Clinical Psychiatry News

The first peer-reviewed consensus statement on healthcare for children with neurodevelopmental disabilities (NDDs) is meant to start correcting the inequitable access to appropriate care that these children experience compared with their peers without NDDs. The statement was published in Pediatrics.

The disparities in healthcare culture, mindset, and practice often start in childhood for young people with conditions including autism spectrum disorder (ASD), intellectual disability, and attention-deficit/hyperactivity disorder (ADHD), wrote co–first authors Carol Weitzman, MD, co-director of the Autism Spectrum Center at Boston Children’s Hospital, Boston, Massachusetts, and Cy Nadler, PhD, section chief of Autism Psychology at Children’s Mercy in Kansas City, Missouri, and colleagues.

Without better access to safe and appropriate care, people with NDDs experience more seclusion, accidents, restraints, and injury in healthcare encounters, the researchers wrote.
 

‘Accessible, Humane, Effective Care’

“At the heart of this consensus statement is an affirmation that all people are entitled to healthcare that is accessible, humane, and effective,” they wrote.

The consensus statement was developed as part of the Supporting Access for Everyone (SAFE) Initiative, launched by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. The consensus panel comprised professionals, caregivers, and adults with NDDs. After a 2-day public forum, the consensus panel held a conference and developed a statement on SAFE care, an NDD Health Care Bill of Rights and Transition Considerations. They developed 10 statements across five domains: training; communication; access and planning; diversity, equity, inclusion, belonging, and anti-ableism; and policy and structural change.
 

Asking the Patient ‘What do You Need?’

One theme in the statement that may have the most impact is “the importance of asking the person in front of you what they need,” and building a care plan around that, said senior author Marilyn Augustyn, MD, Director of the Division of Developmental and Behavioral Pediatrics at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts. “The medical community hasn’t done that very well for individuals with neurodevelopmental disabilities.”

Dr. Weitzman added: “Traditionally in healthcare settings, we’ve asked people to check their disabilities at the door.” Many people with neurodevelopmental disabilities often have “invisible disabilities,” she said, explaining that patients may have accommodation needs that aren’t immediately obvious, but could improve their access to care, so asking them what they need is critical.
 

Examples of ‘Ableism’

The consensus statement also calls attention to structural “ableism” or policies or practices that favor able-bodied people over those with disabilities and details the need for more training and changed policies.

The paper gives some examples of ableism, such as inappropriately excluding people with NDDs from research; staff assuming nonspeaking patients have no capacity for communication; or lack of awareness of sensory needs before using cold stethoscopes or flashing direct light into eyes.

Dr. Weitzman says this work is just the beginning of a complex process. It is intended to be the driver for developing curriculum to train all clinicians and others working with patients about neurodevelopmental disabilities. The hope is it will lead to more research to formalize best practices and make policies mandatory rather than optional.

The urgency in highlighting these issues is partly related to the prevalence of children and adolescents with neurodevelopmental disabilities, which the paper states is approximately 1 in 6.

But there are personal reasons as well for the team who developed the statement.

“We just believe that it is just a human right,” Dr. Weitzman said. “Having a neurodevelopmental disability does not make you any less entitled to good care. “

Dr. Augustyn added, “The children I’ve had the honor of caring for for the last 30 years deserve all this care and more. I think it’s time.”

This work was supported by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. Dr. Weitzman is a past consultant for Helios/Meliora. The other authors report no relevant financial relationships.

The first peer-reviewed consensus statement on healthcare for children with neurodevelopmental disabilities (NDDs) is meant to start correcting the inequitable access to appropriate care that these children experience compared with their peers without NDDs. The statement was published in Pediatrics.

The disparities in healthcare culture, mindset, and practice often start in childhood for young people with conditions including autism spectrum disorder (ASD), intellectual disability, and attention-deficit/hyperactivity disorder (ADHD), wrote co–first authors Carol Weitzman, MD, co-director of the Autism Spectrum Center at Boston Children’s Hospital, Boston, Massachusetts, and Cy Nadler, PhD, section chief of Autism Psychology at Children’s Mercy in Kansas City, Missouri, and colleagues.

Without better access to safe and appropriate care, people with NDDs experience more seclusion, accidents, restraints, and injury in healthcare encounters, the researchers wrote.
 

‘Accessible, Humane, Effective Care’

“At the heart of this consensus statement is an affirmation that all people are entitled to healthcare that is accessible, humane, and effective,” they wrote.

The consensus statement was developed as part of the Supporting Access for Everyone (SAFE) Initiative, launched by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. The consensus panel comprised professionals, caregivers, and adults with NDDs. After a 2-day public forum, the consensus panel held a conference and developed a statement on SAFE care, an NDD Health Care Bill of Rights and Transition Considerations. They developed 10 statements across five domains: training; communication; access and planning; diversity, equity, inclusion, belonging, and anti-ableism; and policy and structural change.
 

Asking the Patient ‘What do You Need?’

One theme in the statement that may have the most impact is “the importance of asking the person in front of you what they need,” and building a care plan around that, said senior author Marilyn Augustyn, MD, Director of the Division of Developmental and Behavioral Pediatrics at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts. “The medical community hasn’t done that very well for individuals with neurodevelopmental disabilities.”

Dr. Weitzman added: “Traditionally in healthcare settings, we’ve asked people to check their disabilities at the door.” Many people with neurodevelopmental disabilities often have “invisible disabilities,” she said, explaining that patients may have accommodation needs that aren’t immediately obvious, but could improve their access to care, so asking them what they need is critical.
 

Examples of ‘Ableism’

The consensus statement also calls attention to structural “ableism” or policies or practices that favor able-bodied people over those with disabilities and details the need for more training and changed policies.

The paper gives some examples of ableism, such as inappropriately excluding people with NDDs from research; staff assuming nonspeaking patients have no capacity for communication; or lack of awareness of sensory needs before using cold stethoscopes or flashing direct light into eyes.

Dr. Weitzman says this work is just the beginning of a complex process. It is intended to be the driver for developing curriculum to train all clinicians and others working with patients about neurodevelopmental disabilities. The hope is it will lead to more research to formalize best practices and make policies mandatory rather than optional.

The urgency in highlighting these issues is partly related to the prevalence of children and adolescents with neurodevelopmental disabilities, which the paper states is approximately 1 in 6.

But there are personal reasons as well for the team who developed the statement.

“We just believe that it is just a human right,” Dr. Weitzman said. “Having a neurodevelopmental disability does not make you any less entitled to good care. “

Dr. Augustyn added, “The children I’ve had the honor of caring for for the last 30 years deserve all this care and more. I think it’s time.”

This work was supported by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. Dr. Weitzman is a past consultant for Helios/Meliora. The other authors report no relevant financial relationships.

The first peer-reviewed consensus statement on healthcare for children with neurodevelopmental disabilities (NDDs) is meant to start correcting the inequitable access to appropriate care that these children experience compared with their peers without NDDs. The statement was published in Pediatrics.

The disparities in healthcare culture, mindset, and practice often start in childhood for young people with conditions including autism spectrum disorder (ASD), intellectual disability, and attention-deficit/hyperactivity disorder (ADHD), wrote co–first authors Carol Weitzman, MD, co-director of the Autism Spectrum Center at Boston Children’s Hospital, Boston, Massachusetts, and Cy Nadler, PhD, section chief of Autism Psychology at Children’s Mercy in Kansas City, Missouri, and colleagues.

Without better access to safe and appropriate care, people with NDDs experience more seclusion, accidents, restraints, and injury in healthcare encounters, the researchers wrote.
 

‘Accessible, Humane, Effective Care’

“At the heart of this consensus statement is an affirmation that all people are entitled to healthcare that is accessible, humane, and effective,” they wrote.

The consensus statement was developed as part of the Supporting Access for Everyone (SAFE) Initiative, launched by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. The consensus panel comprised professionals, caregivers, and adults with NDDs. After a 2-day public forum, the consensus panel held a conference and developed a statement on SAFE care, an NDD Health Care Bill of Rights and Transition Considerations. They developed 10 statements across five domains: training; communication; access and planning; diversity, equity, inclusion, belonging, and anti-ableism; and policy and structural change.
 

Asking the Patient ‘What do You Need?’

One theme in the statement that may have the most impact is “the importance of asking the person in front of you what they need,” and building a care plan around that, said senior author Marilyn Augustyn, MD, Director of the Division of Developmental and Behavioral Pediatrics at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts. “The medical community hasn’t done that very well for individuals with neurodevelopmental disabilities.”

Dr. Weitzman added: “Traditionally in healthcare settings, we’ve asked people to check their disabilities at the door.” Many people with neurodevelopmental disabilities often have “invisible disabilities,” she said, explaining that patients may have accommodation needs that aren’t immediately obvious, but could improve their access to care, so asking them what they need is critical.
 

Examples of ‘Ableism’

The consensus statement also calls attention to structural “ableism” or policies or practices that favor able-bodied people over those with disabilities and details the need for more training and changed policies.

The paper gives some examples of ableism, such as inappropriately excluding people with NDDs from research; staff assuming nonspeaking patients have no capacity for communication; or lack of awareness of sensory needs before using cold stethoscopes or flashing direct light into eyes.

Dr. Weitzman says this work is just the beginning of a complex process. It is intended to be the driver for developing curriculum to train all clinicians and others working with patients about neurodevelopmental disabilities. The hope is it will lead to more research to formalize best practices and make policies mandatory rather than optional.

The urgency in highlighting these issues is partly related to the prevalence of children and adolescents with neurodevelopmental disabilities, which the paper states is approximately 1 in 6.

But there are personal reasons as well for the team who developed the statement.

“We just believe that it is just a human right,” Dr. Weitzman said. “Having a neurodevelopmental disability does not make you any less entitled to good care. “

Dr. Augustyn added, “The children I’ve had the honor of caring for for the last 30 years deserve all this care and more. I think it’s time.”

This work was supported by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. Dr. Weitzman is a past consultant for Helios/Meliora. The other authors report no relevant financial relationships.

In last month’s column, I discussed employees who are “clock watchers” and how to address this issue in your practice if it exists. Here’s another scenario you may encounter from the Office Politics Forum at the recent American Academy of Dermatology annual meeting:

A 40-year-old dermatologist has practiced in the same office since residency and is loved by patients and staff. He remained with the practice through its takeover by a local hospital three years previously. Recently, over a 3-month period, everyone in the office notices a change in this dermatologist’s behavior. He no longer appears happy, is argumentative with staff and patients alike, often dismisses patients’ concerns, and calls in sick during the practice’s busiest days.

It is not difficult to recognize these changes as hallmarks of burnout, which continues to be pervasive across all practice settings and specialties. According to the American Medical Association’s National Burnout Benchmarking report, over 50% of physicians report some characteristics of burnout, which include emotional exhaustion, depersonalization, and a feeling of decreased personal achievement.

olm26250/Thinkstock

Addressing physician burnout requires a systems-based approach that targets these root causes at all levels, from individual coping strategies to organizational and systemic changes in the healthcare industry. Here are some strategies that have worked for me and others:

Optimize Practice Efficiency: This is the consistent theme of this column over several decades: Streamline office processes to enhance the quality of care while reducing unnecessary workload. This can involve adopting efficient patient scheduling systems, improving clinic flow, and utilizing technology like patient portals judiciously to avoid increasing the task load without compensation.

Promote Work-Life Balance: Encourage a culture that values work-life balance. This can include flexible scheduling, respecting off-duty hours by limiting non-emergency work communications, and using your vacation time. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”

Implement Medical Scribes: I’ve written frequently about this, including a recent column on the new artificial intelligence (AI) scribes, such as DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, ScribeLink, and Amazon Web Services’ new HealthScribe product. Utilizing medical scribes to handle documentation can significantly reduce the administrative burden, allowing physicians to focus more on patient care rather than paperwork, potentially improving both physician and patient satisfaction. (As always, I have no financial interest in any product or service mentioned in this column.)

Provide Professional Development Opportunities: Offer opportunities for professional growth and development. This can include attending conferences, participating in research, or providing time and resources for continuing education. Such opportunities can reinvigorate a physician’s passion for medicine and improve job satisfaction.

Foster a Supportive Work Environment: Create a supportive work culture where staff and physicians feel comfortable discussing challenges and seeking support. Regular meetings or check-ins can help identify early signs of burnout and address them proactively.

Evaluate and Adjust Workloads: Regularly assess physician workloads to ensure they are manageable. Adjusting patient loads, redistributing tasks among team members, or hiring additional staff can help prevent burnout.

Leadership Training and Support: Provide training for leaders within the practice on recognizing signs of burnout and effective management strategies. Supportive leadership is crucial in creating an environment where physicians feel valued and heard.

Peer Support and Mentorship Programs: Establish peer support or mentorship programs where physicians can share experiences, offer advice, and provide emotional support to each other.

Feedback and Continuous Improvement: Managers should regularly solicit feedback from physicians regarding their workload, job satisfaction, and suggestions for improvements. Actively work on implementing feasible changes to address concerns.

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

In last month’s column, I discussed employees who are “clock watchers” and how to address this issue in your practice if it exists. Here’s another scenario you may encounter from the Office Politics Forum at the recent American Academy of Dermatology annual meeting:

A 40-year-old dermatologist has practiced in the same office since residency and is loved by patients and staff. He remained with the practice through its takeover by a local hospital three years previously. Recently, over a 3-month period, everyone in the office notices a change in this dermatologist’s behavior. He no longer appears happy, is argumentative with staff and patients alike, often dismisses patients’ concerns, and calls in sick during the practice’s busiest days.

It is not difficult to recognize these changes as hallmarks of burnout, which continues to be pervasive across all practice settings and specialties. According to the American Medical Association’s National Burnout Benchmarking report, over 50% of physicians report some characteristics of burnout, which include emotional exhaustion, depersonalization, and a feeling of decreased personal achievement.

olm26250/Thinkstock

Addressing physician burnout requires a systems-based approach that targets these root causes at all levels, from individual coping strategies to organizational and systemic changes in the healthcare industry. Here are some strategies that have worked for me and others:

Optimize Practice Efficiency: This is the consistent theme of this column over several decades: Streamline office processes to enhance the quality of care while reducing unnecessary workload. This can involve adopting efficient patient scheduling systems, improving clinic flow, and utilizing technology like patient portals judiciously to avoid increasing the task load without compensation.

Promote Work-Life Balance: Encourage a culture that values work-life balance. This can include flexible scheduling, respecting off-duty hours by limiting non-emergency work communications, and using your vacation time. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”

Implement Medical Scribes: I’ve written frequently about this, including a recent column on the new artificial intelligence (AI) scribes, such as DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, ScribeLink, and Amazon Web Services’ new HealthScribe product. Utilizing medical scribes to handle documentation can significantly reduce the administrative burden, allowing physicians to focus more on patient care rather than paperwork, potentially improving both physician and patient satisfaction. (As always, I have no financial interest in any product or service mentioned in this column.)

Provide Professional Development Opportunities: Offer opportunities for professional growth and development. This can include attending conferences, participating in research, or providing time and resources for continuing education. Such opportunities can reinvigorate a physician’s passion for medicine and improve job satisfaction.

Foster a Supportive Work Environment: Create a supportive work culture where staff and physicians feel comfortable discussing challenges and seeking support. Regular meetings or check-ins can help identify early signs of burnout and address them proactively.

Evaluate and Adjust Workloads: Regularly assess physician workloads to ensure they are manageable. Adjusting patient loads, redistributing tasks among team members, or hiring additional staff can help prevent burnout.

Leadership Training and Support: Provide training for leaders within the practice on recognizing signs of burnout and effective management strategies. Supportive leadership is crucial in creating an environment where physicians feel valued and heard.

Peer Support and Mentorship Programs: Establish peer support or mentorship programs where physicians can share experiences, offer advice, and provide emotional support to each other.

Feedback and Continuous Improvement: Managers should regularly solicit feedback from physicians regarding their workload, job satisfaction, and suggestions for improvements. Actively work on implementing feasible changes to address concerns.

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

In last month’s column, I discussed employees who are “clock watchers” and how to address this issue in your practice if it exists. Here’s another scenario you may encounter from the Office Politics Forum at the recent American Academy of Dermatology annual meeting:

A 40-year-old dermatologist has practiced in the same office since residency and is loved by patients and staff. He remained with the practice through its takeover by a local hospital three years previously. Recently, over a 3-month period, everyone in the office notices a change in this dermatologist’s behavior. He no longer appears happy, is argumentative with staff and patients alike, often dismisses patients’ concerns, and calls in sick during the practice’s busiest days.

It is not difficult to recognize these changes as hallmarks of burnout, which continues to be pervasive across all practice settings and specialties. According to the American Medical Association’s National Burnout Benchmarking report, over 50% of physicians report some characteristics of burnout, which include emotional exhaustion, depersonalization, and a feeling of decreased personal achievement.

olm26250/Thinkstock

Addressing physician burnout requires a systems-based approach that targets these root causes at all levels, from individual coping strategies to organizational and systemic changes in the healthcare industry. Here are some strategies that have worked for me and others:

Optimize Practice Efficiency: This is the consistent theme of this column over several decades: Streamline office processes to enhance the quality of care while reducing unnecessary workload. This can involve adopting efficient patient scheduling systems, improving clinic flow, and utilizing technology like patient portals judiciously to avoid increasing the task load without compensation.

Promote Work-Life Balance: Encourage a culture that values work-life balance. This can include flexible scheduling, respecting off-duty hours by limiting non-emergency work communications, and using your vacation time. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”

Implement Medical Scribes: I’ve written frequently about this, including a recent column on the new artificial intelligence (AI) scribes, such as DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, ScribeLink, and Amazon Web Services’ new HealthScribe product. Utilizing medical scribes to handle documentation can significantly reduce the administrative burden, allowing physicians to focus more on patient care rather than paperwork, potentially improving both physician and patient satisfaction. (As always, I have no financial interest in any product or service mentioned in this column.)

Provide Professional Development Opportunities: Offer opportunities for professional growth and development. This can include attending conferences, participating in research, or providing time and resources for continuing education. Such opportunities can reinvigorate a physician’s passion for medicine and improve job satisfaction.

Foster a Supportive Work Environment: Create a supportive work culture where staff and physicians feel comfortable discussing challenges and seeking support. Regular meetings or check-ins can help identify early signs of burnout and address them proactively.

Evaluate and Adjust Workloads: Regularly assess physician workloads to ensure they are manageable. Adjusting patient loads, redistributing tasks among team members, or hiring additional staff can help prevent burnout.

Leadership Training and Support: Provide training for leaders within the practice on recognizing signs of burnout and effective management strategies. Supportive leadership is crucial in creating an environment where physicians feel valued and heard.

Peer Support and Mentorship Programs: Establish peer support or mentorship programs where physicians can share experiences, offer advice, and provide emotional support to each other.

Feedback and Continuous Improvement: Managers should regularly solicit feedback from physicians regarding their workload, job satisfaction, and suggestions for improvements. Actively work on implementing feasible changes to address concerns.

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

The ketogenic diet shows promise in reducing the symptoms of bipolar disorder and schizophrenia and reversing metabolic syndrome, results of a new pilot study show. 

Participants who adhered to the high-fat, low-carb diet experienced a 30% reduction in psychiatric symptoms and an average 10% reduction in weight. 

“We’re seeing huge changes,” first author Shebani Sethi, MD, of Stanford University in Stanford, California said in a press release. “Even if you’re on antipsychotic drugs, we can still reverse the obesity, the metabolic syndrome, and the insulin resistance. I think that’s very encouraging for patients.”

The findings were published online in Psychiatric Research. 
 

Neuroprotective Effect? 

Recent research supports the hypothesis that psychiatric illness may stem, at least in part, from deficits in brain metabolism and that a keto diet may be neuroprotective by reducing inflammation and oxidative stress. 

The pilot study included 21 participants with schizophrenia (n = 5) or bipolar disorder (n = 16) who were aged 18-75 years. All were currently taking psychotropic medications. Participants were overweight (body mass index [BMI] ≥ 25) and had gained more than 5% of their body mass while taking psychotropic medication, or they had at least one metabolic abnormality, such as insulin resistance or dyslipidemia. 

At baseline, participants received a physical and psychiatric evaluation and 1 hour of instruction on how to implement the keto diet, which included 10% carbohydrate, 30% protein, and 60% fat. 

Investigators monitored blood ketone levels at least once a week and defined participants as keto-adherent if their levels were 0.5-5 mM for 80%-100% of the times they were measured.

Health coaches checked in with participants for about 5-10 minutes each week to answer diet-related questions.

Psychiatric assessments, which included mood rating and global functioning scales, were completed at baseline, 2 months, and at the end of the 4-month study. 

The research team tracked participants’ adherence to the diet by weekly measurement of blood ketone levels. 

By the end of the trial, 14 patients had been fully adherent with the diet, six had been semi-adherent, and only one had been nonadherent. Higher ketone levels, suggesting greater adherence, correlated with better metabolic health.

As measured by the Clinical Global Impression-Schizophrenia and Clinical Global Impression for Bipolar Disorder–Overall Severity, participants experienced a 31% reduction in symptom severity (P < .001). Overall, 43% (P < .02) of participants achieved recovery as defined by the Clinical Mood Monitoring Form criteria: 50% of the adherent group and 33% of those who were semi-adherent.
 

Metabolic Benefits

Initially, 29% of participants had metabolic syndrome and more than 85% had co-occurring medical conditions such as obesity, hyperlipidemia, or prediabetes. By the end of the study, none met criteria for metabolic syndrome.

On average, participants experienced a 10% reduction in weight and BMI. Waist circumference was reduced by 11%, fat mass index dropped by 17%, and systolic blood pressure decreased by 6%. In addition, metabolic markers including visceral fat, inflammation, A1c, and insulin resistance also improved. All outcomes were significant at P < .001 except for systolic blood pressure, at P < .005.

There was also a 20% reduction in triglycerides and a 21% increase in low-density lipoprotein cholesterol (both at P < .02). 

The study’s limitations include its small sample size, the lack of control arm, and short duration.

“Mental health and physical health are interconnected and addressing metabolic issues can complement psychiatric treatment to enhance overall well-being. Understanding the

mechanisms and potential synergies between psychiatric treatment and metabolic improvements can also inform the development of more effective interventions,” the researchers wrote. 

The study was funded by the Baszucki Group, Kuen Lau Fund, and the Obesity Treatment Foundation. The authors declare no competing interests.

A version of this article appeared on Medscape.com.

The ketogenic diet shows promise in reducing the symptoms of bipolar disorder and schizophrenia and reversing metabolic syndrome, results of a new pilot study show. 

Participants who adhered to the high-fat, low-carb diet experienced a 30% reduction in psychiatric symptoms and an average 10% reduction in weight. 

“We’re seeing huge changes,” first author Shebani Sethi, MD, of Stanford University in Stanford, California said in a press release. “Even if you’re on antipsychotic drugs, we can still reverse the obesity, the metabolic syndrome, and the insulin resistance. I think that’s very encouraging for patients.”

The findings were published online in Psychiatric Research. 
 

Neuroprotective Effect? 

Recent research supports the hypothesis that psychiatric illness may stem, at least in part, from deficits in brain metabolism and that a keto diet may be neuroprotective by reducing inflammation and oxidative stress. 

The pilot study included 21 participants with schizophrenia (n = 5) or bipolar disorder (n = 16) who were aged 18-75 years. All were currently taking psychotropic medications. Participants were overweight (body mass index [BMI] ≥ 25) and had gained more than 5% of their body mass while taking psychotropic medication, or they had at least one metabolic abnormality, such as insulin resistance or dyslipidemia. 

At baseline, participants received a physical and psychiatric evaluation and 1 hour of instruction on how to implement the keto diet, which included 10% carbohydrate, 30% protein, and 60% fat. 

Investigators monitored blood ketone levels at least once a week and defined participants as keto-adherent if their levels were 0.5-5 mM for 80%-100% of the times they were measured.

Health coaches checked in with participants for about 5-10 minutes each week to answer diet-related questions.

Psychiatric assessments, which included mood rating and global functioning scales, were completed at baseline, 2 months, and at the end of the 4-month study. 

The research team tracked participants’ adherence to the diet by weekly measurement of blood ketone levels. 

By the end of the trial, 14 patients had been fully adherent with the diet, six had been semi-adherent, and only one had been nonadherent. Higher ketone levels, suggesting greater adherence, correlated with better metabolic health.

As measured by the Clinical Global Impression-Schizophrenia and Clinical Global Impression for Bipolar Disorder–Overall Severity, participants experienced a 31% reduction in symptom severity (P < .001). Overall, 43% (P < .02) of participants achieved recovery as defined by the Clinical Mood Monitoring Form criteria: 50% of the adherent group and 33% of those who were semi-adherent.
 

Metabolic Benefits

Initially, 29% of participants had metabolic syndrome and more than 85% had co-occurring medical conditions such as obesity, hyperlipidemia, or prediabetes. By the end of the study, none met criteria for metabolic syndrome.

On average, participants experienced a 10% reduction in weight and BMI. Waist circumference was reduced by 11%, fat mass index dropped by 17%, and systolic blood pressure decreased by 6%. In addition, metabolic markers including visceral fat, inflammation, A1c, and insulin resistance also improved. All outcomes were significant at P < .001 except for systolic blood pressure, at P < .005.

There was also a 20% reduction in triglycerides and a 21% increase in low-density lipoprotein cholesterol (both at P < .02). 

The study’s limitations include its small sample size, the lack of control arm, and short duration.

“Mental health and physical health are interconnected and addressing metabolic issues can complement psychiatric treatment to enhance overall well-being. Understanding the

mechanisms and potential synergies between psychiatric treatment and metabolic improvements can also inform the development of more effective interventions,” the researchers wrote. 

The study was funded by the Baszucki Group, Kuen Lau Fund, and the Obesity Treatment Foundation. The authors declare no competing interests.

A version of this article appeared on Medscape.com.

The ketogenic diet shows promise in reducing the symptoms of bipolar disorder and schizophrenia and reversing metabolic syndrome, results of a new pilot study show. 

Participants who adhered to the high-fat, low-carb diet experienced a 30% reduction in psychiatric symptoms and an average 10% reduction in weight. 

“We’re seeing huge changes,” first author Shebani Sethi, MD, of Stanford University in Stanford, California said in a press release. “Even if you’re on antipsychotic drugs, we can still reverse the obesity, the metabolic syndrome, and the insulin resistance. I think that’s very encouraging for patients.”

The findings were published online in Psychiatric Research. 
 

Neuroprotective Effect? 

Recent research supports the hypothesis that psychiatric illness may stem, at least in part, from deficits in brain metabolism and that a keto diet may be neuroprotective by reducing inflammation and oxidative stress. 

The pilot study included 21 participants with schizophrenia (n = 5) or bipolar disorder (n = 16) who were aged 18-75 years. All were currently taking psychotropic medications. Participants were overweight (body mass index [BMI] ≥ 25) and had gained more than 5% of their body mass while taking psychotropic medication, or they had at least one metabolic abnormality, such as insulin resistance or dyslipidemia. 

At baseline, participants received a physical and psychiatric evaluation and 1 hour of instruction on how to implement the keto diet, which included 10% carbohydrate, 30% protein, and 60% fat. 

Investigators monitored blood ketone levels at least once a week and defined participants as keto-adherent if their levels were 0.5-5 mM for 80%-100% of the times they were measured.

Health coaches checked in with participants for about 5-10 minutes each week to answer diet-related questions.

Psychiatric assessments, which included mood rating and global functioning scales, were completed at baseline, 2 months, and at the end of the 4-month study. 

The research team tracked participants’ adherence to the diet by weekly measurement of blood ketone levels. 

By the end of the trial, 14 patients had been fully adherent with the diet, six had been semi-adherent, and only one had been nonadherent. Higher ketone levels, suggesting greater adherence, correlated with better metabolic health.

As measured by the Clinical Global Impression-Schizophrenia and Clinical Global Impression for Bipolar Disorder–Overall Severity, participants experienced a 31% reduction in symptom severity (P < .001). Overall, 43% (P < .02) of participants achieved recovery as defined by the Clinical Mood Monitoring Form criteria: 50% of the adherent group and 33% of those who were semi-adherent.
 

Metabolic Benefits

Initially, 29% of participants had metabolic syndrome and more than 85% had co-occurring medical conditions such as obesity, hyperlipidemia, or prediabetes. By the end of the study, none met criteria for metabolic syndrome.

On average, participants experienced a 10% reduction in weight and BMI. Waist circumference was reduced by 11%, fat mass index dropped by 17%, and systolic blood pressure decreased by 6%. In addition, metabolic markers including visceral fat, inflammation, A1c, and insulin resistance also improved. All outcomes were significant at P < .001 except for systolic blood pressure, at P < .005.

There was also a 20% reduction in triglycerides and a 21% increase in low-density lipoprotein cholesterol (both at P < .02). 

The study’s limitations include its small sample size, the lack of control arm, and short duration.

“Mental health and physical health are interconnected and addressing metabolic issues can complement psychiatric treatment to enhance overall well-being. Understanding the

mechanisms and potential synergies between psychiatric treatment and metabolic improvements can also inform the development of more effective interventions,” the researchers wrote. 

The study was funded by the Baszucki Group, Kuen Lau Fund, and the Obesity Treatment Foundation. The authors declare no competing interests.

A version of this article appeared on Medscape.com.

Antipsychotic use in older adults with dementia is associated with a significant increased risk for stroke, myocardial infarction, heart failure, pneumonia, fracture, acute kidney injury, and a range of other health problems compared with nonuse, new research showed.

The adverse events are far broader and pose more severe health risks than previously reported, investigators noted, and suggested greater caution is needed when prescribing antipsychotics to treat psychological symptoms of dementia.

The matched cohort study used patient registry data on nearly 174,000 people with dementia and compared those who were prescribed an antipsychotic on or after their dementia diagnosis with those who had not received a prescription for the drugs.

Any antipsychotic use was associated with double the risk for pneumonia, a 1.7-fold increased risk for acute kidney injury, and 1.6-fold higher odds of venous thromboembolism compared to nonuse.

Investigators found an increased risk for all outcomes studied, except for ventricular arrythmia, and risk was highest for most within the first week of treatment.

“Any potential benefits of antipsychotic treatment therefore need to be weighed against the risk of serious harm across multiple outcomes. Although there may be times when an antipsychotic prescription is the least bad option, clinicians should actively consider the risks, considering patients’ pre-existing comorbidities and living support,” lead investigator Pearl Mok, research fellow at the Centre for Pharmacoepidemiology and Drug Safety, The University of Manchester, Manchester, England, and colleagues wrote.

The findings were published online in The BMJ.
 

High Risk

Depression, aggression, anxiety, psychosis, and other behavioral and psychological symptoms are common in people with dementia. Despite earlier reports of increased risk for stroke and mortality with antipsychotic use, the drugs are frequently prescribed to treat these symptoms.

While some preliminary studies identified other adverse outcomes from antipsychotic use, results are limited and inconsistent.

Investigators used primary and secondary care data from the Clinical Practice Research Datalink in England. A total of 173,910 adults (63% women) had a dementia diagnosis between January 1998 and May 2018.

Of the total cohort, 35,339 patients were prescribed an antipsychotic on, or after, a dementia diagnosis. Each was matched with up to 15 patients with dementia with no history of antipsychotic use following diagnosis.

Almost 80% of antipsychotic prescriptions were for risperidone, quetiapine, haloperidol, and olanzapine.

Any antipsychotic use was associated with significantly higher risks for pneumonia (hazard ratio [HR], 2.03; 95% CI, 1.96-2.10), acute kidney injury (HR, 1.57; 95% CI, 1.48-1.66), stroke (HR, 1.54; 95% CI, 1.46-1.63), venous thromboembolism (HR, 1.52; 95% CI, 1.38-1.67), fracture (HR, 1.36; 95% CI, 1.30-1.44), myocardial infarction (HR, 1.22; 95% CI, 1.12-1.34), and heart failure (HR, 1.16; 95% CI, 1.09-1.24).

The risk for all conditions was highest within the first 3 months of treatment, with a cumulative incidence of pneumonia among antipsychotic users of 4.48% vs 1.49% among nonusers. At 1 year, this increased to 10.41% for users vs 5.63% for nonusers.

“Given the higher risks of adverse events in the early days after drug initiation, clinical examinations should be taken before, and clinical reviews conducted shortly after, the start of treatment,” the authors wrote. “Our study reaffirms that these drugs should only be prescribed for the shortest period possible.”
 

‘Serious Harms’

In an accompanying editorial, Raya Elfadel Kheirbek, MD, and Cristina LaFont, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, said the findings “highlight the need for careful justification of antipsychotic use in dementia care, including a comprehensive assessment of the benefits weighed against a broader range of serious harms than previously acknowledged.”

“Using antipsychotics for the management of dementia-related behaviors requires nuanced decision-making after careful assessment, informed by a personalized approach,” they continued. “Dr. Mok and colleagues call for a critical re-evaluation of antipsychotic use in this clinical setting.”

While the findings add to and expand what was already known, “we need to be clear that they don’t show antipsychotics cause all the adverse outcomes reported,” Masud Husain, DPhil, professor of neurology, University of Oxford, England, said in a statement.

While investigators attempted to use matched controls with dementia who had not received antipsychotics, “the people who were prescribed the drugs may simply have been more vulnerable to some of the conditions that occurred more frequently in them, such as pneumonia and cardiovascular disorders,” said Dr. Husain, who was not part of the research.

Although the study was not designed to explore reverse causality, the findings are important for clinicians who prescribe antipsychotics for patients with dementia, Robert Howard, professor of old age psychiatry, at the University of College London, London, England said in a statement.

“Initiation of these drugs in people with dementia should only ever be under specialist supervision, with involvement of patients and family members in informed discussion and review,” said Dr. Howard, who was not involved in the study.

The study was funded by the National Institute for Health and Care Research. Dr. Mok reported no relevant conflicts. Other authors’ disclosures are included in the original article. Dr. Hussain, Dr. Howard, Dr. Kheirbek, and Dr. LeFon reported no relevant conflicts.

A version of this article appeared on Medscape.com.

Antipsychotic use in older adults with dementia is associated with a significant increased risk for stroke, myocardial infarction, heart failure, pneumonia, fracture, acute kidney injury, and a range of other health problems compared with nonuse, new research showed.

The adverse events are far broader and pose more severe health risks than previously reported, investigators noted, and suggested greater caution is needed when prescribing antipsychotics to treat psychological symptoms of dementia.

The matched cohort study used patient registry data on nearly 174,000 people with dementia and compared those who were prescribed an antipsychotic on or after their dementia diagnosis with those who had not received a prescription for the drugs.

Any antipsychotic use was associated with double the risk for pneumonia, a 1.7-fold increased risk for acute kidney injury, and 1.6-fold higher odds of venous thromboembolism compared to nonuse.

Investigators found an increased risk for all outcomes studied, except for ventricular arrythmia, and risk was highest for most within the first week of treatment.

“Any potential benefits of antipsychotic treatment therefore need to be weighed against the risk of serious harm across multiple outcomes. Although there may be times when an antipsychotic prescription is the least bad option, clinicians should actively consider the risks, considering patients’ pre-existing comorbidities and living support,” lead investigator Pearl Mok, research fellow at the Centre for Pharmacoepidemiology and Drug Safety, The University of Manchester, Manchester, England, and colleagues wrote.

The findings were published online in The BMJ.
 

High Risk

Depression, aggression, anxiety, psychosis, and other behavioral and psychological symptoms are common in people with dementia. Despite earlier reports of increased risk for stroke and mortality with antipsychotic use, the drugs are frequently prescribed to treat these symptoms.

While some preliminary studies identified other adverse outcomes from antipsychotic use, results are limited and inconsistent.

Investigators used primary and secondary care data from the Clinical Practice Research Datalink in England. A total of 173,910 adults (63% women) had a dementia diagnosis between January 1998 and May 2018.

Of the total cohort, 35,339 patients were prescribed an antipsychotic on, or after, a dementia diagnosis. Each was matched with up to 15 patients with dementia with no history of antipsychotic use following diagnosis.

Almost 80% of antipsychotic prescriptions were for risperidone, quetiapine, haloperidol, and olanzapine.

Any antipsychotic use was associated with significantly higher risks for pneumonia (hazard ratio [HR], 2.03; 95% CI, 1.96-2.10), acute kidney injury (HR, 1.57; 95% CI, 1.48-1.66), stroke (HR, 1.54; 95% CI, 1.46-1.63), venous thromboembolism (HR, 1.52; 95% CI, 1.38-1.67), fracture (HR, 1.36; 95% CI, 1.30-1.44), myocardial infarction (HR, 1.22; 95% CI, 1.12-1.34), and heart failure (HR, 1.16; 95% CI, 1.09-1.24).

The risk for all conditions was highest within the first 3 months of treatment, with a cumulative incidence of pneumonia among antipsychotic users of 4.48% vs 1.49% among nonusers. At 1 year, this increased to 10.41% for users vs 5.63% for nonusers.

“Given the higher risks of adverse events in the early days after drug initiation, clinical examinations should be taken before, and clinical reviews conducted shortly after, the start of treatment,” the authors wrote. “Our study reaffirms that these drugs should only be prescribed for the shortest period possible.”
 

‘Serious Harms’

In an accompanying editorial, Raya Elfadel Kheirbek, MD, and Cristina LaFont, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, said the findings “highlight the need for careful justification of antipsychotic use in dementia care, including a comprehensive assessment of the benefits weighed against a broader range of serious harms than previously acknowledged.”

“Using antipsychotics for the management of dementia-related behaviors requires nuanced decision-making after careful assessment, informed by a personalized approach,” they continued. “Dr. Mok and colleagues call for a critical re-evaluation of antipsychotic use in this clinical setting.”

While the findings add to and expand what was already known, “we need to be clear that they don’t show antipsychotics cause all the adverse outcomes reported,” Masud Husain, DPhil, professor of neurology, University of Oxford, England, said in a statement.

While investigators attempted to use matched controls with dementia who had not received antipsychotics, “the people who were prescribed the drugs may simply have been more vulnerable to some of the conditions that occurred more frequently in them, such as pneumonia and cardiovascular disorders,” said Dr. Husain, who was not part of the research.

Although the study was not designed to explore reverse causality, the findings are important for clinicians who prescribe antipsychotics for patients with dementia, Robert Howard, professor of old age psychiatry, at the University of College London, London, England said in a statement.

“Initiation of these drugs in people with dementia should only ever be under specialist supervision, with involvement of patients and family members in informed discussion and review,” said Dr. Howard, who was not involved in the study.

The study was funded by the National Institute for Health and Care Research. Dr. Mok reported no relevant conflicts. Other authors’ disclosures are included in the original article. Dr. Hussain, Dr. Howard, Dr. Kheirbek, and Dr. LeFon reported no relevant conflicts.

A version of this article appeared on Medscape.com.

Antipsychotic use in older adults with dementia is associated with a significant increased risk for stroke, myocardial infarction, heart failure, pneumonia, fracture, acute kidney injury, and a range of other health problems compared with nonuse, new research showed.

The adverse events are far broader and pose more severe health risks than previously reported, investigators noted, and suggested greater caution is needed when prescribing antipsychotics to treat psychological symptoms of dementia.

The matched cohort study used patient registry data on nearly 174,000 people with dementia and compared those who were prescribed an antipsychotic on or after their dementia diagnosis with those who had not received a prescription for the drugs.

Any antipsychotic use was associated with double the risk for pneumonia, a 1.7-fold increased risk for acute kidney injury, and 1.6-fold higher odds of venous thromboembolism compared to nonuse.

Investigators found an increased risk for all outcomes studied, except for ventricular arrythmia, and risk was highest for most within the first week of treatment.

“Any potential benefits of antipsychotic treatment therefore need to be weighed against the risk of serious harm across multiple outcomes. Although there may be times when an antipsychotic prescription is the least bad option, clinicians should actively consider the risks, considering patients’ pre-existing comorbidities and living support,” lead investigator Pearl Mok, research fellow at the Centre for Pharmacoepidemiology and Drug Safety, The University of Manchester, Manchester, England, and colleagues wrote.

The findings were published online in The BMJ.
 

High Risk

Depression, aggression, anxiety, psychosis, and other behavioral and psychological symptoms are common in people with dementia. Despite earlier reports of increased risk for stroke and mortality with antipsychotic use, the drugs are frequently prescribed to treat these symptoms.

While some preliminary studies identified other adverse outcomes from antipsychotic use, results are limited and inconsistent.

Investigators used primary and secondary care data from the Clinical Practice Research Datalink in England. A total of 173,910 adults (63% women) had a dementia diagnosis between January 1998 and May 2018.

Of the total cohort, 35,339 patients were prescribed an antipsychotic on, or after, a dementia diagnosis. Each was matched with up to 15 patients with dementia with no history of antipsychotic use following diagnosis.

Almost 80% of antipsychotic prescriptions were for risperidone, quetiapine, haloperidol, and olanzapine.

Any antipsychotic use was associated with significantly higher risks for pneumonia (hazard ratio [HR], 2.03; 95% CI, 1.96-2.10), acute kidney injury (HR, 1.57; 95% CI, 1.48-1.66), stroke (HR, 1.54; 95% CI, 1.46-1.63), venous thromboembolism (HR, 1.52; 95% CI, 1.38-1.67), fracture (HR, 1.36; 95% CI, 1.30-1.44), myocardial infarction (HR, 1.22; 95% CI, 1.12-1.34), and heart failure (HR, 1.16; 95% CI, 1.09-1.24).

The risk for all conditions was highest within the first 3 months of treatment, with a cumulative incidence of pneumonia among antipsychotic users of 4.48% vs 1.49% among nonusers. At 1 year, this increased to 10.41% for users vs 5.63% for nonusers.

“Given the higher risks of adverse events in the early days after drug initiation, clinical examinations should be taken before, and clinical reviews conducted shortly after, the start of treatment,” the authors wrote. “Our study reaffirms that these drugs should only be prescribed for the shortest period possible.”
 

‘Serious Harms’

In an accompanying editorial, Raya Elfadel Kheirbek, MD, and Cristina LaFont, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, said the findings “highlight the need for careful justification of antipsychotic use in dementia care, including a comprehensive assessment of the benefits weighed against a broader range of serious harms than previously acknowledged.”

“Using antipsychotics for the management of dementia-related behaviors requires nuanced decision-making after careful assessment, informed by a personalized approach,” they continued. “Dr. Mok and colleagues call for a critical re-evaluation of antipsychotic use in this clinical setting.”

While the findings add to and expand what was already known, “we need to be clear that they don’t show antipsychotics cause all the adverse outcomes reported,” Masud Husain, DPhil, professor of neurology, University of Oxford, England, said in a statement.

While investigators attempted to use matched controls with dementia who had not received antipsychotics, “the people who were prescribed the drugs may simply have been more vulnerable to some of the conditions that occurred more frequently in them, such as pneumonia and cardiovascular disorders,” said Dr. Husain, who was not part of the research.

Although the study was not designed to explore reverse causality, the findings are important for clinicians who prescribe antipsychotics for patients with dementia, Robert Howard, professor of old age psychiatry, at the University of College London, London, England said in a statement.

“Initiation of these drugs in people with dementia should only ever be under specialist supervision, with involvement of patients and family members in informed discussion and review,” said Dr. Howard, who was not involved in the study.

The study was funded by the National Institute for Health and Care Research. Dr. Mok reported no relevant conflicts. Other authors’ disclosures are included in the original article. Dr. Hussain, Dr. Howard, Dr. Kheirbek, and Dr. LeFon reported no relevant conflicts.

A version of this article appeared on Medscape.com.

People with opioid use disorder (OUD) who have hepatitis C virus (HCV) were twice as likely to be treated and cured of HCV if they received facilitated telemedicine treatment within their opioid treatment program than if they were referred for off-site treatment, the results of a new study showed.

In addition, among cured patients, illicit drug use fell significantly, and there were few reinfections, reported the researchers, led by Andrew Talal, MD, MPH, with the University at Buffalo, State University of New York, Buffalo.

The study was published online in JAMA.

HCV is a major public health concern, especially among people with OUD. Geographic and logistical barriers often prevent this underserved population from accessing treatment; however, telemedicine has the potential to overcome these obstacles.

In a prospective cluster randomized clinical trial, Dr. Talal and colleagues assessed the impact of embedding facilitated telemedicine for HCV care into 12 opioid treatment programs in New York State.

They studied 602 HCV-infected adults (61% male; 51% White) with OUD. Of these, 290 (mean age, 47.1 years) were enrolled in facilitated telemedicine programs onsite, and 312 (mean age, 48.9 years) received an off-site referral (usual care).

Telemedicine participants had an initial telemedicine encounter facilitated by study case managers onsite who also administered a blood test. The telemedicine clinician subsequently evaluated participants and ordered direct-acting antiviral (DAA) medication that was delivered to the opioid treatment program monthly (as refills required) and dispensed along with methadone.

In the telemedicine group, 268 of 290 individuals (92.4%) initiated HCV treatment compared with 126 of 312 (40.4%) in the referral group.

Participants in the telemedicine group were also seen sooner and started treatment faster.

The interval between screening and initial appointments was 14 days with telemedicine vs 18 days with a referral (P = .04). The time between the initial visit and DAA initiation was 49.9 days with telemedicine vs 123.5 days with a referral (P < .001).

Intention-to-treat analysis showed significantly higher HCV cure rates with telemedicine than with referral (90.3% vs 39.4%, respectively). Similarly, the observed cure rates were also higher in the telemedicine group (84.8% vs 34.0%).

Sustained virologic response was durable, with only 13 reinfections (incidence, 2.5 per 100 person-years) occurring during the 2-year follow-up period, the researchers reported.

In addition, illicit drug use decreased significantly among cured patients in both the telemedicine group (P < .001) and the referral group (P = .001). Adults in both groups rated healthcare delivery satisfaction as high or very high.

“Our study demonstrates how telemedicine successfully integrates medical and behavioral treatment,” Dr. Talal said in a statement.

The intervention “builds patient-clinician trust across the screen, and significant decreases in substance use were observed in cured participants with minimal HCV reinfections,” the study team wrote.

Support for this research was provided by the Patient-Centered Outcomes Research Institute and by the Troup Fund of the Kaleida Health Foundation.

A version of this article appeared on Medscape.com .

People with opioid use disorder (OUD) who have hepatitis C virus (HCV) were twice as likely to be treated and cured of HCV if they received facilitated telemedicine treatment within their opioid treatment program than if they were referred for off-site treatment, the results of a new study showed.

In addition, among cured patients, illicit drug use fell significantly, and there were few reinfections, reported the researchers, led by Andrew Talal, MD, MPH, with the University at Buffalo, State University of New York, Buffalo.

The study was published online in JAMA.

HCV is a major public health concern, especially among people with OUD. Geographic and logistical barriers often prevent this underserved population from accessing treatment; however, telemedicine has the potential to overcome these obstacles.

In a prospective cluster randomized clinical trial, Dr. Talal and colleagues assessed the impact of embedding facilitated telemedicine for HCV care into 12 opioid treatment programs in New York State.

They studied 602 HCV-infected adults (61% male; 51% White) with OUD. Of these, 290 (mean age, 47.1 years) were enrolled in facilitated telemedicine programs onsite, and 312 (mean age, 48.9 years) received an off-site referral (usual care).

Telemedicine participants had an initial telemedicine encounter facilitated by study case managers onsite who also administered a blood test. The telemedicine clinician subsequently evaluated participants and ordered direct-acting antiviral (DAA) medication that was delivered to the opioid treatment program monthly (as refills required) and dispensed along with methadone.

In the telemedicine group, 268 of 290 individuals (92.4%) initiated HCV treatment compared with 126 of 312 (40.4%) in the referral group.

Participants in the telemedicine group were also seen sooner and started treatment faster.

The interval between screening and initial appointments was 14 days with telemedicine vs 18 days with a referral (P = .04). The time between the initial visit and DAA initiation was 49.9 days with telemedicine vs 123.5 days with a referral (P < .001).

Intention-to-treat analysis showed significantly higher HCV cure rates with telemedicine than with referral (90.3% vs 39.4%, respectively). Similarly, the observed cure rates were also higher in the telemedicine group (84.8% vs 34.0%).

Sustained virologic response was durable, with only 13 reinfections (incidence, 2.5 per 100 person-years) occurring during the 2-year follow-up period, the researchers reported.

In addition, illicit drug use decreased significantly among cured patients in both the telemedicine group (P < .001) and the referral group (P = .001). Adults in both groups rated healthcare delivery satisfaction as high or very high.

“Our study demonstrates how telemedicine successfully integrates medical and behavioral treatment,” Dr. Talal said in a statement.

The intervention “builds patient-clinician trust across the screen, and significant decreases in substance use were observed in cured participants with minimal HCV reinfections,” the study team wrote.

Support for this research was provided by the Patient-Centered Outcomes Research Institute and by the Troup Fund of the Kaleida Health Foundation.

A version of this article appeared on Medscape.com .

People with opioid use disorder (OUD) who have hepatitis C virus (HCV) were twice as likely to be treated and cured of HCV if they received facilitated telemedicine treatment within their opioid treatment program than if they were referred for off-site treatment, the results of a new study showed.

In addition, among cured patients, illicit drug use fell significantly, and there were few reinfections, reported the researchers, led by Andrew Talal, MD, MPH, with the University at Buffalo, State University of New York, Buffalo.

The study was published online in JAMA.

HCV is a major public health concern, especially among people with OUD. Geographic and logistical barriers often prevent this underserved population from accessing treatment; however, telemedicine has the potential to overcome these obstacles.

In a prospective cluster randomized clinical trial, Dr. Talal and colleagues assessed the impact of embedding facilitated telemedicine for HCV care into 12 opioid treatment programs in New York State.

They studied 602 HCV-infected adults (61% male; 51% White) with OUD. Of these, 290 (mean age, 47.1 years) were enrolled in facilitated telemedicine programs onsite, and 312 (mean age, 48.9 years) received an off-site referral (usual care).

Telemedicine participants had an initial telemedicine encounter facilitated by study case managers onsite who also administered a blood test. The telemedicine clinician subsequently evaluated participants and ordered direct-acting antiviral (DAA) medication that was delivered to the opioid treatment program monthly (as refills required) and dispensed along with methadone.

In the telemedicine group, 268 of 290 individuals (92.4%) initiated HCV treatment compared with 126 of 312 (40.4%) in the referral group.

Participants in the telemedicine group were also seen sooner and started treatment faster.

The interval between screening and initial appointments was 14 days with telemedicine vs 18 days with a referral (P = .04). The time between the initial visit and DAA initiation was 49.9 days with telemedicine vs 123.5 days with a referral (P < .001).

Intention-to-treat analysis showed significantly higher HCV cure rates with telemedicine than with referral (90.3% vs 39.4%, respectively). Similarly, the observed cure rates were also higher in the telemedicine group (84.8% vs 34.0%).

Sustained virologic response was durable, with only 13 reinfections (incidence, 2.5 per 100 person-years) occurring during the 2-year follow-up period, the researchers reported.

In addition, illicit drug use decreased significantly among cured patients in both the telemedicine group (P < .001) and the referral group (P = .001). Adults in both groups rated healthcare delivery satisfaction as high or very high.

“Our study demonstrates how telemedicine successfully integrates medical and behavioral treatment,” Dr. Talal said in a statement.

The intervention “builds patient-clinician trust across the screen, and significant decreases in substance use were observed in cured participants with minimal HCV reinfections,” the study team wrote.

Support for this research was provided by the Patient-Centered Outcomes Research Institute and by the Troup Fund of the Kaleida Health Foundation.

A version of this article appeared on Medscape.com .

DENVER — Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

DENVER — Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

DENVER — Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Co-administration of a probiotic and vitamin D significantly improved cognitive function in patients with schizophrenia, results from a double-blind randomized controlled trial suggested.

The combination also led to favorable changes in total cholesterol, fasting blood sugar, and a marker of inflammation.

“Targeting the microbiota-gut-brain axis with probiotic and vitamin D might provide a novel approach to promote mental health,” investigators led by Gita Sadighi, MD, Department of Psychiatry, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran, wrote.

The study was published online in Neuropsychopharmacology Reports.
 

Cognitive Boost

The research includes data on 70 adults with schizophrenia who were on stable antipsychotic medication for at least 6 months. Half took a capsule containing five different probiotic strains plus 400 IU of vitamin D daily for 12 weeks, and half took a matching placebo capsule.

Primary outcomes were disease severity and cognitive function, measured at baseline, every 2 weeks during the trial, and again at the end of the study. Measurement tools included the Positive and Negative Syndrome Scale (PANSS) for disease severity and the 30-point Montreal Cognitive Assessment (MoCA) for cognitive function.

Secondary outcomes were lipid profile, body mass index, gastrointestinal problems, serum C-reactive protein (CRP), and erythrocyte sedimentation rate.

A total of 69 patients completed the trial, and no adverse effects were observed during the study period.

The marginal mean MoCA score increased by 1.96 units in the probiotic/vitamin D group compared with the placebo group during the study period, indicating significant improvement in cognitive function (P = .004).

In addition, the percentage of patients with a MoCA score of ≥ 26 (indicating normal cognition) increased significantly in the supplement group (P = .031), while there were no significant changes in the placebo group (P = .625).

The probiotic/vitamin D supplement was associated with a reduction in the PANSS score by 2.82 units compared with placebo, but the difference between groups was not statistically significant (P = .247).

The supplement group also saw a significant decrease in total cholesterol (P = .011), fasting blood sugar (P = .009), and CRP (P < .001).
 

Promising ‘Suggestive’ Evidence

Reached for comment, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization that people living with schizophrenia have “significant impairment in general cognitive functions that can be debilitating and impair quality of life.”

This study provides “suggestive evidence” that the combination of probiotics and vitamin D is safe and effective in the treatment of cognitive dysfunction and “provides hope for persons with the lived experience. However, larger rigorous randomized control trials are needed to confirm these findings,” said Dr. McIntyre, who was not part of the study.

Also weighing in, Christopher M. Palmer, MD, assistant professor of psychiatry at Harvard Medical School in Boston, Massachusetts, noted that many researchers are focusing on the gut-brain connection and its role in a range of neuropsychiatric disorders, including schizophrenia.

“The gut microbiome appears to play a role in a range of factors that can impact brain function, including levels of inflammation, blood sugar, insulin signaling, and neurotransmitter production within the digestive tract,” said Dr. Palmer, who was not involved in the trial. “All of these factors can impact the brain, and in particular, brain metabolism, which increasingly is thought to play a key role in schizophrenia and other neuropsychiatric conditions.”

The new study builds on prior work in important ways, Dr. Palmer added. For example, he noted, earlier research did not show a benefit of probiotics alone.

“One of the challenges with probiotic research is the type of probiotic used. There are single-strain versions and multi-strain versions,” Dr. Palmer said. “This study used a probiotic containing five different bacterial species, so it’s possible that prior studies didn’t use the ideal type of probiotic. Combining the probiotic with vitamin D may also play a critical role.”

The new work replicates findings from a 2019 study in people with schizophrenia who received a four-strain probiotic plus vitamin D or a placebo for 12 weeks, he noted.

“The patients who got the probiotic plus vitamin D experienced improvement in psychiatric symptoms and improvement in three of the same biomarkers used in this study (reductions in total cholesterol, fasting blood sugar, and CRP),” Dr. Palmer said.

Like Dr. McIntyre, Dr. Palmer noted that larger clinical trials are needed before a treatment recommendation can be made.

“We also need to better understand which probiotics to use and the optimal dose of vitamin D supplementation,” he said. “In the meantime, however, patients may want to discuss this research with their clinicians to see if this might be something to consider in their own treatment.”

The study had no funding source. The authors and Dr. McIntyre had no relevant disclosures. Dr. Palmer is the author of the book Brain Energy published by Penguin Random House.

A version of this article appeared on Medscape.com.

Co-administration of a probiotic and vitamin D significantly improved cognitive function in patients with schizophrenia, results from a double-blind randomized controlled trial suggested.

The combination also led to favorable changes in total cholesterol, fasting blood sugar, and a marker of inflammation.

“Targeting the microbiota-gut-brain axis with probiotic and vitamin D might provide a novel approach to promote mental health,” investigators led by Gita Sadighi, MD, Department of Psychiatry, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran, wrote.

The study was published online in Neuropsychopharmacology Reports.
 

Cognitive Boost

The research includes data on 70 adults with schizophrenia who were on stable antipsychotic medication for at least 6 months. Half took a capsule containing five different probiotic strains plus 400 IU of vitamin D daily for 12 weeks, and half took a matching placebo capsule.

Primary outcomes were disease severity and cognitive function, measured at baseline, every 2 weeks during the trial, and again at the end of the study. Measurement tools included the Positive and Negative Syndrome Scale (PANSS) for disease severity and the 30-point Montreal Cognitive Assessment (MoCA) for cognitive function.

Secondary outcomes were lipid profile, body mass index, gastrointestinal problems, serum C-reactive protein (CRP), and erythrocyte sedimentation rate.

A total of 69 patients completed the trial, and no adverse effects were observed during the study period.

The marginal mean MoCA score increased by 1.96 units in the probiotic/vitamin D group compared with the placebo group during the study period, indicating significant improvement in cognitive function (P = .004).

In addition, the percentage of patients with a MoCA score of ≥ 26 (indicating normal cognition) increased significantly in the supplement group (P = .031), while there were no significant changes in the placebo group (P = .625).

The probiotic/vitamin D supplement was associated with a reduction in the PANSS score by 2.82 units compared with placebo, but the difference between groups was not statistically significant (P = .247).

The supplement group also saw a significant decrease in total cholesterol (P = .011), fasting blood sugar (P = .009), and CRP (P < .001).
 

Promising ‘Suggestive’ Evidence

Reached for comment, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization that people living with schizophrenia have “significant impairment in general cognitive functions that can be debilitating and impair quality of life.”

This study provides “suggestive evidence” that the combination of probiotics and vitamin D is safe and effective in the treatment of cognitive dysfunction and “provides hope for persons with the lived experience. However, larger rigorous randomized control trials are needed to confirm these findings,” said Dr. McIntyre, who was not part of the study.

Also weighing in, Christopher M. Palmer, MD, assistant professor of psychiatry at Harvard Medical School in Boston, Massachusetts, noted that many researchers are focusing on the gut-brain connection and its role in a range of neuropsychiatric disorders, including schizophrenia.

“The gut microbiome appears to play a role in a range of factors that can impact brain function, including levels of inflammation, blood sugar, insulin signaling, and neurotransmitter production within the digestive tract,” said Dr. Palmer, who was not involved in the trial. “All of these factors can impact the brain, and in particular, brain metabolism, which increasingly is thought to play a key role in schizophrenia and other neuropsychiatric conditions.”

The new study builds on prior work in important ways, Dr. Palmer added. For example, he noted, earlier research did not show a benefit of probiotics alone.

“One of the challenges with probiotic research is the type of probiotic used. There are single-strain versions and multi-strain versions,” Dr. Palmer said. “This study used a probiotic containing five different bacterial species, so it’s possible that prior studies didn’t use the ideal type of probiotic. Combining the probiotic with vitamin D may also play a critical role.”

The new work replicates findings from a 2019 study in people with schizophrenia who received a four-strain probiotic plus vitamin D or a placebo for 12 weeks, he noted.

“The patients who got the probiotic plus vitamin D experienced improvement in psychiatric symptoms and improvement in three of the same biomarkers used in this study (reductions in total cholesterol, fasting blood sugar, and CRP),” Dr. Palmer said.

Like Dr. McIntyre, Dr. Palmer noted that larger clinical trials are needed before a treatment recommendation can be made.

“We also need to better understand which probiotics to use and the optimal dose of vitamin D supplementation,” he said. “In the meantime, however, patients may want to discuss this research with their clinicians to see if this might be something to consider in their own treatment.”

The study had no funding source. The authors and Dr. McIntyre had no relevant disclosures. Dr. Palmer is the author of the book Brain Energy published by Penguin Random House.

A version of this article appeared on Medscape.com.

Co-administration of a probiotic and vitamin D significantly improved cognitive function in patients with schizophrenia, results from a double-blind randomized controlled trial suggested.

The combination also led to favorable changes in total cholesterol, fasting blood sugar, and a marker of inflammation.

“Targeting the microbiota-gut-brain axis with probiotic and vitamin D might provide a novel approach to promote mental health,” investigators led by Gita Sadighi, MD, Department of Psychiatry, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran, wrote.

The study was published online in Neuropsychopharmacology Reports.
 

Cognitive Boost

The research includes data on 70 adults with schizophrenia who were on stable antipsychotic medication for at least 6 months. Half took a capsule containing five different probiotic strains plus 400 IU of vitamin D daily for 12 weeks, and half took a matching placebo capsule.

Primary outcomes were disease severity and cognitive function, measured at baseline, every 2 weeks during the trial, and again at the end of the study. Measurement tools included the Positive and Negative Syndrome Scale (PANSS) for disease severity and the 30-point Montreal Cognitive Assessment (MoCA) for cognitive function.

Secondary outcomes were lipid profile, body mass index, gastrointestinal problems, serum C-reactive protein (CRP), and erythrocyte sedimentation rate.

A total of 69 patients completed the trial, and no adverse effects were observed during the study period.

The marginal mean MoCA score increased by 1.96 units in the probiotic/vitamin D group compared with the placebo group during the study period, indicating significant improvement in cognitive function (P = .004).

In addition, the percentage of patients with a MoCA score of ≥ 26 (indicating normal cognition) increased significantly in the supplement group (P = .031), while there were no significant changes in the placebo group (P = .625).

The probiotic/vitamin D supplement was associated with a reduction in the PANSS score by 2.82 units compared with placebo, but the difference between groups was not statistically significant (P = .247).

The supplement group also saw a significant decrease in total cholesterol (P = .011), fasting blood sugar (P = .009), and CRP (P < .001).
 

Promising ‘Suggestive’ Evidence

Reached for comment, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization that people living with schizophrenia have “significant impairment in general cognitive functions that can be debilitating and impair quality of life.”

This study provides “suggestive evidence” that the combination of probiotics and vitamin D is safe and effective in the treatment of cognitive dysfunction and “provides hope for persons with the lived experience. However, larger rigorous randomized control trials are needed to confirm these findings,” said Dr. McIntyre, who was not part of the study.

Also weighing in, Christopher M. Palmer, MD, assistant professor of psychiatry at Harvard Medical School in Boston, Massachusetts, noted that many researchers are focusing on the gut-brain connection and its role in a range of neuropsychiatric disorders, including schizophrenia.

“The gut microbiome appears to play a role in a range of factors that can impact brain function, including levels of inflammation, blood sugar, insulin signaling, and neurotransmitter production within the digestive tract,” said Dr. Palmer, who was not involved in the trial. “All of these factors can impact the brain, and in particular, brain metabolism, which increasingly is thought to play a key role in schizophrenia and other neuropsychiatric conditions.”

The new study builds on prior work in important ways, Dr. Palmer added. For example, he noted, earlier research did not show a benefit of probiotics alone.

“One of the challenges with probiotic research is the type of probiotic used. There are single-strain versions and multi-strain versions,” Dr. Palmer said. “This study used a probiotic containing five different bacterial species, so it’s possible that prior studies didn’t use the ideal type of probiotic. Combining the probiotic with vitamin D may also play a critical role.”

The new work replicates findings from a 2019 study in people with schizophrenia who received a four-strain probiotic plus vitamin D or a placebo for 12 weeks, he noted.

“The patients who got the probiotic plus vitamin D experienced improvement in psychiatric symptoms and improvement in three of the same biomarkers used in this study (reductions in total cholesterol, fasting blood sugar, and CRP),” Dr. Palmer said.

Like Dr. McIntyre, Dr. Palmer noted that larger clinical trials are needed before a treatment recommendation can be made.

“We also need to better understand which probiotics to use and the optimal dose of vitamin D supplementation,” he said. “In the meantime, however, patients may want to discuss this research with their clinicians to see if this might be something to consider in their own treatment.”

The study had no funding source. The authors and Dr. McIntyre had no relevant disclosures. Dr. Palmer is the author of the book Brain Energy published by Penguin Random House.

A version of this article appeared on Medscape.com.

Adults with alcohol-related hospitalization who were discharged from the hospital with medication for alcohol use disorder (MAUD) were 51% less likely to be rehospitalized for an alcohol-related issue, new research suggested.

Despite the link to better outcomes, the analysis of 6500 Medicare Part D beneficiaries hospitalized for alcohol-related causes revealed that only 2% of patients were discharged with an MAUD prescription.

“Despite known efficacy, medication treatment for alcohol use disorder is underutilized and rarely initiated in the post-hospitalization setting,” lead author Eden Y. Bernstein, MD, a physician scientist in the Division of General Internal Medicine at Massachusetts General Hospital, Boston, said in a news release.

“Our findings highlight the potential clinical benefit associated with increased uptake of these medications in this setting and suggest a need to support and expand ongoing efforts to improve access to these medications upon hospital discharge,” Dr. Bernstein added.

The study was published online in JAMA Network Open.

MAUD prescribing or referral to addiction treatment at hospital discharge is widely recommended, investigators noted, making hospitalizations “important touch points” for alcohol use disorder (AUD) treatment engagement.

To study the association between discharge MAUD and 30-day rehospitalization, the researchers analyzed Medicare claims data from 2015 to 2017 in a retrospective study designed to emulate a randomized clinical trial of hospitalized patients with AUD.

The analysis included data on 6794 beneficiaries with 9834 hospitalizations for alcohol-related causes (median age, 54 years; 33% female; 72% White).

Researchers controlled for several covariates, including sociodemographic, clinical, and rehospitalization factors.
 

‘Sobering’ Findings

After propensity matching, discharge MAUD initiation was associated with a 42% decreased incidence of rehospitalization within 30 days of discharge (including emergency department visits and readmissions) or death within 30 days (incident rate ratio [IRR], 0.58; 95% CI, 0.45-0.76).

These findings remained consistent among secondary outcomes as well. Mortality was rare in both groups.

MAUD initiation at discharge was associated with a 51% decrease in incidence of alcohol-related return to the hospital (IRR, 0.49; 95% CI, 0.34-0.71).

Patients who received discharge MAUD were 22% more likely to have primary care or mental health follow-up visits (IRR, 1.22; 95% CI, 1.04-1.44).

Limitations noted by the authors include the observational study design and lack of information of nonpharmacologic treatment, such as 12-step facilitation or behavioral interventions.

In an accompanying editorial, Wid Yaseen, MD, of the Department of Medicine, University of Toronto, and coauthors noted that at present, most patients with AUD do not receive evidence-based treatment.

“An important first step might be reframing our mindset to consider AUD as a chronic disease,” they wrote. “We should also ask ourselves: Would we accept the status quo if only 2% of our patients with diabetes were prescribed evidence-based therapy?”

They added, “The insufficient use of MAUD is sobering and is also an enormous opportunity to do better for our patients.”

The study was funded by the Institutional National Research Service Award, Massachusetts General Hospital, the Agency for Healthcare Research and Quality, and the National Institute on Aging. Dr. Bernstein received personal fees from Alosa Health outside the submitted work, and Dr. Yaseen reported no relevant financial relationships. Full disclosures are included in the original articles.
 

A version of this article appeared on Medscape.com.

Adults with alcohol-related hospitalization who were discharged from the hospital with medication for alcohol use disorder (MAUD) were 51% less likely to be rehospitalized for an alcohol-related issue, new research suggested.

Despite the link to better outcomes, the analysis of 6500 Medicare Part D beneficiaries hospitalized for alcohol-related causes revealed that only 2% of patients were discharged with an MAUD prescription.

“Despite known efficacy, medication treatment for alcohol use disorder is underutilized and rarely initiated in the post-hospitalization setting,” lead author Eden Y. Bernstein, MD, a physician scientist in the Division of General Internal Medicine at Massachusetts General Hospital, Boston, said in a news release.

“Our findings highlight the potential clinical benefit associated with increased uptake of these medications in this setting and suggest a need to support and expand ongoing efforts to improve access to these medications upon hospital discharge,” Dr. Bernstein added.

The study was published online in JAMA Network Open.

MAUD prescribing or referral to addiction treatment at hospital discharge is widely recommended, investigators noted, making hospitalizations “important touch points” for alcohol use disorder (AUD) treatment engagement.

To study the association between discharge MAUD and 30-day rehospitalization, the researchers analyzed Medicare claims data from 2015 to 2017 in a retrospective study designed to emulate a randomized clinical trial of hospitalized patients with AUD.

The analysis included data on 6794 beneficiaries with 9834 hospitalizations for alcohol-related causes (median age, 54 years; 33% female; 72% White).

Researchers controlled for several covariates, including sociodemographic, clinical, and rehospitalization factors.
 

‘Sobering’ Findings

After propensity matching, discharge MAUD initiation was associated with a 42% decreased incidence of rehospitalization within 30 days of discharge (including emergency department visits and readmissions) or death within 30 days (incident rate ratio [IRR], 0.58; 95% CI, 0.45-0.76).

These findings remained consistent among secondary outcomes as well. Mortality was rare in both groups.

MAUD initiation at discharge was associated with a 51% decrease in incidence of alcohol-related return to the hospital (IRR, 0.49; 95% CI, 0.34-0.71).

Patients who received discharge MAUD were 22% more likely to have primary care or mental health follow-up visits (IRR, 1.22; 95% CI, 1.04-1.44).

Limitations noted by the authors include the observational study design and lack of information of nonpharmacologic treatment, such as 12-step facilitation or behavioral interventions.

In an accompanying editorial, Wid Yaseen, MD, of the Department of Medicine, University of Toronto, and coauthors noted that at present, most patients with AUD do not receive evidence-based treatment.

“An important first step might be reframing our mindset to consider AUD as a chronic disease,” they wrote. “We should also ask ourselves: Would we accept the status quo if only 2% of our patients with diabetes were prescribed evidence-based therapy?”

They added, “The insufficient use of MAUD is sobering and is also an enormous opportunity to do better for our patients.”

The study was funded by the Institutional National Research Service Award, Massachusetts General Hospital, the Agency for Healthcare Research and Quality, and the National Institute on Aging. Dr. Bernstein received personal fees from Alosa Health outside the submitted work, and Dr. Yaseen reported no relevant financial relationships. Full disclosures are included in the original articles.
 

A version of this article appeared on Medscape.com.

Adults with alcohol-related hospitalization who were discharged from the hospital with medication for alcohol use disorder (MAUD) were 51% less likely to be rehospitalized for an alcohol-related issue, new research suggested.

Despite the link to better outcomes, the analysis of 6500 Medicare Part D beneficiaries hospitalized for alcohol-related causes revealed that only 2% of patients were discharged with an MAUD prescription.

“Despite known efficacy, medication treatment for alcohol use disorder is underutilized and rarely initiated in the post-hospitalization setting,” lead author Eden Y. Bernstein, MD, a physician scientist in the Division of General Internal Medicine at Massachusetts General Hospital, Boston, said in a news release.

“Our findings highlight the potential clinical benefit associated with increased uptake of these medications in this setting and suggest a need to support and expand ongoing efforts to improve access to these medications upon hospital discharge,” Dr. Bernstein added.

The study was published online in JAMA Network Open.

MAUD prescribing or referral to addiction treatment at hospital discharge is widely recommended, investigators noted, making hospitalizations “important touch points” for alcohol use disorder (AUD) treatment engagement.

To study the association between discharge MAUD and 30-day rehospitalization, the researchers analyzed Medicare claims data from 2015 to 2017 in a retrospective study designed to emulate a randomized clinical trial of hospitalized patients with AUD.

The analysis included data on 6794 beneficiaries with 9834 hospitalizations for alcohol-related causes (median age, 54 years; 33% female; 72% White).

Researchers controlled for several covariates, including sociodemographic, clinical, and rehospitalization factors.
 

‘Sobering’ Findings

After propensity matching, discharge MAUD initiation was associated with a 42% decreased incidence of rehospitalization within 30 days of discharge (including emergency department visits and readmissions) or death within 30 days (incident rate ratio [IRR], 0.58; 95% CI, 0.45-0.76).

These findings remained consistent among secondary outcomes as well. Mortality was rare in both groups.

MAUD initiation at discharge was associated with a 51% decrease in incidence of alcohol-related return to the hospital (IRR, 0.49; 95% CI, 0.34-0.71).

Patients who received discharge MAUD were 22% more likely to have primary care or mental health follow-up visits (IRR, 1.22; 95% CI, 1.04-1.44).

Limitations noted by the authors include the observational study design and lack of information of nonpharmacologic treatment, such as 12-step facilitation or behavioral interventions.

In an accompanying editorial, Wid Yaseen, MD, of the Department of Medicine, University of Toronto, and coauthors noted that at present, most patients with AUD do not receive evidence-based treatment.

“An important first step might be reframing our mindset to consider AUD as a chronic disease,” they wrote. “We should also ask ourselves: Would we accept the status quo if only 2% of our patients with diabetes were prescribed evidence-based therapy?”

They added, “The insufficient use of MAUD is sobering and is also an enormous opportunity to do better for our patients.”

The study was funded by the Institutional National Research Service Award, Massachusetts General Hospital, the Agency for Healthcare Research and Quality, and the National Institute on Aging. Dr. Bernstein received personal fees from Alosa Health outside the submitted work, and Dr. Yaseen reported no relevant financial relationships. Full disclosures are included in the original articles.
 

A version of this article appeared on Medscape.com.