Boosting Vitamin E Intake May Protect Against MASLD

Article Type
Changed
Fri, 02/23/2024 - 11:34

 

TOPLINE:

Augmenting an intake of vitamin E, via both diet and supplements, may help prevent metabolic dysfunction–associated steatotic liver disease (MASLD), particularly in adults without hyperlipidemia, new data showed.

METHODOLOGY:

  • MASLD (formerly known as nonalcoholic fatty liver disease) is a common chronic liver disease, and its severe form — metabolic dysfunction–associated steatohepatitis (formerly nonalcoholic steatohepatitis) — is associated with oxidative stress. As an antioxidant, vitamin E may protect against MASLD.
  • Researchers analyzed data for 6122 adults from the National Health and Nutrition Examination Survey from 2017 to 2020.
  • Information on dietary, supplementary, and total vitamin E intake was obtained from two 24-hour dietary recall interviews.
  • The extent of hepatic steatosis was measured by liver ultrasound transient elastography, with MASLD defined as a controlled attenuated parameter threshold of ≥ 288 dB/m.

TAKEAWAY:

  • After adjustment for sociodemographic characteristics, adults with MASLD had lower dietary and total intake of vitamin E, and dietary and total vitamin E intake was inversely associated with MASLD outcome.
  • Adults in the top quartile of dietary vitamin E intake had approximately 40% lower odds of MASLD (odds ratio [OR], 0.60; P = .0091).
  • Vitamin E supplement use was associated with 34% reduced odds of MASLD (OR, 0.66; P = .0249), whereas adults in the top quartile of total vitamin E intake had a 33% lower likelihood of MASLD (OR, 0.67; P = .0538).
  • The findings were robust to sensitivity analysis, and the effects were stronger in those without hyperlipidemia.

IN PRACTICE:

“Increasing dietary sources of vitamin E is beneficial for preventing [MASLD], particularly in individuals without hyperlipidemia,” the researchers concluded.

SOURCE:

The study, with first author Xiangjun Qi, Guangzhou University of Chinese Medicine, Guangzhou, China, was published online in Scientific Reports.

LIMITATIONS:

Causality cannot be determined due to the cross-sectional study design. Dietary recalls may not fully reflect the dietary status of participants, which may influence assessment of exposure to some extent.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

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TOPLINE:

Augmenting an intake of vitamin E, via both diet and supplements, may help prevent metabolic dysfunction–associated steatotic liver disease (MASLD), particularly in adults without hyperlipidemia, new data showed.

METHODOLOGY:

  • MASLD (formerly known as nonalcoholic fatty liver disease) is a common chronic liver disease, and its severe form — metabolic dysfunction–associated steatohepatitis (formerly nonalcoholic steatohepatitis) — is associated with oxidative stress. As an antioxidant, vitamin E may protect against MASLD.
  • Researchers analyzed data for 6122 adults from the National Health and Nutrition Examination Survey from 2017 to 2020.
  • Information on dietary, supplementary, and total vitamin E intake was obtained from two 24-hour dietary recall interviews.
  • The extent of hepatic steatosis was measured by liver ultrasound transient elastography, with MASLD defined as a controlled attenuated parameter threshold of ≥ 288 dB/m.

TAKEAWAY:

  • After adjustment for sociodemographic characteristics, adults with MASLD had lower dietary and total intake of vitamin E, and dietary and total vitamin E intake was inversely associated with MASLD outcome.
  • Adults in the top quartile of dietary vitamin E intake had approximately 40% lower odds of MASLD (odds ratio [OR], 0.60; P = .0091).
  • Vitamin E supplement use was associated with 34% reduced odds of MASLD (OR, 0.66; P = .0249), whereas adults in the top quartile of total vitamin E intake had a 33% lower likelihood of MASLD (OR, 0.67; P = .0538).
  • The findings were robust to sensitivity analysis, and the effects were stronger in those without hyperlipidemia.

IN PRACTICE:

“Increasing dietary sources of vitamin E is beneficial for preventing [MASLD], particularly in individuals without hyperlipidemia,” the researchers concluded.

SOURCE:

The study, with first author Xiangjun Qi, Guangzhou University of Chinese Medicine, Guangzhou, China, was published online in Scientific Reports.

LIMITATIONS:

Causality cannot be determined due to the cross-sectional study design. Dietary recalls may not fully reflect the dietary status of participants, which may influence assessment of exposure to some extent.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

 

TOPLINE:

Augmenting an intake of vitamin E, via both diet and supplements, may help prevent metabolic dysfunction–associated steatotic liver disease (MASLD), particularly in adults without hyperlipidemia, new data showed.

METHODOLOGY:

  • MASLD (formerly known as nonalcoholic fatty liver disease) is a common chronic liver disease, and its severe form — metabolic dysfunction–associated steatohepatitis (formerly nonalcoholic steatohepatitis) — is associated with oxidative stress. As an antioxidant, vitamin E may protect against MASLD.
  • Researchers analyzed data for 6122 adults from the National Health and Nutrition Examination Survey from 2017 to 2020.
  • Information on dietary, supplementary, and total vitamin E intake was obtained from two 24-hour dietary recall interviews.
  • The extent of hepatic steatosis was measured by liver ultrasound transient elastography, with MASLD defined as a controlled attenuated parameter threshold of ≥ 288 dB/m.

TAKEAWAY:

  • After adjustment for sociodemographic characteristics, adults with MASLD had lower dietary and total intake of vitamin E, and dietary and total vitamin E intake was inversely associated with MASLD outcome.
  • Adults in the top quartile of dietary vitamin E intake had approximately 40% lower odds of MASLD (odds ratio [OR], 0.60; P = .0091).
  • Vitamin E supplement use was associated with 34% reduced odds of MASLD (OR, 0.66; P = .0249), whereas adults in the top quartile of total vitamin E intake had a 33% lower likelihood of MASLD (OR, 0.67; P = .0538).
  • The findings were robust to sensitivity analysis, and the effects were stronger in those without hyperlipidemia.

IN PRACTICE:

“Increasing dietary sources of vitamin E is beneficial for preventing [MASLD], particularly in individuals without hyperlipidemia,” the researchers concluded.

SOURCE:

The study, with first author Xiangjun Qi, Guangzhou University of Chinese Medicine, Guangzhou, China, was published online in Scientific Reports.

LIMITATIONS:

Causality cannot be determined due to the cross-sectional study design. Dietary recalls may not fully reflect the dietary status of participants, which may influence assessment of exposure to some extent.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

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Health Gains of Exercise Greater in Women?

Article Type
Changed
Thu, 02/22/2024 - 14:07

Women may gain greater health benefits from regular physical activity at equivalent or lower doses of activity, compared with men, according to data from more than 400,000 US adults. 

Over two decades, with any regular physical activity, all-cause mortality risk was reduced by 24% in women vs 15% in men, and cardiovascular mortality risk was reduced by 36% and 14%, respectively, compared with inactivity, researchers found. 

Participating in strength training exercises (vs not) was associated with a reduced risk for all-cause death of 19% in women and 11% men and reductions in cardiovascular death of 30% and 11%, respectively.

“Women have historically and statistically lagged behind men in engaging in meaningful exercise,” co–lead author Martha Gulati, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement. “The beauty of this study is learning that women can get more out of each minute of moderate to vigorous activity than men do. It’s an incentivizing notion that we hope women will take to heart.”

The study was published online February 19 in the Journal of the American College of Cardiology
 

Sex-Specific Exercise Advice? 

The findings are based on leisure-time physical activity data collected over roughly 20 years via the National Health Interview Survey for 412,413 US adults aged 27-61 years. During roughly 4.9 million person-years of follow-up, there were 39,935 all-cause deaths and 11,670 cardiovascular deaths.

Both men and women achieved a peak survival benefit at 300 minutes of weekly moderate to vigorous aerobic physical activity. But the mortality reduction was substantially greater in women than in men for the same amount of regular exercise (24% vs 18%). 

Similarly, for any given dose of physical activity leading up to 300 minutes per week, women derived proportionately greater survival benefits than did men, the authors reported. 

“Importantly, the greater magnitude of physical activity-related survival benefit in women than men was consistently found across varied measures and types of physical activity including frequency, duration per session, and intensity of aerobic physical activity, as well as frequency of muscle strengthening activities,” they wrote. 

They say multiple factors, including variations in anatomy and physiology, may account for the differences in outcomes between men and women. For example, compared with men, women may use more respiratory, metabolic, and strength demands to conduct the same movement and in turn, reap greater health benefits.

The study also showed only 33% of women and 43% of men regularly engaged in aerobic physical activity, whereas only 20% of women and 28% of men completed a weekly strength training session.

“We hope this study will help everyone, especially women, understand they are poised to gain tremendous benefits from exercise,” senior author Susan Cheng, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement.

In an accompanying editorial, Wael A. Jaber, MD, and Erika Hutt, MD, from Cleveland Clinic Ohio, wrote that this analysis “brings us one step farther in gaining insights into the role and influence of physiological responses to exercise with a sex-specific lens.” 

The study is “well designed and adds important information to the body of literature that can potentially close the gender gap and optimize sex-specific physical activity recommendations by policy makers and societal guidelines,” they wrote. 

“This study emphasizes that there is no singular approach for exercise. A person’s physical activity needs and goals may change based on their age, health status, and schedule — but the value of any type of exercise is irrefutable,” Eric J. Shiroma, ScD, with the National Heart, Lung, and Blood Institute, said in a statement. 

The study was supported in part by grants from the National Institutes of Health. The authors and editorial writers have declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

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Women may gain greater health benefits from regular physical activity at equivalent or lower doses of activity, compared with men, according to data from more than 400,000 US adults. 

Over two decades, with any regular physical activity, all-cause mortality risk was reduced by 24% in women vs 15% in men, and cardiovascular mortality risk was reduced by 36% and 14%, respectively, compared with inactivity, researchers found. 

Participating in strength training exercises (vs not) was associated with a reduced risk for all-cause death of 19% in women and 11% men and reductions in cardiovascular death of 30% and 11%, respectively.

“Women have historically and statistically lagged behind men in engaging in meaningful exercise,” co–lead author Martha Gulati, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement. “The beauty of this study is learning that women can get more out of each minute of moderate to vigorous activity than men do. It’s an incentivizing notion that we hope women will take to heart.”

The study was published online February 19 in the Journal of the American College of Cardiology
 

Sex-Specific Exercise Advice? 

The findings are based on leisure-time physical activity data collected over roughly 20 years via the National Health Interview Survey for 412,413 US adults aged 27-61 years. During roughly 4.9 million person-years of follow-up, there were 39,935 all-cause deaths and 11,670 cardiovascular deaths.

Both men and women achieved a peak survival benefit at 300 minutes of weekly moderate to vigorous aerobic physical activity. But the mortality reduction was substantially greater in women than in men for the same amount of regular exercise (24% vs 18%). 

Similarly, for any given dose of physical activity leading up to 300 minutes per week, women derived proportionately greater survival benefits than did men, the authors reported. 

“Importantly, the greater magnitude of physical activity-related survival benefit in women than men was consistently found across varied measures and types of physical activity including frequency, duration per session, and intensity of aerobic physical activity, as well as frequency of muscle strengthening activities,” they wrote. 

They say multiple factors, including variations in anatomy and physiology, may account for the differences in outcomes between men and women. For example, compared with men, women may use more respiratory, metabolic, and strength demands to conduct the same movement and in turn, reap greater health benefits.

The study also showed only 33% of women and 43% of men regularly engaged in aerobic physical activity, whereas only 20% of women and 28% of men completed a weekly strength training session.

“We hope this study will help everyone, especially women, understand they are poised to gain tremendous benefits from exercise,” senior author Susan Cheng, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement.

In an accompanying editorial, Wael A. Jaber, MD, and Erika Hutt, MD, from Cleveland Clinic Ohio, wrote that this analysis “brings us one step farther in gaining insights into the role and influence of physiological responses to exercise with a sex-specific lens.” 

The study is “well designed and adds important information to the body of literature that can potentially close the gender gap and optimize sex-specific physical activity recommendations by policy makers and societal guidelines,” they wrote. 

“This study emphasizes that there is no singular approach for exercise. A person’s physical activity needs and goals may change based on their age, health status, and schedule — but the value of any type of exercise is irrefutable,” Eric J. Shiroma, ScD, with the National Heart, Lung, and Blood Institute, said in a statement. 

The study was supported in part by grants from the National Institutes of Health. The authors and editorial writers have declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

Women may gain greater health benefits from regular physical activity at equivalent or lower doses of activity, compared with men, according to data from more than 400,000 US adults. 

Over two decades, with any regular physical activity, all-cause mortality risk was reduced by 24% in women vs 15% in men, and cardiovascular mortality risk was reduced by 36% and 14%, respectively, compared with inactivity, researchers found. 

Participating in strength training exercises (vs not) was associated with a reduced risk for all-cause death of 19% in women and 11% men and reductions in cardiovascular death of 30% and 11%, respectively.

“Women have historically and statistically lagged behind men in engaging in meaningful exercise,” co–lead author Martha Gulati, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement. “The beauty of this study is learning that women can get more out of each minute of moderate to vigorous activity than men do. It’s an incentivizing notion that we hope women will take to heart.”

The study was published online February 19 in the Journal of the American College of Cardiology
 

Sex-Specific Exercise Advice? 

The findings are based on leisure-time physical activity data collected over roughly 20 years via the National Health Interview Survey for 412,413 US adults aged 27-61 years. During roughly 4.9 million person-years of follow-up, there were 39,935 all-cause deaths and 11,670 cardiovascular deaths.

Both men and women achieved a peak survival benefit at 300 minutes of weekly moderate to vigorous aerobic physical activity. But the mortality reduction was substantially greater in women than in men for the same amount of regular exercise (24% vs 18%). 

Similarly, for any given dose of physical activity leading up to 300 minutes per week, women derived proportionately greater survival benefits than did men, the authors reported. 

“Importantly, the greater magnitude of physical activity-related survival benefit in women than men was consistently found across varied measures and types of physical activity including frequency, duration per session, and intensity of aerobic physical activity, as well as frequency of muscle strengthening activities,” they wrote. 

They say multiple factors, including variations in anatomy and physiology, may account for the differences in outcomes between men and women. For example, compared with men, women may use more respiratory, metabolic, and strength demands to conduct the same movement and in turn, reap greater health benefits.

The study also showed only 33% of women and 43% of men regularly engaged in aerobic physical activity, whereas only 20% of women and 28% of men completed a weekly strength training session.

“We hope this study will help everyone, especially women, understand they are poised to gain tremendous benefits from exercise,” senior author Susan Cheng, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement.

In an accompanying editorial, Wael A. Jaber, MD, and Erika Hutt, MD, from Cleveland Clinic Ohio, wrote that this analysis “brings us one step farther in gaining insights into the role and influence of physiological responses to exercise with a sex-specific lens.” 

The study is “well designed and adds important information to the body of literature that can potentially close the gender gap and optimize sex-specific physical activity recommendations by policy makers and societal guidelines,” they wrote. 

“This study emphasizes that there is no singular approach for exercise. A person’s physical activity needs and goals may change based on their age, health status, and schedule — but the value of any type of exercise is irrefutable,” Eric J. Shiroma, ScD, with the National Heart, Lung, and Blood Institute, said in a statement. 

The study was supported in part by grants from the National Institutes of Health. The authors and editorial writers have declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

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Bariatric Surgery Yields Significant Cognitive Benefits

Article Type
Changed
Wed, 02/21/2024 - 09:54

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s diseaseAlzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

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Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s diseaseAlzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s diseaseAlzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

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Is ChatGPT Reliable for CRC Screening/Surveillance Advice?

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Wed, 02/21/2024 - 11:42

 

TOPLINE:

ChatGPT (version 3.5) provides relatively poor and inconsistent responses when asked about appropriate colorectal cancer (CRC) screening and surveillance, a new study showed.

METHODOLOGY:

  • Three board-certified gastroenterologists with 10+ years of clinical experience developed five CRC screening and five CRC surveillance clinical vignettes (with multiple choice answers), which were fed to ChatGPT version 3.5.
  • ChatGPT’s responses were recorded over four separate sessions and screened for accuracy to determine reliability of the tool.
  • The average number of correct answers was compared to that of 238 gastroenterologists and colorectal surgeons answering the same questions with and without the help of a previously validated CRC screening mobile app.

TAKEAWAY:

  • ChatGPT’s average overall performance was 45%; the average number of correct answers was 2.75 for screening and 1.75 for surveillance.
  • ChatGPT’s responses were inconsistent in a large proportion of questions; the tool gave a different answer in four questions among the different sessions.
  • The average number of total correct answers of ChatGPT was significantly lower (P < .001) than that of physicians with and without the mobile app (7.71 and 5.62 correct answers, respectively).

IN PRACTICE:

“The use of validated mobile apps with decision-making algorithms could serve as more reliable assistants until large language models developed with AI are further refined,” the authors concluded.

SOURCE:

The study, with first author Lisandro Pereyra, MD, Department of Gastroenterology, Hospital Alemán of Buenos Aires, Argentina, was published online on February 7, 2024, in the Journal of Clinical Gastroenterology.

LIMITATIONS:

The 10 clinical vignettes represented a relatively small sample size to assess accuracy. The study did not use the latest version of ChatGPT. No “fine-tuning” attempts with inputs of diverse prompts, instructions, or relevant data were performed, which could potentially improve the performance of the chatbot.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

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TOPLINE:

ChatGPT (version 3.5) provides relatively poor and inconsistent responses when asked about appropriate colorectal cancer (CRC) screening and surveillance, a new study showed.

METHODOLOGY:

  • Three board-certified gastroenterologists with 10+ years of clinical experience developed five CRC screening and five CRC surveillance clinical vignettes (with multiple choice answers), which were fed to ChatGPT version 3.5.
  • ChatGPT’s responses were recorded over four separate sessions and screened for accuracy to determine reliability of the tool.
  • The average number of correct answers was compared to that of 238 gastroenterologists and colorectal surgeons answering the same questions with and without the help of a previously validated CRC screening mobile app.

TAKEAWAY:

  • ChatGPT’s average overall performance was 45%; the average number of correct answers was 2.75 for screening and 1.75 for surveillance.
  • ChatGPT’s responses were inconsistent in a large proportion of questions; the tool gave a different answer in four questions among the different sessions.
  • The average number of total correct answers of ChatGPT was significantly lower (P < .001) than that of physicians with and without the mobile app (7.71 and 5.62 correct answers, respectively).

IN PRACTICE:

“The use of validated mobile apps with decision-making algorithms could serve as more reliable assistants until large language models developed with AI are further refined,” the authors concluded.

SOURCE:

The study, with first author Lisandro Pereyra, MD, Department of Gastroenterology, Hospital Alemán of Buenos Aires, Argentina, was published online on February 7, 2024, in the Journal of Clinical Gastroenterology.

LIMITATIONS:

The 10 clinical vignettes represented a relatively small sample size to assess accuracy. The study did not use the latest version of ChatGPT. No “fine-tuning” attempts with inputs of diverse prompts, instructions, or relevant data were performed, which could potentially improve the performance of the chatbot.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

 

TOPLINE:

ChatGPT (version 3.5) provides relatively poor and inconsistent responses when asked about appropriate colorectal cancer (CRC) screening and surveillance, a new study showed.

METHODOLOGY:

  • Three board-certified gastroenterologists with 10+ years of clinical experience developed five CRC screening and five CRC surveillance clinical vignettes (with multiple choice answers), which were fed to ChatGPT version 3.5.
  • ChatGPT’s responses were recorded over four separate sessions and screened for accuracy to determine reliability of the tool.
  • The average number of correct answers was compared to that of 238 gastroenterologists and colorectal surgeons answering the same questions with and without the help of a previously validated CRC screening mobile app.

TAKEAWAY:

  • ChatGPT’s average overall performance was 45%; the average number of correct answers was 2.75 for screening and 1.75 for surveillance.
  • ChatGPT’s responses were inconsistent in a large proportion of questions; the tool gave a different answer in four questions among the different sessions.
  • The average number of total correct answers of ChatGPT was significantly lower (P < .001) than that of physicians with and without the mobile app (7.71 and 5.62 correct answers, respectively).

IN PRACTICE:

“The use of validated mobile apps with decision-making algorithms could serve as more reliable assistants until large language models developed with AI are further refined,” the authors concluded.

SOURCE:

The study, with first author Lisandro Pereyra, MD, Department of Gastroenterology, Hospital Alemán of Buenos Aires, Argentina, was published online on February 7, 2024, in the Journal of Clinical Gastroenterology.

LIMITATIONS:

The 10 clinical vignettes represented a relatively small sample size to assess accuracy. The study did not use the latest version of ChatGPT. No “fine-tuning” attempts with inputs of diverse prompts, instructions, or relevant data were performed, which could potentially improve the performance of the chatbot.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

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Parent-Led Digital CBT Effective for Childhood Anxiety

Article Type
Changed
Fri, 02/16/2024 - 13:20

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.

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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.

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Long-Acting Injectable Antipsychotics Reduce Schizophrenia Readmission

Article Type
Changed
Wed, 02/14/2024 - 16:07

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.

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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.

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Salt Substitute Reduces Risk for New Hypertension

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Tue, 02/13/2024 - 13:38

Replacing regular salt with a salt substitute reduced the incidence of new hypertension compared with a usual salt group, without provoking hypotension, new data showed.

Among a group of older adults with normal blood pressure (BP), those who swapped table salt for a salt substitute — consisting of 62.5% sodium chloride, 25% potassium chloride, and 12.5% flavorings — were 40% less apt to develop hypertension over 2 years than were peers who continued with regular salt.

“From a public health perspective, our study results indicate that everyone in the whole population, either hypertensive or normotensive, can benefit from replacing regular salt with potassium-enriched salt substitute,” lead author Yangfeng Wu, MD, PhD, professor and executive associate director, Peking University Clinical Research Institute, Beijing, China, told this news organization.

“Thus, salt substitution should be considered and promoted as a whole-population strategy for prevention and control of hypertension and cardiovascular disease,” Dr. Wu said.

The study was published online on February 12 in the Journal of the American College of Cardiology.

“Considering the failing strategy to reduce the intake of salt worldwide, salt substitution is an attractive alternative. The food industry and authorities should prepare strategies for wide-scale implementation of salt substitutes,” Rik Olde Engberink, MD, PhD, with Amsterdam University Medical Center, wrote in a linked editorial.

Population Strategy for Hypertension Prevention

The DECIDE-Salt clinical trial was a cluster-randomized trial conducted in 48 residential elderly care facilities in China with 1612 participants (1230 men and 382 women) aged 55 years or older. The trial assessed the effect of two sodium reduction strategies in lowering BP — replacing salt with a salt substitute and progressive restriction of the salt supply.

In the original study, the salt substitute intervention lowered systolic/diastolic BP significantly by 7.1/1.9 mm Hg vs the usual salt group. The progressive restriction of salt had no impact on BP vs usual salt or salt substitute groups.

This post hoc analysis of DECIDE-Salt focused on 609 participants (mean age, 71 years; 74% men) who were normotensive at baseline (mean BP, 122/74 mm Hg), with 298 in the usual salt group and 313 in the salt substitute group.

Compared with the usual salt group, the salt substitute group had a lower incidence of hypertension over 2 years (adjusted hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; P = .02), with no increase in episodes of hypotension (P = .76).

From baseline to 2 years, there was no change in mean systolic/diastolic BP in the salt substitution group, whereas the usual salt group experienced a significant increase in systolic/diastolic BP (mean, 7.0/2.1 mm Hg).

The post hoc results from DECIDE-Salt are in line with a previous study from Peru, which also investigated mostly normotensive participants and reported a 51% lower risk of developing hypertension in the salt substitute group, as reported previously by this news organization.

“Although the study involved only participants aged 55 years and above, the epidemic of hypertension and its relations with sodium and potassium intake are not limited to older adults. Thus, we believe the salt substitution should also be beneficial to younger adults,” Dr. Wu said.

Notable Analysis

Reached for comment, Ankur Shah, MD, Division of Kidney Disease and Hypertension, Warren Alpert Medical School of Brown University, Providence, Rhode Island, said the study is “notable due to the limited and conflicting reports on the effects of salt substitution in individuals with normal blood pressure.”

“There is a growing body of literature on the impact of salt substitution in controlling hypertension, but less is known about prevention,” Dr. Shah, who was not involved in the study, told this news organization.

“The study certainly has population-level implications, as the design of a cluster-randomized trial at the facility level makes for a clear path to implementation — sodium substitution in elderly care facilities. That said, this is also the greatest limitation — extrapolating to the general population may not be accurate,” Dr. Shah noted.

There is also a potential concern with salt substitutes in patients with kidney disease, who typically are advised to lower potassium intake.

“Supplementing potassium could result in hyperkalemia, which can be life-threatening if severe, and patients taking medications that interfere with the kidney’s ability to excrete potassium should be cautious as well,” Dr. Shah said.

This research was supported by a grant from the National Key Research and Development Program, Ministry of Science and Technology of China. China Salt General Company at Yulin provided the usual salt and salt substitute used in the study free of charge. Dr. Wu, Dr. Engberink, and Dr. Shah had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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Replacing regular salt with a salt substitute reduced the incidence of new hypertension compared with a usual salt group, without provoking hypotension, new data showed.

Among a group of older adults with normal blood pressure (BP), those who swapped table salt for a salt substitute — consisting of 62.5% sodium chloride, 25% potassium chloride, and 12.5% flavorings — were 40% less apt to develop hypertension over 2 years than were peers who continued with regular salt.

“From a public health perspective, our study results indicate that everyone in the whole population, either hypertensive or normotensive, can benefit from replacing regular salt with potassium-enriched salt substitute,” lead author Yangfeng Wu, MD, PhD, professor and executive associate director, Peking University Clinical Research Institute, Beijing, China, told this news organization.

“Thus, salt substitution should be considered and promoted as a whole-population strategy for prevention and control of hypertension and cardiovascular disease,” Dr. Wu said.

The study was published online on February 12 in the Journal of the American College of Cardiology.

“Considering the failing strategy to reduce the intake of salt worldwide, salt substitution is an attractive alternative. The food industry and authorities should prepare strategies for wide-scale implementation of salt substitutes,” Rik Olde Engberink, MD, PhD, with Amsterdam University Medical Center, wrote in a linked editorial.

Population Strategy for Hypertension Prevention

The DECIDE-Salt clinical trial was a cluster-randomized trial conducted in 48 residential elderly care facilities in China with 1612 participants (1230 men and 382 women) aged 55 years or older. The trial assessed the effect of two sodium reduction strategies in lowering BP — replacing salt with a salt substitute and progressive restriction of the salt supply.

In the original study, the salt substitute intervention lowered systolic/diastolic BP significantly by 7.1/1.9 mm Hg vs the usual salt group. The progressive restriction of salt had no impact on BP vs usual salt or salt substitute groups.

This post hoc analysis of DECIDE-Salt focused on 609 participants (mean age, 71 years; 74% men) who were normotensive at baseline (mean BP, 122/74 mm Hg), with 298 in the usual salt group and 313 in the salt substitute group.

Compared with the usual salt group, the salt substitute group had a lower incidence of hypertension over 2 years (adjusted hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; P = .02), with no increase in episodes of hypotension (P = .76).

From baseline to 2 years, there was no change in mean systolic/diastolic BP in the salt substitution group, whereas the usual salt group experienced a significant increase in systolic/diastolic BP (mean, 7.0/2.1 mm Hg).

The post hoc results from DECIDE-Salt are in line with a previous study from Peru, which also investigated mostly normotensive participants and reported a 51% lower risk of developing hypertension in the salt substitute group, as reported previously by this news organization.

“Although the study involved only participants aged 55 years and above, the epidemic of hypertension and its relations with sodium and potassium intake are not limited to older adults. Thus, we believe the salt substitution should also be beneficial to younger adults,” Dr. Wu said.

Notable Analysis

Reached for comment, Ankur Shah, MD, Division of Kidney Disease and Hypertension, Warren Alpert Medical School of Brown University, Providence, Rhode Island, said the study is “notable due to the limited and conflicting reports on the effects of salt substitution in individuals with normal blood pressure.”

“There is a growing body of literature on the impact of salt substitution in controlling hypertension, but less is known about prevention,” Dr. Shah, who was not involved in the study, told this news organization.

“The study certainly has population-level implications, as the design of a cluster-randomized trial at the facility level makes for a clear path to implementation — sodium substitution in elderly care facilities. That said, this is also the greatest limitation — extrapolating to the general population may not be accurate,” Dr. Shah noted.

There is also a potential concern with salt substitutes in patients with kidney disease, who typically are advised to lower potassium intake.

“Supplementing potassium could result in hyperkalemia, which can be life-threatening if severe, and patients taking medications that interfere with the kidney’s ability to excrete potassium should be cautious as well,” Dr. Shah said.

This research was supported by a grant from the National Key Research and Development Program, Ministry of Science and Technology of China. China Salt General Company at Yulin provided the usual salt and salt substitute used in the study free of charge. Dr. Wu, Dr. Engberink, and Dr. Shah had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Replacing regular salt with a salt substitute reduced the incidence of new hypertension compared with a usual salt group, without provoking hypotension, new data showed.

Among a group of older adults with normal blood pressure (BP), those who swapped table salt for a salt substitute — consisting of 62.5% sodium chloride, 25% potassium chloride, and 12.5% flavorings — were 40% less apt to develop hypertension over 2 years than were peers who continued with regular salt.

“From a public health perspective, our study results indicate that everyone in the whole population, either hypertensive or normotensive, can benefit from replacing regular salt with potassium-enriched salt substitute,” lead author Yangfeng Wu, MD, PhD, professor and executive associate director, Peking University Clinical Research Institute, Beijing, China, told this news organization.

“Thus, salt substitution should be considered and promoted as a whole-population strategy for prevention and control of hypertension and cardiovascular disease,” Dr. Wu said.

The study was published online on February 12 in the Journal of the American College of Cardiology.

“Considering the failing strategy to reduce the intake of salt worldwide, salt substitution is an attractive alternative. The food industry and authorities should prepare strategies for wide-scale implementation of salt substitutes,” Rik Olde Engberink, MD, PhD, with Amsterdam University Medical Center, wrote in a linked editorial.

Population Strategy for Hypertension Prevention

The DECIDE-Salt clinical trial was a cluster-randomized trial conducted in 48 residential elderly care facilities in China with 1612 participants (1230 men and 382 women) aged 55 years or older. The trial assessed the effect of two sodium reduction strategies in lowering BP — replacing salt with a salt substitute and progressive restriction of the salt supply.

In the original study, the salt substitute intervention lowered systolic/diastolic BP significantly by 7.1/1.9 mm Hg vs the usual salt group. The progressive restriction of salt had no impact on BP vs usual salt or salt substitute groups.

This post hoc analysis of DECIDE-Salt focused on 609 participants (mean age, 71 years; 74% men) who were normotensive at baseline (mean BP, 122/74 mm Hg), with 298 in the usual salt group and 313 in the salt substitute group.

Compared with the usual salt group, the salt substitute group had a lower incidence of hypertension over 2 years (adjusted hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; P = .02), with no increase in episodes of hypotension (P = .76).

From baseline to 2 years, there was no change in mean systolic/diastolic BP in the salt substitution group, whereas the usual salt group experienced a significant increase in systolic/diastolic BP (mean, 7.0/2.1 mm Hg).

The post hoc results from DECIDE-Salt are in line with a previous study from Peru, which also investigated mostly normotensive participants and reported a 51% lower risk of developing hypertension in the salt substitute group, as reported previously by this news organization.

“Although the study involved only participants aged 55 years and above, the epidemic of hypertension and its relations with sodium and potassium intake are not limited to older adults. Thus, we believe the salt substitution should also be beneficial to younger adults,” Dr. Wu said.

Notable Analysis

Reached for comment, Ankur Shah, MD, Division of Kidney Disease and Hypertension, Warren Alpert Medical School of Brown University, Providence, Rhode Island, said the study is “notable due to the limited and conflicting reports on the effects of salt substitution in individuals with normal blood pressure.”

“There is a growing body of literature on the impact of salt substitution in controlling hypertension, but less is known about prevention,” Dr. Shah, who was not involved in the study, told this news organization.

“The study certainly has population-level implications, as the design of a cluster-randomized trial at the facility level makes for a clear path to implementation — sodium substitution in elderly care facilities. That said, this is also the greatest limitation — extrapolating to the general population may not be accurate,” Dr. Shah noted.

There is also a potential concern with salt substitutes in patients with kidney disease, who typically are advised to lower potassium intake.

“Supplementing potassium could result in hyperkalemia, which can be life-threatening if severe, and patients taking medications that interfere with the kidney’s ability to excrete potassium should be cautious as well,” Dr. Shah said.

This research was supported by a grant from the National Key Research and Development Program, Ministry of Science and Technology of China. China Salt General Company at Yulin provided the usual salt and salt substitute used in the study free of charge. Dr. Wu, Dr. Engberink, and Dr. Shah had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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SARS-CoV-2 a Possible Trigger for Achalasia

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Changed
Tue, 02/13/2024 - 13:04

 

TOPLINE:

New evidence suggests that SARS-CoV-2 infection can lead to the rapid development of achalasia, a rare esophageal motility disorder.

METHODOLOGY:

  • The etiology of achalasia is unclear. Studies have suggested an immune reaction to viral infections, including SARS-CoV-2, as a potential cause.
  • Researchers studied four adults who developed achalasia within 5 months of SARS-CoV-2 infection (group 1), six with longstanding achalasia predating SARS-CoV-2 infection (group 2), and two with longstanding achalasia with no known SARS-CoV-2 infection (group 3).
  • They tested for the presence of SARS-CoV-2 nucleocapsid (N) and spike (S) proteins, as well as inflammatory markers, in esophageal muscle tissue isolated from the participants.

TAKEAWAY:

  • Group 1 patients (confirmed or suspected post–COVID-19 achalasia) had the highest levels of the N protein in all four cases and higher levels of the S protein in the two confirmed cases. No N or S protein was detected in group 3.
  • The presence of mRNA for SARS-CoV-2 N protein correlated with a significant increase in the inflammatory markers of NOD-like receptor family pyrin domain-containing 3 and tumor necrosis factor. There were no differences in interleukin 18 in groups 1 and 2.
  • The S protein was detected in all muscle tissue samples from group 1. It was also detected in some (but not all) samples from group 2 and to a much lesser degree. The presence of S protein was irrespective of the SARS-CoV-2 vaccination status.

IN PRACTICE:

“Our findings not only show the continued presence of SARS-CoV-2 proteins in esophageal muscle tissue isolated from subjects with achalasia post infection, but they further correlate this with the presence of a sustained inflammatory response,” the authors wrote.

SOURCE:

The study, with first author Salih Samo, MD, MS, Division of Gastroenterology, Hepatology, and Motility, University of Kansas School of Medicine, Kansas City, Kansas, was published online on January 24, 2024, in the American Journal of Gastroenterology.

LIMITATIONS:

The sample size was small, and it was not known which SARS-CoV-2 variant each patient had. The study cannot definitively confirm that SARS-CoV-2 is causative for achalasia.

DISCLOSURES:

The study had no specific funding. Samo reported relationships with Castle Biosciences, Sanofi, Evoke, and EndoGastric Solutions.

A version of this article appeared on Medscape.com.

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TOPLINE:

New evidence suggests that SARS-CoV-2 infection can lead to the rapid development of achalasia, a rare esophageal motility disorder.

METHODOLOGY:

  • The etiology of achalasia is unclear. Studies have suggested an immune reaction to viral infections, including SARS-CoV-2, as a potential cause.
  • Researchers studied four adults who developed achalasia within 5 months of SARS-CoV-2 infection (group 1), six with longstanding achalasia predating SARS-CoV-2 infection (group 2), and two with longstanding achalasia with no known SARS-CoV-2 infection (group 3).
  • They tested for the presence of SARS-CoV-2 nucleocapsid (N) and spike (S) proteins, as well as inflammatory markers, in esophageal muscle tissue isolated from the participants.

TAKEAWAY:

  • Group 1 patients (confirmed or suspected post–COVID-19 achalasia) had the highest levels of the N protein in all four cases and higher levels of the S protein in the two confirmed cases. No N or S protein was detected in group 3.
  • The presence of mRNA for SARS-CoV-2 N protein correlated with a significant increase in the inflammatory markers of NOD-like receptor family pyrin domain-containing 3 and tumor necrosis factor. There were no differences in interleukin 18 in groups 1 and 2.
  • The S protein was detected in all muscle tissue samples from group 1. It was also detected in some (but not all) samples from group 2 and to a much lesser degree. The presence of S protein was irrespective of the SARS-CoV-2 vaccination status.

IN PRACTICE:

“Our findings not only show the continued presence of SARS-CoV-2 proteins in esophageal muscle tissue isolated from subjects with achalasia post infection, but they further correlate this with the presence of a sustained inflammatory response,” the authors wrote.

SOURCE:

The study, with first author Salih Samo, MD, MS, Division of Gastroenterology, Hepatology, and Motility, University of Kansas School of Medicine, Kansas City, Kansas, was published online on January 24, 2024, in the American Journal of Gastroenterology.

LIMITATIONS:

The sample size was small, and it was not known which SARS-CoV-2 variant each patient had. The study cannot definitively confirm that SARS-CoV-2 is causative for achalasia.

DISCLOSURES:

The study had no specific funding. Samo reported relationships with Castle Biosciences, Sanofi, Evoke, and EndoGastric Solutions.

A version of this article appeared on Medscape.com.

 

TOPLINE:

New evidence suggests that SARS-CoV-2 infection can lead to the rapid development of achalasia, a rare esophageal motility disorder.

METHODOLOGY:

  • The etiology of achalasia is unclear. Studies have suggested an immune reaction to viral infections, including SARS-CoV-2, as a potential cause.
  • Researchers studied four adults who developed achalasia within 5 months of SARS-CoV-2 infection (group 1), six with longstanding achalasia predating SARS-CoV-2 infection (group 2), and two with longstanding achalasia with no known SARS-CoV-2 infection (group 3).
  • They tested for the presence of SARS-CoV-2 nucleocapsid (N) and spike (S) proteins, as well as inflammatory markers, in esophageal muscle tissue isolated from the participants.

TAKEAWAY:

  • Group 1 patients (confirmed or suspected post–COVID-19 achalasia) had the highest levels of the N protein in all four cases and higher levels of the S protein in the two confirmed cases. No N or S protein was detected in group 3.
  • The presence of mRNA for SARS-CoV-2 N protein correlated with a significant increase in the inflammatory markers of NOD-like receptor family pyrin domain-containing 3 and tumor necrosis factor. There were no differences in interleukin 18 in groups 1 and 2.
  • The S protein was detected in all muscle tissue samples from group 1. It was also detected in some (but not all) samples from group 2 and to a much lesser degree. The presence of S protein was irrespective of the SARS-CoV-2 vaccination status.

IN PRACTICE:

“Our findings not only show the continued presence of SARS-CoV-2 proteins in esophageal muscle tissue isolated from subjects with achalasia post infection, but they further correlate this with the presence of a sustained inflammatory response,” the authors wrote.

SOURCE:

The study, with first author Salih Samo, MD, MS, Division of Gastroenterology, Hepatology, and Motility, University of Kansas School of Medicine, Kansas City, Kansas, was published online on January 24, 2024, in the American Journal of Gastroenterology.

LIMITATIONS:

The sample size was small, and it was not known which SARS-CoV-2 variant each patient had. The study cannot definitively confirm that SARS-CoV-2 is causative for achalasia.

DISCLOSURES:

The study had no specific funding. Samo reported relationships with Castle Biosciences, Sanofi, Evoke, and EndoGastric Solutions.

A version of this article appeared on Medscape.com.

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Can Iron Supplementation Protect Against Celiac Disease?

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Changed
Tue, 02/13/2024 - 12:47

 

TOPLINE:

Genetically lower iron levels were associated with an increased risk for celiac disease, pointing to a potential opportunity to prevent the disease, new data suggested.

METHODOLOGY:

  • Iron deficiency, which is common in celiac disease, has been proposed as an environmental trigger for the disease that has been growing in prevalence. 
  • To investigate, researchers conducted a Mendelian randomization study examining the relationship between single nucleotide polymorphisms (SNPs) associated with iron status and the presence of celiac disease. 
  • SNPs were drawn from a meta-analysis of three genome-wide association studies. Their association with celiac disease was assessed using data from 336,638 White UK Biobank participants, including 1855 with celiac disease. 

TAKEAWAY:

  • Four SNPs were strongly and independently associated with systemic iron status: rs1800562 and rs1799945 in the hemochromatosis gene, rs855791 in the transmembrane protease serine 6 gene, and rs57659670 predicted to affect the Dual Oxidase 2 gene. None were associated with known celiac disease risk factors. 
  • Higher iron status was negatively associated with celiac disease risk (odds ratio per 1 SD increase in serum iron: 0.65). 
  • No single SNP appeared to drive the association in sensitivity analyses. 
  • By relying on SNPs associated with iron status, and not on iron status itself, this Mendelian randomization analysis suggests a causal effect of iron deficiency on subsequent celiac disease development. 

IN PRACTICE:

“These findings suggest that iron supplementation in select individuals may provide a potential protective effect against celiac disease development,” the authors wrote.

SOURCE:

The study, with first author Isabel A. Hujoel, MD, a gastroenterologist with University of Washington, Seattle, was published online on January 4, 2024, in BMJ Open Gastroenterology.

LIMITATIONS:

Researchers used a PheCode to identify celiac disease cases, which could lead to misclassification. Mendelian randomization provides some protection against biases, such as reverse causation, but is not completely invulnerable.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

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TOPLINE:

Genetically lower iron levels were associated with an increased risk for celiac disease, pointing to a potential opportunity to prevent the disease, new data suggested.

METHODOLOGY:

  • Iron deficiency, which is common in celiac disease, has been proposed as an environmental trigger for the disease that has been growing in prevalence. 
  • To investigate, researchers conducted a Mendelian randomization study examining the relationship between single nucleotide polymorphisms (SNPs) associated with iron status and the presence of celiac disease. 
  • SNPs were drawn from a meta-analysis of three genome-wide association studies. Their association with celiac disease was assessed using data from 336,638 White UK Biobank participants, including 1855 with celiac disease. 

TAKEAWAY:

  • Four SNPs were strongly and independently associated with systemic iron status: rs1800562 and rs1799945 in the hemochromatosis gene, rs855791 in the transmembrane protease serine 6 gene, and rs57659670 predicted to affect the Dual Oxidase 2 gene. None were associated with known celiac disease risk factors. 
  • Higher iron status was negatively associated with celiac disease risk (odds ratio per 1 SD increase in serum iron: 0.65). 
  • No single SNP appeared to drive the association in sensitivity analyses. 
  • By relying on SNPs associated with iron status, and not on iron status itself, this Mendelian randomization analysis suggests a causal effect of iron deficiency on subsequent celiac disease development. 

IN PRACTICE:

“These findings suggest that iron supplementation in select individuals may provide a potential protective effect against celiac disease development,” the authors wrote.

SOURCE:

The study, with first author Isabel A. Hujoel, MD, a gastroenterologist with University of Washington, Seattle, was published online on January 4, 2024, in BMJ Open Gastroenterology.

LIMITATIONS:

Researchers used a PheCode to identify celiac disease cases, which could lead to misclassification. Mendelian randomization provides some protection against biases, such as reverse causation, but is not completely invulnerable.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

 

TOPLINE:

Genetically lower iron levels were associated with an increased risk for celiac disease, pointing to a potential opportunity to prevent the disease, new data suggested.

METHODOLOGY:

  • Iron deficiency, which is common in celiac disease, has been proposed as an environmental trigger for the disease that has been growing in prevalence. 
  • To investigate, researchers conducted a Mendelian randomization study examining the relationship between single nucleotide polymorphisms (SNPs) associated with iron status and the presence of celiac disease. 
  • SNPs were drawn from a meta-analysis of three genome-wide association studies. Their association with celiac disease was assessed using data from 336,638 White UK Biobank participants, including 1855 with celiac disease. 

TAKEAWAY:

  • Four SNPs were strongly and independently associated with systemic iron status: rs1800562 and rs1799945 in the hemochromatosis gene, rs855791 in the transmembrane protease serine 6 gene, and rs57659670 predicted to affect the Dual Oxidase 2 gene. None were associated with known celiac disease risk factors. 
  • Higher iron status was negatively associated with celiac disease risk (odds ratio per 1 SD increase in serum iron: 0.65). 
  • No single SNP appeared to drive the association in sensitivity analyses. 
  • By relying on SNPs associated with iron status, and not on iron status itself, this Mendelian randomization analysis suggests a causal effect of iron deficiency on subsequent celiac disease development. 

IN PRACTICE:

“These findings suggest that iron supplementation in select individuals may provide a potential protective effect against celiac disease development,” the authors wrote.

SOURCE:

The study, with first author Isabel A. Hujoel, MD, a gastroenterologist with University of Washington, Seattle, was published online on January 4, 2024, in BMJ Open Gastroenterology.

LIMITATIONS:

Researchers used a PheCode to identify celiac disease cases, which could lead to misclassification. Mendelian randomization provides some protection against biases, such as reverse causation, but is not completely invulnerable.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

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FDA OKs First Oral Agent for Eosinophilic Esophagitis

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Tue, 02/13/2024 - 11:21

The US Food and Drug Administration (FDA) has approved budesonide oral suspension (Eohilia, Takeda), the first oral treatment for eosinophilic esophagitis (EoE). 

Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years. 

It will be available in 2-mg/10-mL single-dose stick packs by the end of February. 

“Developed specifically for EoE, Eohilia’s novel formulation of budesonide confers thixotropic properties — flowing more freely when shaken and returning to a more viscous state when swallowed,” the company said in a news release

Dr. Ikuo Hirano is a professor of medicine, division of gastroenterology, Northwestern University, Chicago.
Northwestern University
Dr. Ikuo Hirano

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” Ikuo Hirano, MD, professor of medicine and director of the Esophageal Center at Northwestern University Feinberg School of Medicine, Chicago, said in the release. 
 

Supporting Data 

The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. 

In study 1, significantly more patients receiving active treatment achieved histologic remission (53.1% vs 1% with placebo). The same was true in study 2, with 38% of patients receiving active treatment achieving histologic remission compared with 2.4% of those receiving placebo. 

The absolute change from baseline in the patient-reported Dysphagia Symptom Questionnaire combined score was -10.2 with budesonide vs -6.5 with placebo in Study 1 and -14.5 vs -5.9 in Study 2. 

During the last 2 weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with those receiving placebo, the company said. 

The most common adverse reactions seen in the clinical trials of budesonide oral suspension for EoE included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). 

Complete prescribing information is available on the FDA website.

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has approved budesonide oral suspension (Eohilia, Takeda), the first oral treatment for eosinophilic esophagitis (EoE). 

Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years. 

It will be available in 2-mg/10-mL single-dose stick packs by the end of February. 

“Developed specifically for EoE, Eohilia’s novel formulation of budesonide confers thixotropic properties — flowing more freely when shaken and returning to a more viscous state when swallowed,” the company said in a news release

Dr. Ikuo Hirano is a professor of medicine, division of gastroenterology, Northwestern University, Chicago.
Northwestern University
Dr. Ikuo Hirano

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” Ikuo Hirano, MD, professor of medicine and director of the Esophageal Center at Northwestern University Feinberg School of Medicine, Chicago, said in the release. 
 

Supporting Data 

The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. 

In study 1, significantly more patients receiving active treatment achieved histologic remission (53.1% vs 1% with placebo). The same was true in study 2, with 38% of patients receiving active treatment achieving histologic remission compared with 2.4% of those receiving placebo. 

The absolute change from baseline in the patient-reported Dysphagia Symptom Questionnaire combined score was -10.2 with budesonide vs -6.5 with placebo in Study 1 and -14.5 vs -5.9 in Study 2. 

During the last 2 weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with those receiving placebo, the company said. 

The most common adverse reactions seen in the clinical trials of budesonide oral suspension for EoE included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). 

Complete prescribing information is available on the FDA website.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved budesonide oral suspension (Eohilia, Takeda), the first oral treatment for eosinophilic esophagitis (EoE). 

Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years. 

It will be available in 2-mg/10-mL single-dose stick packs by the end of February. 

“Developed specifically for EoE, Eohilia’s novel formulation of budesonide confers thixotropic properties — flowing more freely when shaken and returning to a more viscous state when swallowed,” the company said in a news release

Dr. Ikuo Hirano is a professor of medicine, division of gastroenterology, Northwestern University, Chicago.
Northwestern University
Dr. Ikuo Hirano

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” Ikuo Hirano, MD, professor of medicine and director of the Esophageal Center at Northwestern University Feinberg School of Medicine, Chicago, said in the release. 
 

Supporting Data 

The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. 

In study 1, significantly more patients receiving active treatment achieved histologic remission (53.1% vs 1% with placebo). The same was true in study 2, with 38% of patients receiving active treatment achieving histologic remission compared with 2.4% of those receiving placebo. 

The absolute change from baseline in the patient-reported Dysphagia Symptom Questionnaire combined score was -10.2 with budesonide vs -6.5 with placebo in Study 1 and -14.5 vs -5.9 in Study 2. 

During the last 2 weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with those receiving placebo, the company said. 

The most common adverse reactions seen in the clinical trials of budesonide oral suspension for EoE included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). 

Complete prescribing information is available on the FDA website.

A version of this article appeared on Medscape.com.

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