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Hearing loss strongly tied to increased dementia risk
Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.
“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore, Md., told this news organization.
The findings were published online in JAMA.
Dose-dependent effect
For the study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.
Data from the study were collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.
“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.
Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.
Those with moderate to severe hearing loss were 61% more likely to have dementia than those with normal hearing (prevalence ratio, 1.61; 95% confidence interval, 1.09-2.38).
Dementia prevalence increased with increasing severity of hearing loss: normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate/severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).
Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).
Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assistive devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). This news organization last month reported on similar data published in JAMA Neurology suggesting that hearing aids reduce dementia risk.
“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
Robust association
Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.
“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”
Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.
“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.
“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.
The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.
“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore, Md., told this news organization.
The findings were published online in JAMA.
Dose-dependent effect
For the study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.
Data from the study were collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.
“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.
Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.
Those with moderate to severe hearing loss were 61% more likely to have dementia than those with normal hearing (prevalence ratio, 1.61; 95% confidence interval, 1.09-2.38).
Dementia prevalence increased with increasing severity of hearing loss: normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate/severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).
Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).
Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assistive devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). This news organization last month reported on similar data published in JAMA Neurology suggesting that hearing aids reduce dementia risk.
“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
Robust association
Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.
“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”
Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.
“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.
“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.
The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.
“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore, Md., told this news organization.
The findings were published online in JAMA.
Dose-dependent effect
For the study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.
Data from the study were collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.
“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.
Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.
Those with moderate to severe hearing loss were 61% more likely to have dementia than those with normal hearing (prevalence ratio, 1.61; 95% confidence interval, 1.09-2.38).
Dementia prevalence increased with increasing severity of hearing loss: normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate/severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).
Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).
Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assistive devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). This news organization last month reported on similar data published in JAMA Neurology suggesting that hearing aids reduce dementia risk.
“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
Robust association
Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.
“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”
Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.
“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.
“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.
The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA
Telehealth parent-child interaction therapy improved behavior in children with developmental delay
The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.
Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.
Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.
Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.
In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.
The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.
The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.
Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.
Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.
Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.
In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.
For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.
iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
Data support iPCIT potential
Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.
“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.
The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.
The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
Practical pediatric takeaways
“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.
“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.
“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”
That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
Benefits and barriers
“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.
“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.
Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.
The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.
Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.
Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.
Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.
In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.
The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.
The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.
Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.
Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.
Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.
In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.
For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.
iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
Data support iPCIT potential
Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.
“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.
The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.
The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
Practical pediatric takeaways
“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.
“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.
“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”
That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
Benefits and barriers
“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.
“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.
Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.
The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.
Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.
Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.
Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.
In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.
The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.
The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.
Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.
Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.
Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.
In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.
For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.
iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
Data support iPCIT potential
Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.
“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.
The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.
The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
Practical pediatric takeaways
“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.
“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.
“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”
That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
Benefits and barriers
“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.
“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.
Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.
The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
FROM JAMA PEDIATRICS
Chronic pain patients swapping opioids for medical cannabis
new research shows.
“That patients report substituting cannabis for pain medicines so much really underscores the need for research on the benefits and risks of using cannabis for chronic pain,” lead author Mark C. Bicket, MD, PhD, assistant professor, department of anesthesiology, and director, Opioid Prescribing Engagement Network, University of Michigan, Ann Arbor, said in an interview.
However, he added, the question is whether they’re turning to cannabis and away from other pain treatments. “What’s not clear and one of the gaps that we wanted to address in the study was if medical cannabis use is changing the use of other treatments for chronic pain,” said Dr. Bicket.
The study was published online in JAMA Network Open.
Decreased opioid use
The survey included a representative sample of 1724 American adults aged 18 years or older with chronic noncancer pain living in areas with a medical cannabis program.
Respondents were asked about their use of three categories of pain treatments. This included medical cannabis; pharmacologic treatments including prescription opioids, nonopioid analgesics, and over-the-counter analgesics; and common nonpharmacologic treatments such as physical therapy, meditation, and cognitive-behavioral therapy (CBT).
Just over 96% of respondents completed the full survey. About 57% of the sample was female and the mean age of the study sample was 52.3 years.
Among study participants, 31% (95% CI, 28.2% - 34.1%) reported having ever used cannabis to manage pain; 25.9% (95% confidence interval, 23.2%-28.8%) reported use in the past 12 months, and 23.2% (95% CI, 20.6%-26%) reported use in the past 30 days.
“This translates into a large number of individuals who are using cannabis in an intended medical way” to treat chronic condition such as low back pain, migraine, and fibromyalgia, said Dr. Bicket.
More than half of survey respondents reported their medical cannabis use led to a decrease in prescription opioid use, prescription nonopioid use and use of over-the-counter medications.
Dr. Bicket noted “almost no one” said medical cannabis use led to higher use of these drugs.
As for nonpharmacologic treatments, 38.7% reported their use of cannabis led to decreased use of physical therapy, 19.1% to lower use of meditation, and 26% to less CBT. At the same time, 5.9%, 23.7% and 17.1%, respectively, reported it led to increased use of physical therapy, meditation, and CBT.
Medical cannabis is regulated at a state level. On a federal level, it’s considered a Schedule I substance, which means it’s deemed not to have a therapeutic use, although some groups are trying to change that categorization, said Dr. Bicket.
As a result, cannabis products “are quite variable” in terms of how they’re used (smoked, eaten etc.) and in their composition, including percentage of cannabidiol and tetrahydrocannabinol.
“We really don’t have a good sense of the relative risks and benefits that could come from cannabis as a treatment for chronic pain,” said Dr. Bicket. “As a physician, it’s difficult to have discussions with patients because I’m not able to understand the products they’re using based on this regulatory environment we have.”
He added clinicians “are operating in an area of uncertainty right now.”
What’s needed is research to determine how safe and effective medical cannabis is for chronic pain, he said.
Pain a leading indication
Commenting on the findings, Jason W. Busse, PhD, professor, department of anesthesia, and associate director, Centre for Medicinal Cannabis Research, McMaster University, Hamilton, Ont., said the study reinforces results of some prior research.
“It gives us current information certainly highlighting the high rate of use of medical cannabis among individuals with chronic pain once it becomes legally available.”
In addition, this high rate of use “means we desperately need information about the benefits and harms” of medical marijuana, he said.
Dr. Busse noted the survey didn’t provide information on the types of cannabis being used or the mode of administration. Oil drops and sprays cause less pulmonary harm than smoked versions, he said. It’s also not clear from the survey if participants are taking formulations with high levels of tetrahydrocannabinol that are associated with greater risk of harm.
He noted cannabis may interact with prescription drugs to make them less effective or, in some cases, to augment their adverse effects.
Dr. Busse pointed out some patients could be using fewer opioids because providers are under “enormous pressure” to reduce prescriptions of these drugs in the wake of spikes in opioid overdoses and deaths.
Chronic pain is “absolutely the leading indication” for medical marijuana, said Dr. Busse. U.S. reimbursement data suggest up to 65% of individuals get cannabis to treat a listed indication for chronic pain.
He said he hopes this new study will increase interest in funding new trials “so we can have better evidence to guide practice to help patients make decisions.”
The study received support from the National Institute on Drug Abuse. Dr. Bicket reported receiving personal fees from Axial Healthcare as well as grants from the National Institutes of Health, the Centers for Disease Control and Prevention, Michigan Department of Health and Human Services, Arnold Foundation, and the Patient-Centered Outcomes Research Institute outside the submitted work. Dr. Busse reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research shows.
“That patients report substituting cannabis for pain medicines so much really underscores the need for research on the benefits and risks of using cannabis for chronic pain,” lead author Mark C. Bicket, MD, PhD, assistant professor, department of anesthesiology, and director, Opioid Prescribing Engagement Network, University of Michigan, Ann Arbor, said in an interview.
However, he added, the question is whether they’re turning to cannabis and away from other pain treatments. “What’s not clear and one of the gaps that we wanted to address in the study was if medical cannabis use is changing the use of other treatments for chronic pain,” said Dr. Bicket.
The study was published online in JAMA Network Open.
Decreased opioid use
The survey included a representative sample of 1724 American adults aged 18 years or older with chronic noncancer pain living in areas with a medical cannabis program.
Respondents were asked about their use of three categories of pain treatments. This included medical cannabis; pharmacologic treatments including prescription opioids, nonopioid analgesics, and over-the-counter analgesics; and common nonpharmacologic treatments such as physical therapy, meditation, and cognitive-behavioral therapy (CBT).
Just over 96% of respondents completed the full survey. About 57% of the sample was female and the mean age of the study sample was 52.3 years.
Among study participants, 31% (95% CI, 28.2% - 34.1%) reported having ever used cannabis to manage pain; 25.9% (95% confidence interval, 23.2%-28.8%) reported use in the past 12 months, and 23.2% (95% CI, 20.6%-26%) reported use in the past 30 days.
“This translates into a large number of individuals who are using cannabis in an intended medical way” to treat chronic condition such as low back pain, migraine, and fibromyalgia, said Dr. Bicket.
More than half of survey respondents reported their medical cannabis use led to a decrease in prescription opioid use, prescription nonopioid use and use of over-the-counter medications.
Dr. Bicket noted “almost no one” said medical cannabis use led to higher use of these drugs.
As for nonpharmacologic treatments, 38.7% reported their use of cannabis led to decreased use of physical therapy, 19.1% to lower use of meditation, and 26% to less CBT. At the same time, 5.9%, 23.7% and 17.1%, respectively, reported it led to increased use of physical therapy, meditation, and CBT.
Medical cannabis is regulated at a state level. On a federal level, it’s considered a Schedule I substance, which means it’s deemed not to have a therapeutic use, although some groups are trying to change that categorization, said Dr. Bicket.
As a result, cannabis products “are quite variable” in terms of how they’re used (smoked, eaten etc.) and in their composition, including percentage of cannabidiol and tetrahydrocannabinol.
“We really don’t have a good sense of the relative risks and benefits that could come from cannabis as a treatment for chronic pain,” said Dr. Bicket. “As a physician, it’s difficult to have discussions with patients because I’m not able to understand the products they’re using based on this regulatory environment we have.”
He added clinicians “are operating in an area of uncertainty right now.”
What’s needed is research to determine how safe and effective medical cannabis is for chronic pain, he said.
Pain a leading indication
Commenting on the findings, Jason W. Busse, PhD, professor, department of anesthesia, and associate director, Centre for Medicinal Cannabis Research, McMaster University, Hamilton, Ont., said the study reinforces results of some prior research.
“It gives us current information certainly highlighting the high rate of use of medical cannabis among individuals with chronic pain once it becomes legally available.”
In addition, this high rate of use “means we desperately need information about the benefits and harms” of medical marijuana, he said.
Dr. Busse noted the survey didn’t provide information on the types of cannabis being used or the mode of administration. Oil drops and sprays cause less pulmonary harm than smoked versions, he said. It’s also not clear from the survey if participants are taking formulations with high levels of tetrahydrocannabinol that are associated with greater risk of harm.
He noted cannabis may interact with prescription drugs to make them less effective or, in some cases, to augment their adverse effects.
Dr. Busse pointed out some patients could be using fewer opioids because providers are under “enormous pressure” to reduce prescriptions of these drugs in the wake of spikes in opioid overdoses and deaths.
Chronic pain is “absolutely the leading indication” for medical marijuana, said Dr. Busse. U.S. reimbursement data suggest up to 65% of individuals get cannabis to treat a listed indication for chronic pain.
He said he hopes this new study will increase interest in funding new trials “so we can have better evidence to guide practice to help patients make decisions.”
The study received support from the National Institute on Drug Abuse. Dr. Bicket reported receiving personal fees from Axial Healthcare as well as grants from the National Institutes of Health, the Centers for Disease Control and Prevention, Michigan Department of Health and Human Services, Arnold Foundation, and the Patient-Centered Outcomes Research Institute outside the submitted work. Dr. Busse reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research shows.
“That patients report substituting cannabis for pain medicines so much really underscores the need for research on the benefits and risks of using cannabis for chronic pain,” lead author Mark C. Bicket, MD, PhD, assistant professor, department of anesthesiology, and director, Opioid Prescribing Engagement Network, University of Michigan, Ann Arbor, said in an interview.
However, he added, the question is whether they’re turning to cannabis and away from other pain treatments. “What’s not clear and one of the gaps that we wanted to address in the study was if medical cannabis use is changing the use of other treatments for chronic pain,” said Dr. Bicket.
The study was published online in JAMA Network Open.
Decreased opioid use
The survey included a representative sample of 1724 American adults aged 18 years or older with chronic noncancer pain living in areas with a medical cannabis program.
Respondents were asked about their use of three categories of pain treatments. This included medical cannabis; pharmacologic treatments including prescription opioids, nonopioid analgesics, and over-the-counter analgesics; and common nonpharmacologic treatments such as physical therapy, meditation, and cognitive-behavioral therapy (CBT).
Just over 96% of respondents completed the full survey. About 57% of the sample was female and the mean age of the study sample was 52.3 years.
Among study participants, 31% (95% CI, 28.2% - 34.1%) reported having ever used cannabis to manage pain; 25.9% (95% confidence interval, 23.2%-28.8%) reported use in the past 12 months, and 23.2% (95% CI, 20.6%-26%) reported use in the past 30 days.
“This translates into a large number of individuals who are using cannabis in an intended medical way” to treat chronic condition such as low back pain, migraine, and fibromyalgia, said Dr. Bicket.
More than half of survey respondents reported their medical cannabis use led to a decrease in prescription opioid use, prescription nonopioid use and use of over-the-counter medications.
Dr. Bicket noted “almost no one” said medical cannabis use led to higher use of these drugs.
As for nonpharmacologic treatments, 38.7% reported their use of cannabis led to decreased use of physical therapy, 19.1% to lower use of meditation, and 26% to less CBT. At the same time, 5.9%, 23.7% and 17.1%, respectively, reported it led to increased use of physical therapy, meditation, and CBT.
Medical cannabis is regulated at a state level. On a federal level, it’s considered a Schedule I substance, which means it’s deemed not to have a therapeutic use, although some groups are trying to change that categorization, said Dr. Bicket.
As a result, cannabis products “are quite variable” in terms of how they’re used (smoked, eaten etc.) and in their composition, including percentage of cannabidiol and tetrahydrocannabinol.
“We really don’t have a good sense of the relative risks and benefits that could come from cannabis as a treatment for chronic pain,” said Dr. Bicket. “As a physician, it’s difficult to have discussions with patients because I’m not able to understand the products they’re using based on this regulatory environment we have.”
He added clinicians “are operating in an area of uncertainty right now.”
What’s needed is research to determine how safe and effective medical cannabis is for chronic pain, he said.
Pain a leading indication
Commenting on the findings, Jason W. Busse, PhD, professor, department of anesthesia, and associate director, Centre for Medicinal Cannabis Research, McMaster University, Hamilton, Ont., said the study reinforces results of some prior research.
“It gives us current information certainly highlighting the high rate of use of medical cannabis among individuals with chronic pain once it becomes legally available.”
In addition, this high rate of use “means we desperately need information about the benefits and harms” of medical marijuana, he said.
Dr. Busse noted the survey didn’t provide information on the types of cannabis being used or the mode of administration. Oil drops and sprays cause less pulmonary harm than smoked versions, he said. It’s also not clear from the survey if participants are taking formulations with high levels of tetrahydrocannabinol that are associated with greater risk of harm.
He noted cannabis may interact with prescription drugs to make them less effective or, in some cases, to augment their adverse effects.
Dr. Busse pointed out some patients could be using fewer opioids because providers are under “enormous pressure” to reduce prescriptions of these drugs in the wake of spikes in opioid overdoses and deaths.
Chronic pain is “absolutely the leading indication” for medical marijuana, said Dr. Busse. U.S. reimbursement data suggest up to 65% of individuals get cannabis to treat a listed indication for chronic pain.
He said he hopes this new study will increase interest in funding new trials “so we can have better evidence to guide practice to help patients make decisions.”
The study received support from the National Institute on Drug Abuse. Dr. Bicket reported receiving personal fees from Axial Healthcare as well as grants from the National Institutes of Health, the Centers for Disease Control and Prevention, Michigan Department of Health and Human Services, Arnold Foundation, and the Patient-Centered Outcomes Research Institute outside the submitted work. Dr. Busse reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
ADHD beyond medications
Attention-deficit/hyperactivity disorder (ADHD) is often a very challenging condition for parents to manage, both because of the “gleeful mayhem” children with ADHD manifest and because of the nature of effective treatments. Multiple randomized controlled studies and meta-analyses have demonstrated that stimulant medication with behavioral interventions is the optimal first-line treatment for children with both subtypes of ADHD, and that medications alone are superior to behavioral interventions alone. By improving attention and impulse control, the medications effectively decrease the many negative interactions with teachers, peers, and parents, aiding development and healthy self-esteem.
But many parents feel anxious about treating their young children with stimulants. Importantly, how children with ADHD will fare as adults is not predicted by their symptom level, but instead by the quality of their relationships with their parents, their ability to perform at school, and their social skills. Bring this framework to parents as you listen to their questions and help them decide on the best approach for their family. To assist you in these conversations, we will review the evidence for (or against) several of the most common alternatives to medication that parents are likely to ask about.
Diets and supplements
Dietary modifications are among the most popular “natural” approaches to managing ADHD in children. Diets that eliminate processed sugars or food additives (particularly artificial food coloring) are among the most common approaches discussed in the lay press. These diets are usually very time-consuming and disruptive for families to follow, and there is no evidence to support their general use in ADHD management. Those studies that rigorously examined them suggest that, for children with severe impairment who have failed to respond to medications for ADHD, a workup for food intolerance or nutritional deficits may reveal a different problem underlying their behavioral difficulties.1
Similarly, supplementation with high-dose omega-3 fatty acids is modestly helpful only in a subset of children with ADHD symptoms, and not nearly as effective as medications or behavioral interventions. Spending time on an exacting diet or buying expensive supplements is very unlikely to relieve the children’s symptoms and may only add to their stress at home. The “sugar high” parents note may be the rare joy of eating a candy bar and not sugar causing ADHD. Offer parents the guidance to focus on a healthy diet, high in fruits and vegetables, whole grains, and healthy protein, and on meals that emphasize family time instead of struggles around food.
Neurofeedback
Neurofeedback is an approach that grew out of the observation that many adults with ADHD had resting patterns of brain wave activity different from those of neurotypical adults. In neurofeedback, patients learn strategies that amplify the brain waves associated with focused mental activity, rather than listless or hyperactive states. Businesses market this service for all sorts of illnesses and challenges, ADHD chief among them. Despite the marketing, there are very few randomized controlled studies of this intervention for ADHD in youth, and those have shown only the possibility of a benefit.
While there is no evidence of serious side effects, these treatments are time-consuming and expensive and unlikely to be covered by any insurance. You might suggest to parents that they could achieve some of the same theoretical benefits by looking for hobbies that invite sustained focus in their children. That is, they should think about activities that interest the children, such as music lessons or karate, that they could practice in classes and at home. If the children find these activities even somewhat interesting (or just enjoy the reward of their parents’ or teachers’ attention), regular practice will be supporting their developing attention while building social skills and authentic self-confidence, rather than the activities feeling like a treatment for an illness or condition.
Sleep and exercise
There are not many businesses or books selling worried and exhausted parents a quick nonmedication solution for their children’s ADHD in the form of healthy sleep and exercise habits. But these are safe and healthy ways to reduce symptoms and support development. Children with ADHD often enjoy and benefit from participating in a sport, and daily exercise can help with sleep and regulating their energy. They also often have difficulty with sleep initiation, and commonly do not get adequate or restful sleep. Inadequate sleep exacerbates inattention, distractibility, and irritability. Children with untreated ADHD also often spend a lot of time on screens, as it is difficult for them to shift away from rewarding activities, and parents can find screen time to be a welcome break from hyperactivity and negative interactions. But excessive screen time, especially close to bedtime, can worsen irritability and make sleep more difficult. Talk with parents about the value of establishing a routine around screen time, modest daily physical activity, and sleep that everyone can follow. If their family life is currently marked by late bedtimes and long hours in front of video games, this change will take effort. But within a few weeks, it could lead to significant improvements in energy, attention, and interactions at home.
Behavioral treatments
Effective behavioral treatments for ADHD do not change ADHD symptoms, but they do help children learn how to manage them. In “parent management training,” younger children and parents learn together how to avoid negative cycles of behavior (i.e., temper outbursts) by focusing on consistent routines and consequences that support children calmly learning to manage their impulses. The only other evidence-based treatment focuses on helping school age and older children develop executive functions – their planning, organization, and time management skills – with a range of age-appropriate tools. Both of these therapies may be more effective if the children are also receiving medication, but medication is not necessary for them to be helpful. It is important to note that play therapy and other evidence-based psychotherapies are not effective for management of ADHD, although they may treat comorbid problems.
Parent treatment
You may have diagnosed children with ADHD only to hear their parents respond by saying that they suspect (or know) that they (or their spouses) also have ADHD. This would not be surprising, as ADHD has one of the highest rates of heritability of psychiatric disorders, at 80%. Somewhere between 25% and 50% of parents of children with ADHD have ADHD themselves.2 Screening for adults with ADHD, such as the Adult ADHD Self-Report Scale, is widely available and free. Speak with parents about the fact that behavioral treatments for their children’s ADHD are demanding. Such treatments require patience, calm, organization, and consistency.
If parents have ADHD, it may be very helpful for them to prioritize their own effective treatments, so that their attention and impulse control will support their parenting. They may be interested in learning about how treatment might also improve their performance at work and even the quality of their relationships. While there is some evidence that their children’s treatment outcome will hinge on the parents’ treatment,3 they deserve good care independent of the expectations of parenting.
Families benefit from a comprehensive “ADHD plan” for their children. This would start with an assessment of the severity of their children’s symptoms, specifying their impairment at home, school, and in social relationships. It would include their nonacademic performance, exploration of interests, and developing self-confidence. All of these considerations lead to setting reasonable expectations so the children can feel successful. Parents should think about how best to structure their children’s schedules to promote healthy sleep, exercise, and nutrition, and to expand opportunities for building their frustration tolerance, social skills, and executive function.
Parents will need to consider what kind of supports they themselves need to offer this structure. There are good resources available online for information and support, including Children and Adults with ADHD (chadd.org) and the ADHD Resource Center from the American Academy of Child and Adolescent Psychiatry (aacap.org). This approach may help parents to evaluate the potential risks and benefits of medications as a component of treatment. Most of the quick fixes for childhood ADHD on the market will take a family’s time and money without providing meaningful improvement. Parents should focus instead on the tried-and-true routines and supports that will help them to create the setting at home that will enable their children to flourish.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Millichap JG and Yee MM. Pediatrics. 2012 Feb;129(2):330-7.
2. Grimm O et al. Curr Psychiatry Rep. 2020 Feb 27;22(4):18.
3. Chronis-Tuscano A et al. J Abnorm Child Psychol. 2017 Apr;45(3):501-7.
Attention-deficit/hyperactivity disorder (ADHD) is often a very challenging condition for parents to manage, both because of the “gleeful mayhem” children with ADHD manifest and because of the nature of effective treatments. Multiple randomized controlled studies and meta-analyses have demonstrated that stimulant medication with behavioral interventions is the optimal first-line treatment for children with both subtypes of ADHD, and that medications alone are superior to behavioral interventions alone. By improving attention and impulse control, the medications effectively decrease the many negative interactions with teachers, peers, and parents, aiding development and healthy self-esteem.
But many parents feel anxious about treating their young children with stimulants. Importantly, how children with ADHD will fare as adults is not predicted by their symptom level, but instead by the quality of their relationships with their parents, their ability to perform at school, and their social skills. Bring this framework to parents as you listen to their questions and help them decide on the best approach for their family. To assist you in these conversations, we will review the evidence for (or against) several of the most common alternatives to medication that parents are likely to ask about.
Diets and supplements
Dietary modifications are among the most popular “natural” approaches to managing ADHD in children. Diets that eliminate processed sugars or food additives (particularly artificial food coloring) are among the most common approaches discussed in the lay press. These diets are usually very time-consuming and disruptive for families to follow, and there is no evidence to support their general use in ADHD management. Those studies that rigorously examined them suggest that, for children with severe impairment who have failed to respond to medications for ADHD, a workup for food intolerance or nutritional deficits may reveal a different problem underlying their behavioral difficulties.1
Similarly, supplementation with high-dose omega-3 fatty acids is modestly helpful only in a subset of children with ADHD symptoms, and not nearly as effective as medications or behavioral interventions. Spending time on an exacting diet or buying expensive supplements is very unlikely to relieve the children’s symptoms and may only add to their stress at home. The “sugar high” parents note may be the rare joy of eating a candy bar and not sugar causing ADHD. Offer parents the guidance to focus on a healthy diet, high in fruits and vegetables, whole grains, and healthy protein, and on meals that emphasize family time instead of struggles around food.
Neurofeedback
Neurofeedback is an approach that grew out of the observation that many adults with ADHD had resting patterns of brain wave activity different from those of neurotypical adults. In neurofeedback, patients learn strategies that amplify the brain waves associated with focused mental activity, rather than listless or hyperactive states. Businesses market this service for all sorts of illnesses and challenges, ADHD chief among them. Despite the marketing, there are very few randomized controlled studies of this intervention for ADHD in youth, and those have shown only the possibility of a benefit.
While there is no evidence of serious side effects, these treatments are time-consuming and expensive and unlikely to be covered by any insurance. You might suggest to parents that they could achieve some of the same theoretical benefits by looking for hobbies that invite sustained focus in their children. That is, they should think about activities that interest the children, such as music lessons or karate, that they could practice in classes and at home. If the children find these activities even somewhat interesting (or just enjoy the reward of their parents’ or teachers’ attention), regular practice will be supporting their developing attention while building social skills and authentic self-confidence, rather than the activities feeling like a treatment for an illness or condition.
Sleep and exercise
There are not many businesses or books selling worried and exhausted parents a quick nonmedication solution for their children’s ADHD in the form of healthy sleep and exercise habits. But these are safe and healthy ways to reduce symptoms and support development. Children with ADHD often enjoy and benefit from participating in a sport, and daily exercise can help with sleep and regulating their energy. They also often have difficulty with sleep initiation, and commonly do not get adequate or restful sleep. Inadequate sleep exacerbates inattention, distractibility, and irritability. Children with untreated ADHD also often spend a lot of time on screens, as it is difficult for them to shift away from rewarding activities, and parents can find screen time to be a welcome break from hyperactivity and negative interactions. But excessive screen time, especially close to bedtime, can worsen irritability and make sleep more difficult. Talk with parents about the value of establishing a routine around screen time, modest daily physical activity, and sleep that everyone can follow. If their family life is currently marked by late bedtimes and long hours in front of video games, this change will take effort. But within a few weeks, it could lead to significant improvements in energy, attention, and interactions at home.
Behavioral treatments
Effective behavioral treatments for ADHD do not change ADHD symptoms, but they do help children learn how to manage them. In “parent management training,” younger children and parents learn together how to avoid negative cycles of behavior (i.e., temper outbursts) by focusing on consistent routines and consequences that support children calmly learning to manage their impulses. The only other evidence-based treatment focuses on helping school age and older children develop executive functions – their planning, organization, and time management skills – with a range of age-appropriate tools. Both of these therapies may be more effective if the children are also receiving medication, but medication is not necessary for them to be helpful. It is important to note that play therapy and other evidence-based psychotherapies are not effective for management of ADHD, although they may treat comorbid problems.
Parent treatment
You may have diagnosed children with ADHD only to hear their parents respond by saying that they suspect (or know) that they (or their spouses) also have ADHD. This would not be surprising, as ADHD has one of the highest rates of heritability of psychiatric disorders, at 80%. Somewhere between 25% and 50% of parents of children with ADHD have ADHD themselves.2 Screening for adults with ADHD, such as the Adult ADHD Self-Report Scale, is widely available and free. Speak with parents about the fact that behavioral treatments for their children’s ADHD are demanding. Such treatments require patience, calm, organization, and consistency.
If parents have ADHD, it may be very helpful for them to prioritize their own effective treatments, so that their attention and impulse control will support their parenting. They may be interested in learning about how treatment might also improve their performance at work and even the quality of their relationships. While there is some evidence that their children’s treatment outcome will hinge on the parents’ treatment,3 they deserve good care independent of the expectations of parenting.
Families benefit from a comprehensive “ADHD plan” for their children. This would start with an assessment of the severity of their children’s symptoms, specifying their impairment at home, school, and in social relationships. It would include their nonacademic performance, exploration of interests, and developing self-confidence. All of these considerations lead to setting reasonable expectations so the children can feel successful. Parents should think about how best to structure their children’s schedules to promote healthy sleep, exercise, and nutrition, and to expand opportunities for building their frustration tolerance, social skills, and executive function.
Parents will need to consider what kind of supports they themselves need to offer this structure. There are good resources available online for information and support, including Children and Adults with ADHD (chadd.org) and the ADHD Resource Center from the American Academy of Child and Adolescent Psychiatry (aacap.org). This approach may help parents to evaluate the potential risks and benefits of medications as a component of treatment. Most of the quick fixes for childhood ADHD on the market will take a family’s time and money without providing meaningful improvement. Parents should focus instead on the tried-and-true routines and supports that will help them to create the setting at home that will enable their children to flourish.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Millichap JG and Yee MM. Pediatrics. 2012 Feb;129(2):330-7.
2. Grimm O et al. Curr Psychiatry Rep. 2020 Feb 27;22(4):18.
3. Chronis-Tuscano A et al. J Abnorm Child Psychol. 2017 Apr;45(3):501-7.
Attention-deficit/hyperactivity disorder (ADHD) is often a very challenging condition for parents to manage, both because of the “gleeful mayhem” children with ADHD manifest and because of the nature of effective treatments. Multiple randomized controlled studies and meta-analyses have demonstrated that stimulant medication with behavioral interventions is the optimal first-line treatment for children with both subtypes of ADHD, and that medications alone are superior to behavioral interventions alone. By improving attention and impulse control, the medications effectively decrease the many negative interactions with teachers, peers, and parents, aiding development and healthy self-esteem.
But many parents feel anxious about treating their young children with stimulants. Importantly, how children with ADHD will fare as adults is not predicted by their symptom level, but instead by the quality of their relationships with their parents, their ability to perform at school, and their social skills. Bring this framework to parents as you listen to their questions and help them decide on the best approach for their family. To assist you in these conversations, we will review the evidence for (or against) several of the most common alternatives to medication that parents are likely to ask about.
Diets and supplements
Dietary modifications are among the most popular “natural” approaches to managing ADHD in children. Diets that eliminate processed sugars or food additives (particularly artificial food coloring) are among the most common approaches discussed in the lay press. These diets are usually very time-consuming and disruptive for families to follow, and there is no evidence to support their general use in ADHD management. Those studies that rigorously examined them suggest that, for children with severe impairment who have failed to respond to medications for ADHD, a workup for food intolerance or nutritional deficits may reveal a different problem underlying their behavioral difficulties.1
Similarly, supplementation with high-dose omega-3 fatty acids is modestly helpful only in a subset of children with ADHD symptoms, and not nearly as effective as medications or behavioral interventions. Spending time on an exacting diet or buying expensive supplements is very unlikely to relieve the children’s symptoms and may only add to their stress at home. The “sugar high” parents note may be the rare joy of eating a candy bar and not sugar causing ADHD. Offer parents the guidance to focus on a healthy diet, high in fruits and vegetables, whole grains, and healthy protein, and on meals that emphasize family time instead of struggles around food.
Neurofeedback
Neurofeedback is an approach that grew out of the observation that many adults with ADHD had resting patterns of brain wave activity different from those of neurotypical adults. In neurofeedback, patients learn strategies that amplify the brain waves associated with focused mental activity, rather than listless or hyperactive states. Businesses market this service for all sorts of illnesses and challenges, ADHD chief among them. Despite the marketing, there are very few randomized controlled studies of this intervention for ADHD in youth, and those have shown only the possibility of a benefit.
While there is no evidence of serious side effects, these treatments are time-consuming and expensive and unlikely to be covered by any insurance. You might suggest to parents that they could achieve some of the same theoretical benefits by looking for hobbies that invite sustained focus in their children. That is, they should think about activities that interest the children, such as music lessons or karate, that they could practice in classes and at home. If the children find these activities even somewhat interesting (or just enjoy the reward of their parents’ or teachers’ attention), regular practice will be supporting their developing attention while building social skills and authentic self-confidence, rather than the activities feeling like a treatment for an illness or condition.
Sleep and exercise
There are not many businesses or books selling worried and exhausted parents a quick nonmedication solution for their children’s ADHD in the form of healthy sleep and exercise habits. But these are safe and healthy ways to reduce symptoms and support development. Children with ADHD often enjoy and benefit from participating in a sport, and daily exercise can help with sleep and regulating their energy. They also often have difficulty with sleep initiation, and commonly do not get adequate or restful sleep. Inadequate sleep exacerbates inattention, distractibility, and irritability. Children with untreated ADHD also often spend a lot of time on screens, as it is difficult for them to shift away from rewarding activities, and parents can find screen time to be a welcome break from hyperactivity and negative interactions. But excessive screen time, especially close to bedtime, can worsen irritability and make sleep more difficult. Talk with parents about the value of establishing a routine around screen time, modest daily physical activity, and sleep that everyone can follow. If their family life is currently marked by late bedtimes and long hours in front of video games, this change will take effort. But within a few weeks, it could lead to significant improvements in energy, attention, and interactions at home.
Behavioral treatments
Effective behavioral treatments for ADHD do not change ADHD symptoms, but they do help children learn how to manage them. In “parent management training,” younger children and parents learn together how to avoid negative cycles of behavior (i.e., temper outbursts) by focusing on consistent routines and consequences that support children calmly learning to manage their impulses. The only other evidence-based treatment focuses on helping school age and older children develop executive functions – their planning, organization, and time management skills – with a range of age-appropriate tools. Both of these therapies may be more effective if the children are also receiving medication, but medication is not necessary for them to be helpful. It is important to note that play therapy and other evidence-based psychotherapies are not effective for management of ADHD, although they may treat comorbid problems.
Parent treatment
You may have diagnosed children with ADHD only to hear their parents respond by saying that they suspect (or know) that they (or their spouses) also have ADHD. This would not be surprising, as ADHD has one of the highest rates of heritability of psychiatric disorders, at 80%. Somewhere between 25% and 50% of parents of children with ADHD have ADHD themselves.2 Screening for adults with ADHD, such as the Adult ADHD Self-Report Scale, is widely available and free. Speak with parents about the fact that behavioral treatments for their children’s ADHD are demanding. Such treatments require patience, calm, organization, and consistency.
If parents have ADHD, it may be very helpful for them to prioritize their own effective treatments, so that their attention and impulse control will support their parenting. They may be interested in learning about how treatment might also improve their performance at work and even the quality of their relationships. While there is some evidence that their children’s treatment outcome will hinge on the parents’ treatment,3 they deserve good care independent of the expectations of parenting.
Families benefit from a comprehensive “ADHD plan” for their children. This would start with an assessment of the severity of their children’s symptoms, specifying their impairment at home, school, and in social relationships. It would include their nonacademic performance, exploration of interests, and developing self-confidence. All of these considerations lead to setting reasonable expectations so the children can feel successful. Parents should think about how best to structure their children’s schedules to promote healthy sleep, exercise, and nutrition, and to expand opportunities for building their frustration tolerance, social skills, and executive function.
Parents will need to consider what kind of supports they themselves need to offer this structure. There are good resources available online for information and support, including Children and Adults with ADHD (chadd.org) and the ADHD Resource Center from the American Academy of Child and Adolescent Psychiatry (aacap.org). This approach may help parents to evaluate the potential risks and benefits of medications as a component of treatment. Most of the quick fixes for childhood ADHD on the market will take a family’s time and money without providing meaningful improvement. Parents should focus instead on the tried-and-true routines and supports that will help them to create the setting at home that will enable their children to flourish.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Millichap JG and Yee MM. Pediatrics. 2012 Feb;129(2):330-7.
2. Grimm O et al. Curr Psychiatry Rep. 2020 Feb 27;22(4):18.
3. Chronis-Tuscano A et al. J Abnorm Child Psychol. 2017 Apr;45(3):501-7.
Modified Atkins diet beneficial in drug-resistant epilepsy
, new research shows.
In a randomized prospective study, the number of seizures per month dropped by more than half in one-quarter of patients following the high-fat, low-carb diet; and 5% of the group were free from all seizure activity after 6 months.
Both adults and adolescents reported benefits from the diet, which is a less strict version of a traditional ketogenic diet that many patients find difficult to follow. The modified Atkins diet includes foods such as leafy green vegetables and eggs, chicken, fish, bacon, and other animal proteins.
“The use of an exchange list and recipe booklet with local recipes and spices helped in the initiation of modified Atkins diet with the flexibility of meal choices and ease of administration,” said coinvestigator Manjari Tripathi, MD, DM, department of neurology, All India Institute of Medical Science, New Delhi.
“As items were everyday household ingredients in proportion to the requirement of the modified Atkins diet, this diet is possible in low-income countries also,” Dr. Tripathi added.
The findings were published online in the journal Neurology.
Low carbs, high benefit
The modified Atkins diet includes around 65% fat, 25% protein, and 10% carbohydrates. Unlike a traditional ketogenic diet, the modified Atkins diet includes no restrictions on protein, calories, or fluids.
Researchers have long known that ketogenic and Atkins diets are associated with reduced seizure activity in adolescents with epilepsy. But previous studies were small, and many were retrospective analyses.
The current investigators enrolled 160 patients (80 adults, 80 adolescents) aged 10-55 years whose epilepsy was not controlled despite using at least three antiseizure medications at maximum tolerated doses.
The intervention group received training in the modified Atkins diet and were given a food exchange list, sample menu, and recipe booklet. Carbohydrate intake was restricted to 20 grams per day.
Participants took supplemental multivitamins and minerals, kept a food diary, logged seizure activity, and measured urine ketone levels three times a day. They also received weekly check-up phone calls to ensure diet adherence.
The control group received a normal diet with no carbohydrate restrictions. All participants continued their prescribed antiseizure therapy throughout the trial.
Primary outcome met
The primary study outcome was a reduction in seizures of more than 50%. At 6 months, 26.2% of the intervention group had reached that goal, compared with just 2.5% of the control group (P < .001).
When the median number of seizures in the modified Atkins diet group was analyzed, the frequency dropped in the intervention group from 37.5 per month at baseline to 27.5 per month after 3 months of the modified Atkins diet and to 21.5 per month after 6 months.
Adding the modified Atkins diet had a larger effect on seizure activity in adults than in adolescents. At the end of 6 months, 36% of adolescents on the modified Atkins diet had more than a 50% reduction in seizures, while 57.1% of adults on the diet reached that level.
Quality-of-life scores were also higher in the intervention group.
By the end of the trial, 5% of patients on the modified Atkins diet had no seizure activity at all versus none of the control group. In fact, the median number of seizures increased in the control group during the study.
The mean morning and evening levels of urine ketosis in the intervention group were 58.3 ± 8.0 mg/dL and 62.2 ± 22.6 mg/dL, respectively, suggesting satisfactory diet adherence. There was no significant difference between groups in weight loss.
Dr. Tripathi noted that 33% of participants did not complete the study because of poor tolerance of the diet, lack of benefit, or the inability to follow up – in part due to COVID-19. However, she said tolerance of the modified Atkins diet was better than what has been reported with the ketogenic diet.
“Though the exact mechanism by which such a diet protects against seizures is unknown, there is evidence that it causes effects on intermediary metabolism that influences the dynamics of the major inhibitory and excitatory neurotransmitter systems in the brain,” Dr. Tripathi said.
Benefits outweigh cost
Commenting on the research findings, Mackenzie Cervenka, MD, professor of neurology and director of the Adult Epilepsy Diet Center at Johns Hopkins University, Baltimore, noted that the study is the first randomized controlled trial of this size to demonstrate a benefit from adding the modified Atkins diet to standard antiseizure therapy in treatment-resistant epilepsy.
“Importantly, the study also showed improvement in quality of life and behavior over standard-of-care therapies without significant adverse effects,” said Dr. Cervenka, who was not part of the research.
The investigators noted that the flexibility of the modified Atkins diet allows more variation in menu options and a greater intake of protein, making it easier to follow than a traditional ketogenic diet.
One area of debate, however, is whether these diets are manageable for individuals with low income. Poultry, meat, and fish, all of which are staples of a modified Atkins diet, can be more expensive than other high-carb options such as pasta and rice.
“While some of the foods such as protein sources that patients purchase when they are on a ketogenic diet therapy can be more expensive, if you take into account the cost of antiseizure medications and other antiseizure treatments, hospital visits, and missed work related to seizures, et cetera, the overall financial benefits of seizure reduction with incorporating a ketogenic diet therapy may outweigh these costs,” Dr. Cervenka said.
“There are also low-cost foods that can be used since there is a great deal of flexibility with a modified Atkins diet,” she added.
The study was funded by the Centre of Excellence for Epilepsy, which is funded by the Department of Biotechnology, Government of India. Dr. Tripathi and Dr. Cervenka report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
In a randomized prospective study, the number of seizures per month dropped by more than half in one-quarter of patients following the high-fat, low-carb diet; and 5% of the group were free from all seizure activity after 6 months.
Both adults and adolescents reported benefits from the diet, which is a less strict version of a traditional ketogenic diet that many patients find difficult to follow. The modified Atkins diet includes foods such as leafy green vegetables and eggs, chicken, fish, bacon, and other animal proteins.
“The use of an exchange list and recipe booklet with local recipes and spices helped in the initiation of modified Atkins diet with the flexibility of meal choices and ease of administration,” said coinvestigator Manjari Tripathi, MD, DM, department of neurology, All India Institute of Medical Science, New Delhi.
“As items were everyday household ingredients in proportion to the requirement of the modified Atkins diet, this diet is possible in low-income countries also,” Dr. Tripathi added.
The findings were published online in the journal Neurology.
Low carbs, high benefit
The modified Atkins diet includes around 65% fat, 25% protein, and 10% carbohydrates. Unlike a traditional ketogenic diet, the modified Atkins diet includes no restrictions on protein, calories, or fluids.
Researchers have long known that ketogenic and Atkins diets are associated with reduced seizure activity in adolescents with epilepsy. But previous studies were small, and many were retrospective analyses.
The current investigators enrolled 160 patients (80 adults, 80 adolescents) aged 10-55 years whose epilepsy was not controlled despite using at least three antiseizure medications at maximum tolerated doses.
The intervention group received training in the modified Atkins diet and were given a food exchange list, sample menu, and recipe booklet. Carbohydrate intake was restricted to 20 grams per day.
Participants took supplemental multivitamins and minerals, kept a food diary, logged seizure activity, and measured urine ketone levels three times a day. They also received weekly check-up phone calls to ensure diet adherence.
The control group received a normal diet with no carbohydrate restrictions. All participants continued their prescribed antiseizure therapy throughout the trial.
Primary outcome met
The primary study outcome was a reduction in seizures of more than 50%. At 6 months, 26.2% of the intervention group had reached that goal, compared with just 2.5% of the control group (P < .001).
When the median number of seizures in the modified Atkins diet group was analyzed, the frequency dropped in the intervention group from 37.5 per month at baseline to 27.5 per month after 3 months of the modified Atkins diet and to 21.5 per month after 6 months.
Adding the modified Atkins diet had a larger effect on seizure activity in adults than in adolescents. At the end of 6 months, 36% of adolescents on the modified Atkins diet had more than a 50% reduction in seizures, while 57.1% of adults on the diet reached that level.
Quality-of-life scores were also higher in the intervention group.
By the end of the trial, 5% of patients on the modified Atkins diet had no seizure activity at all versus none of the control group. In fact, the median number of seizures increased in the control group during the study.
The mean morning and evening levels of urine ketosis in the intervention group were 58.3 ± 8.0 mg/dL and 62.2 ± 22.6 mg/dL, respectively, suggesting satisfactory diet adherence. There was no significant difference between groups in weight loss.
Dr. Tripathi noted that 33% of participants did not complete the study because of poor tolerance of the diet, lack of benefit, or the inability to follow up – in part due to COVID-19. However, she said tolerance of the modified Atkins diet was better than what has been reported with the ketogenic diet.
“Though the exact mechanism by which such a diet protects against seizures is unknown, there is evidence that it causes effects on intermediary metabolism that influences the dynamics of the major inhibitory and excitatory neurotransmitter systems in the brain,” Dr. Tripathi said.
Benefits outweigh cost
Commenting on the research findings, Mackenzie Cervenka, MD, professor of neurology and director of the Adult Epilepsy Diet Center at Johns Hopkins University, Baltimore, noted that the study is the first randomized controlled trial of this size to demonstrate a benefit from adding the modified Atkins diet to standard antiseizure therapy in treatment-resistant epilepsy.
“Importantly, the study also showed improvement in quality of life and behavior over standard-of-care therapies without significant adverse effects,” said Dr. Cervenka, who was not part of the research.
The investigators noted that the flexibility of the modified Atkins diet allows more variation in menu options and a greater intake of protein, making it easier to follow than a traditional ketogenic diet.
One area of debate, however, is whether these diets are manageable for individuals with low income. Poultry, meat, and fish, all of which are staples of a modified Atkins diet, can be more expensive than other high-carb options such as pasta and rice.
“While some of the foods such as protein sources that patients purchase when they are on a ketogenic diet therapy can be more expensive, if you take into account the cost of antiseizure medications and other antiseizure treatments, hospital visits, and missed work related to seizures, et cetera, the overall financial benefits of seizure reduction with incorporating a ketogenic diet therapy may outweigh these costs,” Dr. Cervenka said.
“There are also low-cost foods that can be used since there is a great deal of flexibility with a modified Atkins diet,” she added.
The study was funded by the Centre of Excellence for Epilepsy, which is funded by the Department of Biotechnology, Government of India. Dr. Tripathi and Dr. Cervenka report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
In a randomized prospective study, the number of seizures per month dropped by more than half in one-quarter of patients following the high-fat, low-carb diet; and 5% of the group were free from all seizure activity after 6 months.
Both adults and adolescents reported benefits from the diet, which is a less strict version of a traditional ketogenic diet that many patients find difficult to follow. The modified Atkins diet includes foods such as leafy green vegetables and eggs, chicken, fish, bacon, and other animal proteins.
“The use of an exchange list and recipe booklet with local recipes and spices helped in the initiation of modified Atkins diet with the flexibility of meal choices and ease of administration,” said coinvestigator Manjari Tripathi, MD, DM, department of neurology, All India Institute of Medical Science, New Delhi.
“As items were everyday household ingredients in proportion to the requirement of the modified Atkins diet, this diet is possible in low-income countries also,” Dr. Tripathi added.
The findings were published online in the journal Neurology.
Low carbs, high benefit
The modified Atkins diet includes around 65% fat, 25% protein, and 10% carbohydrates. Unlike a traditional ketogenic diet, the modified Atkins diet includes no restrictions on protein, calories, or fluids.
Researchers have long known that ketogenic and Atkins diets are associated with reduced seizure activity in adolescents with epilepsy. But previous studies were small, and many were retrospective analyses.
The current investigators enrolled 160 patients (80 adults, 80 adolescents) aged 10-55 years whose epilepsy was not controlled despite using at least three antiseizure medications at maximum tolerated doses.
The intervention group received training in the modified Atkins diet and were given a food exchange list, sample menu, and recipe booklet. Carbohydrate intake was restricted to 20 grams per day.
Participants took supplemental multivitamins and minerals, kept a food diary, logged seizure activity, and measured urine ketone levels three times a day. They also received weekly check-up phone calls to ensure diet adherence.
The control group received a normal diet with no carbohydrate restrictions. All participants continued their prescribed antiseizure therapy throughout the trial.
Primary outcome met
The primary study outcome was a reduction in seizures of more than 50%. At 6 months, 26.2% of the intervention group had reached that goal, compared with just 2.5% of the control group (P < .001).
When the median number of seizures in the modified Atkins diet group was analyzed, the frequency dropped in the intervention group from 37.5 per month at baseline to 27.5 per month after 3 months of the modified Atkins diet and to 21.5 per month after 6 months.
Adding the modified Atkins diet had a larger effect on seizure activity in adults than in adolescents. At the end of 6 months, 36% of adolescents on the modified Atkins diet had more than a 50% reduction in seizures, while 57.1% of adults on the diet reached that level.
Quality-of-life scores were also higher in the intervention group.
By the end of the trial, 5% of patients on the modified Atkins diet had no seizure activity at all versus none of the control group. In fact, the median number of seizures increased in the control group during the study.
The mean morning and evening levels of urine ketosis in the intervention group were 58.3 ± 8.0 mg/dL and 62.2 ± 22.6 mg/dL, respectively, suggesting satisfactory diet adherence. There was no significant difference between groups in weight loss.
Dr. Tripathi noted that 33% of participants did not complete the study because of poor tolerance of the diet, lack of benefit, or the inability to follow up – in part due to COVID-19. However, she said tolerance of the modified Atkins diet was better than what has been reported with the ketogenic diet.
“Though the exact mechanism by which such a diet protects against seizures is unknown, there is evidence that it causes effects on intermediary metabolism that influences the dynamics of the major inhibitory and excitatory neurotransmitter systems in the brain,” Dr. Tripathi said.
Benefits outweigh cost
Commenting on the research findings, Mackenzie Cervenka, MD, professor of neurology and director of the Adult Epilepsy Diet Center at Johns Hopkins University, Baltimore, noted that the study is the first randomized controlled trial of this size to demonstrate a benefit from adding the modified Atkins diet to standard antiseizure therapy in treatment-resistant epilepsy.
“Importantly, the study also showed improvement in quality of life and behavior over standard-of-care therapies without significant adverse effects,” said Dr. Cervenka, who was not part of the research.
The investigators noted that the flexibility of the modified Atkins diet allows more variation in menu options and a greater intake of protein, making it easier to follow than a traditional ketogenic diet.
One area of debate, however, is whether these diets are manageable for individuals with low income. Poultry, meat, and fish, all of which are staples of a modified Atkins diet, can be more expensive than other high-carb options such as pasta and rice.
“While some of the foods such as protein sources that patients purchase when they are on a ketogenic diet therapy can be more expensive, if you take into account the cost of antiseizure medications and other antiseizure treatments, hospital visits, and missed work related to seizures, et cetera, the overall financial benefits of seizure reduction with incorporating a ketogenic diet therapy may outweigh these costs,” Dr. Cervenka said.
“There are also low-cost foods that can be used since there is a great deal of flexibility with a modified Atkins diet,” she added.
The study was funded by the Centre of Excellence for Epilepsy, which is funded by the Department of Biotechnology, Government of India. Dr. Tripathi and Dr. Cervenka report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
What to know about newly approved Alzheimer’s drug
, offering hope where there has been little for patients and their families affected by the devastating disease.
More than 6 million people in the United States live with Alzheimer’s.
It’s not a cure, but the drug, given intravenously every 2 weeks, has shown moderate positive effects in clinical trials in slowing early-stage disease.
But many are wary. As explained in an editorial in the journal The Lancet, “The Alzheimer’s disease community has become accustomed to false hope, disappointment, and controversy.”
Some worry about lecanemab’s safety as some people in clinical trials experienced serious side effects of bleeding and swelling in the brain. Scientists recently attributed a third death to lecanemab, brand name Leqembi, though the drugmaker disputed the medication was the cause.
So what should patients and their families make of this news? Here we answer some of the top questions surrounding the drug.
What does the FDA action mean?
The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing the progression of early-stage disease.
The FDA can grant accelerated approval for drugs that treat serious conditions and fill an unmet medical need while drugs continue to be studied in larger trials.
With the FDA approval in hand, doctors can now prescribe the medication.
Rebecca Edelmayer, PhD, the Alzheimer’s Association senior director of scientific engagement, says that with the FDA’s move, ramping up manufacturing – and eventually nationwide distribution and implementation – will take some time.
“Ask your doctor about availability,” she says. “The main issue is that, without insurance and Medicare coverage of this class of treatments, access for those who could benefit from the newly approved treatment will only be available to those who can pay out-of-pocket. Without coverage, people simply won’t be able to get the treatment.”
The Washington Post reports that with accelerated approval, drugmaker Eisai is expected to immediately apply for full FDA approval, which wouldn’t be likely to come before later this year. Full approval could help clear the path for Medicare coverage of the drug.
Potential benefit?
Those who got Leqembi in a clinical trial for 18 months experienced 27% less decline in memory and thinking relative to the group who got a placebo. It also reduced amyloid in the brain, the sticky protein that builds up in the brains of people with Alzheimer’s and is considered a hallmark of the disease.
Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, says, “It’s the first phase 3 study in our field of a disease-modifying drug where the clinical efficacy was very clear.”
Concerns about side effects
The drug has raised safety concerns as it has been linked with certain serious adverse events, including brain swelling and bleeding. In the trial, 14% of patients who received the drug experienced side effects that included brain swelling and bleeding, compared with about 11% in the placebo group.
Scientists have reportedly linked three deaths during the clinical trial to lecanemab, though it is unclear whether it caused the deaths.
Dr. Fillit notes that the first two people who died were on blood thinners when they received lecanemab.
“There are things about the use of the drug in the real world that we need to work out, especially in the context of people with comorbidities,” he says.
The third death is a little different, Dr. Fillit says. The patient, who had a stroke, showed signs of vasculitis, or inflammation of the blood vessels.
“We don’t know exactly what happened, but we do know it was very, very rare” among the people involved in the trials, he says.
Dr. Edelmayer says that the most common reported side effects during the trials were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). According to the FDA, these abnormalities “are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur.”
The FDA has added these as warnings to the drug’s label, describing the possible infusion-related reactions as flu-like symptoms, nausea, vomiting, and changes in blood pressure.
How much will it cost?
Eisai says that lecanemab will cost $26,500 a year.
In a draft report released in December, the Institute for Clinical and Economic Review said a price ranging from $8,500 to $20,600 a year would make the drug cost-effective. While the group has no authority to set prices, many large health insurers consider its reports when they negotiate prices and some drugmakers take into account ICER’s recommendations when setting prices.
An editorial in The Lancet last month warns that the cost will likely be “prohibitive” for low- and middle-income countries and many health systems don’t have the infrastructure for a widespread rollout.
Will Medicare cover it?
The Centers for Medicare & Medicaid Services, which runs Medicare, which covers most people with Alzheimer’s, has indicated it won’t broadly cover amyloid-lowering drugs until the drug gets full U.S. approval based on clinical benefits, as opposed to accelerated approval.
That means people would have to pay thousands out of pocket at first to get it.
The CMS decision effectively denies Medicare coverage of fast-tracked FDA-approved medications for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.
On Dec. 19, the Alzheimer’s Association filed a formal request asking CMS to remove the trial-only requirement and provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.
CMS says in a statement issued after the announcement: “Because Eisai’s product, lecanemab, was granted accelerated approval by the FDA, it falls under CMS’s existing national coverage determination. CMS is examining available information and may reconsider its current coverage based on this review.”
“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage,” the statement says.
Who benefits most from this drug?
Lecanemab is a treatment for people with early-stage Alzheimer’s disease who have amyloid in their brain. This means people with other types of dementia, or those in the later stages of Alzheimer’s disease, are not likely to improve with this drug.
Who makes lecanemab?
Japan-based Eisai is developing the drug, a monoclonal antibody, in collaboration with the U.S. company Biogen.
What’s the Alzheimer’s Association’s view?
The association urged accelerated FDA approval. In a statement, it says it “welcomes and is further encouraged” by the clinical trial results.
It says data published in the New England Journal of Medicine confirms lecanemab “can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease.”
“We are energized at the progress we are seeing in the research pipeline. The science is telling us that although antiamyloid treatments are not a cure – they are not going to be the end of treating Alzheimer’s – they are certainly the beginning,” Dr. Edelmayer says.
Are there alternatives?
The FDA gave accelerated approval to Biogen to produce another drug for Alzheimer’s, Aduhelm (aducanemab), in 2021, but the move was controversial as the drug’s effectiveness was widely questioned. It has since largely been pulled from the market.
Aduhelm had been the first approved early-stage Alzheimer’s treatment since 2003.
A version of this article first appeared on WebMD.com.
, offering hope where there has been little for patients and their families affected by the devastating disease.
More than 6 million people in the United States live with Alzheimer’s.
It’s not a cure, but the drug, given intravenously every 2 weeks, has shown moderate positive effects in clinical trials in slowing early-stage disease.
But many are wary. As explained in an editorial in the journal The Lancet, “The Alzheimer’s disease community has become accustomed to false hope, disappointment, and controversy.”
Some worry about lecanemab’s safety as some people in clinical trials experienced serious side effects of bleeding and swelling in the brain. Scientists recently attributed a third death to lecanemab, brand name Leqembi, though the drugmaker disputed the medication was the cause.
So what should patients and their families make of this news? Here we answer some of the top questions surrounding the drug.
What does the FDA action mean?
The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing the progression of early-stage disease.
The FDA can grant accelerated approval for drugs that treat serious conditions and fill an unmet medical need while drugs continue to be studied in larger trials.
With the FDA approval in hand, doctors can now prescribe the medication.
Rebecca Edelmayer, PhD, the Alzheimer’s Association senior director of scientific engagement, says that with the FDA’s move, ramping up manufacturing – and eventually nationwide distribution and implementation – will take some time.
“Ask your doctor about availability,” she says. “The main issue is that, without insurance and Medicare coverage of this class of treatments, access for those who could benefit from the newly approved treatment will only be available to those who can pay out-of-pocket. Without coverage, people simply won’t be able to get the treatment.”
The Washington Post reports that with accelerated approval, drugmaker Eisai is expected to immediately apply for full FDA approval, which wouldn’t be likely to come before later this year. Full approval could help clear the path for Medicare coverage of the drug.
Potential benefit?
Those who got Leqembi in a clinical trial for 18 months experienced 27% less decline in memory and thinking relative to the group who got a placebo. It also reduced amyloid in the brain, the sticky protein that builds up in the brains of people with Alzheimer’s and is considered a hallmark of the disease.
Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, says, “It’s the first phase 3 study in our field of a disease-modifying drug where the clinical efficacy was very clear.”
Concerns about side effects
The drug has raised safety concerns as it has been linked with certain serious adverse events, including brain swelling and bleeding. In the trial, 14% of patients who received the drug experienced side effects that included brain swelling and bleeding, compared with about 11% in the placebo group.
Scientists have reportedly linked three deaths during the clinical trial to lecanemab, though it is unclear whether it caused the deaths.
Dr. Fillit notes that the first two people who died were on blood thinners when they received lecanemab.
“There are things about the use of the drug in the real world that we need to work out, especially in the context of people with comorbidities,” he says.
The third death is a little different, Dr. Fillit says. The patient, who had a stroke, showed signs of vasculitis, or inflammation of the blood vessels.
“We don’t know exactly what happened, but we do know it was very, very rare” among the people involved in the trials, he says.
Dr. Edelmayer says that the most common reported side effects during the trials were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). According to the FDA, these abnormalities “are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur.”
The FDA has added these as warnings to the drug’s label, describing the possible infusion-related reactions as flu-like symptoms, nausea, vomiting, and changes in blood pressure.
How much will it cost?
Eisai says that lecanemab will cost $26,500 a year.
In a draft report released in December, the Institute for Clinical and Economic Review said a price ranging from $8,500 to $20,600 a year would make the drug cost-effective. While the group has no authority to set prices, many large health insurers consider its reports when they negotiate prices and some drugmakers take into account ICER’s recommendations when setting prices.
An editorial in The Lancet last month warns that the cost will likely be “prohibitive” for low- and middle-income countries and many health systems don’t have the infrastructure for a widespread rollout.
Will Medicare cover it?
The Centers for Medicare & Medicaid Services, which runs Medicare, which covers most people with Alzheimer’s, has indicated it won’t broadly cover amyloid-lowering drugs until the drug gets full U.S. approval based on clinical benefits, as opposed to accelerated approval.
That means people would have to pay thousands out of pocket at first to get it.
The CMS decision effectively denies Medicare coverage of fast-tracked FDA-approved medications for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.
On Dec. 19, the Alzheimer’s Association filed a formal request asking CMS to remove the trial-only requirement and provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.
CMS says in a statement issued after the announcement: “Because Eisai’s product, lecanemab, was granted accelerated approval by the FDA, it falls under CMS’s existing national coverage determination. CMS is examining available information and may reconsider its current coverage based on this review.”
“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage,” the statement says.
Who benefits most from this drug?
Lecanemab is a treatment for people with early-stage Alzheimer’s disease who have amyloid in their brain. This means people with other types of dementia, or those in the later stages of Alzheimer’s disease, are not likely to improve with this drug.
Who makes lecanemab?
Japan-based Eisai is developing the drug, a monoclonal antibody, in collaboration with the U.S. company Biogen.
What’s the Alzheimer’s Association’s view?
The association urged accelerated FDA approval. In a statement, it says it “welcomes and is further encouraged” by the clinical trial results.
It says data published in the New England Journal of Medicine confirms lecanemab “can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease.”
“We are energized at the progress we are seeing in the research pipeline. The science is telling us that although antiamyloid treatments are not a cure – they are not going to be the end of treating Alzheimer’s – they are certainly the beginning,” Dr. Edelmayer says.
Are there alternatives?
The FDA gave accelerated approval to Biogen to produce another drug for Alzheimer’s, Aduhelm (aducanemab), in 2021, but the move was controversial as the drug’s effectiveness was widely questioned. It has since largely been pulled from the market.
Aduhelm had been the first approved early-stage Alzheimer’s treatment since 2003.
A version of this article first appeared on WebMD.com.
, offering hope where there has been little for patients and their families affected by the devastating disease.
More than 6 million people in the United States live with Alzheimer’s.
It’s not a cure, but the drug, given intravenously every 2 weeks, has shown moderate positive effects in clinical trials in slowing early-stage disease.
But many are wary. As explained in an editorial in the journal The Lancet, “The Alzheimer’s disease community has become accustomed to false hope, disappointment, and controversy.”
Some worry about lecanemab’s safety as some people in clinical trials experienced serious side effects of bleeding and swelling in the brain. Scientists recently attributed a third death to lecanemab, brand name Leqembi, though the drugmaker disputed the medication was the cause.
So what should patients and their families make of this news? Here we answer some of the top questions surrounding the drug.
What does the FDA action mean?
The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing the progression of early-stage disease.
The FDA can grant accelerated approval for drugs that treat serious conditions and fill an unmet medical need while drugs continue to be studied in larger trials.
With the FDA approval in hand, doctors can now prescribe the medication.
Rebecca Edelmayer, PhD, the Alzheimer’s Association senior director of scientific engagement, says that with the FDA’s move, ramping up manufacturing – and eventually nationwide distribution and implementation – will take some time.
“Ask your doctor about availability,” she says. “The main issue is that, without insurance and Medicare coverage of this class of treatments, access for those who could benefit from the newly approved treatment will only be available to those who can pay out-of-pocket. Without coverage, people simply won’t be able to get the treatment.”
The Washington Post reports that with accelerated approval, drugmaker Eisai is expected to immediately apply for full FDA approval, which wouldn’t be likely to come before later this year. Full approval could help clear the path for Medicare coverage of the drug.
Potential benefit?
Those who got Leqembi in a clinical trial for 18 months experienced 27% less decline in memory and thinking relative to the group who got a placebo. It also reduced amyloid in the brain, the sticky protein that builds up in the brains of people with Alzheimer’s and is considered a hallmark of the disease.
Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, says, “It’s the first phase 3 study in our field of a disease-modifying drug where the clinical efficacy was very clear.”
Concerns about side effects
The drug has raised safety concerns as it has been linked with certain serious adverse events, including brain swelling and bleeding. In the trial, 14% of patients who received the drug experienced side effects that included brain swelling and bleeding, compared with about 11% in the placebo group.
Scientists have reportedly linked three deaths during the clinical trial to lecanemab, though it is unclear whether it caused the deaths.
Dr. Fillit notes that the first two people who died were on blood thinners when they received lecanemab.
“There are things about the use of the drug in the real world that we need to work out, especially in the context of people with comorbidities,” he says.
The third death is a little different, Dr. Fillit says. The patient, who had a stroke, showed signs of vasculitis, or inflammation of the blood vessels.
“We don’t know exactly what happened, but we do know it was very, very rare” among the people involved in the trials, he says.
Dr. Edelmayer says that the most common reported side effects during the trials were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). According to the FDA, these abnormalities “are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur.”
The FDA has added these as warnings to the drug’s label, describing the possible infusion-related reactions as flu-like symptoms, nausea, vomiting, and changes in blood pressure.
How much will it cost?
Eisai says that lecanemab will cost $26,500 a year.
In a draft report released in December, the Institute for Clinical and Economic Review said a price ranging from $8,500 to $20,600 a year would make the drug cost-effective. While the group has no authority to set prices, many large health insurers consider its reports when they negotiate prices and some drugmakers take into account ICER’s recommendations when setting prices.
An editorial in The Lancet last month warns that the cost will likely be “prohibitive” for low- and middle-income countries and many health systems don’t have the infrastructure for a widespread rollout.
Will Medicare cover it?
The Centers for Medicare & Medicaid Services, which runs Medicare, which covers most people with Alzheimer’s, has indicated it won’t broadly cover amyloid-lowering drugs until the drug gets full U.S. approval based on clinical benefits, as opposed to accelerated approval.
That means people would have to pay thousands out of pocket at first to get it.
The CMS decision effectively denies Medicare coverage of fast-tracked FDA-approved medications for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.
On Dec. 19, the Alzheimer’s Association filed a formal request asking CMS to remove the trial-only requirement and provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.
CMS says in a statement issued after the announcement: “Because Eisai’s product, lecanemab, was granted accelerated approval by the FDA, it falls under CMS’s existing national coverage determination. CMS is examining available information and may reconsider its current coverage based on this review.”
“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage,” the statement says.
Who benefits most from this drug?
Lecanemab is a treatment for people with early-stage Alzheimer’s disease who have amyloid in their brain. This means people with other types of dementia, or those in the later stages of Alzheimer’s disease, are not likely to improve with this drug.
Who makes lecanemab?
Japan-based Eisai is developing the drug, a monoclonal antibody, in collaboration with the U.S. company Biogen.
What’s the Alzheimer’s Association’s view?
The association urged accelerated FDA approval. In a statement, it says it “welcomes and is further encouraged” by the clinical trial results.
It says data published in the New England Journal of Medicine confirms lecanemab “can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease.”
“We are energized at the progress we are seeing in the research pipeline. The science is telling us that although antiamyloid treatments are not a cure – they are not going to be the end of treating Alzheimer’s – they are certainly the beginning,” Dr. Edelmayer says.
Are there alternatives?
The FDA gave accelerated approval to Biogen to produce another drug for Alzheimer’s, Aduhelm (aducanemab), in 2021, but the move was controversial as the drug’s effectiveness was widely questioned. It has since largely been pulled from the market.
Aduhelm had been the first approved early-stage Alzheimer’s treatment since 2003.
A version of this article first appeared on WebMD.com.
FDA approves second antiamyloid for Alzheimer’s disease
Like its controversial cousin aducanumab (Aduhelm, Biogen/Eisai), lecanemab was approved under the FDA’s accelerated approval pathway, which can be used to fast-track a drug that provides a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.
Unlike aducanumab, however, there was no formal FDA advisory committee meeting on lecanemab prior to approval.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dr. Dunn added.
Eisai has reported that lecanemab will cost $26,500 a year.
Modest benefit, adverse events
The FDA noted, “The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.”
The agency approved the treatment on the basis of findings from the CLARITY AD trial, which showed modest cognitive benefit for patients with early AD – but at a cost of increased risk for amyloid-related edema and effusions.
The trial enrolled 1,795 adults with mild cognitive impairment or early Alzheimer’s disease in whom amyloid pathology in the brain had been confirmed. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
After 18 months of treatment, lecanemab slowed cognitive decline by 27%, compared with placebo, as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB). This was an absolute difference of 0.45 points (change from baseline, 1.21 for lecanemab vs. 1.66 with placebo; P < .001).
While the results are “welcome news,” a 0.45-point difference on the CDR-SB might not be clinically meaningful, authors of a recent editorial in The Lancet cautioned.
Amyloid-related imaging abnormalities that manifest as edema or microhemorrhages also occurred in one in five patients taking lecanemab.
In addition, a newly published case report in The New England Journal of Medicine describes a patient with Alzheimer’s disease who was taking lecanemab and who died after experiencing numerous intracerebral hemorrhages during treatment with tissue plasminogen activator (tPA) for acute ischemic stroke.
“The findings raise the possibility of cerebral hemorrhages and necrotizing vasculopathy associated with tPA infusion in a patient with cerebrovascular amyloid who had received lecanemab,” the authors wrote.
Alzheimer’s Association reaction
Still, in anticipation of accelerated approval of lecanemab and the antiamyloid drug donanemab (Eli Lilly), which the FDA has also fast-tracked, the Alzheimer’s Association filed a formal request last month with the Centers for Medicare & Medicaid Services asking that it provide full and unrestricted coverage for FDA-approved Alzheimer’s disease treatments.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, the association asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved antiamyloid monoclonal antibodies.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and CEO for the Alzheimer’s Association, noted in a news release at the time.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike added.
After news of today’s approval was released, Dr. Pike noted in a new release, “The Alzheimer’s Association welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.”
Maria C. Carrillo, PhD, chief science officer at the Alzheimer’s Association, called today’s approval “a milestone achievement.”
“The progress we’ve seen in not only this class of treatments but also in the diversification of treatment types and targets over the past few years is exciting and provides real hope to those impacted by this devastating disease,” Dr. Carrillo said.
Critical issues
Commenting on the approval, Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School, Boston, and chief medical officer at Linus Health, said FDA approval of lecanemab and its adoption in the clinic represent a “very exciting development and prospect; but arguably some critical issues need to be considered.”
He noted that the health care system “is not currently prepared to cope with the challenges and demands of lecanemab,” as well as future pharmacologic agents.
“First, we need better workflows to identify suitable patients who can most benefit from this treatment,” said Dr. Pascual-Leone. He added that beyond identification of cognitive difficulties, amyloid status will need to be determined.
“Presently, this requires expensive and invasive tests,” such as positron-emission tomography scans or lumbar punctures for cerebrospinal fluid analysis. However, these are not fully covered by insurance companies and would be challenging to fully scale, he noted.
“In addition to screening, health systems will need to resolve the logistics challenges around the administration of lecanemab with twice-monthly infusions and the need for careful longitudinal evaluations for potential side effects,” said Dr. Pascual-Leone.
“While lecanemab may represent the first disease-modifying therapy widely available for early Alzheimer’s disease, the likely more promising approach is the addition of other therapies to lecanemab as part of a multi-intervention strategy combining pharmacologic and nonpharmacologic interventions,” he added.
Dr. Pascual-Leone has served as a paid member on scientific advisory boards for Neuroelectrics, Magstim, TetraNeuron, Skin2Neuron, MedRhythms, and Hearts Radiant and is a cofounder of TI Solutions and Linus Health.
A version of this article first appeared on Medscape.com.
This article was updated 1/9/23.
Like its controversial cousin aducanumab (Aduhelm, Biogen/Eisai), lecanemab was approved under the FDA’s accelerated approval pathway, which can be used to fast-track a drug that provides a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.
Unlike aducanumab, however, there was no formal FDA advisory committee meeting on lecanemab prior to approval.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dr. Dunn added.
Eisai has reported that lecanemab will cost $26,500 a year.
Modest benefit, adverse events
The FDA noted, “The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.”
The agency approved the treatment on the basis of findings from the CLARITY AD trial, which showed modest cognitive benefit for patients with early AD – but at a cost of increased risk for amyloid-related edema and effusions.
The trial enrolled 1,795 adults with mild cognitive impairment or early Alzheimer’s disease in whom amyloid pathology in the brain had been confirmed. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
After 18 months of treatment, lecanemab slowed cognitive decline by 27%, compared with placebo, as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB). This was an absolute difference of 0.45 points (change from baseline, 1.21 for lecanemab vs. 1.66 with placebo; P < .001).
While the results are “welcome news,” a 0.45-point difference on the CDR-SB might not be clinically meaningful, authors of a recent editorial in The Lancet cautioned.
Amyloid-related imaging abnormalities that manifest as edema or microhemorrhages also occurred in one in five patients taking lecanemab.
In addition, a newly published case report in The New England Journal of Medicine describes a patient with Alzheimer’s disease who was taking lecanemab and who died after experiencing numerous intracerebral hemorrhages during treatment with tissue plasminogen activator (tPA) for acute ischemic stroke.
“The findings raise the possibility of cerebral hemorrhages and necrotizing vasculopathy associated with tPA infusion in a patient with cerebrovascular amyloid who had received lecanemab,” the authors wrote.
Alzheimer’s Association reaction
Still, in anticipation of accelerated approval of lecanemab and the antiamyloid drug donanemab (Eli Lilly), which the FDA has also fast-tracked, the Alzheimer’s Association filed a formal request last month with the Centers for Medicare & Medicaid Services asking that it provide full and unrestricted coverage for FDA-approved Alzheimer’s disease treatments.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, the association asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved antiamyloid monoclonal antibodies.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and CEO for the Alzheimer’s Association, noted in a news release at the time.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike added.
After news of today’s approval was released, Dr. Pike noted in a new release, “The Alzheimer’s Association welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.”
Maria C. Carrillo, PhD, chief science officer at the Alzheimer’s Association, called today’s approval “a milestone achievement.”
“The progress we’ve seen in not only this class of treatments but also in the diversification of treatment types and targets over the past few years is exciting and provides real hope to those impacted by this devastating disease,” Dr. Carrillo said.
Critical issues
Commenting on the approval, Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School, Boston, and chief medical officer at Linus Health, said FDA approval of lecanemab and its adoption in the clinic represent a “very exciting development and prospect; but arguably some critical issues need to be considered.”
He noted that the health care system “is not currently prepared to cope with the challenges and demands of lecanemab,” as well as future pharmacologic agents.
“First, we need better workflows to identify suitable patients who can most benefit from this treatment,” said Dr. Pascual-Leone. He added that beyond identification of cognitive difficulties, amyloid status will need to be determined.
“Presently, this requires expensive and invasive tests,” such as positron-emission tomography scans or lumbar punctures for cerebrospinal fluid analysis. However, these are not fully covered by insurance companies and would be challenging to fully scale, he noted.
“In addition to screening, health systems will need to resolve the logistics challenges around the administration of lecanemab with twice-monthly infusions and the need for careful longitudinal evaluations for potential side effects,” said Dr. Pascual-Leone.
“While lecanemab may represent the first disease-modifying therapy widely available for early Alzheimer’s disease, the likely more promising approach is the addition of other therapies to lecanemab as part of a multi-intervention strategy combining pharmacologic and nonpharmacologic interventions,” he added.
Dr. Pascual-Leone has served as a paid member on scientific advisory boards for Neuroelectrics, Magstim, TetraNeuron, Skin2Neuron, MedRhythms, and Hearts Radiant and is a cofounder of TI Solutions and Linus Health.
A version of this article first appeared on Medscape.com.
This article was updated 1/9/23.
Like its controversial cousin aducanumab (Aduhelm, Biogen/Eisai), lecanemab was approved under the FDA’s accelerated approval pathway, which can be used to fast-track a drug that provides a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.
Unlike aducanumab, however, there was no formal FDA advisory committee meeting on lecanemab prior to approval.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dr. Dunn added.
Eisai has reported that lecanemab will cost $26,500 a year.
Modest benefit, adverse events
The FDA noted, “The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.”
The agency approved the treatment on the basis of findings from the CLARITY AD trial, which showed modest cognitive benefit for patients with early AD – but at a cost of increased risk for amyloid-related edema and effusions.
The trial enrolled 1,795 adults with mild cognitive impairment or early Alzheimer’s disease in whom amyloid pathology in the brain had been confirmed. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
After 18 months of treatment, lecanemab slowed cognitive decline by 27%, compared with placebo, as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB). This was an absolute difference of 0.45 points (change from baseline, 1.21 for lecanemab vs. 1.66 with placebo; P < .001).
While the results are “welcome news,” a 0.45-point difference on the CDR-SB might not be clinically meaningful, authors of a recent editorial in The Lancet cautioned.
Amyloid-related imaging abnormalities that manifest as edema or microhemorrhages also occurred in one in five patients taking lecanemab.
In addition, a newly published case report in The New England Journal of Medicine describes a patient with Alzheimer’s disease who was taking lecanemab and who died after experiencing numerous intracerebral hemorrhages during treatment with tissue plasminogen activator (tPA) for acute ischemic stroke.
“The findings raise the possibility of cerebral hemorrhages and necrotizing vasculopathy associated with tPA infusion in a patient with cerebrovascular amyloid who had received lecanemab,” the authors wrote.
Alzheimer’s Association reaction
Still, in anticipation of accelerated approval of lecanemab and the antiamyloid drug donanemab (Eli Lilly), which the FDA has also fast-tracked, the Alzheimer’s Association filed a formal request last month with the Centers for Medicare & Medicaid Services asking that it provide full and unrestricted coverage for FDA-approved Alzheimer’s disease treatments.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, the association asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved antiamyloid monoclonal antibodies.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and CEO for the Alzheimer’s Association, noted in a news release at the time.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike added.
After news of today’s approval was released, Dr. Pike noted in a new release, “The Alzheimer’s Association welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.”
Maria C. Carrillo, PhD, chief science officer at the Alzheimer’s Association, called today’s approval “a milestone achievement.”
“The progress we’ve seen in not only this class of treatments but also in the diversification of treatment types and targets over the past few years is exciting and provides real hope to those impacted by this devastating disease,” Dr. Carrillo said.
Critical issues
Commenting on the approval, Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School, Boston, and chief medical officer at Linus Health, said FDA approval of lecanemab and its adoption in the clinic represent a “very exciting development and prospect; but arguably some critical issues need to be considered.”
He noted that the health care system “is not currently prepared to cope with the challenges and demands of lecanemab,” as well as future pharmacologic agents.
“First, we need better workflows to identify suitable patients who can most benefit from this treatment,” said Dr. Pascual-Leone. He added that beyond identification of cognitive difficulties, amyloid status will need to be determined.
“Presently, this requires expensive and invasive tests,” such as positron-emission tomography scans or lumbar punctures for cerebrospinal fluid analysis. However, these are not fully covered by insurance companies and would be challenging to fully scale, he noted.
“In addition to screening, health systems will need to resolve the logistics challenges around the administration of lecanemab with twice-monthly infusions and the need for careful longitudinal evaluations for potential side effects,” said Dr. Pascual-Leone.
“While lecanemab may represent the first disease-modifying therapy widely available for early Alzheimer’s disease, the likely more promising approach is the addition of other therapies to lecanemab as part of a multi-intervention strategy combining pharmacologic and nonpharmacologic interventions,” he added.
Dr. Pascual-Leone has served as a paid member on scientific advisory boards for Neuroelectrics, Magstim, TetraNeuron, Skin2Neuron, MedRhythms, and Hearts Radiant and is a cofounder of TI Solutions and Linus Health.
A version of this article first appeared on Medscape.com.
This article was updated 1/9/23.
Compulsively checking social media linked with altered brain patterns in teens
Teens who compulsively checked social media networks showed different development patterns in parts of the brain that involve reward and punishment than did those who didn’t check their platforms as often, new research suggests.
Results were published online in JAMA Pediatrics.
Researchers, led by Maria T. Maza, of the department of psychology and neuroscience at University of North Carolina at Chapel Hill, included 169 6th- and 7th-grade students recruited from three public middle schools in rural North Carolina in a 3-year longitudinal cohort.
Participants reported how frequently they checked Facebook, Instagram, and Snapchat. Answers were grouped into eight score groups depending on their per-day check times: less than 1; 1; 2-3; 4-5; 6-10; 11-15; 16-20; or more than 20 times. Those groups were then broken into three categories: low (nonhabitual); moderate; and high (habitual).
Imaging shows reactions
Researchers used functional magnetic resonance imaging (fMRI) to see how different areas of the brain react when participants looked at a series of indicators, such as happy and angry faces, which mimic social media rewards, punishments, or neutral feedback.
The research team focused on adolescents, for whom social media participation and neural sensitivity to social feedback from peers are high.
They found that participants who frequently checked social media showed distinct brain patterns when anticipating social feedback compared with those who had moderate or low use, “suggesting that habitual social media checking early in adolescence is associated with divergent brain development over time.”
The affected regions of the brain included the networks that respond to motivation and cognitive control.
However, the study was not able to determine whether the differences are a good or bad thing.
“While for some individuals with habitual checking behaviors, an initial hyposensitivity to potential social rewards and punishments followed by hypersensitivity may contribute to checking behaviors on social media becoming compulsive and problematic, for others, this change in sensitivity may reflect an adaptive behavior that allows them to better navigate their increasingly digital environment,” the authors wrote.
Chicken-and-egg questions
David Rettew, MD, a child and adolescent psychiatrist at the Oregon Health & Science University in Portland, who was not part of this research, said in an interview that it’s not clear from this study which came first – different brain development in the teens prior to this study that caused compulsive checking, or checking behaviors that caused different brain development. The authors acknowledge this is a limitation of the study.
“Hopefully, someday researchers will look at some of these brain activation patterns before kids have been exposed to social media to help us sort some of these questions out,” Dr. Rettew said.
“It wasn’t as though the groups looked the same at baseline and then diverged as they used more and more social media,” Dr. Rettew said. “It looked like there were some baseline differences that could be traced back maybe years before the study even started.”
People hear “divergent brain development” associated with social media and naturally get alarmed, he acknowledged.
“I get that, but the study isn’t really equipped to tell us what should be happening in the brain and what changes may have implications for other parts of an adolescent’s life,” Dr. Rettew said, “In the end, what we have is an association between heavy social media use and certain brain activation patterns which is cool to see and measure.”
He agrees with the authors, however, that overuse of social media is concerning and studying its effects is important.
Seventy-eight percent of early adolescents check every hour
According to the paper, 78% of 13- to 17-year-olds report checking their devices at least every hour and 46% check “almost constantly.”
“Regardless of which brain regions light up when looking at various emoji responses to their Instagram post, I think it is valid already to have some concerns about youth who can’t stay off their phone for more than 10 minutes,” Dr. Rettew said. “Technology is here to stay, but how we can learn to use it rather than have it use us is probably the more pressing question at this point.”
One coauthor reports grants from the National Institute on Drug Abuse (NIDA) during the conduct of the study and grants from NIDA and the National Science Foundation outside the submitted work; a coauthor reports grants from the Winston Family Foundation; and a coauthor reports a grant from NIDA and funds from the Winston Family Foundation – both during the conduct of the study. No other disclosures were reported. Dr. Rettew is author of the book, “Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.”
Teens who compulsively checked social media networks showed different development patterns in parts of the brain that involve reward and punishment than did those who didn’t check their platforms as often, new research suggests.
Results were published online in JAMA Pediatrics.
Researchers, led by Maria T. Maza, of the department of psychology and neuroscience at University of North Carolina at Chapel Hill, included 169 6th- and 7th-grade students recruited from three public middle schools in rural North Carolina in a 3-year longitudinal cohort.
Participants reported how frequently they checked Facebook, Instagram, and Snapchat. Answers were grouped into eight score groups depending on their per-day check times: less than 1; 1; 2-3; 4-5; 6-10; 11-15; 16-20; or more than 20 times. Those groups were then broken into three categories: low (nonhabitual); moderate; and high (habitual).
Imaging shows reactions
Researchers used functional magnetic resonance imaging (fMRI) to see how different areas of the brain react when participants looked at a series of indicators, such as happy and angry faces, which mimic social media rewards, punishments, or neutral feedback.
The research team focused on adolescents, for whom social media participation and neural sensitivity to social feedback from peers are high.
They found that participants who frequently checked social media showed distinct brain patterns when anticipating social feedback compared with those who had moderate or low use, “suggesting that habitual social media checking early in adolescence is associated with divergent brain development over time.”
The affected regions of the brain included the networks that respond to motivation and cognitive control.
However, the study was not able to determine whether the differences are a good or bad thing.
“While for some individuals with habitual checking behaviors, an initial hyposensitivity to potential social rewards and punishments followed by hypersensitivity may contribute to checking behaviors on social media becoming compulsive and problematic, for others, this change in sensitivity may reflect an adaptive behavior that allows them to better navigate their increasingly digital environment,” the authors wrote.
Chicken-and-egg questions
David Rettew, MD, a child and adolescent psychiatrist at the Oregon Health & Science University in Portland, who was not part of this research, said in an interview that it’s not clear from this study which came first – different brain development in the teens prior to this study that caused compulsive checking, or checking behaviors that caused different brain development. The authors acknowledge this is a limitation of the study.
“Hopefully, someday researchers will look at some of these brain activation patterns before kids have been exposed to social media to help us sort some of these questions out,” Dr. Rettew said.
“It wasn’t as though the groups looked the same at baseline and then diverged as they used more and more social media,” Dr. Rettew said. “It looked like there were some baseline differences that could be traced back maybe years before the study even started.”
People hear “divergent brain development” associated with social media and naturally get alarmed, he acknowledged.
“I get that, but the study isn’t really equipped to tell us what should be happening in the brain and what changes may have implications for other parts of an adolescent’s life,” Dr. Rettew said, “In the end, what we have is an association between heavy social media use and certain brain activation patterns which is cool to see and measure.”
He agrees with the authors, however, that overuse of social media is concerning and studying its effects is important.
Seventy-eight percent of early adolescents check every hour
According to the paper, 78% of 13- to 17-year-olds report checking their devices at least every hour and 46% check “almost constantly.”
“Regardless of which brain regions light up when looking at various emoji responses to their Instagram post, I think it is valid already to have some concerns about youth who can’t stay off their phone for more than 10 minutes,” Dr. Rettew said. “Technology is here to stay, but how we can learn to use it rather than have it use us is probably the more pressing question at this point.”
One coauthor reports grants from the National Institute on Drug Abuse (NIDA) during the conduct of the study and grants from NIDA and the National Science Foundation outside the submitted work; a coauthor reports grants from the Winston Family Foundation; and a coauthor reports a grant from NIDA and funds from the Winston Family Foundation – both during the conduct of the study. No other disclosures were reported. Dr. Rettew is author of the book, “Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.”
Teens who compulsively checked social media networks showed different development patterns in parts of the brain that involve reward and punishment than did those who didn’t check their platforms as often, new research suggests.
Results were published online in JAMA Pediatrics.
Researchers, led by Maria T. Maza, of the department of psychology and neuroscience at University of North Carolina at Chapel Hill, included 169 6th- and 7th-grade students recruited from three public middle schools in rural North Carolina in a 3-year longitudinal cohort.
Participants reported how frequently they checked Facebook, Instagram, and Snapchat. Answers were grouped into eight score groups depending on their per-day check times: less than 1; 1; 2-3; 4-5; 6-10; 11-15; 16-20; or more than 20 times. Those groups were then broken into three categories: low (nonhabitual); moderate; and high (habitual).
Imaging shows reactions
Researchers used functional magnetic resonance imaging (fMRI) to see how different areas of the brain react when participants looked at a series of indicators, such as happy and angry faces, which mimic social media rewards, punishments, or neutral feedback.
The research team focused on adolescents, for whom social media participation and neural sensitivity to social feedback from peers are high.
They found that participants who frequently checked social media showed distinct brain patterns when anticipating social feedback compared with those who had moderate or low use, “suggesting that habitual social media checking early in adolescence is associated with divergent brain development over time.”
The affected regions of the brain included the networks that respond to motivation and cognitive control.
However, the study was not able to determine whether the differences are a good or bad thing.
“While for some individuals with habitual checking behaviors, an initial hyposensitivity to potential social rewards and punishments followed by hypersensitivity may contribute to checking behaviors on social media becoming compulsive and problematic, for others, this change in sensitivity may reflect an adaptive behavior that allows them to better navigate their increasingly digital environment,” the authors wrote.
Chicken-and-egg questions
David Rettew, MD, a child and adolescent psychiatrist at the Oregon Health & Science University in Portland, who was not part of this research, said in an interview that it’s not clear from this study which came first – different brain development in the teens prior to this study that caused compulsive checking, or checking behaviors that caused different brain development. The authors acknowledge this is a limitation of the study.
“Hopefully, someday researchers will look at some of these brain activation patterns before kids have been exposed to social media to help us sort some of these questions out,” Dr. Rettew said.
“It wasn’t as though the groups looked the same at baseline and then diverged as they used more and more social media,” Dr. Rettew said. “It looked like there were some baseline differences that could be traced back maybe years before the study even started.”
People hear “divergent brain development” associated with social media and naturally get alarmed, he acknowledged.
“I get that, but the study isn’t really equipped to tell us what should be happening in the brain and what changes may have implications for other parts of an adolescent’s life,” Dr. Rettew said, “In the end, what we have is an association between heavy social media use and certain brain activation patterns which is cool to see and measure.”
He agrees with the authors, however, that overuse of social media is concerning and studying its effects is important.
Seventy-eight percent of early adolescents check every hour
According to the paper, 78% of 13- to 17-year-olds report checking their devices at least every hour and 46% check “almost constantly.”
“Regardless of which brain regions light up when looking at various emoji responses to their Instagram post, I think it is valid already to have some concerns about youth who can’t stay off their phone for more than 10 minutes,” Dr. Rettew said. “Technology is here to stay, but how we can learn to use it rather than have it use us is probably the more pressing question at this point.”
One coauthor reports grants from the National Institute on Drug Abuse (NIDA) during the conduct of the study and grants from NIDA and the National Science Foundation outside the submitted work; a coauthor reports grants from the Winston Family Foundation; and a coauthor reports a grant from NIDA and funds from the Winston Family Foundation – both during the conduct of the study. No other disclosures were reported. Dr. Rettew is author of the book, “Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.”
FROM JAMA PEDIATRICS
FDA considers regulating CBD products
The products can have drug-like effects on the body and contain CBD (cannabidiol) and THC (tetrahydrocannabinol). Both CBD and THC can be derived from hemp, which was legalized by Congress in 2018.
“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” FDA Principal Deputy Commissioner Janet Woodcock, MD, told The Wall Street Journal.
A 2021 FDA report valued the CBD market at $4.6 billion and projected it to quadruple by 2026. The only FDA-approved CBD product is an oil called Epidiolex, which can be prescribed for the seizure-associated disease epilepsy. Research on CBD to treat other diseases is ongoing.
Food, beverage, and beauty products containing CBD are sold in stores and online in many forms, including oils, vaporized liquids, and oil-based capsules, but “research supporting the drug’s benefits is still limited,” the Mayo Clinic said.
Recently, investigations have found that many CBD products also contain THC, which can be derived from legal hemp in a form that is referred to as Delta 8 and produces a psychoactive high. The CDC warned in 2022 that people “mistook” THC products for CBD products, which are often sold at the same stores, and experienced “adverse events.”
The Centers for Disease Control and Prevention and FDA warn that much is unknown about CBD and delta-8 products. The CDC says known CBD risks include liver damage; interference with other drugs you are taking, which may lead to injury or serious side effects; drowsiness or sleepiness; diarrhea or changes in appetite; changes in mood, such as crankiness; potential negative effects on fetuses during pregnancy or on babies during breastfeeding; or unintentional poisoning of children when mistaking THC products for CBD products or due to containing other ingredients such as THC or pesticides.
“I don’t think that we can have the perfect be the enemy of the good when we’re looking at such a vast market that is so available and utilized,” Norman Birenbaum, a senior FDA adviser who is working on the regulatory issue, told the Journal. “You’ve got a widely unregulated market.”
A version of this article first appeared on WebMD.com.
The products can have drug-like effects on the body and contain CBD (cannabidiol) and THC (tetrahydrocannabinol). Both CBD and THC can be derived from hemp, which was legalized by Congress in 2018.
“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” FDA Principal Deputy Commissioner Janet Woodcock, MD, told The Wall Street Journal.
A 2021 FDA report valued the CBD market at $4.6 billion and projected it to quadruple by 2026. The only FDA-approved CBD product is an oil called Epidiolex, which can be prescribed for the seizure-associated disease epilepsy. Research on CBD to treat other diseases is ongoing.
Food, beverage, and beauty products containing CBD are sold in stores and online in many forms, including oils, vaporized liquids, and oil-based capsules, but “research supporting the drug’s benefits is still limited,” the Mayo Clinic said.
Recently, investigations have found that many CBD products also contain THC, which can be derived from legal hemp in a form that is referred to as Delta 8 and produces a psychoactive high. The CDC warned in 2022 that people “mistook” THC products for CBD products, which are often sold at the same stores, and experienced “adverse events.”
The Centers for Disease Control and Prevention and FDA warn that much is unknown about CBD and delta-8 products. The CDC says known CBD risks include liver damage; interference with other drugs you are taking, which may lead to injury or serious side effects; drowsiness or sleepiness; diarrhea or changes in appetite; changes in mood, such as crankiness; potential negative effects on fetuses during pregnancy or on babies during breastfeeding; or unintentional poisoning of children when mistaking THC products for CBD products or due to containing other ingredients such as THC or pesticides.
“I don’t think that we can have the perfect be the enemy of the good when we’re looking at such a vast market that is so available and utilized,” Norman Birenbaum, a senior FDA adviser who is working on the regulatory issue, told the Journal. “You’ve got a widely unregulated market.”
A version of this article first appeared on WebMD.com.
The products can have drug-like effects on the body and contain CBD (cannabidiol) and THC (tetrahydrocannabinol). Both CBD and THC can be derived from hemp, which was legalized by Congress in 2018.
“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” FDA Principal Deputy Commissioner Janet Woodcock, MD, told The Wall Street Journal.
A 2021 FDA report valued the CBD market at $4.6 billion and projected it to quadruple by 2026. The only FDA-approved CBD product is an oil called Epidiolex, which can be prescribed for the seizure-associated disease epilepsy. Research on CBD to treat other diseases is ongoing.
Food, beverage, and beauty products containing CBD are sold in stores and online in many forms, including oils, vaporized liquids, and oil-based capsules, but “research supporting the drug’s benefits is still limited,” the Mayo Clinic said.
Recently, investigations have found that many CBD products also contain THC, which can be derived from legal hemp in a form that is referred to as Delta 8 and produces a psychoactive high. The CDC warned in 2022 that people “mistook” THC products for CBD products, which are often sold at the same stores, and experienced “adverse events.”
The Centers for Disease Control and Prevention and FDA warn that much is unknown about CBD and delta-8 products. The CDC says known CBD risks include liver damage; interference with other drugs you are taking, which may lead to injury or serious side effects; drowsiness or sleepiness; diarrhea or changes in appetite; changes in mood, such as crankiness; potential negative effects on fetuses during pregnancy or on babies during breastfeeding; or unintentional poisoning of children when mistaking THC products for CBD products or due to containing other ingredients such as THC or pesticides.
“I don’t think that we can have the perfect be the enemy of the good when we’re looking at such a vast market that is so available and utilized,” Norman Birenbaum, a senior FDA adviser who is working on the regulatory issue, told the Journal. “You’ve got a widely unregulated market.”
A version of this article first appeared on WebMD.com.
Strong link between muscle strength, mobility, and brain health
A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD).
Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.
study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.
The study was published online in the Journal of Alzheimer’s Disease.
Brain-body connection
The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”
They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.
The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).
Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.
“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.
The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
‘Use it or lose it’
The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure.
In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.
The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.
However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.
“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.
“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.
This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD).
Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.
study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.
The study was published online in the Journal of Alzheimer’s Disease.
Brain-body connection
The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”
They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.
The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).
Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.
“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.
The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
‘Use it or lose it’
The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure.
In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.
The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.
However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.
“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.
“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.
This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD).
Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.
study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.
The study was published online in the Journal of Alzheimer’s Disease.
Brain-body connection
The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”
They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.
The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).
Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.
“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.
The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
‘Use it or lose it’
The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure.
In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.
The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.
However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.
“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.
“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.
This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ALZHEIMER’S DISEASE