MDedge Neurology

MADRID – Recent research has confirmed the impact of periodontitis on risk of neurologic diseases, especially the increased risks for stroke and Alzheimer’s disease.

The Spanish Society of Dentistry and Osseointegration (SEPA) and the Spanish Society of Neurology (SEN) recently released a report with the latest data on this topic. The report reviews, updates, and presents the most recent scientific evidence regarding this link. It also provides practical recommendations that, on the basis of the evidence, should be applied in dental clinics and neurology centers.

As Yago Leira, DDS, PhD, periodontist and coordinator of the SEPA-SEN working group, told this news organization, “The main takeaway from this scientific report is that patients with periodontitis are at nearly twice the risk of developing Alzheimer’s disease and at triple the risk of ischemic stroke.”

Data from the report show that individuals with periodontitis are at 2.8 times’ higher risk of ischemic stroke. The available evidence regarding hemorrhagic stroke, however, is conflicting.

How does this dental condition affect the course of cardiovascular disease? Observational studies have shown that those who have had an ischemic stroke and have a confirmed diagnosis of periodontitis are at greater risk of suffering a recurrent vascular event, worse neurologic deficit, and postictal depression than are patients without periodontitis.
 

Immune‐mediated inflammation

As far as its link to Alzheimer’s disease, meta-analyses of epidemiologic studies show that periodontitis is associated with a 1.7 times greater risk of this type of dementia and that the risk triples among patients with more serious forms of periodontitis.

Likewise, studies suggest that individuals with dementia or neurocognitive impairment are at a greater risk of suffering periodontitis. Other studies indicate that individuals with periodontitis have worse outcomes on various neuropsychological tests of cognitive function.

The current report presents the evidence from three clearly defined perspectives: The epidemiologic association between periodontitis and these neurologic diseases, the biological mechanisms that may explain this link, and interventional studies of dental treatment as a means of preventing stroke and Alzheimer’s disease.

“There is a possible biological explanation for these epidemiological findings. The report concludes that the low-grade chronic, systemic, immune-mediated inflammatory response induced by the bacteria and their endotoxins and the proinflammatory mediators circulating through the blood contributes to various biological processes that are involved in neurological impairment and cerebral ischemia,” said Dr. Leira, one of the report’s authors.

Ana Frank, MD, PhD, another author of this study, is head of the neurology department at the La Paz University Hospital in Madrid and a member of the SEPA-SEN group. She said in an interview that the main biological mechanism in stroke and Alzheimer’s disease is chronic exposure of the entire brain (vasculature, neurons, and astrocytes) to the harmful effects of periodontal infection. “Although low in intensity, this [exposure] is sufficient to set off a series of events that eventually lead to vascular endothelial injury, changes to neurons and astrocytes, and damage to the neuropil.”

As far as the evidence of an epidemiologic association between periodontitis and both neurologic diseases, Dr. Frank cited the exponential increase in risk brought on by periodontitis. She said that further epidemiologic studies are necessary to gain a better understanding of the magnitude of the problem.
 

A preventive alternative?

Dr. Leira cited evidence that periodontal treatment could provide a means of preventing stroke and dementia. He pointed out that numerous population studies have observed various oral health interventions (e.g., periodic dental prophylaxis or periodontal treatment) and regular dental visits to reduce the risk of developing dementia and stroke. “However, we don’t currently have randomized clinical trials that were designed to investigate whether periodontal treatment may be a primary or a secondary preventive measure against these neurological conditions.”

According to Dr. Leira, “There are currently several research groups in the United States and Europe, including ours, that are performing clinical trials to assess the impact of periodontal treatment on recurrent vascular events in patients with cerebrovascular disease.

“On the other hand, there are various interventional studies underway that are evaluating the potential effect of periodontal treatment on cognitive function in patients with dementia. Along these lines, there appear to be encouraging results from the 1-year follow-up in the GAIN study, which was a phase 2/3 clinical trial testing atuzaginstat. Atuzaginstat is an inhibitor of gingipain, the endotoxin produced by Porphyromonas gingivalis, which is one of the bacteria thought to be responsible for periodontitis. The drug reduces neurocognitive impairment in patients with high levels of antibodies against this periodontal pathogen.”
 

Toward clinical practice

The report has a practical focus. The intention is that this evidence will make its way into recommendations for dentists to implement in clinical practice, especially with elderly patients or patients with risk factors for stroke.

In this regard, Dr. Leira said, “On one hand, dentists have to know how to approach patients who have already suffered a stroke (most of whom have vascular risk factors like diabetes and hypertension), many of whom have polypharmacy and are [taking] certain drugs like blood thinners that could negatively impact various dental procedures. In such cases, it is important to maintain direct contact with a neurologist, since these patients ought to be treated with a multidisciplinary approach.

“On the other hand, each patient who comes to the dental office and has a diagnosis of periodontitis could be screened to identify potential vascular risk factors, even though the definitive diagnosis would need to be given by a specialist physician. To this end, SEPA is carrying out the Promosalud (“Health Promotion”) project, which will soon be applied in a large number of dental clinics in Spain,” added Dr. Leira.

“Lastly, specialists in odontology must understand the potential positive benefits surrounding systemic vascular inflammation that periodontal treatment could provide, including, for example, metabolic control and lowering blood pressure.”

For patients with cognitive impairment, the authors of the report recommended adhering to the following steps during dental visits: Inform the patient and the patient’s caregiver about the importance of good dental hygiene and monitor for any signs of infection or dental disease; address pain in every patient with cognitive impairment and dental problems, especially those with agitation, even if the patient isn’t specifically complaining of pain (also, try not to give opioids); finally, avoid sedation as much as possible and use the smallest effective dose if it becomes necessary.
 

Prescribe oral hygiene

Regarding recommendations that neurologists should follow during consultations in light of the link between these diseases and periodontitis, Dr. Frank said, “Regardless of how old our patients are, I believe it’s important to emphasize the importance of practicing good oral and dental hygiene. It’s a good strategy to put this in writing in medical reports, alongside the usual recommendations about healthy lifestyle habits and monitoring for diseases like high blood pressure, diabetes, or dyslipidemia. These, among other factors like smoking, a sedentary lifestyle, alcoholism, and other drug addictions, are vascular risk factors and are therefore risk factors for stroke and dementia.”

According to Dr. Frank, the public is largely unaware of the relationship between periodontitis and incident neurologic diseases. “We still have a long way to go before we can say that the public is aware of this potential link. And not just the public, either. I believe we must stress among our colleagues and among health care professionals in general the importance of promoting dental health to improve people’s overall health.”

In this regard, Dr. Leira emphasized the authors’ intention to make this report available not only to oral health and neurologic health care professionals but also to primary care physicians and nurses so that patients with cerebrovascular disease or Alzheimer’s disease and their caregivers can develop a greater awareness and thereby improve prevention.

“This study will also provide the scientific basis to support the SEPA-SEN working group as they implement their future activities and projects,” Dr. Leira concluded.

Dr. Leira and Dr. Frank have disclosed no relevant financial relationships.
 

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

MADRID – Recent research has confirmed the impact of periodontitis on risk of neurologic diseases, especially the increased risks for stroke and Alzheimer’s disease.

The Spanish Society of Dentistry and Osseointegration (SEPA) and the Spanish Society of Neurology (SEN) recently released a report with the latest data on this topic. The report reviews, updates, and presents the most recent scientific evidence regarding this link. It also provides practical recommendations that, on the basis of the evidence, should be applied in dental clinics and neurology centers.

As Yago Leira, DDS, PhD, periodontist and coordinator of the SEPA-SEN working group, told this news organization, “The main takeaway from this scientific report is that patients with periodontitis are at nearly twice the risk of developing Alzheimer’s disease and at triple the risk of ischemic stroke.”

Data from the report show that individuals with periodontitis are at 2.8 times’ higher risk of ischemic stroke. The available evidence regarding hemorrhagic stroke, however, is conflicting.

How does this dental condition affect the course of cardiovascular disease? Observational studies have shown that those who have had an ischemic stroke and have a confirmed diagnosis of periodontitis are at greater risk of suffering a recurrent vascular event, worse neurologic deficit, and postictal depression than are patients without periodontitis.
 

Immune‐mediated inflammation

As far as its link to Alzheimer’s disease, meta-analyses of epidemiologic studies show that periodontitis is associated with a 1.7 times greater risk of this type of dementia and that the risk triples among patients with more serious forms of periodontitis.

Likewise, studies suggest that individuals with dementia or neurocognitive impairment are at a greater risk of suffering periodontitis. Other studies indicate that individuals with periodontitis have worse outcomes on various neuropsychological tests of cognitive function.

The current report presents the evidence from three clearly defined perspectives: The epidemiologic association between periodontitis and these neurologic diseases, the biological mechanisms that may explain this link, and interventional studies of dental treatment as a means of preventing stroke and Alzheimer’s disease.

“There is a possible biological explanation for these epidemiological findings. The report concludes that the low-grade chronic, systemic, immune-mediated inflammatory response induced by the bacteria and their endotoxins and the proinflammatory mediators circulating through the blood contributes to various biological processes that are involved in neurological impairment and cerebral ischemia,” said Dr. Leira, one of the report’s authors.

Ana Frank, MD, PhD, another author of this study, is head of the neurology department at the La Paz University Hospital in Madrid and a member of the SEPA-SEN group. She said in an interview that the main biological mechanism in stroke and Alzheimer’s disease is chronic exposure of the entire brain (vasculature, neurons, and astrocytes) to the harmful effects of periodontal infection. “Although low in intensity, this [exposure] is sufficient to set off a series of events that eventually lead to vascular endothelial injury, changes to neurons and astrocytes, and damage to the neuropil.”

As far as the evidence of an epidemiologic association between periodontitis and both neurologic diseases, Dr. Frank cited the exponential increase in risk brought on by periodontitis. She said that further epidemiologic studies are necessary to gain a better understanding of the magnitude of the problem.
 

A preventive alternative?

Dr. Leira cited evidence that periodontal treatment could provide a means of preventing stroke and dementia. He pointed out that numerous population studies have observed various oral health interventions (e.g., periodic dental prophylaxis or periodontal treatment) and regular dental visits to reduce the risk of developing dementia and stroke. “However, we don’t currently have randomized clinical trials that were designed to investigate whether periodontal treatment may be a primary or a secondary preventive measure against these neurological conditions.”

According to Dr. Leira, “There are currently several research groups in the United States and Europe, including ours, that are performing clinical trials to assess the impact of periodontal treatment on recurrent vascular events in patients with cerebrovascular disease.

“On the other hand, there are various interventional studies underway that are evaluating the potential effect of periodontal treatment on cognitive function in patients with dementia. Along these lines, there appear to be encouraging results from the 1-year follow-up in the GAIN study, which was a phase 2/3 clinical trial testing atuzaginstat. Atuzaginstat is an inhibitor of gingipain, the endotoxin produced by Porphyromonas gingivalis, which is one of the bacteria thought to be responsible for periodontitis. The drug reduces neurocognitive impairment in patients with high levels of antibodies against this periodontal pathogen.”
 

Toward clinical practice

The report has a practical focus. The intention is that this evidence will make its way into recommendations for dentists to implement in clinical practice, especially with elderly patients or patients with risk factors for stroke.

In this regard, Dr. Leira said, “On one hand, dentists have to know how to approach patients who have already suffered a stroke (most of whom have vascular risk factors like diabetes and hypertension), many of whom have polypharmacy and are [taking] certain drugs like blood thinners that could negatively impact various dental procedures. In such cases, it is important to maintain direct contact with a neurologist, since these patients ought to be treated with a multidisciplinary approach.

“On the other hand, each patient who comes to the dental office and has a diagnosis of periodontitis could be screened to identify potential vascular risk factors, even though the definitive diagnosis would need to be given by a specialist physician. To this end, SEPA is carrying out the Promosalud (“Health Promotion”) project, which will soon be applied in a large number of dental clinics in Spain,” added Dr. Leira.

“Lastly, specialists in odontology must understand the potential positive benefits surrounding systemic vascular inflammation that periodontal treatment could provide, including, for example, metabolic control and lowering blood pressure.”

For patients with cognitive impairment, the authors of the report recommended adhering to the following steps during dental visits: Inform the patient and the patient’s caregiver about the importance of good dental hygiene and monitor for any signs of infection or dental disease; address pain in every patient with cognitive impairment and dental problems, especially those with agitation, even if the patient isn’t specifically complaining of pain (also, try not to give opioids); finally, avoid sedation as much as possible and use the smallest effective dose if it becomes necessary.
 

Prescribe oral hygiene

Regarding recommendations that neurologists should follow during consultations in light of the link between these diseases and periodontitis, Dr. Frank said, “Regardless of how old our patients are, I believe it’s important to emphasize the importance of practicing good oral and dental hygiene. It’s a good strategy to put this in writing in medical reports, alongside the usual recommendations about healthy lifestyle habits and monitoring for diseases like high blood pressure, diabetes, or dyslipidemia. These, among other factors like smoking, a sedentary lifestyle, alcoholism, and other drug addictions, are vascular risk factors and are therefore risk factors for stroke and dementia.”

According to Dr. Frank, the public is largely unaware of the relationship between periodontitis and incident neurologic diseases. “We still have a long way to go before we can say that the public is aware of this potential link. And not just the public, either. I believe we must stress among our colleagues and among health care professionals in general the importance of promoting dental health to improve people’s overall health.”

In this regard, Dr. Leira emphasized the authors’ intention to make this report available not only to oral health and neurologic health care professionals but also to primary care physicians and nurses so that patients with cerebrovascular disease or Alzheimer’s disease and their caregivers can develop a greater awareness and thereby improve prevention.

“This study will also provide the scientific basis to support the SEPA-SEN working group as they implement their future activities and projects,” Dr. Leira concluded.

Dr. Leira and Dr. Frank have disclosed no relevant financial relationships.
 

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

MADRID – Recent research has confirmed the impact of periodontitis on risk of neurologic diseases, especially the increased risks for stroke and Alzheimer’s disease.

The Spanish Society of Dentistry and Osseointegration (SEPA) and the Spanish Society of Neurology (SEN) recently released a report with the latest data on this topic. The report reviews, updates, and presents the most recent scientific evidence regarding this link. It also provides practical recommendations that, on the basis of the evidence, should be applied in dental clinics and neurology centers.

As Yago Leira, DDS, PhD, periodontist and coordinator of the SEPA-SEN working group, told this news organization, “The main takeaway from this scientific report is that patients with periodontitis are at nearly twice the risk of developing Alzheimer’s disease and at triple the risk of ischemic stroke.”

Data from the report show that individuals with periodontitis are at 2.8 times’ higher risk of ischemic stroke. The available evidence regarding hemorrhagic stroke, however, is conflicting.

How does this dental condition affect the course of cardiovascular disease? Observational studies have shown that those who have had an ischemic stroke and have a confirmed diagnosis of periodontitis are at greater risk of suffering a recurrent vascular event, worse neurologic deficit, and postictal depression than are patients without periodontitis.
 

Immune‐mediated inflammation

As far as its link to Alzheimer’s disease, meta-analyses of epidemiologic studies show that periodontitis is associated with a 1.7 times greater risk of this type of dementia and that the risk triples among patients with more serious forms of periodontitis.

Likewise, studies suggest that individuals with dementia or neurocognitive impairment are at a greater risk of suffering periodontitis. Other studies indicate that individuals with periodontitis have worse outcomes on various neuropsychological tests of cognitive function.

The current report presents the evidence from three clearly defined perspectives: The epidemiologic association between periodontitis and these neurologic diseases, the biological mechanisms that may explain this link, and interventional studies of dental treatment as a means of preventing stroke and Alzheimer’s disease.

“There is a possible biological explanation for these epidemiological findings. The report concludes that the low-grade chronic, systemic, immune-mediated inflammatory response induced by the bacteria and their endotoxins and the proinflammatory mediators circulating through the blood contributes to various biological processes that are involved in neurological impairment and cerebral ischemia,” said Dr. Leira, one of the report’s authors.

Ana Frank, MD, PhD, another author of this study, is head of the neurology department at the La Paz University Hospital in Madrid and a member of the SEPA-SEN group. She said in an interview that the main biological mechanism in stroke and Alzheimer’s disease is chronic exposure of the entire brain (vasculature, neurons, and astrocytes) to the harmful effects of periodontal infection. “Although low in intensity, this [exposure] is sufficient to set off a series of events that eventually lead to vascular endothelial injury, changes to neurons and astrocytes, and damage to the neuropil.”

As far as the evidence of an epidemiologic association between periodontitis and both neurologic diseases, Dr. Frank cited the exponential increase in risk brought on by periodontitis. She said that further epidemiologic studies are necessary to gain a better understanding of the magnitude of the problem.
 

A preventive alternative?

Dr. Leira cited evidence that periodontal treatment could provide a means of preventing stroke and dementia. He pointed out that numerous population studies have observed various oral health interventions (e.g., periodic dental prophylaxis or periodontal treatment) and regular dental visits to reduce the risk of developing dementia and stroke. “However, we don’t currently have randomized clinical trials that were designed to investigate whether periodontal treatment may be a primary or a secondary preventive measure against these neurological conditions.”

According to Dr. Leira, “There are currently several research groups in the United States and Europe, including ours, that are performing clinical trials to assess the impact of periodontal treatment on recurrent vascular events in patients with cerebrovascular disease.

“On the other hand, there are various interventional studies underway that are evaluating the potential effect of periodontal treatment on cognitive function in patients with dementia. Along these lines, there appear to be encouraging results from the 1-year follow-up in the GAIN study, which was a phase 2/3 clinical trial testing atuzaginstat. Atuzaginstat is an inhibitor of gingipain, the endotoxin produced by Porphyromonas gingivalis, which is one of the bacteria thought to be responsible for periodontitis. The drug reduces neurocognitive impairment in patients with high levels of antibodies against this periodontal pathogen.”
 

Toward clinical practice

The report has a practical focus. The intention is that this evidence will make its way into recommendations for dentists to implement in clinical practice, especially with elderly patients or patients with risk factors for stroke.

In this regard, Dr. Leira said, “On one hand, dentists have to know how to approach patients who have already suffered a stroke (most of whom have vascular risk factors like diabetes and hypertension), many of whom have polypharmacy and are [taking] certain drugs like blood thinners that could negatively impact various dental procedures. In such cases, it is important to maintain direct contact with a neurologist, since these patients ought to be treated with a multidisciplinary approach.

“On the other hand, each patient who comes to the dental office and has a diagnosis of periodontitis could be screened to identify potential vascular risk factors, even though the definitive diagnosis would need to be given by a specialist physician. To this end, SEPA is carrying out the Promosalud (“Health Promotion”) project, which will soon be applied in a large number of dental clinics in Spain,” added Dr. Leira.

“Lastly, specialists in odontology must understand the potential positive benefits surrounding systemic vascular inflammation that periodontal treatment could provide, including, for example, metabolic control and lowering blood pressure.”

For patients with cognitive impairment, the authors of the report recommended adhering to the following steps during dental visits: Inform the patient and the patient’s caregiver about the importance of good dental hygiene and monitor for any signs of infection or dental disease; address pain in every patient with cognitive impairment and dental problems, especially those with agitation, even if the patient isn’t specifically complaining of pain (also, try not to give opioids); finally, avoid sedation as much as possible and use the smallest effective dose if it becomes necessary.
 

Prescribe oral hygiene

Regarding recommendations that neurologists should follow during consultations in light of the link between these diseases and periodontitis, Dr. Frank said, “Regardless of how old our patients are, I believe it’s important to emphasize the importance of practicing good oral and dental hygiene. It’s a good strategy to put this in writing in medical reports, alongside the usual recommendations about healthy lifestyle habits and monitoring for diseases like high blood pressure, diabetes, or dyslipidemia. These, among other factors like smoking, a sedentary lifestyle, alcoholism, and other drug addictions, are vascular risk factors and are therefore risk factors for stroke and dementia.”

According to Dr. Frank, the public is largely unaware of the relationship between periodontitis and incident neurologic diseases. “We still have a long way to go before we can say that the public is aware of this potential link. And not just the public, either. I believe we must stress among our colleagues and among health care professionals in general the importance of promoting dental health to improve people’s overall health.”

In this regard, Dr. Leira emphasized the authors’ intention to make this report available not only to oral health and neurologic health care professionals but also to primary care physicians and nurses so that patients with cerebrovascular disease or Alzheimer’s disease and their caregivers can develop a greater awareness and thereby improve prevention.

“This study will also provide the scientific basis to support the SEPA-SEN working group as they implement their future activities and projects,” Dr. Leira concluded.

Dr. Leira and Dr. Frank have disclosed no relevant financial relationships.
 

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

An oral oil containing tetrahydrocannabinol (THC) and cannabidiol (CBD) led to a significant and meaningful reduction in motor and vocal tics in patients with severe Tourette syndrome (TS), results of a double-blind, placebo-controlled, crossover study show.

“In a methodologically robust manner (and independent of any drug company sponsorship), we provide evidence for the effectiveness of repeated dosing with THC:CBD vs. placebo in tic suppression, as well as reduction of comorbid anxiety and obsessive-compulsive disorder in severe TS,” neuropsychiatrist and lead investigator Philip Mosley, PhD, said in an interview.

The results offer support to people with TS who “want to approach their doctor to try medicinal cannabis when other drugs have not worked or are intolerable,” said Dr. Mosley, of the Wesley Research Institute and QIMR Berghofer Medical Research Institute, Herston, Australia.

The study was published online in NEJM Evidence.
 

A viable treatment option

Twenty-two adults (mean age, 31 years) with severe TS received THC:CBD oil titrated upward over 6 weeks to a daily dose of 20 mg of THC and 20 mg of CBD, followed by a 6-week course of placebo (or vice versa). Six participants had not previously used cannabis.

The primary outcome was the total tic score on the Yale Global Tic Severity Scale (YGTSS; range 0 to 50 with higher scores = greater tic severity).

The mean baseline YGTSS total tic score was 35.7. At 6 weeks, the reduction in total tic score was 8.9 with THC:CBD vs. 2.5 with placebo.

A linear mixed-effects model (intention-to-treat) showed a significant interaction of treatment and visit number (P = .008), indicating a greater decrease (improvement) in tic score over time with THC:CBD, the study team reported.

On average, the magnitude of the tic reduction was “moderate” and comparable to the effect observed with existing treatments such as antipsychotic agents, the investigators noted.

THC:CBD also led to a reduction in other symptoms associated with TS, particularly symptoms of OCD and anxiety.

The symptomatic response to THC:CBD correlated with serum metabolites of the cannabinoids, further supporting a biological relationship, the researchers noted.

There were no serious adverse events. Adverse effects with THC:CBD were generally mild. The most common adverse effect was cognitive difficulties, including slowed mentation, memory lapses, and poor concentration.

“Like many studies of psychoactive compounds, blinding among participants was a problem,” the researchers noted. Despite best efforts to conceal treatment allocation and match placebo to the active agent in terms of color and smell, most participants were able to correctly guess their treatment order.

Based on the findings in this small trial, larger and longer trials of THC:CBD in TS are warranted, they concluded.

“We need a plurality of treatment options in Tourette syndrome. For some, antipsychotics are effective tic-suppressing agents but for many these benefits are complicated by side effects such as weight gain & sedation,” Dr. Mosley tweeted. “Cannabinoids are a biologically plausible therapeutic agent. The body’s own ‘endocannabinoid’ receptors are concentrated in the basal ganglia – the neuroanatomical nexus of TS.”

The study was funded by the Wesley Medical Research Institute, Brisbane, and the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded research organization at the University of Sydney, Australia. Dr. Mosley reports no relevant financial relationships.
 

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

An oral oil containing tetrahydrocannabinol (THC) and cannabidiol (CBD) led to a significant and meaningful reduction in motor and vocal tics in patients with severe Tourette syndrome (TS), results of a double-blind, placebo-controlled, crossover study show.

“In a methodologically robust manner (and independent of any drug company sponsorship), we provide evidence for the effectiveness of repeated dosing with THC:CBD vs. placebo in tic suppression, as well as reduction of comorbid anxiety and obsessive-compulsive disorder in severe TS,” neuropsychiatrist and lead investigator Philip Mosley, PhD, said in an interview.

The results offer support to people with TS who “want to approach their doctor to try medicinal cannabis when other drugs have not worked or are intolerable,” said Dr. Mosley, of the Wesley Research Institute and QIMR Berghofer Medical Research Institute, Herston, Australia.

The study was published online in NEJM Evidence.
 

A viable treatment option

Twenty-two adults (mean age, 31 years) with severe TS received THC:CBD oil titrated upward over 6 weeks to a daily dose of 20 mg of THC and 20 mg of CBD, followed by a 6-week course of placebo (or vice versa). Six participants had not previously used cannabis.

The primary outcome was the total tic score on the Yale Global Tic Severity Scale (YGTSS; range 0 to 50 with higher scores = greater tic severity).

The mean baseline YGTSS total tic score was 35.7. At 6 weeks, the reduction in total tic score was 8.9 with THC:CBD vs. 2.5 with placebo.

A linear mixed-effects model (intention-to-treat) showed a significant interaction of treatment and visit number (P = .008), indicating a greater decrease (improvement) in tic score over time with THC:CBD, the study team reported.

On average, the magnitude of the tic reduction was “moderate” and comparable to the effect observed with existing treatments such as antipsychotic agents, the investigators noted.

THC:CBD also led to a reduction in other symptoms associated with TS, particularly symptoms of OCD and anxiety.

The symptomatic response to THC:CBD correlated with serum metabolites of the cannabinoids, further supporting a biological relationship, the researchers noted.

There were no serious adverse events. Adverse effects with THC:CBD were generally mild. The most common adverse effect was cognitive difficulties, including slowed mentation, memory lapses, and poor concentration.

“Like many studies of psychoactive compounds, blinding among participants was a problem,” the researchers noted. Despite best efforts to conceal treatment allocation and match placebo to the active agent in terms of color and smell, most participants were able to correctly guess their treatment order.

Based on the findings in this small trial, larger and longer trials of THC:CBD in TS are warranted, they concluded.

“We need a plurality of treatment options in Tourette syndrome. For some, antipsychotics are effective tic-suppressing agents but for many these benefits are complicated by side effects such as weight gain & sedation,” Dr. Mosley tweeted. “Cannabinoids are a biologically plausible therapeutic agent. The body’s own ‘endocannabinoid’ receptors are concentrated in the basal ganglia – the neuroanatomical nexus of TS.”

The study was funded by the Wesley Medical Research Institute, Brisbane, and the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded research organization at the University of Sydney, Australia. Dr. Mosley reports no relevant financial relationships.
 

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

An oral oil containing tetrahydrocannabinol (THC) and cannabidiol (CBD) led to a significant and meaningful reduction in motor and vocal tics in patients with severe Tourette syndrome (TS), results of a double-blind, placebo-controlled, crossover study show.

“In a methodologically robust manner (and independent of any drug company sponsorship), we provide evidence for the effectiveness of repeated dosing with THC:CBD vs. placebo in tic suppression, as well as reduction of comorbid anxiety and obsessive-compulsive disorder in severe TS,” neuropsychiatrist and lead investigator Philip Mosley, PhD, said in an interview.

The results offer support to people with TS who “want to approach their doctor to try medicinal cannabis when other drugs have not worked or are intolerable,” said Dr. Mosley, of the Wesley Research Institute and QIMR Berghofer Medical Research Institute, Herston, Australia.

The study was published online in NEJM Evidence.
 

A viable treatment option

Twenty-two adults (mean age, 31 years) with severe TS received THC:CBD oil titrated upward over 6 weeks to a daily dose of 20 mg of THC and 20 mg of CBD, followed by a 6-week course of placebo (or vice versa). Six participants had not previously used cannabis.

The primary outcome was the total tic score on the Yale Global Tic Severity Scale (YGTSS; range 0 to 50 with higher scores = greater tic severity).

The mean baseline YGTSS total tic score was 35.7. At 6 weeks, the reduction in total tic score was 8.9 with THC:CBD vs. 2.5 with placebo.

A linear mixed-effects model (intention-to-treat) showed a significant interaction of treatment and visit number (P = .008), indicating a greater decrease (improvement) in tic score over time with THC:CBD, the study team reported.

On average, the magnitude of the tic reduction was “moderate” and comparable to the effect observed with existing treatments such as antipsychotic agents, the investigators noted.

THC:CBD also led to a reduction in other symptoms associated with TS, particularly symptoms of OCD and anxiety.

The symptomatic response to THC:CBD correlated with serum metabolites of the cannabinoids, further supporting a biological relationship, the researchers noted.

There were no serious adverse events. Adverse effects with THC:CBD were generally mild. The most common adverse effect was cognitive difficulties, including slowed mentation, memory lapses, and poor concentration.

“Like many studies of psychoactive compounds, blinding among participants was a problem,” the researchers noted. Despite best efforts to conceal treatment allocation and match placebo to the active agent in terms of color and smell, most participants were able to correctly guess their treatment order.

Based on the findings in this small trial, larger and longer trials of THC:CBD in TS are warranted, they concluded.

“We need a plurality of treatment options in Tourette syndrome. For some, antipsychotics are effective tic-suppressing agents but for many these benefits are complicated by side effects such as weight gain & sedation,” Dr. Mosley tweeted. “Cannabinoids are a biologically plausible therapeutic agent. The body’s own ‘endocannabinoid’ receptors are concentrated in the basal ganglia – the neuroanatomical nexus of TS.”

The study was funded by the Wesley Medical Research Institute, Brisbane, and the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded research organization at the University of Sydney, Australia. Dr. Mosley reports no relevant financial relationships.
 

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

DENVER – In the ongoing absence of a reliable biomarker for multiple sclerosis (MS), misdiagnosis is a common and persistent problem that potentially puts patients at prolonged and unnecessary risk. Experts warn that false-negative diagnoses cause treatment delays, while false-positive diagnoses run the risk for potential harm from needless treatment.

“MS has a misdiagnosis problem,” said Patricia Coyle, MD, professor of neurology and vice chair (academic affairs), department of neurology, Stony Brook (N.Y.) University, in presenting on the issue at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“We currently lack a diagnostic biomarker test, yet diagnosis is key. If you get it wrong – that really can be a problem,” Dr. Coyle said. Recent research indicates that MS misdiagnosis is a widespread problem, she added.

For instance, one research paper reported that nearly 20% of patients were misdiagnosed with MS and that more than 50% carried the misdiagnosis for at least 3 years, while 5% were misdiagnosed for 20 years or more.

The misdiagnosis problem is also reflected at large MS referral centers, where 30%-67% of patients turn out not to have the disease, Dr. Coyle noted.

A study from Argentina further highlights some of the key characteristics of misdiagnosis. In this study, examination of a cohort of 572 patients diagnosed with MS revealed that 16% were incorrectly diagnosed with MS and that women were at an 83% greater risk for misdiagnosis than men. Furthermore, the study showed that MS misdiagnosis increased by 8% per year of older age. The most frequent confirmed diagnoses among those who had been initially misdiagnosed as having MS were cerebrovascular disease, radiologically isolated syndrome, and headache.

The majority (83%) of patients incorrectly diagnosed with MS had an atypical presentation that did not indicate demyelination, 70% had an atypical brain magnetic resonance imaging, and 61% received a prescription for a disease-modifying treatment (DMT), despite not having confirmed MS.
 

The dangers of misdiagnosis

Misdiagnosis and incorrect treatment can be particularly dangerous if patients are diagnosed with MS when, in fact, they have neuromyelitis optica spectrum disorder (NMOSD), commonly mistaken for MS, Dr. Coyle noted.

“Several MS DMTs make NMOSD worse. You are also basically giving an unnecessary and inappropriate drug with potential side effects to the misdiagnosed patient,” she said.

There have been some advances in MS diagnosis on MRI. However, there are many caveats, Dr. Coyle noted.

For instance, leptomeningeal enhancement has been considered as an MS diagnostic indicator, but it is not unique to MS, Dr. Coyle noted. In addition, subpial demyelination is MS specific, but it is hard to see and is often missed, she added.

Central vein sign has received significant attention as an important MRI marker for MS, but, Dr. Coyle said, it is “not ready for prime time. It’s somewhat tedious and you need to use special protocols to identify it,” she said.

In the future, artificial intelligence and deep learning may be key to improving some of these technologies, Dr. Coyle noted.
 

Best hope for an accurate diagnosis

In the meantime, Dr. Coyle said she believes spinal fluid evaluation offers the best chance for a reliable MS diagnosis and is her preference. “I personally find spinal fluid to be extremely helpful to support MS diagnosis. Spinal fluid oligoclonal bands are positive in the vast majority of people with MS, and it is an independent finding from MRI to support an MS diagnosis. Added to MRI, it makes you much more comfortable,” she said.

Dr. Coyle said that a comprehensive workup should include:

• A thorough neurologic history and exam.
• MRI of the brain and spinal cord ensuring use of the MS protocol, and personally reading the studies with a neuroradiologist.
• Adding spinal fluid evaluation, especially in any atypical cases.
• Ruling out myelin oligodendrocyte glycoprotein antibody disease and NMOSD, diseases that mimic relapsing MS, via blood IgG to aquaporin 4.

“You want to be as certain as possible. Everything starts with a thorough workup,” Dr. Coyle said.

Dr. Coyle’s disclosures include consulting, nonbranded speaker fees, and/or research support with Actelion, Alkermes, Accordant, Biogen, Bristol Myers Squibb, Celgene, CorEvitas LLC, GlaxoSmithKline, Genentech/Roche, Horizon Therapeutics, Janssen, MedDay, Labcorp, Eli Lilly, Mylan, NINDS, Novartis, Sanofi Genzyme, and TG Therapeutics.

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

DENVER – In the ongoing absence of a reliable biomarker for multiple sclerosis (MS), misdiagnosis is a common and persistent problem that potentially puts patients at prolonged and unnecessary risk. Experts warn that false-negative diagnoses cause treatment delays, while false-positive diagnoses run the risk for potential harm from needless treatment.

“MS has a misdiagnosis problem,” said Patricia Coyle, MD, professor of neurology and vice chair (academic affairs), department of neurology, Stony Brook (N.Y.) University, in presenting on the issue at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“We currently lack a diagnostic biomarker test, yet diagnosis is key. If you get it wrong – that really can be a problem,” Dr. Coyle said. Recent research indicates that MS misdiagnosis is a widespread problem, she added.

For instance, one research paper reported that nearly 20% of patients were misdiagnosed with MS and that more than 50% carried the misdiagnosis for at least 3 years, while 5% were misdiagnosed for 20 years or more.

The misdiagnosis problem is also reflected at large MS referral centers, where 30%-67% of patients turn out not to have the disease, Dr. Coyle noted.

A study from Argentina further highlights some of the key characteristics of misdiagnosis. In this study, examination of a cohort of 572 patients diagnosed with MS revealed that 16% were incorrectly diagnosed with MS and that women were at an 83% greater risk for misdiagnosis than men. Furthermore, the study showed that MS misdiagnosis increased by 8% per year of older age. The most frequent confirmed diagnoses among those who had been initially misdiagnosed as having MS were cerebrovascular disease, radiologically isolated syndrome, and headache.

The majority (83%) of patients incorrectly diagnosed with MS had an atypical presentation that did not indicate demyelination, 70% had an atypical brain magnetic resonance imaging, and 61% received a prescription for a disease-modifying treatment (DMT), despite not having confirmed MS.
 

The dangers of misdiagnosis

Misdiagnosis and incorrect treatment can be particularly dangerous if patients are diagnosed with MS when, in fact, they have neuromyelitis optica spectrum disorder (NMOSD), commonly mistaken for MS, Dr. Coyle noted.

“Several MS DMTs make NMOSD worse. You are also basically giving an unnecessary and inappropriate drug with potential side effects to the misdiagnosed patient,” she said.

There have been some advances in MS diagnosis on MRI. However, there are many caveats, Dr. Coyle noted.

For instance, leptomeningeal enhancement has been considered as an MS diagnostic indicator, but it is not unique to MS, Dr. Coyle noted. In addition, subpial demyelination is MS specific, but it is hard to see and is often missed, she added.

Central vein sign has received significant attention as an important MRI marker for MS, but, Dr. Coyle said, it is “not ready for prime time. It’s somewhat tedious and you need to use special protocols to identify it,” she said.

In the future, artificial intelligence and deep learning may be key to improving some of these technologies, Dr. Coyle noted.
 

Best hope for an accurate diagnosis

In the meantime, Dr. Coyle said she believes spinal fluid evaluation offers the best chance for a reliable MS diagnosis and is her preference. “I personally find spinal fluid to be extremely helpful to support MS diagnosis. Spinal fluid oligoclonal bands are positive in the vast majority of people with MS, and it is an independent finding from MRI to support an MS diagnosis. Added to MRI, it makes you much more comfortable,” she said.

Dr. Coyle said that a comprehensive workup should include:

• A thorough neurologic history and exam.
• MRI of the brain and spinal cord ensuring use of the MS protocol, and personally reading the studies with a neuroradiologist.
• Adding spinal fluid evaluation, especially in any atypical cases.
• Ruling out myelin oligodendrocyte glycoprotein antibody disease and NMOSD, diseases that mimic relapsing MS, via blood IgG to aquaporin 4.

“You want to be as certain as possible. Everything starts with a thorough workup,” Dr. Coyle said.

Dr. Coyle’s disclosures include consulting, nonbranded speaker fees, and/or research support with Actelion, Alkermes, Accordant, Biogen, Bristol Myers Squibb, Celgene, CorEvitas LLC, GlaxoSmithKline, Genentech/Roche, Horizon Therapeutics, Janssen, MedDay, Labcorp, Eli Lilly, Mylan, NINDS, Novartis, Sanofi Genzyme, and TG Therapeutics.

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

DENVER – In the ongoing absence of a reliable biomarker for multiple sclerosis (MS), misdiagnosis is a common and persistent problem that potentially puts patients at prolonged and unnecessary risk. Experts warn that false-negative diagnoses cause treatment delays, while false-positive diagnoses run the risk for potential harm from needless treatment.

“MS has a misdiagnosis problem,” said Patricia Coyle, MD, professor of neurology and vice chair (academic affairs), department of neurology, Stony Brook (N.Y.) University, in presenting on the issue at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“We currently lack a diagnostic biomarker test, yet diagnosis is key. If you get it wrong – that really can be a problem,” Dr. Coyle said. Recent research indicates that MS misdiagnosis is a widespread problem, she added.

For instance, one research paper reported that nearly 20% of patients were misdiagnosed with MS and that more than 50% carried the misdiagnosis for at least 3 years, while 5% were misdiagnosed for 20 years or more.

The misdiagnosis problem is also reflected at large MS referral centers, where 30%-67% of patients turn out not to have the disease, Dr. Coyle noted.

A study from Argentina further highlights some of the key characteristics of misdiagnosis. In this study, examination of a cohort of 572 patients diagnosed with MS revealed that 16% were incorrectly diagnosed with MS and that women were at an 83% greater risk for misdiagnosis than men. Furthermore, the study showed that MS misdiagnosis increased by 8% per year of older age. The most frequent confirmed diagnoses among those who had been initially misdiagnosed as having MS were cerebrovascular disease, radiologically isolated syndrome, and headache.

The majority (83%) of patients incorrectly diagnosed with MS had an atypical presentation that did not indicate demyelination, 70% had an atypical brain magnetic resonance imaging, and 61% received a prescription for a disease-modifying treatment (DMT), despite not having confirmed MS.
 

The dangers of misdiagnosis

Misdiagnosis and incorrect treatment can be particularly dangerous if patients are diagnosed with MS when, in fact, they have neuromyelitis optica spectrum disorder (NMOSD), commonly mistaken for MS, Dr. Coyle noted.

“Several MS DMTs make NMOSD worse. You are also basically giving an unnecessary and inappropriate drug with potential side effects to the misdiagnosed patient,” she said.

There have been some advances in MS diagnosis on MRI. However, there are many caveats, Dr. Coyle noted.

For instance, leptomeningeal enhancement has been considered as an MS diagnostic indicator, but it is not unique to MS, Dr. Coyle noted. In addition, subpial demyelination is MS specific, but it is hard to see and is often missed, she added.

Central vein sign has received significant attention as an important MRI marker for MS, but, Dr. Coyle said, it is “not ready for prime time. It’s somewhat tedious and you need to use special protocols to identify it,” she said.

In the future, artificial intelligence and deep learning may be key to improving some of these technologies, Dr. Coyle noted.
 

Best hope for an accurate diagnosis

In the meantime, Dr. Coyle said she believes spinal fluid evaluation offers the best chance for a reliable MS diagnosis and is her preference. “I personally find spinal fluid to be extremely helpful to support MS diagnosis. Spinal fluid oligoclonal bands are positive in the vast majority of people with MS, and it is an independent finding from MRI to support an MS diagnosis. Added to MRI, it makes you much more comfortable,” she said.

Dr. Coyle said that a comprehensive workup should include:

• A thorough neurologic history and exam.
• MRI of the brain and spinal cord ensuring use of the MS protocol, and personally reading the studies with a neuroradiologist.
• Adding spinal fluid evaluation, especially in any atypical cases.
• Ruling out myelin oligodendrocyte glycoprotein antibody disease and NMOSD, diseases that mimic relapsing MS, via blood IgG to aquaporin 4.

“You want to be as certain as possible. Everything starts with a thorough workup,” Dr. Coyle said.

Dr. Coyle’s disclosures include consulting, nonbranded speaker fees, and/or research support with Actelion, Alkermes, Accordant, Biogen, Bristol Myers Squibb, Celgene, CorEvitas LLC, GlaxoSmithKline, Genentech/Roche, Horizon Therapeutics, Janssen, MedDay, Labcorp, Eli Lilly, Mylan, NINDS, Novartis, Sanofi Genzyme, and TG Therapeutics.

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

Intranasal (IN) ketamine may be a feasible treatment alternative for people with chronic, refractory migraine who don’t respond to other medications, new research shows.

Half of the study participants who used IN ketamine for chronic, treatment-refractory migraine in a new retrospective cohort study reported it as “very effective” and over one-third said it boosted their quality of life.

“In our study, we showed that with even a few uses per day, intranasal ketamine can still improve patients’ quality of life,” lead investigator Hsiangkuo Yuan, MD, PhD, said in an interview. Dr. Yuan is associate professor of neurology at Thomas Jefferson University, Philadelphia, and director of clinical research at the Jefferson Headache Center.

He added that “multiple medications failed these patients, and the majority of patients were having daily headaches. So, if anything works, even partially and shortly, it may still give patients some relief to get through the day.”

The findings were published online in Regional Anesthesia & Pain Medicine.  
 

Daily migraine, failed medications

Use of IN ketamine has not been studied for the treatment of chronic, treatment-refractory migraine – although it has been studied in patients with cluster headache and migraine, the investigators note.

Ketamine is not yet approved by the Food and Drug Administration to treat migraine.

To further explore ketamine’s effect in those with chronic, treatment-refractory migraine, the investigators retrospectively analyzed electronic health records of patients at the Jefferson Headache Center who had received IN ketamine for the treatment of migraine between January 2019 and February 2020.

Of 242 patients who had received IN ketamine, Dr. Yuan’s team followed up with 169 who agreed to be part of the study.

The majority (67%) had daily migraine, and 85% had tried more than three classes of preventive medications for migraine. They currently used a median of two medications, the most common of which was a CGRP monoclonal antibody.

On average, patients used six sprays per day for a median 10 days per month. Median pain relief onset was 52 minutes after dosage.

Almost three-quarters of patients reported at least one side effect from the ketamine, most commonly fatigue (22%), double/blurred vision (21%), and confusion/dissociation (21%). These effects were mostly temporary, the researchers report.

The most common reasons for initiating IN ketamine included an incomplete response to prior acute medications (59%), incomplete response to prior preventive medications (31%), and prior benefit from IV ketamine (23%).

Study investigators noted that ketamine has the potential to become addictive and indicated that “clinicians should only consider the use of a potentially addictive medication such as ketamine for significantly disabled patients with migraine.”

About half of the participants who used IN ketamine found it “very effective,” and 40% found it “somewhat effective.” Within the same group, 36% and 43% found the overall impact of IN ketamine on their quality of life was much better and somewhat better, respectively.

Among those still using ketamine during study follow-up, 82% reported that ketamine was very effective.

Compared with other acute headache medications, IN ketamine was considered much better (43%) or somewhat better (30%).

Nearly 75% of participants reported using fewer pain relievers when using IN ketamine.

Dr. Yuan said that future research might focus on finding predictors for IN ketamine response or determining the optimal effective and safe dose for the drug in those with chronic, treatment-refractory migraine.  

“We still need a prospective, randomized controlled trial to assess the efficacy and tolerability of intranasal ketamine,” he added.
 

‘Impressive result’

Commenting on the findings for this article, Richard Lipton, MD, professor of neurology, psychiatry and behavioral sciences and director of the Montefiore Headache Center at Albert Einstein College of Medicine, New York, said that “in this refractory population with multiple treatment failures, this is a very impressive, open-label result.”

“This real-world data suggests that ketamine is an effective option for people with medically intractable chronic migraine,” said Dr. Lipton, who was not part of the study. “In these very difficult to treat patients, 65% of those who started on ketamine persisted. Of those who remained on ketamine, 82% found it very effective.”

“This study makes me more confident that intranasal ketamine is a helpful treatment option, and I plan to use it more often in the future,” he added.

Like Dr. Yuan, Dr. Lipton highlighted the need for “well-designed placebo-controlled trials” and “rigorous comparative effectiveness studies.”

The study was funded by Miles for Migraine. Dr. Yuan has received institutional support for serving as an investigator from Teva and AbbVie, and royalties from Cambridge University Press and MedLink. Dr. Lipton has received compensation for consultation from Alder/Lumbeck, Axsome, Supernus, Theranica, Upsher-Smith, and Satsuma. He has participated in speaker bureaus for Eli Lilly and Amgen/Novartis and has received institutional support for serving as principal investigator from Teva, GammaCore, and Allergan/AbbVie. He has received payments for authorship or royalties from Demos Medical, Cambridge University Press, and MedLink.

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

Intranasal (IN) ketamine may be a feasible treatment alternative for people with chronic, refractory migraine who don’t respond to other medications, new research shows.

Half of the study participants who used IN ketamine for chronic, treatment-refractory migraine in a new retrospective cohort study reported it as “very effective” and over one-third said it boosted their quality of life.

“In our study, we showed that with even a few uses per day, intranasal ketamine can still improve patients’ quality of life,” lead investigator Hsiangkuo Yuan, MD, PhD, said in an interview. Dr. Yuan is associate professor of neurology at Thomas Jefferson University, Philadelphia, and director of clinical research at the Jefferson Headache Center.

He added that “multiple medications failed these patients, and the majority of patients were having daily headaches. So, if anything works, even partially and shortly, it may still give patients some relief to get through the day.”

The findings were published online in Regional Anesthesia & Pain Medicine.  
 

Daily migraine, failed medications

Use of IN ketamine has not been studied for the treatment of chronic, treatment-refractory migraine – although it has been studied in patients with cluster headache and migraine, the investigators note.

Ketamine is not yet approved by the Food and Drug Administration to treat migraine.

To further explore ketamine’s effect in those with chronic, treatment-refractory migraine, the investigators retrospectively analyzed electronic health records of patients at the Jefferson Headache Center who had received IN ketamine for the treatment of migraine between January 2019 and February 2020.

Of 242 patients who had received IN ketamine, Dr. Yuan’s team followed up with 169 who agreed to be part of the study.

The majority (67%) had daily migraine, and 85% had tried more than three classes of preventive medications for migraine. They currently used a median of two medications, the most common of which was a CGRP monoclonal antibody.

On average, patients used six sprays per day for a median 10 days per month. Median pain relief onset was 52 minutes after dosage.

Almost three-quarters of patients reported at least one side effect from the ketamine, most commonly fatigue (22%), double/blurred vision (21%), and confusion/dissociation (21%). These effects were mostly temporary, the researchers report.

The most common reasons for initiating IN ketamine included an incomplete response to prior acute medications (59%), incomplete response to prior preventive medications (31%), and prior benefit from IV ketamine (23%).

Study investigators noted that ketamine has the potential to become addictive and indicated that “clinicians should only consider the use of a potentially addictive medication such as ketamine for significantly disabled patients with migraine.”

About half of the participants who used IN ketamine found it “very effective,” and 40% found it “somewhat effective.” Within the same group, 36% and 43% found the overall impact of IN ketamine on their quality of life was much better and somewhat better, respectively.

Among those still using ketamine during study follow-up, 82% reported that ketamine was very effective.

Compared with other acute headache medications, IN ketamine was considered much better (43%) or somewhat better (30%).

Nearly 75% of participants reported using fewer pain relievers when using IN ketamine.

Dr. Yuan said that future research might focus on finding predictors for IN ketamine response or determining the optimal effective and safe dose for the drug in those with chronic, treatment-refractory migraine.  

“We still need a prospective, randomized controlled trial to assess the efficacy and tolerability of intranasal ketamine,” he added.
 

‘Impressive result’

Commenting on the findings for this article, Richard Lipton, MD, professor of neurology, psychiatry and behavioral sciences and director of the Montefiore Headache Center at Albert Einstein College of Medicine, New York, said that “in this refractory population with multiple treatment failures, this is a very impressive, open-label result.”

“This real-world data suggests that ketamine is an effective option for people with medically intractable chronic migraine,” said Dr. Lipton, who was not part of the study. “In these very difficult to treat patients, 65% of those who started on ketamine persisted. Of those who remained on ketamine, 82% found it very effective.”

“This study makes me more confident that intranasal ketamine is a helpful treatment option, and I plan to use it more often in the future,” he added.

Like Dr. Yuan, Dr. Lipton highlighted the need for “well-designed placebo-controlled trials” and “rigorous comparative effectiveness studies.”

The study was funded by Miles for Migraine. Dr. Yuan has received institutional support for serving as an investigator from Teva and AbbVie, and royalties from Cambridge University Press and MedLink. Dr. Lipton has received compensation for consultation from Alder/Lumbeck, Axsome, Supernus, Theranica, Upsher-Smith, and Satsuma. He has participated in speaker bureaus for Eli Lilly and Amgen/Novartis and has received institutional support for serving as principal investigator from Teva, GammaCore, and Allergan/AbbVie. He has received payments for authorship or royalties from Demos Medical, Cambridge University Press, and MedLink.

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

Intranasal (IN) ketamine may be a feasible treatment alternative for people with chronic, refractory migraine who don’t respond to other medications, new research shows.

Half of the study participants who used IN ketamine for chronic, treatment-refractory migraine in a new retrospective cohort study reported it as “very effective” and over one-third said it boosted their quality of life.

“In our study, we showed that with even a few uses per day, intranasal ketamine can still improve patients’ quality of life,” lead investigator Hsiangkuo Yuan, MD, PhD, said in an interview. Dr. Yuan is associate professor of neurology at Thomas Jefferson University, Philadelphia, and director of clinical research at the Jefferson Headache Center.

He added that “multiple medications failed these patients, and the majority of patients were having daily headaches. So, if anything works, even partially and shortly, it may still give patients some relief to get through the day.”

The findings were published online in Regional Anesthesia & Pain Medicine.  
 

Daily migraine, failed medications

Use of IN ketamine has not been studied for the treatment of chronic, treatment-refractory migraine – although it has been studied in patients with cluster headache and migraine, the investigators note.

Ketamine is not yet approved by the Food and Drug Administration to treat migraine.

To further explore ketamine’s effect in those with chronic, treatment-refractory migraine, the investigators retrospectively analyzed electronic health records of patients at the Jefferson Headache Center who had received IN ketamine for the treatment of migraine between January 2019 and February 2020.

Of 242 patients who had received IN ketamine, Dr. Yuan’s team followed up with 169 who agreed to be part of the study.

The majority (67%) had daily migraine, and 85% had tried more than three classes of preventive medications for migraine. They currently used a median of two medications, the most common of which was a CGRP monoclonal antibody.

On average, patients used six sprays per day for a median 10 days per month. Median pain relief onset was 52 minutes after dosage.

Almost three-quarters of patients reported at least one side effect from the ketamine, most commonly fatigue (22%), double/blurred vision (21%), and confusion/dissociation (21%). These effects were mostly temporary, the researchers report.

The most common reasons for initiating IN ketamine included an incomplete response to prior acute medications (59%), incomplete response to prior preventive medications (31%), and prior benefit from IV ketamine (23%).

Study investigators noted that ketamine has the potential to become addictive and indicated that “clinicians should only consider the use of a potentially addictive medication such as ketamine for significantly disabled patients with migraine.”

About half of the participants who used IN ketamine found it “very effective,” and 40% found it “somewhat effective.” Within the same group, 36% and 43% found the overall impact of IN ketamine on their quality of life was much better and somewhat better, respectively.

Among those still using ketamine during study follow-up, 82% reported that ketamine was very effective.

Compared with other acute headache medications, IN ketamine was considered much better (43%) or somewhat better (30%).

Nearly 75% of participants reported using fewer pain relievers when using IN ketamine.

Dr. Yuan said that future research might focus on finding predictors for IN ketamine response or determining the optimal effective and safe dose for the drug in those with chronic, treatment-refractory migraine.  

“We still need a prospective, randomized controlled trial to assess the efficacy and tolerability of intranasal ketamine,” he added.
 

‘Impressive result’

Commenting on the findings for this article, Richard Lipton, MD, professor of neurology, psychiatry and behavioral sciences and director of the Montefiore Headache Center at Albert Einstein College of Medicine, New York, said that “in this refractory population with multiple treatment failures, this is a very impressive, open-label result.”

“This real-world data suggests that ketamine is an effective option for people with medically intractable chronic migraine,” said Dr. Lipton, who was not part of the study. “In these very difficult to treat patients, 65% of those who started on ketamine persisted. Of those who remained on ketamine, 82% found it very effective.”

“This study makes me more confident that intranasal ketamine is a helpful treatment option, and I plan to use it more often in the future,” he added.

Like Dr. Yuan, Dr. Lipton highlighted the need for “well-designed placebo-controlled trials” and “rigorous comparative effectiveness studies.”

The study was funded by Miles for Migraine. Dr. Yuan has received institutional support for serving as an investigator from Teva and AbbVie, and royalties from Cambridge University Press and MedLink. Dr. Lipton has received compensation for consultation from Alder/Lumbeck, Axsome, Supernus, Theranica, Upsher-Smith, and Satsuma. He has participated in speaker bureaus for Eli Lilly and Amgen/Novartis and has received institutional support for serving as principal investigator from Teva, GammaCore, and Allergan/AbbVie. He has received payments for authorship or royalties from Demos Medical, Cambridge University Press, and MedLink.

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

Three big bumps on the weight-loss journey

The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.

Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.

Spencer Davis/Unsplash

Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.

Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.

Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”

The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.

“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.

Like we said before, weight loss is a journey. The right support can only improve the odds of success.
 

Robots vs. mosquitoes

If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.

Yet.

Liu et al., 2023, PLOS Neglected Tropical Diseases, CC-BY 4.0

Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.

To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.

The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?

The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
 

This is knot what you were expecting

Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.

Alain Herzog / EPFL

That’s not enough for you, is it? Fine, we were warned.

Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.

For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.

That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.

But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.

The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.

Three big bumps on the weight-loss journey

The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.

Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.

Spencer Davis/Unsplash

Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.

Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.

Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”

The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.

“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.

Like we said before, weight loss is a journey. The right support can only improve the odds of success.
 

Robots vs. mosquitoes

If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.

Yet.

Liu et al., 2023, PLOS Neglected Tropical Diseases, CC-BY 4.0

Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.

To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.

The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?

The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
 

This is knot what you were expecting

Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.

Alain Herzog / EPFL

That’s not enough for you, is it? Fine, we were warned.

Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.

For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.

That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.

But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.

The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.

Three big bumps on the weight-loss journey

The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.

Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.

Spencer Davis/Unsplash

Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.

Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.

Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”

The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.

“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.

Like we said before, weight loss is a journey. The right support can only improve the odds of success.
 

Robots vs. mosquitoes

If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.

Yet.

Liu et al., 2023, PLOS Neglected Tropical Diseases, CC-BY 4.0

Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.

To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.

The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?

The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
 

This is knot what you were expecting

Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.

Alain Herzog / EPFL

That’s not enough for you, is it? Fine, we were warned.

Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.

For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.

That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.

But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.

The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.

A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?

As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. The bill that was introduced in Maine would enable patients to bring suits many years after treatment took place. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.

“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.

Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.

In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
 

Time of injury versus time of discovery

Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.

This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.

Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.

Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.

“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.

Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
 

Medical malpractice statutes of limitations by state

Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”

In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
 

Statutes of limitations by state

1 Year: California, Kentucky, Louisiana, Ohio, Tennessee

2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming

2.5 Years: New York

3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin

4 Years: Minnesota
 

To protect yourself

Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.

“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.

Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.

“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
 

Keep good records

If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.

“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
 

Keep an eye on malpractice insurance rates

It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.

He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.

“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”

Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.

“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.

In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
 

Key takeaways

Ultimately, to protect yourself and your practice, you can do the following:

• Know the statute of limitations and discovery rules for your state.
• Review your coverage with your insurer to better understand your liability.
• Keep accurate records for as long as your statute requires.
• Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.

“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”

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

A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?

As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. The bill that was introduced in Maine would enable patients to bring suits many years after treatment took place. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.

“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.

Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.

In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
 

Time of injury versus time of discovery

Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.

This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.

Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.

Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.

“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.

Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
 

Medical malpractice statutes of limitations by state

Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”

In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
 

Statutes of limitations by state

1 Year: California, Kentucky, Louisiana, Ohio, Tennessee

2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming

2.5 Years: New York

3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin

4 Years: Minnesota
 

To protect yourself

Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.

“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.

Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.

“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
 

Keep good records

If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.

“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
 

Keep an eye on malpractice insurance rates

It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.

He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.

“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”

Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.

“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.

In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
 

Key takeaways

Ultimately, to protect yourself and your practice, you can do the following:

• Know the statute of limitations and discovery rules for your state.
• Review your coverage with your insurer to better understand your liability.
• Keep accurate records for as long as your statute requires.
• Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.

“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”

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

A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?

As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. The bill that was introduced in Maine would enable patients to bring suits many years after treatment took place. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.

“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.

Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.

In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
 

Time of injury versus time of discovery

Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.

This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.

Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.

Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.

“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.

Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
 

Medical malpractice statutes of limitations by state

Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”

In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
 

Statutes of limitations by state

1 Year: California, Kentucky, Louisiana, Ohio, Tennessee

2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming

2.5 Years: New York

3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin

4 Years: Minnesota
 

To protect yourself

Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.

“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.

Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.

“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
 

Keep good records

If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.

“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
 

Keep an eye on malpractice insurance rates

It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.

He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.

“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”

Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.

“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.

In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
 

Key takeaways

Ultimately, to protect yourself and your practice, you can do the following:

• Know the statute of limitations and discovery rules for your state.
• Review your coverage with your insurer to better understand your liability.
• Keep accurate records for as long as your statute requires.
• Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.

“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”

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

As medical practices become increasingly dependent on digital systems, protecting the data they generate becomes an increasingly relevant issue. While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.

You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.

In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.

A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.

Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.

Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.

Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.

Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.

In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.

Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.

It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.


 

Backing up data

I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.

Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.

The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.

The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

As medical practices become increasingly dependent on digital systems, protecting the data they generate becomes an increasingly relevant issue. While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.

You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.

In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.

A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.

Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.

Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.

Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.

Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.

In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.

Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.

It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.


 

Backing up data

I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.

Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.

The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.

The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

As medical practices become increasingly dependent on digital systems, protecting the data they generate becomes an increasingly relevant issue. While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.

You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.

In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.

A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.

Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.

Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.

Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.

Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.

In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.

Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.

It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.


 

Backing up data

I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.

Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.

The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.

The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Insomnia may increase vulnerability to influenza-like illness, a novel finding that was revealed by the passive collection of biometric data from a smart bed.

The study of smart-bed sleepers found that there was a statistically significant correlation between a higher number of episodes of influenza-like illnesses (ILI) per year with longer duration compared to people without insomnia.

However, more research is needed to determine causality and whether insomnia may predispose to ILI or whether ILI affects long-term sleep behavior, the researchers noted. 

“Several lines of evidence make me think that it’s more likely that insomnia makes one more vulnerable to influenza through pathways that involve decreased immune function,” study investigator Gary Garcia-Molina, PhD, with Sleep Number Labs, San Jose, Calif., said in an interview.

Sleep disorders, including insomnia, can dampen immune function and an individual’s ability to fight off illness, he noted.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Smart, connected devices

Pathophysiological responses to respiratory viral infection affect sleep duration and quality in addition to breathing function. “Smart” and “connected” devices that monitor biosignals over time have shown promise for monitoring infectious disease.

In an earlier study presented at SLEEP 2021, Dr. Garcia-Molina and colleagues found that real-world biometric data obtained from a smart bed can help predict and track symptoms of COVID-19 and other respiratory infections. They showed that worsening of COVID-19 symptoms correlated with an increase in sleep duration, breathing rate, and heart rate and a decrease in sleep quality.

In the new study, the researchers evaluated vulnerability to ILI in people with insomnia.

They quantified insomnia over time using the insomnia severity index (ISI). They quantified ILI vulnerability using an established artificial intelligence model they developed that estimates the daily probability of ILI symptoms from a Sleep Number smart bed using ballistocardiograph sensors.

Smart bed data – including daily and restful sleep duration, sleep latency, sleep quality, heart rate, breathing rate and motion level – were queried from 2019 (pre-COVID) and 2021.

A total of 1,680 smart sleepers had nearly constant ISI scores over the study period, with 249 having insomnia and 1,431 not having insomnia.

Data from both 2019 and 2021 show that smart sleepers with insomnia had significantly more and longer ILI episodes per year, compared with peers without insomnia.

For 2019, individuals without insomnia had 1.2 ILI episodes on average, which was significantly less (P < .01) than individuals with insomnia, at 1.5 episodes. The average ILI episode duration for those without insomnia was 4.3 days, which was significantly lower (P < .01) in those with insomnia group, at 6.1 days.

The data for 2021 show similar results, with the no-insomnia group having significantly fewer (P < .01) ILI episodes (about 1.2), compared with the insomnia group (about 1.5).

The average ILI episode duration for the no-insomnia group was 5 days, which was significantly less (P < .01) than the insomnia group, at 6.1 days.

The researchers said their study adds to other data on the relationship between sleep and overall health and well-being. It also highlights the potential health risk of insomnia and the importance of identifying and treating sleep disorders.

“Sleep has such a profound influence on health and wellness and the ability to capture these data unobtrusively in such an easy way and with such a large number of participants paves the way to investigate different aspects of health and disease,” Dr. Garcia-Molina said.
 

Rich data source

In a comment, Adam C. Powell, PhD, president of Payer+Provider Syndicate, a management advisory and operational consulting firm, said “smart beds provide a new data source for passively monitoring the health of individuals.”

“Unlike active monitoring methods requiring self-report, passive monitoring enables data to be captured without an individual taking any action. This data can be potentially integrated with data from other sources, such as pedometers, smart scales, and smart blood pressure cuffs, to gain a more holistic understanding of how an individual’s activities and behaviors impact their well-being,” said Dr. Powell, who wasn’t involved in the study.

There are some methodological limitations to the study, he noted.

“While the dependent variables examined were the duration and presence of episodes of influenza-like illness, they did not directly measure these episodes. Instead, they calculated the daily probability of influenza-like illness symptoms using a model that received input from the ballistocardiograph sensors in the smart beds,” Dr. Powell noted.

“The model used to calculate daily probability of influenza-like illness was created by examining associations between individuals’ smart-bed sensor data and population-level trends in influenza-like illness reported by the Centers for Disease Control and Prevention,” he explained.

Nonetheless, the findings are “consistent with the literature. It has been established by other researchers that impaired sleep is associated with greater risk of influenza, as well as other illnesses,” Dr. Powell said.

Funding for the study was provided by Sleep Number. Dr. Garcia-Molina and five coauthors are employed by Sleep Number. Dr. Powell reported no relevant financial relationships.

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

Insomnia may increase vulnerability to influenza-like illness, a novel finding that was revealed by the passive collection of biometric data from a smart bed.

The study of smart-bed sleepers found that there was a statistically significant correlation between a higher number of episodes of influenza-like illnesses (ILI) per year with longer duration compared to people without insomnia.

However, more research is needed to determine causality and whether insomnia may predispose to ILI or whether ILI affects long-term sleep behavior, the researchers noted. 

“Several lines of evidence make me think that it’s more likely that insomnia makes one more vulnerable to influenza through pathways that involve decreased immune function,” study investigator Gary Garcia-Molina, PhD, with Sleep Number Labs, San Jose, Calif., said in an interview.

Sleep disorders, including insomnia, can dampen immune function and an individual’s ability to fight off illness, he noted.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Smart, connected devices

Pathophysiological responses to respiratory viral infection affect sleep duration and quality in addition to breathing function. “Smart” and “connected” devices that monitor biosignals over time have shown promise for monitoring infectious disease.

In an earlier study presented at SLEEP 2021, Dr. Garcia-Molina and colleagues found that real-world biometric data obtained from a smart bed can help predict and track symptoms of COVID-19 and other respiratory infections. They showed that worsening of COVID-19 symptoms correlated with an increase in sleep duration, breathing rate, and heart rate and a decrease in sleep quality.

In the new study, the researchers evaluated vulnerability to ILI in people with insomnia.

They quantified insomnia over time using the insomnia severity index (ISI). They quantified ILI vulnerability using an established artificial intelligence model they developed that estimates the daily probability of ILI symptoms from a Sleep Number smart bed using ballistocardiograph sensors.

Smart bed data – including daily and restful sleep duration, sleep latency, sleep quality, heart rate, breathing rate and motion level – were queried from 2019 (pre-COVID) and 2021.

A total of 1,680 smart sleepers had nearly constant ISI scores over the study period, with 249 having insomnia and 1,431 not having insomnia.

Data from both 2019 and 2021 show that smart sleepers with insomnia had significantly more and longer ILI episodes per year, compared with peers without insomnia.

For 2019, individuals without insomnia had 1.2 ILI episodes on average, which was significantly less (P < .01) than individuals with insomnia, at 1.5 episodes. The average ILI episode duration for those without insomnia was 4.3 days, which was significantly lower (P < .01) in those with insomnia group, at 6.1 days.

The data for 2021 show similar results, with the no-insomnia group having significantly fewer (P < .01) ILI episodes (about 1.2), compared with the insomnia group (about 1.5).

The average ILI episode duration for the no-insomnia group was 5 days, which was significantly less (P < .01) than the insomnia group, at 6.1 days.

The researchers said their study adds to other data on the relationship between sleep and overall health and well-being. It also highlights the potential health risk of insomnia and the importance of identifying and treating sleep disorders.

“Sleep has such a profound influence on health and wellness and the ability to capture these data unobtrusively in such an easy way and with such a large number of participants paves the way to investigate different aspects of health and disease,” Dr. Garcia-Molina said.
 

Rich data source

In a comment, Adam C. Powell, PhD, president of Payer+Provider Syndicate, a management advisory and operational consulting firm, said “smart beds provide a new data source for passively monitoring the health of individuals.”

“Unlike active monitoring methods requiring self-report, passive monitoring enables data to be captured without an individual taking any action. This data can be potentially integrated with data from other sources, such as pedometers, smart scales, and smart blood pressure cuffs, to gain a more holistic understanding of how an individual’s activities and behaviors impact their well-being,” said Dr. Powell, who wasn’t involved in the study.

There are some methodological limitations to the study, he noted.

“While the dependent variables examined were the duration and presence of episodes of influenza-like illness, they did not directly measure these episodes. Instead, they calculated the daily probability of influenza-like illness symptoms using a model that received input from the ballistocardiograph sensors in the smart beds,” Dr. Powell noted.

“The model used to calculate daily probability of influenza-like illness was created by examining associations between individuals’ smart-bed sensor data and population-level trends in influenza-like illness reported by the Centers for Disease Control and Prevention,” he explained.

Nonetheless, the findings are “consistent with the literature. It has been established by other researchers that impaired sleep is associated with greater risk of influenza, as well as other illnesses,” Dr. Powell said.

Funding for the study was provided by Sleep Number. Dr. Garcia-Molina and five coauthors are employed by Sleep Number. Dr. Powell reported no relevant financial relationships.

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

Insomnia may increase vulnerability to influenza-like illness, a novel finding that was revealed by the passive collection of biometric data from a smart bed.

The study of smart-bed sleepers found that there was a statistically significant correlation between a higher number of episodes of influenza-like illnesses (ILI) per year with longer duration compared to people without insomnia.

However, more research is needed to determine causality and whether insomnia may predispose to ILI or whether ILI affects long-term sleep behavior, the researchers noted. 

“Several lines of evidence make me think that it’s more likely that insomnia makes one more vulnerable to influenza through pathways that involve decreased immune function,” study investigator Gary Garcia-Molina, PhD, with Sleep Number Labs, San Jose, Calif., said in an interview.

Sleep disorders, including insomnia, can dampen immune function and an individual’s ability to fight off illness, he noted.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Smart, connected devices

Pathophysiological responses to respiratory viral infection affect sleep duration and quality in addition to breathing function. “Smart” and “connected” devices that monitor biosignals over time have shown promise for monitoring infectious disease.

In an earlier study presented at SLEEP 2021, Dr. Garcia-Molina and colleagues found that real-world biometric data obtained from a smart bed can help predict and track symptoms of COVID-19 and other respiratory infections. They showed that worsening of COVID-19 symptoms correlated with an increase in sleep duration, breathing rate, and heart rate and a decrease in sleep quality.

In the new study, the researchers evaluated vulnerability to ILI in people with insomnia.

They quantified insomnia over time using the insomnia severity index (ISI). They quantified ILI vulnerability using an established artificial intelligence model they developed that estimates the daily probability of ILI symptoms from a Sleep Number smart bed using ballistocardiograph sensors.

Smart bed data – including daily and restful sleep duration, sleep latency, sleep quality, heart rate, breathing rate and motion level – were queried from 2019 (pre-COVID) and 2021.

A total of 1,680 smart sleepers had nearly constant ISI scores over the study period, with 249 having insomnia and 1,431 not having insomnia.

Data from both 2019 and 2021 show that smart sleepers with insomnia had significantly more and longer ILI episodes per year, compared with peers without insomnia.

For 2019, individuals without insomnia had 1.2 ILI episodes on average, which was significantly less (P < .01) than individuals with insomnia, at 1.5 episodes. The average ILI episode duration for those without insomnia was 4.3 days, which was significantly lower (P < .01) in those with insomnia group, at 6.1 days.

The data for 2021 show similar results, with the no-insomnia group having significantly fewer (P < .01) ILI episodes (about 1.2), compared with the insomnia group (about 1.5).

The average ILI episode duration for the no-insomnia group was 5 days, which was significantly less (P < .01) than the insomnia group, at 6.1 days.

The researchers said their study adds to other data on the relationship between sleep and overall health and well-being. It also highlights the potential health risk of insomnia and the importance of identifying and treating sleep disorders.

“Sleep has such a profound influence on health and wellness and the ability to capture these data unobtrusively in such an easy way and with such a large number of participants paves the way to investigate different aspects of health and disease,” Dr. Garcia-Molina said.
 

Rich data source

In a comment, Adam C. Powell, PhD, president of Payer+Provider Syndicate, a management advisory and operational consulting firm, said “smart beds provide a new data source for passively monitoring the health of individuals.”

“Unlike active monitoring methods requiring self-report, passive monitoring enables data to be captured without an individual taking any action. This data can be potentially integrated with data from other sources, such as pedometers, smart scales, and smart blood pressure cuffs, to gain a more holistic understanding of how an individual’s activities and behaviors impact their well-being,” said Dr. Powell, who wasn’t involved in the study.

There are some methodological limitations to the study, he noted.

“While the dependent variables examined were the duration and presence of episodes of influenza-like illness, they did not directly measure these episodes. Instead, they calculated the daily probability of influenza-like illness symptoms using a model that received input from the ballistocardiograph sensors in the smart beds,” Dr. Powell noted.

“The model used to calculate daily probability of influenza-like illness was created by examining associations between individuals’ smart-bed sensor data and population-level trends in influenza-like illness reported by the Centers for Disease Control and Prevention,” he explained.

Nonetheless, the findings are “consistent with the literature. It has been established by other researchers that impaired sleep is associated with greater risk of influenza, as well as other illnesses,” Dr. Powell said.

Funding for the study was provided by Sleep Number. Dr. Garcia-Molina and five coauthors are employed by Sleep Number. Dr. Powell reported no relevant financial relationships.

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

This transcript has been edited for clarity.

This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent randomized clinical trial suggesting that multivitamins may improve memory and slow cognitive aging, compared with placebo, known as COSMOS (Cocoa Supplement and Multivitamins Outcome Study). This is the second COSMOS trial to show a benefit of multivitamins on memory and cognition. This trial involved a collaboration between Brigham and Columbia University and was published in the American Journal of Clinical Nutrition. I’d like to acknowledge that I am a coauthor of this study, together with Dr. Howard Sesso, who co-leads the main COSMOS trial with me.

Preserving memory and cognitive function is of critical importance to older adults. Nutritional interventions play an important role because we know the brain requires several nutrients for optimal health, and deficiencies in one or more of these nutrients may accelerate cognitive decline. Some of the micronutrients that are known to be important for brain health include vitamin B12, thiamin, other B vitamins, lutein, magnesium, and zinc, among others.

The current trial included 3,500 participants aged 60 or older, looking at performance on a web-based memory test. The multivitamin group did significantly better than the placebo group on memory tests and word recall, a finding that was estimated as the equivalent of slowing age-related memory loss by about 3 years. The benefit was first seen at 1 year and was sustained across the 3 years of the trial.

Intriguingly, in both COSMOS and COSMOS-Web, and the earlier COSMOS-Mind study, which was done in collaboration with Wake Forest, the participants with a history of cardiovascular disease showed the greatest benefits from multivitamins, perhaps due to lower nutrient status. But the basis for this finding needs to be explored further.

A few important caveats need to be emphasized. First, multivitamins and other dietary supplements will never be a substitute for a healthy diet and healthy lifestyle and should not distract from those goals. But multivitamins may have a role as a complementary strategy. Another caveat is that the randomized trials tested recommended dietary allowances and not megadoses of these micronutrients. In fact, randomized trials of high doses of isolated micronutrients have not clearly shown cognitive benefits, and this suggests that more is not necessarily better and may be worse. High doses also may be associated with toxicity, or they may interfere with absorption or bioavailability of other nutrients.

In COSMOS, over the average 3.6 years of follow-up and in the earlier Physicians’ Health Study II,  over 1 year of supplementation, multivitamins were found to be safe without any clear risks or safety concerns. A further caveat is that although Centrum Silver was tested in this trial, we would not expect that this is a brand-specific benefit, and other high-quality multivitamin brands would be expected to confer similar benefits. Of course, it’s important to check bottles for quality-control documentation such as the seals of the U.S. Pharmacopeia, National Science Foundation, ConsumerLab.com, and other auditors.

Overall, the finding that a daily multivitamin improved memory and slowed cognitive decline in two separate COSMOS randomized trials is exciting, suggesting that multivitamin supplementation holds promise as a safe, accessible, and affordable approach to protecting cognitive health in older adults. Further research will be needed to understand who is most likely to benefit and the biological mechanisms involved. Expert committees will have to look at the research and decide whether any changes in guidelines are indicated in the future.

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School and director of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston. She reported receiving funding/donations from Mars Symbioscience.

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

This transcript has been edited for clarity.

This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent randomized clinical trial suggesting that multivitamins may improve memory and slow cognitive aging, compared with placebo, known as COSMOS (Cocoa Supplement and Multivitamins Outcome Study). This is the second COSMOS trial to show a benefit of multivitamins on memory and cognition. This trial involved a collaboration between Brigham and Columbia University and was published in the American Journal of Clinical Nutrition. I’d like to acknowledge that I am a coauthor of this study, together with Dr. Howard Sesso, who co-leads the main COSMOS trial with me.

Preserving memory and cognitive function is of critical importance to older adults. Nutritional interventions play an important role because we know the brain requires several nutrients for optimal health, and deficiencies in one or more of these nutrients may accelerate cognitive decline. Some of the micronutrients that are known to be important for brain health include vitamin B12, thiamin, other B vitamins, lutein, magnesium, and zinc, among others.

The current trial included 3,500 participants aged 60 or older, looking at performance on a web-based memory test. The multivitamin group did significantly better than the placebo group on memory tests and word recall, a finding that was estimated as the equivalent of slowing age-related memory loss by about 3 years. The benefit was first seen at 1 year and was sustained across the 3 years of the trial.

Intriguingly, in both COSMOS and COSMOS-Web, and the earlier COSMOS-Mind study, which was done in collaboration with Wake Forest, the participants with a history of cardiovascular disease showed the greatest benefits from multivitamins, perhaps due to lower nutrient status. But the basis for this finding needs to be explored further.

A few important caveats need to be emphasized. First, multivitamins and other dietary supplements will never be a substitute for a healthy diet and healthy lifestyle and should not distract from those goals. But multivitamins may have a role as a complementary strategy. Another caveat is that the randomized trials tested recommended dietary allowances and not megadoses of these micronutrients. In fact, randomized trials of high doses of isolated micronutrients have not clearly shown cognitive benefits, and this suggests that more is not necessarily better and may be worse. High doses also may be associated with toxicity, or they may interfere with absorption or bioavailability of other nutrients.

In COSMOS, over the average 3.6 years of follow-up and in the earlier Physicians’ Health Study II,  over 1 year of supplementation, multivitamins were found to be safe without any clear risks or safety concerns. A further caveat is that although Centrum Silver was tested in this trial, we would not expect that this is a brand-specific benefit, and other high-quality multivitamin brands would be expected to confer similar benefits. Of course, it’s important to check bottles for quality-control documentation such as the seals of the U.S. Pharmacopeia, National Science Foundation, ConsumerLab.com, and other auditors.

Overall, the finding that a daily multivitamin improved memory and slowed cognitive decline in two separate COSMOS randomized trials is exciting, suggesting that multivitamin supplementation holds promise as a safe, accessible, and affordable approach to protecting cognitive health in older adults. Further research will be needed to understand who is most likely to benefit and the biological mechanisms involved. Expert committees will have to look at the research and decide whether any changes in guidelines are indicated in the future.

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School and director of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston. She reported receiving funding/donations from Mars Symbioscience.

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

This transcript has been edited for clarity.

This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent randomized clinical trial suggesting that multivitamins may improve memory and slow cognitive aging, compared with placebo, known as COSMOS (Cocoa Supplement and Multivitamins Outcome Study). This is the second COSMOS trial to show a benefit of multivitamins on memory and cognition. This trial involved a collaboration between Brigham and Columbia University and was published in the American Journal of Clinical Nutrition. I’d like to acknowledge that I am a coauthor of this study, together with Dr. Howard Sesso, who co-leads the main COSMOS trial with me.

Preserving memory and cognitive function is of critical importance to older adults. Nutritional interventions play an important role because we know the brain requires several nutrients for optimal health, and deficiencies in one or more of these nutrients may accelerate cognitive decline. Some of the micronutrients that are known to be important for brain health include vitamin B12, thiamin, other B vitamins, lutein, magnesium, and zinc, among others.

The current trial included 3,500 participants aged 60 or older, looking at performance on a web-based memory test. The multivitamin group did significantly better than the placebo group on memory tests and word recall, a finding that was estimated as the equivalent of slowing age-related memory loss by about 3 years. The benefit was first seen at 1 year and was sustained across the 3 years of the trial.

Intriguingly, in both COSMOS and COSMOS-Web, and the earlier COSMOS-Mind study, which was done in collaboration with Wake Forest, the participants with a history of cardiovascular disease showed the greatest benefits from multivitamins, perhaps due to lower nutrient status. But the basis for this finding needs to be explored further.

A few important caveats need to be emphasized. First, multivitamins and other dietary supplements will never be a substitute for a healthy diet and healthy lifestyle and should not distract from those goals. But multivitamins may have a role as a complementary strategy. Another caveat is that the randomized trials tested recommended dietary allowances and not megadoses of these micronutrients. In fact, randomized trials of high doses of isolated micronutrients have not clearly shown cognitive benefits, and this suggests that more is not necessarily better and may be worse. High doses also may be associated with toxicity, or they may interfere with absorption or bioavailability of other nutrients.

In COSMOS, over the average 3.6 years of follow-up and in the earlier Physicians’ Health Study II,  over 1 year of supplementation, multivitamins were found to be safe without any clear risks or safety concerns. A further caveat is that although Centrum Silver was tested in this trial, we would not expect that this is a brand-specific benefit, and other high-quality multivitamin brands would be expected to confer similar benefits. Of course, it’s important to check bottles for quality-control documentation such as the seals of the U.S. Pharmacopeia, National Science Foundation, ConsumerLab.com, and other auditors.

Overall, the finding that a daily multivitamin improved memory and slowed cognitive decline in two separate COSMOS randomized trials is exciting, suggesting that multivitamin supplementation holds promise as a safe, accessible, and affordable approach to protecting cognitive health in older adults. Further research will be needed to understand who is most likely to benefit and the biological mechanisms involved. Expert committees will have to look at the research and decide whether any changes in guidelines are indicated in the future.

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School and director of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston. She reported receiving funding/donations from Mars Symbioscience.

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

TOPLINE:

Among Korean women younger than 50 years, hysterectomy is associated with an increased risk of cardiovascular disease (CVD), especially stroke, a new cohort study shows.

METHODOLOGY:

• Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
• Results of previous studies of the association between hysterectomy and CVD were mixed.
• Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
• The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.

TAKEAWAY:

• During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
• The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
• This increase in risk was similar after excluding patients who also underwent adnexal surgery.

IN PRACTICE:

Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.

STUDY DETAILS:

The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.

LIMITATIONS:

The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.

DISCLOSURES:

The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.

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

TOPLINE:

Among Korean women younger than 50 years, hysterectomy is associated with an increased risk of cardiovascular disease (CVD), especially stroke, a new cohort study shows.

METHODOLOGY:

• Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
• Results of previous studies of the association between hysterectomy and CVD were mixed.
• Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
• The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.

TAKEAWAY:

• During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
• The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
• This increase in risk was similar after excluding patients who also underwent adnexal surgery.

IN PRACTICE:

Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.

STUDY DETAILS:

The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.

LIMITATIONS:

The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.

DISCLOSURES:

The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.

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

TOPLINE:

Among Korean women younger than 50 years, hysterectomy is associated with an increased risk of cardiovascular disease (CVD), especially stroke, a new cohort study shows.

METHODOLOGY:

• Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
• Results of previous studies of the association between hysterectomy and CVD were mixed.
• Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
• The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.

TAKEAWAY:

• During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
• The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
• This increase in risk was similar after excluding patients who also underwent adnexal surgery.

IN PRACTICE:

Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.

STUDY DETAILS:

The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.

LIMITATIONS:

The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.

DISCLOSURES:

The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.

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