to breathe. “It’s sort of a failure of arousal that is potentially the underlying mechanism.”

In some cases, there are signs children had a seizure just prior to death, said Dr. Whittemore.

The researchers have now collected information for 2018 and 2019 and plan to add these data to the current 3-year results. “We will now expand our analysis to include these new numbers to make sure the trends we saw in those 3 years are continuing,” said Dr. Whittemore. The new results should help raise awareness that SUDEP is not as rare as previously believed.

Parents of children with epilepsy can take steps to help reduce the risk for SUDEP, she added. For example, they can use night monitors, and for the children at highest risk (e.g., those with Dravet syndrome), they can use an “alarm blanket” that alerts them when the child moves.
 

Much is still unknown

Commenting on the study, Daniel Goldenholz, MD, PhD, division of epilepsy, department of neurology, Beth Israel Deaconess Medical Center, New York, who has participated in SUDEP research, said it “raises important questions about SUDEP in children and about racial disparities in SUDEP.”

The understanding of SUDEP so far “leaves much to be desired,” said Dr. Goldenholz. “We don’t yet know why it happens, and we don’t yet know how to prevent it.” The current study “brings a couple of new data points to the table which need further validation, confirmation, and explanation.”

The Sudden Death in Young Case Registry is supported by the National Heart, Lung, and Blood Institute; the National Institute of Neurological Disorders and Stroke; and the CDC. The investigators and Dr. Goldenholz disclosed no relevant financial relationships.

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

Sudden unexpected death in epilepsy (SUDEP) may explain 3% of all sudden deaths in children – a prevalence rate that is at least three times greater than previously reported estimates – new research shows.

Just a few years ago, the message regarding SUDEP was that “it’s very rare in children so you don’t need to worry about it,” said study investigator Vicky Whittemore, PhD, program director at the National Institute of Neurological Disorders and Stroke.

These new study results should refocus the message that “the condition is rare, but not as rare as we thought it was,” she said.

The findings were presented at the American Epilepsy Society’s 74th Annual Meeting, which was held online this year because of the COVID-19 pandemic.
 

Population-based study

Most of the research examining the pediatric SUDEP rate in the United States is based on convenience samples, with few population-based studies.

The investigators used data from the National Institutes of Health/Centers for Disease Control and Prevention Sudden Death in the Young Case Registry. The CDC set up the registry several years ago to record cases of sudden infant death syndrome and sudden deaths in children resulting from violence, trauma, and abuse. Its mandate has since expanded, and the registry now includes data on sudden cardiac death and SUDEP in children.

The current study included children with SUDEP or cardiac/SUDEP who were aged 0-17 years from several states or jurisdictions from 2015 to 2017. Cases were deemed to be SUDEP if the patient had a history of epilepsy, with or without evidence of seizure at the time of death, but excluding status epilepticus.

Criteria for cardiac/SUDEP cases included having a family history of a heritable cardiac condition or sudden death before age 50 years, a personal history of cardiac disease, or a clinical history suggestive of a cardiac disorder, such as death during exertion.

This second category, said Dr. Whittemore, might capture children with Dravet syndrome, a type of epilepsy caused by a genetic mutation that affects both the heart and the brain. “In these cases, it’s sometimes difficult to tell if the child died due to a heart complication or due to epilepsy,” she said.

The analysis included 1,776 cases. Of these, 3% were categorized as SUDEP, and 1% were categorized as cardiac/SUDEP.

The relatively high prevalence of SUDEP was somewhat unexpected, inasmuch as previous reports estimated the rate to be 0.5%-1%, said Dr. Whittemore.

She noted that the current study is population based and included all cases of child death, whereas past reports relied on death certificates. “That probably missed a lot of deaths because they weren’t recorded accurately on the death certificate or weren’t reported in a way that anyone could ascertain that it was a death in someone that had epilepsy.”
 

Racial differences

Autopsy rates were lower for SUDEP (70%), compared with other categories of death in the registry (81%-100%).

In most jurisdictions, parents must give consent for an autopsy to be performed for a child, and many parents who have suffered such a sudden loss don’t want further investigation, said Dr. Whittemore. “If you know your child had epilepsy, doing an autopsy really isn’t going to tell you very much. You already know they had epilepsy; you may not know the cause of the epilepsy, but an autopsy isn’t going to reveal as much as it would in children with sudden cardiac death.”

SUDEP was equally common in boys and girls. However, the SUDEP mortality rate was higher in Black children (0.32/100,000) than in White children (0.22/100,000). It’s unclear from this study why this is so, but another study that examined SUDEP rates by ZIP code suggested that the higher rate may be caused by socioeconomic factors, said Dr. Whittemore. “Black children from a lower-income family who don’t have access to care may not be getting as good treatment and so have more uncontrolled seizures, which may lead to higher incidence of SUDEP.”

SUDEP occurred at all ages, but mortality rates were highest among patients aged 0-1 year (0.53/100,000) and in those aged 14-17 years (0.31/100,000). Dr. Whittemore speculated that SUDEP rates were higher among the youngest patients because their seizures have just started, and it may be more difficult to bring them under control. In the past, some of these cases may have been classified as sudden infant death syndrome but are now recognized as SUDEP.

As for the older group, research shows that puberty can result in poorer seizure control, which may put teens at elevated risk for SUDEP, said Dr. Whittemore. She added that, as teens continue to age, SUDEP risk may continue to increase. Dr. Whittemore suggested that young adults who head off to college may stop taking their antiseizure medications or consume alcohol while taking these drugs.
 

Failure of arousal

The study results revealed that most SUDEP cases occurred during sleep without a witness. Dr. Whittemore believes that sleeping with one’s face in a pillow may prevent the reflex required to turn the head to breathe. “It’s sort of a failure of arousal that is potentially the underlying mechanism.”

In some cases, there are signs children had a seizure just prior to death, said Dr. Whittemore.

The researchers have now collected information for 2018 and 2019 and plan to add these data to the current 3-year results. “We will now expand our analysis to include these new numbers to make sure the trends we saw in those 3 years are continuing,” said Dr. Whittemore. The new results should help raise awareness that SUDEP is not as rare as previously believed.

Parents of children with epilepsy can take steps to help reduce the risk for SUDEP, she added. For example, they can use night monitors, and for the children at highest risk (e.g., those with Dravet syndrome), they can use an “alarm blanket” that alerts them when the child moves.
 

Much is still unknown

Commenting on the study, Daniel Goldenholz, MD, PhD, division of epilepsy, department of neurology, Beth Israel Deaconess Medical Center, New York, who has participated in SUDEP research, said it “raises important questions about SUDEP in children and about racial disparities in SUDEP.”

The understanding of SUDEP so far “leaves much to be desired,” said Dr. Goldenholz. “We don’t yet know why it happens, and we don’t yet know how to prevent it.” The current study “brings a couple of new data points to the table which need further validation, confirmation, and explanation.”

The Sudden Death in Young Case Registry is supported by the National Heart, Lung, and Blood Institute; the National Institute of Neurological Disorders and Stroke; and the CDC. The investigators and Dr. Goldenholz disclosed no relevant financial relationships.

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

Children with epilepsy with no previous psychiatric diagnosis have alarmingly high rates of suicidal thoughts and behaviors, new research suggests. In a study of more than 100 youth with the disorder, more than 40% had depression, 30% had anxiety, and about 1 in 10 exhibited signs of suicidal thoughts and behaviors.

These rates “are really worrisome” and highlight the need to screen all children and young adults with epilepsy for psychiatric disorders, said study author Tatiana Falcone, MD, assistant professor of neurology and child and adolescent psychiatry at the Cleveland Clinic.

“It’s very important to screen for suicidality and for depression and anxiety, even when patients aren’t reporting symptoms,” said Dr. Falcone.

Previous research shows children with epilepsy will attend the emergency room with symptoms such as headache or stomachache “when the main reason for the visit was the kid was suicidal,” Dr. Falcone said. “Unless you ask the specific question: ‘Are you having thoughts about hurting yourself?’ this will go unreported,” she added.

The findings were presented at the American Epilepsy Society’s 74th Annual Meeting, which was held online this year because of the COVID-19 pandemic.
 

Red flag

Not much is known about suicidality in children and youth with epilepsy except that depression and anxiety – the most common psychiatric comorbidities in this population – appear to contribute to suicidal thoughts.

Dr. Falcone said that she and her colleagues often see children and adolescents with epilepsy in their clinic who have attempted suicide. In recent years, the clinicians have increased efforts to try to identify them before they carry out a successful suicide attempt, said lead investigator Anjali Dagar, MD, clinical research psychiatry fellow at Cleveland Clinic.

The study included 119 patients aged 10-24 years (mean age, 15.8 years; 54.6% female). All attended an epilepsy clinic or underwent testing in the pediatric epilepsy monitoring unit at the Cleveland Clinic and did not have a psychiatric diagnosis.

Epilepsy severity ranged among study participants. About half were drug resistant and were at the center for surgical evaluation and the others were newly diagnosed.

Participants filled out questionnaires to self-report psychiatric conditions. The validated screening tools included the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Screen for Child Anxiety Related Emotional Disorders (SCARED), and the Ask Suicide–Screening Questions (ASQ).

A score of 15 or higher on the CES-DC indicates a risk for depression. On the SCARED test, a score higher than 32 indicates anxiety. Recent research has shown that anxiety is a main risk factor “in moving people from contemplating suicide to actually carrying it out,” Dr. Falcone said.

The ASQ includes four questions about suicidal thoughts and whether respondents have tried to hurt themselves. Dr. Dagar noted that a positive response to any of these questions should raise a red flag.
 

Very high rates

Results showed that almost one-third (30.2%) of the participants scored positive for anxiety on SCARED and 41.2% scored positive for depression on the CSE-DC. These are “very high” rates, Dr. Falcone said. For comparison, the rate of reported anxiety is less than 10% in school surveys.

In addition, the Centers for Disease Control and Prevention reports about 3% of 2- to 17-year-olds in the general population have depression. Even compared with other chronic illnesses (including diabetes, heart disease, and cancer), children with epilepsy have a higher rate of depression, said Dr. Falcone.

More than 1 in 10 (10.9%) participants in the study exhibited signs of suicidality, as shown by having at least one positive response on the ASQ. “That’s a lot,” and much higher than the estimated rate in the general teen population, Dr. Falcone noted.

She noted that “these are just general kids with epilepsy” who had not been previously diagnosed with a psychiatric disorder.

“Depression, anxiety, and suicidality are very frequent comorbidities in patients with epilepsy; and even if a patient is not reporting any symptoms, we should be asking these questions to help them,” she said.

Study participants who had at least one positive response on the ASQ had a mean score of 32.1 on the SCARED, compared with a mean score of 18.3 for those who did not have a positive response on the ASQ (P = .003).

“We wanted to see if there was a direct association in our sample between anxiety and suicidal thoughts, and we found [that] yes there was,” Dr. Falcone said. There was also an association with depression. More than 26% of participants who scored 16 or higher on the CES-DC indicated at least one positive response on the ASQ. This is significantly higher than those who scored 15 or below on the CES-DC (P < .0001).
 

Bidirectional relationship

The findings suggest that either depression or anxiety may contribute to suicidal thoughts or behaviors, Dr. Dagar said. “It’s like two hands. It could be anxiety leading to suicidality, or it could be depression, or it could be both.”

Dr. Falcone noted that children with epilepsy who aren’t sure when they’ll get their next seizure, or who are bullied at school for being different, may be especially prone to anxiety or depression.

There’s a bit of a “chicken-and-egg” relationship between depression and epilepsy, a disorder affecting electrical signals in the brain, she said. Previous research has shown that a “bidirectional relationship” is involved.

“Even in patients with depression who are not diagnosed with epilepsy, the incidence of epilepsy is 3% higher just because you have depression,” Dr. Falcone said.

Suicidal youth tend to attempt suicide more than once. Dr. Falcone and colleagues are trying to intervene “at different levels,” be that in the hospital or as an outpatient, to prevent this from happening. “We want to find out what different things we can do to engage them and improve the probability they don’t reattempt,” she said.

All children and youth with epilepsy should be screened for anxiety, depression, and suicidal thoughts and behaviors. From age 10 years, children with epilepsy should be screened at least once a year, but those with a psychiatric disorder should be screened more often, Dr. Falcone added. The investigators note their findings need to be confirmed in larger, more diverse studies.
 

Importance of screening

Michael Privitera, MD, director of the Epilepsy Center and professor of neurology at the University of Cincinnati Gardner Neuroscience Institute, said the findings reinforce that, as with adults, depression and anxiety are common in children with epilepsy.

“Neurologists should take advantage of the many psychiatric screening tools available to identify these problems in their pediatric and adult patients,” Dr. Privitera said. Even more importantly, screening may help identify those who may be at highest risk of suicide.

The study was funded by the Health Resources Services Administration. The investigators and Dr. Privitera have disclosed no relevant financial relationships.

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

Children with epilepsy with no previous psychiatric diagnosis have alarmingly high rates of suicidal thoughts and behaviors, new research suggests. In a study of more than 100 youth with the disorder, more than 40% had depression, 30% had anxiety, and about 1 in 10 exhibited signs of suicidal thoughts and behaviors.

These rates “are really worrisome” and highlight the need to screen all children and young adults with epilepsy for psychiatric disorders, said study author Tatiana Falcone, MD, assistant professor of neurology and child and adolescent psychiatry at the Cleveland Clinic.

“It’s very important to screen for suicidality and for depression and anxiety, even when patients aren’t reporting symptoms,” said Dr. Falcone.

Previous research shows children with epilepsy will attend the emergency room with symptoms such as headache or stomachache “when the main reason for the visit was the kid was suicidal,” Dr. Falcone said. “Unless you ask the specific question: ‘Are you having thoughts about hurting yourself?’ this will go unreported,” she added.

The findings were presented at the American Epilepsy Society’s 74th Annual Meeting, which was held online this year because of the COVID-19 pandemic.
 

Red flag

Not much is known about suicidality in children and youth with epilepsy except that depression and anxiety – the most common psychiatric comorbidities in this population – appear to contribute to suicidal thoughts.

Dr. Falcone said that she and her colleagues often see children and adolescents with epilepsy in their clinic who have attempted suicide. In recent years, the clinicians have increased efforts to try to identify them before they carry out a successful suicide attempt, said lead investigator Anjali Dagar, MD, clinical research psychiatry fellow at Cleveland Clinic.

The study included 119 patients aged 10-24 years (mean age, 15.8 years; 54.6% female). All attended an epilepsy clinic or underwent testing in the pediatric epilepsy monitoring unit at the Cleveland Clinic and did not have a psychiatric diagnosis.

Epilepsy severity ranged among study participants. About half were drug resistant and were at the center for surgical evaluation and the others were newly diagnosed.

Participants filled out questionnaires to self-report psychiatric conditions. The validated screening tools included the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Screen for Child Anxiety Related Emotional Disorders (SCARED), and the Ask Suicide–Screening Questions (ASQ).

A score of 15 or higher on the CES-DC indicates a risk for depression. On the SCARED test, a score higher than 32 indicates anxiety. Recent research has shown that anxiety is a main risk factor “in moving people from contemplating suicide to actually carrying it out,” Dr. Falcone said.

The ASQ includes four questions about suicidal thoughts and whether respondents have tried to hurt themselves. Dr. Dagar noted that a positive response to any of these questions should raise a red flag.
 

Very high rates

Results showed that almost one-third (30.2%) of the participants scored positive for anxiety on SCARED and 41.2% scored positive for depression on the CSE-DC. These are “very high” rates, Dr. Falcone said. For comparison, the rate of reported anxiety is less than 10% in school surveys.

In addition, the Centers for Disease Control and Prevention reports about 3% of 2- to 17-year-olds in the general population have depression. Even compared with other chronic illnesses (including diabetes, heart disease, and cancer), children with epilepsy have a higher rate of depression, said Dr. Falcone.

More than 1 in 10 (10.9%) participants in the study exhibited signs of suicidality, as shown by having at least one positive response on the ASQ. “That’s a lot,” and much higher than the estimated rate in the general teen population, Dr. Falcone noted.

She noted that “these are just general kids with epilepsy” who had not been previously diagnosed with a psychiatric disorder.

“Depression, anxiety, and suicidality are very frequent comorbidities in patients with epilepsy; and even if a patient is not reporting any symptoms, we should be asking these questions to help them,” she said.

Study participants who had at least one positive response on the ASQ had a mean score of 32.1 on the SCARED, compared with a mean score of 18.3 for those who did not have a positive response on the ASQ (P = .003).

“We wanted to see if there was a direct association in our sample between anxiety and suicidal thoughts, and we found [that] yes there was,” Dr. Falcone said. There was also an association with depression. More than 26% of participants who scored 16 or higher on the CES-DC indicated at least one positive response on the ASQ. This is significantly higher than those who scored 15 or below on the CES-DC (P < .0001).
 

Bidirectional relationship

The findings suggest that either depression or anxiety may contribute to suicidal thoughts or behaviors, Dr. Dagar said. “It’s like two hands. It could be anxiety leading to suicidality, or it could be depression, or it could be both.”

Dr. Falcone noted that children with epilepsy who aren’t sure when they’ll get their next seizure, or who are bullied at school for being different, may be especially prone to anxiety or depression.

There’s a bit of a “chicken-and-egg” relationship between depression and epilepsy, a disorder affecting electrical signals in the brain, she said. Previous research has shown that a “bidirectional relationship” is involved.

“Even in patients with depression who are not diagnosed with epilepsy, the incidence of epilepsy is 3% higher just because you have depression,” Dr. Falcone said.

Suicidal youth tend to attempt suicide more than once. Dr. Falcone and colleagues are trying to intervene “at different levels,” be that in the hospital or as an outpatient, to prevent this from happening. “We want to find out what different things we can do to engage them and improve the probability they don’t reattempt,” she said.

All children and youth with epilepsy should be screened for anxiety, depression, and suicidal thoughts and behaviors. From age 10 years, children with epilepsy should be screened at least once a year, but those with a psychiatric disorder should be screened more often, Dr. Falcone added. The investigators note their findings need to be confirmed in larger, more diverse studies.
 

Importance of screening

Michael Privitera, MD, director of the Epilepsy Center and professor of neurology at the University of Cincinnati Gardner Neuroscience Institute, said the findings reinforce that, as with adults, depression and anxiety are common in children with epilepsy.

“Neurologists should take advantage of the many psychiatric screening tools available to identify these problems in their pediatric and adult patients,” Dr. Privitera said. Even more importantly, screening may help identify those who may be at highest risk of suicide.

The study was funded by the Health Resources Services Administration. The investigators and Dr. Privitera have disclosed no relevant financial relationships.

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

Children with epilepsy with no previous psychiatric diagnosis have alarmingly high rates of suicidal thoughts and behaviors, new research suggests. In a study of more than 100 youth with the disorder, more than 40% had depression, 30% had anxiety, and about 1 in 10 exhibited signs of suicidal thoughts and behaviors.

These rates “are really worrisome” and highlight the need to screen all children and young adults with epilepsy for psychiatric disorders, said study author Tatiana Falcone, MD, assistant professor of neurology and child and adolescent psychiatry at the Cleveland Clinic.

“It’s very important to screen for suicidality and for depression and anxiety, even when patients aren’t reporting symptoms,” said Dr. Falcone.

Previous research shows children with epilepsy will attend the emergency room with symptoms such as headache or stomachache “when the main reason for the visit was the kid was suicidal,” Dr. Falcone said. “Unless you ask the specific question: ‘Are you having thoughts about hurting yourself?’ this will go unreported,” she added.

The findings were presented at the American Epilepsy Society’s 74th Annual Meeting, which was held online this year because of the COVID-19 pandemic.
 

Red flag

Not much is known about suicidality in children and youth with epilepsy except that depression and anxiety – the most common psychiatric comorbidities in this population – appear to contribute to suicidal thoughts.

Dr. Falcone said that she and her colleagues often see children and adolescents with epilepsy in their clinic who have attempted suicide. In recent years, the clinicians have increased efforts to try to identify them before they carry out a successful suicide attempt, said lead investigator Anjali Dagar, MD, clinical research psychiatry fellow at Cleveland Clinic.

The study included 119 patients aged 10-24 years (mean age, 15.8 years; 54.6% female). All attended an epilepsy clinic or underwent testing in the pediatric epilepsy monitoring unit at the Cleveland Clinic and did not have a psychiatric diagnosis.

Epilepsy severity ranged among study participants. About half were drug resistant and were at the center for surgical evaluation and the others were newly diagnosed.

Participants filled out questionnaires to self-report psychiatric conditions. The validated screening tools included the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Screen for Child Anxiety Related Emotional Disorders (SCARED), and the Ask Suicide–Screening Questions (ASQ).

A score of 15 or higher on the CES-DC indicates a risk for depression. On the SCARED test, a score higher than 32 indicates anxiety. Recent research has shown that anxiety is a main risk factor “in moving people from contemplating suicide to actually carrying it out,” Dr. Falcone said.

The ASQ includes four questions about suicidal thoughts and whether respondents have tried to hurt themselves. Dr. Dagar noted that a positive response to any of these questions should raise a red flag.
 

Very high rates

Results showed that almost one-third (30.2%) of the participants scored positive for anxiety on SCARED and 41.2% scored positive for depression on the CSE-DC. These are “very high” rates, Dr. Falcone said. For comparison, the rate of reported anxiety is less than 10% in school surveys.

In addition, the Centers for Disease Control and Prevention reports about 3% of 2- to 17-year-olds in the general population have depression. Even compared with other chronic illnesses (including diabetes, heart disease, and cancer), children with epilepsy have a higher rate of depression, said Dr. Falcone.

More than 1 in 10 (10.9%) participants in the study exhibited signs of suicidality, as shown by having at least one positive response on the ASQ. “That’s a lot,” and much higher than the estimated rate in the general teen population, Dr. Falcone noted.

She noted that “these are just general kids with epilepsy” who had not been previously diagnosed with a psychiatric disorder.

“Depression, anxiety, and suicidality are very frequent comorbidities in patients with epilepsy; and even if a patient is not reporting any symptoms, we should be asking these questions to help them,” she said.

Study participants who had at least one positive response on the ASQ had a mean score of 32.1 on the SCARED, compared with a mean score of 18.3 for those who did not have a positive response on the ASQ (P = .003).

“We wanted to see if there was a direct association in our sample between anxiety and suicidal thoughts, and we found [that] yes there was,” Dr. Falcone said. There was also an association with depression. More than 26% of participants who scored 16 or higher on the CES-DC indicated at least one positive response on the ASQ. This is significantly higher than those who scored 15 or below on the CES-DC (P < .0001).
 

Bidirectional relationship

The findings suggest that either depression or anxiety may contribute to suicidal thoughts or behaviors, Dr. Dagar said. “It’s like two hands. It could be anxiety leading to suicidality, or it could be depression, or it could be both.”

Dr. Falcone noted that children with epilepsy who aren’t sure when they’ll get their next seizure, or who are bullied at school for being different, may be especially prone to anxiety or depression.

There’s a bit of a “chicken-and-egg” relationship between depression and epilepsy, a disorder affecting electrical signals in the brain, she said. Previous research has shown that a “bidirectional relationship” is involved.

“Even in patients with depression who are not diagnosed with epilepsy, the incidence of epilepsy is 3% higher just because you have depression,” Dr. Falcone said.

Suicidal youth tend to attempt suicide more than once. Dr. Falcone and colleagues are trying to intervene “at different levels,” be that in the hospital or as an outpatient, to prevent this from happening. “We want to find out what different things we can do to engage them and improve the probability they don’t reattempt,” she said.

All children and youth with epilepsy should be screened for anxiety, depression, and suicidal thoughts and behaviors. From age 10 years, children with epilepsy should be screened at least once a year, but those with a psychiatric disorder should be screened more often, Dr. Falcone added. The investigators note their findings need to be confirmed in larger, more diverse studies.
 

Importance of screening

Michael Privitera, MD, director of the Epilepsy Center and professor of neurology at the University of Cincinnati Gardner Neuroscience Institute, said the findings reinforce that, as with adults, depression and anxiety are common in children with epilepsy.

“Neurologists should take advantage of the many psychiatric screening tools available to identify these problems in their pediatric and adult patients,” Dr. Privitera said. Even more importantly, screening may help identify those who may be at highest risk of suicide.

The study was funded by the Health Resources Services Administration. The investigators and Dr. Privitera have disclosed no relevant financial relationships.

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

Scientists at Washington University in St. Louis have developed the most sensitive blood test yet for Alzheimer’s. In studies, the test identified patients with amyloid deposits, using mass spectrometry, before brain scans did.

Of course, amyloid is a normal brain protein; most people with amyloid deposits will not develop dementia, but it’s a significant risk factor. When blood amyloid levels are low, it may indicate it is clumping in the brain.

Researchers used mass spectrometry to test volunteers’ stored blood for beta amyloid, then checked if the levels predicted the results of PET scans. Mass spectrometry identified asymptomatic people accumulating beta amyloid in their brains when PET scans were still negative. The scans only showed beta amyloid in the brain years later. The blood test predicted the presence of plaque even in mostly asymptomatic people with 94% accuracy.

The test will not be available for clinical use for years, but prior to that it will be helpful to scientists conducting trials of drugs to prevent Alzheimer’s, seeking participants in the earliest stages of the disease.
 

Reference

1. Kolata G. A Blood Test for Alzheimer’s? It’s Coming, Scientists Report. New York Times. Aug. 1, 2019. https://www.nytimes.com/2019/08/01/health/alzheimers-blood-test.html.

Scientists at Washington University in St. Louis have developed the most sensitive blood test yet for Alzheimer’s. In studies, the test identified patients with amyloid deposits, using mass spectrometry, before brain scans did.

Of course, amyloid is a normal brain protein; most people with amyloid deposits will not develop dementia, but it’s a significant risk factor. When blood amyloid levels are low, it may indicate it is clumping in the brain.

Researchers used mass spectrometry to test volunteers’ stored blood for beta amyloid, then checked if the levels predicted the results of PET scans. Mass spectrometry identified asymptomatic people accumulating beta amyloid in their brains when PET scans were still negative. The scans only showed beta amyloid in the brain years later. The blood test predicted the presence of plaque even in mostly asymptomatic people with 94% accuracy.

The test will not be available for clinical use for years, but prior to that it will be helpful to scientists conducting trials of drugs to prevent Alzheimer’s, seeking participants in the earliest stages of the disease.
 

Reference

1. Kolata G. A Blood Test for Alzheimer’s? It’s Coming, Scientists Report. New York Times. Aug. 1, 2019. https://www.nytimes.com/2019/08/01/health/alzheimers-blood-test.html.

Scientists at Washington University in St. Louis have developed the most sensitive blood test yet for Alzheimer’s. In studies, the test identified patients with amyloid deposits, using mass spectrometry, before brain scans did.

Of course, amyloid is a normal brain protein; most people with amyloid deposits will not develop dementia, but it’s a significant risk factor. When blood amyloid levels are low, it may indicate it is clumping in the brain.

Researchers used mass spectrometry to test volunteers’ stored blood for beta amyloid, then checked if the levels predicted the results of PET scans. Mass spectrometry identified asymptomatic people accumulating beta amyloid in their brains when PET scans were still negative. The scans only showed beta amyloid in the brain years later. The blood test predicted the presence of plaque even in mostly asymptomatic people with 94% accuracy.

The test will not be available for clinical use for years, but prior to that it will be helpful to scientists conducting trials of drugs to prevent Alzheimer’s, seeking participants in the earliest stages of the disease.
 

Reference

1. Kolata G. A Blood Test for Alzheimer’s? It’s Coming, Scientists Report. New York Times. Aug. 1, 2019. https://www.nytimes.com/2019/08/01/health/alzheimers-blood-test.html.

New clinical practice guidelines on Lyme disease place a strong emphasis on antibody testing to assess for rheumatologic and neurologic syndromes. “Diagnostically, we recommend testing via antibodies, and an index of antibodies in cerebrospinal fluid [CSF] versus serum. Importantly, we recommend against using polymerase chain reaction [PCR] in CSF,” Jeffrey A. Rumbaugh, MD, PhD, a coauthor of the guidelines and a member of the American Academy of Neurology, said in an interview.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

The Infectious Diseases Society of America, AAN, and the American College of Rheumatology convened a multidisciplinary panel to develop the 43 recommendations, seeking input from 12 additional medical specialties, and patients. The panel conducted a systematic review of available evidence on preventing, diagnosing, and treating Lyme disease, using the Grading of Recommendations Assessment, Development and Evaluation model to evaluate clinical evidence and strength of recommendations. The guidelines were simultaneous published in Clinical Infectious Diseases, Neurology, Arthritis & Rheumatology, and Arthritis Care & Research.

This is the first time these organizations have collaborated on joint Lyme disease guidelines, which focus mainly on neurologic, cardiac, and rheumatologic manifestations.

“We are very excited to provide these updated guidelines to assist clinicians working in numerous medical specialties around the country, and even the world, as they care for patients suffering from Lyme disease,” Dr. Rumbaugh said.
 

When to use and not to use PCR

Guideline authors called for specific testing regimens depending on presentation of symptoms. Generally, they advised that individuals with a skin rash suggestive of early disease seek a clinical diagnosis instead of laboratory testing.

Recommendations on Lyme arthritis support previous IDSA guidelines published in 2006, Linda K. Bockenstedt, MD, professor of medicine at Yale University, New Haven, Conn., and a coauthor of the guidelines, said in an interview.

To evaluate for potential Lyme arthritis, clinicians should choose serum antibody testing over PCR or culture of blood or synovial fluid/tissue. However, if a doctor is assessing a seropositive patient for Lyme arthritis diagnosis but needs more information for treatment decisions, the authors recommended PCR applied to synovial fluid or tissue over Borrelia culture.

“Synovial fluid can be analyzed by PCR, but sensitivity is generally lower than serology,” Dr. Bockenstedt explained. Additionally, culture of joint fluid or synovial tissue for Lyme spirochetes has 0% sensitivity in multiple studies. “For these reasons, we recommend serum antibody testing over PCR of joint fluid or other methods for an initial diagnosis.”

Serum antibody testing over PCR or culture is also recommended for identifying Lyme neuroborreliosis in the peripheral nervous system (PNS) or CNS.

Despite the recent popularity of Lyme PCR testing in hospitals and labs, “with Lyme at least, antibodies are better in the CSF,” Dr. Rumbaugh said. Studies have shown that “most patients with even early neurologic Lyme disease are seropositive by conventional antibody testing at time of initial clinical presentation, and that intrathecal antibody production, as demonstrated by an elevated CSF:serum index, is highly specific for CNS involvement.”

If done correctly, antibody testing is both sensitive and specific for neurologic Lyme disease. “On the other hand, sensitivity of Lyme PCR performed on CSF has been only in the 5%-17% range in studies. Incidentally, Lyme PCR on blood is also not sensitive and therefore not recommended,” Dr. Rumbaugh said.

Guideline authors recommended testing in patients with the following conditions: acute neurologic disorders such as meningitis, painful radiculoneuritis, mononeuropathy multiplex; evidence of spinal cord or brain inflammation; and acute myocarditis/pericarditis of unknown cause in an appropriate epidemiologic setting.

They did not recommend testing in patients with typical amyotrophic lateral sclerosis; relapsing remitting multiple sclerosis; Parkinson’s disease, dementia, or cognitive decline; new-onset seizures; other neurologic syndromes or those lacking clinical or epidemiologic history that would support a diagnosis of Lyme disease; and patients with chronic cardiomyopathy of unknown cause.

The authors also called for judicious use of electrocardiogram to screen for Lyme carditis, recommending it only in patients signs or symptoms of this condition. However, patients at risk for or showing signs of severe cardiac complications of Lyme disease should be hospitalized and monitored via ECG.

Timelines for antibiotics

Most patients with Lyme disease should receive oral antibiotics, although duration times vary depending on the disease state. “We recommend that prophylactic antibiotic therapy be given to adults and children only within 72 hours of removal of an identified high-risk tick bite, but not for bites that are equivocal risk or low risk,” according to the guideline authors.

Specific antibiotic treatment regimens by condition are as follows: 10-14 days for early-stage disease, 14 days for Lyme carditis, 14-21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis.

“Despite arthritis occurring late in the course of infection, treatment with a 28-day course of oral antibiotic is effective, although the rates of complete resolution of joint swelling can vary,” Dr. Bockenstedt said. Clinicians may consider a second 28-day course of oral antibiotics or a 2- to 4-week course of ceftriaxone in patients with persistent swelling, after an initial course of oral antibiotics.

Citing knowledge gaps, the authors made no recommendation on secondary antibiotic treatment for unresolved Lyme arthritis. Rheumatologists can play an important role in the care of this small subset of patients, Dr. Bockenstedt noted. “Studies of patients with ‘postantibiotic Lyme arthritis’ show that they can be treated successfully with intra-articular steroids, nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, biologic response modifiers, and even synovectomy with successful outcomes.” Some of these therapies also work in cases where first courses of oral and intravenous antibiotics are unsuccessful.

“Antibiotic therapy for longer than 8 weeks is not expected to provide additional benefit to patients with persistent arthritis if that treatment has included one course of IV therapy,” the authors clarified.

For patients with Lyme disease–associated meningitis, cranial neuropathy, radiculoneuropathy, or other PNS manifestations, the authors recommended intravenous ceftriaxone, cefotaxime, penicillin G, or oral doxycycline over other antimicrobials.

“For most neurologic presentations, oral doxycycline is just as effective as appropriate IV antibiotics,” Dr. Rumbaugh said. “The exception is the relatively rare situation where the patient is felt to have parenchymal involvement of brain or spinal cord, in which case the guidelines recommend IV antibiotics over oral antibiotics.” In the studies, there was no statistically significant difference between oral or intravenous regimens in response rate or risk of adverse effects.

Patients with nonspecific symptoms such as fatigue, pain, or cognitive impairment following treatment should not receive additional antibiotic therapy if there’s no evidence of treatment failure or infection. These two markers “would include objective signs of disease activity, such as arthritis, meningitis, or neuropathy,” the guideline authors wrote in comments accompanying the recommendation.

Clinicians caring for patients with symptomatic bradycardia caused by Lyme carditis should consider temporary pacing measures instead of a permanent pacemaker. For patients hospitalized with Lyme carditis, “we suggest initially using IV ceftriaxone over oral antibiotics until there is evidence of clinical improvement, then switching to oral antibiotics to complete treatment,” they advised. Outpatients with this condition should receive oral antibiotics instead of intravenous antibiotics.

Advice on antibodies testing ‘particularly cogent’

For individuals without expertise in these areas, the recommendations are clear and useful, Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy), said in an interview.

“As a rheumatologist, I would have appreciated literature references for some of the recommendations but, nevertheless, find these useful. I applaud the care with which the evidence was gathered and the general formatting, which tried to review multiple possible scenarios surrounding Lyme arthritis,” said Dr. Furst, offering a third-party perspective.

The advice on using antibodies tests to make a diagnosis of Lyme arthritis “is particularly cogent and more useful than trying to culture these fastidious organisms,” he added.

The IDSA, AAN, and ACR provided support for the guideline. Dr. Bockenstedt reported receiving research funding from the National Institutes of Health and the Gordon and the Llura Gund Foundation and remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research. Dr. Rumbaugh had no conflicts of interest to disclose. Dr. Furst reported no conflicts of interest in commenting on these guidelines.

SOURCE: Rumbaugh JA et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1215.

New clinical practice guidelines on Lyme disease place a strong emphasis on antibody testing to assess for rheumatologic and neurologic syndromes. “Diagnostically, we recommend testing via antibodies, and an index of antibodies in cerebrospinal fluid [CSF] versus serum. Importantly, we recommend against using polymerase chain reaction [PCR] in CSF,” Jeffrey A. Rumbaugh, MD, PhD, a coauthor of the guidelines and a member of the American Academy of Neurology, said in an interview.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

The Infectious Diseases Society of America, AAN, and the American College of Rheumatology convened a multidisciplinary panel to develop the 43 recommendations, seeking input from 12 additional medical specialties, and patients. The panel conducted a systematic review of available evidence on preventing, diagnosing, and treating Lyme disease, using the Grading of Recommendations Assessment, Development and Evaluation model to evaluate clinical evidence and strength of recommendations. The guidelines were simultaneous published in Clinical Infectious Diseases, Neurology, Arthritis & Rheumatology, and Arthritis Care & Research.

This is the first time these organizations have collaborated on joint Lyme disease guidelines, which focus mainly on neurologic, cardiac, and rheumatologic manifestations.

“We are very excited to provide these updated guidelines to assist clinicians working in numerous medical specialties around the country, and even the world, as they care for patients suffering from Lyme disease,” Dr. Rumbaugh said.
 

When to use and not to use PCR

Guideline authors called for specific testing regimens depending on presentation of symptoms. Generally, they advised that individuals with a skin rash suggestive of early disease seek a clinical diagnosis instead of laboratory testing.

Recommendations on Lyme arthritis support previous IDSA guidelines published in 2006, Linda K. Bockenstedt, MD, professor of medicine at Yale University, New Haven, Conn., and a coauthor of the guidelines, said in an interview.

To evaluate for potential Lyme arthritis, clinicians should choose serum antibody testing over PCR or culture of blood or synovial fluid/tissue. However, if a doctor is assessing a seropositive patient for Lyme arthritis diagnosis but needs more information for treatment decisions, the authors recommended PCR applied to synovial fluid or tissue over Borrelia culture.

“Synovial fluid can be analyzed by PCR, but sensitivity is generally lower than serology,” Dr. Bockenstedt explained. Additionally, culture of joint fluid or synovial tissue for Lyme spirochetes has 0% sensitivity in multiple studies. “For these reasons, we recommend serum antibody testing over PCR of joint fluid or other methods for an initial diagnosis.”

Serum antibody testing over PCR or culture is also recommended for identifying Lyme neuroborreliosis in the peripheral nervous system (PNS) or CNS.

Despite the recent popularity of Lyme PCR testing in hospitals and labs, “with Lyme at least, antibodies are better in the CSF,” Dr. Rumbaugh said. Studies have shown that “most patients with even early neurologic Lyme disease are seropositive by conventional antibody testing at time of initial clinical presentation, and that intrathecal antibody production, as demonstrated by an elevated CSF:serum index, is highly specific for CNS involvement.”

If done correctly, antibody testing is both sensitive and specific for neurologic Lyme disease. “On the other hand, sensitivity of Lyme PCR performed on CSF has been only in the 5%-17% range in studies. Incidentally, Lyme PCR on blood is also not sensitive and therefore not recommended,” Dr. Rumbaugh said.

Guideline authors recommended testing in patients with the following conditions: acute neurologic disorders such as meningitis, painful radiculoneuritis, mononeuropathy multiplex; evidence of spinal cord or brain inflammation; and acute myocarditis/pericarditis of unknown cause in an appropriate epidemiologic setting.

They did not recommend testing in patients with typical amyotrophic lateral sclerosis; relapsing remitting multiple sclerosis; Parkinson’s disease, dementia, or cognitive decline; new-onset seizures; other neurologic syndromes or those lacking clinical or epidemiologic history that would support a diagnosis of Lyme disease; and patients with chronic cardiomyopathy of unknown cause.

The authors also called for judicious use of electrocardiogram to screen for Lyme carditis, recommending it only in patients signs or symptoms of this condition. However, patients at risk for or showing signs of severe cardiac complications of Lyme disease should be hospitalized and monitored via ECG.

Timelines for antibiotics

Most patients with Lyme disease should receive oral antibiotics, although duration times vary depending on the disease state. “We recommend that prophylactic antibiotic therapy be given to adults and children only within 72 hours of removal of an identified high-risk tick bite, but not for bites that are equivocal risk or low risk,” according to the guideline authors.

Specific antibiotic treatment regimens by condition are as follows: 10-14 days for early-stage disease, 14 days for Lyme carditis, 14-21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis.

“Despite arthritis occurring late in the course of infection, treatment with a 28-day course of oral antibiotic is effective, although the rates of complete resolution of joint swelling can vary,” Dr. Bockenstedt said. Clinicians may consider a second 28-day course of oral antibiotics or a 2- to 4-week course of ceftriaxone in patients with persistent swelling, after an initial course of oral antibiotics.

Citing knowledge gaps, the authors made no recommendation on secondary antibiotic treatment for unresolved Lyme arthritis. Rheumatologists can play an important role in the care of this small subset of patients, Dr. Bockenstedt noted. “Studies of patients with ‘postantibiotic Lyme arthritis’ show that they can be treated successfully with intra-articular steroids, nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, biologic response modifiers, and even synovectomy with successful outcomes.” Some of these therapies also work in cases where first courses of oral and intravenous antibiotics are unsuccessful.

“Antibiotic therapy for longer than 8 weeks is not expected to provide additional benefit to patients with persistent arthritis if that treatment has included one course of IV therapy,” the authors clarified.

For patients with Lyme disease–associated meningitis, cranial neuropathy, radiculoneuropathy, or other PNS manifestations, the authors recommended intravenous ceftriaxone, cefotaxime, penicillin G, or oral doxycycline over other antimicrobials.

“For most neurologic presentations, oral doxycycline is just as effective as appropriate IV antibiotics,” Dr. Rumbaugh said. “The exception is the relatively rare situation where the patient is felt to have parenchymal involvement of brain or spinal cord, in which case the guidelines recommend IV antibiotics over oral antibiotics.” In the studies, there was no statistically significant difference between oral or intravenous regimens in response rate or risk of adverse effects.

Patients with nonspecific symptoms such as fatigue, pain, or cognitive impairment following treatment should not receive additional antibiotic therapy if there’s no evidence of treatment failure or infection. These two markers “would include objective signs of disease activity, such as arthritis, meningitis, or neuropathy,” the guideline authors wrote in comments accompanying the recommendation.

Clinicians caring for patients with symptomatic bradycardia caused by Lyme carditis should consider temporary pacing measures instead of a permanent pacemaker. For patients hospitalized with Lyme carditis, “we suggest initially using IV ceftriaxone over oral antibiotics until there is evidence of clinical improvement, then switching to oral antibiotics to complete treatment,” they advised. Outpatients with this condition should receive oral antibiotics instead of intravenous antibiotics.

Advice on antibodies testing ‘particularly cogent’

For individuals without expertise in these areas, the recommendations are clear and useful, Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy), said in an interview.

“As a rheumatologist, I would have appreciated literature references for some of the recommendations but, nevertheless, find these useful. I applaud the care with which the evidence was gathered and the general formatting, which tried to review multiple possible scenarios surrounding Lyme arthritis,” said Dr. Furst, offering a third-party perspective.

The advice on using antibodies tests to make a diagnosis of Lyme arthritis “is particularly cogent and more useful than trying to culture these fastidious organisms,” he added.

The IDSA, AAN, and ACR provided support for the guideline. Dr. Bockenstedt reported receiving research funding from the National Institutes of Health and the Gordon and the Llura Gund Foundation and remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research. Dr. Rumbaugh had no conflicts of interest to disclose. Dr. Furst reported no conflicts of interest in commenting on these guidelines.

SOURCE: Rumbaugh JA et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1215.

New clinical practice guidelines on Lyme disease place a strong emphasis on antibody testing to assess for rheumatologic and neurologic syndromes. “Diagnostically, we recommend testing via antibodies, and an index of antibodies in cerebrospinal fluid [CSF] versus serum. Importantly, we recommend against using polymerase chain reaction [PCR] in CSF,” Jeffrey A. Rumbaugh, MD, PhD, a coauthor of the guidelines and a member of the American Academy of Neurology, said in an interview.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

The Infectious Diseases Society of America, AAN, and the American College of Rheumatology convened a multidisciplinary panel to develop the 43 recommendations, seeking input from 12 additional medical specialties, and patients. The panel conducted a systematic review of available evidence on preventing, diagnosing, and treating Lyme disease, using the Grading of Recommendations Assessment, Development and Evaluation model to evaluate clinical evidence and strength of recommendations. The guidelines were simultaneous published in Clinical Infectious Diseases, Neurology, Arthritis & Rheumatology, and Arthritis Care & Research.

This is the first time these organizations have collaborated on joint Lyme disease guidelines, which focus mainly on neurologic, cardiac, and rheumatologic manifestations.

“We are very excited to provide these updated guidelines to assist clinicians working in numerous medical specialties around the country, and even the world, as they care for patients suffering from Lyme disease,” Dr. Rumbaugh said.
 

When to use and not to use PCR

Guideline authors called for specific testing regimens depending on presentation of symptoms. Generally, they advised that individuals with a skin rash suggestive of early disease seek a clinical diagnosis instead of laboratory testing.

Recommendations on Lyme arthritis support previous IDSA guidelines published in 2006, Linda K. Bockenstedt, MD, professor of medicine at Yale University, New Haven, Conn., and a coauthor of the guidelines, said in an interview.

To evaluate for potential Lyme arthritis, clinicians should choose serum antibody testing over PCR or culture of blood or synovial fluid/tissue. However, if a doctor is assessing a seropositive patient for Lyme arthritis diagnosis but needs more information for treatment decisions, the authors recommended PCR applied to synovial fluid or tissue over Borrelia culture.

“Synovial fluid can be analyzed by PCR, but sensitivity is generally lower than serology,” Dr. Bockenstedt explained. Additionally, culture of joint fluid or synovial tissue for Lyme spirochetes has 0% sensitivity in multiple studies. “For these reasons, we recommend serum antibody testing over PCR of joint fluid or other methods for an initial diagnosis.”

Serum antibody testing over PCR or culture is also recommended for identifying Lyme neuroborreliosis in the peripheral nervous system (PNS) or CNS.

Despite the recent popularity of Lyme PCR testing in hospitals and labs, “with Lyme at least, antibodies are better in the CSF,” Dr. Rumbaugh said. Studies have shown that “most patients with even early neurologic Lyme disease are seropositive by conventional antibody testing at time of initial clinical presentation, and that intrathecal antibody production, as demonstrated by an elevated CSF:serum index, is highly specific for CNS involvement.”

If done correctly, antibody testing is both sensitive and specific for neurologic Lyme disease. “On the other hand, sensitivity of Lyme PCR performed on CSF has been only in the 5%-17% range in studies. Incidentally, Lyme PCR on blood is also not sensitive and therefore not recommended,” Dr. Rumbaugh said.

Guideline authors recommended testing in patients with the following conditions: acute neurologic disorders such as meningitis, painful radiculoneuritis, mononeuropathy multiplex; evidence of spinal cord or brain inflammation; and acute myocarditis/pericarditis of unknown cause in an appropriate epidemiologic setting.

They did not recommend testing in patients with typical amyotrophic lateral sclerosis; relapsing remitting multiple sclerosis; Parkinson’s disease, dementia, or cognitive decline; new-onset seizures; other neurologic syndromes or those lacking clinical or epidemiologic history that would support a diagnosis of Lyme disease; and patients with chronic cardiomyopathy of unknown cause.

The authors also called for judicious use of electrocardiogram to screen for Lyme carditis, recommending it only in patients signs or symptoms of this condition. However, patients at risk for or showing signs of severe cardiac complications of Lyme disease should be hospitalized and monitored via ECG.

Timelines for antibiotics

Most patients with Lyme disease should receive oral antibiotics, although duration times vary depending on the disease state. “We recommend that prophylactic antibiotic therapy be given to adults and children only within 72 hours of removal of an identified high-risk tick bite, but not for bites that are equivocal risk or low risk,” according to the guideline authors.

Specific antibiotic treatment regimens by condition are as follows: 10-14 days for early-stage disease, 14 days for Lyme carditis, 14-21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis.

“Despite arthritis occurring late in the course of infection, treatment with a 28-day course of oral antibiotic is effective, although the rates of complete resolution of joint swelling can vary,” Dr. Bockenstedt said. Clinicians may consider a second 28-day course of oral antibiotics or a 2- to 4-week course of ceftriaxone in patients with persistent swelling, after an initial course of oral antibiotics.

Citing knowledge gaps, the authors made no recommendation on secondary antibiotic treatment for unresolved Lyme arthritis. Rheumatologists can play an important role in the care of this small subset of patients, Dr. Bockenstedt noted. “Studies of patients with ‘postantibiotic Lyme arthritis’ show that they can be treated successfully with intra-articular steroids, nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, biologic response modifiers, and even synovectomy with successful outcomes.” Some of these therapies also work in cases where first courses of oral and intravenous antibiotics are unsuccessful.

“Antibiotic therapy for longer than 8 weeks is not expected to provide additional benefit to patients with persistent arthritis if that treatment has included one course of IV therapy,” the authors clarified.

For patients with Lyme disease–associated meningitis, cranial neuropathy, radiculoneuropathy, or other PNS manifestations, the authors recommended intravenous ceftriaxone, cefotaxime, penicillin G, or oral doxycycline over other antimicrobials.

“For most neurologic presentations, oral doxycycline is just as effective as appropriate IV antibiotics,” Dr. Rumbaugh said. “The exception is the relatively rare situation where the patient is felt to have parenchymal involvement of brain or spinal cord, in which case the guidelines recommend IV antibiotics over oral antibiotics.” In the studies, there was no statistically significant difference between oral or intravenous regimens in response rate or risk of adverse effects.

Patients with nonspecific symptoms such as fatigue, pain, or cognitive impairment following treatment should not receive additional antibiotic therapy if there’s no evidence of treatment failure or infection. These two markers “would include objective signs of disease activity, such as arthritis, meningitis, or neuropathy,” the guideline authors wrote in comments accompanying the recommendation.

Clinicians caring for patients with symptomatic bradycardia caused by Lyme carditis should consider temporary pacing measures instead of a permanent pacemaker. For patients hospitalized with Lyme carditis, “we suggest initially using IV ceftriaxone over oral antibiotics until there is evidence of clinical improvement, then switching to oral antibiotics to complete treatment,” they advised. Outpatients with this condition should receive oral antibiotics instead of intravenous antibiotics.

Advice on antibodies testing ‘particularly cogent’

For individuals without expertise in these areas, the recommendations are clear and useful, Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy), said in an interview.

“As a rheumatologist, I would have appreciated literature references for some of the recommendations but, nevertheless, find these useful. I applaud the care with which the evidence was gathered and the general formatting, which tried to review multiple possible scenarios surrounding Lyme arthritis,” said Dr. Furst, offering a third-party perspective.

The advice on using antibodies tests to make a diagnosis of Lyme arthritis “is particularly cogent and more useful than trying to culture these fastidious organisms,” he added.

The IDSA, AAN, and ACR provided support for the guideline. Dr. Bockenstedt reported receiving research funding from the National Institutes of Health and the Gordon and the Llura Gund Foundation and remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research. Dr. Rumbaugh had no conflicts of interest to disclose. Dr. Furst reported no conflicts of interest in commenting on these guidelines.

SOURCE: Rumbaugh JA et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1215.

Adjunctive oral prednisone appears to significantly reduce cluster headache attacks, new research shows. Results of the multicenter, randomized, double-blind trial show that patients who received the steroid had 25% fewer attacks in the first week of therapy, compared with their counterparts who received placebo.

In addition, more than a third of patients in the prednisone group were pain free, and for almost half, headache frequency was reduced by at least 50% at day 7 of treatment.

These findings provide clear evidence that prednisone, in conjunction with the use of verapamil, is effective in cluster headache, said lead author Mark Obermann, MD, director, Center for Neurology, Asklepios Hospitals Seesen (Germany), and associate professor, University of Duisburg-Essen (Germany).

The key message, he added, is that all patients with cluster headache should receive prednisone at the start of an episode.

The study was published online Nov. 24 in the Lancet Neurology.
 

‘Suicide headaches’

Cluster headaches are intense unilateral attacks of facial and head pain. They last 15-180 minutes and predominantly affect men. They are accompanied by trigeminal autonomic symptoms and are extremely painful. “They’re referred to as ‘suicide headaches’ because the pain is so severe that patients often report they think about killing themselves to get rid of the pain,” said Dr. Obermann.

The cause is unclear, although there is some evidence that the hypothalamus is involved. The headaches sometimes follow a “strict circadian pattern,” said Dr. Obermann. He noted that the attacks might occur over a few weeks or months and then not return for months or even years.

An estimated 1 in 1,000 people experience cluster headache, but the condition is underrecognized, and research is scarce and poorly funded. Previous research does show that the calcium channel blocker verapamil, which is used to treat high blood pressure, is effective in cluster headache. However, it takes about 14 days to work and has to be slowly titrated because of cardiac side effects, said Dr. Obermann. For these reasons, international guidelines recommend initiating short-term preventive treatment with corticosteroids to suppress, or at least lessen, cluster headache attacks until long-term prevention is effective.

Although some clinicians treat cluster headaches with corticosteroids, others don’t because of a lack of evidence that shows they are effective. “There’s no evidence whatsoever on what the correct dose is or whether it helps at all. This is the gap we wanted to close,” said Dr. Obermann.

The study included 116 adult patients with cluster headache from 10 centers who were experiencing a cluster headache episode and were not taking prophylactic medication.

The trial only included patients who had an attack within 30 days of their current episode. The investigators included this restriction to reduce the possibility of spontaneous remission, which is “a big problem” in cluster headache trials, he said. To confirm that episodes were cluster headache attacks, patients were also required to have moderate to severe pain, indicated by a score of at least 5 on a numerical rating scale in which 0 indicates no pain and 10 indicates the worse imaginable pain.

Participants were allowed to use treatments for acute attack, but these therapies were limited to triptans, high-flow oxygen, intranasal lidocaine, ergotamine, and oral analgesics.
 

Debilitating pain

Patients were randomly assigned to receive oral prednisone (n = 53) or placebo (n = 56). The study groups were matched with respect to demographic and clinical characteristics. Prednisone was initiated at 100 mg/d for 5 days and was then tapered by 20 mg every 3 days in the active-treatment group. All patients also received oral verapamil at a starting dose of 40 mg three times per day. The dose was increased every 3 days by 40 mg to a maximum of 360 mg/d.

All participants received pantoprazole 20 mg to prevent the gastric side effects of prednisone. An attack was defined as a unilateral headache of moderate to severe intensity. The study lasted 28 days.

The study’s primary outcome was the mean number of cluster headache attacks during the first week of treatment with prednisone versus placebo.

The mean number of attacks during the first week of treatment was 7.1 in the prednisone group and 9.5 in the placebo group, for a difference of –2.4 attacks (95% confidence interval, –4.8 to –0.03; P = .002). “This might not sound like much,” but reducing the number of daily attacks from, say, eight to six “really makes a difference because the attacks are so painful,” said Dr. Obermann.

The prednisone group also came out on top for a number secondary outcomes. After the first 7 days, attacks ceased in 35% of the prednisone group versus 7% in the placebo group.
 

‘Clear evidence’ of efficacy

About 49% of patients who took prednisone reported a reduction of at least 50% in attack frequency at day 7. By comparison, 15% of patients who received placebo reported such a reduction. The number of cluster attacks at day 28 was less in the prednisone group than in the patients who received placebo.

With respect to treatment effect, the difference between prednisone and placebo gradually lessened over time “in parallel to the verapamil dose reaching its therapeutic effect,” the investigators noted. “Therefore, attack frequency reduction slowly converged between groups,” they added.

The study results provide “clear evidence” and should reassure clinicians that short-term prednisone early in a cluster headache attack is effective, said Dr. Obermann.

Adverse events, which included headache, palpitations, dizziness, and nausea, were as expected and were similar in the two groups. There were only two severe adverse events, both of which occurred in participants in the placebo group.

Dr. Obermann said the investigators were surprised that so many patients in the study were taking analgesics. “Analgesics don’t work in cluster headache; they just don’t work in this kind of pain.”

He noted that prednisone exposure of study patients spanned only 19 days and amounted to only 1,100 mg, which he believes is safe.

The prednisone dose used in the study is “what most clinicians use in clinical practice,” although there have been reports of success using 500 mg of IV prednisone over 5 days, said Dr. Obermann. He added that it would be “interesting to see if 50 mg would be just as good” as a starting dose.

Potential limitations of the study include the fact that the majority of participants were White, so the findings may not be generalizable to other populations.
 

Long-awaited results

In an accompanying editorial, Anne Ducros, MD, PhD, professor of neurology and director of the Headache Center, Montpellier (France) University Hospital, said the study provides “strong and long-awaited evidence supporting the use of oral steroids as a transitional treatment option.”

The trial “raises many topics for future research,” one of which is the long-term safety of prednisone for patients with cluster headache, said Dr. Ducros. She noted that use of high-dose steroids once or twice a year for 15 years or more “has the potential for severe systemic toxic effects,” such as corticosteroid-induced osteonecrosis of the femoral head.

Other questions about corticosteroid use for patients with cluster headache remain. These include understanding whether these agents provide better efficacy than occipital nerve injections and determining the optimal verapamil regimen, she noted.

In addition, the risk for oral steroid misuse needs to be studied, she said. She noted that drug misuse is common among patients with cluster headache.

Despite these questions, the results of this new study “provide an important step forward for patients with cluster headache, for whom safe and effective transitional therapies are much needed,” Dr. Ducros wrote.


Dr. Obermann has received fees from Sanofi, Biogen, Novartis, Teva Pharmaceuticals, and Eli Lilly and grants from Allergan and Heel Pharmaceuticals outside of this work. Dr. Ducros has received fees from Amgen, Novartis, Teva, and Eli Lilly; grants from the Programme Hospitalier de Recherche Clinique and from the Appel d’Offre Interne of Montpellier University Hospital; and nonfinancial support from SOS Oxygene.

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

Adjunctive oral prednisone appears to significantly reduce cluster headache attacks, new research shows. Results of the multicenter, randomized, double-blind trial show that patients who received the steroid had 25% fewer attacks in the first week of therapy, compared with their counterparts who received placebo.

In addition, more than a third of patients in the prednisone group were pain free, and for almost half, headache frequency was reduced by at least 50% at day 7 of treatment.

These findings provide clear evidence that prednisone, in conjunction with the use of verapamil, is effective in cluster headache, said lead author Mark Obermann, MD, director, Center for Neurology, Asklepios Hospitals Seesen (Germany), and associate professor, University of Duisburg-Essen (Germany).

The key message, he added, is that all patients with cluster headache should receive prednisone at the start of an episode.

The study was published online Nov. 24 in the Lancet Neurology.
 

‘Suicide headaches’

Cluster headaches are intense unilateral attacks of facial and head pain. They last 15-180 minutes and predominantly affect men. They are accompanied by trigeminal autonomic symptoms and are extremely painful. “They’re referred to as ‘suicide headaches’ because the pain is so severe that patients often report they think about killing themselves to get rid of the pain,” said Dr. Obermann.

The cause is unclear, although there is some evidence that the hypothalamus is involved. The headaches sometimes follow a “strict circadian pattern,” said Dr. Obermann. He noted that the attacks might occur over a few weeks or months and then not return for months or even years.

An estimated 1 in 1,000 people experience cluster headache, but the condition is underrecognized, and research is scarce and poorly funded. Previous research does show that the calcium channel blocker verapamil, which is used to treat high blood pressure, is effective in cluster headache. However, it takes about 14 days to work and has to be slowly titrated because of cardiac side effects, said Dr. Obermann. For these reasons, international guidelines recommend initiating short-term preventive treatment with corticosteroids to suppress, or at least lessen, cluster headache attacks until long-term prevention is effective.

Although some clinicians treat cluster headaches with corticosteroids, others don’t because of a lack of evidence that shows they are effective. “There’s no evidence whatsoever on what the correct dose is or whether it helps at all. This is the gap we wanted to close,” said Dr. Obermann.

The study included 116 adult patients with cluster headache from 10 centers who were experiencing a cluster headache episode and were not taking prophylactic medication.

The trial only included patients who had an attack within 30 days of their current episode. The investigators included this restriction to reduce the possibility of spontaneous remission, which is “a big problem” in cluster headache trials, he said. To confirm that episodes were cluster headache attacks, patients were also required to have moderate to severe pain, indicated by a score of at least 5 on a numerical rating scale in which 0 indicates no pain and 10 indicates the worse imaginable pain.

Participants were allowed to use treatments for acute attack, but these therapies were limited to triptans, high-flow oxygen, intranasal lidocaine, ergotamine, and oral analgesics.
 

Debilitating pain

Patients were randomly assigned to receive oral prednisone (n = 53) or placebo (n = 56). The study groups were matched with respect to demographic and clinical characteristics. Prednisone was initiated at 100 mg/d for 5 days and was then tapered by 20 mg every 3 days in the active-treatment group. All patients also received oral verapamil at a starting dose of 40 mg three times per day. The dose was increased every 3 days by 40 mg to a maximum of 360 mg/d.

All participants received pantoprazole 20 mg to prevent the gastric side effects of prednisone. An attack was defined as a unilateral headache of moderate to severe intensity. The study lasted 28 days.

The study’s primary outcome was the mean number of cluster headache attacks during the first week of treatment with prednisone versus placebo.

The mean number of attacks during the first week of treatment was 7.1 in the prednisone group and 9.5 in the placebo group, for a difference of –2.4 attacks (95% confidence interval, –4.8 to –0.03; P = .002). “This might not sound like much,” but reducing the number of daily attacks from, say, eight to six “really makes a difference because the attacks are so painful,” said Dr. Obermann.

The prednisone group also came out on top for a number secondary outcomes. After the first 7 days, attacks ceased in 35% of the prednisone group versus 7% in the placebo group.
 

‘Clear evidence’ of efficacy

About 49% of patients who took prednisone reported a reduction of at least 50% in attack frequency at day 7. By comparison, 15% of patients who received placebo reported such a reduction. The number of cluster attacks at day 28 was less in the prednisone group than in the patients who received placebo.

With respect to treatment effect, the difference between prednisone and placebo gradually lessened over time “in parallel to the verapamil dose reaching its therapeutic effect,” the investigators noted. “Therefore, attack frequency reduction slowly converged between groups,” they added.

The study results provide “clear evidence” and should reassure clinicians that short-term prednisone early in a cluster headache attack is effective, said Dr. Obermann.

Adverse events, which included headache, palpitations, dizziness, and nausea, were as expected and were similar in the two groups. There were only two severe adverse events, both of which occurred in participants in the placebo group.

Dr. Obermann said the investigators were surprised that so many patients in the study were taking analgesics. “Analgesics don’t work in cluster headache; they just don’t work in this kind of pain.”

He noted that prednisone exposure of study patients spanned only 19 days and amounted to only 1,100 mg, which he believes is safe.

The prednisone dose used in the study is “what most clinicians use in clinical practice,” although there have been reports of success using 500 mg of IV prednisone over 5 days, said Dr. Obermann. He added that it would be “interesting to see if 50 mg would be just as good” as a starting dose.

Potential limitations of the study include the fact that the majority of participants were White, so the findings may not be generalizable to other populations.
 

Long-awaited results

In an accompanying editorial, Anne Ducros, MD, PhD, professor of neurology and director of the Headache Center, Montpellier (France) University Hospital, said the study provides “strong and long-awaited evidence supporting the use of oral steroids as a transitional treatment option.”

The trial “raises many topics for future research,” one of which is the long-term safety of prednisone for patients with cluster headache, said Dr. Ducros. She noted that use of high-dose steroids once or twice a year for 15 years or more “has the potential for severe systemic toxic effects,” such as corticosteroid-induced osteonecrosis of the femoral head.

Other questions about corticosteroid use for patients with cluster headache remain. These include understanding whether these agents provide better efficacy than occipital nerve injections and determining the optimal verapamil regimen, she noted.

In addition, the risk for oral steroid misuse needs to be studied, she said. She noted that drug misuse is common among patients with cluster headache.

Despite these questions, the results of this new study “provide an important step forward for patients with cluster headache, for whom safe and effective transitional therapies are much needed,” Dr. Ducros wrote.


Dr. Obermann has received fees from Sanofi, Biogen, Novartis, Teva Pharmaceuticals, and Eli Lilly and grants from Allergan and Heel Pharmaceuticals outside of this work. Dr. Ducros has received fees from Amgen, Novartis, Teva, and Eli Lilly; grants from the Programme Hospitalier de Recherche Clinique and from the Appel d’Offre Interne of Montpellier University Hospital; and nonfinancial support from SOS Oxygene.

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

Adjunctive oral prednisone appears to significantly reduce cluster headache attacks, new research shows. Results of the multicenter, randomized, double-blind trial show that patients who received the steroid had 25% fewer attacks in the first week of therapy, compared with their counterparts who received placebo.

In addition, more than a third of patients in the prednisone group were pain free, and for almost half, headache frequency was reduced by at least 50% at day 7 of treatment.

These findings provide clear evidence that prednisone, in conjunction with the use of verapamil, is effective in cluster headache, said lead author Mark Obermann, MD, director, Center for Neurology, Asklepios Hospitals Seesen (Germany), and associate professor, University of Duisburg-Essen (Germany).

The key message, he added, is that all patients with cluster headache should receive prednisone at the start of an episode.

The study was published online Nov. 24 in the Lancet Neurology.
 

‘Suicide headaches’

Cluster headaches are intense unilateral attacks of facial and head pain. They last 15-180 minutes and predominantly affect men. They are accompanied by trigeminal autonomic symptoms and are extremely painful. “They’re referred to as ‘suicide headaches’ because the pain is so severe that patients often report they think about killing themselves to get rid of the pain,” said Dr. Obermann.

The cause is unclear, although there is some evidence that the hypothalamus is involved. The headaches sometimes follow a “strict circadian pattern,” said Dr. Obermann. He noted that the attacks might occur over a few weeks or months and then not return for months or even years.

An estimated 1 in 1,000 people experience cluster headache, but the condition is underrecognized, and research is scarce and poorly funded. Previous research does show that the calcium channel blocker verapamil, which is used to treat high blood pressure, is effective in cluster headache. However, it takes about 14 days to work and has to be slowly titrated because of cardiac side effects, said Dr. Obermann. For these reasons, international guidelines recommend initiating short-term preventive treatment with corticosteroids to suppress, or at least lessen, cluster headache attacks until long-term prevention is effective.

Although some clinicians treat cluster headaches with corticosteroids, others don’t because of a lack of evidence that shows they are effective. “There’s no evidence whatsoever on what the correct dose is or whether it helps at all. This is the gap we wanted to close,” said Dr. Obermann.

The study included 116 adult patients with cluster headache from 10 centers who were experiencing a cluster headache episode and were not taking prophylactic medication.

The trial only included patients who had an attack within 30 days of their current episode. The investigators included this restriction to reduce the possibility of spontaneous remission, which is “a big problem” in cluster headache trials, he said. To confirm that episodes were cluster headache attacks, patients were also required to have moderate to severe pain, indicated by a score of at least 5 on a numerical rating scale in which 0 indicates no pain and 10 indicates the worse imaginable pain.

Participants were allowed to use treatments for acute attack, but these therapies were limited to triptans, high-flow oxygen, intranasal lidocaine, ergotamine, and oral analgesics.
 

Debilitating pain

Patients were randomly assigned to receive oral prednisone (n = 53) or placebo (n = 56). The study groups were matched with respect to demographic and clinical characteristics. Prednisone was initiated at 100 mg/d for 5 days and was then tapered by 20 mg every 3 days in the active-treatment group. All patients also received oral verapamil at a starting dose of 40 mg three times per day. The dose was increased every 3 days by 40 mg to a maximum of 360 mg/d.

All participants received pantoprazole 20 mg to prevent the gastric side effects of prednisone. An attack was defined as a unilateral headache of moderate to severe intensity. The study lasted 28 days.

The study’s primary outcome was the mean number of cluster headache attacks during the first week of treatment with prednisone versus placebo.

The mean number of attacks during the first week of treatment was 7.1 in the prednisone group and 9.5 in the placebo group, for a difference of –2.4 attacks (95% confidence interval, –4.8 to –0.03; P = .002). “This might not sound like much,” but reducing the number of daily attacks from, say, eight to six “really makes a difference because the attacks are so painful,” said Dr. Obermann.

The prednisone group also came out on top for a number secondary outcomes. After the first 7 days, attacks ceased in 35% of the prednisone group versus 7% in the placebo group.
 

‘Clear evidence’ of efficacy

About 49% of patients who took prednisone reported a reduction of at least 50% in attack frequency at day 7. By comparison, 15% of patients who received placebo reported such a reduction. The number of cluster attacks at day 28 was less in the prednisone group than in the patients who received placebo.

With respect to treatment effect, the difference between prednisone and placebo gradually lessened over time “in parallel to the verapamil dose reaching its therapeutic effect,” the investigators noted. “Therefore, attack frequency reduction slowly converged between groups,” they added.

The study results provide “clear evidence” and should reassure clinicians that short-term prednisone early in a cluster headache attack is effective, said Dr. Obermann.

Adverse events, which included headache, palpitations, dizziness, and nausea, were as expected and were similar in the two groups. There were only two severe adverse events, both of which occurred in participants in the placebo group.

Dr. Obermann said the investigators were surprised that so many patients in the study were taking analgesics. “Analgesics don’t work in cluster headache; they just don’t work in this kind of pain.”

He noted that prednisone exposure of study patients spanned only 19 days and amounted to only 1,100 mg, which he believes is safe.

The prednisone dose used in the study is “what most clinicians use in clinical practice,” although there have been reports of success using 500 mg of IV prednisone over 5 days, said Dr. Obermann. He added that it would be “interesting to see if 50 mg would be just as good” as a starting dose.

Potential limitations of the study include the fact that the majority of participants were White, so the findings may not be generalizable to other populations.
 

Long-awaited results

In an accompanying editorial, Anne Ducros, MD, PhD, professor of neurology and director of the Headache Center, Montpellier (France) University Hospital, said the study provides “strong and long-awaited evidence supporting the use of oral steroids as a transitional treatment option.”

The trial “raises many topics for future research,” one of which is the long-term safety of prednisone for patients with cluster headache, said Dr. Ducros. She noted that use of high-dose steroids once or twice a year for 15 years or more “has the potential for severe systemic toxic effects,” such as corticosteroid-induced osteonecrosis of the femoral head.

Other questions about corticosteroid use for patients with cluster headache remain. These include understanding whether these agents provide better efficacy than occipital nerve injections and determining the optimal verapamil regimen, she noted.

In addition, the risk for oral steroid misuse needs to be studied, she said. She noted that drug misuse is common among patients with cluster headache.

Despite these questions, the results of this new study “provide an important step forward for patients with cluster headache, for whom safe and effective transitional therapies are much needed,” Dr. Ducros wrote.


Dr. Obermann has received fees from Sanofi, Biogen, Novartis, Teva Pharmaceuticals, and Eli Lilly and grants from Allergan and Heel Pharmaceuticals outside of this work. Dr. Ducros has received fees from Amgen, Novartis, Teva, and Eli Lilly; grants from the Programme Hospitalier de Recherche Clinique and from the Appel d’Offre Interne of Montpellier University Hospital; and nonfinancial support from SOS Oxygene.

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

There is “compelling” evidence of the harmful effects of alcohol on the brain. The greatest risk occurs during three periods of life that are marked by dynamic brain changes, say researchers from Australia and the United Kingdom.

alenkadr/Thinkstock

The three periods are:

• Gestation (conception to birth), which is characterized by extensive production, migration, and differentiation of neurons, as well as substantial apoptosis.
• Later adolescence (aged 15-19 years), a period marked by synaptic pruning and increased axonal myelination.
• Older adulthood (aged 65 and beyond), a period associated with brain atrophy. Changes accelerate after age 65, largely driven by decreases in neuron size and reductions in the number of dendritic spines and synapses.

These changes in neurocircuitry could increase sensitivity to the neurotoxic effects of alcohol, Louise Mewton, PhD, of the Center for Healthy Brain Aging, University of New South Wales, Sydney, and colleagues said.

“A life course perspective on brain health supports the formulation of policy and public health interventions to reduce alcohol use and misuse at all ages,” they wrote in an editorial published online Dec. 4 in The BMJ.
 

Worrisome trends

Research has shown that globally about 10% of pregnant women drink alcohol. In European countries, the rates are much higher than the global average.

Heavy drinking during gestation can cause fetal alcohol spectrum disorder, which is associated with widespread reductions in brain volume and cognitive impairment.

Even low or moderate alcohol consumption during pregnancy is significantly associated with poorer psychological and behavioral outcomes in children, the investigators noted.

In adolescence, more than 20% of 15- to 19-year-olds in European and other high-income countries report at least occasional binge drinking, which is linked to reduced brain volume, poorer white matter development, and deficits in a range of cognitive functions, they added.

In a recent study of older adults, alcohol use disorders emerged as one of the strongest modifiable risk factors for dementia (particularly early-onset dementia), compared with other established risk factors such as high blood pressure and smoking.

Alcohol use disorders are relatively rare in older adults, but even moderate drinking during midlife has been linked to “small but significant” brain volume loss, the authors said.

Dr. Mewton and colleagues said demographic trends may compound the effect of alcohol use on brain health.

They noted that women are now just as likely as men to drink alcohol and suffer alcohol-related problems. Global consumption is forecast to increase further in the next decade.

Although the effects of the COVID-19 pandemic on alcohol intake and related harms remain unclear, alcohol use has increased in the long term after other major public health crises, they added.

Given the data, Dr. Mewton and colleagues called for “an integrated approach” to reducing the harms of alcohol intake at all ages.

“Population-based interventions such as guidelines on low-risk drinking, alcohol pricing policies, and lower drink driving limits need to be accompanied by the development of training and care pathways that consider the human brain at risk throughout life,” they concluded.

The authors have disclosed no relevant financial relationships.
 

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

There is “compelling” evidence of the harmful effects of alcohol on the brain. The greatest risk occurs during three periods of life that are marked by dynamic brain changes, say researchers from Australia and the United Kingdom.

alenkadr/Thinkstock

The three periods are:

• Gestation (conception to birth), which is characterized by extensive production, migration, and differentiation of neurons, as well as substantial apoptosis.
• Later adolescence (aged 15-19 years), a period marked by synaptic pruning and increased axonal myelination.
• Older adulthood (aged 65 and beyond), a period associated with brain atrophy. Changes accelerate after age 65, largely driven by decreases in neuron size and reductions in the number of dendritic spines and synapses.

These changes in neurocircuitry could increase sensitivity to the neurotoxic effects of alcohol, Louise Mewton, PhD, of the Center for Healthy Brain Aging, University of New South Wales, Sydney, and colleagues said.

“A life course perspective on brain health supports the formulation of policy and public health interventions to reduce alcohol use and misuse at all ages,” they wrote in an editorial published online Dec. 4 in The BMJ.
 

Worrisome trends

Research has shown that globally about 10% of pregnant women drink alcohol. In European countries, the rates are much higher than the global average.

Heavy drinking during gestation can cause fetal alcohol spectrum disorder, which is associated with widespread reductions in brain volume and cognitive impairment.

Even low or moderate alcohol consumption during pregnancy is significantly associated with poorer psychological and behavioral outcomes in children, the investigators noted.

In adolescence, more than 20% of 15- to 19-year-olds in European and other high-income countries report at least occasional binge drinking, which is linked to reduced brain volume, poorer white matter development, and deficits in a range of cognitive functions, they added.

In a recent study of older adults, alcohol use disorders emerged as one of the strongest modifiable risk factors for dementia (particularly early-onset dementia), compared with other established risk factors such as high blood pressure and smoking.

Alcohol use disorders are relatively rare in older adults, but even moderate drinking during midlife has been linked to “small but significant” brain volume loss, the authors said.

Dr. Mewton and colleagues said demographic trends may compound the effect of alcohol use on brain health.

They noted that women are now just as likely as men to drink alcohol and suffer alcohol-related problems. Global consumption is forecast to increase further in the next decade.

Although the effects of the COVID-19 pandemic on alcohol intake and related harms remain unclear, alcohol use has increased in the long term after other major public health crises, they added.

Given the data, Dr. Mewton and colleagues called for “an integrated approach” to reducing the harms of alcohol intake at all ages.

“Population-based interventions such as guidelines on low-risk drinking, alcohol pricing policies, and lower drink driving limits need to be accompanied by the development of training and care pathways that consider the human brain at risk throughout life,” they concluded.

The authors have disclosed no relevant financial relationships.
 

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

There is “compelling” evidence of the harmful effects of alcohol on the brain. The greatest risk occurs during three periods of life that are marked by dynamic brain changes, say researchers from Australia and the United Kingdom.

alenkadr/Thinkstock

The three periods are:

• Gestation (conception to birth), which is characterized by extensive production, migration, and differentiation of neurons, as well as substantial apoptosis.
• Later adolescence (aged 15-19 years), a period marked by synaptic pruning and increased axonal myelination.
• Older adulthood (aged 65 and beyond), a period associated with brain atrophy. Changes accelerate after age 65, largely driven by decreases in neuron size and reductions in the number of dendritic spines and synapses.

These changes in neurocircuitry could increase sensitivity to the neurotoxic effects of alcohol, Louise Mewton, PhD, of the Center for Healthy Brain Aging, University of New South Wales, Sydney, and colleagues said.

“A life course perspective on brain health supports the formulation of policy and public health interventions to reduce alcohol use and misuse at all ages,” they wrote in an editorial published online Dec. 4 in The BMJ.
 

Worrisome trends

Research has shown that globally about 10% of pregnant women drink alcohol. In European countries, the rates are much higher than the global average.

Heavy drinking during gestation can cause fetal alcohol spectrum disorder, which is associated with widespread reductions in brain volume and cognitive impairment.

Even low or moderate alcohol consumption during pregnancy is significantly associated with poorer psychological and behavioral outcomes in children, the investigators noted.

In adolescence, more than 20% of 15- to 19-year-olds in European and other high-income countries report at least occasional binge drinking, which is linked to reduced brain volume, poorer white matter development, and deficits in a range of cognitive functions, they added.

In a recent study of older adults, alcohol use disorders emerged as one of the strongest modifiable risk factors for dementia (particularly early-onset dementia), compared with other established risk factors such as high blood pressure and smoking.

Alcohol use disorders are relatively rare in older adults, but even moderate drinking during midlife has been linked to “small but significant” brain volume loss, the authors said.

Dr. Mewton and colleagues said demographic trends may compound the effect of alcohol use on brain health.

They noted that women are now just as likely as men to drink alcohol and suffer alcohol-related problems. Global consumption is forecast to increase further in the next decade.

Although the effects of the COVID-19 pandemic on alcohol intake and related harms remain unclear, alcohol use has increased in the long term after other major public health crises, they added.

Given the data, Dr. Mewton and colleagues called for “an integrated approach” to reducing the harms of alcohol intake at all ages.

“Population-based interventions such as guidelines on low-risk drinking, alcohol pricing policies, and lower drink driving limits need to be accompanied by the development of training and care pathways that consider the human brain at risk throughout life,” they concluded.

The authors have disclosed no relevant financial relationships.
 

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

Cases of poisoning – intentional and unintentional – from ingestion of alcohol-based hand sanitizer have soared during the COVID-19 pandemic.

In the United Kingdom alone, alcohol-based hand sanitizer poisonings reported to the National Poisons Information Service jumped 157% – from 155 between January 1 and September 16, 2019, to 398 between Jan. 1 and Sept. 14, 2020, new research shows.

More needs to be done to protect those at risk of unintentional and intentional swallowing of alcohol-based hand sanitizer, including children, people with dementia/confusion, and those with mental health issues, according to Georgia Richards, DPhil student, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford (England).

“If providers are supplying alcohol-based hand sanitizers in the community to reduce the spread of SARS-CoV-2, the contents should be supplied in lockable and automated dispensers to reduce contamination and improve safety,” Ms. Richards said in an interview.

The study was published online Dec. 1 in BMJ Evidence-Based Medicine.
 

European, U.S. poisoning rates soar

In the paper Ms. Richards described two deaths that occurred in hospitals in England.

In one case, a 30-year-old woman, detained in a psychiatric unit who received the antidepressant venlafaxine was found dead in her hospital bed with a container of hand-sanitizing gel beside her.

“The gel was readily accessible to patients on the ward from a communal dispenser, and patients were allowed to fill cups or other containers with it to keep in their rooms,” Ms. Richards reported.

A postmortem analysis found a high level of alcohol in her blood (214 mg of alcohol in 100 mL of blood). The medical cause of death was listed as “ingestion of alcohol and venlafaxine.” The coroner concluded that the combination of these substances suppressed the patient’s breathing, leading to her death.

The other case involved a 76-year-old man who unintentionally swallowed an unknown quantity of alcohol-based hand-sanitizing foam attached to the foot of his hospital bed.

The patient had a history of agitation and depression and was treated with antidepressants. He had become increasingly confused over the preceding 9 months, possibly because of vascular dementia.

His blood ethanol concentration was 463 mg/dL (100 mmol/L) initially and 354 mg/dL (77mmol/L) 10 hours later. He was admitted to the ICU, where he received lorazepam and haloperidol and treated with ventilation, with a plan to allow the alcohol to be naturally metabolized.

The patient developed complications and died 6 days later. The primary causes of death were bronchopneumonia and acute alcohol toxicity, secondary to acute delirium and coronary artery disease.

Since COVID-19 started, alcohol-based hand sanitizers are among the most sought-after commodities around the world. The volume of these products – now found in homes, hospitals, schools, workplaces, and elsewhere – “may be a cause for concern,” Ms. Richards wrote.

Yet, warnings about the toxicity and lethality of intentional or unintentional ingestion of these products have not been widely disseminated, she noted.

To reduce the risk of harm, Ms. Richards suggested educating the public and health care professionals, improving warning labels on products, and increasing the awareness and reporting of such exposures to public health authorities.

“While governments and public health authorities have successfully heightened our awareness of, and need for, better hand hygiene during the COVID-19 outbreak, they must also make the public aware of the potential harms and encourage the reporting of such harms to poisons information centers,” she noted.

Increases in alcohol-based hand sanitizer poisoning during the pandemic have also been reported in the United States.

The American Association of Poison Control Centers reports that data from the National Poison Data System show 32,892 hand sanitizer exposure cases reported to the 55 U.S. poison control centers from Jan. 1 to Nov. 15, 2020 – an increase of 73%, compared with the same time period during the previous year.
 

An increase in self-harm

Weighing in on this issue, Robert Bassett, DO, associate medical director of the Poison Control Center at Children’s Hospital of Philadelphia, said in an interview that “cleaning agents and disinfectants have been around for eons and their potential for toxicity hasn’t changed.

“Now with COVID, and this hypervigilance when it comes to cleanliness, there is increased access and the exposure risk has gone up,” he said.

“One of the sad casualties of an overstressed health care system and a globally depressed environment is worsening behavioral health emergencies and, as part of that, the risk of self-harm goes up,” Dr. Bassett added.

“The consensus is that there has been an exacerbation of behavioral health emergencies and behavioral health needs since COVID started and hand sanitizers are readily accessible to someone who may be looking to self-harm,” he said.

This research had no specific funding. Ms. Richards is the editorial registrar of BMJ Evidence Based Medicine and is developing a website to track preventable deaths. Dr. Bassett disclosed no relevant financial relationships.

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

Cases of poisoning – intentional and unintentional – from ingestion of alcohol-based hand sanitizer have soared during the COVID-19 pandemic.

In the United Kingdom alone, alcohol-based hand sanitizer poisonings reported to the National Poisons Information Service jumped 157% – from 155 between January 1 and September 16, 2019, to 398 between Jan. 1 and Sept. 14, 2020, new research shows.

More needs to be done to protect those at risk of unintentional and intentional swallowing of alcohol-based hand sanitizer, including children, people with dementia/confusion, and those with mental health issues, according to Georgia Richards, DPhil student, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford (England).

“If providers are supplying alcohol-based hand sanitizers in the community to reduce the spread of SARS-CoV-2, the contents should be supplied in lockable and automated dispensers to reduce contamination and improve safety,” Ms. Richards said in an interview.

The study was published online Dec. 1 in BMJ Evidence-Based Medicine.
 

European, U.S. poisoning rates soar

In the paper Ms. Richards described two deaths that occurred in hospitals in England.

In one case, a 30-year-old woman, detained in a psychiatric unit who received the antidepressant venlafaxine was found dead in her hospital bed with a container of hand-sanitizing gel beside her.

“The gel was readily accessible to patients on the ward from a communal dispenser, and patients were allowed to fill cups or other containers with it to keep in their rooms,” Ms. Richards reported.

A postmortem analysis found a high level of alcohol in her blood (214 mg of alcohol in 100 mL of blood). The medical cause of death was listed as “ingestion of alcohol and venlafaxine.” The coroner concluded that the combination of these substances suppressed the patient’s breathing, leading to her death.

The other case involved a 76-year-old man who unintentionally swallowed an unknown quantity of alcohol-based hand-sanitizing foam attached to the foot of his hospital bed.

The patient had a history of agitation and depression and was treated with antidepressants. He had become increasingly confused over the preceding 9 months, possibly because of vascular dementia.

His blood ethanol concentration was 463 mg/dL (100 mmol/L) initially and 354 mg/dL (77mmol/L) 10 hours later. He was admitted to the ICU, where he received lorazepam and haloperidol and treated with ventilation, with a plan to allow the alcohol to be naturally metabolized.

The patient developed complications and died 6 days later. The primary causes of death were bronchopneumonia and acute alcohol toxicity, secondary to acute delirium and coronary artery disease.

Since COVID-19 started, alcohol-based hand sanitizers are among the most sought-after commodities around the world. The volume of these products – now found in homes, hospitals, schools, workplaces, and elsewhere – “may be a cause for concern,” Ms. Richards wrote.

Yet, warnings about the toxicity and lethality of intentional or unintentional ingestion of these products have not been widely disseminated, she noted.

To reduce the risk of harm, Ms. Richards suggested educating the public and health care professionals, improving warning labels on products, and increasing the awareness and reporting of such exposures to public health authorities.

“While governments and public health authorities have successfully heightened our awareness of, and need for, better hand hygiene during the COVID-19 outbreak, they must also make the public aware of the potential harms and encourage the reporting of such harms to poisons information centers,” she noted.

Increases in alcohol-based hand sanitizer poisoning during the pandemic have also been reported in the United States.

The American Association of Poison Control Centers reports that data from the National Poison Data System show 32,892 hand sanitizer exposure cases reported to the 55 U.S. poison control centers from Jan. 1 to Nov. 15, 2020 – an increase of 73%, compared with the same time period during the previous year.
 

An increase in self-harm

Weighing in on this issue, Robert Bassett, DO, associate medical director of the Poison Control Center at Children’s Hospital of Philadelphia, said in an interview that “cleaning agents and disinfectants have been around for eons and their potential for toxicity hasn’t changed.

“Now with COVID, and this hypervigilance when it comes to cleanliness, there is increased access and the exposure risk has gone up,” he said.

“One of the sad casualties of an overstressed health care system and a globally depressed environment is worsening behavioral health emergencies and, as part of that, the risk of self-harm goes up,” Dr. Bassett added.

“The consensus is that there has been an exacerbation of behavioral health emergencies and behavioral health needs since COVID started and hand sanitizers are readily accessible to someone who may be looking to self-harm,” he said.

This research had no specific funding. Ms. Richards is the editorial registrar of BMJ Evidence Based Medicine and is developing a website to track preventable deaths. Dr. Bassett disclosed no relevant financial relationships.

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

Cases of poisoning – intentional and unintentional – from ingestion of alcohol-based hand sanitizer have soared during the COVID-19 pandemic.

In the United Kingdom alone, alcohol-based hand sanitizer poisonings reported to the National Poisons Information Service jumped 157% – from 155 between January 1 and September 16, 2019, to 398 between Jan. 1 and Sept. 14, 2020, new research shows.

More needs to be done to protect those at risk of unintentional and intentional swallowing of alcohol-based hand sanitizer, including children, people with dementia/confusion, and those with mental health issues, according to Georgia Richards, DPhil student, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford (England).

“If providers are supplying alcohol-based hand sanitizers in the community to reduce the spread of SARS-CoV-2, the contents should be supplied in lockable and automated dispensers to reduce contamination and improve safety,” Ms. Richards said in an interview.

The study was published online Dec. 1 in BMJ Evidence-Based Medicine.
 

European, U.S. poisoning rates soar

In the paper Ms. Richards described two deaths that occurred in hospitals in England.

In one case, a 30-year-old woman, detained in a psychiatric unit who received the antidepressant venlafaxine was found dead in her hospital bed with a container of hand-sanitizing gel beside her.

“The gel was readily accessible to patients on the ward from a communal dispenser, and patients were allowed to fill cups or other containers with it to keep in their rooms,” Ms. Richards reported.

A postmortem analysis found a high level of alcohol in her blood (214 mg of alcohol in 100 mL of blood). The medical cause of death was listed as “ingestion of alcohol and venlafaxine.” The coroner concluded that the combination of these substances suppressed the patient’s breathing, leading to her death.

The other case involved a 76-year-old man who unintentionally swallowed an unknown quantity of alcohol-based hand-sanitizing foam attached to the foot of his hospital bed.

The patient had a history of agitation and depression and was treated with antidepressants. He had become increasingly confused over the preceding 9 months, possibly because of vascular dementia.

His blood ethanol concentration was 463 mg/dL (100 mmol/L) initially and 354 mg/dL (77mmol/L) 10 hours later. He was admitted to the ICU, where he received lorazepam and haloperidol and treated with ventilation, with a plan to allow the alcohol to be naturally metabolized.

The patient developed complications and died 6 days later. The primary causes of death were bronchopneumonia and acute alcohol toxicity, secondary to acute delirium and coronary artery disease.

Since COVID-19 started, alcohol-based hand sanitizers are among the most sought-after commodities around the world. The volume of these products – now found in homes, hospitals, schools, workplaces, and elsewhere – “may be a cause for concern,” Ms. Richards wrote.

Yet, warnings about the toxicity and lethality of intentional or unintentional ingestion of these products have not been widely disseminated, she noted.

To reduce the risk of harm, Ms. Richards suggested educating the public and health care professionals, improving warning labels on products, and increasing the awareness and reporting of such exposures to public health authorities.

“While governments and public health authorities have successfully heightened our awareness of, and need for, better hand hygiene during the COVID-19 outbreak, they must also make the public aware of the potential harms and encourage the reporting of such harms to poisons information centers,” she noted.

Increases in alcohol-based hand sanitizer poisoning during the pandemic have also been reported in the United States.

The American Association of Poison Control Centers reports that data from the National Poison Data System show 32,892 hand sanitizer exposure cases reported to the 55 U.S. poison control centers from Jan. 1 to Nov. 15, 2020 – an increase of 73%, compared with the same time period during the previous year.
 

An increase in self-harm

Weighing in on this issue, Robert Bassett, DO, associate medical director of the Poison Control Center at Children’s Hospital of Philadelphia, said in an interview that “cleaning agents and disinfectants have been around for eons and their potential for toxicity hasn’t changed.

“Now with COVID, and this hypervigilance when it comes to cleanliness, there is increased access and the exposure risk has gone up,” he said.

“One of the sad casualties of an overstressed health care system and a globally depressed environment is worsening behavioral health emergencies and, as part of that, the risk of self-harm goes up,” Dr. Bassett added.

“The consensus is that there has been an exacerbation of behavioral health emergencies and behavioral health needs since COVID started and hand sanitizers are readily accessible to someone who may be looking to self-harm,” he said.

This research had no specific funding. Ms. Richards is the editorial registrar of BMJ Evidence Based Medicine and is developing a website to track preventable deaths. Dr. Bassett disclosed no relevant financial relationships.

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

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.