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Even mild COVID is hard on the brain
early research suggests.
“Our results suggest a severe pattern of changes in how the brain communicates as well as its structure, mainly in people with anxiety and depression with long-COVID syndrome, which affects so many people,” study investigator Clarissa Yasuda, MD, PhD, from University of Campinas, São Paulo, said in a news release.
“The magnitude of these changes suggests that they could lead to problems with memory and thinking skills, so we need to be exploring holistic treatments even for people mildly affected by COVID-19,” Dr. Yasuda added.
The findings were released March 6 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
Brain shrinkage
Some studies have shown a high prevalence of symptoms of anxiety and depression in COVID-19 survivors, but few have investigated the associated cerebral changes, Dr. Yasuda told this news organization.
The study included 254 adults (177 women, 77 men, median age 41 years) who had mild COVID-19 a median of 82 days earlier. A total of 102 had symptoms of both anxiety and depression, and 152 had no such symptoms.
On brain imaging, those with COVID-19 and anxiety and depression had atrophy in the limbic area of the brain, which plays a role in memory and emotional processing.
No shrinkage in this area was evident in people who had COVID-19 without anxiety and depression or in a healthy control group of individuals without COVID-19.
The researchers also observed a “severe” pattern of abnormal cerebral functional connectivity in those with COVID-19 and anxiety and depression.
In this functional connectivity analysis, individuals with COVID-19 and anxiety and depression had widespread functional changes in each of the 12 networks assessed, while those with COVID-19 but without symptoms of anxiety and depression showed changes in only 5 networks.
Mechanisms unclear
“Unfortunately, the underpinning mechanisms associated with brain changes and neuropsychiatric dysfunction after COVID-19 infection are unclear,” Dr. Yasuda told this news organization.
“Some studies have demonstrated an association between symptoms of anxiety and depression with inflammation. However, we hypothesize that these cerebral alterations may result from a more complex interaction of social, psychological, and systemic stressors, including inflammation. It is indeed intriguing that such alterations are present in individuals who presented mild acute infection,” Dr. Yasuda added.
“Symptoms of anxiety and depression are frequently observed after COVID-19 and are part of long-COVID syndrome for some individuals. These symptoms require adequate treatment to improve the quality of life, cognition, and work capacity,” she said.
Treating these symptoms may induce “brain plasticity, which may result in some degree of gray matter increase and eventually prevent further structural and functional damage,” Dr. Yasuda said.
A limitation of the study was that symptoms of anxiety and depression were self-reported, meaning people may have misjudged or misreported symptoms.
Commenting on the findings for this news organization, Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, said the idea that COVID-19 is bad for the brain isn’t new. Dr. Raji was not involved with the study.
Early in the pandemic, Dr. Raji and colleagues published a paper detailing COVID-19’s effects on the brain, and Dr. Raji followed it up with a TED talk on the subject.
“Within the growing framework of what we already know about COVID-19 infection and its adverse effects on the brain, this work incrementally adds to this knowledge by identifying functional and structural neuroimaging abnormalities related to anxiety and depression in persons suffering from COVID-19 infection,” Dr. Raji said.
The study was supported by the São Paulo Research Foundation. The authors have no relevant disclosures. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution LLC.
early research suggests.
“Our results suggest a severe pattern of changes in how the brain communicates as well as its structure, mainly in people with anxiety and depression with long-COVID syndrome, which affects so many people,” study investigator Clarissa Yasuda, MD, PhD, from University of Campinas, São Paulo, said in a news release.
“The magnitude of these changes suggests that they could lead to problems with memory and thinking skills, so we need to be exploring holistic treatments even for people mildly affected by COVID-19,” Dr. Yasuda added.
The findings were released March 6 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
Brain shrinkage
Some studies have shown a high prevalence of symptoms of anxiety and depression in COVID-19 survivors, but few have investigated the associated cerebral changes, Dr. Yasuda told this news organization.
The study included 254 adults (177 women, 77 men, median age 41 years) who had mild COVID-19 a median of 82 days earlier. A total of 102 had symptoms of both anxiety and depression, and 152 had no such symptoms.
On brain imaging, those with COVID-19 and anxiety and depression had atrophy in the limbic area of the brain, which plays a role in memory and emotional processing.
No shrinkage in this area was evident in people who had COVID-19 without anxiety and depression or in a healthy control group of individuals without COVID-19.
The researchers also observed a “severe” pattern of abnormal cerebral functional connectivity in those with COVID-19 and anxiety and depression.
In this functional connectivity analysis, individuals with COVID-19 and anxiety and depression had widespread functional changes in each of the 12 networks assessed, while those with COVID-19 but without symptoms of anxiety and depression showed changes in only 5 networks.
Mechanisms unclear
“Unfortunately, the underpinning mechanisms associated with brain changes and neuropsychiatric dysfunction after COVID-19 infection are unclear,” Dr. Yasuda told this news organization.
“Some studies have demonstrated an association between symptoms of anxiety and depression with inflammation. However, we hypothesize that these cerebral alterations may result from a more complex interaction of social, psychological, and systemic stressors, including inflammation. It is indeed intriguing that such alterations are present in individuals who presented mild acute infection,” Dr. Yasuda added.
“Symptoms of anxiety and depression are frequently observed after COVID-19 and are part of long-COVID syndrome for some individuals. These symptoms require adequate treatment to improve the quality of life, cognition, and work capacity,” she said.
Treating these symptoms may induce “brain plasticity, which may result in some degree of gray matter increase and eventually prevent further structural and functional damage,” Dr. Yasuda said.
A limitation of the study was that symptoms of anxiety and depression were self-reported, meaning people may have misjudged or misreported symptoms.
Commenting on the findings for this news organization, Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, said the idea that COVID-19 is bad for the brain isn’t new. Dr. Raji was not involved with the study.
Early in the pandemic, Dr. Raji and colleagues published a paper detailing COVID-19’s effects on the brain, and Dr. Raji followed it up with a TED talk on the subject.
“Within the growing framework of what we already know about COVID-19 infection and its adverse effects on the brain, this work incrementally adds to this knowledge by identifying functional and structural neuroimaging abnormalities related to anxiety and depression in persons suffering from COVID-19 infection,” Dr. Raji said.
The study was supported by the São Paulo Research Foundation. The authors have no relevant disclosures. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution LLC.
early research suggests.
“Our results suggest a severe pattern of changes in how the brain communicates as well as its structure, mainly in people with anxiety and depression with long-COVID syndrome, which affects so many people,” study investigator Clarissa Yasuda, MD, PhD, from University of Campinas, São Paulo, said in a news release.
“The magnitude of these changes suggests that they could lead to problems with memory and thinking skills, so we need to be exploring holistic treatments even for people mildly affected by COVID-19,” Dr. Yasuda added.
The findings were released March 6 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
Brain shrinkage
Some studies have shown a high prevalence of symptoms of anxiety and depression in COVID-19 survivors, but few have investigated the associated cerebral changes, Dr. Yasuda told this news organization.
The study included 254 adults (177 women, 77 men, median age 41 years) who had mild COVID-19 a median of 82 days earlier. A total of 102 had symptoms of both anxiety and depression, and 152 had no such symptoms.
On brain imaging, those with COVID-19 and anxiety and depression had atrophy in the limbic area of the brain, which plays a role in memory and emotional processing.
No shrinkage in this area was evident in people who had COVID-19 without anxiety and depression or in a healthy control group of individuals without COVID-19.
The researchers also observed a “severe” pattern of abnormal cerebral functional connectivity in those with COVID-19 and anxiety and depression.
In this functional connectivity analysis, individuals with COVID-19 and anxiety and depression had widespread functional changes in each of the 12 networks assessed, while those with COVID-19 but without symptoms of anxiety and depression showed changes in only 5 networks.
Mechanisms unclear
“Unfortunately, the underpinning mechanisms associated with brain changes and neuropsychiatric dysfunction after COVID-19 infection are unclear,” Dr. Yasuda told this news organization.
“Some studies have demonstrated an association between symptoms of anxiety and depression with inflammation. However, we hypothesize that these cerebral alterations may result from a more complex interaction of social, psychological, and systemic stressors, including inflammation. It is indeed intriguing that such alterations are present in individuals who presented mild acute infection,” Dr. Yasuda added.
“Symptoms of anxiety and depression are frequently observed after COVID-19 and are part of long-COVID syndrome for some individuals. These symptoms require adequate treatment to improve the quality of life, cognition, and work capacity,” she said.
Treating these symptoms may induce “brain plasticity, which may result in some degree of gray matter increase and eventually prevent further structural and functional damage,” Dr. Yasuda said.
A limitation of the study was that symptoms of anxiety and depression were self-reported, meaning people may have misjudged or misreported symptoms.
Commenting on the findings for this news organization, Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, said the idea that COVID-19 is bad for the brain isn’t new. Dr. Raji was not involved with the study.
Early in the pandemic, Dr. Raji and colleagues published a paper detailing COVID-19’s effects on the brain, and Dr. Raji followed it up with a TED talk on the subject.
“Within the growing framework of what we already know about COVID-19 infection and its adverse effects on the brain, this work incrementally adds to this knowledge by identifying functional and structural neuroimaging abnormalities related to anxiety and depression in persons suffering from COVID-19 infection,” Dr. Raji said.
The study was supported by the São Paulo Research Foundation. The authors have no relevant disclosures. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution LLC.
High CV risk factor burden in young adults a ‘smoldering’ crisis
New data show a high and rising burden of most cardiovascular (CV) risk factors among young adults aged 20-44 years in the United States.
In this age group, over the past 10 years, there has been an increase in the prevalence of diabetes and obesity, no improvement in the prevalence of hypertension, and a decrease in the prevalence of hyperlipidemia.
Yet medical treatment rates for CV risk factors are “surprisingly” low among young adults, study investigator Rishi Wadhera, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, told this news organization.
The findings are “extremely concerning. We’re witnessing a smoldering public health crisis. The onset of these risk factors earlier in life is associated with a higher lifetime risk of heart disease and potentially life-threatening,” Dr. Wadhera added.
The study was presented March 5 at the joint scientific sessions of the American College of Cardiology and the World Heart Federation and was simultaneously published in JAMA.
The burden of CV risk factors among young adults is “unacceptably high and increasing,” write the co-authors of a JAMA editorial.
“The time is now for aggressive preventive measures in young adults. Without immediate action there will continue to be a rise in heart disease and the burden it places on patients, families, and communities,” say Norrina Allen, PhD, and John Wilkins, MD, with Northwestern University, Chicago.
Preventing a tsunami of heart disease
The findings stem from a cross-sectional study of 12,294 U.S. adults aged 20-44 years (mean age, 32; 51% women) who participated in National Health and Nutrition Examination Survey (NHANES) cycles for 2009-2010 to 2017-2020.
Overall, the prevalence of hypertension was 9.3% in 2009-2010 and increased to 11.5% in 2017-2020. The prevalence of diabetes rose from 3.0% to 4.1%, and the prevalence of obesity rose from 32.7% to 40.9%. The prevalence of hyperlipidemia decreased from 40.5% to 36.1%.
Black adults consistently had high rates of hypertension during the study period – 16.2% in 2009-2010 and 20.1% in 2017-2020 – and significant increases in hypertension occurred among Mexican American adults (from 6.5% to 9.5%) and other Hispanic adults (from 4.4% to 10.5%), while Mexican American adults had a significant uptick in diabetes (from 4.3% to 7.5%).
Equally concerning, said Dr. Wadhera, is the fact that only about 55% of young adults with hypertension were receiving antihypertensive medication, and just 1 in 2 young adults with diabetes were receiving treatment. “These low rates were driven, in part, by many young adults not being aware of their diagnosis,” he noted.
The NHANES data also show that the percentage of young adults who were treated for hypertension and who achieved blood pressure control did not change significantly over the study period (65.0% in 2009-2010 and 74.8% in 2017-2020). Blood sugar control among young adults being treated for diabetes remained suboptimal throughout the study period (45.5% in 2009-2010 and 56.6% in 2017-2020).
“The fact that blood pressure control and glycemic control are so poor is really worrisome,” Jeffrey Berger, MD, director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart, who wasn’t involved in the study, told this news organization.
“Even in the lipid control, while it did get a little bit better, it’s still only around 30%-40%. So, I think we have ways to go as a society,” Dr. Berger noted.
Double down on screening
Dr. Wadhera said “we need to double down on efforts to screen for and treat cardiovascular risk factors like high blood pressure and diabetes in young adults. We need to intensify clinical and public health interventions focused on primordial and primary prevention in young adults now so that we can avoid a tsunami of cardiovascular disease in the long term.”
“It’s critically important that young adults speak with their health care provider about whether – and when – they should undergo screening for high blood pressure, diabetes, and high cholesterol,” Dr. Wadhera added.
Dr. Berger said one problem is that younger people often have a “superman or superwoman” view and don’t comprehend that they are at risk for some of these conditions. Studies such as this “reinforce the idea that it’s never too young to be checked out.”
As a cardiologist who specializes in cardiovascular prevention, Dr. Berger said he sometimes hears patients say things like, “I don’t ever want to need a cardiologist,” or “I hope I never need a cardiologist.”
“My response is, ‘There are many different types of cardiologists,’ and I think it would really be helpful for many people to see a prevention-focused cardiologist way before they have problems,” he said in an interview.
“As a system, medicine has become very good at treating patients with different diseases. I think we need to get better in terms of preventing some of these problems,” Dr. Berger added.
In their editorial, Dr. Allen and Dr. Wilkins say the “foundation of cardiovascular health begins early in life. These worsening trends in risk factors highlight the importance of focusing on prevention in adolescence and young adulthood in order to promote cardiovascular health across the lifetime.”
The study was funded by a grant from the National Heart, Lung, and Blood Institute. Dr. Wadhera has served as a consultant for Abbott and CVS Health. Dr. Wilkins has received personal fees from 3M. Dr. Berger has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New data show a high and rising burden of most cardiovascular (CV) risk factors among young adults aged 20-44 years in the United States.
In this age group, over the past 10 years, there has been an increase in the prevalence of diabetes and obesity, no improvement in the prevalence of hypertension, and a decrease in the prevalence of hyperlipidemia.
Yet medical treatment rates for CV risk factors are “surprisingly” low among young adults, study investigator Rishi Wadhera, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, told this news organization.
The findings are “extremely concerning. We’re witnessing a smoldering public health crisis. The onset of these risk factors earlier in life is associated with a higher lifetime risk of heart disease and potentially life-threatening,” Dr. Wadhera added.
The study was presented March 5 at the joint scientific sessions of the American College of Cardiology and the World Heart Federation and was simultaneously published in JAMA.
The burden of CV risk factors among young adults is “unacceptably high and increasing,” write the co-authors of a JAMA editorial.
“The time is now for aggressive preventive measures in young adults. Without immediate action there will continue to be a rise in heart disease and the burden it places on patients, families, and communities,” say Norrina Allen, PhD, and John Wilkins, MD, with Northwestern University, Chicago.
Preventing a tsunami of heart disease
The findings stem from a cross-sectional study of 12,294 U.S. adults aged 20-44 years (mean age, 32; 51% women) who participated in National Health and Nutrition Examination Survey (NHANES) cycles for 2009-2010 to 2017-2020.
Overall, the prevalence of hypertension was 9.3% in 2009-2010 and increased to 11.5% in 2017-2020. The prevalence of diabetes rose from 3.0% to 4.1%, and the prevalence of obesity rose from 32.7% to 40.9%. The prevalence of hyperlipidemia decreased from 40.5% to 36.1%.
Black adults consistently had high rates of hypertension during the study period – 16.2% in 2009-2010 and 20.1% in 2017-2020 – and significant increases in hypertension occurred among Mexican American adults (from 6.5% to 9.5%) and other Hispanic adults (from 4.4% to 10.5%), while Mexican American adults had a significant uptick in diabetes (from 4.3% to 7.5%).
Equally concerning, said Dr. Wadhera, is the fact that only about 55% of young adults with hypertension were receiving antihypertensive medication, and just 1 in 2 young adults with diabetes were receiving treatment. “These low rates were driven, in part, by many young adults not being aware of their diagnosis,” he noted.
The NHANES data also show that the percentage of young adults who were treated for hypertension and who achieved blood pressure control did not change significantly over the study period (65.0% in 2009-2010 and 74.8% in 2017-2020). Blood sugar control among young adults being treated for diabetes remained suboptimal throughout the study period (45.5% in 2009-2010 and 56.6% in 2017-2020).
“The fact that blood pressure control and glycemic control are so poor is really worrisome,” Jeffrey Berger, MD, director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart, who wasn’t involved in the study, told this news organization.
“Even in the lipid control, while it did get a little bit better, it’s still only around 30%-40%. So, I think we have ways to go as a society,” Dr. Berger noted.
Double down on screening
Dr. Wadhera said “we need to double down on efforts to screen for and treat cardiovascular risk factors like high blood pressure and diabetes in young adults. We need to intensify clinical and public health interventions focused on primordial and primary prevention in young adults now so that we can avoid a tsunami of cardiovascular disease in the long term.”
“It’s critically important that young adults speak with their health care provider about whether – and when – they should undergo screening for high blood pressure, diabetes, and high cholesterol,” Dr. Wadhera added.
Dr. Berger said one problem is that younger people often have a “superman or superwoman” view and don’t comprehend that they are at risk for some of these conditions. Studies such as this “reinforce the idea that it’s never too young to be checked out.”
As a cardiologist who specializes in cardiovascular prevention, Dr. Berger said he sometimes hears patients say things like, “I don’t ever want to need a cardiologist,” or “I hope I never need a cardiologist.”
“My response is, ‘There are many different types of cardiologists,’ and I think it would really be helpful for many people to see a prevention-focused cardiologist way before they have problems,” he said in an interview.
“As a system, medicine has become very good at treating patients with different diseases. I think we need to get better in terms of preventing some of these problems,” Dr. Berger added.
In their editorial, Dr. Allen and Dr. Wilkins say the “foundation of cardiovascular health begins early in life. These worsening trends in risk factors highlight the importance of focusing on prevention in adolescence and young adulthood in order to promote cardiovascular health across the lifetime.”
The study was funded by a grant from the National Heart, Lung, and Blood Institute. Dr. Wadhera has served as a consultant for Abbott and CVS Health. Dr. Wilkins has received personal fees from 3M. Dr. Berger has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New data show a high and rising burden of most cardiovascular (CV) risk factors among young adults aged 20-44 years in the United States.
In this age group, over the past 10 years, there has been an increase in the prevalence of diabetes and obesity, no improvement in the prevalence of hypertension, and a decrease in the prevalence of hyperlipidemia.
Yet medical treatment rates for CV risk factors are “surprisingly” low among young adults, study investigator Rishi Wadhera, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, told this news organization.
The findings are “extremely concerning. We’re witnessing a smoldering public health crisis. The onset of these risk factors earlier in life is associated with a higher lifetime risk of heart disease and potentially life-threatening,” Dr. Wadhera added.
The study was presented March 5 at the joint scientific sessions of the American College of Cardiology and the World Heart Federation and was simultaneously published in JAMA.
The burden of CV risk factors among young adults is “unacceptably high and increasing,” write the co-authors of a JAMA editorial.
“The time is now for aggressive preventive measures in young adults. Without immediate action there will continue to be a rise in heart disease and the burden it places on patients, families, and communities,” say Norrina Allen, PhD, and John Wilkins, MD, with Northwestern University, Chicago.
Preventing a tsunami of heart disease
The findings stem from a cross-sectional study of 12,294 U.S. adults aged 20-44 years (mean age, 32; 51% women) who participated in National Health and Nutrition Examination Survey (NHANES) cycles for 2009-2010 to 2017-2020.
Overall, the prevalence of hypertension was 9.3% in 2009-2010 and increased to 11.5% in 2017-2020. The prevalence of diabetes rose from 3.0% to 4.1%, and the prevalence of obesity rose from 32.7% to 40.9%. The prevalence of hyperlipidemia decreased from 40.5% to 36.1%.
Black adults consistently had high rates of hypertension during the study period – 16.2% in 2009-2010 and 20.1% in 2017-2020 – and significant increases in hypertension occurred among Mexican American adults (from 6.5% to 9.5%) and other Hispanic adults (from 4.4% to 10.5%), while Mexican American adults had a significant uptick in diabetes (from 4.3% to 7.5%).
Equally concerning, said Dr. Wadhera, is the fact that only about 55% of young adults with hypertension were receiving antihypertensive medication, and just 1 in 2 young adults with diabetes were receiving treatment. “These low rates were driven, in part, by many young adults not being aware of their diagnosis,” he noted.
The NHANES data also show that the percentage of young adults who were treated for hypertension and who achieved blood pressure control did not change significantly over the study period (65.0% in 2009-2010 and 74.8% in 2017-2020). Blood sugar control among young adults being treated for diabetes remained suboptimal throughout the study period (45.5% in 2009-2010 and 56.6% in 2017-2020).
“The fact that blood pressure control and glycemic control are so poor is really worrisome,” Jeffrey Berger, MD, director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart, who wasn’t involved in the study, told this news organization.
“Even in the lipid control, while it did get a little bit better, it’s still only around 30%-40%. So, I think we have ways to go as a society,” Dr. Berger noted.
Double down on screening
Dr. Wadhera said “we need to double down on efforts to screen for and treat cardiovascular risk factors like high blood pressure and diabetes in young adults. We need to intensify clinical and public health interventions focused on primordial and primary prevention in young adults now so that we can avoid a tsunami of cardiovascular disease in the long term.”
“It’s critically important that young adults speak with their health care provider about whether – and when – they should undergo screening for high blood pressure, diabetes, and high cholesterol,” Dr. Wadhera added.
Dr. Berger said one problem is that younger people often have a “superman or superwoman” view and don’t comprehend that they are at risk for some of these conditions. Studies such as this “reinforce the idea that it’s never too young to be checked out.”
As a cardiologist who specializes in cardiovascular prevention, Dr. Berger said he sometimes hears patients say things like, “I don’t ever want to need a cardiologist,” or “I hope I never need a cardiologist.”
“My response is, ‘There are many different types of cardiologists,’ and I think it would really be helpful for many people to see a prevention-focused cardiologist way before they have problems,” he said in an interview.
“As a system, medicine has become very good at treating patients with different diseases. I think we need to get better in terms of preventing some of these problems,” Dr. Berger added.
In their editorial, Dr. Allen and Dr. Wilkins say the “foundation of cardiovascular health begins early in life. These worsening trends in risk factors highlight the importance of focusing on prevention in adolescence and young adulthood in order to promote cardiovascular health across the lifetime.”
The study was funded by a grant from the National Heart, Lung, and Blood Institute. Dr. Wadhera has served as a consultant for Abbott and CVS Health. Dr. Wilkins has received personal fees from 3M. Dr. Berger has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACC 2023
Aerobic, breathing exercises tied to faster concussion recovery
, preliminary findings from a new study suggest.
Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.
“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.
“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.
The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
Targeting autonomic dysfunction
Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.
Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.
The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.
The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.
All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.
The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.
Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.
The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.
The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.
Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.
A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
Complex problem
Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.
Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.
“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.
Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.
“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.
“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO2 sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.
“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.
The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, preliminary findings from a new study suggest.
Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.
“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.
“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.
The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
Targeting autonomic dysfunction
Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.
Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.
The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.
The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.
All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.
The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.
Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.
The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.
The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.
Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.
A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
Complex problem
Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.
Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.
“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.
Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.
“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.
“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO2 sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.
“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.
The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, preliminary findings from a new study suggest.
Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.
“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.
“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.
The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
Targeting autonomic dysfunction
Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.
Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.
The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.
The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.
All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.
The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.
Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.
The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.
The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.
Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.
A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
Complex problem
Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.
Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.
“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.
Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.
“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.
“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO2 sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.
“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.
The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAN 2023
Childhood trauma tied to increased Parkinson’s disease severity
new research shows.
Results of the first study to evaluate the relationship between childhood trauma and PD investigators found that the relationship appears to be dose dependent. Patients with PD who reported more than one ACE all experienced a statistically significant decrease in QOL, and for each additional ACE, there was significant worsening of motor symptoms.
This study supports a recent-call to-action paper in JAMA Neurology encouraging adoption of “trauma-informed neurology,” study investigator Indu Subramanian, MD, clinical professor, department of neurology, University of California, Los Angeles, said in an interview.
“We need to start asking about ACEs in everyone. It should be part of our medical intake,” said Dr. Subramanian, who is also the director of the Southwest Parkinson’s Disease Research, Education, and Clinical Center, West Los Angeles Veterans Affairs Medical Center.
The study was published online in Neurology: Clinical Practice.
Hard on the mind and body
A robust body of literature has clearly established a connection between ACEs, which include physical and emotional abuse, neglect, and household dysfunction, and negative physical health outcomes across the lifespan. These include stroke, dementia, diabetes, cancer, cardiovascular disease, autoimmune disorders, hypertension, and premature death as well as psychosocial health outcomes such as anxiety, depression, substance use, and suicide.
However, until now, the effects of childhood trauma have not been evaluated in a PD population.
As part of the MVP study, 712 adults with PD responded to an online survey asking about childhood trauma.
As anticipated, patients with the least reported childhood trauma reported the highest current QOL and lowest patient-reported motor and nonmotor symptom burden compared with peers with higher reported childhood trauma, the researchers reported.
PD symptom burden increased and QOL decreased as the number of ACEs increased.
Patients with ACE scores of 4 or higher reported greater PD symptom severity for 45% of the variables assessed, including apathy, muscle pain, daytime sleepiness, restless leg syndrome, depression, fatigue, comprehension, and anxiety (P < .05), compared with peers with trauma scores of 0.
Limitations of the study included the cross-sectional nature, which prevents making any causal determinations. Also, the ACE questionnaire, because it is self-reported and a retrospective collection of data, introduces the risk for recall bias. In addition, 65% of respondents were women, and racial and ethnic minority groups were not well represented.
Looking ahead, Dr. Subramanian and coauthors believe future research should “attempt to include more diverse populations, attempt improve the response rate of these sensitive questions and, most importantly, determine whether the adverse outcomes associated with childhood trauma can be mitigated with lifestyle modification, psychosocial support, and intervention in adulthood.”
“As a trauma-informed approach, something sorely lacking yet needed in the field of movement disorders, clinicians can proactively screen for ACEs while being mindful to avoid retraumatization,” they suggested. “They can begin to identify how ACEs may physiologically contribute to PD symptom and focus on targeting appropriate interventions that may improve outcomes.”
Life experiences matter
In a comment, Michael S. Okun, MD, medical advisor, Parkinson’s Foundation, and director of the Norman Fixel Institute for Neurological Diseases, University of Florida Health, Gainesville, said that “the idea that childhood trauma could be associated with a mild increase in severity of Parkinson’s symptoms such as apathy, pain, sleepiness and depression is fascinating.”
“We should however temper our enthusiasm for the results of this study because they were obtained through a direct patient survey, and not collected from large well characterized medical database,” Dr. Okun said.
He added” “If the data on childhood trauma and Parkinson’s can be replicated, we must ask why this could be?
“For Parkinson clinicians this as a reminder of how important obtaining a complete life history can be when strategizing on a plan to reduce motor and nonmotor Parkinson symptoms. Life experiences matter and can impact symptoms,” Dr. Okun said.
The MVP study was initiated with support of the National Center for Complementary and Integrative Health. The ongoing data collection has been supported by a donation from Sondra and Bill Fondren. Dr. Subramanian and Dr. Okun disclosed no potential conflicts of interest.
A version of this article first appeared on Medscape.com.
new research shows.
Results of the first study to evaluate the relationship between childhood trauma and PD investigators found that the relationship appears to be dose dependent. Patients with PD who reported more than one ACE all experienced a statistically significant decrease in QOL, and for each additional ACE, there was significant worsening of motor symptoms.
This study supports a recent-call to-action paper in JAMA Neurology encouraging adoption of “trauma-informed neurology,” study investigator Indu Subramanian, MD, clinical professor, department of neurology, University of California, Los Angeles, said in an interview.
“We need to start asking about ACEs in everyone. It should be part of our medical intake,” said Dr. Subramanian, who is also the director of the Southwest Parkinson’s Disease Research, Education, and Clinical Center, West Los Angeles Veterans Affairs Medical Center.
The study was published online in Neurology: Clinical Practice.
Hard on the mind and body
A robust body of literature has clearly established a connection between ACEs, which include physical and emotional abuse, neglect, and household dysfunction, and negative physical health outcomes across the lifespan. These include stroke, dementia, diabetes, cancer, cardiovascular disease, autoimmune disorders, hypertension, and premature death as well as psychosocial health outcomes such as anxiety, depression, substance use, and suicide.
However, until now, the effects of childhood trauma have not been evaluated in a PD population.
As part of the MVP study, 712 adults with PD responded to an online survey asking about childhood trauma.
As anticipated, patients with the least reported childhood trauma reported the highest current QOL and lowest patient-reported motor and nonmotor symptom burden compared with peers with higher reported childhood trauma, the researchers reported.
PD symptom burden increased and QOL decreased as the number of ACEs increased.
Patients with ACE scores of 4 or higher reported greater PD symptom severity for 45% of the variables assessed, including apathy, muscle pain, daytime sleepiness, restless leg syndrome, depression, fatigue, comprehension, and anxiety (P < .05), compared with peers with trauma scores of 0.
Limitations of the study included the cross-sectional nature, which prevents making any causal determinations. Also, the ACE questionnaire, because it is self-reported and a retrospective collection of data, introduces the risk for recall bias. In addition, 65% of respondents were women, and racial and ethnic minority groups were not well represented.
Looking ahead, Dr. Subramanian and coauthors believe future research should “attempt to include more diverse populations, attempt improve the response rate of these sensitive questions and, most importantly, determine whether the adverse outcomes associated with childhood trauma can be mitigated with lifestyle modification, psychosocial support, and intervention in adulthood.”
“As a trauma-informed approach, something sorely lacking yet needed in the field of movement disorders, clinicians can proactively screen for ACEs while being mindful to avoid retraumatization,” they suggested. “They can begin to identify how ACEs may physiologically contribute to PD symptom and focus on targeting appropriate interventions that may improve outcomes.”
Life experiences matter
In a comment, Michael S. Okun, MD, medical advisor, Parkinson’s Foundation, and director of the Norman Fixel Institute for Neurological Diseases, University of Florida Health, Gainesville, said that “the idea that childhood trauma could be associated with a mild increase in severity of Parkinson’s symptoms such as apathy, pain, sleepiness and depression is fascinating.”
“We should however temper our enthusiasm for the results of this study because they were obtained through a direct patient survey, and not collected from large well characterized medical database,” Dr. Okun said.
He added” “If the data on childhood trauma and Parkinson’s can be replicated, we must ask why this could be?
“For Parkinson clinicians this as a reminder of how important obtaining a complete life history can be when strategizing on a plan to reduce motor and nonmotor Parkinson symptoms. Life experiences matter and can impact symptoms,” Dr. Okun said.
The MVP study was initiated with support of the National Center for Complementary and Integrative Health. The ongoing data collection has been supported by a donation from Sondra and Bill Fondren. Dr. Subramanian and Dr. Okun disclosed no potential conflicts of interest.
A version of this article first appeared on Medscape.com.
new research shows.
Results of the first study to evaluate the relationship between childhood trauma and PD investigators found that the relationship appears to be dose dependent. Patients with PD who reported more than one ACE all experienced a statistically significant decrease in QOL, and for each additional ACE, there was significant worsening of motor symptoms.
This study supports a recent-call to-action paper in JAMA Neurology encouraging adoption of “trauma-informed neurology,” study investigator Indu Subramanian, MD, clinical professor, department of neurology, University of California, Los Angeles, said in an interview.
“We need to start asking about ACEs in everyone. It should be part of our medical intake,” said Dr. Subramanian, who is also the director of the Southwest Parkinson’s Disease Research, Education, and Clinical Center, West Los Angeles Veterans Affairs Medical Center.
The study was published online in Neurology: Clinical Practice.
Hard on the mind and body
A robust body of literature has clearly established a connection between ACEs, which include physical and emotional abuse, neglect, and household dysfunction, and negative physical health outcomes across the lifespan. These include stroke, dementia, diabetes, cancer, cardiovascular disease, autoimmune disorders, hypertension, and premature death as well as psychosocial health outcomes such as anxiety, depression, substance use, and suicide.
However, until now, the effects of childhood trauma have not been evaluated in a PD population.
As part of the MVP study, 712 adults with PD responded to an online survey asking about childhood trauma.
As anticipated, patients with the least reported childhood trauma reported the highest current QOL and lowest patient-reported motor and nonmotor symptom burden compared with peers with higher reported childhood trauma, the researchers reported.
PD symptom burden increased and QOL decreased as the number of ACEs increased.
Patients with ACE scores of 4 or higher reported greater PD symptom severity for 45% of the variables assessed, including apathy, muscle pain, daytime sleepiness, restless leg syndrome, depression, fatigue, comprehension, and anxiety (P < .05), compared with peers with trauma scores of 0.
Limitations of the study included the cross-sectional nature, which prevents making any causal determinations. Also, the ACE questionnaire, because it is self-reported and a retrospective collection of data, introduces the risk for recall bias. In addition, 65% of respondents were women, and racial and ethnic minority groups were not well represented.
Looking ahead, Dr. Subramanian and coauthors believe future research should “attempt to include more diverse populations, attempt improve the response rate of these sensitive questions and, most importantly, determine whether the adverse outcomes associated with childhood trauma can be mitigated with lifestyle modification, psychosocial support, and intervention in adulthood.”
“As a trauma-informed approach, something sorely lacking yet needed in the field of movement disorders, clinicians can proactively screen for ACEs while being mindful to avoid retraumatization,” they suggested. “They can begin to identify how ACEs may physiologically contribute to PD symptom and focus on targeting appropriate interventions that may improve outcomes.”
Life experiences matter
In a comment, Michael S. Okun, MD, medical advisor, Parkinson’s Foundation, and director of the Norman Fixel Institute for Neurological Diseases, University of Florida Health, Gainesville, said that “the idea that childhood trauma could be associated with a mild increase in severity of Parkinson’s symptoms such as apathy, pain, sleepiness and depression is fascinating.”
“We should however temper our enthusiasm for the results of this study because they were obtained through a direct patient survey, and not collected from large well characterized medical database,” Dr. Okun said.
He added” “If the data on childhood trauma and Parkinson’s can be replicated, we must ask why this could be?
“For Parkinson clinicians this as a reminder of how important obtaining a complete life history can be when strategizing on a plan to reduce motor and nonmotor Parkinson symptoms. Life experiences matter and can impact symptoms,” Dr. Okun said.
The MVP study was initiated with support of the National Center for Complementary and Integrative Health. The ongoing data collection has been supported by a donation from Sondra and Bill Fondren. Dr. Subramanian and Dr. Okun disclosed no potential conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY: CLINICAL PRACTICE
Does CRC risk in IBD extend to close family members?
new research suggests.
In a large Swedish study, a history of IBD among first-degree relatives was not associated with an increased risk of CRC, even when considering various characteristics of IBD and CRC history.
The findings suggest that extra screening for CRC may not be needed for children, siblings, or parents of those with IBD, say the study authors, led by Kai Wang, MD, PhD, with Harvard School of Public Health, Boston. The findings strengthen the theory that it’s inflammation or atypism of the colon of people with IBD that confers the increased CRC risk.
“There is nothing in this study that changes our existing practice,” said Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who was not involved in the research. “It is already the thought that inflammation in IBD increases risk of cancer,” which would not increase CRC risk among family members.
The study appeared in the International Journal of Cancer.
Patients with IBD are known to be at increased risk for CRC. However, the association between family history of IBD and CRC risk remains less clear. Current CRC screening recommendations are the same for patients who have family members with IBD and for those who do not.
The Swedish nationwide case-control study included 69,659 individuals with CRC, of whom 1,599 (2.3%) had IBD, and 343,032 matched control persons who did not have CRC, of whom 1,477 (0.4%) had IBD.
Overall, 2.2% of CRC case patients and control patients had at least one first-degree relative who had a history of IBD.
After adjusting for family history of CRC, the authors did not find an increase in risk for CRC among first-degree relatives of people with IBD (odds ratio, 0.96; 95% confidence interval, 0.91-1.02).
The null association was consistently observed regardless of IBD subtype (Crohn’s disease or ulcerative colitis), the number of first-degree relatives with IBD, age at first IBD diagnosis, maximum location or extent of IBD, or type of relative (parent, sibling, or offspring). The null association remained for early-onset CRC diagnosed before age 50.
Overall, these findings suggest that IBD and CRC may not have substantial familial clustering or shared genetic susceptibility and provide “robust evidence that a family history of IBD did not increase the risk of CRC, supporting use of the same routine CRC screening strategy in offspring, siblings, and parents of IBD patients as in the general population,” Dr. Wang and colleagues conclude.
This “well-done” study is one of the largest to date to evaluate first-degree relatives of IBD patients and their risk of CRC, said Shannon Chang, MD, with NYU Langone Health Inflammatory Bowel Disease Center, who wasn’t involved in the research.
The findings are reassuring, as the authors assessed several factors and found that family members of patients with IBD are not at higher risk for CRC, compared with the general population, Dr. Chang added.
Support for the study was provided by the National Institutes of Health, the American Cancer Society, ALF funding, the Swedish Research Council, and the Swedish Cancer Foundation. Dr. Wang, Dr. Chang, and Dr. Ananthakrishnan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
In a large Swedish study, a history of IBD among first-degree relatives was not associated with an increased risk of CRC, even when considering various characteristics of IBD and CRC history.
The findings suggest that extra screening for CRC may not be needed for children, siblings, or parents of those with IBD, say the study authors, led by Kai Wang, MD, PhD, with Harvard School of Public Health, Boston. The findings strengthen the theory that it’s inflammation or atypism of the colon of people with IBD that confers the increased CRC risk.
“There is nothing in this study that changes our existing practice,” said Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who was not involved in the research. “It is already the thought that inflammation in IBD increases risk of cancer,” which would not increase CRC risk among family members.
The study appeared in the International Journal of Cancer.
Patients with IBD are known to be at increased risk for CRC. However, the association between family history of IBD and CRC risk remains less clear. Current CRC screening recommendations are the same for patients who have family members with IBD and for those who do not.
The Swedish nationwide case-control study included 69,659 individuals with CRC, of whom 1,599 (2.3%) had IBD, and 343,032 matched control persons who did not have CRC, of whom 1,477 (0.4%) had IBD.
Overall, 2.2% of CRC case patients and control patients had at least one first-degree relative who had a history of IBD.
After adjusting for family history of CRC, the authors did not find an increase in risk for CRC among first-degree relatives of people with IBD (odds ratio, 0.96; 95% confidence interval, 0.91-1.02).
The null association was consistently observed regardless of IBD subtype (Crohn’s disease or ulcerative colitis), the number of first-degree relatives with IBD, age at first IBD diagnosis, maximum location or extent of IBD, or type of relative (parent, sibling, or offspring). The null association remained for early-onset CRC diagnosed before age 50.
Overall, these findings suggest that IBD and CRC may not have substantial familial clustering or shared genetic susceptibility and provide “robust evidence that a family history of IBD did not increase the risk of CRC, supporting use of the same routine CRC screening strategy in offspring, siblings, and parents of IBD patients as in the general population,” Dr. Wang and colleagues conclude.
This “well-done” study is one of the largest to date to evaluate first-degree relatives of IBD patients and their risk of CRC, said Shannon Chang, MD, with NYU Langone Health Inflammatory Bowel Disease Center, who wasn’t involved in the research.
The findings are reassuring, as the authors assessed several factors and found that family members of patients with IBD are not at higher risk for CRC, compared with the general population, Dr. Chang added.
Support for the study was provided by the National Institutes of Health, the American Cancer Society, ALF funding, the Swedish Research Council, and the Swedish Cancer Foundation. Dr. Wang, Dr. Chang, and Dr. Ananthakrishnan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
In a large Swedish study, a history of IBD among first-degree relatives was not associated with an increased risk of CRC, even when considering various characteristics of IBD and CRC history.
The findings suggest that extra screening for CRC may not be needed for children, siblings, or parents of those with IBD, say the study authors, led by Kai Wang, MD, PhD, with Harvard School of Public Health, Boston. The findings strengthen the theory that it’s inflammation or atypism of the colon of people with IBD that confers the increased CRC risk.
“There is nothing in this study that changes our existing practice,” said Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who was not involved in the research. “It is already the thought that inflammation in IBD increases risk of cancer,” which would not increase CRC risk among family members.
The study appeared in the International Journal of Cancer.
Patients with IBD are known to be at increased risk for CRC. However, the association between family history of IBD and CRC risk remains less clear. Current CRC screening recommendations are the same for patients who have family members with IBD and for those who do not.
The Swedish nationwide case-control study included 69,659 individuals with CRC, of whom 1,599 (2.3%) had IBD, and 343,032 matched control persons who did not have CRC, of whom 1,477 (0.4%) had IBD.
Overall, 2.2% of CRC case patients and control patients had at least one first-degree relative who had a history of IBD.
After adjusting for family history of CRC, the authors did not find an increase in risk for CRC among first-degree relatives of people with IBD (odds ratio, 0.96; 95% confidence interval, 0.91-1.02).
The null association was consistently observed regardless of IBD subtype (Crohn’s disease or ulcerative colitis), the number of first-degree relatives with IBD, age at first IBD diagnosis, maximum location or extent of IBD, or type of relative (parent, sibling, or offspring). The null association remained for early-onset CRC diagnosed before age 50.
Overall, these findings suggest that IBD and CRC may not have substantial familial clustering or shared genetic susceptibility and provide “robust evidence that a family history of IBD did not increase the risk of CRC, supporting use of the same routine CRC screening strategy in offspring, siblings, and parents of IBD patients as in the general population,” Dr. Wang and colleagues conclude.
This “well-done” study is one of the largest to date to evaluate first-degree relatives of IBD patients and their risk of CRC, said Shannon Chang, MD, with NYU Langone Health Inflammatory Bowel Disease Center, who wasn’t involved in the research.
The findings are reassuring, as the authors assessed several factors and found that family members of patients with IBD are not at higher risk for CRC, compared with the general population, Dr. Chang added.
Support for the study was provided by the National Institutes of Health, the American Cancer Society, ALF funding, the Swedish Research Council, and the Swedish Cancer Foundation. Dr. Wang, Dr. Chang, and Dr. Ananthakrishnan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF CANCER
FDA declines approval for omecamtiv mecarbil in HFrEF
The Food and Drug Administration has declined to approve omecamtiv mecarbil (Cytokinetics) for treatment of adults with chronic heart failure with reduced ejection fraction (HFrEF), citing a lack of evidence on efficacy.
Omecamtiv mecarbil is a first-in-class, selective cardiac myosin activator designed to improve cardiac performance.
Last December, a panel of FDA advisers recommended against approval of omecamtiv mecarbil for chronic HFrEF, as reported by this news organization.
The FDA Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 (with no abstentions) that the benefits of omecamtiv mecarbil do not outweigh the risks for HFrEF. The drug had a PDUFA date of February 28.
The committee’s decision was based on results from the phase 3 GALACTIC-HF trial, which enrolled 8,256 patients with HFrEF who were at risk of hospitalization and death, despite standard-of-care therapy.
As previously reported by this news organization, omecamtiv mecarbil produced a positive result for the study’s primary endpoint, with a 2.1% absolute reduction in the combined rate of cardiovascular (CV) death, first HF hospitalization, or first urgent visit for HF, compared with placebo during a median follow-up of about 22 months.
This represented an 8% relative risk reduction and broke down as a 0.6% absolute drop in CV death, compared with placebo, a 0.7% cut in HF hospitalization, and a 0.8% drop in urgent outpatient HF visits.
In a complete response letter, the FDA said GALACTIC-HF is “not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death” in adults with HFrEF, Cytokinetics shared in a news release.
Further, the FDA said results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks, Cytokinetics said.
The company said it will request a meeting with the FDA to gain a better understanding of what may be required to support potential approval of omecamtiv mecarbil. However, the company also said it has “no plans” to conduct an additional clinical trial of omecamtiv mecarbil.
Instead, the company said its focus remains on the development of aficamten, the next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has declined to approve omecamtiv mecarbil (Cytokinetics) for treatment of adults with chronic heart failure with reduced ejection fraction (HFrEF), citing a lack of evidence on efficacy.
Omecamtiv mecarbil is a first-in-class, selective cardiac myosin activator designed to improve cardiac performance.
Last December, a panel of FDA advisers recommended against approval of omecamtiv mecarbil for chronic HFrEF, as reported by this news organization.
The FDA Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 (with no abstentions) that the benefits of omecamtiv mecarbil do not outweigh the risks for HFrEF. The drug had a PDUFA date of February 28.
The committee’s decision was based on results from the phase 3 GALACTIC-HF trial, which enrolled 8,256 patients with HFrEF who were at risk of hospitalization and death, despite standard-of-care therapy.
As previously reported by this news organization, omecamtiv mecarbil produced a positive result for the study’s primary endpoint, with a 2.1% absolute reduction in the combined rate of cardiovascular (CV) death, first HF hospitalization, or first urgent visit for HF, compared with placebo during a median follow-up of about 22 months.
This represented an 8% relative risk reduction and broke down as a 0.6% absolute drop in CV death, compared with placebo, a 0.7% cut in HF hospitalization, and a 0.8% drop in urgent outpatient HF visits.
In a complete response letter, the FDA said GALACTIC-HF is “not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death” in adults with HFrEF, Cytokinetics shared in a news release.
Further, the FDA said results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks, Cytokinetics said.
The company said it will request a meeting with the FDA to gain a better understanding of what may be required to support potential approval of omecamtiv mecarbil. However, the company also said it has “no plans” to conduct an additional clinical trial of omecamtiv mecarbil.
Instead, the company said its focus remains on the development of aficamten, the next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has declined to approve omecamtiv mecarbil (Cytokinetics) for treatment of adults with chronic heart failure with reduced ejection fraction (HFrEF), citing a lack of evidence on efficacy.
Omecamtiv mecarbil is a first-in-class, selective cardiac myosin activator designed to improve cardiac performance.
Last December, a panel of FDA advisers recommended against approval of omecamtiv mecarbil for chronic HFrEF, as reported by this news organization.
The FDA Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 (with no abstentions) that the benefits of omecamtiv mecarbil do not outweigh the risks for HFrEF. The drug had a PDUFA date of February 28.
The committee’s decision was based on results from the phase 3 GALACTIC-HF trial, which enrolled 8,256 patients with HFrEF who were at risk of hospitalization and death, despite standard-of-care therapy.
As previously reported by this news organization, omecamtiv mecarbil produced a positive result for the study’s primary endpoint, with a 2.1% absolute reduction in the combined rate of cardiovascular (CV) death, first HF hospitalization, or first urgent visit for HF, compared with placebo during a median follow-up of about 22 months.
This represented an 8% relative risk reduction and broke down as a 0.6% absolute drop in CV death, compared with placebo, a 0.7% cut in HF hospitalization, and a 0.8% drop in urgent outpatient HF visits.
In a complete response letter, the FDA said GALACTIC-HF is “not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death” in adults with HFrEF, Cytokinetics shared in a news release.
Further, the FDA said results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks, Cytokinetics said.
The company said it will request a meeting with the FDA to gain a better understanding of what may be required to support potential approval of omecamtiv mecarbil. However, the company also said it has “no plans” to conduct an additional clinical trial of omecamtiv mecarbil.
Instead, the company said its focus remains on the development of aficamten, the next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy.
A version of this article first appeared on Medscape.com.
FDA warns of potential problems with Abbott Trifecta valves
There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the U.S. Food and Drug Administration says in a letter to health care professionals posted on its website.
Evidence in the literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.
The Trifecta and Trifecta GT valves are heart valve replacement devices intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves, the letter notes. The first-generation Trifecta valve was approved in 2011 but is no longer marketed in the United States. The Trifecta GT valve was approved in 2016.
Medical device reports (MDRs) received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant. “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death,” the FDA notes.
In a letter to customers, Abbott says a “complaint analysis has shown that most cases of early SVD which occur within 5 years post-implant are characterized as a non-calcific leaflet tear, while most cases of late SVD which occur beyond 5 years post-implant are characterized as a fibrous-calcific SVD.”
The FDA recommends that health care providers take the following actions:
- Be aware of the potential risk of early SVD with Trifecta valves, and current patient management considerations, as communicated by Abbott.
- Discuss the risks and benefits of all available aortic valve treatment options with patients and caregivers as part of shared clinical decision-making prior to surgery.
- Read and carefully follow the Instructions for Use when implanting a Trifecta GT valve.
- Monitor patients who have undergone implantation with Trifecta valves for signs and symptoms of potential SVD.
- Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
- Ensure lifelong follow-up visits, conducted at least yearly, including transthoracic echocardiogram assessment of the valve beginning 1-year post-implant.
The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.
Clinicians are encouraged to report any adverse events or quality problems with the Trifecta valves to their local Abbott representative or the customer service department at 1-800-544-1664.
Health care professionals can also report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the U.S. Food and Drug Administration says in a letter to health care professionals posted on its website.
Evidence in the literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.
The Trifecta and Trifecta GT valves are heart valve replacement devices intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves, the letter notes. The first-generation Trifecta valve was approved in 2011 but is no longer marketed in the United States. The Trifecta GT valve was approved in 2016.
Medical device reports (MDRs) received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant. “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death,” the FDA notes.
In a letter to customers, Abbott says a “complaint analysis has shown that most cases of early SVD which occur within 5 years post-implant are characterized as a non-calcific leaflet tear, while most cases of late SVD which occur beyond 5 years post-implant are characterized as a fibrous-calcific SVD.”
The FDA recommends that health care providers take the following actions:
- Be aware of the potential risk of early SVD with Trifecta valves, and current patient management considerations, as communicated by Abbott.
- Discuss the risks and benefits of all available aortic valve treatment options with patients and caregivers as part of shared clinical decision-making prior to surgery.
- Read and carefully follow the Instructions for Use when implanting a Trifecta GT valve.
- Monitor patients who have undergone implantation with Trifecta valves for signs and symptoms of potential SVD.
- Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
- Ensure lifelong follow-up visits, conducted at least yearly, including transthoracic echocardiogram assessment of the valve beginning 1-year post-implant.
The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.
Clinicians are encouraged to report any adverse events or quality problems with the Trifecta valves to their local Abbott representative or the customer service department at 1-800-544-1664.
Health care professionals can also report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the U.S. Food and Drug Administration says in a letter to health care professionals posted on its website.
Evidence in the literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.
The Trifecta and Trifecta GT valves are heart valve replacement devices intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves, the letter notes. The first-generation Trifecta valve was approved in 2011 but is no longer marketed in the United States. The Trifecta GT valve was approved in 2016.
Medical device reports (MDRs) received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant. “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death,” the FDA notes.
In a letter to customers, Abbott says a “complaint analysis has shown that most cases of early SVD which occur within 5 years post-implant are characterized as a non-calcific leaflet tear, while most cases of late SVD which occur beyond 5 years post-implant are characterized as a fibrous-calcific SVD.”
The FDA recommends that health care providers take the following actions:
- Be aware of the potential risk of early SVD with Trifecta valves, and current patient management considerations, as communicated by Abbott.
- Discuss the risks and benefits of all available aortic valve treatment options with patients and caregivers as part of shared clinical decision-making prior to surgery.
- Read and carefully follow the Instructions for Use when implanting a Trifecta GT valve.
- Monitor patients who have undergone implantation with Trifecta valves for signs and symptoms of potential SVD.
- Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
- Ensure lifelong follow-up visits, conducted at least yearly, including transthoracic echocardiogram assessment of the valve beginning 1-year post-implant.
The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.
Clinicians are encouraged to report any adverse events or quality problems with the Trifecta valves to their local Abbott representative or the customer service department at 1-800-544-1664.
Health care professionals can also report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Regular laxative use tied to increased dementia risk
Among more than 500,000 middle-aged or older adults in the UK Biobank, those who reported regular laxative use had a 51% increased risk of dementia due to any cause, compared with their counterparts who did not regularly use laxatives.
Individuals who used only osmotic laxatives had a 64% increased risk, compared with peers who did not use laxatives, while those using one or more types of laxatives, including bulk-forming, stool-softening, or stimulating laxatives, had a 90% increased risk.
“Constipation and laxative use are common among middle-aged and older adults,” study investigator Feng Sha, PhD, with the Chinese Academy of Sciences in Guangdong, China, said in a news release.
“However, regular laxative use may change the microbiome of the gut, possibly affecting nerve signaling from the gut to the brain or increasing the production of intestinal toxins that may affect the brain,” Dr. Sha noted.
The study was published online in Neurology.
Robust link
The findings are based on 502,229 people (54% women; mean age, 57 at baseline) from the UK biobank database. All were dementia-free at baseline.
A total of 18,235 participants (3.6%) said they used over-the-counter laxatives regularly, which was defined as using them most days of the week during the month before the study.
Over an average of 9.8 years, dementia was recorded in 218 (1.3%) of those who regularly used laxatives and in 1,969 (0.4%) of those did not.
After adjusting for factors such as age, sex, education, other illnesses, medication use, and a family history of dementia, regular use of laxatives was significantly associated with increased risk of all-cause dementia (adjusted hazard ratio, 1.51; 95% confidence interval, 1.30-1.75) and vascular dementia (aHR, 1.65; 95% CI, 1.21-2.27), with no significant association observed for Alzheimer’s disease (aHR, 1.05; 95% CI, 0.79-1.40).
The risk of dementia also increased with the number of laxative types used. All-cause dementia risk increased by 28% (aHR, 1.28; 95% CI, 1.03-1.61) for those using a single laxative type and by 90% (aHR, 1.90; 95% CI, 1.20-3.01) for those using two or more types, compared with nonuse.
Among those who reported using only one type of laxative, only those using osmotic laxatives had a statistically significant higher risk of all-cause dementia (aHR, 1.64; 95% CI, 1.20-2.24) and vascular dementia (aHR, 1.97; 95% CI, 1.04-3.75).
“These results remained robust in various subgroup and sensitivity analyses,” the investigators report.
They caution that they had no data on laxative dosage and so they were unable to explore the relationship between various laxative dosages and dementia risk.
Interpret with caution
Commenting on the findings for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, said the results are “interesting and demonstrate an association between laxative use and later life risk of dementia.”
However, “there is no proven causation, and there are some caveats,” Dr. Snyder said. “It’s unclear what may be driving this association, though other lines of research have suggested a linkage between our overall gut health, our immune system, and our brain health.”
Dr. Snyder said it’s also worth noting that the data came from the UK Biobank, which, “while a wealth of information for research purposes, is not representative of other countries. More research is needed.”
The Alzheimer’s Association is leading a 2-year clinical trial, U.S. Pointer, to examine the impact of behavioral interventions on the gut-brain axis to “better understand how our gut health may affect our brains,” Dr. Snyder told this news organization.
“While we await the results of that study, people should talk to their doctor about the risks and benefits of laxatives for their health, as well as discuss alternative methods of alleviating constipation, such as increasing dietary fiber and drinking more water,” she advised.
The study was funded by the National Natural Science Foundation of China, Shenzhen Science and Technology Program, and the Chinese Academy of Sciences. The authors and Dr. Snyder have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Among more than 500,000 middle-aged or older adults in the UK Biobank, those who reported regular laxative use had a 51% increased risk of dementia due to any cause, compared with their counterparts who did not regularly use laxatives.
Individuals who used only osmotic laxatives had a 64% increased risk, compared with peers who did not use laxatives, while those using one or more types of laxatives, including bulk-forming, stool-softening, or stimulating laxatives, had a 90% increased risk.
“Constipation and laxative use are common among middle-aged and older adults,” study investigator Feng Sha, PhD, with the Chinese Academy of Sciences in Guangdong, China, said in a news release.
“However, regular laxative use may change the microbiome of the gut, possibly affecting nerve signaling from the gut to the brain or increasing the production of intestinal toxins that may affect the brain,” Dr. Sha noted.
The study was published online in Neurology.
Robust link
The findings are based on 502,229 people (54% women; mean age, 57 at baseline) from the UK biobank database. All were dementia-free at baseline.
A total of 18,235 participants (3.6%) said they used over-the-counter laxatives regularly, which was defined as using them most days of the week during the month before the study.
Over an average of 9.8 years, dementia was recorded in 218 (1.3%) of those who regularly used laxatives and in 1,969 (0.4%) of those did not.
After adjusting for factors such as age, sex, education, other illnesses, medication use, and a family history of dementia, regular use of laxatives was significantly associated with increased risk of all-cause dementia (adjusted hazard ratio, 1.51; 95% confidence interval, 1.30-1.75) and vascular dementia (aHR, 1.65; 95% CI, 1.21-2.27), with no significant association observed for Alzheimer’s disease (aHR, 1.05; 95% CI, 0.79-1.40).
The risk of dementia also increased with the number of laxative types used. All-cause dementia risk increased by 28% (aHR, 1.28; 95% CI, 1.03-1.61) for those using a single laxative type and by 90% (aHR, 1.90; 95% CI, 1.20-3.01) for those using two or more types, compared with nonuse.
Among those who reported using only one type of laxative, only those using osmotic laxatives had a statistically significant higher risk of all-cause dementia (aHR, 1.64; 95% CI, 1.20-2.24) and vascular dementia (aHR, 1.97; 95% CI, 1.04-3.75).
“These results remained robust in various subgroup and sensitivity analyses,” the investigators report.
They caution that they had no data on laxative dosage and so they were unable to explore the relationship between various laxative dosages and dementia risk.
Interpret with caution
Commenting on the findings for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, said the results are “interesting and demonstrate an association between laxative use and later life risk of dementia.”
However, “there is no proven causation, and there are some caveats,” Dr. Snyder said. “It’s unclear what may be driving this association, though other lines of research have suggested a linkage between our overall gut health, our immune system, and our brain health.”
Dr. Snyder said it’s also worth noting that the data came from the UK Biobank, which, “while a wealth of information for research purposes, is not representative of other countries. More research is needed.”
The Alzheimer’s Association is leading a 2-year clinical trial, U.S. Pointer, to examine the impact of behavioral interventions on the gut-brain axis to “better understand how our gut health may affect our brains,” Dr. Snyder told this news organization.
“While we await the results of that study, people should talk to their doctor about the risks and benefits of laxatives for their health, as well as discuss alternative methods of alleviating constipation, such as increasing dietary fiber and drinking more water,” she advised.
The study was funded by the National Natural Science Foundation of China, Shenzhen Science and Technology Program, and the Chinese Academy of Sciences. The authors and Dr. Snyder have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Among more than 500,000 middle-aged or older adults in the UK Biobank, those who reported regular laxative use had a 51% increased risk of dementia due to any cause, compared with their counterparts who did not regularly use laxatives.
Individuals who used only osmotic laxatives had a 64% increased risk, compared with peers who did not use laxatives, while those using one or more types of laxatives, including bulk-forming, stool-softening, or stimulating laxatives, had a 90% increased risk.
“Constipation and laxative use are common among middle-aged and older adults,” study investigator Feng Sha, PhD, with the Chinese Academy of Sciences in Guangdong, China, said in a news release.
“However, regular laxative use may change the microbiome of the gut, possibly affecting nerve signaling from the gut to the brain or increasing the production of intestinal toxins that may affect the brain,” Dr. Sha noted.
The study was published online in Neurology.
Robust link
The findings are based on 502,229 people (54% women; mean age, 57 at baseline) from the UK biobank database. All were dementia-free at baseline.
A total of 18,235 participants (3.6%) said they used over-the-counter laxatives regularly, which was defined as using them most days of the week during the month before the study.
Over an average of 9.8 years, dementia was recorded in 218 (1.3%) of those who regularly used laxatives and in 1,969 (0.4%) of those did not.
After adjusting for factors such as age, sex, education, other illnesses, medication use, and a family history of dementia, regular use of laxatives was significantly associated with increased risk of all-cause dementia (adjusted hazard ratio, 1.51; 95% confidence interval, 1.30-1.75) and vascular dementia (aHR, 1.65; 95% CI, 1.21-2.27), with no significant association observed for Alzheimer’s disease (aHR, 1.05; 95% CI, 0.79-1.40).
The risk of dementia also increased with the number of laxative types used. All-cause dementia risk increased by 28% (aHR, 1.28; 95% CI, 1.03-1.61) for those using a single laxative type and by 90% (aHR, 1.90; 95% CI, 1.20-3.01) for those using two or more types, compared with nonuse.
Among those who reported using only one type of laxative, only those using osmotic laxatives had a statistically significant higher risk of all-cause dementia (aHR, 1.64; 95% CI, 1.20-2.24) and vascular dementia (aHR, 1.97; 95% CI, 1.04-3.75).
“These results remained robust in various subgroup and sensitivity analyses,” the investigators report.
They caution that they had no data on laxative dosage and so they were unable to explore the relationship between various laxative dosages and dementia risk.
Interpret with caution
Commenting on the findings for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, said the results are “interesting and demonstrate an association between laxative use and later life risk of dementia.”
However, “there is no proven causation, and there are some caveats,” Dr. Snyder said. “It’s unclear what may be driving this association, though other lines of research have suggested a linkage between our overall gut health, our immune system, and our brain health.”
Dr. Snyder said it’s also worth noting that the data came from the UK Biobank, which, “while a wealth of information for research purposes, is not representative of other countries. More research is needed.”
The Alzheimer’s Association is leading a 2-year clinical trial, U.S. Pointer, to examine the impact of behavioral interventions on the gut-brain axis to “better understand how our gut health may affect our brains,” Dr. Snyder told this news organization.
“While we await the results of that study, people should talk to their doctor about the risks and benefits of laxatives for their health, as well as discuss alternative methods of alleviating constipation, such as increasing dietary fiber and drinking more water,” she advised.
The study was funded by the National Natural Science Foundation of China, Shenzhen Science and Technology Program, and the Chinese Academy of Sciences. The authors and Dr. Snyder have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM NEUROLOGY
Real-world survival benefit with CDK4/6 inhibitors in MBC
(MBC).
Three years after starting first-line treatment, overall survival rates were 49% with endocrine therapy alone versus 73% with endocrine therapy plus a CDK4/6 inhibitor – findings largely consistent with clinical trial data.
Treatment with endocrine therapy alone “should have a limited role in early lines of therapy for patients with HR-positive/HER2-negative MBC,” the researchers concluded.
The study was published online in the journal Cancer.
The Food and Drug Administration has approved the CDK4/6 inhibitors palbociclib, abemaciclib, and ribociclib for HR-positive/HER2-negative MBC in first and advanced therapy lines. The approval was based on phase 3, randomized, controlled trial data.
Yet gaps in evidence remain regarding survival outcomes in real-world settings for patients starting treatment with a CDK4/6 inhibitor, particularly for patients aged 65 and older, who typically aren’t included in randomized clinical trials.
To address these gaps, Ravi Goyal, PhD, with the University of Houston, and colleagues conducted a retrospective cohort study using the Survey Epidemiology and End Results Medicare database.
Dr. Goyal and coauthors identified 630 Medicare patients with HR-positive/HER2-negative MBC for whom first-line treatment was initiated within 12 months of diagnosis. Patients received either endocrine therapy alone (461 patients) or endocrine therapy plus a CDK4/6 inhibitor (169 patients), most commonly palbociclib.
The median duration of follow-up from the start of treatment was 24 months in the endocrine therapy–alone group and 30 months in the combination therapy group.
In a Kaplan-Meier analysis, the overall survival rate at 3 years after starting first-line treatment was 73% for the combination therapy group versus49% for the endocrine therapy group (P < .0001). Median overall survival from first-line therapy was not estimable in the endocrine therapy plus CDK4/6 inhibitor group; it was 34.8 months in the endocrine therapy–only group.
In multivariable Cox regression models, first-line dual therapy was independently associated with 41% lower rate of death in comparison with endocrine therapy alone (adjusted hazard ratio, 0.59).
Dr. Goyal and colleagues also performed a separate analysis of 206 patients for whom treatment was initiated in the second line; 88 received endocrine therapy alone, and 118 received endocrine therapy plus CDK4/6 inhibitor therapy.
In this setting, a similar benefit of dual therapy was observed. The 3-year overall survival rate was 68% for the combination group versus 50% for endocrine therapy alone (P = .0051). Median overall survival with second-line therapy was not estimable for the combination group; it was 30.9 months for the endocrine therapy group.
In the second line, multivariable Cox regression analysis showed that combination therapy was associated with a nearly 58% lower rate of death in comparison with endocrine therapy alone (aHR, 0.42).
The coauthors of an editorial in Cancer explain that the combination of a CDK4/6 inhibitor and endocrine therapy has become the “preferred first-line approach” in the management of HR-positive/HER2-negative MBC.
Dario Trapani, MD, and Erica Mayer, MD, with Dana-Farber Cancer Institute, Boston, noted that an overall survival benefit of similar magnitude from endocrine therapy plus a CDK4/6 inhibitor has also been reported in a recent real-world study of palbociclib and letrozole.
The work of Dr. Goyal and colleagues provides “confirmatory real-world evidence observed in clinical trials for endocrine sensitive, de novo, metastatic [breast cancer] in an older population,” Dr. Trapani and Dr. Mayer wrote.
The study had no specific funding. The authors and Dr. Trapani disclosed no relevant financial relaitonships. Dr. Mayer has consulted for Lilly, Novartis, Gilead, AstraZeneca, and Diaccurate.
A version of this article first appeared on Medscape.com.
(MBC).
Three years after starting first-line treatment, overall survival rates were 49% with endocrine therapy alone versus 73% with endocrine therapy plus a CDK4/6 inhibitor – findings largely consistent with clinical trial data.
Treatment with endocrine therapy alone “should have a limited role in early lines of therapy for patients with HR-positive/HER2-negative MBC,” the researchers concluded.
The study was published online in the journal Cancer.
The Food and Drug Administration has approved the CDK4/6 inhibitors palbociclib, abemaciclib, and ribociclib for HR-positive/HER2-negative MBC in first and advanced therapy lines. The approval was based on phase 3, randomized, controlled trial data.
Yet gaps in evidence remain regarding survival outcomes in real-world settings for patients starting treatment with a CDK4/6 inhibitor, particularly for patients aged 65 and older, who typically aren’t included in randomized clinical trials.
To address these gaps, Ravi Goyal, PhD, with the University of Houston, and colleagues conducted a retrospective cohort study using the Survey Epidemiology and End Results Medicare database.
Dr. Goyal and coauthors identified 630 Medicare patients with HR-positive/HER2-negative MBC for whom first-line treatment was initiated within 12 months of diagnosis. Patients received either endocrine therapy alone (461 patients) or endocrine therapy plus a CDK4/6 inhibitor (169 patients), most commonly palbociclib.
The median duration of follow-up from the start of treatment was 24 months in the endocrine therapy–alone group and 30 months in the combination therapy group.
In a Kaplan-Meier analysis, the overall survival rate at 3 years after starting first-line treatment was 73% for the combination therapy group versus49% for the endocrine therapy group (P < .0001). Median overall survival from first-line therapy was not estimable in the endocrine therapy plus CDK4/6 inhibitor group; it was 34.8 months in the endocrine therapy–only group.
In multivariable Cox regression models, first-line dual therapy was independently associated with 41% lower rate of death in comparison with endocrine therapy alone (adjusted hazard ratio, 0.59).
Dr. Goyal and colleagues also performed a separate analysis of 206 patients for whom treatment was initiated in the second line; 88 received endocrine therapy alone, and 118 received endocrine therapy plus CDK4/6 inhibitor therapy.
In this setting, a similar benefit of dual therapy was observed. The 3-year overall survival rate was 68% for the combination group versus 50% for endocrine therapy alone (P = .0051). Median overall survival with second-line therapy was not estimable for the combination group; it was 30.9 months for the endocrine therapy group.
In the second line, multivariable Cox regression analysis showed that combination therapy was associated with a nearly 58% lower rate of death in comparison with endocrine therapy alone (aHR, 0.42).
The coauthors of an editorial in Cancer explain that the combination of a CDK4/6 inhibitor and endocrine therapy has become the “preferred first-line approach” in the management of HR-positive/HER2-negative MBC.
Dario Trapani, MD, and Erica Mayer, MD, with Dana-Farber Cancer Institute, Boston, noted that an overall survival benefit of similar magnitude from endocrine therapy plus a CDK4/6 inhibitor has also been reported in a recent real-world study of palbociclib and letrozole.
The work of Dr. Goyal and colleagues provides “confirmatory real-world evidence observed in clinical trials for endocrine sensitive, de novo, metastatic [breast cancer] in an older population,” Dr. Trapani and Dr. Mayer wrote.
The study had no specific funding. The authors and Dr. Trapani disclosed no relevant financial relaitonships. Dr. Mayer has consulted for Lilly, Novartis, Gilead, AstraZeneca, and Diaccurate.
A version of this article first appeared on Medscape.com.
(MBC).
Three years after starting first-line treatment, overall survival rates were 49% with endocrine therapy alone versus 73% with endocrine therapy plus a CDK4/6 inhibitor – findings largely consistent with clinical trial data.
Treatment with endocrine therapy alone “should have a limited role in early lines of therapy for patients with HR-positive/HER2-negative MBC,” the researchers concluded.
The study was published online in the journal Cancer.
The Food and Drug Administration has approved the CDK4/6 inhibitors palbociclib, abemaciclib, and ribociclib for HR-positive/HER2-negative MBC in first and advanced therapy lines. The approval was based on phase 3, randomized, controlled trial data.
Yet gaps in evidence remain regarding survival outcomes in real-world settings for patients starting treatment with a CDK4/6 inhibitor, particularly for patients aged 65 and older, who typically aren’t included in randomized clinical trials.
To address these gaps, Ravi Goyal, PhD, with the University of Houston, and colleagues conducted a retrospective cohort study using the Survey Epidemiology and End Results Medicare database.
Dr. Goyal and coauthors identified 630 Medicare patients with HR-positive/HER2-negative MBC for whom first-line treatment was initiated within 12 months of diagnosis. Patients received either endocrine therapy alone (461 patients) or endocrine therapy plus a CDK4/6 inhibitor (169 patients), most commonly palbociclib.
The median duration of follow-up from the start of treatment was 24 months in the endocrine therapy–alone group and 30 months in the combination therapy group.
In a Kaplan-Meier analysis, the overall survival rate at 3 years after starting first-line treatment was 73% for the combination therapy group versus49% for the endocrine therapy group (P < .0001). Median overall survival from first-line therapy was not estimable in the endocrine therapy plus CDK4/6 inhibitor group; it was 34.8 months in the endocrine therapy–only group.
In multivariable Cox regression models, first-line dual therapy was independently associated with 41% lower rate of death in comparison with endocrine therapy alone (adjusted hazard ratio, 0.59).
Dr. Goyal and colleagues also performed a separate analysis of 206 patients for whom treatment was initiated in the second line; 88 received endocrine therapy alone, and 118 received endocrine therapy plus CDK4/6 inhibitor therapy.
In this setting, a similar benefit of dual therapy was observed. The 3-year overall survival rate was 68% for the combination group versus 50% for endocrine therapy alone (P = .0051). Median overall survival with second-line therapy was not estimable for the combination group; it was 30.9 months for the endocrine therapy group.
In the second line, multivariable Cox regression analysis showed that combination therapy was associated with a nearly 58% lower rate of death in comparison with endocrine therapy alone (aHR, 0.42).
The coauthors of an editorial in Cancer explain that the combination of a CDK4/6 inhibitor and endocrine therapy has become the “preferred first-line approach” in the management of HR-positive/HER2-negative MBC.
Dario Trapani, MD, and Erica Mayer, MD, with Dana-Farber Cancer Institute, Boston, noted that an overall survival benefit of similar magnitude from endocrine therapy plus a CDK4/6 inhibitor has also been reported in a recent real-world study of palbociclib and letrozole.
The work of Dr. Goyal and colleagues provides “confirmatory real-world evidence observed in clinical trials for endocrine sensitive, de novo, metastatic [breast cancer] in an older population,” Dr. Trapani and Dr. Mayer wrote.
The study had no specific funding. The authors and Dr. Trapani disclosed no relevant financial relaitonships. Dr. Mayer has consulted for Lilly, Novartis, Gilead, AstraZeneca, and Diaccurate.
A version of this article first appeared on Medscape.com.
FROM CANCER
Spinal cord stimulation restores poststroke arm, hand function in two patients
The results provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” wrote first author Marc P. Powell, PhD, of Reach Neuro Inc., Pittsburgh, and colleagues.
The findings were published online in Nature Medicine.
Top cause of paralysis
“Stroke is the largest cause of paralysis in the world,” with nearly three-quarters of patients with stroke experiencing lasting deficits in motor control of their arm and hand, co–senior study author Marco Capogrosso, PhD, assistant professor of neurological surgery at the University of Pittsburgh, said during a press briefing.
Stroke can disrupt communication between the brain and the spinal cord, leading to motor deficits in the arm and hand. However, below the lesion, the spinal circuits that control movement remain intact and could be targeted to restore function, Dr. Capogrosso noted.
Spinal cord stimulation has shown promise in promoting long-lasting recovery of leg motor function in patients with spinal cord injury; but until now, it’s been largely unexplored for upper-limb recovery.
In this “first-in-human” study, the investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two patients.
One of the patients was a woman (age, 31 years) who had experienced a right thalamic hemorrhagic stroke secondary to a cavernous malformation 9 years before enrolling in the pilot study.
The other patient was a woman (age, 47 years) who experienced a right ischemic middle cerebral artery (MCA) stroke secondary to a right carotid dissection, resulting in a large MCA territory infarct 3 years before entering the study.
In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.
The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that the younger woman had not been able to do for 9 years.
“Perhaps even more interesting, we found that after a few weeks of use, some of these improvements endure when the stimulation is switched off, indicating exciting avenues for the future of stroke therapies,” Dr. Capogrosso said in a news release.
No serious adverse events were reported.
‘Easily translated’
Dr. Capogrosso said that, thanks to years of preclinical research, the investigators have developed a practical, easy-to-use stimulation protocol adapting existing clinical technologies that “could be easily translated to the hospital and quickly moved from the lab to the clinic.”
The researchers noted, however, that further studies in larger cohorts will be required to validate the safety and efficacy of this approach.
They are currently working with more patients with stroke to fine-tune placement of the leads and stimulation protocol, as well as determine which patients are best suited for the approach.
“Creating effective neurorehabilitation solutions for people affected by movement impairment after stroke is becoming ever more urgent,” co–senior author Elvira Pirondini, PhD, assistant professor of physical medicine and rehabilitation at the University of Pittsburgh, said in the release.
“Even mild deficits resulting from a stroke can isolate people from social and professional lives and become very debilitating, with motor impairments in the arm and hand being especially taxing and impeding simple daily activities, such as writing, eating, and getting dressed,” she added.
This research was funded by the National Institutes of Health BRAIN Initiative, with additional research support provided by the Department of Neurological Surgery and the Department of Physical Medicine and Rehabilitation at Pitt, and the Department of Mechanical Engineering and the Neuroscience Institute at Carnegie Mellon University. Three investigators have financial interests in Reach Neuro, which has an interest in the technology being evaluated in this study.
A version of this article first appeared on Medscape.com.
The results provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” wrote first author Marc P. Powell, PhD, of Reach Neuro Inc., Pittsburgh, and colleagues.
The findings were published online in Nature Medicine.
Top cause of paralysis
“Stroke is the largest cause of paralysis in the world,” with nearly three-quarters of patients with stroke experiencing lasting deficits in motor control of their arm and hand, co–senior study author Marco Capogrosso, PhD, assistant professor of neurological surgery at the University of Pittsburgh, said during a press briefing.
Stroke can disrupt communication between the brain and the spinal cord, leading to motor deficits in the arm and hand. However, below the lesion, the spinal circuits that control movement remain intact and could be targeted to restore function, Dr. Capogrosso noted.
Spinal cord stimulation has shown promise in promoting long-lasting recovery of leg motor function in patients with spinal cord injury; but until now, it’s been largely unexplored for upper-limb recovery.
In this “first-in-human” study, the investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two patients.
One of the patients was a woman (age, 31 years) who had experienced a right thalamic hemorrhagic stroke secondary to a cavernous malformation 9 years before enrolling in the pilot study.
The other patient was a woman (age, 47 years) who experienced a right ischemic middle cerebral artery (MCA) stroke secondary to a right carotid dissection, resulting in a large MCA territory infarct 3 years before entering the study.
In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.
The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that the younger woman had not been able to do for 9 years.
“Perhaps even more interesting, we found that after a few weeks of use, some of these improvements endure when the stimulation is switched off, indicating exciting avenues for the future of stroke therapies,” Dr. Capogrosso said in a news release.
No serious adverse events were reported.
‘Easily translated’
Dr. Capogrosso said that, thanks to years of preclinical research, the investigators have developed a practical, easy-to-use stimulation protocol adapting existing clinical technologies that “could be easily translated to the hospital and quickly moved from the lab to the clinic.”
The researchers noted, however, that further studies in larger cohorts will be required to validate the safety and efficacy of this approach.
They are currently working with more patients with stroke to fine-tune placement of the leads and stimulation protocol, as well as determine which patients are best suited for the approach.
“Creating effective neurorehabilitation solutions for people affected by movement impairment after stroke is becoming ever more urgent,” co–senior author Elvira Pirondini, PhD, assistant professor of physical medicine and rehabilitation at the University of Pittsburgh, said in the release.
“Even mild deficits resulting from a stroke can isolate people from social and professional lives and become very debilitating, with motor impairments in the arm and hand being especially taxing and impeding simple daily activities, such as writing, eating, and getting dressed,” she added.
This research was funded by the National Institutes of Health BRAIN Initiative, with additional research support provided by the Department of Neurological Surgery and the Department of Physical Medicine and Rehabilitation at Pitt, and the Department of Mechanical Engineering and the Neuroscience Institute at Carnegie Mellon University. Three investigators have financial interests in Reach Neuro, which has an interest in the technology being evaluated in this study.
A version of this article first appeared on Medscape.com.
The results provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” wrote first author Marc P. Powell, PhD, of Reach Neuro Inc., Pittsburgh, and colleagues.
The findings were published online in Nature Medicine.
Top cause of paralysis
“Stroke is the largest cause of paralysis in the world,” with nearly three-quarters of patients with stroke experiencing lasting deficits in motor control of their arm and hand, co–senior study author Marco Capogrosso, PhD, assistant professor of neurological surgery at the University of Pittsburgh, said during a press briefing.
Stroke can disrupt communication between the brain and the spinal cord, leading to motor deficits in the arm and hand. However, below the lesion, the spinal circuits that control movement remain intact and could be targeted to restore function, Dr. Capogrosso noted.
Spinal cord stimulation has shown promise in promoting long-lasting recovery of leg motor function in patients with spinal cord injury; but until now, it’s been largely unexplored for upper-limb recovery.
In this “first-in-human” study, the investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two patients.
One of the patients was a woman (age, 31 years) who had experienced a right thalamic hemorrhagic stroke secondary to a cavernous malformation 9 years before enrolling in the pilot study.
The other patient was a woman (age, 47 years) who experienced a right ischemic middle cerebral artery (MCA) stroke secondary to a right carotid dissection, resulting in a large MCA territory infarct 3 years before entering the study.
In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.
The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that the younger woman had not been able to do for 9 years.
“Perhaps even more interesting, we found that after a few weeks of use, some of these improvements endure when the stimulation is switched off, indicating exciting avenues for the future of stroke therapies,” Dr. Capogrosso said in a news release.
No serious adverse events were reported.
‘Easily translated’
Dr. Capogrosso said that, thanks to years of preclinical research, the investigators have developed a practical, easy-to-use stimulation protocol adapting existing clinical technologies that “could be easily translated to the hospital and quickly moved from the lab to the clinic.”
The researchers noted, however, that further studies in larger cohorts will be required to validate the safety and efficacy of this approach.
They are currently working with more patients with stroke to fine-tune placement of the leads and stimulation protocol, as well as determine which patients are best suited for the approach.
“Creating effective neurorehabilitation solutions for people affected by movement impairment after stroke is becoming ever more urgent,” co–senior author Elvira Pirondini, PhD, assistant professor of physical medicine and rehabilitation at the University of Pittsburgh, said in the release.
“Even mild deficits resulting from a stroke can isolate people from social and professional lives and become very debilitating, with motor impairments in the arm and hand being especially taxing and impeding simple daily activities, such as writing, eating, and getting dressed,” she added.
This research was funded by the National Institutes of Health BRAIN Initiative, with additional research support provided by the Department of Neurological Surgery and the Department of Physical Medicine and Rehabilitation at Pitt, and the Department of Mechanical Engineering and the Neuroscience Institute at Carnegie Mellon University. Three investigators have financial interests in Reach Neuro, which has an interest in the technology being evaluated in this study.
A version of this article first appeared on Medscape.com.
FROM NATURE MEDICINE