Mental Health

The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).

In a news release, the company reports that a single oral dose of MM120 met its key secondary endpoint, maintaining “clinically and statistically significant” reductions in Hamilton Anxiety Scale (HAM-A) score, compared with placebo, at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.

The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.

“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.

MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.

MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.

Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.

Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.

MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.

The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.

The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.

The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).

In a news release, the company reports that a single oral dose of MM120 met its key secondary endpoint, maintaining “clinically and statistically significant” reductions in Hamilton Anxiety Scale (HAM-A) score, compared with placebo, at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.

The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.

“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.

MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.

MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.

Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.

Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.

MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.

The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.

The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.

The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).

In a news release, the company reports that a single oral dose of MM120 met its key secondary endpoint, maintaining “clinically and statistically significant” reductions in Hamilton Anxiety Scale (HAM-A) score, compared with placebo, at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.

The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.

“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.

MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.

MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.

Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.

Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.

MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.

The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.

The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.

The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.

A version of this article appeared on Medscape.com.

Calls to US poison centers related to psilocybin more than tripled among teens and more than doubled in young adults between 2019 and 2022, new research suggests. Investigators say the increase may be linked to decriminalization efforts in US cities and states.

METHODOLOGY:

• Investigators used data from the National Poison Data System (NPDS) to identify calls involving psilocybin between January 2013 and December 2022.
• Researchers focused on calls about individuals between the ages of 13 and 25 years.
• Exposures to psilocybin were examined based on demographics, clinical effects, level of care, and medical outcome.

TAKEAWAY:

• During the entire 10-year study period, 4055 psilocybin-involved exposures were reported in the age groups studied, with 66% being single-substance exposures and close to three quarters receiving medical attention.
• Psilocybin’s most common effects were hallucinations or delusions (37% of calls), agitation (28%), tachycardia (20%), and confusion (16%).
• The number of psilocybin-related calls to poison control centers for youth were largely unchanged from 2013 to 2018 but more than tripled among adolescents (aged 13-19 years) from 2019 and 2022 and more than doubled among young adults (aged 20-25 years) between 2018 and 2022 (P < .0001).

IN PRACTICE:

The increase in poison center calls coincides with psilocybin decriminalization efforts in several states in 2019, the authors noted. However, because those efforts only legalized use in adults aged 21 years and older, the rise among younger people is concerning, they added. “As psilocybin may become more widely available, it is important for parents to be aware that psilocybin is also available in edible forms such as chocolate and gummies. And we learned from our experience with edible cannabis that young children can mistake edibles for candy,” lead author Rita Farah, PharmD, MPH, PhD, Blue Ridge Poison Center epidemiologist, said in a news release.

SOURCE:

Christopher Holstege, MD, director of UVA Health’s Blue Ridge Poison Center and chief of the Division of Medical Toxicology at the UVA School of Medicine was the senior and corresponding author of the study. It was published online on February 26 in the Journal of Adolescent Health.

LIMITATIONS:

NPDS data are not designed to assess potential risk factors leading to increases in psilocybin-related cases. Moreover, because reports to poison control centers are voluntary and don’t capture all exposures, NPDS data likely under-represent cases of hallucinogenic mushroom poisonings. Lastly, NPDS data are susceptible to reporting and misclassification biases.

DISCLOSURES:

Funding source was not disclosed. The authors reported no relevant financial relationships.

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

Calls to US poison centers related to psilocybin more than tripled among teens and more than doubled in young adults between 2019 and 2022, new research suggests. Investigators say the increase may be linked to decriminalization efforts in US cities and states.

METHODOLOGY:

• Investigators used data from the National Poison Data System (NPDS) to identify calls involving psilocybin between January 2013 and December 2022.
• Researchers focused on calls about individuals between the ages of 13 and 25 years.
• Exposures to psilocybin were examined based on demographics, clinical effects, level of care, and medical outcome.

TAKEAWAY:

• During the entire 10-year study period, 4055 psilocybin-involved exposures were reported in the age groups studied, with 66% being single-substance exposures and close to three quarters receiving medical attention.
• Psilocybin’s most common effects were hallucinations or delusions (37% of calls), agitation (28%), tachycardia (20%), and confusion (16%).
• The number of psilocybin-related calls to poison control centers for youth were largely unchanged from 2013 to 2018 but more than tripled among adolescents (aged 13-19 years) from 2019 and 2022 and more than doubled among young adults (aged 20-25 years) between 2018 and 2022 (P < .0001).

IN PRACTICE:

The increase in poison center calls coincides with psilocybin decriminalization efforts in several states in 2019, the authors noted. However, because those efforts only legalized use in adults aged 21 years and older, the rise among younger people is concerning, they added. “As psilocybin may become more widely available, it is important for parents to be aware that psilocybin is also available in edible forms such as chocolate and gummies. And we learned from our experience with edible cannabis that young children can mistake edibles for candy,” lead author Rita Farah, PharmD, MPH, PhD, Blue Ridge Poison Center epidemiologist, said in a news release.

SOURCE:

Christopher Holstege, MD, director of UVA Health’s Blue Ridge Poison Center and chief of the Division of Medical Toxicology at the UVA School of Medicine was the senior and corresponding author of the study. It was published online on February 26 in the Journal of Adolescent Health.

LIMITATIONS:

NPDS data are not designed to assess potential risk factors leading to increases in psilocybin-related cases. Moreover, because reports to poison control centers are voluntary and don’t capture all exposures, NPDS data likely under-represent cases of hallucinogenic mushroom poisonings. Lastly, NPDS data are susceptible to reporting and misclassification biases.

DISCLOSURES:

Funding source was not disclosed. The authors reported no relevant financial relationships.

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

Calls to US poison centers related to psilocybin more than tripled among teens and more than doubled in young adults between 2019 and 2022, new research suggests. Investigators say the increase may be linked to decriminalization efforts in US cities and states.

METHODOLOGY:

• Investigators used data from the National Poison Data System (NPDS) to identify calls involving psilocybin between January 2013 and December 2022.
• Researchers focused on calls about individuals between the ages of 13 and 25 years.
• Exposures to psilocybin were examined based on demographics, clinical effects, level of care, and medical outcome.

TAKEAWAY:

• During the entire 10-year study period, 4055 psilocybin-involved exposures were reported in the age groups studied, with 66% being single-substance exposures and close to three quarters receiving medical attention.
• Psilocybin’s most common effects were hallucinations or delusions (37% of calls), agitation (28%), tachycardia (20%), and confusion (16%).
• The number of psilocybin-related calls to poison control centers for youth were largely unchanged from 2013 to 2018 but more than tripled among adolescents (aged 13-19 years) from 2019 and 2022 and more than doubled among young adults (aged 20-25 years) between 2018 and 2022 (P < .0001).

IN PRACTICE:

The increase in poison center calls coincides with psilocybin decriminalization efforts in several states in 2019, the authors noted. However, because those efforts only legalized use in adults aged 21 years and older, the rise among younger people is concerning, they added. “As psilocybin may become more widely available, it is important for parents to be aware that psilocybin is also available in edible forms such as chocolate and gummies. And we learned from our experience with edible cannabis that young children can mistake edibles for candy,” lead author Rita Farah, PharmD, MPH, PhD, Blue Ridge Poison Center epidemiologist, said in a news release.

SOURCE:

Christopher Holstege, MD, director of UVA Health’s Blue Ridge Poison Center and chief of the Division of Medical Toxicology at the UVA School of Medicine was the senior and corresponding author of the study. It was published online on February 26 in the Journal of Adolescent Health.

LIMITATIONS:

NPDS data are not designed to assess potential risk factors leading to increases in psilocybin-related cases. Moreover, because reports to poison control centers are voluntary and don’t capture all exposures, NPDS data likely under-represent cases of hallucinogenic mushroom poisonings. Lastly, NPDS data are susceptible to reporting and misclassification biases.

DISCLOSURES:

Funding source was not disclosed. The authors reported no relevant financial relationships.

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

While TikTok overflows with images of influencers making “adrenal cocktails” to combat what they call adrenal fatigue, the Endocrine Society says “no scientific proof exists to support adrenal fatigue as a true medical condition.”

Even before influencers began touting it on social media, a 2016 systematic review concluded that there is “no substantiation that adrenal fatigue” is an actual medical condition. Therefore, adrenal fatigue is still a myth.

Lynette Nieman, MD, Senior Investigator and Chief of the Endocrinology Consultation Service at the National Institutes of Health Clinical Center, Bethesda, Maryland, concurs.

“There is no scientific evidence that adrenal fatigue exists or causes [general] fatigue, depression, or the many common symptoms that are said to result from this condition,” she told this news organization via email.

Still, the term has gained currency among not only social media influencers who blame it for everything from cortisol surges to estrogen imbalances but also functional and integrative medical practitioners as an explanation for chronic dysfunction related to stress. 
 

Adrenal Fatigue, Burnout, or Adrenal Insufficiency?

Rather than “adrenal fatigue,” Marcelo Campos, MD, a primary care doctor at Atrius Health, said he prefers the medical term “burnout.”

Use of “burnout” shifts attention to the brain’s role in stress-related chronic dysfunction rather than the adrenal glands, said Dr. Campos, who also teaches at Harvard Medical School, Cambridge, Massachusetts.

More specifically still, the focuses might shift to the stress-response via the hypothalamic-pituitary-adrenocortical axis and its role in reducing levels of these cortisol and dehydroepiandrosterone sulfate.

He points out that part of the reason for the misuse of the term adrenal fatigue arises from the fact that burnout is often only associated with work stress.

“Recently, the ICD-11 [International Classification of Diseases-11] recognized burnout as a disease but focused only on work stress as a cause. The truth is that people can be burned out for many other reasons,” said Dr. Campos.

The Endocrine Society notes on their webpage dedicated to the topic that “adrenal fatigue” as a term, relates to long-term mental, emotional, or physical stress.

“The problem is not the adrenals — it is the exposure to stress in the brain. The brain — only one organ — is responsible for 40% of energy consumption in the body. As you can imagine, if you are under constant stress, you run out of gas very quickly and cannot function well,” he explained.

Adrenal fatigue theory suggests that, under stress, the adrenal glands produce too many short bursts of cortisol resulting in overall reduced cortisol levels and a feeling of being drained.

“As with many other psychiatric diseases, we do not have a way to measure biomarkers in the brain. The testing for cortisol does not work because it fluctuates too much from time to time. So, it is not reliable or reproducible,” Dr. Campos said. 

This leads to the ongoing question of the best way to test and diagnose adrenal fatigue, whether it should be via blood, urine and/or saliva. And even if that is determined, there are still questions about the best time to test, how often, what the normal ranges are and how reliable the tests are.

While adrenal fatigue is not a recognized condition, adrenal insufficiency is medically recognized, resulting from an inability of the adrenal glands to make the life-essential hormones aldosterone and/or cortisol, with symptoms that include fatigue, belly pain, nausea, vomiting, diarrhea, and joint aches.

“Adrenal cocktails are not an effective treatment for adrenal insufficiency because they do not replace the missing hormones,” Dr. Nieman stated, pointing out that anyone with symptoms of adrenal insufficiency needs to see an endocrinologist.

Pratibha Rao, MD, MPH, an endocrinologist at the Cleveland Clinic, Ohio, and medical director of the Adrenal Center at Cleveland Clinic, agreed, advising that if people continue to feel exhausted beyond their normal exertion, then they should get checked for signs of adrenal insufficiency.

“In primary adrenal insufficiency, you can actually start seeing darkening of the gums and of the skin on the palms of the hands or the soles of your feet. Sometimes people can feel dizzy or experience some loss of consciousness,” she said. “If it’s sudden and severe, you may crave salt or have extreme heat or cold intolerance.”

Recognizing and Managing Patient Frustration

The lack of formal diagnostic criteria and medical evidence, however, doesn’t mean that such symptoms as fatigue and depression don’t present, often causing significant distress for patients. While the symptoms might not be associated with the adrenal glands, they still need addressing — but how that is done is, in essence, a bone of contention.

Dr. Rao empathizes with the situation that many people, often young women, find themselves in.

“Patients are frustrated. They’ve gone to multiple doctors across the country, and they feel convinced they have adrenal fatigue, but no medical doctor has endorsed it. They end up coming to us with a cry that has so often gone unanswered.”

This issue also highlights that there are millions of people experiencing mental, emotional, and physical distress of unknown cause who seek help, many of whom believe it is related to their adrenal gland function.

But rather than turning to a social media cure, Dr. Rao stresses that people would benefit more from paying greater attention to following a healthy lifestyle than regularly consuming sugar-rich drinks claimed to offer a solution. Adrenal cocktails are energy-rich, frothy blends of orange juice, coconut milk, cream of tartar, and Himalayan salt.

“We truly are what we eat, and we are what we think,” she noted.

The body is a miraculous machine, but “we forget that it does need maintenance,” Dr. Rao said. “Up to age 30, the body is so forgiving with drugs, alcohol, or whatever insult we do to it, but after the third decade, slowly every cell starts to degenerate instead of growing. We start to see the ill or beneficial effects of lifestyle habits.” 

“We insult the body, and then we say, ‘oh, I have fatigue’ and seek a quick fix,” she added. “Everyone wants instant gratification.”

Dr. Rao cautioned that adrenal cocktails could be dangerous for someone who has other medical conditions.

“If someone has kidney disease, uncontrolled hypertension, or diabetes, for example, then adrenal cocktails are definitely not safe,” Dr. Rao said. “Loading up with potassium and sodium, which is found in high quantities in adrenal cocktails, will actually worsen any kidney damage, while consuming so much sugar will cause an unregulated rise in blood sugar and further damage in someone with diabetes.”

Dr. Rao also stressed that nonprofessional advice given on social media could take patient people down the wrong path with associated danger.

A version of this article appeared on Medscape.com.

While TikTok overflows with images of influencers making “adrenal cocktails” to combat what they call adrenal fatigue, the Endocrine Society says “no scientific proof exists to support adrenal fatigue as a true medical condition.”

Even before influencers began touting it on social media, a 2016 systematic review concluded that there is “no substantiation that adrenal fatigue” is an actual medical condition. Therefore, adrenal fatigue is still a myth.

Lynette Nieman, MD, Senior Investigator and Chief of the Endocrinology Consultation Service at the National Institutes of Health Clinical Center, Bethesda, Maryland, concurs.

“There is no scientific evidence that adrenal fatigue exists or causes [general] fatigue, depression, or the many common symptoms that are said to result from this condition,” she told this news organization via email.

Still, the term has gained currency among not only social media influencers who blame it for everything from cortisol surges to estrogen imbalances but also functional and integrative medical practitioners as an explanation for chronic dysfunction related to stress. 
 

Adrenal Fatigue, Burnout, or Adrenal Insufficiency?

Rather than “adrenal fatigue,” Marcelo Campos, MD, a primary care doctor at Atrius Health, said he prefers the medical term “burnout.”

Use of “burnout” shifts attention to the brain’s role in stress-related chronic dysfunction rather than the adrenal glands, said Dr. Campos, who also teaches at Harvard Medical School, Cambridge, Massachusetts.

More specifically still, the focuses might shift to the stress-response via the hypothalamic-pituitary-adrenocortical axis and its role in reducing levels of these cortisol and dehydroepiandrosterone sulfate.

He points out that part of the reason for the misuse of the term adrenal fatigue arises from the fact that burnout is often only associated with work stress.

“Recently, the ICD-11 [International Classification of Diseases-11] recognized burnout as a disease but focused only on work stress as a cause. The truth is that people can be burned out for many other reasons,” said Dr. Campos.

The Endocrine Society notes on their webpage dedicated to the topic that “adrenal fatigue” as a term, relates to long-term mental, emotional, or physical stress.

“The problem is not the adrenals — it is the exposure to stress in the brain. The brain — only one organ — is responsible for 40% of energy consumption in the body. As you can imagine, if you are under constant stress, you run out of gas very quickly and cannot function well,” he explained.

Adrenal fatigue theory suggests that, under stress, the adrenal glands produce too many short bursts of cortisol resulting in overall reduced cortisol levels and a feeling of being drained.

“As with many other psychiatric diseases, we do not have a way to measure biomarkers in the brain. The testing for cortisol does not work because it fluctuates too much from time to time. So, it is not reliable or reproducible,” Dr. Campos said. 

This leads to the ongoing question of the best way to test and diagnose adrenal fatigue, whether it should be via blood, urine and/or saliva. And even if that is determined, there are still questions about the best time to test, how often, what the normal ranges are and how reliable the tests are.

While adrenal fatigue is not a recognized condition, adrenal insufficiency is medically recognized, resulting from an inability of the adrenal glands to make the life-essential hormones aldosterone and/or cortisol, with symptoms that include fatigue, belly pain, nausea, vomiting, diarrhea, and joint aches.

“Adrenal cocktails are not an effective treatment for adrenal insufficiency because they do not replace the missing hormones,” Dr. Nieman stated, pointing out that anyone with symptoms of adrenal insufficiency needs to see an endocrinologist.

Pratibha Rao, MD, MPH, an endocrinologist at the Cleveland Clinic, Ohio, and medical director of the Adrenal Center at Cleveland Clinic, agreed, advising that if people continue to feel exhausted beyond their normal exertion, then they should get checked for signs of adrenal insufficiency.

“In primary adrenal insufficiency, you can actually start seeing darkening of the gums and of the skin on the palms of the hands or the soles of your feet. Sometimes people can feel dizzy or experience some loss of consciousness,” she said. “If it’s sudden and severe, you may crave salt or have extreme heat or cold intolerance.”

Recognizing and Managing Patient Frustration

The lack of formal diagnostic criteria and medical evidence, however, doesn’t mean that such symptoms as fatigue and depression don’t present, often causing significant distress for patients. While the symptoms might not be associated with the adrenal glands, they still need addressing — but how that is done is, in essence, a bone of contention.

Dr. Rao empathizes with the situation that many people, often young women, find themselves in.

“Patients are frustrated. They’ve gone to multiple doctors across the country, and they feel convinced they have adrenal fatigue, but no medical doctor has endorsed it. They end up coming to us with a cry that has so often gone unanswered.”

This issue also highlights that there are millions of people experiencing mental, emotional, and physical distress of unknown cause who seek help, many of whom believe it is related to their adrenal gland function.

But rather than turning to a social media cure, Dr. Rao stresses that people would benefit more from paying greater attention to following a healthy lifestyle than regularly consuming sugar-rich drinks claimed to offer a solution. Adrenal cocktails are energy-rich, frothy blends of orange juice, coconut milk, cream of tartar, and Himalayan salt.

“We truly are what we eat, and we are what we think,” she noted.

The body is a miraculous machine, but “we forget that it does need maintenance,” Dr. Rao said. “Up to age 30, the body is so forgiving with drugs, alcohol, or whatever insult we do to it, but after the third decade, slowly every cell starts to degenerate instead of growing. We start to see the ill or beneficial effects of lifestyle habits.” 

“We insult the body, and then we say, ‘oh, I have fatigue’ and seek a quick fix,” she added. “Everyone wants instant gratification.”

Dr. Rao cautioned that adrenal cocktails could be dangerous for someone who has other medical conditions.

“If someone has kidney disease, uncontrolled hypertension, or diabetes, for example, then adrenal cocktails are definitely not safe,” Dr. Rao said. “Loading up with potassium and sodium, which is found in high quantities in adrenal cocktails, will actually worsen any kidney damage, while consuming so much sugar will cause an unregulated rise in blood sugar and further damage in someone with diabetes.”

Dr. Rao also stressed that nonprofessional advice given on social media could take patient people down the wrong path with associated danger.

A version of this article appeared on Medscape.com.

While TikTok overflows with images of influencers making “adrenal cocktails” to combat what they call adrenal fatigue, the Endocrine Society says “no scientific proof exists to support adrenal fatigue as a true medical condition.”

Even before influencers began touting it on social media, a 2016 systematic review concluded that there is “no substantiation that adrenal fatigue” is an actual medical condition. Therefore, adrenal fatigue is still a myth.

Lynette Nieman, MD, Senior Investigator and Chief of the Endocrinology Consultation Service at the National Institutes of Health Clinical Center, Bethesda, Maryland, concurs.

“There is no scientific evidence that adrenal fatigue exists or causes [general] fatigue, depression, or the many common symptoms that are said to result from this condition,” she told this news organization via email.

Still, the term has gained currency among not only social media influencers who blame it for everything from cortisol surges to estrogen imbalances but also functional and integrative medical practitioners as an explanation for chronic dysfunction related to stress. 
 

Adrenal Fatigue, Burnout, or Adrenal Insufficiency?

Rather than “adrenal fatigue,” Marcelo Campos, MD, a primary care doctor at Atrius Health, said he prefers the medical term “burnout.”

Use of “burnout” shifts attention to the brain’s role in stress-related chronic dysfunction rather than the adrenal glands, said Dr. Campos, who also teaches at Harvard Medical School, Cambridge, Massachusetts.

More specifically still, the focuses might shift to the stress-response via the hypothalamic-pituitary-adrenocortical axis and its role in reducing levels of these cortisol and dehydroepiandrosterone sulfate.

He points out that part of the reason for the misuse of the term adrenal fatigue arises from the fact that burnout is often only associated with work stress.

“Recently, the ICD-11 [International Classification of Diseases-11] recognized burnout as a disease but focused only on work stress as a cause. The truth is that people can be burned out for many other reasons,” said Dr. Campos.

The Endocrine Society notes on their webpage dedicated to the topic that “adrenal fatigue” as a term, relates to long-term mental, emotional, or physical stress.

“The problem is not the adrenals — it is the exposure to stress in the brain. The brain — only one organ — is responsible for 40% of energy consumption in the body. As you can imagine, if you are under constant stress, you run out of gas very quickly and cannot function well,” he explained.

Adrenal fatigue theory suggests that, under stress, the adrenal glands produce too many short bursts of cortisol resulting in overall reduced cortisol levels and a feeling of being drained.

“As with many other psychiatric diseases, we do not have a way to measure biomarkers in the brain. The testing for cortisol does not work because it fluctuates too much from time to time. So, it is not reliable or reproducible,” Dr. Campos said. 

This leads to the ongoing question of the best way to test and diagnose adrenal fatigue, whether it should be via blood, urine and/or saliva. And even if that is determined, there are still questions about the best time to test, how often, what the normal ranges are and how reliable the tests are.

While adrenal fatigue is not a recognized condition, adrenal insufficiency is medically recognized, resulting from an inability of the adrenal glands to make the life-essential hormones aldosterone and/or cortisol, with symptoms that include fatigue, belly pain, nausea, vomiting, diarrhea, and joint aches.

“Adrenal cocktails are not an effective treatment for adrenal insufficiency because they do not replace the missing hormones,” Dr. Nieman stated, pointing out that anyone with symptoms of adrenal insufficiency needs to see an endocrinologist.

Pratibha Rao, MD, MPH, an endocrinologist at the Cleveland Clinic, Ohio, and medical director of the Adrenal Center at Cleveland Clinic, agreed, advising that if people continue to feel exhausted beyond their normal exertion, then they should get checked for signs of adrenal insufficiency.

“In primary adrenal insufficiency, you can actually start seeing darkening of the gums and of the skin on the palms of the hands or the soles of your feet. Sometimes people can feel dizzy or experience some loss of consciousness,” she said. “If it’s sudden and severe, you may crave salt or have extreme heat or cold intolerance.”

Recognizing and Managing Patient Frustration

The lack of formal diagnostic criteria and medical evidence, however, doesn’t mean that such symptoms as fatigue and depression don’t present, often causing significant distress for patients. While the symptoms might not be associated with the adrenal glands, they still need addressing — but how that is done is, in essence, a bone of contention.

Dr. Rao empathizes with the situation that many people, often young women, find themselves in.

“Patients are frustrated. They’ve gone to multiple doctors across the country, and they feel convinced they have adrenal fatigue, but no medical doctor has endorsed it. They end up coming to us with a cry that has so often gone unanswered.”

This issue also highlights that there are millions of people experiencing mental, emotional, and physical distress of unknown cause who seek help, many of whom believe it is related to their adrenal gland function.

But rather than turning to a social media cure, Dr. Rao stresses that people would benefit more from paying greater attention to following a healthy lifestyle than regularly consuming sugar-rich drinks claimed to offer a solution. Adrenal cocktails are energy-rich, frothy blends of orange juice, coconut milk, cream of tartar, and Himalayan salt.

“We truly are what we eat, and we are what we think,” she noted.

The body is a miraculous machine, but “we forget that it does need maintenance,” Dr. Rao said. “Up to age 30, the body is so forgiving with drugs, alcohol, or whatever insult we do to it, but after the third decade, slowly every cell starts to degenerate instead of growing. We start to see the ill or beneficial effects of lifestyle habits.” 

“We insult the body, and then we say, ‘oh, I have fatigue’ and seek a quick fix,” she added. “Everyone wants instant gratification.”

Dr. Rao cautioned that adrenal cocktails could be dangerous for someone who has other medical conditions.

“If someone has kidney disease, uncontrolled hypertension, or diabetes, for example, then adrenal cocktails are definitely not safe,” Dr. Rao said. “Loading up with potassium and sodium, which is found in high quantities in adrenal cocktails, will actually worsen any kidney damage, while consuming so much sugar will cause an unregulated rise in blood sugar and further damage in someone with diabetes.”

Dr. Rao also stressed that nonprofessional advice given on social media could take patient people down the wrong path with associated danger.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

Cancer patients with behavioral health disorders are significantly less likely to undergo surgical resections, and more likely to experience poor outcomes when they do have surgery, based on data from a new study of nearly 700,000 individuals.

The reason for this association remains unclear, and highlights the need to address existing behavioral health disorders (BHDs), which can be exacerbated after a patient is diagnosed with cancer, wrote Timothy M. Pawlik, MD, of The Ohio State University, Columbus, and colleagues. A cancer diagnosis can cause not only physical stress, but mental, emotional, social, and economic stress that can prompt a new BHD, cause relapse of a previous BHD, or exacerbate a current BHD, the researchers noted.
 

What is Known About BHDs and Cancer?

Although previous studies have shown a possible association between BHDs and increased cancer risk, as well as reduced compliance with care, the effect of BHDs on outcomes in cancer patients undergoing surgical resection has not been examined, wrote Dr. Pawlik and colleagues.

Previous research has focused on the impact of having a preexisting serious mental illness (SMI) such as schizophrenia and bipolar disorder on cancer care.

A 2023 literature review of 27 studies published in the Journal of Medical Imaging and Radiation Sciences showed that patients with preexisting severe mental illness (such as schizophrenia or bipolar disorder) had greater cancer-related mortality. In that study, the researchers also found that patients with severe mental illness were more likely to have metastatic disease at diagnosis, but less likely to receive optimal treatments, than individuals without SMIs.

Many studies also have focused on patients developing mental health problems (including BHDs) after a cancer diagnosis, but the current study is the first known to examine outcomes in those with BHDs before cancer. 
 

Why Was It Important to Conduct This Study?

“BHDs are a diverse set of mental illnesses that affect an individual’s psychosocial wellbeing, potentially resulting in maladaptive behaviors,” Dr. Pawlik said in an interview. BHDs, which include substance abuse, eating disorders, and sleep disorders, are less common than anxiety/depression, but have an estimated prevalence of 1.3%-3.1% among adults in the United States, he said.

What Does the New Study Add?

In the new review by Dr. Pawlik and colleagues, published in the Journal of the American College of Surgeons (Katayama ES. J Am Coll Surg. 2024 Feb 29. doi: 2024. 10.1097/XCS.0000000000000954), BHDs were defined as substance abuse, eating disorders, or sleep disorders, which had not been the focus of previous studies. The researchers reviewed data from 694,836 adult patients with lung, esophageal, gastric, liver, pancreatic, or colorectal cancer between 2018-2021 using the Medicare Standard Analytic files. A total of 46,719 patients (6.7%) had at least one BHD.

Overall, patients with a BHD were significantly less likely than those without a BHD to undergo surgical resection (20.3% vs. 23.4%). Patients with a BHD also had significantly worse long-term postoperative survival than those without BHDs (median 37.1 months vs. 46.6 months) and significantly higher in-hospital costs ($17,432 vs. 16,159, P less than .001 for all).

Among patients who underwent cancer surgery, the odds of any complication were significantly higher for those with a BHD compared to those with no BHD (odds ratio 1.32), as were the odds of a prolonged length of stay (OR 1.67) and 90-day readmission (OR 1.57).

Dr. Pawlik said he was surprised by several of the findings, including that 1 in 15 Medicare beneficiaries had a BHD diagnosis, “with male sex and minority racial status, as well as higher social vulnerability, being associated with a higher prevalence of BHD.”

Also, the independent association of having a BHD with 30%-50% higher odds of a complication, prolonged length of stay, and 90-day readmission was higher than Dr. Pawlik had anticipated.
 

Why Do Patients With BHDs Have Fewer Surgeries and Worse Outcomes?

The reasons for this association were likely multifactorial and may reflect the greater burden of medical comorbidity and chronic illness in many patients with BHDs because of maladaptive lifestyles or poor nutrition status, Dr. Pawlik said.

“Patients with BHDs also likely face barriers to accessing care, which was noted particularly among patients with BHDs who lived in socially vulnerable areas,” he said. BHD patients also were more likely to be treated at low-volume rather than high-volume hospitals, “which undoubtedly contributed in part to worse outcomes in this cohort of patients,” he added.
 

What Can Oncologists Do to Help?

The take-home message for clinicians is that BHDs are linked to worse surgical outcomes and higher health care costs in cancer patients, Dr. Pawlik said in an interview.

“Enhanced accessibility to behavioral healthcare, as well as comprehensive policy reform related to mental health services are needed to improve care of patients with BHDs,” he said. “For example, implementing psychiatry compensation programs may encourage practice in vulnerable areas,” he said.

Other strategies include a following a collaborative care model involving mental health professionals working in tandem with primary care and mid-level practitioners and increasing use and establishment of telehealth systems to improve patient access to BHD services, he said.
 

What Are the Limitations?

The study by Dr. Pawlik and colleagues was limited by several factors, including the lack of data on younger patients and the full range of BHDs, as well as underreporting of BHDs and the high copays for mental health care, the researchers noted. However, the results suggest that concomitant BHDs are associated with worse cancer outcomes and higher in-hospital costs, and illustrate the need to screen for and target these conditions in cancer patients, the researchers concluded.

What Are the Next Steps for Research?

The current study involved Medicare beneficiaries aged 65 years or older, and more research is needed to investigate the impact of BHDs among younger cancer patients in whom the prevalence may be higher and the impact of BHDs may be different, Dr. Pawlik said in an interview. In addition, the analysis of BHDs as a composite of substance abuse, eating disorders, and sleep disorders (because the numbers were too small to break out data for each disorder, separately) prevented investigation of potential differences and unique challenges faced by distinct subpopulations of BHD patients, he said.

“Future studies should examine the individual impact of substance abuse, eating disorders, and sleep disorders on access to surgery, as well as the potential different impact that each one of these different BHDs may have on postoperative outcomes,” Dr. Pawlik suggested.

The study was supported by The Ohio State University College of Medicine Roessler Summer Research Scholarship. The researchers had no financial conflicts to disclose.

Cancer patients with behavioral health disorders are significantly less likely to undergo surgical resections, and more likely to experience poor outcomes when they do have surgery, based on data from a new study of nearly 700,000 individuals.

The reason for this association remains unclear, and highlights the need to address existing behavioral health disorders (BHDs), which can be exacerbated after a patient is diagnosed with cancer, wrote Timothy M. Pawlik, MD, of The Ohio State University, Columbus, and colleagues. A cancer diagnosis can cause not only physical stress, but mental, emotional, social, and economic stress that can prompt a new BHD, cause relapse of a previous BHD, or exacerbate a current BHD, the researchers noted.
 

What is Known About BHDs and Cancer?

Although previous studies have shown a possible association between BHDs and increased cancer risk, as well as reduced compliance with care, the effect of BHDs on outcomes in cancer patients undergoing surgical resection has not been examined, wrote Dr. Pawlik and colleagues.

Previous research has focused on the impact of having a preexisting serious mental illness (SMI) such as schizophrenia and bipolar disorder on cancer care.

A 2023 literature review of 27 studies published in the Journal of Medical Imaging and Radiation Sciences showed that patients with preexisting severe mental illness (such as schizophrenia or bipolar disorder) had greater cancer-related mortality. In that study, the researchers also found that patients with severe mental illness were more likely to have metastatic disease at diagnosis, but less likely to receive optimal treatments, than individuals without SMIs.

Many studies also have focused on patients developing mental health problems (including BHDs) after a cancer diagnosis, but the current study is the first known to examine outcomes in those with BHDs before cancer. 
 

Why Was It Important to Conduct This Study?

“BHDs are a diverse set of mental illnesses that affect an individual’s psychosocial wellbeing, potentially resulting in maladaptive behaviors,” Dr. Pawlik said in an interview. BHDs, which include substance abuse, eating disorders, and sleep disorders, are less common than anxiety/depression, but have an estimated prevalence of 1.3%-3.1% among adults in the United States, he said.

What Does the New Study Add?

In the new review by Dr. Pawlik and colleagues, published in the Journal of the American College of Surgeons (Katayama ES. J Am Coll Surg. 2024 Feb 29. doi: 2024. 10.1097/XCS.0000000000000954), BHDs were defined as substance abuse, eating disorders, or sleep disorders, which had not been the focus of previous studies. The researchers reviewed data from 694,836 adult patients with lung, esophageal, gastric, liver, pancreatic, or colorectal cancer between 2018-2021 using the Medicare Standard Analytic files. A total of 46,719 patients (6.7%) had at least one BHD.

Overall, patients with a BHD were significantly less likely than those without a BHD to undergo surgical resection (20.3% vs. 23.4%). Patients with a BHD also had significantly worse long-term postoperative survival than those without BHDs (median 37.1 months vs. 46.6 months) and significantly higher in-hospital costs ($17,432 vs. 16,159, P less than .001 for all).

Among patients who underwent cancer surgery, the odds of any complication were significantly higher for those with a BHD compared to those with no BHD (odds ratio 1.32), as were the odds of a prolonged length of stay (OR 1.67) and 90-day readmission (OR 1.57).

Dr. Pawlik said he was surprised by several of the findings, including that 1 in 15 Medicare beneficiaries had a BHD diagnosis, “with male sex and minority racial status, as well as higher social vulnerability, being associated with a higher prevalence of BHD.”

Also, the independent association of having a BHD with 30%-50% higher odds of a complication, prolonged length of stay, and 90-day readmission was higher than Dr. Pawlik had anticipated.
 

Why Do Patients With BHDs Have Fewer Surgeries and Worse Outcomes?

The reasons for this association were likely multifactorial and may reflect the greater burden of medical comorbidity and chronic illness in many patients with BHDs because of maladaptive lifestyles or poor nutrition status, Dr. Pawlik said.

“Patients with BHDs also likely face barriers to accessing care, which was noted particularly among patients with BHDs who lived in socially vulnerable areas,” he said. BHD patients also were more likely to be treated at low-volume rather than high-volume hospitals, “which undoubtedly contributed in part to worse outcomes in this cohort of patients,” he added.
 

What Can Oncologists Do to Help?

The take-home message for clinicians is that BHDs are linked to worse surgical outcomes and higher health care costs in cancer patients, Dr. Pawlik said in an interview.

“Enhanced accessibility to behavioral healthcare, as well as comprehensive policy reform related to mental health services are needed to improve care of patients with BHDs,” he said. “For example, implementing psychiatry compensation programs may encourage practice in vulnerable areas,” he said.

Other strategies include a following a collaborative care model involving mental health professionals working in tandem with primary care and mid-level practitioners and increasing use and establishment of telehealth systems to improve patient access to BHD services, he said.
 

What Are the Limitations?

The study by Dr. Pawlik and colleagues was limited by several factors, including the lack of data on younger patients and the full range of BHDs, as well as underreporting of BHDs and the high copays for mental health care, the researchers noted. However, the results suggest that concomitant BHDs are associated with worse cancer outcomes and higher in-hospital costs, and illustrate the need to screen for and target these conditions in cancer patients, the researchers concluded.

What Are the Next Steps for Research?

The current study involved Medicare beneficiaries aged 65 years or older, and more research is needed to investigate the impact of BHDs among younger cancer patients in whom the prevalence may be higher and the impact of BHDs may be different, Dr. Pawlik said in an interview. In addition, the analysis of BHDs as a composite of substance abuse, eating disorders, and sleep disorders (because the numbers were too small to break out data for each disorder, separately) prevented investigation of potential differences and unique challenges faced by distinct subpopulations of BHD patients, he said.

“Future studies should examine the individual impact of substance abuse, eating disorders, and sleep disorders on access to surgery, as well as the potential different impact that each one of these different BHDs may have on postoperative outcomes,” Dr. Pawlik suggested.

The study was supported by The Ohio State University College of Medicine Roessler Summer Research Scholarship. The researchers had no financial conflicts to disclose.

Cancer patients with behavioral health disorders are significantly less likely to undergo surgical resections, and more likely to experience poor outcomes when they do have surgery, based on data from a new study of nearly 700,000 individuals.

The reason for this association remains unclear, and highlights the need to address existing behavioral health disorders (BHDs), which can be exacerbated after a patient is diagnosed with cancer, wrote Timothy M. Pawlik, MD, of The Ohio State University, Columbus, and colleagues. A cancer diagnosis can cause not only physical stress, but mental, emotional, social, and economic stress that can prompt a new BHD, cause relapse of a previous BHD, or exacerbate a current BHD, the researchers noted.
 

What is Known About BHDs and Cancer?

Although previous studies have shown a possible association between BHDs and increased cancer risk, as well as reduced compliance with care, the effect of BHDs on outcomes in cancer patients undergoing surgical resection has not been examined, wrote Dr. Pawlik and colleagues.

Previous research has focused on the impact of having a preexisting serious mental illness (SMI) such as schizophrenia and bipolar disorder on cancer care.

A 2023 literature review of 27 studies published in the Journal of Medical Imaging and Radiation Sciences showed that patients with preexisting severe mental illness (such as schizophrenia or bipolar disorder) had greater cancer-related mortality. In that study, the researchers also found that patients with severe mental illness were more likely to have metastatic disease at diagnosis, but less likely to receive optimal treatments, than individuals without SMIs.

Many studies also have focused on patients developing mental health problems (including BHDs) after a cancer diagnosis, but the current study is the first known to examine outcomes in those with BHDs before cancer. 
 

Why Was It Important to Conduct This Study?

“BHDs are a diverse set of mental illnesses that affect an individual’s psychosocial wellbeing, potentially resulting in maladaptive behaviors,” Dr. Pawlik said in an interview. BHDs, which include substance abuse, eating disorders, and sleep disorders, are less common than anxiety/depression, but have an estimated prevalence of 1.3%-3.1% among adults in the United States, he said.

What Does the New Study Add?

In the new review by Dr. Pawlik and colleagues, published in the Journal of the American College of Surgeons (Katayama ES. J Am Coll Surg. 2024 Feb 29. doi: 2024. 10.1097/XCS.0000000000000954), BHDs were defined as substance abuse, eating disorders, or sleep disorders, which had not been the focus of previous studies. The researchers reviewed data from 694,836 adult patients with lung, esophageal, gastric, liver, pancreatic, or colorectal cancer between 2018-2021 using the Medicare Standard Analytic files. A total of 46,719 patients (6.7%) had at least one BHD.

Overall, patients with a BHD were significantly less likely than those without a BHD to undergo surgical resection (20.3% vs. 23.4%). Patients with a BHD also had significantly worse long-term postoperative survival than those without BHDs (median 37.1 months vs. 46.6 months) and significantly higher in-hospital costs ($17,432 vs. 16,159, P less than .001 for all).

Among patients who underwent cancer surgery, the odds of any complication were significantly higher for those with a BHD compared to those with no BHD (odds ratio 1.32), as were the odds of a prolonged length of stay (OR 1.67) and 90-day readmission (OR 1.57).

Dr. Pawlik said he was surprised by several of the findings, including that 1 in 15 Medicare beneficiaries had a BHD diagnosis, “with male sex and minority racial status, as well as higher social vulnerability, being associated with a higher prevalence of BHD.”

Also, the independent association of having a BHD with 30%-50% higher odds of a complication, prolonged length of stay, and 90-day readmission was higher than Dr. Pawlik had anticipated.
 

Why Do Patients With BHDs Have Fewer Surgeries and Worse Outcomes?

The reasons for this association were likely multifactorial and may reflect the greater burden of medical comorbidity and chronic illness in many patients with BHDs because of maladaptive lifestyles or poor nutrition status, Dr. Pawlik said.

“Patients with BHDs also likely face barriers to accessing care, which was noted particularly among patients with BHDs who lived in socially vulnerable areas,” he said. BHD patients also were more likely to be treated at low-volume rather than high-volume hospitals, “which undoubtedly contributed in part to worse outcomes in this cohort of patients,” he added.
 

What Can Oncologists Do to Help?

The take-home message for clinicians is that BHDs are linked to worse surgical outcomes and higher health care costs in cancer patients, Dr. Pawlik said in an interview.

“Enhanced accessibility to behavioral healthcare, as well as comprehensive policy reform related to mental health services are needed to improve care of patients with BHDs,” he said. “For example, implementing psychiatry compensation programs may encourage practice in vulnerable areas,” he said.

Other strategies include a following a collaborative care model involving mental health professionals working in tandem with primary care and mid-level practitioners and increasing use and establishment of telehealth systems to improve patient access to BHD services, he said.
 

What Are the Limitations?

The study by Dr. Pawlik and colleagues was limited by several factors, including the lack of data on younger patients and the full range of BHDs, as well as underreporting of BHDs and the high copays for mental health care, the researchers noted. However, the results suggest that concomitant BHDs are associated with worse cancer outcomes and higher in-hospital costs, and illustrate the need to screen for and target these conditions in cancer patients, the researchers concluded.

What Are the Next Steps for Research?

The current study involved Medicare beneficiaries aged 65 years or older, and more research is needed to investigate the impact of BHDs among younger cancer patients in whom the prevalence may be higher and the impact of BHDs may be different, Dr. Pawlik said in an interview. In addition, the analysis of BHDs as a composite of substance abuse, eating disorders, and sleep disorders (because the numbers were too small to break out data for each disorder, separately) prevented investigation of potential differences and unique challenges faced by distinct subpopulations of BHD patients, he said.

“Future studies should examine the individual impact of substance abuse, eating disorders, and sleep disorders on access to surgery, as well as the potential different impact that each one of these different BHDs may have on postoperative outcomes,” Dr. Pawlik suggested.

The study was supported by The Ohio State University College of Medicine Roessler Summer Research Scholarship. The researchers had no financial conflicts to disclose.

TOPLINE:

Scents that trigger specific, vivid autobiographical memories (AMs) could improve deficits in memory recall in patients with major depressive disorder (MDD), new research suggests. Investigators found that odor cues may be a stronger tool than word cues for improving memory, which could help reduce MDD symptoms.

METHODOLOGY:

• Participants included 32 individuals aged 18-55 years (mean age, 30 years; 26 females) with a diagnosis of MDD recruited from the community.
• Those with psychosis, bipolar I or II, neurological disorders, or drug or alcohol abuse were excluded.
• Participants were presented with a series of 12 words and 12 odors, such as cough syrup, tobacco ash, and Vicks VapoRub, and asked to recall a specific memory in response to each cue.
• AMs were rated in terms of vividness, frequency, and whether they were associated with positive or negative emotions.

TAKEAWAY:

• Although participants only guessed correct stimulus odors 30% of the time, they recalled more specific memories from odor cues than from word cues (68% vs 52%; P < .001).
• Odor-cued recall was more arousing and vivid (P < .001) than recall responses generated by word cues.
• Compared with the population mean for responses to word cues in healthy controls, study participants recalled fewer specific memories in response to words (P < .001), but the percentage of specific memories recalled in response to odor cues did not differ from the healthy control population mean.
• Investigators hoped to further their research by investigating the mechanisms underlying odor-cued AMs, particularly to test if the amygdala and hippocampus are activated during recall.

IN PRACTICE:

“This study suggests the potential for increasing autobiographical memory specificity in individuals with MDD, with the future goal of reducing depression symptoms for this population and informing a better understanding of the neural mechanisms influencing odor-based AM recall,” the authors wrote. “We hope this initial study spurs larger studies in more diverse samples that include healthy control participants to further investigate and explain these associations.”

SOURCE:

Kymberly D. Young, PhD, of the University of Pittsburgh, Pennsylvania, led the study, which was published online on February 13, 2024, in JAMA Network Open. 

LIMITATIONS:

Study limitations included the lack of a healthy control group and the small sample size. 

DISCLOSURES:

The study was funded internally by the University of Pittsburgh School of Medicine, Pennsylvania. No disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Scents that trigger specific, vivid autobiographical memories (AMs) could improve deficits in memory recall in patients with major depressive disorder (MDD), new research suggests. Investigators found that odor cues may be a stronger tool than word cues for improving memory, which could help reduce MDD symptoms.

METHODOLOGY:

• Participants included 32 individuals aged 18-55 years (mean age, 30 years; 26 females) with a diagnosis of MDD recruited from the community.
• Those with psychosis, bipolar I or II, neurological disorders, or drug or alcohol abuse were excluded.
• Participants were presented with a series of 12 words and 12 odors, such as cough syrup, tobacco ash, and Vicks VapoRub, and asked to recall a specific memory in response to each cue.
• AMs were rated in terms of vividness, frequency, and whether they were associated with positive or negative emotions.

TAKEAWAY:

• Although participants only guessed correct stimulus odors 30% of the time, they recalled more specific memories from odor cues than from word cues (68% vs 52%; P < .001).
• Odor-cued recall was more arousing and vivid (P < .001) than recall responses generated by word cues.
• Compared with the population mean for responses to word cues in healthy controls, study participants recalled fewer specific memories in response to words (P < .001), but the percentage of specific memories recalled in response to odor cues did not differ from the healthy control population mean.
• Investigators hoped to further their research by investigating the mechanisms underlying odor-cued AMs, particularly to test if the amygdala and hippocampus are activated during recall.

IN PRACTICE:

“This study suggests the potential for increasing autobiographical memory specificity in individuals with MDD, with the future goal of reducing depression symptoms for this population and informing a better understanding of the neural mechanisms influencing odor-based AM recall,” the authors wrote. “We hope this initial study spurs larger studies in more diverse samples that include healthy control participants to further investigate and explain these associations.”

SOURCE:

Kymberly D. Young, PhD, of the University of Pittsburgh, Pennsylvania, led the study, which was published online on February 13, 2024, in JAMA Network Open. 

LIMITATIONS:

Study limitations included the lack of a healthy control group and the small sample size. 

DISCLOSURES:

The study was funded internally by the University of Pittsburgh School of Medicine, Pennsylvania. No disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Scents that trigger specific, vivid autobiographical memories (AMs) could improve deficits in memory recall in patients with major depressive disorder (MDD), new research suggests. Investigators found that odor cues may be a stronger tool than word cues for improving memory, which could help reduce MDD symptoms.

METHODOLOGY:

• Participants included 32 individuals aged 18-55 years (mean age, 30 years; 26 females) with a diagnosis of MDD recruited from the community.
• Those with psychosis, bipolar I or II, neurological disorders, or drug or alcohol abuse were excluded.
• Participants were presented with a series of 12 words and 12 odors, such as cough syrup, tobacco ash, and Vicks VapoRub, and asked to recall a specific memory in response to each cue.
• AMs were rated in terms of vividness, frequency, and whether they were associated with positive or negative emotions.

TAKEAWAY:

• Although participants only guessed correct stimulus odors 30% of the time, they recalled more specific memories from odor cues than from word cues (68% vs 52%; P < .001).
• Odor-cued recall was more arousing and vivid (P < .001) than recall responses generated by word cues.
• Compared with the population mean for responses to word cues in healthy controls, study participants recalled fewer specific memories in response to words (P < .001), but the percentage of specific memories recalled in response to odor cues did not differ from the healthy control population mean.
• Investigators hoped to further their research by investigating the mechanisms underlying odor-cued AMs, particularly to test if the amygdala and hippocampus are activated during recall.

IN PRACTICE:

“This study suggests the potential for increasing autobiographical memory specificity in individuals with MDD, with the future goal of reducing depression symptoms for this population and informing a better understanding of the neural mechanisms influencing odor-based AM recall,” the authors wrote. “We hope this initial study spurs larger studies in more diverse samples that include healthy control participants to further investigate and explain these associations.”

SOURCE:

Kymberly D. Young, PhD, of the University of Pittsburgh, Pennsylvania, led the study, which was published online on February 13, 2024, in JAMA Network Open. 

LIMITATIONS:

Study limitations included the lack of a healthy control group and the small sample size. 

DISCLOSURES:

The study was funded internally by the University of Pittsburgh School of Medicine, Pennsylvania. No disclosures were reported.

A version of this article appeared on Medscape.com.

In my previous article, “Mental Health Characteristics of Refugee Children,” we learned that in recent decades, refugeeism has become a growing problem that disproportionately affects children. Refugee children and their families experience a variety of traumas, often sustained across years and even decades, because of armed conflict, persecution, social upheavals, or environmental disasters. Refugees are at greater risks for PTSD and affective and psychotic disorders presumably due to increased traumatic life events before, during, and after migration. I used my own experience as a child refugee from Vietnam to elucidate the stressors evident in various phases of forced displacement.¹

Risk Factors and Protective Factors

To a certain extent, the experiences of refugees are universal. All refugees experience some sort of humanitarian crisis that forces an emergent escape from their home across international borders to a new resettlement area. It is important to note that internally displaced people do not meet the United Nations’ (UN) official designation of refugee status; however, some agencies use a broader definition where they are designated as such.^2,3 We will refer to those not meeting the UN criteria as displaced people, while refugees are those that do meet the UN criteria. Dr. Mina Fazel’s 2012 systematic review in The Lancet of mental health risk factors and protective factors for displaced and refugee children is the most comprehensive of its kind.⁴ It will be summarized in this section with some relevant personal reflection.

In terms of risk factors, external displacement likely results in additional stress and trauma, presumably from the lack of assess to one’s culture and the host country’s language. Understandably, this makes rebuilding of one’s life more difficult. Several studies show that displaced/refugee children experience more difficulty with psychosocial adaptation than non-displaced children. Violence, directly experienced or indirectly feared, both to the child and their parents, was the strongest predictor of mental health problems and withdrawn behavior. Children who were separated from their parents clearly fared worst in their mental health than those who did not, which is not surprising given the nature of their dependence on caregivers for protection and guidance. During resettlement, experienced or perceived discrimination from the host country was also a risk factor, as well as instability in housing and a drawn-out resettlement process. Female sex was a risk factor mainly for emotional problems. Poor financial support post-migration is associated with depression, but it is unclear whether pre-migration financial status was protective. From my own experience, it is likely not, given that once one becomes a refugee one does not have access to one’s wealth, except that which could be hidden on one’s body. Another risk factor was also if one’s parent had psychiatric problems or was single. Due to the migration, my mother was separated permanently from her husband, which caused her extraordinary isolation and loneliness, something that was palpably felt by myself as I grew up.

In terms of protective factors, family cohesion and cultural continuity appear critical. For myself, not only would I not have survived without my mother and aunt, but they constantly protected me from the harsh realities. My mother would distract me with seemingly trivial goals once we got to America, like finally tasting a hamburger, or talking about school and being reunited with my uncle. This is in line with another finding — that children have better mental health outcomes when their parents do not talk about their hardships. Once my family was resettled with my uncle and his family, they played a critical role in smoothing our transition, not only by providing us with housing, but also cultural knowledge. Cultural havens can restore some of the social position and way of life that refugees lose when they are able to reconnect with a society that recognizes their previous achievements and status. Finally, religion also seemed to be a protective factor.
 

Mental Health Interventions

In 2018, Dr. Fazel identified mental health interventions for refugee children in a narrative review.⁵ She acknowledged that these conclusions are limited by the paucity of preventive mental health research in children in general, as well as the mobile nature and complex cultural differences of refugee children. This is exacerbated by the small evidence base. Given that, she makes these recommendations for varying levels of interventions: individual, group, family, living circumstances, social interactions, and school.

On an individual level, effective interventions developed to address PTSD include narrative exposure therapy, trauma-focused cognitive behavior therapy, and eye-movement and desensitization therapy. Group-based interventions for trauma, for example school-based PTSD intervention programs in conflicted areas, have either been shown to not be effective, or only effective for reducing depression. The mental health of unaccompanied children separated from family fare better when placed in foster care, rather than other types of social support. This is further enhanced if the foster family is the same ethnicity.

On a family level, improvements in parenting style and parental mental health, family engagement with local culture and structures, and family-based mental health interventions all positively impact refugee children. Not surprisingly, refugee parents have a greater prevalence of mental health conditions. Several studies on refugeeism point out a greater occurrence of intimate partner violence (that negatively affects children) as well has harsher discipline and maltreatment of refugee children. Thus, mental health treatment for parents also directly improves the well-being of their children. Teaching parenting skills to mitigate the violent effect of their PTSD symptoms, as well as parenting classes that teach gentler styles, have been shown to reduce harsh parenting and mitigate aggressive behaviors in these children. These improvements are enhanced when these classes are taught by other refugees themselves.

School is key for helping refugee children since it is a site where they can access language proficiency, successful acculturation, and medical and mental health services. Several studies have identified the positive effects of better parental engagement with school, resulting in improved academic performance and reduced levels of depressive and PTSD symptoms. A review of learning problems in refugee children identified several factors for success. These include high academic and life ambition, parental involvement in education, accurate educational assessment and grade placement, teacher understanding of linguistic and cultural heritage, culturally appropriate school transition, supportive peer relationships, and successful acculturation. School certainly was key for my acculturation and language proficiency. When I arrived at 6 years old I was selectively mute for my year in first grade, namely because I did not know how to speak English and because I did not share the culture. However, my teacher correctly identified my deficiency and chose to place me in kindergarten, which allowed me the time to gain English proficiency. Though I was always the oldest one in class, that remediation was key in allowing eventual success in school leading up to my admission to UC Berkeley.
 

Summary

In recent decades, refugeeism has become a growing problem that disproportionately affects children leading to traumas sustained across years and even decades, and greater risks for PTSD, as well as affective and psychotic disorders. Risk factors include the experience of violence, the separation from family, female gender, discrimination in the host country, unstable housing, and a drawn-out resettlement process. Protective factors consist of family cohesion, cultural continuity, support at schools, being protected from the truth of their harsh reality, stable housing, language acquisition, and quick resettlement. From these factors, effective mental interventions have been found to be the promotion of these protective factors as well as support for parental mental health and parenting skills, better parental engagement at school, and schools that correctly identify and address these children’s educational needs.

Dr. Nguyen is a second-year resident at UCSF Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously.*

References

1. Nguyen D. Mental Health Characteristics of Refugee Children. Pediatric News. 2023 Nov. 14. https://www.mdedge.com/pediatrics/article/266518/mental-health/mental-health-characteristics-refugee-children.

2. Office of the United Nations High Commissioner for Refugees. The Refugee Concept Under International Law. Global Compact for Safe, Orderly and Regular Migration. 2018 March 8. https://www.unhcr.org/sites/default/files/legacy-pdf/5aa290937.pdf.

3. Winer JP. Mental Health Practice with Immigrant and Refugee Youth [Power Point Slides]. Michigan Medicine. 2021 June 24. https://www.youtube.com/watch?v=ICkg4132SQY

4. Fazel M et al. Mental Health of Displaced and Refugee Children Resettled in High-Income Countries: Risk and Protective Factors. Lancet. 2012 Jan 21;379(9812):266-282. doi: 10.1016/S0140-6736(11)60051-2.

5. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5.

*Correction, 2/27: An earlier version of this article misstated Dr. Nguyen's affiliation.

In my previous article, “Mental Health Characteristics of Refugee Children,” we learned that in recent decades, refugeeism has become a growing problem that disproportionately affects children. Refugee children and their families experience a variety of traumas, often sustained across years and even decades, because of armed conflict, persecution, social upheavals, or environmental disasters. Refugees are at greater risks for PTSD and affective and psychotic disorders presumably due to increased traumatic life events before, during, and after migration. I used my own experience as a child refugee from Vietnam to elucidate the stressors evident in various phases of forced displacement.¹

Risk Factors and Protective Factors

To a certain extent, the experiences of refugees are universal. All refugees experience some sort of humanitarian crisis that forces an emergent escape from their home across international borders to a new resettlement area. It is important to note that internally displaced people do not meet the United Nations’ (UN) official designation of refugee status; however, some agencies use a broader definition where they are designated as such.^2,3 We will refer to those not meeting the UN criteria as displaced people, while refugees are those that do meet the UN criteria. Dr. Mina Fazel’s 2012 systematic review in The Lancet of mental health risk factors and protective factors for displaced and refugee children is the most comprehensive of its kind.⁴ It will be summarized in this section with some relevant personal reflection.

In terms of risk factors, external displacement likely results in additional stress and trauma, presumably from the lack of assess to one’s culture and the host country’s language. Understandably, this makes rebuilding of one’s life more difficult. Several studies show that displaced/refugee children experience more difficulty with psychosocial adaptation than non-displaced children. Violence, directly experienced or indirectly feared, both to the child and their parents, was the strongest predictor of mental health problems and withdrawn behavior. Children who were separated from their parents clearly fared worst in their mental health than those who did not, which is not surprising given the nature of their dependence on caregivers for protection and guidance. During resettlement, experienced or perceived discrimination from the host country was also a risk factor, as well as instability in housing and a drawn-out resettlement process. Female sex was a risk factor mainly for emotional problems. Poor financial support post-migration is associated with depression, but it is unclear whether pre-migration financial status was protective. From my own experience, it is likely not, given that once one becomes a refugee one does not have access to one’s wealth, except that which could be hidden on one’s body. Another risk factor was also if one’s parent had psychiatric problems or was single. Due to the migration, my mother was separated permanently from her husband, which caused her extraordinary isolation and loneliness, something that was palpably felt by myself as I grew up.

In terms of protective factors, family cohesion and cultural continuity appear critical. For myself, not only would I not have survived without my mother and aunt, but they constantly protected me from the harsh realities. My mother would distract me with seemingly trivial goals once we got to America, like finally tasting a hamburger, or talking about school and being reunited with my uncle. This is in line with another finding — that children have better mental health outcomes when their parents do not talk about their hardships. Once my family was resettled with my uncle and his family, they played a critical role in smoothing our transition, not only by providing us with housing, but also cultural knowledge. Cultural havens can restore some of the social position and way of life that refugees lose when they are able to reconnect with a society that recognizes their previous achievements and status. Finally, religion also seemed to be a protective factor.
 

Mental Health Interventions

In 2018, Dr. Fazel identified mental health interventions for refugee children in a narrative review.⁵ She acknowledged that these conclusions are limited by the paucity of preventive mental health research in children in general, as well as the mobile nature and complex cultural differences of refugee children. This is exacerbated by the small evidence base. Given that, she makes these recommendations for varying levels of interventions: individual, group, family, living circumstances, social interactions, and school.

On an individual level, effective interventions developed to address PTSD include narrative exposure therapy, trauma-focused cognitive behavior therapy, and eye-movement and desensitization therapy. Group-based interventions for trauma, for example school-based PTSD intervention programs in conflicted areas, have either been shown to not be effective, or only effective for reducing depression. The mental health of unaccompanied children separated from family fare better when placed in foster care, rather than other types of social support. This is further enhanced if the foster family is the same ethnicity.

On a family level, improvements in parenting style and parental mental health, family engagement with local culture and structures, and family-based mental health interventions all positively impact refugee children. Not surprisingly, refugee parents have a greater prevalence of mental health conditions. Several studies on refugeeism point out a greater occurrence of intimate partner violence (that negatively affects children) as well has harsher discipline and maltreatment of refugee children. Thus, mental health treatment for parents also directly improves the well-being of their children. Teaching parenting skills to mitigate the violent effect of their PTSD symptoms, as well as parenting classes that teach gentler styles, have been shown to reduce harsh parenting and mitigate aggressive behaviors in these children. These improvements are enhanced when these classes are taught by other refugees themselves.

School is key for helping refugee children since it is a site where they can access language proficiency, successful acculturation, and medical and mental health services. Several studies have identified the positive effects of better parental engagement with school, resulting in improved academic performance and reduced levels of depressive and PTSD symptoms. A review of learning problems in refugee children identified several factors for success. These include high academic and life ambition, parental involvement in education, accurate educational assessment and grade placement, teacher understanding of linguistic and cultural heritage, culturally appropriate school transition, supportive peer relationships, and successful acculturation. School certainly was key for my acculturation and language proficiency. When I arrived at 6 years old I was selectively mute for my year in first grade, namely because I did not know how to speak English and because I did not share the culture. However, my teacher correctly identified my deficiency and chose to place me in kindergarten, which allowed me the time to gain English proficiency. Though I was always the oldest one in class, that remediation was key in allowing eventual success in school leading up to my admission to UC Berkeley.
 

Summary

In recent decades, refugeeism has become a growing problem that disproportionately affects children leading to traumas sustained across years and even decades, and greater risks for PTSD, as well as affective and psychotic disorders. Risk factors include the experience of violence, the separation from family, female gender, discrimination in the host country, unstable housing, and a drawn-out resettlement process. Protective factors consist of family cohesion, cultural continuity, support at schools, being protected from the truth of their harsh reality, stable housing, language acquisition, and quick resettlement. From these factors, effective mental interventions have been found to be the promotion of these protective factors as well as support for parental mental health and parenting skills, better parental engagement at school, and schools that correctly identify and address these children’s educational needs.

Dr. Nguyen is a second-year resident at UCSF Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously.*

References

1. Nguyen D. Mental Health Characteristics of Refugee Children. Pediatric News. 2023 Nov. 14. https://www.mdedge.com/pediatrics/article/266518/mental-health/mental-health-characteristics-refugee-children.

2. Office of the United Nations High Commissioner for Refugees. The Refugee Concept Under International Law. Global Compact for Safe, Orderly and Regular Migration. 2018 March 8. https://www.unhcr.org/sites/default/files/legacy-pdf/5aa290937.pdf.

3. Winer JP. Mental Health Practice with Immigrant and Refugee Youth [Power Point Slides]. Michigan Medicine. 2021 June 24. https://www.youtube.com/watch?v=ICkg4132SQY

4. Fazel M et al. Mental Health of Displaced and Refugee Children Resettled in High-Income Countries: Risk and Protective Factors. Lancet. 2012 Jan 21;379(9812):266-282. doi: 10.1016/S0140-6736(11)60051-2.

5. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5.

*Correction, 2/27: An earlier version of this article misstated Dr. Nguyen's affiliation.

In my previous article, “Mental Health Characteristics of Refugee Children,” we learned that in recent decades, refugeeism has become a growing problem that disproportionately affects children. Refugee children and their families experience a variety of traumas, often sustained across years and even decades, because of armed conflict, persecution, social upheavals, or environmental disasters. Refugees are at greater risks for PTSD and affective and psychotic disorders presumably due to increased traumatic life events before, during, and after migration. I used my own experience as a child refugee from Vietnam to elucidate the stressors evident in various phases of forced displacement.¹

Risk Factors and Protective Factors

To a certain extent, the experiences of refugees are universal. All refugees experience some sort of humanitarian crisis that forces an emergent escape from their home across international borders to a new resettlement area. It is important to note that internally displaced people do not meet the United Nations’ (UN) official designation of refugee status; however, some agencies use a broader definition where they are designated as such.^2,3 We will refer to those not meeting the UN criteria as displaced people, while refugees are those that do meet the UN criteria. Dr. Mina Fazel’s 2012 systematic review in The Lancet of mental health risk factors and protective factors for displaced and refugee children is the most comprehensive of its kind.⁴ It will be summarized in this section with some relevant personal reflection.

In terms of risk factors, external displacement likely results in additional stress and trauma, presumably from the lack of assess to one’s culture and the host country’s language. Understandably, this makes rebuilding of one’s life more difficult. Several studies show that displaced/refugee children experience more difficulty with psychosocial adaptation than non-displaced children. Violence, directly experienced or indirectly feared, both to the child and their parents, was the strongest predictor of mental health problems and withdrawn behavior. Children who were separated from their parents clearly fared worst in their mental health than those who did not, which is not surprising given the nature of their dependence on caregivers for protection and guidance. During resettlement, experienced or perceived discrimination from the host country was also a risk factor, as well as instability in housing and a drawn-out resettlement process. Female sex was a risk factor mainly for emotional problems. Poor financial support post-migration is associated with depression, but it is unclear whether pre-migration financial status was protective. From my own experience, it is likely not, given that once one becomes a refugee one does not have access to one’s wealth, except that which could be hidden on one’s body. Another risk factor was also if one’s parent had psychiatric problems or was single. Due to the migration, my mother was separated permanently from her husband, which caused her extraordinary isolation and loneliness, something that was palpably felt by myself as I grew up.

In terms of protective factors, family cohesion and cultural continuity appear critical. For myself, not only would I not have survived without my mother and aunt, but they constantly protected me from the harsh realities. My mother would distract me with seemingly trivial goals once we got to America, like finally tasting a hamburger, or talking about school and being reunited with my uncle. This is in line with another finding — that children have better mental health outcomes when their parents do not talk about their hardships. Once my family was resettled with my uncle and his family, they played a critical role in smoothing our transition, not only by providing us with housing, but also cultural knowledge. Cultural havens can restore some of the social position and way of life that refugees lose when they are able to reconnect with a society that recognizes their previous achievements and status. Finally, religion also seemed to be a protective factor.
 

Mental Health Interventions

In 2018, Dr. Fazel identified mental health interventions for refugee children in a narrative review.⁵ She acknowledged that these conclusions are limited by the paucity of preventive mental health research in children in general, as well as the mobile nature and complex cultural differences of refugee children. This is exacerbated by the small evidence base. Given that, she makes these recommendations for varying levels of interventions: individual, group, family, living circumstances, social interactions, and school.

On an individual level, effective interventions developed to address PTSD include narrative exposure therapy, trauma-focused cognitive behavior therapy, and eye-movement and desensitization therapy. Group-based interventions for trauma, for example school-based PTSD intervention programs in conflicted areas, have either been shown to not be effective, or only effective for reducing depression. The mental health of unaccompanied children separated from family fare better when placed in foster care, rather than other types of social support. This is further enhanced if the foster family is the same ethnicity.

On a family level, improvements in parenting style and parental mental health, family engagement with local culture and structures, and family-based mental health interventions all positively impact refugee children. Not surprisingly, refugee parents have a greater prevalence of mental health conditions. Several studies on refugeeism point out a greater occurrence of intimate partner violence (that negatively affects children) as well has harsher discipline and maltreatment of refugee children. Thus, mental health treatment for parents also directly improves the well-being of their children. Teaching parenting skills to mitigate the violent effect of their PTSD symptoms, as well as parenting classes that teach gentler styles, have been shown to reduce harsh parenting and mitigate aggressive behaviors in these children. These improvements are enhanced when these classes are taught by other refugees themselves.

School is key for helping refugee children since it is a site where they can access language proficiency, successful acculturation, and medical and mental health services. Several studies have identified the positive effects of better parental engagement with school, resulting in improved academic performance and reduced levels of depressive and PTSD symptoms. A review of learning problems in refugee children identified several factors for success. These include high academic and life ambition, parental involvement in education, accurate educational assessment and grade placement, teacher understanding of linguistic and cultural heritage, culturally appropriate school transition, supportive peer relationships, and successful acculturation. School certainly was key for my acculturation and language proficiency. When I arrived at 6 years old I was selectively mute for my year in first grade, namely because I did not know how to speak English and because I did not share the culture. However, my teacher correctly identified my deficiency and chose to place me in kindergarten, which allowed me the time to gain English proficiency. Though I was always the oldest one in class, that remediation was key in allowing eventual success in school leading up to my admission to UC Berkeley.
 

Summary

In recent decades, refugeeism has become a growing problem that disproportionately affects children leading to traumas sustained across years and even decades, and greater risks for PTSD, as well as affective and psychotic disorders. Risk factors include the experience of violence, the separation from family, female gender, discrimination in the host country, unstable housing, and a drawn-out resettlement process. Protective factors consist of family cohesion, cultural continuity, support at schools, being protected from the truth of their harsh reality, stable housing, language acquisition, and quick resettlement. From these factors, effective mental interventions have been found to be the promotion of these protective factors as well as support for parental mental health and parenting skills, better parental engagement at school, and schools that correctly identify and address these children’s educational needs.

Dr. Nguyen is a second-year resident at UCSF Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously.*

References

1. Nguyen D. Mental Health Characteristics of Refugee Children. Pediatric News. 2023 Nov. 14. https://www.mdedge.com/pediatrics/article/266518/mental-health/mental-health-characteristics-refugee-children.

2. Office of the United Nations High Commissioner for Refugees. The Refugee Concept Under International Law. Global Compact for Safe, Orderly and Regular Migration. 2018 March 8. https://www.unhcr.org/sites/default/files/legacy-pdf/5aa290937.pdf.

3. Winer JP. Mental Health Practice with Immigrant and Refugee Youth [Power Point Slides]. Michigan Medicine. 2021 June 24. https://www.youtube.com/watch?v=ICkg4132SQY

4. Fazel M et al. Mental Health of Displaced and Refugee Children Resettled in High-Income Countries: Risk and Protective Factors. Lancet. 2012 Jan 21;379(9812):266-282. doi: 10.1016/S0140-6736(11)60051-2.

5. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5.

*Correction, 2/27: An earlier version of this article misstated Dr. Nguyen's affiliation.

An online program that helps parents apply principles of cognitive-behavioral therapy (CBT) using digital resources and remote support from a therapist is as effective as traditional talk therapies for overcoming child anxiety problems while substantially reducing cost and therapist time, new research showed.

In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.

“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.

“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”

The study was published online in The Lancet Psychiatry
 

Care Gaps for Common Problem

Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.

OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.

The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.

There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.

The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.

A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
 

‘Compelling’ Evidence

The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.

On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).

The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.

In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.

“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.

“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
 

‘Call to Action’

“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.

“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”

“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.

However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.

In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.

Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.

“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”

The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.

A version of this article appeared on Medscape.com.

An online program that helps parents apply principles of cognitive-behavioral therapy (CBT) using digital resources and remote support from a therapist is as effective as traditional talk therapies for overcoming child anxiety problems while substantially reducing cost and therapist time, new research showed.

In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.

“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.

“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”

The study was published online in The Lancet Psychiatry
 

Care Gaps for Common Problem

Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.

OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.

The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.

There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.

The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.

A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
 

‘Compelling’ Evidence

The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.

On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).

The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.

In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.

“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.

“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
 

‘Call to Action’

“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.

“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”

“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.

However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.

In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.

Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.

“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”

The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.

A version of this article appeared on Medscape.com.

An online program that helps parents apply principles of cognitive-behavioral therapy (CBT) using digital resources and remote support from a therapist is as effective as traditional talk therapies for overcoming child anxiety problems while substantially reducing cost and therapist time, new research showed.

In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.

“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.

“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”

The study was published online in The Lancet Psychiatry
 

Care Gaps for Common Problem

Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.

OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.

The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.

There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.

The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.

A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
 

‘Compelling’ Evidence

The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.

On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).

The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.

In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.

“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.

“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
 

‘Call to Action’

“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.

“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”

“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.

However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.

In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.

Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.

“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”

The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.

A version of this article appeared on Medscape.com.

Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.

Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).

Consider the Side Effects

In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.

Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.

Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.

This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.

Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
 

Misuse and abuse

Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.

You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
 

Additional concerns

With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.

Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.

To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.

While we need to educate ourselves and our patients about potential and manifest side effects and risks of stimulants, we need to balance those concerns with their high effectiveness for improving daily functioning of our many patients with ADHD.

Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.

Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).

Consider the Side Effects

In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.

Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.

Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.

This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.

Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
 

Misuse and abuse

Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.

You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
 

Additional concerns

With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.

Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.

To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.

While we need to educate ourselves and our patients about potential and manifest side effects and risks of stimulants, we need to balance those concerns with their high effectiveness for improving daily functioning of our many patients with ADHD.

Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.

Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).

Consider the Side Effects

In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.

Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.

Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.

This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.

Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
 

Misuse and abuse

Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.

You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
 

Additional concerns

With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.

Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.

To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.

While we need to educate ourselves and our patients about potential and manifest side effects and risks of stimulants, we need to balance those concerns with their high effectiveness for improving daily functioning of our many patients with ADHD.

Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

Patients receiving long-acting injectable (LAI) antipsychotics upon hospital discharge were 75% less likely to be readmitted 30 days later compared with those who received an oral antipsychotic, new research showed.

Investigators reported the findings support the use of LAI antipsychotics over oral medication following a hospital stay for schizophrenia or schizoaffective disorder.

“I suspect the lower readmission rate that has been observed with long-acting injections has more to do with people forgetting to take a pill each and every day than with any inherent superiority of the injectable medication,” lead author Daniel Greer, PharmD, BCPP, clinical assistant professor at Rutgers University Ernest Mario School of Pharmacy, Piscataway, New Jersey, said in a news release.

“Other studies on the use of antipsychotic medication have found that roughly three fourths of patients do not take oral medications exactly as directed, and it’s much easier to get a shot every few months than it is to take a pill every day, even though the shot requires a trip to the doctor,” Dr. Greer added.

The study was published online on January 17, 2024, in the Journal of Clinical Psychopharmacology.
 

Fewer Repeat Stays

Investigators compared 30-day readmission rates for all 343 patients with schizophrenia or schizoaffective disorder who were discharged from an inpatient psychiatric unit between August 2019 and June 2022.

A total of 240 patients (70%) were discharged on an oral antipsychotic, most commonly risperidone or olanzapine, and 103 (30%) were sent home on an LAI antipsychotic, most commonly aripiprazole lauroxil or haloperidol decanoate.

Within 30 days of discharge, 22 patients (6.4%) were readmitted for a schizophrenic or schizoaffective exacerbation — two in the LAI antipsychotic group and 20 in the oral antipsychotic group (1.9% vs 8.3%; P = .03).

The LAI antipsychotic group had a higher average daily chlorpromazine equivalent antipsychotic dose than the oral group (477.3 mg vs 278.6 mg; P < .001), which investigators said may indicate a difference in illness severity between the patient groups.

There was no significant between-group difference in the use of anticholinergic medications to treat extrapyramidal symptoms (22% in the LAI group and 31% in the oral group) despite the LAI group receiving greater doses.

That suggests “that both formulations may be equally as likely to cause these adverse effects,” the researchers noted.

Thirty-day readmission rates are important both medically and financially, investigators noted. In schizophrenia, access to medications and nonadherence are “significant problems.” LAI antipsychotic medications may alleviate some of these burdens but come with a high up-front cost.

“Medication access through pharmaceutical company free trial replacement programs may be an option for facilities with restricted formularies or limited medication funding to decrease 30-day readmissions,” investigators wrote.

“The cost of the injections is far lower than the cost of hospital treatments,” Dr. Greer added in the news release. “And each additional visit to the hospital increases the odds that there will be more visits in the future. Every time someone experiences psychosis, they lose gray matter, and they suffer damage that never heals. That’s why it’s so vital to minimize psychotic episodes.”

Chief limitations of the study included its single-center, retrospective chart review design and small sample size. Also, complete patient medication history was not obtained.

The study had no specific funding. The authors declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

Patients receiving long-acting injectable (LAI) antipsychotics upon hospital discharge were 75% less likely to be readmitted 30 days later compared with those who received an oral antipsychotic, new research showed.

Investigators reported the findings support the use of LAI antipsychotics over oral medication following a hospital stay for schizophrenia or schizoaffective disorder.

“I suspect the lower readmission rate that has been observed with long-acting injections has more to do with people forgetting to take a pill each and every day than with any inherent superiority of the injectable medication,” lead author Daniel Greer, PharmD, BCPP, clinical assistant professor at Rutgers University Ernest Mario School of Pharmacy, Piscataway, New Jersey, said in a news release.

“Other studies on the use of antipsychotic medication have found that roughly three fourths of patients do not take oral medications exactly as directed, and it’s much easier to get a shot every few months than it is to take a pill every day, even though the shot requires a trip to the doctor,” Dr. Greer added.

The study was published online on January 17, 2024, in the Journal of Clinical Psychopharmacology.
 

Fewer Repeat Stays

Investigators compared 30-day readmission rates for all 343 patients with schizophrenia or schizoaffective disorder who were discharged from an inpatient psychiatric unit between August 2019 and June 2022.

A total of 240 patients (70%) were discharged on an oral antipsychotic, most commonly risperidone or olanzapine, and 103 (30%) were sent home on an LAI antipsychotic, most commonly aripiprazole lauroxil or haloperidol decanoate.

Within 30 days of discharge, 22 patients (6.4%) were readmitted for a schizophrenic or schizoaffective exacerbation — two in the LAI antipsychotic group and 20 in the oral antipsychotic group (1.9% vs 8.3%; P = .03).

The LAI antipsychotic group had a higher average daily chlorpromazine equivalent antipsychotic dose than the oral group (477.3 mg vs 278.6 mg; P < .001), which investigators said may indicate a difference in illness severity between the patient groups.

There was no significant between-group difference in the use of anticholinergic medications to treat extrapyramidal symptoms (22% in the LAI group and 31% in the oral group) despite the LAI group receiving greater doses.

That suggests “that both formulations may be equally as likely to cause these adverse effects,” the researchers noted.

Thirty-day readmission rates are important both medically and financially, investigators noted. In schizophrenia, access to medications and nonadherence are “significant problems.” LAI antipsychotic medications may alleviate some of these burdens but come with a high up-front cost.

“Medication access through pharmaceutical company free trial replacement programs may be an option for facilities with restricted formularies or limited medication funding to decrease 30-day readmissions,” investigators wrote.

“The cost of the injections is far lower than the cost of hospital treatments,” Dr. Greer added in the news release. “And each additional visit to the hospital increases the odds that there will be more visits in the future. Every time someone experiences psychosis, they lose gray matter, and they suffer damage that never heals. That’s why it’s so vital to minimize psychotic episodes.”

Chief limitations of the study included its single-center, retrospective chart review design and small sample size. Also, complete patient medication history was not obtained.

The study had no specific funding. The authors declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

Patients receiving long-acting injectable (LAI) antipsychotics upon hospital discharge were 75% less likely to be readmitted 30 days later compared with those who received an oral antipsychotic, new research showed.

Investigators reported the findings support the use of LAI antipsychotics over oral medication following a hospital stay for schizophrenia or schizoaffective disorder.

“I suspect the lower readmission rate that has been observed with long-acting injections has more to do with people forgetting to take a pill each and every day than with any inherent superiority of the injectable medication,” lead author Daniel Greer, PharmD, BCPP, clinical assistant professor at Rutgers University Ernest Mario School of Pharmacy, Piscataway, New Jersey, said in a news release.

“Other studies on the use of antipsychotic medication have found that roughly three fourths of patients do not take oral medications exactly as directed, and it’s much easier to get a shot every few months than it is to take a pill every day, even though the shot requires a trip to the doctor,” Dr. Greer added.

The study was published online on January 17, 2024, in the Journal of Clinical Psychopharmacology.
 

Fewer Repeat Stays

Investigators compared 30-day readmission rates for all 343 patients with schizophrenia or schizoaffective disorder who were discharged from an inpatient psychiatric unit between August 2019 and June 2022.

A total of 240 patients (70%) were discharged on an oral antipsychotic, most commonly risperidone or olanzapine, and 103 (30%) were sent home on an LAI antipsychotic, most commonly aripiprazole lauroxil or haloperidol decanoate.

Within 30 days of discharge, 22 patients (6.4%) were readmitted for a schizophrenic or schizoaffective exacerbation — two in the LAI antipsychotic group and 20 in the oral antipsychotic group (1.9% vs 8.3%; P = .03).

The LAI antipsychotic group had a higher average daily chlorpromazine equivalent antipsychotic dose than the oral group (477.3 mg vs 278.6 mg; P < .001), which investigators said may indicate a difference in illness severity between the patient groups.

There was no significant between-group difference in the use of anticholinergic medications to treat extrapyramidal symptoms (22% in the LAI group and 31% in the oral group) despite the LAI group receiving greater doses.

That suggests “that both formulations may be equally as likely to cause these adverse effects,” the researchers noted.

Thirty-day readmission rates are important both medically and financially, investigators noted. In schizophrenia, access to medications and nonadherence are “significant problems.” LAI antipsychotic medications may alleviate some of these burdens but come with a high up-front cost.

“Medication access through pharmaceutical company free trial replacement programs may be an option for facilities with restricted formularies or limited medication funding to decrease 30-day readmissions,” investigators wrote.

“The cost of the injections is far lower than the cost of hospital treatments,” Dr. Greer added in the news release. “And each additional visit to the hospital increases the odds that there will be more visits in the future. Every time someone experiences psychosis, they lose gray matter, and they suffer damage that never heals. That’s why it’s so vital to minimize psychotic episodes.”

Chief limitations of the study included its single-center, retrospective chart review design and small sample size. Also, complete patient medication history was not obtained.

The study had no specific funding. The authors declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.